verifying haccp regulatory requirements · haccp for raw processes – regulatory process 3/8/2012...

HACCP for Raw Processes – Regulatory Process 3/8/2012

FSRE/PHIS 1

VERIFYING HACCP REGULATORY REQUIREMENTS

Objectives

After completion of this unit, the participant will be able to:

1. Describe the two components used when performing the HACCP verification tasks.

2. Identify the regulatory requirements verified with the HAV task.

3. Apply the HAV methodology to the review of each hazard analysis for all products produced by an establishment.

4. Identify issues that represent noncompliance with an establishment‘s hazard analysis and supporting documentation.

5. Identify the types of issues or concerns that are to be discussed with a supervisor before determining compliance and completing the HAV task.

6. Identify the regulatory requirements verified with the HACCP verification task.

7. Explain how CSIs are to perform the HACCP verification task.

8. Identify issues that represent noncompliance with an establishment‘s HACCP plan and inadequacy of the HACCP system.

9. Identify the type of issues or concerns that are to be discussed with supervision

before determining compliance and completing the HACCP verification task.

Introduction An establishment‘s food safety system consists of the HACCP plans, a Sanitation SOP and other programs, measures, and procedures that it implements to prevent, eliminate, or otherwise control identified food safety hazards in the products it produces. IPP apply the mark of inspection to products when they are able to find that the products are not adulterated. A fundamental step in producing products that are not adulterated is to produce the product in accordance with the elements of a valid HACCP system. The HACCP system, referenced in 9 CFR 417.4, is defined in 9 CFR 417.1 as ―the HACCP plan in operation, including the HACCP plan itself‖. The HACCP plan in operation includes the:

hazard analysis,

HACCP plan

supporting documentation including prerequisite programs used to make decisions in the hazard analysis, and

HACCP records generated on an ongoing basis. IPP must focus on the overall effectiveness of the establishment‘s HACCP system. Hands-on sensory inspection to determine whether individual product units are wholesome is important but is not the best method of assessing the ongoing


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effectiveness of the establishment‘s HACCP system. Sensory inspection may not identify all products that may be unsafe or unwholesome. By verifying that an establishment is implementing an effective HACCP system, FSIS can best ensure that the establishment is producing wholesome, unadulterated products. In this section, we will focus on how CSIs verify the compliance of the establishment‘s food safety system with the HACCP regulatory requirements of 9 CFR Part 417. We will cover the regulatory process for HACCP verification tasks in raw processes by following the blocks as depicted by the diagram on page 3. There are four main processes that we will cover.

Methodology

Decision-making

Documentation

Enforcement

FSIS Responsibilities FSIS responsibilities are outlined in FSIS PHIS Directive 5000.1. You are responsible for understanding and properly performing the HACCP verification tasks in the Public Health Information System (PHIS) as described in this Directive. The information in the Directive follows the regulatory process. The Directive is the foundation for the remainder of this training. CSIs verify HACCP regulatory requirements by performing the HACCP verification tasks that appear on the establishment‘s task list. The HACCP verification tasks appear on the establishment‘s inspection task list as routine tasks according to the specific HACCP process categories (listed in 9 CFR 417.2(b)) entered in the establishment profile in PHIS. CSIs may initiate directed HACCP verification tasks when they observe HACCP noncompliance or are instructed to do so by their supervisor. Example: If an establishment slaughters, fabricates and grinds meat, there will be HACCP verification tasks for the raw HACCP category of Slaughter, Raw Intact, and Raw Non-Intact on the task list. Each task in PHIS directs CSIs to the applicable policy documents and provides instructions to help them understand how to verify HACCP requirements for the particular HACCP process or product type.


FSRE/PHIS 3

Regulatory Process for HACCP Verification Tasks in Raw HACCP Processes Categories

5. Inadequate

System?

Methodology Decision-making

3. Noncompliance

Found?

6. Complete NR

Yes

No

Yes

Documentation

7. Complete NR

Enforcement

1. Perform

HAV Task

4. Stop

8. Follow

ROP

9. Notify District Office

10. District Office will determine

appropriate enforcement action based on the ROP No

2. Perform HACCP

verification Task


FSRE/PHIS 4

The Regulatory Thought Process When CSIs perform HACCP verification tasks, they need to use the regulatory thought process described below. CSIs are to gather all available information to help them determine regulatory compliance by:

Reviewing establishment hazard analyzes, HACCP plans, prerequisite programs and other supporting documentation

Reviewing establishment records documenting the implementation of HACCP plans, prerequisite programs and other supporting programs or procedures

Observing establishment employees implementing each HACCP plan, prerequisite program or other supporting program or procedure, and

Observe product and occasionally take measurements as specified in the establishment HACCP plans, prerequisite programs, or other supporting programs or procedures.

Note: 9 CFR 417.5(f) requires that all records required under Part 417 be available for official review by FSIS inspection personnel. CSIs are to contact their supervisor if an establishment refuses to make necessary records available for review. CSIs are to assess the significance and meaning of information gathered by:

Comparing the information gathered to HACCP regulatory requirements

Considering what each piece of information, either taken separately or with other findings, says about how the HACCP system is functioning to ensure that products are not adulterated

Considering the information in the context of past findings to identify any patterns or trends, e.g., Is this an isolated or recurring problem? Are conditions getting worse? Is the establishment responding effectively and in a timely manner to problems?

CSIs are to determine whether the information supports a finding of regulatory compliance by considering the following questions:

Is there an insanitary condition?

Has adulterated product been produced or shipped?

Is the HACCP system effectively controlling the relevant food safety hazards?

Has the establishment failed to meet one or more HACCP regulatory requirements?


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Note: If CSIs are uncertain whether the information supports a particular compliance determination, they are to discuss the issue with their supervisor. Once a sound determination has been made, CSIs are to document their determination in accordance with FSIS PHIS 5000.1. While any issue of noncompliance is important and must be properly documented, the purpose of the HACCP verification tasks is more than just to identify isolated instances of noncompliance. CSIs must also consider what their findings; whether positive, negative, or inconclusive; suggest about the overall effectiveness of the establishment‘s HACCP system. When CSIs have concerns about the ability of the establishment‘s HACCP system to produce safe products, they are to discuss those concerns with their supervisor. It is important that CSIs consider each piece of information in the context of the HACCP system and the potential for product adulteration. The following questions will help CSIs to consider the significance of each finding for the HACCP system:

Is this piece of information part of a pattern? For example, if the establishment skipped a measurement for a prerequisite program. Is this an isolated incident or does the establishment regularly fail to implement prerequisite programs?

Is there other information to indicate that the HACCP system is working or is not working? For example, an establishment‘s prerequisite program specifies product will be received with supplier certificates of analysis (COA) and periodically tested. If the establishment failed to receive a COA for a particular product, how did they respond on whether or not to use the product?

Does the information seem to agree with the other available information about the food safety system? For example, the establishment uses a prerequisite program to prevent a hazard in incoming products, and the records appear to show that a particular hazard is being prevented. However, the establishment‘s testing of finished product for the particular hazard finds positive results.

Do these results support each other or is there an apparent contradiction? For example, an establishment that uses a prerequisite program to prevent E. coli O157:H7 in incoming beef has certificates of analysis and verification test results on incoming trim that appear to indicate that the hazard is not reasonably likely to occur, but the establishment gets a positive test result on a finished product lot. The finished product test result calls into question the effectiveness of the prerequisite program as means of supporting the decision that E. coli O157:H7 is not reasonably likely to occur.


FSRE/PHIS 6

HACCP Verification Tasks (Blocks 1 and 2 on page 3) CSIs perform two HACCP tasks to verify that establishments are complying with 9 CFR Part 417. The Hazard Analysis Verification (HAV) task directs the CSI to review the establishment‘s hazard analyses, HACCP plans, prerequisite programs, and other supporting

documentation. The HACCP verification task focuses the attention of the CSI on the execution or implementation of the establishment‘s HACCP plans, prerequisite programs and other supporting programs, i.e., implementation of the establishment‘s HACCP system. CSIs perform a HACCP verification task for each of the HACCP process categories listed in the establishment‘s profile. Both of the HACCP verification tasks can be performed as a routine or directed task. Each HACCP task has two components:

A recordkeeping component, and

A review and observation component CSIs use either component or a combination of the components to verify regulatory compliance. For example, a CSI may decide to review monitoring records at one CCP and take a measurement, or observe the establishment taking a measurement at another CCP to verify that the monitoring requirement is met. Similarly, a CSI may observe something while reviewing monitoring records for a CCP that prompts him or her to perform a review or observation at that CCP.

How to Perform the Two Components Recordkeeping Component To perform the recordkeeping (Rk) component, the CSI will gather information by reviewing establishment records associated with the HACCP system. Depending on the HACCP verification task, these records might include the hazard analysis, records of any prerequisite or supporting programs, the HACCP plans, or HACCP records that document monitoring, verification, corrective actions, and reassessment activities. For example, the CSI may review HACCP records to determine if the establishment recorded its test results or measurements at the required frequency, if all required data was recorded, if the data is accurate, if critical limits have been met, and if corrective action was taken when necessary. When the CSI performs the recordkeeping component, he or she is only reviewing records. Typically, this review would take place where the records are maintained and may not be at the physical location of the CCP. Regulation 9 CFR 417.5(f) requires the establishment to make all such records available for official review. Some establishments, however, control access to their food safety records. In such situations, the CSI needs to work with the establishment to develop a mechanism to allow him or her access to food safety records within a reasonable time of a request. If the establishment does not provide access to the records needed to perform the verification tasks, the CSI is to document noncompliance with 417.5(f) and bring the matter to the attention of his or her immediate supervisor.

Perform HAV or HACCP

verification task


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Example: The CSI is performing a HACCP verification task and is verifying the monitoring regulatory requirement. He decides to perform the recordkeeping component and reviews the monitoring records generated for the chilling CCP listed in the HACCP plan. He looks at the frequency of the temperature entries and the actual recorded temperature values and then compares the recorded temperatures to the critical limit for this step. Review and Observation Component To perform the review and observation (R&O) component, CSIs are to gather information by directly observing the establishment employees performing procedures or activities as stated in the HACCP plan or prerequisite program (observation), taking measurements to see if the values they obtained match those recorded by the establishment (review), or observing the product or conditions within the establishment. Note: When taking a measurement, CSIs are to use the calibrated instrument that the establishment uses for the monitoring or verification activities and uses the procedures as described in the HACCP plan. Example: The CSI is performing a HACCP verification task and verifying the monitoring requirement, which in this case, is a product temperature check. She decides to perform both parts of the review and observation component. She directly observes the establishment employee carry out the product temperature check. Then, she takes a product temperature measurement, and compares the result that she obtained to the one just recorded by the establishment employee.


FSRE/PHIS 8

The Hazard Analysis Verification (HAV) Task The Hazard Analysis Verification (HAV) task is a work method that provides CSIs with a powerful approach to verifying compliance with certain requirements of 9 CFR 417, specifically those that pertain to certain foundational elements of an establishment‘s HACCP system. These foundational elements are:

A flowchart and hazard analysis that matches the actual production processes in the establishment;

A hazard analysis in which the establishment accurately considers applicable food safety hazards given the nature of the process, product, and intended use of the product and determines whether each hazard is reasonably likely to occur;

Critical control points (CCPs) for hazards that are reasonably likely to occur in the process and documentation supporting those CCPs;

Documentation supporting any decision that a food safety hazard is not reasonably likely to occur in the process;

Evidence supporting the validity of the HACCP system; and

Reassessment of the HACCP system annually and anytime changes occur that could affect the hazard analysis or HACCP plan.

We refer to these elements of a HACCP system as foundational because each element is critical to the sound development and maintenance of a HACCP plan. If an establishment fails to meet a regulatory requirement associated with any one of these elements, the HACCP plan, and ultimately the HACCP system may be fundamentally flawed. Even if the HACCP plan is well executed, a HACCP system that is inadequate with respect to these foundational elements may result in the production of adulterated product. The HAV methodology gives CSIs an enhanced, step-by-step approach for reviewing these foundational elements of an establishment‘s HACCP system. Combined with the reporting and automated data management features of PHIS, the HAV task significantly enhances the Agency‘s ability to prevent unsafe meat and poultry products from entering commerce.

Expectations of CSIs Conducting the HAV Task The safety of meat and poultry products depends on establishments developing and implementing effective food safety systems. CSIs are in the best position to identify concerns about the effectiveness of an establishment‘s HACCP system because they are familiar with the daily operations and actual conditions in the establishment. By identifying concerns about the hazard analysis, supporting documentation, or prerequisite programs, CSIs are acting to protect the public health by preventing products that present a risk from entering commerce. Many establishments have developed unique and complicated HACCP systems. It is understandable and even expected that CSIs involved in performing the HAV task will not always have the scientific, technical, or regulatory expertise necessary to determine the significance of their findings. When CSIs have concerns about the establishment‘s


FSRE/PHIS 9

hazard analysis but are unable to determine whether their findings constitute noncompliance, they should discuss their concerns with their supervisor. IPP in slaughter establishments are to consult with a Supervisory Public Health Veterinarian (SPHV) or Supervisory Consumer Safety Inspector (SCSI) assigned to the establishment if they are uncertain about whether the available information supports a particular determination. SPHVs are to consult with the Frontline Supervisor (FLS) as necessary. CSIs in processing establishments are to consult with the FLS. Supervisors should be contacted immediately whenever IPP have reason to believe there are systematic problems with the establishment‘s food safety system or that adulterated product may have been produced and shipped. Note that what is expected of IPP differs from what is expected of EIAOs. When conducting a comprehensive food safety assessment, EIAOs determine the adequacy of an establishment‘s hazard analysis and supporting documentation. However, the EIAO‘s role is involves more than the HAV methodology. EIAOs must comprehensively investigate every detail of an establishment‘s food safety system, and not only determine whether specific findings represent compliance or noncompliance, but analyze the various kinds of food safety noncompliance in that establishment to arrive at a sound, supportable conclusion about the adequacy of that establishment's overall food safety system.

Scope and Frequency of the HAV Task CSIs are to review all hazard analyses, HACCP plans, and supporting documents for all HACCP process categories in the establishment when performing routine or directed HAV tasks. CSIs perform a routine HAV task anytime it appears in the establishment‘s inspection task list. PHIS adds routine HAV tasks to an establishment‘s task list at a frequency based on specific information in the profile and the ongoing food safety performance history of the establishment. Routine HAV tasks appear in the task list only once a quarter for establishments that demonstrate good process control. PHIS may also add a directed HAV task to the task list in response to certain events or inspection results that indicate that the establishment may not be maintaining control of its food safety system. Examples of such events include positive pathogen test results, trends of food safety noncompliance, or the production of adulterated or misbranded product. CSIs may at times be instructed by their supervisor or district office to perform a directed HAV task. During any directed HAV task, CSIs include all HACCP categories as in a routine HAV task but pay particular attention to the parts of the hazard analysis and supporting programs that relate to the reason for the directed HAV task. For example, when a ground beef sample taken by FSIS is positive for E. coli O157:H7, CSIs focus on aspects of the hazard analysis that address the control and prevention of E. coli O157:H7 while performing the resulting directed HAV task.

Meat and Poultry Hazards and Controls Guide FSIS developed the Meat and Poultry Hazards and Controls Guide (Guide) to help FSIS personnel evaluate all aspects of an establishment‘s HACCP system for producing meat and poultry products. Before detailing each step of the HAV task we will introduce how


FSRE/PHIS 10

this Guide can support CSIs in gathering and assessing information about an establishment‘s hazard analysis. The Guide identifies common process steps that may be employed in each HACCP process category with the exception of slaughter. It lists the common biological, chemical and physical food safety hazards that have been traditionally associated with particular types of products or process steps, and cites some of the controls frequently used by processors to address these hazards. This Guide provides CSIs with suggested general and process-specific verification questions needed to determine whether the establishment considered all the possible hazards for each process step and verify that the hazard analysis and the HACCP plan appropriately take into account the relevant food safety information. Using the Guide, CSIs should be able to more effectively verify whether an establishment‘s HACCP system has appropriately accounted for hazards that are reasonably likely to occur in its operations. CSIs are to use the Guide to inform their consideration of the following matters:

1. Does the establishment‘s flowchart and hazard analysis include all the applicable steps for the types of products that it produces?

2. Has the establishment considered the food safety hazards that would typically be

associated with the steps in its production process?

3. Has the establishment implemented measures to prevent or control the hazards at the relevant points in the process?

It is important to note that differences between the Guide and an establishment's hazard analysis are not, in themselves, sufficient to support a determination of noncompliance. However, CSIs can use the Guide as a helpful reference when evaluating whether an establishment has considered the potential hazards associated with a particular production process.

HAV Task Steps When performing the HAV task, CSIs are to use both the recordkeeping and review and observation components to verify that the establishment complies with the HACCP regulatory requirements. For instance, CSIs use the recordkeeping component to verify that the establishment has developed a flow chart and conducted a hazard analysis that addresses the relevant food safety hazards for the process, product, and intended use of the product in accordance with 9 CFR 417.2(a). CSIs also use the recordkeeping component to verify that the establishment has developed a HACCP plan that has at least one CCP for each hazard that is reasonably likely to occur in the process and has support for the decisions made at that CCP in accordance with 9 CFR 417.2(c)(2) and 417.5(a)(2). When the establishment uses a prerequisite program (such as a Sanitation SOP, GMP, or purchase specifications) to support that an applicable hazard is not reasonably likely to occur, CSIs use the recordkeeping component to verify that the establishment has the support for that decision in accordance with 9 CFR 417.5(a)(1). CSIs use the review and observation component to verify the flow diagram represents the actual production process and verify that the establishment implements


FSRE/PHIS 11

prerequisite programs effectively to support the decision that a hazard is not reasonably likely to occur in the process. These are just few examples demonstrating the use of both components. CSIs use the thought process and methodology summarized in the HAV Task Summary Table below and discussed in subsequent sections of this handout to gather and assess information while performing the HAV task.

Note: If an establishment determines that no food safety hazards are reasonably likely to occur in the process, it is not required to develop CCPs or a HACCP plan. CSIs will not perform HACCP verification tasks in this establishment. However, CSIs will perform the HAV task in the establishment to verify that it has support for the decision that no hazards are reasonably likely to occur in the process.

HAV Task Summary Table

Refer to applicable sections of Directive 5000.1 for additional information about each step.

Step Description Verification Questions Regulations

1 Review flowchart and compare to production process.

Does the flowchart represent the actual production process?

417.2(a)(2)

2 Review the hazard analysis and consider guidance in the FSIS Meat and Poultry Hazards and Controls Guide.

Does the flowchart or hazard analysis identify the intended use or consumers of the product?

Does the hazard analysis appear to consider the relevant food safety hazards for the establishment‘s process, product, and intended use?

For each hazard, does the establishment consider it reasonably likely to occur or not reasonably likely to occur? Does hazard analysis reflect all the steps in the process?

417.2(a)(2)

417.2(a)(1)

3

For each hazard the establishment considers reasonably likely to occur, verify that the HACCP plan(s) include one or more CCPs to control it. If no hazards are reasonably likely to occur, skip to step 4.

Does the establishment have one or more CCPs to control each hazard it considered reasonably likely to occur?

Does the establishment have information to support the development of its CCPs, critical limits, and monitoring and verification procedures and frequencies?

417.2(c)(2)

417.5(a)(2)

4

For each hazard the establishment considers not reasonably likely to occur, determine what information the establishment uses to support the decision.

Does the establishment prevent the hazard by implementing a prerequisite or other supporting program (SSOP, GMP, SOP, etc.)? – proceed to step 5.

Does the establishment support the decision with other documentation besides a prerequisite or other supporting program? –proceed to step 6.

417.5(a)(1)


FSRE/PHIS 12

5 Review prerequisite programs and other supporting programs, including written programs, records, and employee activities.

Does the written program appear to prevent the relevant hazard?

Do the records and your observations indicate the program is consistently being implemented as written?

Do the records and your observations indicate that the program continues to prevent the relevant hazard on an ongoing basis?

417.5(a)(1)

6 Review other supporting documentation

Does the establishment maintain copies of the documents referenced in the hazard analysis?

Do the documents appear to support the relevant decisions?

417.5(a)(1)

7 Review establishment validation documents, including scientific supporting documents and validation data.

Do the establishment CCPs and prerequisite programs follow the parameters in the scientific documents?

Does the validation data seem to show that the establishment‘s CCPs and prerequisite programs are effectively controlling or preventing the relevant hazards?

417.4(a)(1)

8

Verify reassessment requirements. Check most recent signature date for each HACCP plan.

Has the establishment reassessed at least once in the most recent calendar year?

Has the establishment reassessed, if necessary, in response to any changes that could affect the hazard analysis?

Has the establishment reassessed, if necessary in response to any unforeseen hazard?

417.4(a)(3)

417.4(b)

417.3(b)

9 Document your findings in PHIS

No problems detected – document HAV task results in PHIS.

Clear case of noncompliance – document HAV task results and NR in PHIS.

Concerns about the establishment HACCP system – discuss situation with your supervisor for assistance in determining how to proceed. Document HAV task results in PHIS.

Each time the CSI performs the HAV task they should follow these steps for all the HACCP processing categories in an establishment.

When conducting a directed HAV task, CSIs are still expected to include all HACCP categories, but pay particular attention to the parts of the hazard analysis and supporting programs that relate to those findings prompting the directed task.

CSIs are to contact their supervisor if the establishment does not make necessary records available for review as this may represent noncompliance with 9 CFR 417.5(f).


FSRE/PHIS 13

Step 1: Review the Flow Chart The regulatory requirement for the flow chart is:

9 CFR 417.2(a)(2): A flow chart describing the steps of each process and product flow in the establishment shall be prepared, and the intended use or consumers of the finished product shall be identified.

The flow chart and hazard analysis are essential for the development of an accurate and effective HACCP Plan. Each step in the establishment‘s process must be properly identified before the establishment can conduct an adequate hazard analysis. It is essential that CSIs accurately assess and verify that flow charts accurately represent the steps in each process and the flow of product through each process. This requires CSIs to become familiar with the production steps and product flow within the establishment by observing operations. If they have questions about the process steps and product flow, they are to ask establishment management for assistance in understanding the production process, including how the establishment handles rework or returned products. When verifying compliance with 9 CFR 417.2(a)(2), CSIs should consider questions such as:

1. Does the hazard analysis include a flow chart that describes the steps of each process and production flow in the establishment?

2. Does the flow chart accurately represent all of the steps in the establishment‘s production process?

CSIs are to refer to the Guide as they consider an establishment‘s flow chart. The table on page 6 of the Guide lists the process steps that are frequently associated with each HACCP process category except slaughter. CSIs are to review the process steps in the table for each process category in the establishment. The establishment process may not include all the steps listed in the Guide, but the steps in the table will help CSIs identify steps in the establishment process that are not in the flow chart. An establishment may have a single flow chart that shows an entire production process or it may have multiple flow charts. In some establishments, the flow chart will be part of the HACCP plan, while in others it will be a separate document. All of these approaches to presenting the information are acceptable. CSIs are not to focus on the format or structure of the flow chart. They are to verify that the flow chart or flow charts contain the required information for the entire production process. FSIS does not dictate the level of detail in the establishment flow chart. The establishment may incorporate several production steps into one step in a flow chart. However, the establishment must consider all the food safety hazards associated with all the activities embedded in that flow chart step to meet the requirements of 9 CFR 417.2(a). The flow chart or hazard analysis must document the operations considered at each step of the process.


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Compliance Example 1:

An establishment performs several different activities (cutting, needle tenderizing, injecting, and tumbling) when processing raw, non-intact products. The flow chart groups these activities in to the single step of ―processing,‖ but the flow chart lists each activity included in that step. Since the establishment listed the different activities associated with the step identified as ―processing,‖ this would not represent noncompliance with 9 CFR 417.2(a)(2). Compliance Example 2:

An establishment has a single flow chart that accurately reflects all steps and product flow for both its pork slaughter process and its raw, intact process (hot boning of carcasses). The single flow chart accurately represents the steps in both HACCP process categories; therefore, this would not represent noncompliance with 9 CFR 417.2(a)(2). Compliance Example 3:

An establishment does not have a statement of intended use on its raw, intact process flow chart, but has included it with the written product description with its hazard analysis. Since the establishment has accurately identified the intended use or consumer, this would not represent noncompliance with 9 CFR 417.2(a)(2). Noncompliance with the Flow Chart: CSIs are to document noncompliance with 9 CFR 417.2(a)(2), whenever findings clearly indicate one or more of the following:

• The establishment‘s flow chart does not accurately represent all the steps in the establishment‘s production process.

• The establishment‘s flow chart does not accurately describe product flow.

• The establishment‘s flow chart (or hazard analysis) does not identify the intended

use or consumers for all finished products. Noncompliance Example:

A CSI is conducting a HAV task in a portion control establishment that produces steaks, chops, and roasts for HRI use. While reviewing the flow chart he notes the establishment has no returned product step in its flow chart, but recalls observing several cases of frozen sirloin steaks being offloaded from food service truck the day before. At that time, a shipping supervisor had stated a restaurant was returning these steaks. The CSI determines that the establishment’s flow chart is not in compliance with 417.2(a)(2).


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Step 2: Review the Hazard Analysis The regulatory requirements for the hazard analysis are:

9 CFR 417.2(a)(1): Every official establishment shall conduct, or have conducted for it, a hazard analysis to determine the food safety hazards reasonably likely to occur in the production process and identify the preventive measures the establishment can apply to control those hazards. The hazard analysis shall include food safety hazards that can occur before, during, and after entry into the establishment. A food safety hazard that is reasonably likely to occur is one for which a prudent establishment would establish controls because it historically has occurred or because there is a reasonable possibility that it will occur in the particular type of product being produced in the absence of those controls.

When performing the HAV task, CSIs review the establishment‘s hazard analyses for all products produced in the establishment in all HACCP categories. CSIs are to verify that each hazard analysis reflects all the steps in the flow chart and the establishment‘s actual production processes. When verifying compliance with 9 CFR 417.5(a)(2), CSIs should consider questions such as:

1. Did the establishment conduct a hazard analysis or have one conducted for it?

2. Did the establishment‘s analysis start by identifying all hazards that may occur?

3. Does the hazard analysis identify preventive measures the establishment can

apply to the food safety hazards?

4. Does the hazard analysis identify the intended use of the consumers of the finished product?

5. Does the result of the establishment‘s hazard analysis reveal that one or more food safety hazards are reasonably likely to occur?

6. Did the establishment considered the relevant hazards for each step in the

process? In addition, CSIs are to compare the establishment‘s hazard analysis to information in the Guide and:

1. Determine whether the establishment considered the relevant hazards for each step in the process.

2. Compare information in the Guide to the establishment‘s hazard analysis for each step.

3. Consider the general verification questions in the Guide as well as the suggested

verification questions for each specific process step.


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4. Determine whether the establishment considers potential food safety hazards reasonably likely to occur in the production process or not reasonably likely to occur in the production process. Note: A hazard is reasonably likely to occur if it historically has occurred or there is a reasonable possibility that it will occur in the particular product in the absence of controls.

Based on the establishment‘s hazard analysis, information in the Guide, and their knowledge of the actual establishment process, CSIs are to assess whether the establishment‘s hazard analysis complies with 9 CFR 417.2(a)(1). CSIs are to contact their supervisors for assistance if they are uncertain whether the establishment has considered the appropriate hazards at each process step. Compliance Example The CSIs reviews a hazard analysis and determines that all the steps in the flow chart that appropriately reflect all steps in the production process are also included in the hazard analysis. She uses the Guide and the general and specific questions as an aid to verify whether the establishment has identified the logical food safety hazards at each step. She reviews the establishment’s decisions for whether a hazard is reasonably likely to occur or not and the basis for the decision. For hazards deemed reasonably likely to occur, she verifies the establishment has identified critical control point(s). A beef grinding establishment determined that a biological hazard (E. coli O157:H7) was reasonably likely to occur at the raw beef trim receiving step. Based on the Guide and her knowledge of pathogens, this appears logical. The establishment identified that E. coli O157:H7 would be controlled by requiring their suppliers to have validated antimicrobial intervention and provide a Certificate of Analysis with every shipment (CCP). For all other process steps, logical hazards and controls were considered. Based on the information gathered, she determined that the hazard analysis meets the requirements of 417.2(a)(1). Noncompliance with the Hazard Analysis: CSIs are to document noncompliance with 9 CFR 417.2(a)(1), whenever findings clearly indicate one or more of the following:

The hazard analysis does not reflect all the steps in the establishment‘s actual production process.

The hazard analysis does not consider the relevant food safety hazards at each step in the production process.

The establishment failed to consider whether a hazard was reasonably likely to occur or not reasonably likely to occur.


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Noncompliance Example After verifying the flow chart matched the establishment’s actual process flow, the CSI determines that the establishment is receiving returned products. However, the establishment failed to conduct the hazard analysis for the returned products step. The CSI determines that the establishment is not in compliance with 417.2(a)(1).

Step 3: Review the HACCP Plan and Its Supporting Documentation The regulatory requirements for including a CCP in the HACCP plan and supporting the decisions for the development each CCP are:

9 CFR 417.2(c)(2): List the critical control points for each of the identified food safety hazards, including, as appropriate: (i) Critical control points designed to control food safety hazards introduced in the establishment, and (ii) Critical control points designed to control food safety hazards introduced outside the establishment, including food safety hazards that occur before, during, and after entry into the establishment;

9 CFR 417.5(a)(2): The written HACCP plan, including decision making documents associated with the selection and development of CCPs and critical limits, and documents supporting both the monitoring and verification procedures selected and the frequency of those procedures.

For each hazard that an establishment determines is reasonably likely to occur in its process, CSIs are to verify the establishment has included one or more CCPs to control that hazard in a HACCP plan associated with that process in accordance with 9 CFR 417.2(c)(2). In addition, CSIs are to review establishment records to verify that the establishment has information to support the development of all CCPs, critical limits, and monitoring and verification procedures as required by 9 CFR 417.5(a)(2). These supporting documents must be applicable to the establishment‘s actual process, and support the relevant establishment programs or interventions. CSIs are to pay particular attention to verifying that the establishment has supporting documentation for any CCPs that have been added or modified since the last review. Note: If an establishment determines no hazards are reasonably likely to occur at any step in its process, CSIs move on to Step 4. When verifying compliance with 9 CFR 417.5(a)(2), CSIs should consider questions such as:

1. Does the establishment have the decision-making documents associated with the selection of each CCP?

2. Do the documents explain why the establishment selected that location for the

CCP?

3. Is there a control at the identified point in the process that will prevent, eliminate, or reduce to acceptable levels the identified hazards?


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4. Does the establishment have scientific, technical, or regulatory support for the critical limit?

5. Does the support appear credible?

6. Does the establishment have documents supporting the monitoring procedures

and frequencies listed in the HACCP plan?

7. Does the establishment have documents supporting the verification procedures and frequencies listed in the HACCP plan?

8. Do the documents support what the establishment has done?

9. If the establishment has supporting documents for these decisions, does the

documentation support the decisions? When seeking answers to these questions, the CSI should review the following:

Hazard analysis

HACCP plan

Decision-making documents associated with the selection and development of the CCP and critical limits

Supporting documentation for the verification procedures and frequencies

Supporting documentation for the monitoring procedures and frequencies Some examples of supporting documentation that an establishment might use to support decisions made in the HACCP plan include:

Scientific journal articles

Regulations

Pathogen modeling program results

Processing authority documents

Research

In-plant (historical) data Reviewing Supporting Documentation for the HACCP Plan When reviewing the HACCP plan and supporting documentation for compliance with 417.5(a)(2), the CSI should verify that the establishment has the documents to support the selection of each CCP and why that location was selected. In addition, CSIs should verify that there is a control at the identified point in the process that will prevent, eliminate, or reduce the identified hazard to an acceptable level. There should also be credible scientific, technical, or regulatory support for the critical limit at the CCP, and there should be documents supporting the monitoring and verification procedures and their frequencies identified in the HACCP plan. Compliance Example 1: An establishment has an antimicrobial intervention CCP in the beef slaughter process at the carcass wash location that identifies minimum concentration as the critical limit. The


FSRE/PHIS 19

establishment maintains the following supporting documents to meet the requirement of 9 CFR 417.5(a)(2):

A decision-making document that describes how establishment management designed the CCP based on a particular scientific article because the article addresses the establishment’s particular hazard and product. The decision-making document describes how the critical parameters (temperature, dwell time, application method, and pressure) will be met.

A copy of the referenced scientific article.

A document from the test kit manufacturer that describes a method for monitoring the concentration of the antimicrobial solution to support the establishment’s monitoring procedure.

A written decision memo stating the critical limit will be monitored once per day because the establishment mixes the antimicrobial solution daily.

A written decision memo stating that the establishment will follow the verification procedures listed in 9 CFR 417.4(a)(2) and stating that the frequency will be weekly because historical records show consistent control of this CCP.

Compliance Example 2: The CSI reviews the hazard analysis and HACCP plan for a beef slaughter operation. The CSI finds that at the receiving step the establishment has identified that there is a biological food safety hazard, ―presence of Salmonella spp. and E. coli O157:H7 microorganisms on the live animal and in the intestinal tract‖ that is reasonably likely to occur. Later steps in the process, evisceration and final wash, are identified as the points (CCPs) to reduce the prevalence of these pathogens in the finished product. The HACCP plan indicates that a steam-vacuum sanitizer is utilized to remove visible fecal contamination after the carcass is eviscerated. The steam vacuum delivers a continuous stream of 7 to 10 PSI water at a temperature between 179.6° F and 185° F at the inside of the nozzle. The static vacuum for the system is a minimum of 7 inches of mercury. The CSI decides to request the supporting documentation for these critical parameters. The establishment provides a copy of a scientific article. The article addresses the effectiveness of steam-vacuum sanitizing for reducing E. coli O157:H7 on beef carcass surface tissue that has been inoculated E. coli O157:H7. The same operating parameters for the steam vacuum that the establishment is using in the HACCP plan are identified in the materials and methods section of the paper. The abstract and results and discussion sections of the article state that the steam-vacuum sanitizer reduced aerobic plate counts associated with bovine fecal contamination 2.5 log10 cfu/cm2 on beef carcass short plates and on the same beef carcass short plates inoculated with E. coli O157:H7 in feces there was a 5.5 log10 cfu/cm2 reduction after steam-vacuum treatment. The CSI concludes that the article is relevant to the process, identifies the hazard, level of pathogen reduction achieved, and supports the establishment’s critical limits in the HACCP plan. Based upon the review, the CSI determines that the establishment is in compliance with 417.5(a)(2).


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Compliance Example 3: The CSI reviews the hazard analysis and HACCP plan for a young chicken slaughter operation. The CSI finds that at the carcass chilling step the establishment has identified that there is a biological food safety hazard, ―growth of Salmonella spp and Campylobacter can result in higher prevalence of these pathogens in the final product.‖ A time and temperature combination is listed at the chilling step in the HACCP plan. Carcasses and major portions of carcasses are chilled immediately after processing to an internal temperature of 40°F or less within 4 hours. The CSI decides to request the supporting documentation for these critical limits. The establishment provides a copy of 9 CFR 381.66 that has the same temperature values listed for chilling poultry carcasses. Based upon the review, the CSI determines that the establishment is in compliance with 417.5(a)(2). Compliance Example 4:

A CSI reviews the HACCP plan, hazard analysis, and supporting documentation for the steam pasteurization CCP in a beef slaughter operation to verify that it meets the requirement in 417.5(a)(2). He finds that the supporting documents describe the rationale for the location and critical limits of the CCP. The supporting documentation includes scientific articles by researchers at various institutions supporting the location and the critical limits for the steam pasteurization CCP. The establishment also has documents supporting the monitoring and verification procedures and frequencies. Based upon the review, the CSI determines that the establishment is in compliance with 417.5(a)(2). After the CSI has gathered and assessed all available information pertaining to the supporting documentation requirement, he or she must determine regulatory compliance. If he or she finds that the establishment has met all regulatory requirements for §417.5(a)(2), then there is no regulatory noncompliance. If he or she finds that the establishment has not met all regulatory requirements for §417.5(a) (2), there is noncompliance. More information about making compliance determinations is provided in another section of the training. Noncompliance with the HACCP Plan and Its Supporting Documentation: CSIs are to document noncompliance with 9 CFR 417.2(c)(2), whenever findings clearly indicate the establishment has not included one or more CCPs to control each hazard identified as reasonably likely to occur. CSIs are to document noncompliance with 9 CFR 417.5(a)(2), whenever findings clearly indicate the establishment does not have documentation to support the development of CCPs, critical limits, or monitoring and verification procedures. If CSIs have concerns about whether the documentation is adequate, they are to discuss the issue with their supervisor. Noncompliance Example 1: The hazard analysis addresses the biological hazards of Salmonella and E. coli O157:H7 in raw materials received, and the establishment has determined the hazards are reasonably likely to occur. There is no CCP identified in the HACCP plan to address


FSRE/PHIS 21

these hazards. When the CSI requests decision-making documents to support this determination, the establishment is not able to provide any. The establishment has identified a hazard as reasonably likely to occur with no corresponding CCP in the HACCP plan. Noncompliance Example 2: A CSI is reviewing the HACCP plan for a large beef slaughter establishment and finds that it has a CCP for E. coli O157:H7 at the steam pasteurization step prior to chilling. The verification procedures specify that maintenance will calibrate the temperature recording device once a week prior to operations. She asks the establishment for documentation supporting this frequency of calibrating the temperature recording device, and they finally produce some technical documents from the manufacturer that states the temperature recording device should be calibrated daily. The establishment has no documentation supporting the verification procedure and frequency; therefore, it is not in compliance with 417.5(a)(2). Noncompliance Example 3: The HACCP plan has a monitoring procedure for checking the finished product chilling medium by hand thermometer at the beginning of each shift. The establishment is not able to provide any supporting documentation for this procedure or frequency. The establishment has no documentation supporting the monitoring procedures and frequencies; therefore, it is not in compliance with 417.5(a)(2). Noncompliance Example 4: The hazard analysis has identified that Salmonella is reasonably likely to occur, and a CCP was established to control this hazard. The establishment provides as supporting documentation for its critical limit some charts from a microbial pathogen computer modeling program. Upon examination, the CSI observes that the parameters used in the predictive model do not match the ones used by the establishment in its process. The establishment has documentation, but the documentation does not support what the establishment is trying to support. The CSI discusses the finding with his supervisor and they determine the establishment is not in compliance with 417.5(a)(2).

Step 4: Determine Hazard Analysis Supporting Documentation The regulatory requirement for supporting the decisions made in the hazard analysis is:

9 CFR 417.5(a)(1): The establishment shall maintain the following records documenting the establishment’s HACCP plan: (1) The written hazard analysis prescribed in §417.2(a) of this part, including all supporting documentation;

Where an establishment determines that a food safety hazard is not reasonably likely to occur (NRLTO), CSIs are to determine what information the establishment uses to support the decision and review that information. Supporting documentation for the NRLTO decisions in an establishment‘s hazard analysis may include scientific, technical, regulatory, or establishment generated information, which support why a particular food


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safety hazard is unlikely to occur in the establishment‘s process. Alternatively, it is common for establishments to base some NRLTO decisions on implementation of prerequisite programs, including sanitation standard operating procedures, other standard operating procedures, good manufacturing practices, certain purchase specifications, or other supporting programs. In some cases, support for a NRLTO decision may involve both a prerequisite program and some other form of supporting documentation. Inadequate supporting documentation for one or more NRLTO decisions in an establishment‘s hazard analysis calls into question the adequacy of that hazard analysis and represents noncompliance with 9 CFR 417.5(a)(1). In Step 4 of the HAV task, CSIs are to determine what information an establishment uses to support the NRLTO decisions in its hazard analysis. Therefore, CSIs should consider questions such as:

1. Does the establishment support a decision that a hazard is not reasonably likely to occur in the hazard analysis by implementing a prerequisite program?

2. Does the establishment support a decision that a hazard is not reasonably likely

to occur in the hazard analysis by maintaining certain supporting documentation, e.g., specific records such letters of guaranty, certificates of analysis (COAs), age certificates etc?

When an establishment supports an NRLTO decision by implementing a prerequisite program, CSIs will review that program during Step 5. When an establishment supports an NRLTO decision with documentation other than a prerequisite program, CSIs will review that other supporting documentation during Step 6. Whenever CSIs are unsure how to proceed, they should always seek supervisory guidance. The key in distinguishing a prerequisite program from other supporting documentation is that a program will involve the establishment implementing one or more operational procedures. Consider the following examples: Prerequisite Program Example:

An establishment produced raw ground turkey. In its hazard analysis, the establishment concluded that contamination with metallic foreign material was not reasonably likely to occur in the product because the establishment implemented a prerequisite program for metal detection. The hazard analysis referred to the written metal detection program to justify the decision that the physical hazard was not reasonably likely to occur in the product. The written metal detection program described the steps the establishment would take to ensure that the metal detector functioned effectively and specified records that would be used to document implementation of the program. Establishment employees implemented the program as written and the records documented that each batch of product was subject to metal detection and no metal that would be a hazard was detected. Other Supporting Documentation Example:

An establishment received raw boneless beef cuts and processed them into steaks, roasts, and non-intact products. The establishment considered whether Specified Risk Materials (SRMs) were reasonably likely to occur in the product that it received. It determined that SRMs were not reasonably likely to occur, because boneless cuts of


FSRE/PHIS 23

beef would not contain SRMs. The establishment supported this decision with records of invoices for incoming products showing that it received only boneless products.

Step 5: Review Prerequisite Programs As previously mentioned, the regulatory requirement for supporting the decisions made in the hazard analysis is:

9 CFR 417.5(a)(1): The establishment shall maintain the following records documenting the establishment’s HACCP plan: (1) The written hazard analysis prescribed in §417.2(a) of this part, including all supporting documentation.

After identifying that the establishment determined that a particular hazard was not reasonably likely to occur because of implementation of a prerequisite program (including Sanitation SOPs, SOP, GMP, purchase specifications or other programs), CSIs are to review the details of these supporting programs and consider whether the program supports the decision. Note that this review focuses specifically on those prerequisite programs the establishment references in its hazard analysis, not the broad, general types of prerequisite programs that are not referenced as support for some NRLTO decision. Any information provided by the broad, general types of prerequisite programs relevant to the effectiveness of the HACCP system may be important to consider within the bigger picture of making sense out of one‘s findings, but Step 5 involves only those prerequisite programs referenced in the hazard analysis. Characteristics of Prerequisite Programs When reviewing the contents of any prerequisite programs an establishment uses to support a decision that a hazard is NRLTO, CSIs should consider whether the prerequisite program has the following characteristics:

1. The program is written and describes procedures that the establishment will implement to show the hazard is not reasonably likely to occur.

2. The program describes records that the establishment will keep to demonstrate that the program is being implemented as written.

3. The program describes records that the establishment will keep to demonstrate that the program effectively prevents the hazard.

4. The program describes actions that the establishment will take when it fails to implement the program, or when it finds that the program has failed to prevent the hazard.

If an establishment‘s prerequisite program does not appear to have these characteristics, then it is likely that the establishment has not met the requirements of 9 CFR 417.5(a)(1). CSIs are to discuss any concerns they have about whether the prerequisite program is designed to prevent the relevant hazard with their supervisors. Note: In most cases, there are no regulations that explicitly address prerequisite program documentation and recordkeeping. When an establishment bases a NRLTO


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decision on the use of a prerequisite program, it must maintain sufficient documentation, including records documenting implementation, to demonstrate adequate support for the relevant decision on an ongoing basis. However, there are specific documentation and recordkeeping requirements for the Sanitation SOP (which is an example prerequisite program, specific risk material (SRM) segregation and disposal when addressed through the use of a prerequisite program and for meeting certain regulatory requirements when using of prerequisite programs to address of Listeria monocytogenes in post-lethality exposed, ready-to-eat products. Verifying Implementation of Prerequisite and Other Supporting Programs When verifying compliance with 9 CFR 417.5(a)(1), CSIs should consider questions such as:

1. Is the establishment is implementing the procedures as set out in the program‘s design?

2. Does the establishment maintain records to support the implementation of the program, including verification records and results from outside auditors?

3. Does the establishment evaluate the implementation of the program?

4. Does the establishment have means to correct implementation problems? To answer the questions above, CSIs verify that the establishment implements any prerequisite programs or other control measures in a way that supports the decision in the hazard analysis for a specific production. For each prerequisite program or other program the establishment uses to support a decision that a hazard is not reasonably likely to occur, CSIs verify implementation of the program by:

1. Reviewing the records generated by the program.

2. Considering whether the records show the program supports the decision in the hazard analysis that the relevant hazard is not reasonably likely to occur on an ongoing basis.

3. Observing establishment employees implementing the procedures in the program.

4. Considering whether establishment employees are implementing the prerequisite

program procedures as written and making corrections as needed. Compliance Example 1:

An establishment implements a prerequisite program to maintain raw product coolers below 35°F to prevent the hazard of pathogen growth from being reasonably likely to occur. On 3 separate days last week, the employee recording the cooler temperature records did not record his initials as specified in the written program. This minor failure to follow the program would not represent a failure to support the hazard analysis, as long as there is no reason to believe that the 35°F temperature was not maintained. Therefore, the establishment is in compliance with 9 CFR 417.5(a)(1).


FSRE/PHIS 25

Compliance Example 2:

A CSI was performing the HAV task at a poultry slaughter and further processing establishment, which produced a variety of fresh and frozen products for distribution to retailers and food service companies. At its product packaging material receiving step in its raw intact process, the establishment concluded that no biological, chemical, or physical food safety hazards were reasonably likely to occur. This decision was based on having letters of guaranty from it’s suppliers as per 9 CFR 381.144 and establishment history, which was described as, ―Shipping manager or designee inspects all shipments of packaging materials for visible damage and contamination at receiving. Shipments with evidence of damage or contamination are rejected.‖ The CSI determined that the letters of guaranty were a form of other supporting documentation to be verified with Step 6, and proceeded to review the prerequisite program for inspection of incoming packaging materials. She requested establishment historical documents from the QA manager. The QA manager provided receiving logs that indicated the shipping manager or a designee had inspected each shipment of packaging material for damage and contamination. The inspector concluded that the establishment was adequately implementing this prerequisite program and proceeded to Step 6 to review the establishment’s other supporting documentation for this step. Compliance Example 3: While conducting an HAV task, a CSI noted that in its hazard analysis, a poultry slaughter establishment referenced a chlorination system to prevent pathogens (Salmonella & Campylobacter) from occurring in its poultry chiller water reuse (a.k.a. ―red water‖). This was a patented system, and its effectiveness depended on precise control of both the free available (residual) chlorine and pH levels through the addition of chlorine and carbon dioxide to the red water. The inspector reviewed the prerequisite program, which specified the following:

Chlorine Residual pH Procedure Frequency Actions

1-5 ppm 5.5 – 6.0 Sample red water at inflow to chiller

Determine chlorine and pH levels with handheld colorimeter

QA will test chlorine and pH every hour of production

Record results on Red Water Check form

Contact maintenance if chlorine or pH are out of range so adjustments can be made

The CSI asked for documentation supporting the operating parameters in the establishment’s prerequisite program. The CSI discussed these operating parameters with his supervisor, who agreed they were adequate. The CSI next verified that the establishment was collecting and testing red water samples every hour of production, as specified in the written prerequisite program, and documenting the results of chlorine and pH tests sufficiently to support the decision in the hazard analysis. The CSI noted the establishment had failed to document a couple of the chlorine test results on a few production days over the past three months. All other results recorded for those production days indicated that the establishment had been maintaining the chlorine and pH levels within the specified operating parameters. Therefore, the inspector concluded


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that with respect to this particular hazard analysis decision, the establishment was in compliance with 9 CFR 417.5(a)(1). Whenever CSIs are uncertain, based on their review of records and observations, whether a prerequisite program supports the relevant hazard analysis decision, they are to discuss the issue with their supervisor. Noncompliance with Prerequisite and Other Supporting Programs IPP are to document noncompliance with 9 CFR 417.5(a)(1), whenever findings clearly indicate one or more of the following:

1. The establishment employees are not implementing the procedures in the prerequisite program sufficiently to prevent the relevant hazard.

2. The prerequisite program records indicate consistent or repeated failures to

implement the procedures that support the decision that the relevant hazard is not reasonably likely to occur.

3. The prerequisite program records do not demonstrate that the program is

effectively preventing the relevant hazard from being reasonably likely to occur. Note: In most cases, minor failures in prerequisite records would not support a finding of noncompliance. For example, missing an occasional record entry, failing to put a time or initials, or a similar deficiency does not necessarily mean that the prerequisite program is not being implemented effectively. While these failures might be examples of sloppy prerequisite program recordkeeping, they do not necessarily mean the prerequisite program is not being implemented effectively. In contrast, failing to implement procedures in a prerequisite program or evidence that the program is not effectively preventing the hazard means that the establishment does not have adequate support for the relevant decisions in its hazard analysis. Failure to support hazard analysis decisions is cause for the CSI to document noncompliance with 9 CFR 417.5(a)(1) and may be grounds for additional enforcement action. Noncompliance Example 1:

An establishment implements a prerequisite program to support that the hazard of E. coli O157:H7 is not reasonably likely to occur in received beef trimmings. The prerequisite program states that a production supervisor will verify receipt of a certificate of analysis (COA) for each lot of trimmings before grinding. It also states that the establishment will sample and test a lot of its finished ground product for E. coli O157:H7 quarterly. While performing the HAV task, the CSI notes that the establishment has not received a COA for the lot of trimmings they are presently grinding. This finding calls into question the establishment’s decision that E. coli O157:H7 is not reasonably likely to occur. Therefore, the finding would represent noncompliance with 9 CFR 417.5(a)(1) because the establishment does not have the records specified in the prerequisite program to support that the hazard of E. coli O157:H7 was not reasonably likely to occur. Noncompliance Example 2:

At the product receiving step, an establishment that further processed raw poultry determined the potential hazard of contamination with pathogens was not reasonably


FSRE/PHIS 27

likely to occur based on its Product Receiving SOP. The written SOP specified the shipping manager or a designee would visually inspect and check temperatures on incoming product. Product was to be returned to suppliers if there was any evidence of contamination or temperature abuse. When performing the HAV task, the CSI reviewed the prerequisite program records and discovered that establishment employees had failed to document results of visual inspection and temperature checks on 10 loads of incoming product over the previous 4 weeks. The CSI determined that the establishment had failed to maintain adequate supporting documentation for these decisions in its hazard analysis because this was not an isolated incident; the establishment was regularly failing to implement the procedures specified in its prerequisite program.

Step 6: Review Other Supporting Documentation As previously mentioned, the regulatory requirement for supporting the decisions made in the hazard analysis is:

9 CFR 417.5(a)(1): The establishment shall maintain the following records documenting the establishment’s HACCP plan: (1) The written hazard analysis prescribed in §417.2(a) of this part, including all supporting documentation.

Reviewing Other Supporting Documentation CSIs must review any other documentation that an establishment uses to support a decision that a food safety hazard is not reasonably likely to occur. In many cases, this supporting documentation will take the form of scientific documents, establishment historical records, or other establishment-generated data. CSIs are to verify that the establishment maintains the documents referenced in the hazard analysis to support the relevant decision regarding a hazard being not reasonably likely to occur. When verifying compliance with 9 CFR 417.5(a)(1), CSIs should consider questions such as:

1. Does the establishment maintain records to support their decision that a food safety hazard is not reasonably likely to occur, including verification records and results from outside auditors?

2. Does the establishment evaluate that their decision is still supportable by reviewing records?

3. Does the establishment have means to correct implementation problems? In some cases, an establishment may determine that certain hazards are not reasonably likely to occur because of the intended use of the product. In these cases, CSIs are to verify that the establishment has documentation to support the intended use of the product. This support might include labeling records, shipping invoices, letters of intent from receiving establishments or other records that demonstrate how the establishment ensures that products will be appropriate for their intended use.


FSRE/PHIS 28

CSIs should also consider whether the supporting documentation applies to the establishment‘s current process and supports the applicable decision. If CSIs have concerns that documents referenced in the hazard analysis do not support the relevant decisions, they are to discuss the issue with their supervisors before making a compliance determination. Compliance Example:

Recall from a previous example (in Step 5) that a CSI was reviewing an establishment’s support for its NRLTO decision at the product packaging material receiving step. The support was based in part on letters of guaranty from its packaging material suppliers as per 9 CFR 381.144(b). The CSI reviewed 9 CFR 381.144, which specifies that all product-packaging materials must be safe for their intended use and accompanied or covered by letters of guaranty from the supplier stating that the intended use of the packaging materials complies with the Federal Food Drug and Cosmetic Act. Next, the CSI requested the letters of guaranty from the QA manager. While reviewing the letters of guaranty, the inspector took notes on suppliers, types of packaging material, and the shipments of packaging material covered by a particular letter of guaranty based on information in the receiving logs. The inspector then went to the area where packaging materials were stored and verified that all packaging materials could be associated with a particular letter of guaranty. She concluded that the establishment was in compliance with 381.144(b), and with respect to this particular decision in its hazard analysis, also in compliance with 417.5(a)(1). Noncompliance with Other Supporting Documentation IPP are to document noncompliance with 9 CFR 417.5(a)(1), whenever findings clearly indicate one or more of the following:

1. The establishment has no documentation to support a decision that a hazard is NRLTO.

2. The establishment is not maintaining copies of the documents referenced in the hazard analysis.

3. Supporting documents are irrelevant to the establishment‘s process or otherwise

fail to adequately support the NRLTO decision. Noncompliance Example 1: A CSI is performing a HAV task and notes in the hazard analysis that SRMs are deemed not reasonably likely to occur at the receiving step of a raw intact process because the establishment obtains supplier certificates with each shipment that state carcasses and primals parts are derived from cattle that are less than 30 months of age. He asks the establishment for the certificates from the previous 2 weeks of production so he can review them. Establishment management informs you that their supplier neglected to send them. The establishment had received 12 shipments of carcasses and primal parts during this period.


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Noncompliance Example 2: A CSI is performing an HAV task in an establishment that slaughters approximately 2000 market hogs per production day. Below is the portion of the establishment’s hazard analysis where the establishment considered the possibility of drug and pesticide residues at the animal receiving step.

The establishment has a copy of the scientific journal article on file, but no additional documentation or programs supporting this decision. After discussing his concerns with his supervisor, the CSI determines that the basis for the establishment’s decision is inadequate because even though it references a scientific article on prevention strategies and has a copy of the article, the establishment does not identify any specific strategies (e.g., supplier purchase specifications, supplier quality assurance programs, or residue testing) it uses to prevent violative chemical residue levels from occurring in its pork slaughter process.

Step 7: Review Validation Documents The regulatory requirements for validating the HACCP system are:

9 CFR 417.4(a): Every establishment shall validate the HACCP plan’s adequacy in controlling the food safety hazards identified during the hazard analysis, and shall verify that the plan is being effectively implemented.

9 CFR 417.4(a)(1): Initial validation. Upon completion of the hazard analysis and development of the HACCP plan, the establishment shall conduct activities designed to determine that the HACCP plan is functioning as intended. During this HACCP plan validation period, the establishment shall repeatedly test the adequacy of the CCP, critical limits, monitoring and recordkeeping procedures, and corrective actions set forth in the HACCP plan. Validation also encompasses reviews of the records themselves, routinely generated by the HACCP system, in the context of other validation activities.

Establishments are required to validate the adequacy of their HACCP systems in controlling the food safety hazards identified in its hazard analysis. Validation is composed of two parts or elements: (1) scientific and technical support and (2) initial in-plant demonstration proving the HACCP system can perform as expected.

Step Potential Hazard

RLTO Justification CCP

Receiving live hogs

Chemical: Drug and pesticide residues

No Potential for chemical residues is not significant because no residue-related illness in the U.S. associated with consumption of commercial pork. [Kindred T. P., and W.T. Hubbert. 1993. Residue prevention strategies in the United States. Journal of the American Veterinary Medicine Association. 202 (1) 46-49.]

No


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Scientific and Technical Support The scientific and technical support establishes a documented basis for the HACCP system. This consists of having scientific and technical documentation demonstrating that the designed process can control the identified hazards. In other words, will the HACCP system work in theory. The following are examples of scientific or technical support for a HACCP system:

Agency regulations or guidance documents

Documented expert advice from processing authorities

An article from a peer-reviewed journal

A documented scientific study

Documented results from a pathogen modeling program

Other information that demonstrates that particular measures can adequately prevent or control the specific food safety hazards.

The documentation should identify the hazard, the level of hazard prevention or control to be achieved, all critical parameters or conditions, the processing steps that will achieve the specified prevention, reduction or control, and the way these processing steps will be monitored. The supporting documentation must be complete, available for review and related to the process, product and hazard identified in the hazard analysis. The process should also be implemented in the establishment as described in the supporting documentation. Failure to take these steps would raise questions about whether the HACCP system has been adequately validated. To be effective, the process procedures should relate and adhere to the specifications in the supporting documentation. For example, if the documentation listed the critical parameter as the concentration of an antimicrobial agent, then that concentration should be used in the process. If metal detection equipment is used to identify metal in a product, then the supporting data used to validate the metal detection system should demonstrate that the metal detectors can detect the targeted materials in the product. If the process specifications described in the supporting documentation are not implemented in the same or similar way in the establishment‘s process, additional studies need to be conducted and documented to ensure the modified implementation achieves the desired food safety objective. These additional studies could be conducted either in a laboratory or an in-plant setting. The scientific and technical support element of validation is supporting documentation as required by 9 CFR 417.5(a)(1) for prerequisite programs supporting the hazard analysis and 9 CFR 417.5(a)(2) for CCPs. The approach to verifying such support has already been covered under Step 3 and Step 5.


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Initial In-Plant Validation The second element is the initial in-plant validation data, which includes the in-plant observations, measurements, microbiological test results, or other information demonstrating that the control measures, as written into a HACCP system, can be implemented within a particular establishment, and that when the are, they achieve the intended food safety objectives. The initial in-plant demonstration takes place during the initial 90 days of operation under that HACCP system according to 9 CFR 304.3(b) and 381.22(b). It involves collecting data that proves the system can perform as expected in the establishment‘s process with its own equipment, employees, environment, etc. This initial in-plant demonstration has two distinct parts showing that:

1. The critical operational parameters of the CCP or control are consistently met.

2. The CCP or control achieves the intended food safety result. Establishments must collect in-plant data to demonstrate that they are able to routinely meet the critical operational parameters for the controls, interventions, or other procedures in their HACCP systems. This data would include observations, measurements, or other information that demonstrates the establishment can successfully implement these parameters in its process. Example:

An establishment utilizes an antimicrobial carcass spray intervention. Supporting scientific documentation for this intervention provides critical parameters of water pressure at the nozzle, water temperature at the carcass surface, whole carcass coverage, and a water/carcass contact time. The establishment would be expected to have data showing that those parameters are being actually being achieved in the process. It is crucial that measurements for collecting the data be designed to actually measure the correct parameter. For instance, the water temperature measured at a holding tank or at the nozzle may not be the actual water temperature at point of contact with a carcass so the measurements for this parameter must be indicative of carcass surface temperature. If an establishment uses parameters that vary from the scientific and technical support, then additional information would need to be provided to support the parameters that are actually used in practice. For example, if the establishment uses antimicrobial carcass sprays on chilled carcasses and the supporting documentation provides for spray on warm carcasses, the establishment would need to provide additional information to support the efficacy of spraying chilled carcasses. Establishments often incorporate antimicrobial interventions into their process to reduce the level of certain pathogens and will use published scientific literature to support its effectiveness. A part of the in-plant demonstration the establishment may include data (not a requirement) to show that the intervention as used in that process achieves the intended food safety results. For example, does the antimicrobial intervention applied in the establishment environment actually achieve the level of pathogen reduction (e.g., log kill) documented in the scientific supporting documentation? The in-plant demonstration


FSRE/PHIS 32

is important because laboratory conditions used to establish a particular intervention or control measure are often different than the actual conditions in the establishment. Laboratory conditions present a highly controlled environment and specific microbial log reductions achieved in the laboratory may not be easily attained or monitored in an actual establishment setting. Verifying Initial In-Plant Validation The in-plant demonstration element of validation requires that the establishment gather information during the establishment‘s initial experience with the HACCP system (the first 90 days) to demonstrate that the system performs as expected. Some examples of in-plant demonstration documentation that an establishment might provide include:

Observations

Measurements Microbiological testing

Other information When verifying compliance with 9 CFR 417.4(a)(1), CSIs should consider questions such as:

1. Does the establishment have a complete copy or at least a copy of the relevant

portions of the text from scientific literature, textbooks, compliance guidelines, or regulations used to support the effectiveness of the intervention in the HACCP system?

2. Has the establishment conducted validation activities to determine whether the HACCP plan will function as intended?

3. Does the data show that the establishment can implement the HACCP system‘s preventive measures, controls, and interventions as written?

4. Do the establishment CCPs and prerequisite programs follow the operational parameters in the scientific documents?

5. Do the establishment‘s records include multiple results that verify the monitoring of the CCPs and conformance with critical limits?

6. If the establishment has not incorporated the exact critical operational

parameters for the food safety interventions or control measures given in the scientific references into its HACCP system, does the establishment have additional data or a document to support the adequacy of the modified critical parameters in preventing or controlling the hazard?

7. Does the establishment have subsequent results that support the adequacy of corrective actions in achieving control at a CCP after a deviation from a critical limit has occurred?


FSRE/PHIS 33

8. Do records show that prerequisite programs used in decision-making are being implemented to support relevant decisions in the hazard analysis?

During the period of initial validation for a new or modified HACCP system, CSIs are to verify that the scientific and technical support for the interventions and control measures in the HACCP system are complete and provide support that the HACCP system will, in theory, effectively prevent or control the relevant food safety hazards. The records to document initial in-plant validation may not be complete at this time. Once the establishment completes the 90-day initial validation, CSIs are to verify that the establishment has data to demonstrate that it can achieve the critical parameters in its process or critical limits established at the CCPs by implementing the HACCP system as designed. This data would include measurements or observations showing that the controls have been effectively implemented in the process. When reviewing the initial in-plant demonstration validation data for a HACCP system, CSIs should verify the following:

1. The establishment implements the HACCP system‘s preventive measures and controls as written.

2. The establishment‘s CCPs, prerequisites, or other programs incorporate the

parameters described in the scientific supporting documentation.

3. The establishment maintains additional data to support the adequacy of control measures that do not incorporate the exact parameters from scientific references.

4. Establishment employees can fully perform all elements of specified corrective

action when there is a deviation from a critical limit.

5. The preventive measures and controls, when implemented, are effective in preventing or controlling the applicable food safety hazard.

6. Recordkeeping procedures associated with CCPs are complete, accurate, and

usable by the establishment.

7. Records generated by prerequisite programs or other interventions or processes designed to prevent or control identified hazards show that the programs are being implemented to support the relevant decisions in the hazard analysis on an ongoing basis

Compliance Example: A small cattle slaughter establishment has a CCP for antimicrobial carcass treatment with lactic acid. The establishment’s supporting document for this CCP and critical limit is a journal article. The CSI verifies that the journal article supports the critical parameters of the intervention and that the establishment is able to consistently meet those parameters. Records reflecting the first 90 days implementation of this CCP are available and show that the critical parameters are consistently met.


FSRE/PHIS 34

Noncompliance with Initial In-Plant Validation CSIs are to document noncompliance with the listed regulatory requirement whenever findings clearly indicate one or more of the following:

1. The establishment does not perform initial in-plant validation of control measures in the HACCP system (including CCPs and prerequisite programs) during the initial 90-day validation period. 9 CFR 417.4(a)(1)

2. The records of initial validation do not demonstrate that establishment employees

are able to implement the control measures and corrective actions as written in the HACCP system 9 CFR 417.4(a)

3. The records of initial validation do not demonstrate that the HACCP system is

effective at preventing or controlling the identified food safety hazards. (9 CFR 417.4(a)(1)

If CSIs have concerns about the adequacy of the establishment‘s validation records, they are to discuss the issue with their supervisor. Related Issues of Noncompliance:

1. If an establishment does not maintain documents to support the scientific or technical basis for the CCPs used to control the identified food safety hazards, there is noncompliance with 9 CFR 417.5(a)(2).

2. If an establishment‘s CCPs do not incorporate the parameters described in the scientific references and the establishment does not have additional data to support the technical adequacy of the CCPs, there is noncompliance with 9 CFR 417.5(a)(2).

3. If an establishment does not maintain documents to support the scientific or

technical basis for prerequisite programs used to support NRLTO decisions, there is noncompliance with 9 CFR 417.5(a)(1).

4. If an establishment‘s prerequisite programs do not incorporate the parameters

described in the scientific references and the establishment does not have additional data to support the technical adequacy of the prerequisite programs, there is noncompliance with 9 CFR 417.5(a)(1).

5. If an establishment does not make documents or data demonstrating both parts

of validation available to the CSI, he or she needs to discuss the situation with his or her supervisor as this may represent noncompliance with 9 CFR 417.5(f).

Noncompliance Example:

An establishment has an antimicrobial carcass treatment CCP and supports it with a scientific journal article. However, the establishment does not have documentation showing that it meets all the critical parameters stated in the journal article. The supporting document provides for acid at a certain temperature and concentration to be sprayed on a warm carcass at a certain pressure and spray configuration. The only


FSRE/PHIS 35

parameter that the establishment is measuring and recording is concentration of the acid. The CSI determines that the acid is actually being applied to a cold carcass at a different solution temperature. He asks the establishment for support for these parameters and there was none. In this case, the establishment has not validated the CCP because it does not have support for the critical parameters that are being used in the process. This represents noncompliance with 9 CFR 417.5(a)(2).

Step 8: Verify Reassessment Requirements

Reassessment (Annual and Changes in Establishment Processes) and Establishment Training Requirements The regulatory requirements for reassessment of the HACCP plan and establishment personnel training are:

9 CFR 417.4(a)(3): Reassessment of the HACCP plan. Every establishment shall reassess the adequacy of the HACCP plan at least annually and whenever any changes occur that could affect the hazard analysis or alter the HACCP plan. Such changes may include, but are not limited to, changes in: raw materials or source of raw materials; product formulation; slaughter or processing methods or systems; production volume; personnel; packaging; finished product distribution systems; or, the intended use or consumers of the finished product. The reassessment shall be performed by an individual trained in accordance with Sec. 417.7 of this part. The HACCP plan shall be modified immediately whenever a reassessment reveals that the plan no longer meets the requirements of Sec. 417.2(c) of this part.

9 CFR 417.7(a)—Only an individual who has met the requirements of paragraph (b) of this section, but who need not be an employee of the establishment shall be permitted to perform the following functions: (1) Development of the HACCP plan, in accordance with section 417.2(b) of this part, which could include adapting a generic model that is appropriate for the specific product, and (2) Reassessment and modification of the HACCP plan, in accordance with section 417.3 of this part. (b) The individual performing the functions listed in paragraph (a) of this section shall have successfully completed course of instruction in the application of the seven HACCP principles to meat and poultry product processing including a segment on the development of a HACCP plan for a specific product and on record review. 9 CFR 417.2(d)—Signing and dating the HACCP plan. (1) The HACCP plan shall be signed and dated by the responsible establishment individual. The signature shall signify that the establishment accepts and will implement the HACCP plan. (2) The HACCP plan shall be dated and signed: (i) Upon initial acceptance; (ii) Upon any modification; and (iii) At least annually, upon reassessment, as required under section 417.4(a)(3) of this part


FSRE/PHIS 36

An establishment is required to reassess its HACCP system (including the hazard analysis and any prerequisite programs) at least annually, and whenever any changes occur that could affect the hazard analysis or alter the HACCP plan (9 CFR 417.4(a)(3)). The establishment can reassess its HACCP plan, or plans, any time during the calendar year to meet the annual reassessment requirement. This requirement does not expect the establishment to reassess every 12 months. To demonstrate that the annual reassessment has been performed, the establishment is required to sign and date the HACCP plan (9 CFR 417.2(d)(2)(iii)). The establishment must reassess the adequacy of the HACCP plan whenever a change occurs that could affect the hazard analysis or alter the HACCP plan, but it is not required to document such reassessments, unless the reassessment reveals that modification of the plan is necessary. If reassessment reveals that the HACCP plan no longer meets regulatory requirements, the HACCP plan must be modified immediately, and signed and dated (9 CFR 417.2(d)(2)(ii)) . The occurrence of unforeseen hazards may also reflect changes that could affect the hazard analysis or alter the HACCP plan (9 CFR 417.4(a)(3)), therefore establishments must reassess the hazard analysis and any applicable prerequisite programs when an unforeseen hazard occurs as part of complying with the corrective action requirement specified by 9 CFR 417.3(b)(4). If the establishment determines that the unforeseen hazard is not reasonably likely to occur in their process, the establishment must have adequate support for that decision. 9 CFR 417.4(a)(3) makes reference to 9 CFR 417.7, which requires the individual who performs a reassessment or makes modifications to the HACCP plan to have successfully completed a training course in the application of the seven HACCP principles to meat or poultry product processing. However, there is no requirement for the establishment to provide documentation of training. CSIs are to accept oral statements that establishment employees have been trained in accordance with 9 CFR 417.7. When verifying compliance with §417.4(a)(3), §417.7 and §417.2(d), CSIs should consider the following questions:

1. Did the establishment perform the annual reassessment of its plan or plans at

some point during the previous calendar year? 2. Did the establishment consider any significant developments that have occurred

in the establishment or that have occurred with respect to the types of products produced by the establishment, in its analysis?

3. Has any change occurred that could affect the hazard analysis or HACCP plan? 4. Has an unforeseen hazard occurred since the last HAV task? 5. Did the establishment reassess?

6. If the reassessment revealed that the establishment determined that an

unforeseen hazard was not reasonably likely to occur, does the establishment have adequate support for that decision?


FSRE/PHIS 37

7. If the reassessment revealed that the HACCP plan no longer met regulatory requirements, was the HACCP plan modified immediately?

8. Did the establishment sign and date the HACCP plan or plans during the

previous calendar year and upon any modification to the plan? 9. Has the individual who reassessed the HACCP plan, or who modified the plan,

completed training or a course in the seven principles of HACCP including a segment on the development of a HACCP plan for specific product and review of records?

While performing the HAV task, CSIs verify compliance with §417.4(a)(3), §417.7, and §417.2(d) by:

Reviewing reassessment records, if available,

Reviewing the HACCP plan,

Asking establishment management about reassessments conducted since the previous HAV task, and

Asking establishment management whether the individual performing any

reassessments or making modifications to the HACCP plan have been trained.

Note: For the year 2012, the annual reassessment and establishment training requirements are verified using the appropriate HACCP verification task because the HAV task is not being generated in PHIS but will be in the future. CSIs will add a 'comment' on the 'Findings' tab when documenting the result of the verification to identify this as the ―Annual Reassessment and Training verification.‖ Compliance Example 1: On 1-28-2012, a CSI is performing the HAV task(HACCP verification task for 2012) in a turkey slaughter operation. She reviews the HACCP plan and verifies that the annual reassessment was last performed and signed off on 4-1-2011. She learned in her HACCP training that the establishment reassessment requirement is based upon the calendar year and not upon a 12-month period. The person who signed the plan has been identified as someone who completed a HACCP training course meeting the requirements in §417.7. Therefore, she determines that the establishment is in compliance with the annual reassessment and training requirements since reassessment was performed in 2011 and the person that reassessed the plan was HACCP trained. Compliance Example 2: A small beef slaughter operation has recently begun to slaughter bob veal calves. On 10-10-2011, The CSI decides to schedule a HAV task (HACCP verification task for 2012) as a direct task. He proceeds to review the HACCP plan to determine if a reassessment was performed and, if so, were any changes made to the HACCP plan as


FSRE/PHIS 38

a result of that reassessment. He finds that reassessment was last performed and signed off on 10-2-2011. He also notes that, as a result of the reassessment, the HACCP plan was changed by adding a CCP for chemical hazards at receiving. The supporting documentation for adding the CCP states the establishment had begun slaughtering bob veal calves. There were several sources of data in the supporting documentation that showed bob veal calves to be a much greater risk for residue violations. Based on his review, he determines that the establishment is in compliance with the reassessment requirement as a result of process changes. Noncompliance with Reassessment of the HACCP Plan and Establishment Training One or more of the following findings are evidence that the establishment does not comply with 9 CFR 417.4(a)(3) or 9 CFR 417.7.

1. Changes that could affect the hazard analysis or HACCP plan have occurred, but the establishment has not performed a reassessment.

2. The establishment did not perform a reassessment at least once in the previous calendar year (i.e. the 12-month period ending on the previous December 31st).

3. An individual trained in accordance with 9 CFR 417.7 did not perform the reassessment.

Noncompliance Example 1: On 2-2-2012, the CSI is performing the HAV task (HACCP verification task for 2012) and is reviewing the HACCP plan to verify it meets the annual reassessment and training requirements. The HACCP plan is signed and dated 11-11-2010. She questions the HACCP coordinator and determines that the last reassessment was in November of 2010. The annual reassessment requirement was not met. Noncompliance Example 2: In mid September of 2011, a large beef slaughter establishment reassessed its HACCP plan based on its own testing results showing E. coli O157:H7 is more prevalent than previously thought. On 2-6-12, the CSI is reviewing the hazard analysis and finds that E. coli O157:H7 was judged to be a hazard reasonably likely to occur at dehiding and evisceration. However, in reviewing the HACCP plan he finds no CCP to address the hazard. In this case, reassessment revealed that the HACCP plan no longer met the requirements of 417.2(c) and the plan was not immediately modified.


FSRE/PHIS 39

Reassessment of the Hazard Analysis The regulatory requirement for reassessment of the hazard analysis is:

9 CFR 417.4(b)--Reassessment of the hazard analysis. Any establishment that does not have a HACCP plan because a hazard analysis has revealed no food safety hazards that are reasonably likely to occur shall reassess the adequacy of the hazard analysis whenever a change occurs that could reasonably affect whether a food safety hazard exists. Such changes may include, but are not limited to, changes in: raw materials or source of raw materials, product formulation, slaughter or processing methods or systems, production volume, personnel, packaging, finished product distribution systems, or the intended use or consumers of the finished product

Establishments that do not have a HACCP plan because they determined that no hazards were reasonably likely to occur must reassess their hazard analysis and any prerequisite programs whenever any changes occur that could reasonably affect whether a food safety hazard is reasonably likely to occur. If CSIs encounter an establishment with no HACCP plan, they should notify the District Office through supervisory channels. CSIs should verify food safety to ensure the process is not producing adulterated product. When verifying compliance with §417.4(b)), and §417.7, CSIs should consider the following questions:

1. Does the establishment have a process without a HACCP plan because the hazard analysis has revealed there is no food safety hazard likely to occur?

2. Have any changes occurred in the process that could reasonably affect whether

a food safety hazard exists? 3. If changes have occurred in the process, has a reassessment been conducted as

a result of these changes? 4. Has the individual who reassessed the hazard analysis met the training

requirement prescribed in §417.7? Note: Unlike the requirement for a HACCP plan, there is no annual reassessment regulatory requirement for the hazard analysis in establishments that only have a hazard analysis because it revealed no hazards that were reasonably likely to occur in the process. While performing the HAV task, CSIs verify compliance with §417.4(b and §417.7, by:

Reviewing the hazard analysis,

Observing operations to determine if any changes have occurred that would require a reassessment of the hazard analysis, and


FSRE/PHIS 40

Asking establishment management whether the individual performing the reassessment of the hazard analysis has been trained.

Noncompliance with Reassessment of the Hazard Analysis and Establishment Training If an establishment does not have a HACCP plan because the hazard analysis shows that no food safety hazards are reasonably likely to occur, the following findings are evidence that the establishment does not comply with 9 CFR 417.4(b):

1. Changes that could affect the hazard analysis have occurred but the establishment has not performed a reassessment.

2. An individual trained in accordance with 9 CFR 417.7 did not perform the reassessment.

Step 9: Document Findings in PHIS CSIs are to use PHIS to document the results of HAV tasks. PHIS is designed to capture information about the regulatory requirements verified and whether there was compliance or noncompliance with each regulatory requirement. Therefore, CSIs will document findings of regulatory compliance and findings of noncompliance when conducting the HAV task. Compliance Determination If CSIs do not identify any issues of noncompliance, and find no evidence of potential problems in the food safety system, they are to document the results of the HAV task in PHIS, including specifying compliance with each of the regulatory requirements verified. Noncompliance Determination Anytime CSIs find noncompliance, they are to notify establishment management as soon as possible, document the noncompliance in PHIS, and present the Noncompliance Record (NR) to establishment management. CSIs are to discuss noncompliance regarding an establishment‘s hazard analysis and supporting documentation with their supervisor to determine if additional action may be necessary. When documenting noncompliance identified with the HAV task, CSIs are to describe why the findings led them to a determination of noncompliance. For example, a single failure to make a temperature entry on prerequisite program record for received product is not, in itself, sufficient to support noncompliance. However, failure to complete the temperature log multiple times over the course of a production week, or inspection findings that received product exceeded the specified temperature in even one instance, may be sufficient to determine that this prerequisite program does not support the establishment‘s decisions about product receiving. Therefore, CSIs need to precisely describe the facts of a case in such a way as to show how they arrived at a decision of noncompliance.


FSRE/PHIS 41

Before the HAV task can be completed, CSIs must (1) verify that the establishment takes necessary actions to return to compliance with the applicable regulatory requirement(s) and (2) record in PHIS that the establishment has brought itself back into compliance. The HAV inspection task cannot be marked as completed in PHIS until the CSI has documented the establishment‘s return to compliance. Note: If noncompliance is determined with a HAV task, CSIs will perform a directed, follow-up HAV task to verify that the establishment continues to comply with the applicable regulatory requirements. PHIS will automatically include this directed HAV task in the establishment‘s task list. Unable to Determine Compliance If CSIs are unable to determine whether their findings represent regulatory noncompliance, they are to discuss those findings with their supervisor before making a determination. In some cases, it may be necessary to request policy and technical guidance through askFSIS. Non-Regulatory Concerns During the HAV task, CSIs may have findings that do not rise to the level of noncompliance but warrant discussion with establishment management. These issues should be discussed as they arise or in weekly meetings with establishment management. CSIs are to document these discussions in an MOI in PHIS, and provide establishment management with a copy of the MOI.


FSRE/PHIS 42

Job Aid for Considering Supporting Documentation

Important Note: These are just examples and should not be considered a comprehensive listing.

All Processes Systems

Examples of Supporting Documentation

Receive Raw Materials LOG (Letter of Guarantee); COA (Certificate of Analysis); Product temperature controls; Microbial Testing

+

Receive Packaging Materials and Non-Meat Ingredients

LOG to show free of hazards; Storage to prevent contamination; Temperature controls

+

Allergen controls

Store Raw Materials Temperature controls; Sanitation; Maintain package integrity+; Store raw meat at

41˚F or below;

Example: FDA Food Code states ‗Red meat, which is a potentially hazardous food, must be stored at 41˚F or below.‘

++

Thawing frozen meat Temperature controls during thawing; Specifically surface temperatures +

Example: In potable, flowing water at 70°F, chicken thawed to an internal temperature of 40°F in 5 hours showed no increase in Salmonella.

++

Formulation Allergen Controls (clean up, progressive scheduling, & color-coding); Control of nitrate/nitrites; Temperature controls

+

Mixing/Grinding Temperature controls during processing

Physical contamination: use most sensitive detection technique available +;

Monitoring equipment should be sensitive enough to detect contamination as small as 1/32‖ (0.8mm); A visible inspection is prudent in addition to metal detection or x-ray machines; Hard or sharp objects 7-25mm represent a potential physical hazard, but objects < 7mm could also be a potential physical hazard for certain populations (children).

++

Rework Cross-contamination of lots; Records to support distinction between lot/specific productions; Microbial testing

+

Returned Product Condition of product; Package Integrity +

Animal Receiving/Feed Control

Feed withdrawal and holding animals (beef/pork) 2 to 6 hours prior to slaughter has been shown to reduce the incidence of ruptured viscera and cross-contamination.

++

Residue controls Slaughter establishments may request LOGs and copies of relevant animal treatment records.

+

Best Practices: animals identified for trace back, producers notified in writing when there‘s a positive/residue violation, require suppliers to participate in residue avoidance program, conduct live animal testing

Residue Violators listing: www.fsis.usda.gov/Science/Chemistry/index.asp +++

Hide removal/ evisceration

Steam vacuuming beef carcasses at 162°F, followed by a hot water spray of 203°F, at 24 psi, and/or an 11 second spray of 2% lactic acid at 131°F; Fecal contamination will be removed by steam vacuuming when accompanied by either or both of the hot water or lactic acid treatments. E. coli, Enterobacteriaceae, and total

and thermotolerant coliforms were consistently reduced to less than 1.0 log. ++


FSRE/PHIS 43

Carcass Wash/

Antimicrobial Interventions

- Assure that time, temperature, pressure, dwell time, and other parameters are consistent with supporting documents.

- Rinse beef carcasses with low pressure (10 psi) followed by high pressure (250 psi) 95°F water, then spray the area with a fine mist of 131˚F 2% acetic acid for 11 seconds; The addition of the 2% acetic acid treatment with the water wash, reduced E. coli, and S. typhimurium count 2.4 to 5.1 log units inside the contaminated area and to < 0.5 log units outside the initial contamination area to below detection level more effectively than just the water wash, or trimming.

++

- Spraying pork carcasses with 2% lactic acid solution reduced S. typhimurium by 2.25 log units.

++

- Lactic acid spray: concentration, time/temperature dwell time, pressure+; Lactic

acid (livestock carcasses, offal, and variety meats prior to fabrication up to a 5% lactic acid solution; Beef heads and tongues 2.0-2.8% solution applied to brushes in a washer cabinet system used to clean beef heads and tongues.

- Organic Acids (lactic, acetic, citric acid) As part of a carcass wash applied pre-chill up to 2.5% solution FSIS Notice 49-94

Scalding Pork Carcasses

Scalding in water to 145°F; E. coli, Salmonella and Campylobacter are killed at 145°F instantaneous.

++

Poultry Scalding Counter-current scalders; multistage tanks; maintain water pH at either above or below 6.5-7.5 to preclude the growth of Salmonella

Poultry Dip/Rinse - Chlorine, chlorine dioxide, acidifed sodium chlorite (500-1200ppm to achieve pH of 2.3-2.9; 21 CFR 173.325), TSP, Inspexx 100 ( peroxyacetic acid), lactic acid

- Sodium hypochlorite Reprocessing contaminated poultry carcasses 20 ppm calculated as free available chlorine

Note: Agency guidance has allowed the use of up to 50 ppm calculated as free available chlorine (9 CFR 381.91)

++++

SRM controls 9 CFR 310.22 - recordkeeping requirments - www.fsis.usda.gov/PDF/9CFR_310.22.pdf

E. coli Prerequisites Validated interventions ; Certificates of Analysis; Microbial testing of product by supplier and processor; 3

rd party audits

References:

Meat and Poultry Hazards and Controls Guide; FSIS +

Supporting Document Materials for HACCP Decisions, Folk and Knipe, The Ohio State University ++

FSRE training+++

FSIS Directive 7120.1++++

http://www.fsis.usda.gov/PDF/9CFR_310.22.pdf


FSRE/PHIS 44

Workshop: HAV Task Refer to the handout and to FSIS PHIS Directive 5000.1 to complete the following questions. 1. When should the CSI perform the HAV task? 2. Review the flow diagram, product description, hazard analysis, and HACCP plan on

the following pages, and answer the following questions:

a. How did the establishment address biological hazards at receiving? (circle the answer on the form and mark ―a‖)

b. How did the establishment address physical hazards at receiving? (circle the answer on the form and mark ―b‖)

c. How did the establishment address biological hazards at storage? (circle the answer on the form and mark ―c‖)

3. What decisions in the hazard analysis would the CSI request supporting documentation for, if any? Please explain your answer?

4. Are all steps in the flow diagram addressed in the hazard analysis? If not, please

explain. 5. Are all hazards identified as reasonably likely to occur addressed by a CCP

somewhere in the process? If not please explain.

6. At the receiving step in the hazard analysis, what could be a justification for the

identified biological hazard listed as not reasonably likely to occurin the process?


FSRE/PHIS 45

7. How does the establishment control the biological hazard – growth of pathogens- that was identified at storage?

8. How does the establishment monitor temperature control at storage? 9. Is the use of terms like ―microbial growth‖ or ―growth of pathogens‖ sufficient to

identify microbiological hazards??

10. What decisions in the HACCP plan would the CSI request supporting documentation

for, if any? Please explain your answer


FSRE/PHIS 46

Raw ground beef patties Process flow diagram

Product Description: Process category: Raw ground Product: Frozen ground beef patties Name: Ground beef patties 6 per pound Type of package: 10 pounds per box, in plastic bag with paper liners separating layers Length of shelf life: 3-6 months if maintained frozen as recommended on label; 5 days if thawed and held refrigerated Intended use: Fast food restaurant Labeling instructions: Keep frozen, safe food handling label Distribution: Frozen

Note: No rework used in this process

Freezing

Packaging

Patty formation

Mix

Grind

Storage

Receiving Trimmings

Distribution

Metal Detection

Example: for training use only


FSRE/PHIS 47

Hazard Analysis: raw ground beef patties Process Step

Food Safety Hazards Is hazard likely to occur?

Justification for decision

What control measures can be applied to prevent the significant hazards?

Is step a critical control point?

Receiving trimmings

Biological: Pathogens E. coli O157:H7 and Salmonella Chemical: none Physical: foreign material

Yes No

E. coli O157:H7 or Salmonella may be present on trimmings received Establishment records show that there has been no incidence of foreign material in products in past several years

Purchase specifications for certification from all suppliers that trimmings are from carcasses that received validated interventions effective to eliminate or reduce E. coli O157:H7 to an undetectable level & negative microbiological test results for E. coli O157:H7 required from suppliers

Yes No

Storage Biological: Growth of pathogens Chemical: none Physical: none

Yes E. coli O157:H7 or Salmonella may grow if not maintained at proper refrigeration temperatures

Maintain product temperature at or below a level sufficient to prevent growth

Yes

Grind Biological: none Chemical: none Physical: metal contamination

Yes

Past history indicates that metal contamination has occurred during grinding

Proper maintenance of equipment, routine examination during cleaning, metal detector later in process

No



FSRE/PHIS 48

Hazard Analysis: raw ground beef patties Continued Process Step

Food Safety Hazards Is hazard likely to occur?

Justification for decision

What control measures can be applied to prevent the significant hazards?

Is step a critical control point?

Mix Biological: none Chemical: none Physical: none

Patty formation

Biological: none Chemical: none Physical: metal contamination

Yes

Past history indicates that metal contamination has occurred during patty formation

Proper maintenance of equipment, routine examination during cleaning, metal detector later in process

No

Freezing Biological: none Chemical: none Physical: none

Metal Detection

Biological: none Chemical: none Physical: none

Past history indicates that metal contamination has occurred in previous process steps

Functioning metal detection equipment to identify and reject contaminated product

Yes

Packaging Biological: none Chemical: none Physical: none



FSRE/PHIS 49

HACCP plan: raw ground beef patties CCP Critical Limits Monitoring

Procedures & Frequencies

HACCP Records

Verification Procedures & Frequencies

Corrective Actions

1 Receiving

Product not received without certification of interventions and micro testing

Receipt of certification letter for valid antimicrobial intervention and COA for E. coli O157:H7 for each load of product received

Receiving log Corrective Action Log

Every two months QA will request FSIS Salmonella data results and E. coli O157:H7 intervention validation results from at least two suppliers

Corrective actions shall meet all requirements of Part 417.3 (a)

2 Temperature control at storage

Product temperature ≤44 degrees F

QC personnel will record temperature of product exiting grinder every hour

Product Temperature Log Corrective Action Log Thermometer Calibration Log

HACCP Coordinator will verify accuracy of the Product Temperature Log once per shift and observe QC personnel performing monitoring HACCP Coordinator will verify temperature of raw materials cooler and freezer daily. QC will check all thermometers used for monitoring devices for accuracy by immersion in slush ice, and will verify to within 2 degrees F daily All thermometers found to be inaccurate will be calibrated using immersion in slush ice and re-evaluated


3 Metal Detection

Functional Metal Detector

Packaging line supervisor will check the metal detector using a seeded sample every two hours to determine limits are not exceeded

Metal Detection Log Corrective Action Log

QC personnel will verify that the metal detector is functioning as intended by running the seeded sample (2 mm) through the metal detector twice per shift. Functioning metal detector must identify and remove the seeded sample. HACCP Coordinator will verify accuracy of the Metal Detection Log and observe packaging line supervisor performing monitoring once per shift. Maintenance personnel will perform calibration procedure once per shift.




FSRE/PHIS 50

Case Study. A CSI is reviewing the HACCP plan for a large beef slaughter establishment and finds that it has a CCP for control of E. coli O157:H7 at the hot water carcass rinse prior to chilling. The critical limit for the hot water wash is 140º F. He is not certain that this temperature is adequate to reduce E. coli O157:H7; therefore, he asks the establishment for scientific support that this temperature is effective in reducing E. coli O157:H7. The establishment provides him with a scientific study paper from researchers at a major university that supports the use of hot water washes with a minimum of 165º F as a method to effectively reduce the numbers of E. coli O157:H7. He asks the establishment for supporting documents for making 140º F the critical limit at the CCP. The establishment tells him that the critical limit was put at 140º F because that was the maximum output temperature for the establishment boiler. Is this a noncompliance? Explain your answer and cite the relevant regulation.

Workshop: HAV Task—Reassessment 1. On 1-15-2011, a CSI is performing a scheduled HAV task in a turkey slaughter

operation and elects to include verification of the annual reassessment as part of the task. He reviews the HACCP plan and finds that the annual reassessment was last performed and signed on 1-1-2010.

What would be the last date this plan would be in compliance with the regulatory requirement for reassessment?

2. A CSI is performing the HAV task at a raw ground beef patty operation. She

observes employees adding dry seasoning ingredients at the mixer. She is familiar with this establishment, and this is the first time that she has observed any non-meat ingredients being used. After verifying that the non-food safety consumer protection (other consumer protection) requirements have been met, she goes to the HACCP office and reviews the HACCP plan. She finds no documentation that this change to the product formula has triggered a reassessment.

a. What should she do next? b. Why would she do that?

c. Is there a HACCP noncompliance? If so, what regulations apply to this situation?


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The HACCP Verification Task

Expectations of CSIs Conducting the HACCP Verification Task CSIs must be familiar with the establishment‘s hazard analysis, HACCP plan, and any prerequisite or other programs that the establishment uses to support that specific food safety hazards are not reasonably likely to occur. The purpose of the HACCP verification task is to verify that the establishment is effectively implementing the procedures set out in its HACCP system. CSIs use the recordkeeping and/or the review and observation components to verify that establishments are meeting all the HACCP regulatory requirements including monitoring, verification, recordkeeping, and corrective action at all CCPs for a specific production. When CSIs complete the HACCP verification task, they document their findings of compliance or noncompliance in PHIS. As part of verifying the recordkeeping requirement, CSIs use the recordkeeping and the review and observation components to verify the implementation of prerequisite programs or other control measures the establishment uses to support that specific hazards are not reasonably likely to occur, and that the records generated for the program continue to support the decision that the applicable hazard is not reasonably likely to occur in the process. As part of the HACCP recordkeeping requirements, CSIs also verify that the establishment completes the pre-shipment review for before the affected product enters commerce. If CSIs cannot complete the HACCP verification task in one day, they are to enter partial findings in PHIS and then complete the task at a later date. The HACCP verification task cannot be completed until all mandatory regulatory requirements have been verified, including the pre-shipment review.

Routine and Directed HACCP Verification Tasks CSIs are to perform the HACCP verification tasks for the applicable HACCP process category as often as they appear in the establishment‘s inspection task list. PHIS adds routine HACCP verification tasks to the establishment‘s task list for the HACCP process categories listed in the establishment profile. PHIS may also add a directed HACCP verification task to the task list in response to certain events or results (e.g. positive pathogen test results or a trend of food safety noncompliances) that suggest that the establishment is either not implementing or maintaining control of its food safety system. CSIs are to initiate a directed HACCP verification task as a necessary response to finding noncompliance or as instructed by their immediate supervisor, FLS, DO, or Headquarters personnel. In these cases, they add a directed instance of the routine HACCP verification task to their task calendar and perform the task.

When CSIs find noncompliance, PHIS automatically creates a directed HACCP verification task to verify that the establishment continues to comply with the applicable regulatory requirements as a follow-up. When they perform this directed task, CSIs are to verify the same regulatory requirements in the same type of product as they did for the task that detected the noncompliance.


FSRE/PHIS 52

Performing the HACCP Verification Task PHIS adds HACCP verification tasks to the establishment‘s task list based on the HACCP process categories specified in the establishment‘s profile. CSIs add these tasks to their monthly calendar. To perform the HACCP verification task, the CSIs are to verify all applicable HACCP regulatory requirements at each process step and verify implementation of any prerequisite programs that apply to the selected product by performing the following steps:

1. Select a product type within the specified HACCP process category If the establishment produces multiple types of products within the HACCP category, CSIs are to ensure that they verify HACCP implementation for all product types produced in the establishment over the course of time. CSIs are to select a product type that the establishment is currently producing.

2. Select a specific production for the selected product type Next, CSIs are to select a specific production of the selected product type, such as the product produced during a specific time period, a specific production lot, or other designated product. CSIs are to verify that the establishment has met all applicable HACCP regulatory requirements at each step and any prerequisite programs applicable to that specific production by following the instructions that follows throughout this section. Specific production is a term that is used to refer to whatever method the establishment uses to group product, e.g., product produced during a specific time period, a specific production lot, or other designated product. FSIS does not determine the method used to define specific production; this is an establishment‘s responsibility. CSIs will see a variety of different of methods used. For example, a poultry slaughter establishment might define all the birds from one house as specific production; another might define it by all carcasses produced in one hour on one line. Establishments might define all products from one formulation batch, one shift‘s production, or the product in one chiller as a specific production. It is important for CSIs to understand the method used by the establishment to which they are assigned. They can determine this by asking establishment management.

3. Review the HACCP plan for the selected product type: Before performing a HACCP verification task, CSIs are to review the relevant HACCP plan to ensure they have full knowledge of its contents. They need to be familiar with the written procedures for monitoring and verification and their frequencies at each CCP in the HACCP plan. CSIs are also to be familiar with any prerequisite programs or other control measures that the establishment uses to support that an identified food safety hazard is not reasonably likely to occur. They may also review the HACCP plan again if questions arise during the verification task. While reviewing the HACCP plan, CSIs are to particularly note the most recent date when the HACCP plan was signed by a responsible establishment representative. 9 CFR 417.2(d) requires the establishment is to sign and date the HACCP plan upon initial


FSRE/PHIS 53

acceptance, after any modifications, and after the annual reassessment required by 9 CFR 417.4(a)(3). One or more of the following findings evidence that the establishment does not comply with 9 CFR 417.2(d):

Establishment management has not signed and dated the HACCP plan.

Establishment management has not signed and dated the HACCP plan at least once since January 1 of the previous calendar year.

Establishment management has modified the HACCP plan without updating the signature and date

If the date is recent, IPPs are to pay close attention to the contents of the HACCP plan because a recent date on the HACCP plan may indicate that the establishment has recently revised the monitoring or verification procedures in the HACCP plan. Note: When CSIs identify an addition to or modification of the CCPs in the HACCP plan, they are to note the changes and update the PHIS establishment profile to accurately reflect the revised content of the HACCP plan. CSIs are to follow the instructions in FSIS Directive 5300.1 on how to update the HACCP information in the PHIS establishment profile.

4. Verify that all four of the HACCP requirements have been met for all CCPs in the HACCP plan for that specific production

CSIs verify HACCP implementation by verifying that the establishment has met the monitoring, verification, recordkeeping, and corrective action HACCP regulatory requirements at each step. The instructions for verifying each of the HACCP regulatory requirements are discussed later in this section of training.

5. Verify the implementation of any prerequisite programs or other programs that apply to the specific production

The implementation of the program and the records generated from the program must demonstrate that the relevant food safety hazard is not reasonably likely to occur on an ongoing basis. Instructions for verifying the implementation of prerequisite programs are discussed later in this section of training.

6. Verify that the pre-shipment review requirement for that specific production has been met

The HACCP verification task cannot be completed until the establishment performs the pre-shipment review for that specific production. Because the HACCP verification task is performed by verifying the HACCP regulatory requirements for a specific production, CSIs are also determining whether the establishment‘s HACCP system prevented the distribution of adulterated product.


FSRE/PHIS 54

HACCP Verification Task Example: The Raw Non-Intact HACCP verification task is on the CSI’s PHIS task calendar for today. The establishment has one HACCP plan in this processing category for ground beef patties. The CSI knows from previous experience that this establishment defines specific production as each day’s production, and that they generally perform pre-shipment review each morning on the previous day’s production. The HACCP plan identifies one CCP for chilling the finished patties and the establishment implements a temperature control program for processing rooms and coolers/freezers. The establishment is producing a lot of patties today. The CSI decides to use the review and observation and recordkeeping components to verify the four HACCP regulatory requirements at the CCP and the recordkeeping component for verifying the implementation of the temperature control program. He proceeds to the production floor to begin verifying that all of the HACCP requirements were met for the CCP by reviewing the current day’s HACCP records and prerequisite program records. After reviewing these records, he will observe the establishment employee performing the monitoring activity for today’s production lot. Since the establishment had not performed all of the verification activities when he reviewed the HACCP records, he knows that he will have to review the HACCP records again to verify the establishment meets the HACCP verification requirement and verify that the establishment conducted the pre-shipment review tomorrow before he can complete the task.


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Workshop: HACCP Verification Task Methodology Refer to the handout and to FSIS PHIS Directive 5000.1 to complete the following questions.

1. What HACCP regulatory requirements are verified during the performance of the

HACCP verification task?

2. What are the two components that may be used to verify the HACCP regulatory requirements when CSIs perform HACCP verification tasks?

3. Explain how to perform the recordkeeping and review and observation components. 4. An establishment has one HACCP plan with two CCPs (identified as 1-2). Describe

the steps in performing the HACCP verification task.


FSRE/PHIS 56

Verifying Compliance with the HACCP Regulatory Requirements There are four regulatory requirements that the establishment must comply with during the day-to-day or ongoing operation of the HACCP system. The regulatory requirements are:

1. Monitoring 2. Verification 3. Recordkeeping 4. Corrective Actions

CSIs use the HACCP verification tasks to verify that the establishment complies with these four regulatory requirements. This section covers how to verify regulatory compliance and make supportable decisions when performing the HACCP verification tasks. Below is a chart with the HACCP requirements, regulatory references, and the components utilized in verifying compliance.

Requirement Regulatory References

Component

Monitoring 417.2(c)(4) Monitoring Requirement Rk R&O

Verification 417.2(c)(7) Verification Requirement 417.4(a)(2)(i)(ii)(iii)Verification Activities

Rk R&O

Recordkeeping 417.2(c)(6) Recordkeeping System Rk

417.5(a)(3) HACCP Records

Rk

417.5(b) Records Authenticity

Rk R&O

417.5(d) Computerized Records

Rk

417.5(e)(1) and (2) Record Retention Rk

417.5(f) Official Review Rk

Prerequisite Program

Implementation (Recordkeeping)

417.5(a)(1) Supporting Documentation

Rk R&O

Corrective Action 417.3(a) Deviation from a critical limit 417.3(b) Deviation not covered by a specified corrective action/unforeseen hazard

Rk R&O

Pre-Shipment Review

(Recordkeeping)

417.5(c) Pre-shipment Review

Rk R&O (on occasion)


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Regulatory References for Verifying the HACCP Requirements

Monitoring 417.2(c)4 - List the procedures, and the frequency with which those procedures will be performed, that will be used to monitor each of the critical control points to ensure compliance with the critical limits;

Verification 417.2(c)7- List the verification procedures, and the frequency with which those procedures will be performed, that the establishment will use in accordance with Sec. 417.4 of this part. 417.4(a)2(i)(ii)(iii)- Ongoing verification activities -Ongoing verification activities include, but are not limited to: (i) The calibration of process-monitoring instruments; (ii) Direct observations of monitoring activities and corrective actions; and (iii) The review of records generated and maintained in accordance with Sec. 417.5(a)(3) of this part.

Recordkeeping 417.2(c)(6) Recordkeeping System -Provide for a recordkeeping system that documents the monitoring of the critical control points. The records shall contain the actual values and observations obtained during monitoring. 417.5(a)(3) HACCP Records - Records documenting the monitoring of CCP's and their critical limits, including the recording of actual times, temperatures, or other quantifiable values, as prescribed in the establishment's HACCP plan; the calibration of process-monitoring instruments; corrective actions, including all actions taken in response to a deviation; verification procedures and results; product code(s), product name or identity, or slaughter production lot. Each of these records shall include the date the record was made. 417.5(b) Records Authenticity - Each entry on a record maintained under the HACCP plan shall be made at the time the specific event occurs and include the date and time recorded, and shall be signed or initialed by the establishment employee making the entry. 417.5(d) Computerized Records - Records maintained on computers. The use of records maintained on computers is acceptable, provided that appropriate controls are implemented to ensure the integrity of the electronic data and signatures. 417.5(e)(1) and (2) Record Retention and Availability -(1) Establishments shall retain all records required by paragraph (a)(3) of this section as follows: for slaughter activities for at least one year; for refrigerated product, for at least one year; for frozen, preserved, or shelf-stable products, for at least two years. (2) Off-site storage of records required by paragraph (a)(3) of this section is permitted after six months, if such records can be retrieved and provided, on-site, within 24 hours of an FSIS employee's request. 417.5(f) Official Review. - All records required by this part and all plans and procedures required by this part shall be available for official review and copying


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Prerequisite Program Implementation 417.5(a)(1) Supporting Documentation -(a) The establishment shall maintain the following records documenting the establishment's HACCP plan: (1) The written hazard analysis prescribed in Sec. 417.2(a) of this part, including all supporting documentation;

Corrective Actions 417.3(a) - The written HACCP plan shall identify the corrective action to be followed in response to a deviation from a critical limit. The HACCP plan shall describe the corrective action to be taken, and assign responsibility for taking corrective action, to ensure: (1) The cause of the deviation is identified and eliminated; (2) The CCP will be under control after the corrective action is taken; (3) Measures to prevent recurrence are established; and (4) No product that is injurious to health or otherwise adulterated as a result of the deviation enters commerce. 417.3(b) - If a deviation not covered by a specified corrective action occurs, or if another unforeseen hazard arises, the establishment shall: (1) Segregate and hold the affected product, at least until the requirements of paragraphs (b)(2) and (b)(3) of this section are met; (2) Perform a review to determine the acceptability of the affected product for distribution; (3) Take action, when necessary, with respect to the affected product to ensure that no product that is injurious to health or otherwise adulterated, as a result of the deviation, enters commerce; (4) Perform or obtain reassessment by an individual trained in accordance with Sec. 417.7 of this part, to determine whether the newly identified deviation or other unforeseen hazard should be incorporated into the HACCP plan.

Pre-shipment Review 417.5(c) Pre-shipment Review - Prior to shipping product, the establishment shall review the records associated with the production of that product, documented in accordance with this section, to ensure completeness, including the determination that all critical limits were met and, if appropriate, corrective actions were taken, including the proper disposition of product. Where practicable, this review shall be conducted, dated, and signed by an individual who did not produce the record(s), preferably by someone trained in accordance with Sec. 417.7 of this part, or the responsible establishment official.


FSRE/PHIS 59

HACCP Verification Task Methodology

This thought process should be utilized when verifying all of the HACCP regulatory requirements. The following diagram illustrates the thought process.

2. Select a specific production for the selected product type

4. Verify the four HACCP requirements at all CCPs for the specific production

6. Verify that the pre-shipment review has been performed

3. Review the HACCP plan for the selected product type

5. Verify any prerequisite programs that apply to the specific production

1. Select a

product type within the specified HACCP process category

Using a logical thought process to arrive at a sound, supportable

conclusion

Gather information by asking questions

Assess information

Determine compliance


FSRE/PHIS 60

Monitoring The regulation that applies to monitoring is:

9 CFR 417.2(c)(4)—List the procedures, and the frequency with which those procedures will be performed, that will be used to monitor each of the critical control points to ensure compliance with the critical limits

The establishment is required to develop and implement procedures to monitor each of the CCPs to ensure compliance with the critical limits (9 CFR 417.2(c)(4)). CSIs verify the monitoring requirement when performing the HACCP verification tasks. They can use either the recordkeeping or review and observation component, or both. The thought process they should use when verifying regulatory requirements includes:

gathering information by asking questions;

assessing the information; and

determining regulatory compliance.

Gather information by asking questions When CSIs verify HACCP implementation, they are to verify the regulatory requirements for monitoring by reviewing the HACCP plan, reviewing HACCP records, observing establishment employees performing monitoring activities, and taking measurements at the CCP. When verifying the monitoring requirements, CSIs should seek the answer to the following questions:

1. Does the HACCP plan list the monitoring procedures and frequencies that are

used to monitor each of the critical control points to ensure compliance with the critical limits?

2. Are the monitoring procedures being performed as described in the HACCP

plan? 3. Are the monitoring procedures being performed at the frequencies for the CCP

listed in the HACCP plan? 4. Are the critical limits met?

Assess the information To answer these questions the CSI should:

Review the HACCP plan

Review the HACCP monitoring records

Observe the establishment employees perform monitoring activities


FSRE/PHIS 61

Take measurements at critical control points

Now let‘s review each of these activities in detail. Reviewing the HACCP Plan When reviewing the establishment‘s HACCP plan for raw processes, CSIs will determine whether the HACCP plan includes the monitoring procedures and frequencies that are used to monitor each critical control point. It is very important for CSIs to be familiar with the monitoring procedures and frequencies in the current HACCP plan. CSIs should review the HACCP plan each time the monitoring requirement is verified since the establishment can modify the plan without notifying inspection. When reviewing the monitoring procedures and frequencies in the HACCP plan, the CSI should be able to

visualize what is occurring at the CCP. If CSIs do not understand how the establishment is performing the monitoring activity at the CCP, they are to seek clarification of the monitoring procedure from establishment management before continuing with the HACCP verification task. If the CSI cannot visualize what is occurring at the CCP, it could be an indication that the monitoring requirement is not being met. Monitoring Example 1: A CSI is performing the Slaughter HACCP verification task and verifying the monitoring requirements for the steam pasteurization CCP. She reviews the establishment’s HACCP plan and finds that it specifies monitoring personnel will observe and record the temperature as measured by the steam pasteurization cabinet gauges. The plan states that this monitoring procedure is to be performed hourly. Based upon her review of the plan, she decides the monitoring procedures and frequencies for this CCP are included in the HACCP plan. Reviewing HACCP Monitoring Records CSIs may decide to use the recordkeeping component to verify the monitoring requirement to determine if the establishment is performing the monitoring procedures at the frequency specified in the HACCP plan for raw processes. Monitoring Example 2: The CSI is performing the Slaughter HACCP verification task and verifying the monitoring requirements for the steam pasteurization CCP. Reviewing the records, she finds that monitoring personnel have recorded temperatures hourly as per the HACCP plan for this CCP. She determines that the establishment is monitoring at the frequency stated for this CCP and is in compliance. Observing Establishment Employees CSIs should observe an establishment employee performing HACCP monitoring activities in the raw process to determine whether the procedures are being carried out as written in the HACCP plan. Monitoring Example 3: The CSI is performing the Slaughter HACCP verification task and verifying the monitoring requirements for the steam pasteurization CCP. She observes the establishment monitoring personnel as they make the temperature determinations and document them on the records for the steam pasteurization CCP.


FSRE/PHIS 62

From her observation, she determines that the establishment is in compliance with the monitoring procedure because it is performed as described in the HACCP plan. Taking Measurements at Critical Control Points

CSIs should occasionally perform the establishment monitoring procedure to verify that product meets the critical limit. When CSIs take measurements to verify that product meets the critical limit, they are to use the calibrated instrument that the establishment uses for the monitoring or verification activities. Monitoring Example 4: Continuing with the Slaughter HACCP verification task from the above example, the CSI proceeds to the temperature gauges on the steam pasteurization cabinet and observes the temperature reading. She then compares her temperature reading with the temperature reading that was recorded by the establishment monitoring personnel. She determines that the establishment is in compliance because her temperature reading is within the critical limits and compares with the temperature reading that was recorded by establishment monitoring personnel.

Determine Compliance After the CSI has gathered and assessed all available information pertaining to the monitoring requirement, the CSI must determine regulatory compliance. Based on reviewing the monitoring records or on the basis of observing the establishment performing the monitoring procedures, the CSI must determine whether the monitoring procedures described in the HACCP plan are being performed in the manner and at the frequencies specified in the HACCP plan. If the CSI finds that the establishment has met all monitoring regulatory requirements, then there is no regulatory noncompliance. If the CSI finds that the establishment has not met all monitoring regulatory requirements, there is noncompliance. More information about making compliance determinations is provided in another section of the training.

Noncompliance with the Monitoring Requirement One or more of the following findings evidence that the establishment does not comply with 9 CFR 417.2(c)(4):

The HACCP plan does not include a written monitoring procedure to ensure that product meets the critical limit at each CCP.

Establishment employees do not implement the monitoring procedures as written in the HACCP plan.

Establishment employees do not implement the monitoring procedures at the frequency specified in the HACCP plan.

CSIs observe a deviation from the critical limit that was not detected by the establishment monitoring procedure. This finding includes any time CSIs observe the deviation in product that has already passed the CCP, product that is at the point of the CCP that would not be selected for monitoring by the establishment,


FSRE/PHIS 63

or product that was selected for monitoring but the deviation was not detected by the establishment.

The following are examples of noncompliance with the monitoring requirement. Noncompliance Example 1: The HACCP plan specifies that monitoring personnel will examine 20 poultry carcasses for visible fecal contamination off-line at the pre-chill inspection station every hour. While performing verification for the monitoring requirement, the CSI observes that the procedure is being performed on-line with only 10 carcasses per hour. The establishment is not conducting the monitoring procedures as specified in the HACCP plan. Noncompliance Example 2: The HACCP plan specifies that the concentration of the organic acid beef carcass rinse will be monitored hourly by establishment personnel and recorded in the Pathogen Reduction Logbook. The CSI reviews the logbook and finds that the monitoring checks were recorded every 2 hours. Upon further inquiry, she determines that the monitoring checks were actually being performed every 2 hours. The establishment is not performing the monitoring procedures at the frequencies specified in the HACCP plan. Noncompliance Example 3: The HACCP plan specifies that the concentration of the trisodium phosphate (TSP) rinse will be maintained at a minimum of 8 percent. The CSI observes the concentration gauge on the TSP equipment and finds that it reads 6 percent. The critical limit for the CCP is not met. If CSIs find a monitoring noncompliance, they are to take a regulatory control action, if necessary, to prevent adulterated product from entering commerce. In addition, CSIs are to consider whether the noncompliance may have resulted in adulterated product entering commerce. If they find that adulterated product may have entered commerce, CSIs are to notify DO personnel through supervisory channels immediately. CSIs document the HACCP verification task results in PHIS including any noncompliance in accordance with the discussion of documentation and enforcement in a later section.


FSRE/PHIS 64

Workshop: Monitoring Refer to the handout and to FSIS PHIS Directive 5000.1 to complete the following questions.

1. Fill in the Blanks:

9 CFR 417.2(c)(4)—List the _________ ________, and the ______________ with

which those _________________will be performed, that will be used to

______________ each of the critical control points to ensure compliance with the

critical limits

2. A CSI is assigned to a small goat slaughter establishment and is performing the

Slaughter HACCP verification task. He is verifying the monitoring requirement for the slaughter food safety standard CCP. Review the HACCP plan and answer the following questions.

Goat Slaughter HACCP Plan

Process Step

CCP Number

CCP Description

Critical Limits Monitoring Procedures

Carcass Trim zero tolerance

1B No visible contamination

No visible feces, milk, or ingesta

Every carcass will be visually examined by the carcass trimmer for visible feces, ingesta, or milk

a. If the CSI decides to perform the recordkeeping component in verifying the

monitoring requirement, what question would he seek the answer to when reviewing the HACCP plan? What would the answer to the question be?

b. Review the record below and answer the questions. In reviewing the monitoring

records for the recordkeeping component, what questions would the CSI seek the answer to?

Slaughter Number

Feces, ingesta, milk present? (Y or N)*

Performed by

Date: 2-8-12 Time

Corrective Actions and/or Comments

1 N TDM 0840

2 N TDM 0915

3 N TDM 0955

4 N TDM 1035

5 N TDM 1140

6 N TDM 1229

7 N TDM 1320

8 N TDM 1405

9 N TDM 1455

* N indicates no feces, ingesta or milk present. Y indicates feces, ingesta or milk

was observed. If so, described in comments.


FSRE/PHIS 65

c. Where would he perform this component?

d. If he decides to perform the review and observation component, how would he proceed?

3. Case Study. A Consumer Safety Inspector, assigned to Est. 38M as the Inspector-

in–Charge. Est. 38M is a small cull beef slaughter facility with a simple processing operation. A Slaughter HACCP verification task appears on today‘s PHIS task calendar.

The CSI verifies that the establishment meets the regulatory requirements for monitoring. After he reviews of the establishment‘s written HACCP plan, he confirms that the slaughter process contains only one CCP, which is located in the carcass cooler. The critical limit for this CCP is zero for fecal, milk, or ingesta contamination.

He proceeds to the location of the CCP in the carcass cooler and selects a random sampling of beef sides. Within his random sample, he notes a side of beef that has a two-inch by one-inch streak of ingesta on its left foreshank.

Answer the following questions:

a. Is there evidence of product adulteration?

b. Is there a food safety concern as a result of this situation? Why?

c. What is the regulation that relates to this situation?

d. What action should he take?


FSRE/PHIS 66

4. Case Study. A Consumer Safety Inspector, is assigned to Est. 38M, a large feedlot cattle slaughter facility. She reviews Est. 38M‘s HACCP program for slaughter and she finds that there is a designated critical control point in the carcass cooler for monitoring the temperature of carcasses during the chilling process. The establishment‘s monitoring procedure for this CCP states, ―Carcass temperature checks are taken daily to verify that all carcasses are 40º F or below within 8 hours of slaughter processing. The monitor measures the temperature of five randomly selected carcasses 8 hours after the first carcasses enter the cooler. Temperatures are taken 1 mm under fascia on the inside round.‖ Subsequently, as part of a routine Slaughter HACCP verification task, she chooses to verify that this activity is being performed accordingly.

Later that day, she observes a quality control (QC) technician monitoring this CCP by taking temperature measurements of five selected carcasses by inserting the thermometer into the brisket muscle of each carcass. She observes and records the results of these measurements for her personal notes. The five carcass temperatures are 37º F, 39º F, 37º F, 38º F and 37º F. The QC technician records these same temperature results on the HACCP record for the CCP.

a. What is the regulation that applies to this situation? b. Is there a deviation from the critical limit of this CCP? c. Are the monitoring procedures being performed as described in the HACCP

plan? Explain your answer. d. Has a noncompliance occurred? If so, what type of noncompliance?

5. Case Study. The following is the monitoring procedure for the pre-evisceration wash

as written in a pork slaughter HACCP plan:

QC evaluates 10% of carcasses for visible contaminants. QC monitors washing and antimicrobial equipment to ensure proper adjustment. Concentration of antimicrobial is tested.

Is anything missing according to 417.2(c)(4)? If so, what?


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Verification Verification activities are tools the establishment uses to establish that the HACCP plan is being followed correctly. The regulations that apply to verification procedures and frequencies are:

9 CFR 417.2(c)(7)—List the verification procedures, and the frequency with which those procedures will be performed, that the establishment will use in accordance with §417.4 of this part.

9 CFR 417.4(a)(2)(i)(ii)(iii)—Ongoing verification activities include, but are not limited to: The calibration of process-monitoring instruments; direct observations of monitoring activities and corrective actions; and the review of records generated and maintained in accordance with §417.5(a)(3) of this part.

The establishment is required to develop and implement procedures to verify the ongoing effective implementation of the HACCP plan (9 CFR 417.2(c)(7) and 417.4(a)(2)). The verification procedures provide for the calibration of process monitoring instruments, direct observation of monitoring activities and corrective actions, and review of HACCP records unless one or more activity is not applicable in a particular establishment. The verification procedures may also include other activities the establishment develops to verify the effective implementation of the HACCP plan (e.g. microbial sampling of products). The verification procedures may be particular to each CCP or may apply more broadly across all CCPs. For example, an establishment may use thermometers to monitor several different CCPs. It would not be necessary to have a specific thermometer calibration procedure for each CCP. The establishment could have a single thermometer calibration procedure that covers the HACCP plan as a whole. CSIs verify the verification requirement by performing the HACCP verification procedures. They can use either the recordkeeping, or review and observation component, or both. The thought process they should use when verifying regulatory requirements includes:



determining regulatory compliance. This thought process should be utilized when verifying all of the regulatory requirements.

Gather information by asking questions Verify the regulatory requirements for verification by reviewing the HACCP plan, HACCP records, and observing establishment employees performing verification activities. When verifying the verification requirements, CSIs should seek the answer to the following questions:


FSRE/PHIS 68

1. Does the HACCP plan contain procedures and frequencies for the calibration of the process-monitoring instruments?

2. Does the HACCP plan contain procedures and frequencies for direct

observations of monitoring activities and corrective actions? It is important that the establishment implement corrective actions that meet the requirements of 9 CFR 417.3(a) each time that a deviation from a critical limit occurs, and the requirements of 9 CFR 417.3(b) each time an unforeseen hazard occurs. Since it cannot be predicted when a deviation from a critical limit or an unforeseen hazard will occur, it would be counterproductive to require that the establishment have specific procedures and frequencies in its HACCP plan for directly observing corrective actions. It is necessary, however, for an establishment to directly observe corrective actions frequently enough to verify that these actions are being performed by establishment employees in a manner that meets the applicable regulatory requirements. Under the regulations (417.4(a)(2)(ii)), the establishment is to document these direct observations of corrective action in the same manner that it documents other verifications.

3. Does the HACCP plan list procedures and frequencies for the review of records generated and maintained in accordance with 9 CFR 417.5(a)(3)?

4. Does the HACCP plan list product sampling as a verification activity? 5. Are process-monitoring instrument calibration activities conducted as per the

HACCP plan? 6. Are direct observation verification activities conducted as per the HACCP

plan?

7. Are records generated in accordance with 9 CFR 417.5(a)(3) [HACCP

records] being reviewed by the establishment?

Assess the information

To answer these questions the CSI should:

Review the HACCP plan

Review HACCP records

Observe establishment employees performing verification activities When the CSIs verify HACCP implementation, they are to perform the following activities to verify that the establishment is meeting the verification regulatory requirements: Now let‘s review each of these activities in detail. Reviewing HACCP Plan When reviewing the establishment‘s HACCP plan for raw processes, CSIs determine whether it includes verification procedures such as direct observation procedures and


FSRE/PHIS 69

frequencies, records review procedures and frequencies, and process monitoring instrument calibration procedures and frequencies. All three verification activities do not have to occur at each CCP, but all three should be addressed in the HACCP plan. However, if the verification activity is applicable at a CCP and it is not being addressed in the HACCP plan, the establishment must have support in accordance with 417.5(a)(2) for not performing the verification activity. The CSI should review the HACCP plan each time the verification requirement is verified since the establishment can modify the plan without notifying inspection. Verification Example 1: A CSI is performing the Slaughter HACCP verification task in a poultry slaughter operation and verifying the establishment verification requirements for the chilling CCP. He reviews the establishment’s HACCP plan and finds that it specifies verification personnel will review the temperature records and observe the monitoring procedures at this CCP once per shift. It also specifies that maintenance personnel will verify the accuracy of the temperature recording charts once per shift by taking an independent temperature check. Based upon his review of the HACCP plan, he determines that the establishment is in compliance with 417.2(c)(7) and 417.4(a)(2)(i)(ii)(iii). It is important to point out here that some HACCP plans might not contain all three verification activities that are found in 417.4(a)(2)(i)(ii)(iii). If an establishment has a CCP that is monitored without the use of process monitoring equipment, there would be no need for process monitoring equipment calibration verification procedures. If the monitoring procedure involves automatic monitoring devices and does not require any human action to accomplish the monitoring of the critical limit, then direct observation of the automatic portion of the monitoring procedure is not required. If an establishment only has one employee, it would not be possible for that person to conduct a direct observation of the monitoring activity. In this situation, the HACCP plan would not need to list a direct observation of the monitoring activities. Verification Example 2: A CSI is performing the Slaughter HACCP verification task in a very small sheep and goat slaughter operation and verifying the establishment verification requirements for the contamination (feces/ingesta/milk) CCP. She reviews the establishment’s HACCP plan and finds that it does not provide for direct observation of monitoring procedures. She determines that the establishment only has one employee working on the slaughter floor and it would be impossible for direct observation of monitoring to take place. There is no noncompliance in this instance. Reviewing HACCP Verification Records CSIs should review the verification records to determine if the establishment is performing the verification procedures at the frequencies specified in the HACCP plan for raw processes. Verification Example 3: A CSI is performing the Raw-Intact HACCP verification task in a poultry cut-up operation and verifying the verification requirements for the finished product storage CCP. He reviews the establishment’s HACCP plan and finds one of the verification procedures specifies the HACCP Coordinator will observe maintenance personnel perform the monitoring check once per shift. He reviews several recent room temperature logs and observe that the HACCP Coordinator has recorded results for the


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verification procedure for each shift. He determines that this requirement is in compliance because the verification procedures are being performed at the frequency specified in the HACCP plan.

Observing Establishment Employees CSIs should observe an establishment employee performing the verification activities listed in the plan to determine if the procedures are being carried out as written in the HACCP plan. Verification Example 4: Continuing with the Raw-Intact HACCP verification task from the above example, the CSI reviews of the establishment’s HACCP plan revealed that the other verification procedure specified is that the HACCP Coordinator will check the accuracy of the finished product storage temperature monitoring equipment daily, and calibrate as necessary. He proceeds to the HACCP office, and observe the thermometers being checked for accuracy, and results being recorded on the thermometer calibration log. He determines that this requirement is in compliance because the verification procedure is being carried out as written in the HACCP plan. Keep in mind that the establishment employee performing the direct observation ongoing verification procedure should directly observe the employee doing the monitoring activity. An establishment verifier that is performing the same activity as the monitor does not meet the regulatory requirement in 417.4(a)(2)(ii). Verification Example 5: Continuing with the Raw-Intact HACCP verification task, the CSI decides to observe the direct observation verification procedure. He observes the HACCP Coordinator in the finished product storage area, observing the maintenance personnel performing the monitoring check. From his observations, he determines that the direct observation verification procedure requirements are met. Product sampling is considered a verification activity if the establishment incorporates it as such into the HACCP plan. It may be used to verify a CCP or it may be used as an overall verification of the HACCP system, (e.g., end-product sampling) and not be associated with any one CCP. For example, some establishments may include their E. coli O157:H7 testing programs in their HACCP plans. When that is the case, CSIs must verify the testing program as part of the verification requirement (§417.4(a)(2)). If the establishment received positive results that indicate the presence of a food safety hazard, CSIs are to verify that the establishment met the corrective action requirements of 9 CFR 417.3. Verification Example 6: A CSI is performing the Raw Non-Intact HACCP verification task in a raw ground beef operation and verifying the establishment verification requirements for the finished ground beef temperature CCP. She reviews the establishment’s HACCP plan and finds one of the verification procedures specifies the establishment will conduct finished product testing for E. coli O157:H7 daily. She observes the HACCP Coordinator take the samples from the finished ground beef. She observes the production lot control procedures. She reviews several days’ records in the laboratory testing log and finds negative test results were recorded for each day. She determines that the establishment is in compliance because the verification procedures are being performed as described, and at the frequency stated.


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Determine Compliance After the CSIs have gathered and assessed all available information pertaining to the verification requirement, they must determine regulatory compliance. If they find that the establishment has met all verification regulatory requirements, then there is no regulatory noncompliance. If they find that the establishment has not met all verification regulatory requirements, there is noncompliance. More information about making compliance determinations is provided in another section of the training. If CSIs find a verification noncompliance, they are to consider whether the noncompliance may have resulted in adulterated product entering commerce. For example, if the verification results show that establishment employees have not been implementing the monitoring procedure correctly, is there sufficient information to determine whether the product met the critical limit? If the establishment cannot demonstrate that the product met the critical limit, CSIs are to take a regulatory control action on any affected product to prevent it from entering commerce. If adulterated product may have entered commerce, CSIs are to contact their supervisor immediately to discuss the issue.

Noncompliance with the Verification Requirement The following are examples of noncompliance with the verification requirement (417.4(a)(2):

The HACCP plan does not include written verification procedures and frequencies for calibration of any process monitoring instruments used to monitor the CCPs (also noncompliance with 417.2(c)(7)). Calibration methods should be in accordance with accepted procedures or manufacturer instructions.

The HACCP plan does not include written verification procedures and frequencies for direct observation of monitoring activities (also noncompliance with 417.2(c)(7)).

The HACCP plan does not include written verification procedures and frequencies for review of records (also noncompliance with 417.2(c)(7)).

Establishment employees do not implement the verification procedures at the frequencies specified in the HACCP plan.

The HACCP plan does not include written description of additional verification procedures (if any) and frequencies the establishment uses to verify the effective implementation of the HACCP plan (e.g. microbiological sampling) (also noncompliance with 417.2(c)(7)).

Establishment employees do not implement the verification procedures as written in the HACCP plan.

The establishment verification employee does not actually observe the monitoring employee performing the monitoring procedure during the direct observation verification procedure.


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The verification results indicate that the establishment is not implementing the HACCP plan as written, and the establishment has not corrected the situation.

The following are examples of noncompliance with the verification requirement. Noncompliance Example 1: The HACCP plan, which has one CCP at the product storage area, specifies that the verification procedure is that the QC supervisor will calibrate thermometers daily and that the QC supervisor will review the finished product room temperature logs daily. The CSI observes that there is no direct observation verification procedure listed for this HACCP plan. She recalls that the regulations require that all three verifications must be listed in the HACCP plan when they are applicable. One verification, direct observation, is missing. The HACCP plan does not, at a minimum, list records review verification procedures; direct observation verification procedures; or calibration of process instruments verification procedures. Noncompliance Example 2: The HACCP plan specifies that the verification procedure for the finished product storage area CCP is that the QC supervisor will calibrate thermometers, that the QC supervisor will observe the establishment employee performing the monitoring check, and that the QC supervisor will review the finished product room temperature logs daily. The CSI observes that there is no frequency listed for the calibration of thermometers. The HACCP plan does not list the frequencies at which the calibration verification procedure will be performed. Noncompliance Example 3: The HACCP plan specifies that one of the verification procedures for the finished product storage area CCP is that the QC supervisor will review the finished product room temperature logs daily. The CSI’s review of the record reveals that there is no documentation of this verification procedure for the last three days. The establishment is not performing the records review verification procedures as specified in the HACCP plan. Noncompliance Example 4: The HACCP plan specifies that one of the verification procedures for the product storage area CCP is that the QC supervisor will observe the establishment employee performing the monitoring check. The CSI observes that the QC supervisor performs a monitoring check and records it on the product storage area room temperature log as a direct observation verification procedure. She observes that the QC supervisor did not perform a direct observation of the establishment employee performing the monitoring check as described in the HACCP plan. The establishment is not performing the direct observation verification procedures as specified in the HACCP plan. Noncompliance Example 5: The HACCP plan specifies that one of the verification procedures for the product temperature CCP is that the QC supervisor will verify the accuracy and calibrate, if needed, all stem thermometers daily. The CSI observes that the QC supervisor verifies the accuracy of only about half of the thermometers. When the CSI asks, he is provided the explanation that "we have learned that checking every other thermometer is sufficient." The establishment is not performing the process monitoring verification procedures as specified in the HACCP plan. Noncompliance Example 6: The HACCP plan specifies that one of the verification procedures is that finished product will be sampled and tested for E. coli O157:H7 once


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per day. When the CSI reviews the micro records he observes that there are only results for two samples a week. When he asks about these results he is told that the financial department required QC to cut back on the number of samples sent to outside labs. The establishment is not performing one or more of the verification procedures listed in the HACCP plan at the frequencies specified in the HACCP plan. CSIs document the HACCP verification task results in PHIS including any noncompliance in accordance with the discussion of documentation and enforcement in a later section.


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Workshop: Verification Refer to the handout and to FSIS PHIS Directive 5000.1 to complete the following questions.

1. Fill in the Blanks: 9 CFR 417.2(c)(7)—List the _____________ procedures, and the _____________ with

which those procedures will be performed, that the establishment will use in accordance

with §417.4 of this part.

9 CFR 417.4(a)(2)(i)(ii)(iii)—Ongoing verification activities include, but are not limited to:

(i) the _____________ of process-monitoring instruments; (ii) _____________ of

monitoring activities and corrective actions; and (iii) the ______________ generated and

maintained in accordance with §417.5(a)(3) of this part.

2. A CSI is performing the Raw-Intact HACCP verification task in a poultry-boning

operation and verifying the establishment verification requirements for the chilling CCP. While performing the task, she reviews the establishment's HACCP plan:

HACCP plan: raw boneless skinless chicken breasts CCP # Critical

Limits Monitoring Procedures & Frequencies

HACCP Records


Corrective Actions

2 Chilling

Product temperature not to exceed 40 degrees F

QC personnel will record temperature every 4 hours

Product Temperature Log Corrective Action Log Thermometer Calibration Log

HACCP Coordinator will review the Product Temperature Log and observe QC personnel performing monitoring once per shift QC will check all thermometers used for monitoring devices for accuracy by immersion in slush ice, and will verify to within 2 degrees F daily All thermometers found to be inaccurate will be calibrated using immersion in slush ice and re-evaluated

Corrective actions shall meet all requirements of Part 417.3(a)

a. Does the HACCP plan contain procedures and frequencies for the calibration of

the process-monitoring instruments?

If yes, what is the procedure?


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If yes, what is the frequency?

b. Does the HACCP plan contain procedures and frequencies for direct observation of monitoring activities and corrective actions? If yes, what is the procedure? If yes, what is the frequency?

c. Does the HACCP plan list procedures and frequencies for the review of records generated and maintained in accordance with 9 CFR 417.5(a)(3)? If yes, what is the procedure? If yes, what is the frequency?

d. How would you determine whether process-monitoring calibration activities were being conducted as per the HACCP plan?

If you perform the review and observation component: If you perform the recordkeeping component:

e. How would you determine whether direct observation verification activities were being conducted as per the HACCP plan? If you perform the review and observation component:

If you perform the recordkeeping component:


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f. How would you determine if records generated in accordance with 9 CFR 417.5(a)(3) were being reviewed by the establishment? If you perform the review and observation component: If you perform the recordkeeping component:

She requests the Thermometer Calibration Logs and the Product Temperature Logs.

Thermometer Calibration Log Calibrate to 32º F in slush ice water

Thermometer ID #

Temperature Adjustment Required?

Date Time Initials

A1 32 No 1-2-12 5:23 am NM

A2 32 No 1-2-12 5:25 am NM

Product Temperature Log Critical limit 40°F or below Date: 1-2-12

Time Temperature Initials Comments Verification

6:20 am 36 NM

7:30 am 38 NM Direct observation, results as per HACCP plan JP 7:30 am, 1-2-12

g. What do you conclude from the records?

She proceeds to the storage cooler and observes the HACCP coordinator watching the QC personnel perform monitoring, recording the monitoring check, reviewing the Product Temperature Log, and signing the record.

h. What is your determination regarding compliance based on what she has seen?

3. A HACCP plan‘s CCP at receiving lists as a monitoring activity ―the receipt of a letter

of guaranty that validated antimicrobial interventions were applied and a certificate of analysis (COA) for E coli O157:H7 for each product lot‖ and QC‘s review of the receiving log. There is no calibration verification procedure listed for this CCP.

Does this meet regulatory requirements? Please explain.


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4. A Consumer Safety Inspector is assigned to a large market hog slaughter facility.

Walking through the kill floor, she sees the QA Supervisor at the critical control point (CCP) monitoring location after the head wash cabinet. He is examining the outer surfaces of a representative sample of swine heads as the heads exit the head wash cabinet. He is alone and appears to be performing the monitoring procedure for the CCP. Usually, she sees one of the QA technicians performing this monitoring activity. Curious, she pauses to observe the QA Supervisor‘s activities. When he completes the check, he writes his initials in the ‗Verified by‘ column on the Head Wash CCP HACCP record, then writes in the current time (0820 hours) and today‘s date next to his initials. A previous entry indicates a QA technician had made a monitoring check at 0720 hours. Puzzled by the QA Supervisor‘s actions, the CSI asks, ―Did you just complete your daily verification check for monitoring this CCP?‖ and he replies, ―Yes.‖

She decides to review the written HACCP plan and proceeds to the QA office. She reviews the plan and confirms that the monitoring procedures for the CCP after the head wash cabinet are performed every two hours. The verification procedures for monitoring the CCP are ‖Once per shift the QA supervisor will review all logs and observe trained QA personnel monitoring for visible contamination.‖ a. Are the direct observation verification procedures being performed as described

in the HACCP plan? Please explain.

b. Has a noncompliance occurred? c. What is the regulation that applies to this situation?


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Recordkeeping CSIs verify the recordkeeping requirements when performing the HACCP verification tasks. CSIs verify the recordkeeping requirements by reviewing the following:

The HACCP plan

The HACCP records

CSIs may use the recordkeeping and review and observation components to verify the establishment complies with the recordkeeping regulations. In most instances, they only use the recordkeeping component of the HACCP verification task when they are verifying the recordkeeping requirements. CSIs must use the review and observation component to verify that establishment employees make an entry on the record at the time the specific event occurs (record authenticity). There are several regulations that pertain to HACCP recordkeeping practices. The table below summarizes the recordkeeping regulatory requirements.

HACCP Recordkeeping Requirements

Now let‘s go into more detail about each requirement as they relate to raw process HACCP plans. These regulations will be covered in Sections A-F as follows.

Regulatory Recordkeeping Requirement

Recordkeeping system 417.2(c)(6)

HACCP Records 417.5(a)(3)

Record Authenticity 417.5(b)

Computerized Records 417.5(d)

Record Retention 417.5(e)(1) and (2)

Official Review of Records/Plans 417.5(f)


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A. Recordkeeping System The regulatory requirement for a recordkeeping system is:

9 CFR 417.2(c)(6)—Provide for a recordkeeping system that documents the monitoring of the critical control points. The records shall contain the actual values and observations obtained during monitoring.

CSIs verify this requirement using the recordkeeping components while performing the HACCP verification task.

Gather information by asking questions In performing the tasks, CSIs should seek the answer to the following questions:

1. Does the HACCP plan set out a recordkeeping system that documents the monitoring of the CCP?

2. Do the records contain actual values and observations obtained during

monitoring?

Assess the information To verify that the establishment is in compliance with this regulation, CSIs should review the following:

HACCP plan

HACCP monitoring records Reviewing the HACCP Plan for Recordkeeping System Requirement In reviewing the HACCP plan for compliance with 417.2(c)(6), CSIs should verify that it lists the records that will be used to document the monitoring of critical control points. Recordkeeping Example 1:

HACCP plan: raw boneless skinless chicken breasts CCP # Critical

Limits Monitoring Procedures & Frequencies

HACCP Records


Corrective Actions

2 Chilling

Product temperature not to exceed 40 degrees F

QC personnel will record temperature every 4 hours

Product Temperature Log Thermometer Calibration log

HACCP Coordinator will review the Product Temperature Log and observe QC personnel performing monitoring once per shift

Corrective actions shall meet all requirements of Part 417.3(a)


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The establishment’s HACCP plan identifies the ―Product Temperature Log‖ as the record that the establishment uses to document product temperatures taken at the chilling step. The establishment is in compliance with 9 CFR 417.2(c)(6) because it has a recordkeeping system for documenting the monitoring activities at the CCP. Reviewing HACCP Records for Recordkeeping System Requirement In reviewing the HACCP records for compliance with 417.2(c)(6), CSIs should verify that it contains the actual values and observations that were obtained during the monitoring of critical control points. Recordkeeping Example 2: A CSI is performing the Slaughter HACCP verification task in a poultry slaughter operation. He reviewed the HACCP plan to verify that it lists the records used to document the monitoring of the critical control points and he found the following records listed for the fecal CCP: Establishment Finished Product Standards Form, Antimicrobial Log, Equipment Maintenance Log, and Corrective Action Log. He also reviewed the Fecal Monitoring Log and observed that monitoring personnel have recorded the actual time, test results, and initials. Based upon his review, he determined that the establishment is in compliance with this part of the recordkeeping requirements of 417.2(c)(6) at this CCP. Recordkeeping Example 3: A CSI is performing the HACCP verification task to verify the establishment recordkeeping requirements for the only CCP, product storage. He reviewed the establishment’s HACCP plan and found that it lists the records used to document the monitoring of the critical control points, including the room temperature log, calibration log, and the corrective action log. He also found the monitoring procedure specifies that maintenance personnel observe the product storage area thermometer every two hours, and record results on the room temperature log. He reviewed the room temperature logs and observed that the maintenance personnel have recorded actual temperatures and times on the form, and initialed each result. Based upon his review, he determined that the establishment is in compliance with this part of the recordkeeping requirements of 417.2(c)(6) at this CCP.

Determine Compliance After the CSIs have gathered and assessed all available information pertaining to the recordkeeping system requirement, they must determine regulatory compliance. If they find that the establishment has met all regulatory requirements for §417.2(c)(6), then there is no regulatory noncompliance. If they find that the establishment has not met all §417.2(c)(6) regulatory requirements, there is noncompliance. More information about making compliance determinations is provided in another section of the training. Noncompliance with the Recordkeeping System Requirement The following are examples of noncompliance with 417.2(c)(6). Noncompliance Example 1: A CSI is reviewing the HACCP monitoring log for the chilling CCP in a large beef slaughter establishment and finds that monitoring personnel are placing a check mark on the Cooler Temperature Log instead of the actual thermometer reading as specified in the HACCP plan. The monitoring personnel are not recording actual values as required in 417.2(c)(6).


FSRE/PHIS 81

Noncompliance Example 2: A CSI is reviewing the HACCP plan for a very small swine slaughter establishment and he notices that there is a CCP for finished product storage but the plan does not provide for any records for documenting the monitoring of cooler temperatures. The HACCP plan does not provide for a recordkeeping system that documents the monitoring of the CCP.


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B. HACCP Records Requirement The regulatory requirement for HACCP records is:

9 CFR 417.5(a)(3)—The establishment shall maintain: Records documenting the monitoring of CCP and their critical limits, including the recording of actual times, temperatures, or other quantifiable values, as prescribed in the establishment’s HACCP plan; the calibration of process-monitoring instruments; corrective actions, including all actions taken in response to a deviation; verification procedures and results; product code(s), product name or identity, or slaughter production lot. Each of these records shall include the date the record was made.

CSIs will verify compliance with this regulation by performing the HACCP verification task. CSIs will use the recordkeeping component to verify this regulation. The thought process CSIs should use when verifying regulatory requirements includes:




Gather information by asking questions When reviewing HACCP records for compliance with 417.5(a)(3), CSIs should seek the answer to the following questions:

1. Do the records document the monitoring of CCP and their critical limits? 2. Do the records include actual times, temperatures, or other quantifiable

values, as prescribed in the establishment‘s HACCP plan? 3. Do the monitoring, verification, and corrective action records include product

codes, product name or identity, or slaughter production lot, and the date each record was made?

4. Are the verification procedures and results of those procedures documented?

5. Is the time recorded when the verification activity was performed?

6. Does the record contain the date the record was made?

7. Are the process-monitoring calibration procedures and results being recorded?


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Assess the information To answer these questions, the CSI should review:

HACCP records that document monitoring and verification procedures for CCP and their critical limits

Documentation of corrective actions taken in response to a deviation from a critical limit, a deviation not covered by a critical limit, or an unforeseen hazard.

When reviewing the HACCP records for compliance with 417.5(a)(3), CSIs will verify that the records document the monitoring of CCP and their critical limits, including the recording of actual times, temperatures, or other quantifiable values, as prescribed in the establishment‘s HACCP plan and verification procedures and results. Recordkeeping Example 4: A CSI is performing the Slaughter HACCP verification task in a pork slaughter operation and as part of the task he is verifying all requirements for all CCP for a specific production. As part of his review, he examines all HACCP records produced. While verifying the recordkeeping requirement in 417.5(a) (3) for the pre-evisceration carcass rinse CCP. He reviews the HACCP records for this CCP and finds that the monitoring and verification personnel have made the following entries:

Antimicrobial Intervention Log Date Lot No. Time Solution

Conc. Pressure Corrective

Actions Monitored by

Verified by *

2-1-2012

1

0730

2.2%

30psi

- TDM

PP

*direct observation verification-results as per HACCP plan

Based upon his records review, he determines that the establishment is in compliance with this part of the recordkeeping requirements of 417.5(a)(3). In addition, he will verify that monitoring and corrective action records include product codes, product name or identity, or production lot, and the date the record was made. Recordkeeping Example 5: A CSI is performing the Raw Non-Intact verification task in a raw pork sausage operation and as part of the task he is verifying all requirements for all CCP for a specific production. As part of his review, he examines all HACCP records produced. He observes that each of the records includes actual values, the production code and the product name, where applicable, and that each record includes the date. Based on his review, he decides that the establishment is in compliance with this part of the recordkeeping requirement. The CSI will also verify that process monitoring calibration procedures and results are recorded if that is part of the HACCP plan. Recordkeeping Example 6: A CSI is performing the Slaughter HACCP verification task in a poultry slaughter operation and as part of the task she is verifying the recordkeeping requirement in 417.5(a)(3) for the carcass chilling CCP. She reviews the HACCP records for this CCP and finds that the verification personnel have made the following entries:


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Thermometer Calibration Log Calibrate to 32º F in slush ice water

Date Time Area Thermometer ID

Personal Thermometer

Reading

Adjustment Required

Initials Comments

2-1-2012

0800

Carcass Chilling

2A

32

No

TDM

Based upon her records review, she determines that the establishment is in compliance with this part of the recordkeeping requirements for the chilling CCP. She would then proceed to verify the other recordkeeping requirements.

Determine Compliance After the CSIs have gathered and assessed all available information pertaining to the HACCP records requirement, they must determine regulatory compliance. If they find that the establishment has met all regulatory requirements for §417.5(a)(3), then there is no regulatory noncompliance. If they find that the establishment has not met all regulatory requirements for §417.5(a)(3), there is noncompliance. More information about making compliance determinations is provided in another section of the training. Noncompliance with the HACCP Records Requirement One or more of the following findings evidence that the establishment does not comply with 9 CFR 417.5(a)(3):

Establishment monitoring records do not document all monitoring activities or do not include actual times, temperatures, or other quantifiable values.

Establishment verification records do not document all verification activities or do not include the results of verification procedures.

Establishment corrective action records do not document all corrective actions performed by the establishment.

Note: When CSIs observe that records are missing. They are to carefully consider whether the record is missing because the establishment employee failed to perform the specified task or because the employee failed to make the appropriate record entry. If they determine that the employee failed to perform the specified procedure (monitoring, verification, or corrective action), they are to document noncompliance with the applicable regulation (9 CFR 417.2(c)(4), 417.4(a), or 417.3, respectively) rather than 9 CFR 417.5(a)(3).

Establishment HACCP records (including pre-shipment review) do not include product names, product codes, or other identifying information sufficient to demonstrate which specific production is covered by a particular record.

The following are examples of noncompliance with 417.5(a)(3): Noncompliance Example 3: A CSI is reviewing the monitoring records for the poultry TSP antimicrobial spray CCP and he finds there is no record of a monitoring procedure


FSRE/PHIS 85

being performed in the last 3 hours. The HACCP plan specifies that monitoring at this CCP will take place on an hourly basis. He asks the establishment about these missing records. They provide a signed statement from the monitor stating that the monitoring took place, and that the results were within critical limits, but that the monitor neglected to write this on the record at the time it was done. The CSI concludes that the monitoring took place but it was not recorded. The records do not have the monitoring results recorded. Noncompliance Example 4: A CSI is reviewing the poultry chiller CCP monitoring records and finds that the temperatures have been recorded on the monitoring log but no times are recorded. Upon further investigation, she was provided evidence that the monitoring checks were performed at the proper times. The records do not include the actual times that monitoring is performed. Noncompliance Example 5: A CSI is reviewing the monitoring records for the carcass wash CCP in a poultry establishment and he finds that the chlorine monitoring results are recorded simply as ―O.K.‖ instead of the actual value in ppm as described in the HACCP plan. The records do not include the actual values as required.

Noncompliance Example 6: A CSI is reviewing the HACCP records for the finished product storage CCP in a small sheep slaughter operation and she notices that the product temperature log does not record the lot number or product ID as is specified in the HACCP plan. The monitoring entries do not include the product identification or code. Noncompliance Example 7: A CSI is reviewing the verification records for the organic acid pre-evisceration rinse CCP in a large swine slaughter operation and he notices that the verification results are being recorded once per day. The HACCP plan lists the frequency of this verification as twice per shift. The establishment provides other written evidence that the verification procedures were performed. The verification procedures and results are not being recorded. Noncompliance Example 8: A CSI is reviewing the corrective actions for the fecal CCP in a poultry slaughter operation and he notices the establishment monitoring procedure at 0700 had a fecal finding and the following procedure at 0710 also had a fecal finding. He looks at the corrective action log and finds no record of any corrective actions. He requests more information and the establishment provides satisfactory evidence that the corrective actions were performed but not recorded. The corrective actions taken in response to a deviation from a critical limit are not recorded. Noncompliance Example 9: A CSI is reviewing the records for the thermal organic acid rinse CCP prior to chilling in a beef slaughter operation and she finds that the calibration for the temperature recording device had not been documented for the shift. The HACCP plan specifies that the calibration will be performed and recorded prior to every shift startup. She requests more information and the establishment provides her with evidence that the calibration was performed. The results of calibration of process monitoring instruments are not recorded. CSIs document the HACCP verification task results in PHIS including any noncompliance in accordance with the discussion of documentation and enforcement in a later section.


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C. Records Authenticity The regulatory requirement for record authenticity is:

9 CFR 417.5(b)—Each entry on a record maintained under the HACCP plan shall be made at the time the specific event occurs and include the date and time recorded, and shall be signed or initialed by the establishment employee making the entry.

CSIs will verify compliance with this regulation by performing the HACCP verification task. They are going to use the recordkeeping and the review and observation component. The thought process CSIs should use when verifying regulatory requirements includes:




Gather information by asking questions When verifying that the establishment is in compliance with this requirement, CSIs should seek the answer to these questions:

1. Was each entry on the record made at the time the event occurred? 2. Does each entry include the time?

3. Was each entry on the record signed or initialed by the establishment

employee making the entry? 4. Does each record include the date?

Assess the information CSIs will review: HACCP records documenting monitoring, verification activities, and corrective action. When reviewing the HACCP records for compliance with 417.5(b), CSIs should verify that each record entry is made at the time the event occurred and includes the time as part of the entry. In addition, they should verify that the record was signed and initialed by the establishment employee making the entry. Recordkeeping Example 7: A CSI is performing the Raw Intact HACCP verification task in a poultry cut-up operation and as part of the task he is verifying the establishment recordkeeping requirements for the product storage CCP. He reviews the establishment’s HACCP plan and finds that the verification procedure is that QC personnel will check the product storage area temperature recording device (continuous process monitoring instrument) every two hours, and record the results on the chart. He reviews the chart and observes that the QC personnel have recorded actual time and


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temperature results for each entry, and initialed each entry, and that the date is recorded at the top of the form. He notices that it is almost time for the next check and so he remains in the area and observes that the QC employee performs the check and records the results at the time of the check. He determines that this part of the recordkeeping requirement is in compliance because the entries are made at the time the event occurs, each entry includes the time, the form includes the date, and each entry is initialed.

Determine Compliance After the CSIs gathered and assessed all available information pertaining to the HACCP record authenticity requirement, they must determine regulatory compliance. If they find that the establishment has met all regulatory requirements for §417.5(b), then there is no regulatory noncompliance. If they find that the establishment has not met all regulatory requirements for §417.5(b), there is noncompliance. More information about making compliance determinations is provided in another section of the training.

Noncompliance with HACCP Record Authenticity

One or more of the following findings evidence that the establishment does not comply with 9 CFR 417.5(b):

Establishment employees do not make entries in HACCP records at the time that specific events occur.

Note: Some establishments may choose to record HACCP results on ―scratch paper‖ or a note pad‖ and then transfer the results to a clean record at a later time (significantly after the event occurred). This practice is allowed, but the initial ―scratch paper or note pad‖ record needs to meet HACCP recordkeeping requirements and must be retained as an official HACCP record. Scratch paper or note pad used during a monitoring procedure is not a HACCP record when the data is transcribed to the HACCP record immediately when the employee finishes taking the measurements.

Establishment records do not clearly state the date and time when each entry was made

Note: The establishment may elect not to enter a date or time for every separate entry in the HACCP record when they make several entries at the same time or on the same date. This practice is acceptable as long as the CSI is able to determine the time and date when each entry was made. For example, an establishment may place a single date at the top of a record to cover all entries made during that day.

Establishment employees do not sign or initial their entries in HACCP records.

The following is an example of noncompliance with 417.5(b):


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Noncompliance Example 10: The HACCP plan has a monitoring procedure for checking temperature of incoming trimmings by checking 2 combos from each truck with a long-stem thermometer. A CSI observes this record:

Incoming trimmings log Critical limit = 38 F or lower Date: 2-8-12 Truck ID Truck

condition Combo ID Source Tracking # Temp Time Monitor initials

138 A -981 Bexel 380001 34 4:56 am JP

138 A -982 Bexel 380002 34 5:05 am JP

8526 B -020 Donfort 380003 36 7:20 am GM

8526 B -021 Donfort 380004

He observes the next truck unloaded. The establishment employee ―GM‖ performs the monitoring procedure on the combo bins, and does not enter the results on the form until much later in the day. He determines that there is a recordkeeping noncompliance. One entry on the record does not contain the time the event occurred or the temperature. The records do not include the signature or initials of the person performing the activity. Results are not being recorded when the events occur. CSIs document the HACCP verification task results in PHIS including any noncompliance in accordance with the discussion of documentation and enforcement in a later section.


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D. Computerized Records The regulatory requirement for computerized records is:

9 CFR 417.5(d)—Records maintained on computers. The use of records maintained on computers is acceptable, provided that appropriate controls are implemented to ensure the integrity of the electronic data and signatures.

Electronic signatures are different from the digitized signature used for signing a credit card purchase. An electronic signature, or digital signature, uses computer technology to ensure the security of records or messages. The person making the record or message uses an electronic ―code‖ to identify themselves. The computer, using an electronic ―key,‖ de-codes the record or message. This endorses the identity of the user. CSIs will verify compliance with this regulation by performing the HACCP verification task using the recordkeeping component. The thought process CSIs should use when verifying regulatory requirements includes:




Gather information by asking questions When verifying this requirement, CSIs should seek the answer to this question:

Are appropriate controls provided to ensure integrity of electronic data and signatures?

Assess the information To obtain answers to this question, CSIs would review the computerized recordkeeping system. Recordkeeping Example 8: An establishment enters all HACCP activity results into hand-held computer devices. Network access is for QA employees only. Each employee has a unique log-in name and password that is kept secure. Passwords are changed periodically. Once an entry is made, it is saved as read-only, and cannot be changed.

Determine Compliance After CSIs have gathered and assessed all available information pertaining to the computerized records requirement, they must determine regulatory compliance. If they find that the establishment has met all regulatory requirements for §417.5(d), then there is no regulatory noncompliance. If they find that the establishment has not met all regulatory requirements for §417.5(d), there is noncompliance. More information about making compliance determinations is provided in another section of the training.


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Noncompliance with the Computerized HACCP Records Requirement The following are examples of noncompliance with 417.5(d): Noncompliance Example 11: The establishment uses a computer-based system to monitor and record the temperatures in all processing rooms, coolers, and chillers. The CSI requests information about controls to ensure the integrity of the records, which the establishment is not able to provide. The establishment does not have controls in place to ensure the integrity of the electronic records. Noncompliance Example 12: The establishment uses a computer-based system to monitor and record the temperatures in all processing rooms, coolers, and chillers. The CSI observes that on a warm day a processing room employee adjusts the computer settings so that the alarm will not keep going off. The CSI observes that the passwords are prominently posted near the computer station. The establishment has controls to ensure the integrity of the electronic records but is not following those controls. The passwords are not kept secure. CSIs document the HACCP verification task results in PHIS including any noncompliance in accordance with the discussion of documentation and enforcement in a later section.


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E. Record Retention The regulatory requirements for record retention and off-site storage of records is:

9 CFR 417.5(e)(1) and (2)—Record retention. (1) Establishments shall retain all records required by paragraph (a)(3) of this section as follows: for slaughter activities for at least one year; for refrigerated products, for at least one year; for frozen, preserved, or shelf-stable products, for at least two years. (2) Off-site storage of records required by paragraph (a)(3) of this section is permitted after six months, if such records can be retrieved and provided, on-site, within 24 hours of an FSIS employee’s request.

CSIs will verify compliance with this regulation by performing the HACCP verification task using the recordkeeping component. The thought process CSIs should use when verifying regulatory requirements includes:




Gather information by asking questions CSIs should seek the answer to the following questions.

1. Are the records being maintained for the required amount of time, i.e., 1 year

for slaughter and refrigerated products and 2 years for frozen products? 2. Are the records kept on-site for 6 months? 3. If the records are stored off-site after 6 months, can they be retrieved within

24 hours? Note: Only the HACCP records set out in 9 CFR 417.5(a)(3) may be stored off-site after 6 months. Prerequisite program records and other supporting documentation must be maintained and stored at the establishment.

Assess the information CSIs should verify that the records are being maintained the required amount of time by reviewing HACCP records. If CSIs suspect that records stored off-site are not being maintained for the required amount of time, they should contact the Frontline Supervisor for instructions. CSIs might request records stored off-site one time to ensure they can be provided, but it would not be necessary for the CSI to routinely request records that are stored off-site to verify this requirement.


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Recordkeeping Example 9: On January 5th 2012 at 11.30 am a CSI was performing the Slaughter HACCP verification task in a small beef slaughter establishment. The establishment has 2 critical control points: CCP 1 to monitor the critical limit of the lactic acid concentration in the carcass wash, and CCP 2 for the zero tolerance fecal check. As part of the task, the CSI verified the establishment’s compliance with the records maintenance requirements. He asked the establishment to provide him with CCP 1 and CCP 2 monitoring, verification, and corrective action records for October 6th of 2011 and April 10th of 2011. The establishment provided him with October’s records and informed him that April’s records are stored off-site. April’s records were provided to the CSI on January 6th at 8.00 am.

Determine Compliance After CSIs have gathered and assessed all available information pertaining to the records retention and availability requirement, they must determine regulatory compliance. If they find that the establishment has met all regulatory requirements for §417.5(e)(1) and (2), then there is no regulatory noncompliance. If they find that the establishment has not met all regulatory requirements for §417.5(e)(1) and (2), there is noncompliance. More information about making compliance determinations is provided in another section of the training. Noncompliance with Records Retention and Availability

One or more of the following findings evidence that the establishment does not comply with 9 CFR 417.5(e)(1) and (2):

HACCP records are not kept on-site for 6 months

HACCP records are not maintained for the required amount of time

A HACCP record stored off-site cannot be retrieved within 24 hours of the CSI

request?

The following are examples of noncompliance with 417.5(e)(1) and (2):

Noncompliance Example 13: In October, the CSI asks the establishment to provide a sample of the fecal CCP monitoring log records from last January. They give him a folder that contains February’s records. He asks the establishment about January’s records and they tell him they had to clean out the files because they were getting too full. The establishment cannot produce January’s records. The establishment is not maintaining records for the required length of time. Noncompliance Example 14: In October, the CSI is reviewing the establishment HACCP records for the sampling component of the steam pasteurization CCP in a large beef establishment. She suspects the establishment is not maintaining records on site. She discusses this with her frontline supervisor and then she asks the establishment for the records from May. They tell her that they can give her the records for the past month but they will have to retrieve any other month’s records from the corporate headquarters


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500 miles away. The records are not being maintained on-site for 6 months. Noncompliance Example 15: A CSI is newly assigned to a large poultry establishment and is performing records maintenance verification as part of the Slaughter HACCP verification task. He wonders about whether the establishment is able to retrieve records stored off-site and discusses this with his supervisor. He decides to ask the establishment to provide a sample of records from 7 months in the past. Management tells him that after 6 months they store them at corporate headquarters. He requests that the establishment retrieve 2 days of records from corporate headquarters. He receives the records 5 days later. The establishment cannot retrieve the records within 24 hours when stored off-site.


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F. Official Review Records The regulatory requirement for making establishment records available to CSIs upon request for official review is:

417.5(f) Official Review. - All records required by this part and all plans and procedures required by this part shall be available for official review and copying.

CSIs will verify compliance with this regulation by performing the HACCP verification task using the recordkeeping component. The thought process CSIs should use when verifying regulatory requirements includes:




Gather information by asking questions When verifying this requirement CSIs should seek the answer to this question:

Are all records, plans, and procedures required by Part 417 available for official review?

Assess the information To obtain the answer to this question, CSIs would request HACCP records, HACCP plans, hazard analyses, and supporting documentation including prerequisite programs and records from the establishment.

Some establishments keep their HACCP plans, HACCP records, and other official records in secured areas (locked cabinets or offices). In these cases, IICs are to work with establishment management to develop a method for an establishment employee to provide access to the secured area upon request. CSIs are to follow any such established procedure when requesting access to records. CSIs are only to request those records normally required to perform their verification duties. They are not to test the establishment by requesting additional records.

CSIs are to contact their supervisor if the establishment will not make HACCP plans, HACCP records, or supporting documents available for review. Recordkeeping Example 10 A relief CSI assigned to a large poultry slaughter establishment is verifying the establishment’s compliance with making records available for official review as part of the Slaughter HACCP verification task. He asks the establishment manager to provide him with the HACCP plan, hazard analysis and support documentation records. The establishment manager informs the CSI that they keep all HACCP records in a lock


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cabinet in his office. The establishment manager opens the locked cabinet and gives the CSI access to the records. The CSI determines that the establishment is in compliance with 9 CFR 417.5(f) of the recordkeeping requirements.

Determine Compliance After CSIs have gathered and assessed all available information pertaining to the availability records requirement, they must determine regulatory compliance. If they find that the establishment has met all regulatory requirements for §417.5(f), then there is no regulatory noncompliance. If they find that the establishment has not met all regulatory requirements for §417.5(f), there is noncompliance. More information about making compliance determinations is provided in another section of the training.

Noncompliance with Official Review of Records

The following are examples of noncompliance with 417.5(f) Noncompliance Example 16: A CSI is assigned to 2ND shift in a large beef slaughter establishment. While he was performing the Slaughter HACCP verification task, he needed access the establishment monitoring records to verify the monitoring requirement for the slaughter food safety standard CCP. The CSI asked the kill floor supervisor to provide him with the monitoring records. The kill floor supervisor informed him that all of the monitoring records were locked in the HACCP manager’s office. The manager is available only during the day shift. This is non compliance with 417.5(f) because the records are not available for official review. Noncompliance Example 17: A CSI was performing the Slaughter HACCP verification task. As part of her verification activities she needed to review the HACCP plan. The establishment uses a computer-based system to electronically store the HACCP plan, hazard analysis, support documentation and all HACCP system records. When the CSI asked the establishment owner to provide her with access to the records, he stated that ―we have very high-security computer systems the only person who can access the system is Mr. John Hunt who is sick today‖. This is a non compliance with 417.5(f) because the records are not available for official review. CSIs document the HACCP verification task results in PHIS including any noncompliance in accordance with the discussion of documentation and enforcement in a later section.


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Records Misrepresentation A HACCP system will not work unless consistent, reliable records are generated during the plan‘s operation. The availability of well maintained records that contain objective, relevant data, reflecting actual operating conditions benefits both industry and regulatory officials. The legitimacy of these records is extremely important. FSIS views recordkeeping as a serious matter with potentially grave implications if records are falsified or not properly maintained. When enforcement action is required, it is important to distinguish between unintentional (one time or sporadic) errors or isolated cases of sloppy recordkeeping, and errors that reveal a pattern of noncompliance with the procedure or plan, willful errors or omissions, or intentional misinformation. As CSIs become familiar with establishment records, and how they appear under ordinary circumstances, they should be able to distinguish between unintentional and willful errors, omissions, and intentional misrepresentation. When deliberate misrepresentation of records is suspected, CSIs should not discuss the situation with an establishment employee. They should notify the IIC and document the findings in a memorandum to the files—not on an NR. The IIC should use a secure method (email or a telephone off-premises if necessary) to inform the District Office. FSIS does not consider the telephone in the Government office and cellular phones to be secure. The District Manager will provide instructions for further action. If the IIC is not available, the inspector should use a secure method to notify the District Office and follow the District Manager‘s instructions.


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Workshop: Recordkeeping Refer to the handout and to FSIS PHIS Directive 5000.1 to complete the following questions. 1. Fill in the blanks for the following regulatory references: 9 CFR 417.2(c)(6)—Provide for a system that documents the

__________ of the critical control points. The records shall contain the

values and observations obtained during monitoring.

9 CFR 417.5(a)(3)—The establishment shall maintain: Records documenting the

monitoring of CCP and their critical limits, including the recording of ___________

___________, temperatures, or other quantifiable ___________, as prescribed in the

establishment‘s HACCP plan; the ______________ of process-monitoring instruments;

corrective actions, including all actions taken in response to a deviation; verification

procedures and results; product ___________, product __________ or identity, or

slaughter production __________. Each of these records shall include the __________

the record was made.

9 CFR 417.5(b)—Each __________ on a record maintained under the HACCP plan

shall be made at the time the specific event __________ and include the __________

and __________ recorded, and shall be __________ or ___________ by the

establishment employee making the entry.

9 CFR 417.5(f)—All __________ required by this part and all plans and procedures

required by this part shall be _________ _ for official review and copying.

2. What recordkeeping requirement must be verified using the review and observation component?


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3. Case Study. A CSI is verifying the recordkeeping requirement at the pre-evisceration antimicrobial rinse CCP as part of the Slaughter HACCP verification task. He reviews the monitoring record for the CCP, which follows.

Pathogen Reduction Log Date Lot No. Time Solution

Conc. (%) Pressure

(psi) Corrective

Actions Monitored by

Verified by *

2-1-2012 1 0730 OK OK - TDM PP

*direct observation verification-results as per HACCP plan

a. Are there any noncompliances in this record? Please explain and cite the

relevant regulation. b. What should he do next?

4. How soon after the monitoring and verification activities do the results have to be

recorded on the establishment records? What is the regulatory reference for this?

5. Evaluate the record below.

Thermometer Calibration Log Calibrate to 32° F while in slush ice water

Date Time Dept. Thermometer ID

Personal Thermometer

Reading

Adjustment Required?

(Yes or No)

Initials Comments

2/15/2012

PM

Carcass Cooler

2B

32°F

No

TDM

a. Is there any noncompliance with recordkeeping requirements here? b. If so, what is the regulatory reference?


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6. Case Study. A CSI is verifying the recordkeeping requirement as part of a Slaughter HACCP verification task and has decided to review the poultry reprocessing slaughter food safety standard CCP. According to the HACCP plan, the frequency for monitoring is hourly and the frequency for direct observation and record review verifications is daily. The shift runs from 0600-1430 with a 30-minute lunch from 1100-1130. The critical limit for the CCP is 0. Evaluate the following record.

Reprocessing Log

Time Product ID

Results of Inspection

Monitor Initials

Verification procedure and results

Corrective Actions or Comments

0645 Lot 1 0 BK

0750 Lot 1 0 BK

0840 Lot 2 1 CH ½ inch smear of green fecal material

0955 Lot 2 0 BK

1330 Lot 3 0 CH

1430 Lot 4 0 CH

a. Do you see any obvious noncompliance with this record? If so, list what it is and give

the regulatory references? b. Based on what you have observed, could there be more noncompliance? If so, list

what it is and give the regulatory references? c. What should the CSI do next, if anything?


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Supporting Documentation- Prerequisite Programs and Other Supporting Programs The regulatory requirement that addresses the use of prerequisite programs to support decisions in the hazards analysis is:

9 CFR 417.5(a)—the establishment shall maintain the following records documenting the establishment‘s HACCP plan: (1) the written hazard analysis prescribed in §417.2(a) of this part, including all supporting documentation;

CSIs verify this requirement using both the review and observation and the recordkeeping components while performing the HACCP verification task.

The establishment is required to maintain documentation to support the decisions in the hazard analysis (9 CFR 417.5(a) (1). If the establishment uses prerequisite programs or other measures to support a decision that a particular hazard is not reasonably likely to occur, the records of the ongoing implementation of those prerequisite programs or measures is part of the supporting documentation required by 9 CFR 417.5(a)(1).

9 CFR 417.5(f) requires that all records required under 9 CFR 417 be available for official review by FSIS inspection personnel. CSIs are to contact their supervisor if the establishment will not make prerequisite programs, prerequisite program records, or other supporting documents available for review. The thought process CSIs should use when verifying regulatory requirements includes:



determining regulatory compliance. This thought process should be utilized when verifying all of the regulatory requirements. Prerequisite Program, GMPs or SOPs Based on the regulatory requirements of 9 CFR 417.2(a)(2) and 9 CFR 417.5(a)(1), FSIS believes that the results of testing and monitoring activities related to the production of product are subject to FSIS review and must be available to FSIS personnel upon request, including records from a prerequisite program. CSIs should be aware of all monitoring and testing conducted by the establishment and should ask establishment management to share the data that is generated by this monitoring and testing. CSIs review this data while performing the HACCP verification task and Review Establishment Data task (refer to FSIS Directive 5000.2) when verifying the requirement for supporting documentation. When reviewing records, results, and supporting documentation associated with testing, monitoring, and verification activities that are from procedures or prerequisite programs outside the HACCP plan, CSIs should determine if the records generated from these programs continue to support the decisions made in the establishment‘s hazard analysis that the hazard is not reasonably likely to occur in the process. They should also verify that if there is information in the


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records that requires the establishment to reevaluate or reassess its HACCP plan, the establishment has conducted the reassessment. Verifying prerequisite programs When an establishment references a prerequisite program in its hazard analysis as supporting documentation that a food safety hazard is not likely to occur, verify that the establishment:

1. has written procedures that set out the design of the prerequisite program;

Note: There is no regulatory requirement that the prerequisite program has to be written. However, if the program is not written, the establishment would probably not be able to support the decision the hazard is not reasonably likely to occur. (Exceptions: If the establishment addresses the removal, segregation and disposal of SRMs using a prerequisite program, the measures it implements to segregate and dispose of them must be written as stated in 9 CFR 310.22). If the establishment uses the Sanitation SOP to support a decision that a hazard is not reasonably likely to occur, the procedure will be in the written Sanitation SOP.

2. is executing the program as designed, and

3. has evidence that the program is being executed as designed and continues to

support decisions made in the hazard analysis (e.g., information on suppliers‘ interventions, test results from suppliers, results from its own testing, or documents regarding the on-going effectiveness of the program).

Unlike with HACCP plans, CSIs do not verify compliance with specific regulatory requirements for such activities as monitoring, verification, and recordkeeping. For instance, there are no specific regulations that address monitoring activities or recordkeeping practices for prerequisite programs. Hence, an occasional missed measurement, or failures to initial entries on records, failures to enter the time on records, or a missing entry on the record would not represent noncompliance or would not necessarily mean the prerequisite program is not being implemented effectively. Minor deviations from executing the prerequisite program usually would not create a food safety concern or necessitate action on the product, whereas deviations from the critical limit in a HACCP plan would cause food safety concerns and generally require action on the affected product. By means of records review and observations, and discussions with the establishment at the weekly meeting, CSIs should focus on: 1. the overall program to verify that the establishment:

a. implements the procedures as set out in the program‘s design?

b. maintains records to support the implementation of the program, including verification records and results from outside auditors?

c. evaluates the implementation of the program?

d. has a means to correct implementation problems?


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2. any problems that indicate that the prerequisite program may no longer be supporting the decision made in the hazard analysis that a hazard is not likely to occur, and consider questions such as:

a. are elements of the program not being implemented?

b. are adjustments made to the programs when necessary? c. do the same implementation problem continue to reoccur?

d. are there numerous or recurrent mistakes made in the implementation of the

program?

Gather information by asking questions CSIs are to verify that establishment employees are implementing the procedures in the prerequisite program and the records generated by the prerequisite program continue to demonstrate that the relevant hazard is not reasonably likely to occur. CSIs should seek the answer to the following questions:

1. Is the establishment implementing the procedures in the program as written? 2. Does the establishment maintain records to support the implementation of the

program including verification records and results from outside auditors? 3. Do the records show that the prerequisite program continues to support the

decision that the relevant hazard is not reasonably likely to occur on an ongoing basis?

Assess the information To answer these questions, CSIs should:

Review the establishment‘s hazard analysis,

Review the records generated by the prerequisite program, and

Observe establishment employees implementing the procedures in the

prerequisite program. Now let‘s review each of these activities in detail.

Reviewing the Hazard Analysis When reviewing the hazard analysis, CSIs determine if the establishment uses a prerequisite program or other supporting program to support a decision that a particular hazard is not reasonably likely to occur. Prerequisite Program Example 1: A CSI is reviewing the hazard analysis in a raw ground beef patty operation during the performance of the Raw Non-Intact HACCP task.


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She observes that at the receiving step the establishment has identified that there is a physical food safety hazard, ―foreign material,‖ but determined that it was not reasonably likely to occur, on the basis that ―establishment records show that there has been no incidence of foreign materials in products received in the establishment.‖ She decides to request the supporting documentation for this decision. The establishment provides a copy of a procedure for physical examination of raw materials at receiving. Prerequisite Program Example 2: A CSI is reviewing the hazard analysis in a raw ground beef patty operation during the performance of the Raw Non-Intact HACCP task. He observes at the raw material storage step that the establishment is implementing a temperature control prerequisite program to maintain the internal product temperature below 42°F to support that the hazard of pathogen growth is not reasonably likely to occur. He decides to request the supporting documentation for this decision. The establishment provides a copy of a procedures for measuring product temperature and recording results.

Reviewing Prerequisite Program Records For each prerequisite program or other program the establishment uses to support a decision that a hazard is not reasonably likely to occur, CSIs are to review the records generated by the program for the specific production selected to determine if they continue to support the decision that that the relevant hazard is not reasonably likely to occur on an ongoing basis. Prerequisite Program Example 1a: Continuing with the example 1 above, the CSI requests completed raw material examination records for the trimmings that were used in the specific production she has selected. She reviews the records and finds there are no entries that would represent a foreign material hazard. She determines that the establishment in compliance with 9 CFR 417.5(a)(1) because it is implementing the program in a manner that supports the hazard analysis decision and the records generated from the program show that the relevant hazard is not reasonably likely to occur on an ongoing basis.

Prerequisite Program Example 2a: Continuing with example 2 above, the CSI knows that a specific production is an 8 hour shift’s production and the temperature control procedure states that the internal temperature of product will be measured at the grinding step three times a day. He decides to review internal product temperature record that’s on a table next to the grinder for day’s shift. He notices that the establishment employee did not record a time for the second temperature measurement as specified in the written program. The temperature result is 39°F. He realizes that this minor failure to follow the program would not represent a failure to support the hazard analysis because the temperature result is less than 42°F. Note: CSIs should discuss the less-than-perfect implementation of prerequisite programs or other supporting programs with establishment management at the weekly meeting. The establishment‘s response should be documented in the Memorandum of Interview (MOI) the CSI gives to the establishment.


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Observing Establishment Employees For each prerequisite program or other program the establishment uses to support a decision that a hazard is not reasonably likely to occur, CSIs are to observe an establishment employee performing the procedures listed in the program to determine if the procedures are being carried out as written in the program.

Prerequisite Program Example 2b: Continuing with example 2a above, the CSI is in the production room and notices that an establishment employee is going to take the last product temperature of the shift at the grinding step. He stops to observe the employee taking the measurement. The establishment employee measures the product temperature as written in the program and documents the result. The CSI decides to observe the temperature result that the employee recorded. The product temperature result is 40°F and the time of the measurement is recorded. Based on these observations, he determines that the establishment in compliance with 9 CFR 417.5(a)(1) because it is implementing the program in a manner that supports the hazard analysis decision and the records generated from the program show that relevant hazard is not reasonably likely to occur on an ongoing basis.

Determine Compliance

After the CSIs has gathered and assessed all available information pertaining to the supporting documentation requirement, they must determine regulatory compliance. There are three possible outcomes when verifying whether the on-going implementation of a prerequisite program and the records generated from the program continue to support the decision that a particular hazard is not reasonably likely to occur.

1. Compliance 2. Noncompliance

3. Inability to determine compliance because more information is needed

If CSIs find that the establishment has met all verification regulatory requirements, then there is no regulatory noncompliance. If they find that the establishment has clearly not met all supporting documentation regulatory requirements, there is noncompliance. When CSIs determine that there is not enough information available to determine whether the establishment complies with 9 CFR §417.5(a) (1), they should notify establishment management. This provides the establishment with an opportunity to support the decisions made, or to reassess the hazard analysis and make decisions that it can support. After allowing the establishment the opportunity to provide additional support, if CSIs are still uncertain whether the implementation of the prerequisite program and the records generated from a prerequisite program support the decisions in the hazard analysis, they are to discuss the issue with their supervisor.

If CSIs have concerns about the design of the procedures or programs an establishment is using to support decisions in the hazard analysis, they should contact the Policy Development Division (PDD) or an EIAO through supervisory channels.


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EIAOs conduct comprehensive food safety assessments in establishments to verify that the design of the food safety systems in operation meet regulatory requirements.

Noncompliance with the Supporting Documentation Requirement When Using a Prerequisite Program or Other Supporting Program One or more of the following findings evidence that the establishment has not met the requirement of 9 CFR 417.5(a) (1):

The establishment employees are not implementing the procedures in the prerequisite program sufficiently to continue to support that the relevant hazard is not reasonably likely to occur.

The prerequisite program records indicate consistent or repeated failures to implement the procedures that are used to support the decision in the hazard analysis that the relevant hazard is not reasonably likely to occur.

The prerequisite program records do not demonstrate that the program continues to support the decision in the hazard analysis that the relevant hazard is not reasonably likely to occur.

If a CSI finds, based on records or observations, that the prerequisite program is not continuing to support the decision in the hazard analysis that a food safety hazard is not likely to occur in the process (i.e., the program is not being executed), document a noncompliance with 9 CFR 417.5(a) (1), and verify that the establishment:

reassesses its hazard analysis as required in 9 CFR 417.4(b) because a change has occurred in the process (i.e., decisions made in the hazard analysis are no longer supported as required by 9 CFR 417.5(a)(1)), and

provides data supporting the decisions made during this reassessment required by 9 CFR 417.5(a) (1).

The following are examples of noncompliance with the supporting documentation requirement. Noncompliance Example: A CSI is performing the Slaughter HACCP verification task to verify that an establishment is in compliance with 9 CFR 417.5(a)(1). She reviews the hazard analysis and finds that the establishment implements a prerequisite program for the specified risk materials to support that the hazard of SRM is not reasonably likely to occur. The prerequisite program states that all of the specified risk materials will be removed from the carcasses at different SRM removal stations. This procedure is implemented throughout the processing steps to ensure the absence of all of the SRM from edible products before boxing. The establishment will have 5 SRM removal stations.

Station one (located in the kill floor next to the head inspection area): the

establishment’s trained employee will remove the palatine and the lingual tonsils

from the head and the tongue.


FSRE/PHIS 106

Station two (located in the auger room): the establishment’s trained employee will

remove the brain by a suction apparatus and dispose the skull in the marked SRM

containers.

Station three (located in the kill floor after the viscera inspection): The entire intestine

including the distal ileum will be condemned and disposed in the marked SRM

containers.

Station four (located on the kill floor before the final trim rail): the spinal cord will be

removed entirely by specified marked tools (orange handle).

Station five (located in the boning room): the vertebral column will be removed by

specified marked tools (orange handle) and disposed of in the marked SRM

containers.

All SRM will be destroyed through denaturing with a formula consisting of one part

FD&C No. 3 green coloring, 40 part water, 40 parts liquid detergent, and 40 parts oil of

citronella.

The establishment employees who are assigned to the SRM stations will be trained on the SRM removal procedure (the procedure is attached to the prerequisite program file).

The establishment will maintain daily records to document the implementation and the monitoring of the procedures for the removal, segregation, disposition of the SRM, and any corrective actions taken.

The QC supervisors will monitor the effectiveness of the SRM removal at all of the SRM removal stations twice per day (per station), and log the monitoring time, and sign. This information will be documented on the prerequisite program record Form A.

The establishment will maintain daily records to document the absence of SRM from the edible products. This will be done by the QC supervisor who will randomly check 20 hanging carcasses in the cooler and open, examine 4 boxes of finished products. This check will be done twice per day. The first check should be done before 11.30 am, and the second check should be done after 11.30 am and before 2.30 pm. This information will be documented on the prerequisite program record Form B.

If the QC supervisor observes any errors in implementing the program or observes any identifiable SRM on edible product, all corrective action steps should be followed (a copy of the corrective action steps is attached to the prerequisite program file).

The CSI asked the establishment manger to provide her with all prerequisite program records for the past 5 days. The manager provided her with the following records informing her that these are all the records that he has:


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Pre requisite program form A

Date Station #

time finding Corrective actions

signature

01-01-2012 1 6 am No finding N/A JOHN SMITH

01-01-2012 1 11.30 am

01-01-2012 2 6.30 am

01-01-2012 2 12.30 pm

01-01-2012 3 7.00 am No finding JOHN SMITH

01-01-2012 3 1.00 pm

01-01-2012 4 7.30 am

01-01-2012 4 1.30 am

01-01-2012 5 8.00 am

01-01-2012 5 2.00 pm No finding JOHN SMITH

The CSI asked the establishment manager if he has the rest of the prerequisite program records, he replied that ―These are all of the records I have.‖ The CSI subsequently went to the kill floor and found that the establishment had 5 SRM stations, but 2 stations did not have any employees on location. This finding would call into question the establishment’s decision SRM is not reasonably likely to occur. The finding would represent noncompliance with 9 CFR 417.5(a) (1) because the establishment does not have the records specified in the prerequisite program to support that SRM would not be a hazard reasonably likely to occur. The CSI decided to discuss this noncompliance with her supervisor to identify further enforcement actions. CSIs document the HACCP verification task results in PHIS including any noncompliance in accordance with the discussion of documentation and enforcement in a later section.

Pre requisite program form A

Date Station #

time finding Corrective actions

signature

01-05-2012 1 6 am No finding N/A JOHN SMITH

01-05-2012 1 11.30 am

01-05-2012 2 6.30 am

01-05-2012 2 12.30 pm

01-05-2012 3 7.00 am No finding N/A JOHN SMITH

01-05-2012 3 1.00 pm

01-05-2012 4 7.30 am

01-05-2012 4 1.30 am

01-05-2012 5 8.00 am

01-05-2012 5 2.00 pm


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Workshop: Supporting Documentation- Prerequisite Programs and Other Supporting Programs Refer to the handout and to FSIS PHIS Directive 5000.1 to complete the following questions. 1. Fill in the blanks for the following regulatory reference:

9 CFR 417. 5(a)—the establishment shall maintain the following records documenting

the establishment‘s HACCP plan: (1) the written prescribed in

§417.2(a) of this part, including all .

2. A CSI is performing the Raw Non-Intact HACCP verification task, he reviews the

hazard analysis and finds that the establishment implements a prerequisite program for metal detection to support the decision they made in the hazard analysis that the physical hazard/metal (broken needles) is not reasonably likely to occur. He reviews the metal detection program and finds that the establishment maintains a daily record of the metal detection results. He asks the establishment manager to provide him with the prerequisite program‘s records for the previous 5 working days. The establishment manger provided him with a day‘s records stating that ―These are all of the records I have.‖

a. Is there any noncompliance with the support documentation recordkeeping

requirements in this scenario?

b. What should he do next?

3. A CSI is performing the Raw Intact HACCP verification task, she reviews the hazard

analysis and finds that the establishment implements a prerequisite program for product temperature control to support the decision they made in the hazard analysis that the growth of pathogens is not reasonably likely to occur. The temperature control program indicates that 2 internal product temperatures are taken daily. She asks the establishment manager to provide her with the prerequisite program‘s records for the past 2 days. She sees that only one measurement is documented on one of the days‘ record instead of two results.

a. Is there any noncompliance with the support documentation recordkeeping

requirements at this point?

b. What should she do next?


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Corrective Actions Before we elaborate on the corrective action requirements, let‘s review the difference between a deviation from a critical limit and a HACCP noncompliance. A deviation from a critical limit is the failure to meet the applicable value determined by the establishment for a CCP. If a deviation from a critical limit occurs, an establishment is required to take corrective actions in accordance with 9 CFR 417.3. A HACCP noncompliance is the failure to meet any of the regulatory requirements of 9 CFR parts 417. If a HACCP noncompliance occurs, an establishment is expected to take immediate and further planned actions to bring itself back into compliance with regulations. When CSIs verify HACCP implementation, they are to verify that establishments meet the corrective action requirements whenever an event occurs that requires corrective action. For instance, whenever CSIs determine through their own observations or through the review establishment records (e.g. monitoring records) that a deviation from a critical limit or other unforeseen hazard has occurred, they are to verify that the establishment implements corrective actions that meet the regulatory requirements. CSIs verify that corrective action requirements are met while performing the HACCP verification task. If necessary, CSIs are to initiate a directed HACCP verification task to document their verification of corrective action requirements when a routine HACCP verification task is not available (e.g., all of the routine tasks have either been scheduled or already performed for the month). Note: CSIs may not be able to verify corrective action requirements during a routine HACCP verification task if no corrective action is required for that specific production.

A. Corrective Actions in Response to a Deviation from a Critical Limit When a deviation from a critical limit occurs, the establishment must implement the corrective actions specified in the HACCP plan. The regulation that applies to corrective actions taken in response to a deviation from a critical limit is:

9 CFR Part 417.3(a)—The written HACCP plan shall identify the corrective action to be followed in response to a deviation from a critical limit. The HACCP plan shall describe the corrective action to be taken, and assign responsibility for taking corrective action, to ensure: (1) The cause of the deviation is identified and eliminated; (2) The CCP will be under control after the corrective action is taken; (3) Measures to prevent recurrence are established; and (4) No product that is injurious to health or otherwise adulterated as a result of the deviation enters commerce.

The thought process you should use when verifying regulatory requirements includes:





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Gather information by asking questions To verify compliance with the corrective action regulatory requirements, CSIs should seek the answer to the following questions:

1. Did the establishment identify and eliminate the cause of the deviation? 2. Did the corrective actions ensure that the CCP is brought under control? 3. Were measures implemented to prevent recurrence of the deviation? 4. Did the actions ensure that no product that is injurious to health or otherwise

adulterated, as a result of the deviation, enters commerce?

Assess the information

When seeking answer to these questions, the CSI should:

Observe the establishment executing the corrective actions.

Review the corrective action records associated with the deviation from the critical limit.

Compare the establishment‘s recorded corrective actions to the regulatory requirements listed in 9 CFR 417.3(a) to determine whether the corrective actions taken by the establishment in response to the deviation from the critical limit meet the requirements.

Now let‘s have a look at each of these in more detail.

Observing the Establishment Execute Corrective Actions In observing the establishment executing corrective actions, the CSI should verify that the appropriate affected product has been identified. Corrective Action Example 1, Part 1: Upon arrival at a raw ground beef patty operation establishment on a CSI’s patrol assignment at 10:30 am, the CSI is notified by the establishment management that there has been a deviation of the metal detection critical limit. He thanks the establishment manager for voluntarily notifying him about this situation. He knows that he must verify that the corrective action requirements are met, and realizes he could do this by performing the review and observation component of the Raw Non-intact HACCP verification task. He reviews the establishment’s HACCP plan and finds that the monitoring procedure is that the packaging line supervisor will check the metal detector using a seeded sample every two hours to determine that the metal detector is functioning, that results are recorded on the metal detection control log, and that corrective actions are recorded on the corrective action log. He finds that the corrective actions are ―all parts of 417.3 will be met.‖ He proceeds to the production area and reviews the metal detection control log, and finds the deviation noted at the 10:04 am monitoring check. The form notes that the equipment failed to detect the seeded sample. He notes that the form states that at the 8:00 check the equipment was


FSRE/PHIS 111

operating properly. He observes that the establishment has product identified and segregated. He inspects the amount and the codes of segregated product and compares them to the codes on the monitoring record. He asks the packaging line supervisor about the segregation of product and is informed that all products produced after the 8:00 am check has been identified and segregated. He determines that the establishment has segregated the appropriate affected product. Note: CSIs are to verify that the establishment applies corrective actions to all product affected by the deviation. CSIs must consider how the establishment defined the affected product and verify that additional products are not implicated by the deviation hazard. CSIs must consider any available information about the establishment process that could indicate whether additional product was affected. These sources of information may include:

Other establishment HACCP monitoring or verification records,

SSOP records,

Establishment testing results, and

The records of any related prerequisite programs.

He would observe the execution of corrective actions to verify that the cause of the deviation has been identified and eliminated. Corrective Action Example 1, Part 2: Continuing with the above example, the CSI continues to observe the establishment’s actions in the production area. He observes that production has stopped. Maintenance employees are working on the metal detector, which is then removed from the area. The packaging line supervisor reports to him that the unit is malfunctioning, and that it will not be used until it is repaired. Later, the establishment informs him that the cause of the deviation was that water got into the machine during cleanup. They establish a new SOP for removing the machine from the area during wet cleanup. Based on these observations, he determines that the establishment has identified and eliminated the cause of the deviation. He would observe the execution of corrective actions to verify that the CCP is under control upon completion. Corrective Action Example 1, Part 3: Continuing with the above example, the CSI continues to observe the establishment’s actions in the production area. The establishment brings in a replacement unit for the metal detector. The packaging line supervisor checks the replacement unit with the seeded sample, and the equipment responds appropriately. The CSI observes production resume. The packaging line supervisor notifies him that they will perform the monitoring checks at an increased frequency of once per hour for one week. Based on these observations, he determines that the establishment has the CCP under control. He would observe the execution of corrective actions to verify that the establishment prevents product that is injurious to health or otherwise adulterated, as a result of this deviation, from entering commerce. Corrective Action Example 1, Part 4: Continuing with the above example, the CSI returns to the production area. He observes a monitoring check on the metal detector.


FSRE/PHIS 112

Next, he observes as the establishment begins to run the segregated product through the metal detector. No metal is detected, and the packaging line supervisor releases the segregated product. Based on these observations, he determines that the establishment has prevented product that is injurious to health or otherwise adulterated, as a result of this deviation, from entering commerce. He would observe the execution of corrective actions to verify that preventive measures are established. Corrective Action Example 1, Part 5: Continuing with the above example, it is now about two weeks since the deviation. The CSI reviews the establishment’s HACCP plan and finds that a verification procedure has been added, ―make an observation that the machine has been placed in a dry room during cleanup‖. He goes to the production area. He notices that the original metal detector, the one that malfunctioned, is back in place. He observes that the metal detector appears to be working. He reviews the monitoring records and observes that the monitoring had been done at the increased frequency for one week, as proposed. Later, he observes that the machine is removed to a dry room during cleanup. Based on these observations, he determines that the establishment has established preventive measures. Reviewing the Corrective Action Records In reviewing the corrective action records, the CSI should compare the establishment‘s recorded corrective actions with the requirements of 417.3(a). Corrective Action Example 1, Part 6: Continuing with the above example, the CSI reviews the establishment’s corrective action log for this deviation. He compares the recorded corrective actions with what he has observed, and with the requirements of 417.3(a), and finds that all requirements were met The establishment identified and eliminated the cause of the deviation, the CCP was under control after the corrective action was taken, measures to prevent recurrence were established, and no product that is injurious to health or otherwise adulterated, as a result of the deviation, entered commerce. The CSI observes the record that shows the proposed maintenance repairs were performed. He determines that this requirement is met.

Determine Compliance After the CSIs have gathered and assessed all available information pertaining to the corrective action requirement, they must determine regulatory compliance. If they find that the establishment has met all corrective action regulatory requirements in 9 CFR 417.3(a), then there is no regulatory noncompliance. When CSIs document compliance with the corrective action requirement, they are to briefly describe their observations that support a finding of compliance as described in FSIS PHIS Directive 5000.1. If they find that the establishment has not met all corrective action regulatory requirements, there is noncompliance. More information about making compliance determinations is provided in another section of the training.


FSRE/PHIS 113

Noncompliance with the Corrective Action Requirements One or more of the following findings evidence that the establishment does not comply with 9 CFR 417.3(a):

The establishment does not implement a corrective action specified in the HACCP plan in response to a deviation from a critical limit.

The establishment‘s corrective action does not identify and eliminate the cause of the deviation.

The establishment‘s corrective action does not result in the CCP coming back under control.

The establishment‘s corrective action does not prevent adulterated product from entering commerce.

The establishment‘s corrective action does not prevent recurrence of the deviation.

The following are examples of noncompliance with 417.3(a): Noncompliance Example, Part 1: A CSI is reviewing monitoring records for the TSP CCP in a poultry slaughter operation and he finds that at 0800 the recorded TSP concentration was below the critical limit of 8%. She proceeds to verify that corrective actions were taken as required in 417.3(a) by reviewing an excerpt from the entries in the corrective action log, which reads as follows: ―TSP concentration control dial was increased to 9% at 0805. Chlorine in the chiller was increased from 20 to 50 ppm and the post-chill chlorinated rinse cabinets were turned on at 0810.‖ These actions are consistent with the corrective actions regulations but she finds no documentation and observes no evidence that the establishment attempted to identify the cause of the deviation from the critical limit. Noncompliance Example, Part 2: Continuing from the example above, the establishment later documents that the deviation from the critical limit was due to a defect in the electronic apparatus that controls the TSP concentration. She finds no record and no evidence that the establishment took any actions to repair or replace the electronic device. The establishment identified the cause of the deviation from the critical limit but did not take appropriate actions to eliminate the cause. Noncompliance Example, Part 3: Continuing the example above, she reviews the corrective action records again and finds that there was no follow-up measurement to verify that the TSP concentration was above the critical limit of 8% after the electronic control was turned up to 9%. The establishment did not implement appropriate measures to ensure the CCP was under control after the actions were taken. Noncompliance Example, Part 4: Continuing the example above, if the establishment had not implemented the measures of increasing the chiller chlorination and turning on the chlorinated rinse cabinets, it could be assumed that the establishment did not take


FSRE/PHIS 114

measures to ensure that no product injurious to health or otherwise adulterated enters commerce. CSIs document the HACCP verification task results in PHIS including any noncompliance in accordance with the discussion of documentation and enforcement in a later section.

B. Corrective Actions in Response to a Deviation Not Covered by a Specific Corrective Action, or an Unforeseen Hazard The regulation that applies when a deviation not covered by a specific corrective action or an unforeseen hazard occurs is:

9 CFR 417.3(b)—If a deviation not covered by a specified corrective action occurs, or if another unforeseen hazard arises, the establishment shall: (1) Segregate and hold the affected product, at least until the requirements of paragraphs (b)(2) and (b)(3) of this section are met; (2) Perform a review to determine the acceptability of the affected product for distribution; (3) Take action, when necessary, with respect to the affected product to ensure that no product that is injurious to health or otherwise adulterated, as a result of the deviation, enters commerce; (4) Perform or obtain reassessment by an individual trained in accordance with §417.7 of this part, to determine whether the newly identified deviation or other unforeseen hazard should be incorporated into the HACCP plan.

The thought process you should use when verifying regulatory requirements includes:




Gather information by asking questions CSIs should answer the following questions to determine whether the corrective action requirements have been met:

1. Did the establishment segregate and hold all affected product? 2. Did the establishment perform a review to determine the acceptability of the

affected product for distribution? 3. Did the establishment take necessary action with respect to the affected

product to ensure that no product that is injurious to health, or otherwise adulterated as a result of the deviation, enters commerce?

4. Was a reassessment conducted to determine whether the newly identified

deviation or other unforeseen hazard should be incorporated into the HACCP plan?


FSRE/PHIS 115

Assess the information When seeking answer to these questions, the CSI should:

Review the corrective action records associated with the deviation not covered by a specific corrective action or unforeseen hazard and observe the establishment executing the corrective actions.

Compare the establishment‘s recorded corrective actions to the regulatory requirements listed in 9 CFR 417.3(b) (1) and (2) (3)(4) to determine whether the corrective actions taken in response to the deviation from the critical limit meets all of these requirements.

Observe the establishment segregating and holding the affected product to verify that the establishment segregated and held all affected product.

Observe the establishment evaluating the affected product to verify that only acceptable product is released.

Review the corrective action records, determine if a reassessment was performed.

Now let‘s look at each of these in more detail. Reviewing the Corrective Action Records In reviewing the corrective action records, the CSI should compare the establishment‘s recorded corrective actions with the requirements of 417.3(b). Corrective Action Example 2, Part 1: A CSI is performing the Slaughter HACCP verification task in a poultry slaughter establishment. She finds that an event has occurred earlier in the shift, in which the establishment monitoring personnel found metal shavings on the carcasses exiting from the chill system. The establishment decided that the metal would constitute a food safety hazard. The establishment has no CCP for metal contaminants in the chill system. She reviews the corrective action log dated 2-1-2012 and finds the following entry for this incident: All carcasses exiting the chill system held by QA in vats and placed in the cooler. Carcasses were visually examined by production personnel for the presence of metal. Metal shavings were removed from affected carcasses. All carcasses will be deboned and resulting product run through a metal detector system. The HACCP plan will be reassessed by 2-3-2012. Based upon her review of the records, she determines that the recorded actions meet the requirements of 417.3(b). Observing the Establishment Execute Corrective Actions She would observe the establishment executing corrective actions to verify that all affected product is segregated and held.


FSRE/PHIS 116

Corrective Action Example 2, Part 2: Continuing from the previous example in which there were metal shavings on the product, the CSI verifies that the establishment segregates and holds the affected product by going to the chiller and the cooler to observe the product. At the chiller, she finds no product exiting the chiller since operations ceased an hour earlier. She finds the affected product held by a QA tag and segregated in the cooler. Based upon her observations, she determines that the establishment has adequately held and segregated affected product. She would observe the establishment evaluating the affected product to verify that only acceptable product is released. Corrective Action Example 2, Part 3: Continuing from the previous example in which there were metal shavings on the product, the CSI observes the establishment examine and remove the metal contaminants, debone the carcasses, and run the boneless product through a metal detector. Upon completion of the establishment’s corrective actions, she inspects several samples of boneless product and finds no trace of metal contamination. Based upon her observations the establishment took necessary measures to ensure that only acceptable product was released. Determine if a reassessment was performed CSIs verify that establishments perform a reassessment when an unforeseen hazard occurs. They also verify that the establishment has supporting documentation for decisions made during the reassessment while performing the directed HACCP verification task. Corrective Action Example 3: During a Raw Non-intact HACCP verification task and while reviewing the establishment’s HACCP plan for raw ground beef, the CSI observes a notation that the HACCP plan has been reassessed, and updates made. She further observes that the establishment has added a CCP at receiving that reads, ―E. coli O157:H7 in raw beef trimmings‖. The critical limit is that suppliers must provide certification that products have been subjected to a validated antimicrobial carcass treatment. She decides to investigate further and asks for more information, and any supporting documentation, from establishment management. She learns that this reassessment was conducted as a result of an unforeseen hazard. She is shown a laboratory test result that the establishment conducted on finished product, which came back positive for E. coli O157:H7. This is the first positive result for this organism. The corrective action log shows that all corrective actions were met, and product was diverted for cooking. The CSI was shown a record documenting the reassessment, which states that because of the positive result the establishment determined that E. coli O157:H7 was now considered ―reasonably likely to occur‖ and therefore this update was made to the hazard analysis and HACCP plan. The CSI determines that the establishment has met its requirement to perform reassessment when an unforeseen hazard arises and to determine whether the unforeseen hazard should be incorporated into the HACCP plan. She determines that the establishment is in compliance with 9 CFR 417.3(b). Note: She would also verify the support for the decisions in the hazard analysis and HACCP plan during the directed HACCP verification task performed as a result of the unforeseen hazard, e.g., the documentation the establishment receives from its supplier stating what antimicrobial treatment is applied to the trimmings that are received, and the


FSRE/PHIS 117

specified reduction in the number of pathogens achieved, documentation for the selection and placement of the CCP and the support for monitoring and verification procedures and frequencies at the receiving CCP, etc.

Determine Compliance After CSIs have gathered and assessed all available information pertaining to the corrective action requirement, they must determine regulatory compliance. If they find that the establishment has met all corrective action regulatory requirements in 9 CFR 417.3(b), then there is no regulatory noncompliance. When CSIs document compliance with the corrective action requirement, they are to briefly describe their observations that support a finding of compliance as described in FSIS PHIS Directive 5000.1. If they find that the establishment has not met all regulatory requirements for corrective action, there is noncompliance. More information about making compliance determinations is provided in another section of the training. Noncompliance with the Corrective Action Requirements One or more of the following findings evidence that the establishment does not comply with 9 CFR 417.3(b):

An unforeseen hazard occurs or there is a deviation not covered by a specified

corrective action and the establishment fails to take the corrective actions required by 9 CFR 417.3(b).

The establishment‘s corrective action does not segregate and hold all affected product.

The establishment does not perform a review to determine the acceptability of the affected product.

The establishment‘s corrective action does not prevent adulterated product from entering commerce.

The establishment does not reassess the relevant HACCP plan to determine whether to address the unforeseen hazard

The following are examples of noncompliance with 417.3(b): Noncompliance Example 1, Part 1: Continuing from our above example in which metal shavings were found on carcasses coming out of the poultry chiller, if the CSI found product in the cooler with metal shavings that the establishment had not held, she would conclude that all affected product was not held. Noncompliance Example 1, Part 2: If the personnel collecting the birds coming out of the chill system had misunderstood which chiller was affected and held product from the wrong chill system, the establishment would have held product but it would not be the

affected product.


FSRE/PHIS 118

Noncompliance Example 1, Part 3: If the establishment did not thoroughly examine the

product and pass the deboned product through a metal detector, the establishment did not evaluate the product to determine whether it was acceptable for distribution.

Noncompliance Example 1, Part 4: If the establishment found metal in the product

after corrective actions were completed and did not hold the product, the establishment did not take necessary action to ensure that no product injurious to health enters commerce. Noncompliance Example 1, Part 5: If the establishment did not perform a HACCP plan reassessment after the unforeseen hazard event, it would not be in compliance with 417.3(b).

Noncompliance Example 2: A CSI is performing the Raw Non-Intact HACCP verification task in a small beef grinding operation and he is verifying the establishment recordkeeping requirements for all CCPs. He reviews a recent corrective action log that documents a large fecal smear observed on the boneless bull meat chucks as they were being prepared for grinding. Currently, the establishment does not have a CCP for visual observation of raw materials. Under preventive measures on the corrective action log, ―none needed‖ is recorded. He asks whether they considered this an unforeseen hazard, and whether they performed a reassessment of the hazard analysis and HACCP plan. The QC manager replies ―No, because this was the only time we’ve observed this.‖ A deviation not covered by a specific corrective action or an unforeseen hazard occurred, and a reassessment was not conducted.

CSIs document the HACCP verification task results in PHIS including any noncompliance in accordance with the discussion of documentation and enforcement in a later section.


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Workshop: Corrective Action Refer to the handout and to FSIS PHIS Directive 5000.1 to complete the following questions. 1. Fill in the blanks: 9 CFR Part 417.3(a) – The written HACCP plan shall identify the corrective action to be

followed in response to a ______________ from a _______________. The HACCP

plan shall describe the corrective action to be taken, and assign responsibility for taking

corrective action, to ensure: (1) The ______________ of the deviation is

______________ and _______________; (2) The CCP will be _____________

_____________ after the corrective action is taken; (3) Measures to _____________

______________ are established; and (4) No product that is ______________ to

______________ or otherwise adulterated as a result of the deviation enters

______________.

9 CFR 417.3(b) – If a deviation not covered by a specified corrective action occurs, or if

another unforeseen hazard arises, the establishment shall: (1) _________________ and

hold the affected product, at least until the requirements of paragraphs (b)(2) and (b)(3)

of this section are met; (2) Perform a review to determine the _________________ of

the affected product for distribution; (3) Take action, when necessary, with respect to the

affected product to ensure that no product that is injurious to health or otherwise

adulterated, as a result of the deviation, enters commerce; (4) Perform or obtain

______________ by an individual trained in accordance with §417.7 of this part, to

determine whether the newly identified deviation or other unforeseen hazard should be

______________ into the HACCP plan.

2. A CSI is reviewing a HACCP record and observes that a result of 3% is recorded as

a monitoring check. The critical limit at this CCP is ―at least 6%.‖

a. At this point in the review, is this a deviation from a critical limit and/or a HACCP noncompliance?

b. Continuing with the above, if the establishment‘s records indicate that all

corrective actions met the requirements of 417.3(a), is there a HACCP noncompliance?


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3. The HACCP plan specifies that the CCP for product temperature will be monitored

by checking product at three locations in the cooler each hour, and recording all results. A CSI reviews the temperature log and observes that at each monitoring check there are only two temperatures recorded. All results are within critical limits.

a. Based only on the information given, is this a deviation from a critical limit, an

unforeseen hazard, or a HACCP noncompliance? b. Would the CSI expect to see all corrective actions in section 417.3(a) taken for

this situation? Please explain. 4. A CSI is making observations in the poultry boning room, when she observes that

there is a commotion among employees at the automatic breast deboning equipment. Investigating, she observes that a full set of viscera has gotten hung up on the equipment, and intestinal contents are spread all over. The employees shut off the line. Because she reviewed the HACCP plan this morning, she realizes that there is no CCP that addresses this situation. a. Which regulation would apply in this situation?

b. At this point, is there a HACCP noncompliance?

c. What should the CSI do next?


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The CSI observes the employees gather all of the chicken breasts from the area, put them into inedible containers, and begin cleaning up. She returns to her other duties, and later she goes to the QA office and asks for documentation of the actions taken.

d. Do the establishment‘s recorded corrective actions meet all of the corrective action regulatory requirements?

e. What else should the CSI do in this situation?

HACCP CORRECTIVE ACTION OR UNFORESEEN HAZARD REPORT XYZ Corporation Date: 1-2-2012 Product and amount affected: 397 lbs chicken breasts Describe the unforeseen hazard, including cause: At 8:30 am viscera present in box of breasts got onto equipment causing major contamination. We stopped the line, disposed of product and did a full cleanup AB 8:50 am. Describe how the affected product was segregated and held: All product from line or near line disposed of as inedible AB 8:50 am. Describe how the product was reviewed to determine acceptability for distribution: In addition, we did a visual inspection of all product that we had not yet run from that lot, and reinspected a sample of the product already produced. No other defects found AB 9:15 am. Describe measures taken to prevent a reoccurrence and/or to eliminate the cause: Production employees were instructed to observe dumping of raw materials more closely. We have contacted the supplying establishment and their written reply attached. The next load of product from that supplier will be given 100 % reinspection before use CD 2:00 pm. State whether HACCP plan reassessed, conclusions, and any changes: Yes, hazard analysis done, no changes to the HACCP plan. A new SOP for supplier certification/acceptability added for purchasing/receiving CD 3:00 pm 1-3-12. Adel Brezil 1-3-12 Craig Darrow 1-3-12 Plant Management, date QA Manager, date

Example: For Training Use Only


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5. A CSI has recently rotated assignments and his new patrol includes a pork

fabrication operation. Today‘s schedule includes the Raw Intact HACCP verification task. He observes that there is a metal detector in use on the pork cuts before they enter the tenderizer injector. He reviews the HACCP plan and hazard analysis, and he sees that the hazard analysis identifies metal, but finds it is not likely to occur. The HACCP plan does not have a CCP for metal detection.

What might the CSI conclude at this point?

Later that day, he learns that the metal detector has rejected product. He reviews the corrective action log.

a. What regulation applies to this situation? b. Did the establishment meet corrective action requirements? c. Is there a HACCP noncompliance?

HACCP CORRECTIVE ACTION OR UNFORESEEN HAZARD REPORT IJK Corporation Date: 3-2-12 Product and amount affected: 25 lb boneless pork loin Describe the unforeseen hazard, including cause: At 9:00 am the metal detector rejected product, which was carefully examined by QC, what looks like a syringe needle was found EF 10:05 am. Describe how the affected product was segregated and held: We disposed of the piece as inedible EF 10:05 am Describe how the product was reviewed to determine acceptability for distribution: All product from that same load was run back through the metal detector but nothing else was found EF 1:00 pm. Describe measures taken to prevent a reoccurrence and/or to eliminate the cause: We have contacted the supplying establishment XYZ and notified them that if it happens again we will no longer purchase from that supplier GH 11:00 am. State whether HACCP plan reassessed, conclusions, and any changes: Yes. Established a new CCP for metal detection. See new version of HACCP plan, dated 3-2-12 GH 1:00 pm. Eric Fazoli 3-2-12 Gerry Harroldson 3-2-12 Plant Management, date QA Manager, date

Example: For Training Use Only


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d. What else should the CSI do? 6. Read each of the following statements and then summarize in your own words what

the HACCP noncompliance is. What regulation would you cite on the NR?

a. The HACCP plan lists a monitoring procedure for the temperature of the hot water pasteurization spray as ―visual checking the temperature gauge three times per shift.‖ The critical limit is 180º F or above. The CSI reviews the monitoring log.

Hot Water Pasteurization Spray, critical limit 180º F or above Date: 1-2-12

Time Temp Monitor Comments

6:45 am 182 OP

9:30 am 175 OP

12:00 183 OP

The CSI asks the monitor whether any corrective actions were done after the second check and the reply is ―none.‖ She asks for the associated corrective action log and is told that there is none. What is the noncompliance and the regulatory reference?

b. The HACCP plan has a monitoring procedure for measuring internal product

temperature of fresh pork sausage chubs. The CSI reviews the temperature log and observe a deviation recorded. He reviews the associated corrective action log and finds that the establishment recorded the cause of the deviation, eliminated the cause, and ensured that the CCP was in control before continuing production. His review also reveals that the establishment implemented an effective preventive measure. The corrective action report does not contain any record of what was done with the product that was produced while the critical limit was out of control. He reviews shipping records and observes that the product has been distributed. The establishment cannot produce any further records to demonstrate the safety of this product. What is the noncompliance and the regulatory reference?


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Pre-Shipment Review Requirement The regulatory requirement for pre-shipment review is:

9 CFR 417.5(c)--Prior to shipping product, the establishment shall review the records associated with the production of that product, documented in accordance with this section, to ensure completeness, including the determination that all critical limits were met and, if appropriate, corrective actions were taken, including the proper disposition of product. Where practicable, this review shall be conducted, dated, and signed by an individual who did not produce the record(s), preferably by someone trained in accordance with §417.7 of this part, or the responsible establishment official.

FSIS considers product to be ―produced and shipped‖ when the establishment completes the pre-shipment review even if the product is still at the establishment. Verifying that the establishment has completed pre-shipment review enables CSIs to know whether the company has taken full and final responsibility for applying its HACCP system controls to the product that it has produced. For a pre-shipment review, the establishment must review the records associated with the production of specific product. There is no regulatory requirement for an establishment to conduct a pre-shipment review when the product moves from one process category to another in same establishment, e.g., carcasses from the slaughter process moving to further processing (cut-up or boning). When CSIs verify HACCP implementation, they are to review establishment pre-shipment review records for the specific production to verify that the establishment meets the requirement of 9 CFR 417.5(c). Occasionally, when verifying HACCP implementation, CSIs are to observe the establishment employee perform the pre-shipment review. This type of observation is particularly important if the CSI is new to the establishment. Once the observation verification has been performed, this regulatory requirement can be verified using the recordkeeping component of the HACCP verification task. CSIs should understand that pre-shipment review can be accomplished if the product is at a location other than the producing establishment, as long as the review of appropriate documents and compliance with 9 CFR 417.5(c) occurs before the product leaves the control of the producing establishment. The thought process that CSIs should use when verifying regulatory requirements includes:

gathering information


Determining regulatory compliance. This thought process should be utilized when verifying all of the regulatory requirements.


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Gather information by asking questions CSIs should seek the answer to the following questions:

1. Has the establishment reviewed the records associated with the production of

the product, prior to shipment? 2. Has the pre-shipment review been signed and dated by an establishment

employee?

Assess the information To answer these questions, the CSIs should review the pre-shipment review records. Pre-shipment Review Compliance Example: A CSI is performing the Slaughter HACCP verification task in poultry slaughter establishment, and verifying the establishment’s compliance with the pre-shipment review requirement. The establishment performs pre-shipment review by looking at the HACCP records associated with a shift’s production at each CCP. The establishment has two CCPs: final wash and carcass chilling. He reviews the Sanova antimicrobial rinse log for the final wash CCP from yesterday’s shift and finds that all the results were entered, no corrective action was needed, and the establishment’s QC supervisor has signed and dated at the bottom of the record. He also reviews the chilling log from yesterday’s shift and finds the same results. Based on his observations, he determines that the establishment is in compliance with 9 CFR 417.5(c) because the establishment has conducted the pre-shipment review.

Determine Compliance After the CSI has gathered and assessed all available information pertaining to the pre-shipment review requirement, he or she must determine regulatory compliance. If the CSI finds that the establishment has met all pre-shipment review regulatory requirements in 9 CFR 417.5(c), then there is no regulatory noncompliance. If the CSI finds that the establishment has not met all regulatory requirements for pre-shipment review, there is noncompliance. More information about making compliance determinations is provided in another section of the training. Noncompliance examples with Pre-Shipment Review Requirement 417.5(c) One or more of the following findings evidence that the establishment does not comply with 9 CFR 417.5(c):

The establishment ships product in commerce without performing a pre-shipment review.

The establishment transports product to another location prior to pre-shipment review and cannot demonstrate that it maintains control of the product.

An establishment employee does not sign and date the pre-shipment review.


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An establishment employee does not review the appropriate HACCP records associated with the production covered by the pre-shipment review. The appropriate HACCP records typically include the records of any monitoring activities, verification activities, or corrective actions that were performed during the production period covered by the pre-shipment review.

Note: CSIs are to determine noncompliance with 9 CFR 417.5(a)(3) if the pre-shipment review records do not identify the specific production to which they apply (e.g., product codes, lot codes, product name, production periods The following are examples of noncompliance with 417.5(c). Noncompliance Example 1: The CSI is performing the Slaughter HACCP verification task on a specific production of turkey carcasses that has left the control of the establishment. She requests the pre-shipment review records for this production, which the establishment is not able to provide. The establishment shipped the product without conducting a pre-shipment review. Noncompliance Example 2: The CSI is performing the Slaughter HACCP verification task in a pork slaughter operation. He decides to perform the review and observation component by observing the establishment employee complete the pre-shipment review for a specific production of swine carcasses. He observes a establishment employee review the records associated with the production these carcasses, but not sign or date any record to indicate the review is complete. The establishment performs pre-shipment review but does not sign and date the records.

CSIs document the HACCP verification task results in PHIS including any noncompliance in accordance with the discussion of documentation and enforcement in a later section.


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Workshop: Pre-shipment Review Refer to the handout and to FSIS PHIS Directive 5000.1 to complete the following questions. 1. Fill in the blanks for the following regulatory references.

9 CFR 417.5(c)—Prior to ____________ product, the establishment shall

____________ the records associated with the ____________ of that product,

documented in accordance with this section, to ensure completeness, including the

determination that all ___________ ___________ were met and, if appropriate,

______________ actions were taken, including the proper _____________ of product.

Where practicable, this review shall be __________________, __________, and

__ _ by an individual who did not produce the record(s), preferably by someone

trained in accordance with §417.7 of this part, or the responsible establishment official.

2. The establishment must accomplish the pre-shipment review prior to the specific

production leaving the physical premises. True or False? 3. A CSI is assigned to a very small beef slaughter establishment that stores a wide

variety of finished products (raw and cooked) for several months in the freezer. The HACCP plan includes a CCP for cold storage of finished products after processing. The establishment monitors the CCP daily and documents the results. The pre-shipment review form is then signed and dated, and any product in the freezer is clear to be shipped that day.

Does this fulfill the regulatory requirements for pre-shipment review? Why or why not?


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Summary-Verifying the HACCP Regulatory Requirements Table 1 below summarizes the Steps that CSIs perform during the HACCP verification task. Table 2 and Table 3 on the following pages provide a quick reference for the questions that CSIs should seek answers to when verifying each of the HACCP Implementation regulatory requirements.

Table 1 HACCP VerificationTask Summary

Step 1: Select Product Type and Specific Production

Select product type within the process category Ensure all product types within process category are verified over time. Select product type that the est. is currently producing.

Select specific production

Verify all HACCP regulatory requirements at each CCP by following Steps 2-8

Step 2: Review the HACCP Plan for the Selected Product Type

Understand the monitoring and verification procedures and frequencies

Note the most recent signature date (must be entered into PHIS)

417.2(d)

Note changes to the HACCP plan and update the establishment profile

Step 3: Verify Monitoring Per Directive 5000.1 417.2(c)(4)

Step 4: Verify Verification Per Directive 5000.1 417.2(c)(7), 417.4(a)(2)(i)(ii)(iii)

Step 5: Verify Recordkeeping

Per Directive 5000.1 417.2(c)(6), 417.5(a)(3), 417.5(b), 417.5(d), 417.5(e)(2) 417.5(f)-Note: contact supervisor if records are not made available

Step 6: Verify Implementation of Prerequisite program (PRP)/Other Control Measures Used to Support Hazards Not Reasonably Likely to Occur (NRLTO)

Per Directive 5000.1 417.5(a)(1)

Review PRP records for the specific production, Observe program implementation, Verify implemented as written, and Verify records continue to support decision that hazard is NRLTO

Contact supervisor if records are not made available per 417.5(f)

Consider whether implemented in a manner that supports the Hazard Analysis decisions

Contact supervisor if uncertain whether implementation or records support the decision in the Hazard Analysis

Step 7: Verify Corrective Action (CA)

Per Directive 5000.1 Initiate a directed HACCP verification task to verify CA when no routine HACCP verification task is available

417.3(a), 417.3(b)

When documenting compliance with the CA requirement, briefly describe the observations that support a finding of compliance in PHIS

Step 8: Verify Pre-shipment Review

Per Directive 5000.1 417.5(c)

If IPP find that adulterated product may have entered commerce, they are to notify the DO personnel through supervisory channels immediately.


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Table 2—Monitoring, Verification, and Recordkeeping Requirements

Monitoring

Verification

Recordkeeping

9CFR 417.2(c)(4)

1. Does the HACCP plan list the monitoring procedures and frequencies that are used to monitor each of the CCP to ensure compliance with the critical limits? 2. Are the monitoring procedures being performed as described in the HACCP plan? 3. Are the monitoring procedures being performed at the frequencies for the CCP listed in the HACCP plan? 4. Are the CL met?

9CFR 417.2(c)(7) 417.4(a)(2)(i)(ii)(iii)

1. Does the HACCP plan contain procedures and frequencies for the calibration of the process-monitoring instruments? 2. Does the HACCP plan contain procedures and frequencies for direct observations of monitoring activities & corrective actions? 3. Does the HACCP plan list procedures and frequencies for the review of records generated and maintained in accordance with 9 CFR 417.5(a)(3)? 4. Does the HACCP plan list product sampling as a verification activity? 5. Are process-monitoring instrument calibration activities conducted as per the HACCP plan? 6. Are direct observation verification activities conducted as per the HACCP plan? 7. Are records generated in accordance with 9 CFR 417.5(a)(3) being reviewed by the establishment?

Recordkeeping Requirement – 9CFR 417.2(c)(6)

1. Does the HACCP plan set out a recordkeeping system that documents the monitoring of the CCP? 2. Do the records contain actual values & observations obtained during monitoring? HACCP Records Requirement – 9CFR 417.5(a)(3)

1. Do the records document the monitoring of CCP and critical limits? 2. Do the records include actual times, temperatures, or other quantifiable values, as prescribed in the establishment‘s HACCP plan? 3. Do the monitoring, verification, and corrective action records include product codes, product name or identity, or slaughter production lot, and the date each record was made? 4. Are verification procedures and results documented? 5. Is the time recorded when the verification activity was performed? 6. Does the record contain the date the record was made? 7. Are process-monitoring calibration procedures & results recorded? Records Authenticity Requirement – 9CFR 417.5(b)

1. Was each entry on the record made at the time the event occurred? 2. Does each entry include the time? 3. Was each entry on the record signed or initialed by the establishment employee making the entry? 4. Does each record include the date? Computerized Records Requirement – 9CFR 417.5(d)

Are appropriate controls provided to ensure integrity of electronic data and signatures? Record Retention and Availability Requirement – 9CFR 417.5(e)(1) and (2)

1. Are the records being maintained for the required amount of time, i.e., one year for slaughter and refrigerated products and two years for frozen, preserved, or shelf-stable products? 2. Are the records kept on-site for 6 months? 3. If the records are stored off-site, can they be retrieved in 24 hours? Official Review of Records – 9 CFR 417.5(f)

Are all records, plans, and procedures required by Part 417 available for official review?


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Table 3- Prerequisite Program Implementation, Corrective Action and Pre-shipment Review Requirements

Prerequisite Program Implementation

Corrective Actions

Pre-shipment Review

Supporting Documentation Requirement – 9CFR 417.5(a)1 1. Is the establishment implementing the procedures in the program as written? 2. Does the establishment maintain records to support the implementation of the program, including verification records and results from outside auditors? 3.Do the records show that the prerequisite program continues to support the decision that the relevant hazard is not reasonably likely to occur on an ongoing basis

Corrective actions in response to a deviation from a critical limit – 9CFR 417.3(a) 1. Did the establishment identify and eliminate the cause of the deviation? 2. Did the corrective actions ensure that the CCP is brought under control? 3. Were measures implemented to prevent recurrence of the deviation? 4. Did the actions ensure that no product that is injurious to health or otherwise adulterated, as a result of the deviation, enters commerce? Corrective Actions in Response to a Deviation Not Covered by a Specific Corrective Action or an Unforeseen Hazard – 9CFR 417.3(b) 1. Did the establishment segregate and hold all affected product? 2. Did the establishment perform a review to determine the acceptability of the affected product for distribution? 3. Did the establishment take necessary action with respect to the affected product to ensure that no product that is injurious to health, or otherwise adulterated as a result of the deviation, enters commerce? 4. Was a reassessment conducted to determine whether the newly identified deviation or other unforeseen hazard should be incorporated into the HACCP plan?

Pre-shipment Review Requirement – 417.5(c) 1. Has the establishment reviewed the records associated with the production of the product, prior to shipment? 2. Has the pre-shipment review been signed and dated by an establishment employee?


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Slaughter Food Safety Standard In slaughter establishments, fecal contamination of carcasses is the primary avenue for contamination by pathogens. Pathogens may reside in fecal material, both in the gastrointestinal tract and on the exterior surfaces of the animal or bird going to slaughter. Without care being taken in handling and dressing procedures during slaughter and processing, the edible portions of the carcass can become contaminated with bacteria capable of causing illness in humans. Once introduced into the establishment environment, the organisms may be spread from carcass to carcass or by other means. Therefore, FSIS enforces a ―zero tolerance‖ standard for visible fecal material on poultry carcasses and no visible fecal, ingesta, or milk material on carcasses, head, cheek, weasand meat at inspected establishments that slaughter livestock. Under 9 CFR 417, a HACCP plan must include, as appropriate, critical control points that are designed to control identified food safety hazards (9 CFR 417.2(c)(2)). Because fecal material is a vehicle for pathogens, and because virtually all slaughter establishments recognize that contamination of meat by pathogenic microorganisms from fecal material, ingesta, or milk is a food safety hazard that is reasonably likely to occur in the slaughter production process, IPP are to verify that slaughter establishments have adopted controls that they can demonstrate are effective in reducing the occurrence of pathogens, including controls that prevent contamination of carcasses with fecal contamination, milk and ingesta. Now let‘s discuss the food safety standard for livestock and poultry postmortem and how they are verified.

Enforcing Food Safety Standard for Livestock Postmortem

References: FSIS Directive 6420.2, Regulations: 9 CFR 310.17(a), 310.18(a), and part 417. On-Line IPP On-line IPP verify removal of contamination during examination of carcasses and parts as part of post-mortem inspection, i.e., verify that livestock slaughter establishments are complying with 9 CFR 307.2(g), 310.3, 310.17(a), and 310.18(a). 9 CFR 310.18(a) states: Carcasses, organs, and other parts shall be handled in a sanitary manner to prevent contamination with fecal material, urine, bile, hair, dirt, or foreign matter; however, if contamination occurs, it shall be promptly removed in a manner satisfactory to the inspector. On-line inspectors do not follow the instructions or verification methods including performing HACCP verification tasks as outlined in FSIS PHIS Directive 5000.1 or follow the instructions or verification methods including performing Livestock Zero Tolerance tasks as outlined in FSIS Directive 6420.2. They focus their attention on product examination and determine whether or not the establishment is meeting the regulatory requirements in the regulations referenced above.


FSRE/PHIS 132

When on-line inspectors at the rail station find feces, ingesta, or milk on livestock carcasses, the establishment reexamines and reconditions the entire carcass (trimming all contamination). On-line inspectors are to stop the slaughter line for carcass reexamination and reconditioned by the establishment unless:

The establishment has elected to provide a rail-out loop to rail contaminated carcasses off-line for reexamination, trimming, and positioning back on the line for final inspection, and

The IIC has not determined that the establishment‘s rail-out procedure is inadequate to prevent carcass accumulation or cross-contamination of other carcasses.

Note: On-line IPP who retain a carcass for veterinary disposition are not to authorize establishment trimming until after disposition by a veterinary medical officer. Additionally, on-line inspectors are to notify the IIC or, if unavailable, other off-line inspection program personnel when they believe that:

An establishment‘s rail-out procedure is inadequate to prevent carcass accumulation or cross-contamination of other carcasses, or

An establishment‘s slaughter or dressing processes are not under control (for example, when repeated presentation of carcasses contaminated with fecal material, ingesta, or milk for postmortem inspection at the rail inspection station indicates failure to control sanitary dressing processes).

If the on-line head inspector finds fecal, milk, or ingesta contamination, the contamination must be removed by the establishment before the head can be passed. Also, if the on-line inspector finds fecal, milk, or ingesta contamination on weasand meat during the harvesting step, the establishment must remove the contamination before the weasand meat can be passed. If fecal, milk, or ingesta contamination is repeatedly found, on-line inspection personnel are to notify the off-line inspection personnel. The off-line inspection personnel will perform verification activities to determine if the establishment‘s process and sanitary dressing procedures are controlling fecal, milk, and ingesta contamination during the head meat or weasand meat production process.

Livestock Food Safety Standard Verification Off-line CSIs verify that an establishment has adopted controls in its food safety system that it can demonstrate are effective in reducing the occurrence of pathogens, including the controls that prevent contamination of carcasses and carcass parts with fecal material, milk and ingesta. Off-line CSIs follow the instructions and verification methods outline in FSIS PHIS Directive 5000.1 When off-line CSIs verify the adequacy of the establishment‘s procedures in preventing the contamination of carcasses and head, cheek, and weasand meat with fecal material, ingesta, or milk, they follow the instructions and verification methods including performing Livestock Zero Tolerance tasks as outlined in FSIS Directive 6420.2.


FSRE/PHIS 133

FSIS enforces food safety standards for fecal, ingesta, and milk contamination on livestock carcasses and on head meat, cheek meat, and weasand meat through postmortem inspection activities at establishments that slaughter livestock. The establishment must meet the food safety standard for visible fecal, milk, and ingesta contamination on livestock carcasses at or after the postmortem rail inspection station, regardless of the location of the CCP. The CCP for pathogen contamination or visible contaminants may be at other locations as supported by the hazard analysis.

For example, the establishment may locate the critical control point after the postmortem rail inspection station.

In other cases, the establishment may have a CCP prior to the postmortem rail inspection station.

Note: Regardless of the location of the CCP, FSIS off-line CSIs will verify compliance with the food safety standard at the rail inspection station. Head meat, check meat and weasand meat is frequently used in the production ground beef products. If the meat from these parts is contaminated, it represents a way of importing pathogens, including E. coli O157:H7, into ground beef. Hence, to reduce the possibility of E. coli O157:H7 contamination, establishments must also meet the food safety standard for no visible fecal, milk, or ingesta contamination on head meat, cheek meat, and weasand meat at the end of the harvesting process after all of the establishment controls and interventions have been implemented. This verification usually takes place at the time of packaging or when product is placed in a container for storage which is considered to be the end of the harvesting process. Livestock Zero Tolerance Verification Task The IIC and other off-line CSIs verify the adequacy of establishment procedures to ensure compliance with the food safety standard for fecal, ingesta, or milk

contamination, by performing the Livestock Zero Tolerance Verification Task at the frequency determined by PHIS in the establishment‘s task list and when notified by on-line IPP of an apparent problem. The off-line CSI performs a directed instance of the routine task when notified by the on-line inspector of a problem unless a Livestock Zero Tolerance Verification task is already scheduled for that day and has not been performed.

The off-line CSI follows these steps when verifying establishment procedures for livestock carcasses: 1. Randomly select carcass units at the postmortem rail inspection station for

examination on-line, at or after the postmortem rail inspection station, regardless of the location of the CCP. (This inspection should occur before the final wash. In situations where this is difficult, such as those related to worker safety, the IIC should develop appropriate procedures with establishment management in order for this inspection to be properly conducted).


FSRE/PHIS 134

2. Based on the expected slaughter volume for the shift (i.e., the number of animals), determine the number of carcass units to be examined, using the following table. If carcasses are split, each half carcass is ½ of a carcass unit. (Select two times as many half-carcasses.)

Slaughter Volume (# of animals per day) # of Carcass Units (Unit = whole carcass)

100 or less 2

101 to 250 4

251 to 500 7

More than 500 11

Note: It is not necessary to examine all of these units at the same time. 3. Examine the outside of the selected carcass units using the same technique that on-

line inspection program personnel use at the postmortem rail inspection station. Identify fecal material or ingesta using the color and texture characteristics, and milk using the color and consistency characteristics provided in Directive 6420.2.

The off-line CSI follows these steps in livestock slaughter establishments when verifying establishment procedures for head meat, cheek meat, and weasand meat: 1. Review the HACCP plan; 2. Examine the same amount of product as the establishment has listed in the HACCP

plan for its monitoring procedure;

Note: 9 CFR 417.5(a)(2) requires that the establishment maintain a written HACCP plan, including decisionmaking documents associated with the selection and development of the CCPs and critical limits, and documents that support both the monitoring and verification procedures selected and the frequency of those procedures. Because the establishment is required to have documents to support the monitoring procedures (amount of product examined), CSIs should examine the same amount of product as the establishment has listed in the HACCP plan for the monitoring procedure. If the establishment does not have documents supporting the monitoring procedures and frequency, there is noncompliance with 9 CFR 417.5(a) (2).)

3. Select product at the completion of the harvesting process, (e.g., at the packaging

step or when the product is place in a container for storage) after all of the establishment controls and interventions; and

4. Examine all outer surfaces of the product selected for fecal material, ingesta, or milk.

Identify fecal material or ingesta using the color and texture characteristics, and milk using the color and consistency characteristics provided in Directive 6420.2


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Documentation If the CSI does not observe any fecal material, ingesta, or milk on livestock carcasses or on head, cheek, or weasand meat during this verification, and no other regulatory noncompliance is observed, the Livestock Zero Tolerance task is marked as completed in the Inspection Results page of PHIS. If the CSI finds identifiable fecal material, ingesta, or milk on any carcass or head, cheek, or weasand meat while performing the Livestock Zero Tolerance task, he or she must notify establishment management of the contamination and document this noncompliance on FSIS Form 5400-4, Noncompliance Record (NR). As part of completing the Livestock Zero Tolerance task, the CSI must verify that the establishment implements corrective action that meets the requirements of 417.3. The CSI can observe the establishment isolating affected product, which is all product back to the last acceptable establishment check, and review the corrective action records, to verify that the establishment:

Identifies and eliminates the cause of the deviation;

Ensures that the CCP is under control after the action is taken;

Establishes measures to prevent recurrence; and

Ensures that no product that is injurious to health enters commerce.

Note: If the establishment does not meet the corrective action requirements, document this noncompliance on the same NR as the zero tolerance failure. Note: When CSIs find zero tolerance failures while performing other inspection duties (e.g., stumble-on occurrences), they are to documented the noncompliance under the Slaughter HACCP verification task. CSIs must verify that the establishment implements corrective action that meets the requirements of 417.3 during the performance of this task. The Zero Tolerance Verification task is used to document performance of the zero tolerance verification checks as described in FSIS PHIS Directive 6420.2.

Enforcing the Food Safety Standard for Poultry Postmortem References: FSIS PHIS Directive 6420.2, 381.65(e), and part 417. FSIS enforces a food safety standard for visible fecal material on poultry carcasses and poultry carcass parts through postmortem inspection and reinspection activities at poultry slaughter establishments.

9 CFR 381.65(e) states: Poultry carcasses contaminated with visible fecal material shall be prevented from entering the chilling tank. FSIS views preventing carcasses with visible fecal contamination from entering the chilling tank as critical to preventing the cross-contamination of other carcasses.


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Poultry Zero Tolerance Verification Task Each day, off-line CSIs are to conduct at least two fecal contamination checks for each evisceration line for every shift (i.e., the number of checks will total at least 2 times the number of shifts times the number of evisceration lines). The routine Poultry Zero Tolerance verification task in PHIS has an expected frequency of twice per shift without regard for the number of slaughter lines. Therefore, only 60 Poultry Zero Tolerance verification tasks will appear on the establishment‘s task list each month. In establishments with multiple slaughter lines, CSIs are to schedule additional instances of the routine task as directed tasks. For example, if a CSI is assigned to poultry slaughter establishment with 2 evisceration lines, he or she needs to perform a minimum of 4 Poultry Zero Tolerance verification tasks each day the establishment operates. If 2 routine Poultry Zero Tolerance verification tasks are scheduled for a particular operating day, then he or she will need to schedule 2 more Poultry Zero Tolerance verification tasks directed tasks. The CSI will enter the individual results of the 4 separate Poultry Zero Tolerance verification tasks into PHIS. The fecal contamination checks are performed at either the same location as pre-chill testing in establishments inspected under the finished products standards (FPS), or the inspection station where Acceptable Quality Level (AQL) testing is conducted in an establishment under traditional inspection, regardless of the location of the establishment‘s CCP. The CSI follows these steps when verifying establishment dressing procedures for poultry carcasses:

1. Select 10 carcasses randomly (using an established FSIS method), and

2. Examine the selected carcasses off line using the following inspection method:

For the outside back – While holding the carcass, with the back of the carcass

toward the observer, start at the hock area and observe the hocks, back part of the legs, tail area, back of the carcass and top side of the wings.

For the outside front – Turn the carcass and observe the bottom side of the

wings, breast, and front part of the legs

For the inside – Observe the inside surfaces of the carcass and the abdominal flaps and fat.

For the neck flap area – Observe the neck flap and the thoracic inlet area.

Identify fecal material using the color, consistency and composition characteristics provided in Directive 6420.2.


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Documentation If the CSI does not observe any identifiable fecal material on poultry carcasses that would have entered the chiller or parts placed on ice during this verification, and no other regulatory noncompliance is observed, the Poultry Zero Tolerance task is marked as completed in the Inspection Results page of PHIS. If the CSI finds identifiable fecal material on poultry carcasses or parts that would have entered the chiller or parts placed on ice while performing the Poultry Zero Tolerance task, he or she must notify establishment management of the contamination and document this noncompliance on FSIS Form 5400-4, Noncompliance Record (NR). As part of completing the Poultry Zero Tolerance task, the CSI must verify that the establishment implements corrective action that meets the requirements of 417.3. The CSI can observe the establishment isolating affected product, which is all product back to the last acceptable establishment check, and review the corrective action records, to verify that the establishment:

Identifies and eliminates the cause of the deviation;

Ensures that the CCP is under control after the action is taken;

Establishes measures to prevent recurrence; and

Ensures that no product that is injurious to health enters commerce. Note: If the establishment does not meet the corrective action requirements, document this noncompliance on the same NR as the zero tolerance failure. Note: If ingesta is observed during the fecal contamination check, the establishment should be notified of this finding. The ingesta should be removed from the bird. There would be no noncompliance for this finding. Note: When CSIs find zero tolerance failures while performing other inspection duties (e.g., stumble-on occurrences), they are to documented the noncompliance under the Slaughter HACCP verification task. CSIs must verify that the establishment implements corrective action that meets the requirements of 417.3 during the performance of this task. The Zero Tolerance Verification task is used to document the performance of the zero tolerance verification checks as described in FSIS PHIS Directive 6420.2

Enforcement If CSIs find repeated fecal material noncompliances and determine that these findings are from the same cause, the NRs should be associated (linked) in PHIS. If the noncompliance findings are not from the same cause, the NRs should not be associated (linked) in PHIS. When associating NRs, CSIs follow the methodology set out in FSIS PHIS Directive 5000.1. Also, when CSIs have concerns about whether the documented fecal findings are evidence a systemic problem, the IIC should review all relevant records including generic E. coli results, compliance with HACCP requirements, Sanitation SOP compliance, Sanitation Performance Standard compliance, Salmonella test results, and any other microbiological testing results.


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The IIC will make a determination as to whether the findings show that there have been isolated incidents of fecal material noncompliance, or if the findings evidence a systemic problem with the slaughter food safety system. When making this determination, the IIC should seek answers to questions such as: 1. What is the rate of noncompliance? 2. Has the establishment implemented meaningful preventive measures? 3. Has the rate of noncompliance decreased? 4. Does the generic E. coli testing indicate a problem with the sanitary dressing

procedures or sanitation in the establishment? 5. Are there indications that other parts of the HACCP system are not appropriately

designed to prevent food safety hazards? 6. Is the establishment doing any other testing that is relevant (e.g., testing for

customers)? If so, what are the results of that testing? 7. Are all parts of the HACCP system being implemented as designed? 8. Are there indications that the establishment's antimicrobial interventions are not

operating as intended? 9. Do the establishment's microbiological testing program results have spikes that

might indicate problems with sanitation? If so, does the establishment implement corrective actions to eliminate these problems?

If the IIC determines that repetitive findings of fecal material, ingesta, and milk represent a developing trend, the NRs would be associated to document that the slaughter process is not effective in preventing contamination of carcasses. This situation can lead to a determination that the food safety system is inadequate. If so, the IIC is to follow the methodology set out in FSIS PHIS Directive 5000.1, Chapter IV, Enforcement, and Rules of Practice to determine the appropriate enforcement action.


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Workshop: Food Safety Standard in Slaughter Refer to the handout to complete the following questions. 1. What contaminants are covered by the food safety standard in livestock slaughter?

2. What parts must be free of these contaminants?

3. At what location will FSIS verify the food safety standards for livestock carcasses?

4. Where will FSIS verify the food safety standard for head meat, cheek meat, and weasand meat in livestock slaughter operations?

5. If a livestock slaughter establishment has a CCP for visible contaminants for

livestock carcasses at the final washer, where would FSIS verify compliance with the food safety standard?

6. A GS-7 inspector is working the rail inspection station in a large beef slaughter

establishment. He notices a fecal smear on the hindquarter of a carcass. The establishment has a rail-out procedure.

a. What action would he take?

b. What action would he take if the establishment had no rail-out procedure?

c. What is expected of the establishment?

d. Would a Noncompliance Record (NR) be completed by the on-line inspector? By the off-line inspector if he or she was functioning as the on-line inspector?

e. If the GS-7 found repeated instances of contaminated carcasses during his time at the rail inspection station, what would he do?


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7. A GS-8 off-line slaughter inspector is assigned to a large beef slaughter establishment that kills 2000 head per shift. He is performing a Livestock Zero tolerance verification task to verify compliance with the slaughter food safety standard.

a. How many sides would be selected for examination?

b. Where, and with what technique, would the sample sides be examined?

c. If no feces, ingesta, or milk is found on the samples, what action would he take?

d. If ingesta were found on one carcass side, what action would he take? 8. What contaminants are covered by the food safety standard in poultry slaughter? 9. At what location will FSIS verify the food safety standard for poultry slaughter? 10. If the establishment has a CCP at the antimicrobial rinse after the pre-chill FPS

inspection location and just prior to the chiller, where would FSIS verify compliance with the slaughter food safety standard?

11. A new GS-8 off-line slaughter inspector is assigned to a large poultry slaughter

operation that has 4 lines and slaughters 160,000 per shift. The establishment has two shifts.

a. How many fecal contamination checks would need to be performed for one shift

including all lines?

b. How many birds are examined at each check?

c. How are the birds selected at the pre-chill inspection station?


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d. If she found identifiable fecal material, what actions would she take?

e. If she does not find any fecal material in any of the checks, what actions would she take?

12. The establishment sets ―specific production‖ as all product from one line for a shift. While performing a Poultry Zero tolerance task to verify the slaughter food safety standard on line 2, the CSI found feces on a chicken carcass and documented noncompliance on an NR. About two hours later, he notices feces on a carcass on the same line after the washer and prior to the chiller. The establishment tells him that since this fecal contamination finding was not part of the Poultry Zero Tolerance verification task, his finding was not a slaughter food safety standard failure. Is the establishment correct? Why or why not?

13. How do off-line CSIs determine the amount of product to inspect when performing

the Livestock Zero Tolerance verification task in a livestock slaughter establishment to verify that the meat from heads, cheeks, and weasands are not contaminated with fecal material, ingesta, or milk?