aib standards for inspection dairy-plants

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  • AIB InternationalI

    www.aibonline.org

    The AIB International

    ConsolidatedStandards

    forInspection

    DairyFacilities

  • IIAIB International

    Disclaimer AIB International 2010

    The information provided in this or any other version of the AIB International Consolidated Standards is not legal advice, but general information based on good manufacturing practices, common regulatory requirements, and food safety practices typically encountered in a packaging manufacturing facility. These Standards have been developed as a guide to best practices and are not intended, under anycircumstances, to replace or modify the requirement for compliance with applicable laws and regulations. These Standards are not intended to meet all existing laws and regulations, nor those laws or regulations that may be added or modified subsequent to the publication of these Standards. AIB International shall not be liable for any damages of any kind, arising in contract, tort, or otherwise, in connection with the information contained in these Standards, or from any action or omission or decision taken as a result of these Standards or related information. Further, AIB International expressly disclaims any and allrepresentations or warranties of any kind regarding these Standards.

    Copyright AIB International 2010. All rights reserved.

    Users of these Standards and associated documents are reminded that copyright subsists in all AIBInternational publications and software. Except where the Copyright Act allows and except where provided for below no part of this publication may be transmitted or reproduced, stored in a retrieval system in any form, or transmitted by any means without prior permission in writing from AIB International. All requests for permission should be addressed to the Vice President of Administration at the address below.

    No part of this publication may be translated without the written permission of the copyright owner.

    The use of this material in print form or in computer software programs to be used commercially, with or without payment, or in commercial contracts is subject to the payment of a royalty. AIB International may vary this policy at any time. AIB International 1213 Bakers Way PO Box 3999 Manhattan, KS 66505-3999

    The AIB International Consolidated Standards for Inspection. Issued May 2010.

    1-880877-14-7

    10.1.A

  • AIB Internationali

    Preface........................................................................................................................................ ii

    Inspection and Audit..................................................................................................................1Definitions of Inspection and Audit .................................................................................................... 1Benefits of Inspection and Audit ........................................................................................................ 1Reasons for Having Inspection and Audit ........................................................................................... 2 1. Regulations ............................................................................................................................. 2 2. Industry Best Practices .............................................................................................................. 2 3. Customer Demands ................................................................................................................. 3 4. Process Improvements .............................................................................................................. 3

    AIB International........................................................................................................................4History ............................................................................................................................................ 4Mission ........................................................................................................................................... 4Key Offerings................................................................................................................................... 4 Consolidated Standards and Educational Inspections ..................................................................... 4 Benchmarked Standard Audits ...................................................................................................... 4

    Introduction to the Standards...................................................................................................5The Categories ................................................................................................................................ 5How to Read the Standards .............................................................................................................. 7

    Ratings........................................................................................................................................8Step 1: Assessment .......................................................................................................................... 8Step 2: Category Score .................................................................................................................... 9Step 3: Total Score ........................................................................................................................... 9Step 4: Rating .................................................................................................................................. 9Rating Exceptions ........................................................................................................................... 11 Exception 1: An Unsatisfactory Observation Occurs ...................................................................... 11 Exception 2: A Serious Observation Occurs .................................................................................. 12 Exception 3: A Category Has Worse Observations than the Adequacy Category ............................. 13Automatic Assessment of Unsatisfactory .......................................................................................... 14Public Recognition .......................................................................................................................... 15

    Consolidated Standards for Inspection Operational Methods and Personnel Practices ................................................................................. 17Maintenance for Food Safety .......................................................................................................... 39Cleaning Practices ......................................................................................................................... 51Integrated Pest Management .......................................................................................................... 57Adequacy of Prerequisite and Food Safety Programs ........................................................................ 67

    Appendices...............................................................................................................................87The Inspection ProcessA: Participating in an Inspection ..................................................................................................... 88B: Documents to Have Ready for an Inspection ............................................................................... 91C: Conflict Resolution Process....................................................................................................... 100

    Maintaining and Expanding ProgramsD: Conducting a Self-Inspection ................................................................................................... 101E: Non-Rated Program Enhancements .......................................................................................... 103F: GFSI Benchmarked Standard Audit Requirements ..................................................................... 113

    LearningG: Integrated Quality System (IQS) ............................................................................................... 118H: Training and Education Materials ............................................................................................. 120I: Glossary ................................................................................................................................. 121

    Standards Index....................................................................................................................... 127

    The AIB InternationalConsolidated Standards for Inspection

    For Dairy Facilities

    Table.of.Contents

  • iiAIB International

    PrefaceDescription of the DocumentThe AIB International Consolidated Standards for Inspection of Prerequisite and Food Safety Programs is a collection of information gathered to help a reader understand:

    What an inspection is The difference between an inspection and an audit The benefits of and drivers for having an inspection or audit AIB Internationals role in inspection and audit What the AIB International Consolidated Standards for Inspection are How to read and use the AIB International Consolidated Standards How an AIB International Consolidated Inspection is rated How to prepare for and participate in an AIB International Inspection Additional sources for understanding, implementing and expanding

    Prerequisite and Food Safety Programs

    Audience for the DocumentThis document was designed for multiple readers for multiple purposes:

    Facility personnel preparing for an AIB International Inspection Newcomers to the food industry needing to understand the elements of, and

    reasons for Prerequisite and Food Safety Programs Experienced personnel who want an easy-to-use reference for the AIB

    International Consolidated Standards Corporate and Facility personnel wishing to make a business case for the

    benefits of inspection Regulators and Trade Associations making decisions on industry Standard

    direction and support Multi-national organizations that want a common Standard that can be

    implemented globally Organizations that need central Standards for evaluating multiple suppliers Any facility involved in food:

    Manufacturing Processing Packaging Storing Distribution

    Any facility wanting to establish and maintain a wholesome and safe food processing environment

    Preface

  • AIB Internationaliii

    Structure of the DocumentInspection and Audit

    This section defines inspection and audit, describes benefits of each, and details drivers for having inspection and audit.

    AIB International

    This section gives the history and mission of AIB International, and describes the organizations unique position as it relates to inspection.

    Introduction to the Standards

    This section describes the Standards, defines how they are categorized and formatted, and visually shows how to read the Standards.

    Ratings

    This section defines step-by-step rating procedures, uses graphics to demonstrate various rating scenarios, and describes exceptions to the ratings process.

    Consolidated Standards for Inspection

    This section is the core of the document. It documents each Standard and gives the requirements for each.

    Appendices

    The multiple appendices attached to this document are not critical to the Standards, but can greatly enhance a facilitys inspection experience and food safety performance.

    Standards Index

    This section lists each of the Standards by category, and provides a page number so readers can quickly find specific Standards.

    Design of the DocumentThe design of the document employs the following strategies to support ease of use:

    Consistent terminology used throughout the document Unambiguous language that can be globally understood Current-use language and not regulation speak Related content grouped in one location Standards constructed with the same hierarchy:

    Category x Standard

    Requirement As much as possible, one item measured per Standard Meaningful phrases highlighted to support quick scanning

    Preface

  • AIB International1

    Inspection and AuditDefinitions of Inspection and AuditAn inspection is a thorough physical review of a food facility to assess what is actually happening in a facility at a moment in time. This snapshot gives a realistic assessment of conditions that can be both positive and negative for food processing. An inspection focuses on physical review.

    An audit is a systematic evaluation of food facility documentation to determine if Programs and related activities achieve planned expectations. An auditor looks at data over time to see if positive or negative trends are developing. An audit focuses on documentation review.

    Benefits of Inspection and AuditChoosing an inspection or an audit depends on the goal. Many organizations choose both because inspections and audits support each other.

    Choose an inspection to: Reveal actual practices or issues that may not be apparent from paperwork Focus on root causes, not just on symptoms Educate personnel through interaction with an inspector Identify, reduce, eliminate and prevent food hazards in a facility Prevent expensive and damaging recalls Comply with government regulation and industry expectations for safe food Improve and maintain a healthy, sanitary environment for food handling Produce safe food products

    Choose an audit to: Comply with benchmarked standards Realize efficiencies through better management of documentation Achieve certification Look at trends over time

    Inspection and Audit

  • 2AIB International

    Reasons for Having Inspection and Audit1: Regulations

    There are many reasons for having an inspection or audit, but the most obvious is to ensure that the facility is meeting regulatory requirements. The following are examples of region-specific regulations that impact inspections and audits:

    Where there are no region-specific regulations, internationally developed and recognized standards may be used to develop Prerequisite and Food Safety Programs. One example of such a standard is:

    The Codex Alimentarius Commission Food Hygiene Basic Texts (2003)

    Other standards that may impact Program requirements are provided by the body requesting the inspection or audit. Two such examples of this would be:

    The Global Food Safety Initiative (GFSI) Benchmarked Standards The U.S. Military Standards

    2: Industry Best PracticesThe regulations listed above drive regulated standards, but the food industry changes very quickly, and often the regulatory process takes time to catch up. New advances related to the production of safe food are being developed continuously. As the food industry learns about new food safety issues and processes, innovation becomes part of food safety practice. In fact, some large companies create their own standards that are even tougher than the regulations demand.

    Inspection and Audit

    Regulation Region

    FoodStandardsAustraliaNewZealand(FSANZ)Act1991 Australia/NewZealandTheFoodandDrugsAct CanadaFoodandDrugRegulations CanadaTechnicalRegulationRTCA67.01.33.66 CentralAmericaRegulation(EC)852/2004 EuropeanCommunityFoodSafetyBasicLaw JapanFoodSanitationLaw JapanTechnicalRegulationGMCNo.80/96 MercosurMexicanOfficialNormNOM-120-SSA1-1994 MexicoFoodHygieneLawofthePeoplesRepublicofChina PeoplesRepublicofChinaSans10049:2001FoodHygieneManagement SouthAfricaTheFoodHygiene(England)Regulations2006 UnitedKingdomTheU.S.FederalFoodDrugandCosmeticAct(1938) U.S.A.GoodManufacturingPractices,CFRTitle21,Part110(2008) U.S.A.TheBioterrorismAct(2002) U.S.A.U.S.FederalInsecticide,Fungicide,andRodenticideAct(1972) U.S.A.

  • AIB International3

    Inspection and Audit

    3: Customer DemandsIf food facilities do not demand excellence of themselves, their customers will. An ill-timed recall can send consumers to alternate providers, or ruin the reputation of a particular brand or product category. In some cases, the customer demands external verification of Prerequisite and Food Safety Programs as a condition of doing business.

    4: Process ImprovementsHaving established Prerequisite and Food Safety Programs provides an environment for the production of safe, legal and quality foods. Periodic verification of Program implementation can assist with identifying opportunities for improvements in productivity and potential profitability.

  • 4AIB International

    AIB International History AIB International operates as a non-profit business founded in 1919 as a technology transfer center for food processors and bakers. Although AIB International is historically linked with North American wholesale and retail baking, the Institute currently serves all segments of the food processing, distribution, foodservice, and retail industries worldwide.

    MissionAIB International exists to serve the food industry. Its mission statement formally reads:

    AIBInternationaliscommittedtoprotectingthesafetyofthefoodsupplychainanddeliveringhighvaluetechnicalandeducationalprograms. Throughrigorousindependentinspections,superiorauditsandtraining,andsharedexpertise,wewillempowerourclientstolowertheirbusinessriskandstrengthentheirreputations.

    Essentially, AIB International helps food processing facilities help themselves through inspections, audits and education.

    Key OfferingsConsolidated Standards and Educational InspectionsThe AIB International inspection offering began as a needed service to the food industry in 1948.

    With the Consolidated Standards and Educational Inspections, AIB International has objectives of:

    1. Offering easy-to-use Standards that consolidate regulation, industry best practices and experience into one Standard

    2. Providing very experienced and highly-calibrated inspectors that are just as interested in educating facility personnel as they are in rating facilities against the Standards

    3. Using the extensive experience of conducting thousands of inspections and audits in multiple industries to gather state-of-the-art understanding and interpretation of often conflicting and complex regulations

    4. Being incorruptible, objective, unbiased and confidential during inspections

    Benchmarked Standard AuditsAIB International firmly believes in the value of inspection, and considers the AIB International Consolidated Standards for Inspection of Prerequisite and Food Safety Programs a unique value to the food industry. However, AIB International is also aware of the growing interest in internationally accepted certification audit schemes, and is fully accredited to conduct audits against various benchmarked standards.

    AIB International

  • AIB International5

    The Categories The Standards include five Categories:

    1. Operational Methods and Personnel PracticesThe receipt, storage, monitoring, handling, and processing of raw materials to manufacture and distribute safe final product.

    Standards in this category are related to food handling and processing.Facilities need to be confident that personnel, processes and conditions do not introduce a food safety concern as raw materials are received, transferred, stored, transported, manipulated, or processed to deliver a final product. The Operational Methods and Personnel Practices Standards show how a facility can prevent people and processes from contaminating a product.

    2. Maintenance for Food SafetyThe design, upkeep and management of equipment, buildings and grounds to provide a sanitary, efficient, and reliable manufacturing environment.

    Standards in this category are related to equipment, grounds and structures. The design, construction, and maintenance of equipment and buildings are critical to providing and maintaining a food-safe environment. The Maintenance for Food Safety Standards provide best practices for optimizing the design and care of the facility and equipment so that they are easy to manage and do not create sanitation or food safety issues.

    3. Cleaning PracticesThe cleaning and sanitizing of equipment, utensils and buildings to provide a wholesome and safe processing environment.

    Standards in this category are related to cleaning and sanitizing. The methods of cleaning and sanitizing, the types of chemicals used, the frequency of cleaning activities, and the control of microbes must all be done expertly to protect products from food safety issues. The Cleaning Practices Standards give cleaning guidelines to prevent contamination.

    Introduction to the Standards

    Introduction to the StandardsThe AIB International Consolidated Standards for Inspection of Prerequisite for Fresh Cut Produce are statements that represent key requirements that a facility must meet in order to keep the food products in a facility wholesome and safe. The Standards also reflect what an inspector would expect to see in a facility that maintains a food-safe processing environment.

  • 6AIB International

    4. Integrated Pest ManagementThe assessment, monitoring, and management of pest activity to identify, prevent and eliminate conditions that could promote or sustain a pestpopulation.

    Standards in this category are related to pest management. While it is important to remove pests from a facility, it is more important to prevent pests from ever having the opportunity to thrive in a food environment. The Integrated Pest Management Standards give strategies for managing multiple approaches to ensure that pests do not adulterate food products.

    5. Adequacy of Prerequisite and Food Safety ProgramsThe coordination of management support, cross-functional teams,documentation, education, training and monitoring systems to ensure all departments of the facility work together effectively to deliver a wholesome and safe final product.

    Standards in this category are related to management and teamwork. It is important to have Programs in place, but if a Program is not formalized through designing, planning, management, documentation and review, then Prerequisite Programs will depend on who is undertaking a given activity or task that day. The Adequacy Standards make sure that Prerequisite Programs are carefully designed and implemented to ensure consistency across the entire facility.

    Note: While other categories focus mainly on inspection, this category largely involves evaluation of Program documentation. However, the observations made and documents reviewed in the first four categories will directly affect how the inspector will assess the facility in the Adequacy category. Findings on the floor are a direct reflection of how well Programs have been implemented.

    Introduction to the Standards

  • AIB International7

    2.1. Facility

    .Location

    Selectiona

    ndmanagem

    entofthefa

    cilitylocati

    onwillallo

    wpersonne

    l

    toidentifya

    ndcontrol

    potentially

    negativeim

    pactsofsu

    rrounding

    operations.

    Critical Req

    uirements

    2.1.1.1

    The facility

    identifies a

    nd takes me

    asures to p

    revent prod

    uct

    contaminat

    ion from lo

    cal activitie

    s that could

    have adve

    rse

    impacts.

    Minor Requ

    irements

    2.1.2.1

    Facility bo

    undaries a

    re clearly d

    efined and c

    ontrolled.

    2.1.2.2

    Effective m

    easures are

    in place to

    prevent pro

    duct

    contaminat

    ion from ne

    ighboring p

    roperties. T

    hese

    measures ar

    e periodica

    lly reviewe

    d.

    2.2. Outside

    .Grounds

    Thefacility

    groundsare

    maintained

    inawaytha

    tpreventsf

    ood

    adulteration

    .

    Critical R

    equirements

    2.2.1.1

    Equipment

    stored out

    side is plac

    ed to preve

    nt pest

    harborage,

    to make the

    inspection

    process eas

    ier, and to

    protect equi

    pment from

    deteriorati

    on and con

    tamination.

    2.2.1.2

    Litter and

    waste are re

    moved from

    the proper

    ty.

    2.2.1.3

    Weeds and

    tall grass a

    re not near

    the building

    .

    2.2.1.4

    Roads, yar

    ds and par

    king areas

    are maintai

    ned to be fr

    ee

    of dust, sta

    nding wate

    r and other

    potential co

    ntaminants

    .

    2.2.1.5

    Adequate d

    rainage is

    provided fo

    r grounds, r

    oofs and oth

    er

    areas.

    2.2.1.6

    Outside we

    t and dry w

    aste or scra

    p compacto

    rs, module

    s

    and contai

    ners are ins

    talled in a w

    ay that prev

    ents produc

    t

    contaminat

    ion. Contain

    ers are mai

    ntained to m

    inimize an

    d

    contain lea

    kage, and a

    re removabl

    e so that th

    e area can b

    e

    cleaned.

    2.2.1.7

    Waste conta

    iners and c

    ompactors

    are closed

    or covered

    , and

    located on a

    concrete p

    ad or in a m

    anner to mi

    nimize pest

    attraction a

    nd harbora

    ge.

    2. Maintenanc

    e for Food Sa

    fety

    The design

    , upkeep a

    nd manag

    ement of e

    quipment, b

    uildings an

    d

    grounds to

    provide a sa

    nitary, effic

    ient, and r

    eliable ma

    nufacturing

    environmen

    t.

    Category NameCategory DescriptionA full sentence describing how the Standards in the category are related

    StandardDescriptionA full sentencethat describes whya facility would want to implement the Standard

    CriticalRequirementsThe critical requirements against which a facility is rated. In many regulations, critical requirements are described as SHALLS. Critical requirement observations are rated as Improvement Needed, Serious or Unsatisfactory unless there is an alternate program in place that meets the intent of the requirements. A 4-place number with a 3rd place value of 1 identifies Critical Requirements.

    How to Read the Standards

    StandardA short phrase defining the key point of the Standard

    Key PointsBold type highlights key points to simplify scanning of Critical and Minor Requirements

    Introduction to the Standards

    MinorRequirementsThese are the minor requirement against which a facility is rated. In many regulations, minor requirements are described as SHOULDS. Minor requirement observations are rated as Minor Issues Noted. A 4-place number with a 3rd place value of 2 identifies Minor Requirements.

    AIB International7

  • 8AIB International

    The RatingsThe rating of the facility occurs in four steps:

    1. Assessment: The evaluation of the facility against the AIB International Consolidated Standards for Inspection

    2. Category Score: The scoring of the facility within each Category based on the worst observations found in that Category

    3. Total Score: The total of all Category Scores4. Rating: The descriptive equivalent of the Total Score

    Steps 1-4 are described below, and an example is shown in Table 4.

    Step 1: Assessment1. During the inspection, the inspector takes notes on observations of the facility.2. As part of the inspection, the inspector assesses the severity of each observation

    using the criteria in Table 1.

    Table 1AssessmentsAssessment Abbreviation Description

    Minor Issues Noted MI No potential for contamination

    Improvement Needed IN A potential hazard, partial Program omission or food safety finding that is inconsistent with the Standards. If this hazard, omission or finding is not corrected, it could lead to a Program failure

    Serious S A significant food safety risk or risk of Program failure

    Unsatisfactory U An imminent food safety hazard, Program failure or departure from the Good Manufacturing Practices (GMPs)

    Ratings

  • AIB International9

    Step 2: Category Score1. For each Category, the inspector totals the number of observations according

    to severity (Minor Issues Noted, Improvement Needed, Serious, or Unsatisfactory).

    2. The inspector assigns a Category Score Range based on the Assessment of the worst identified observations in the Category. The Category Score Ranges are defined in Table 2.

    Table 2Category Score Ranges

    Assessment Category Score RangeNo Issues Observed 200Minor Issues Noted 180-195Improvement Needed 160-175Serious 140-155Unsatisfactory Less Than or Equal to 135

    3. The inspector assigns a final Category Score based on the severity or total number of the worst observations in the Category:

    If the severity is low, or if the total number of observations within a category is small, then the final Category Score is likely to be at the upper range of the Category Score Range.

    If an observation is severe, or if the total number of observations is large, then the final Category Score will probably be at the lower end of the Category Score Range.

    A score of 200 will only be assigned if there are no identified observations or suggestions for improvement within the Category. Category Scores are assigned in 5-point increments.

    Step 3: Total Score1. The inspector totals all the Category Scores to determine the Total Score.

    Step 4: Rating1. The inspector uses the Total Score to determine the assigned Rating as

    described in Table 3.

    Table 3Ratings

    Total Score Rating 900 - 1000 Superior 800 - 895 Excellent 700 - 795 PassLess than 700 Unsatisfactory

    Ratings

  • 10AIB International

    Category Score Range 180-195 160-175 140-155 135

    Category

    #Minor Issues Noted

    Observations

    #Improvement Needed

    Observations

    #Serious

    Observations

    #UnsatisfactoryObservations Category Score

    OperationalMethodsandPersonnelPractices

    1 0 0 0 190

    MaintenanceforFoodSafety

    8 0 0 0 180

    CleaningPractices8 9 0 0 160

    IntegratedPestManagement

    2 4 0 0 165

    AdequacyofPrerequisiteandFoodSafetyPrograms

    6 1 0 0 175

    TOTALSCORE 870RATING EXCELLENT

    Category Score varies depending on the severity and total number of observations in each Category.TOTAL SCORE: Score adds up to 870 RATING: Excellent

    Table 4Example of Rating Analysis

    Ratings

  • AIB International11

    Rating.Exceptions.While Rating steps 14 work in most instances, there are 3 exceptions:

    Exception 1: An Unsatisfactory Observation Occurs1. If an Unsatisfactory observation (Category Score range of less than or equal

    to 135) occurs in any Category, the Rating is an automatic Unsatisfactory (see Table 5).

    2. AIB International does this because an Unsatisfactory observation in any Category indicates that the product or production environment is definitely at risk. If the product or production environment is at risk, then the facility is considered Unsatisfactory.

    Category Score Range 180-195 160-175 140-155 135

    Category

    #Minor Issues Noted

    Observations

    #Improvement Needed

    Observations

    #Serious

    Observations

    #UnsatisfactoryObservations Category Score

    OperationalMethodsandPersonnelPractices

    1 0 0 0 195

    MaintenanceforFoodSafety

    8 0 0 0 180

    CleaningPractices8 9 0 2 130

    IntegratedPestManagement

    2 4 0 0 165

    AdequacyofPrerequisiteandFoodSafetyPrograms

    6 1 0 1 135

    TOTALSCORE 805RATING UNSATISFACTORY

    TOTAL SCORE: Score adds up to an Excellent Rating

    But

    RATING: Excellent Rating becomes Unsatisfactory because one or more Unsatisfactory observations are noted.

    Note: A category with a single Unsatisfactory observation begins with a Category Score of 135. For each additional Unsatisfactory observation, a 5-point deduction is taken from the category. In Table 5, for example, there are 2 Unsatisfactories in the Cleaning Practices Category, and therefore the Category Score is 130.

    Table 5Exception 1: An Unsatisfactory Observation Occurs

    Ratings

  • 12AIB International

    Exception 2: A Serious Observation Occurs1. If a Serious observation occurs in a facility that would otherwise have a

    rating of Superior or Excellent, the Rating is automatically lowered one level (see Tables 6 and 7). In the case of a Superior rating, the Rating becomes an Excellent. In the case of an Excellent rating, the Rating becomes a Satisfactory. In the case of a Pass rating, the Rating remains a Pass.

    2. AIB International does this because a Serious observation in any Category indicates that the inspection has identified a significant breakdown in a Program, a food safety hazard, or a risk to product. Because of the significance of the risk identified, the Rating is stepped down by one level despite the overall score.

    Category Score Range 180-195 160-175 140-155 135

    Category

    #Minor Issues Noted

    Observations

    #Improvement Needed

    Observations

    #Serious

    Observations

    #UnsatisfactoryObservations Category Score

    OperationalMethodsandPersonnelPractices

    1 0 0 0 195

    MaintenanceforFoodSafety

    8 0 0 0 180

    CleaningPractices8 9 2 0 155

    IntegratedPestManagement

    2 4 0 0 165

    AdequacyofPrerequisiteandFoodSafetyPrograms

    6 1 1 0 155

    TOTALSCORE 850RATING SATISFACTORY

    TOTAL SCORE: Score adds up to an Excellent Rating

    But

    RATING: Excellent Rating becomes Satisfactory because one or more Serious observations are noted.

    Note: A Rating of Satisfactory can only occur in a case of Exception 2.

    Table 7Exception 2: A Serious Observation Occurs

    Ratings

    Total Score Rating Withouta Serious Observation

    Rating With aSerious Observation

    900-1000 Superior Excellent800-895 Excellent Satisfactory700-795 (Not Possible) Pass

    Table 6Ratings With and Without a Serious Observation

  • AIB International13

    Category Score Range 180-195 160-175 140-155 135

    Category

    #Minor Issues Noted

    Observations

    #Improvement Needed

    Observations

    #Serious

    Observations

    #UnsatisfactoryObservations Category Score

    OperationalMethodsandPersonnelPractices

    1 0 0 0 195

    MaintenanceforFoodSafety

    8 0 0 0 180

    CleaningPractices8 9 1 0 155

    IntegratedPestManagement

    2 4 0 0 165

    AdequacyofPrerequisiteandFoodSafetyPrograms

    6 1 0 0 175

    TOTALSCORE 870RATING SATISFACTORY

    Cleaning Practices Category Score is 155 (in 140-155 Category Score Range)

    So

    Adequacy Category Score cannot be greater than the 160-175Category Score Range.

    Note: The Rating on Table 8 is Satisfactory because a Seriousobservation was identified. Exception 2 applies to this case.

    Table 8Exception 3: A Category Has Worse Observations than the Adequacy Category

    Exception 3: A Category Has Worse Observations than the Adequacy Category1. The highest Category Score Range that a facility can achieve in the Adequacy

    Category is one Category Score Range above the Category Score Range of the Category with the worst observations (see Table 8).

    2. AIB International does this because facilities have to prove successful implementation of Prerequisite and Food Safety Programs (in the first four categories) in addition to successful design and documentation of Programs (in the Adequacy Category). Having an Adequacy Score that is out of alignment with other Category Scores could mean that the Programs are not being implemented or monitored properly, the Programs are missing key elements, are not well executed, or records are not accurate.

    Ratings

  • 14AIB International

    Automatic Assessment of Unsatisfactory

    Ratings

    The following list includes examples of a few commonly found conditions that require an assessment of unsatisfactory. This list onlyrepresentsexamples of unsatisfactory conditions, and is not complete. Similar conditions not specifically stated will be assessed by the inspector.

    1. Operational Methods and Personnel Practicesa. Holding temperatures (refrigerators or coolers) in excess of 40F or 4C

    for microbiologically sensitive ingredients or products (Note: the exact temperature limit may vary depending on country regulation)

    b. Open sores or boils on personnel who have direct contact with product, ingredients or product zones

    c. Torn liquid receiving strainerd. Ingredients that are internally infestede. Milk not tested for antibiotics at receipt

    2. Maintenance for Food Safetya. Flaking paint, rust, or other materials in product zone where product

    contamination is likelyb. Maintenance activity or equipment condition resulting in oil, metal, or

    other foreign material in or over a product zonec. Broken regulatory seals not reported to the appropriate authority

    3. Cleaning Practicesa. The presence of extensive amounts of mold either on or near product zonesb. Widespread infestation above sensitive or exposed ingredients, above

    product zones or in equipment4. Integrated Pest Management

    a. Insectsi. Houseflies or fruit flies in excessive numbers with little control

    providedii. Any cockroach activity on or in a product zone

    b. Rodentsi. Visual presence of live rodents

    ii. Evidence of rodent excreta or gnaw marks on raw materials or finished product

    iii. Decomposed rodentc. Birds

    i. Birds residing in processing areas or warehousesii. Bird excreta on product zones, raw materials, or finished product

    d. Pesticides used inconsistently with label directions5. Adequacy of the Prerequisite and Food Safety Programs

    a. Non-compliance with written Programsi. Failure to comply with HACCP Critical Limits or monitoring

    requirementsb. Poorly-defined written Prerequisite Programs

    i. Inadequate or ineffective implementation of a Prerequisite Program resulting in actual or likely product contamination

    c. Release of product that does not meet regulatory requirements for pasteurization or microbiological testing

  • AIB International15

    Public RecognitionAIB International awards two types of recognition:

    Recognition Type Required RatingRecognition.of.Achievement Superior.or.ExcellentRecognition.of.Participation Superior,.Excellent,.Pass.or.

    Satisfactory

    Note: A facility receiving a rating of either Superior or Excellent will receive both types of recognition.

    An AIB International recognition award: Is recognition that on the day of the inspection, the facility achieved a

    certain Rating according to the AIB International Consolidated Standards for Inspection

    Is not a certificate of compliance (such as an ISO certificate) Does not have an expiration date Is labeled as announced or unannounced Defines which areas of the facility were included in the inspection

    Ratings

    Indicates standards not applicable to Dairy FacilitiesNote: The Consolidated Standards for Inspection of Dairy Facilities is a targetedversion of the more general AIB International Consolidated Standards for Inspection of Prerequisite and Food Safety Programs. The numbering convention from thePrerequisite and Food Safety Programs Standard is preserved in the Dairy Facility Standard in order to keep numbering consistent. However, any Standards or require-ments from the Prerequisite and Food Safety Programs Standard that are notapplicable to dairy facilities are not included in this document. A symbol, , signifies that missing numbers in series of Standards or requirements are intentional.

  • AIB International17

    1. Operational Methods and Personnel Practices

    Consolidated Standards for Inspection

    Operational Methods and Personnel Practices

    The receipt, storage, monitoring, handling, and processing of rawmaterials to manufacture and distribute safe final product.

    1.1. Rejection.of.ShipmentsAfacilitycansafeguarditsfoodproductsbyidentifyingandbarringentrytopotentiallycontaminatedrawmaterials.

    Critical Requirements.1.1.1.1 Damaged, infested or dirty transports/containers are

    rejected. 1.1.1.2 Materials shipped in damaged, infested or dirty vehicles

    are rejected.1.1.1.3 Perishable or frozen materials meet specific minimum

    temperature requirements, i.e. 45F (7C) for raw milk, at points of shipment, transportation, and receipt.

    1.1.1.4 The facility maintains documentation of temperature checks for perishable goods at receiving points.

    1.1.1.5 The facility maintains documentation of rejected shipments that includes defect specifications and reasons

    for rejection.

    1.2. Storage.PracticesAfterreceiving,rawmaterialsarestoredinawaytomeetProgramrequirementsforsafestorageofmaterials.

    Critical Requirements1.2.1.1 Ingredients are stored and removed from storage in a

    manner that prevents contamination.1.2.1.2 Receiving dates are visible on the bottom unit of the pallet

    or individual container.1.2.1.3 Raw materials are stored off the floor on pallets, slipsheets

    or stands.1.2.1.4 Raw materials are stored at least 18 in or 45 cm away from

    walls and ceilings.1.2.1.5 Adequate space is maintained between rows of stored raw

    materials to allow cleaning and inspection. Procedures are followed to guarantee the proper cleaning, inspection and monitoring for pest activity in storage areas, where an 18 in or 45 cm inspection perimeter cannot be provided.

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    Consolidated Standards for Inspection

    1.2.1.6 If materials are stored outside, materials are adequately protected against deterioration and contamination.

    Minor Requirements1.2.2.1 Receiving dates are on a permanent part of the raw material

    packaging (i.e., not on stretch-wrap).1.2.2.2 There are at least 14 in or 35 cm of space between pallet

    rows.1.2.2.3 Storage slots and traffic lanes are provided for items stored

    at floor level.1.2.2.4 If an 18 in or 45 cm clearance from walls is impossible due

    to aisle widths and forklift turning space, a rack system can be installed against the wall. In this case, a bottom rail is installed 18 in or 45 cm off the floor so that no pallets are stored on the floor.

    1.3. Storage.ConditionsRawmaterialsarestoredinacleanstorageareatoprotectthemfromcontaminationsources.

    Critical Requirements 1.3.1.1 Storage areas are clean, well ventilated, and dry. Raw

    materials and packaging materials, including labels, are protected from condensate, sewage, dust, dirt, chemicals or other contaminants.

    1.3.1.2 Partially used packaging materials are protected before being returned to storage.

    1.3.1.3 All toxic chemicals, including cleaning and maintenance compounds, and non-product materials, including equipment and utensils, are stored in a separate area.

    1.3.1.4 Research and Development items, and infrequently used raw materials and packaging supplies are regularly inspected for signs of infestation.

    1.3.1.5 Special handling procedures are followed for packaging materials that pose a product safety risk if mishandled (e.g., aseptic or glass packaging). Failures and Corrective Actions are documented.

    1.3.1.9 Condensate from cooling units is drained to prevent

    product contamination.

    Minor Requirements1.3.2.1 Packaging is stored away from raw materials and finished

    product in a designated area, if possible.

  • AIB International19

    Operational Methods and Personnel Practices

    1.4. Raw.Material.Inventory.Rawmaterialinventoriesaremaintainedatreasonablevolumestoavoidexcessiveageandinsectinfestation.

    Critical Requirements1.4.1.1 Ingredients, packaging supplies and other materials are

    rotated on a First-In, First-Out (FIFO) basis or other verifiable method (such as First Expired, First Out [FEFO]) to ensure stock rotation.

    1.4.1.2 Insect-susceptible materials in storage longer than four weeks are regularly inspected.

    Minor Requirements1.4.2.1 The repalletizing date or inspection date is located near the

    original receiving date.

    1.5. PalletsCleanandwell-maintainedpalletsminimizeopportunitiesforcontamination.

    Critical Requirements1.5.1.1 Pallets are clean and in good repair.

    Minor Requirements 1.5.2.1 Pallets and other wooden surfaces are properly dried after

    being washed.1.5.2.2 Slipsheets are placed between pallets and bags of

    ingredients, and between double-stacked pallets to protect ingredients from damage by the pallet.

    1.5.2.6 Plastic pallets or skids are used in production areas.

    1.6. Designated.Rework.AreasReworkorsalvage,ifnotsegregatedandmanagedproperly,cancausecontaminationofrawmaterials.

    Critical Requirements1.6.1.1 There is a designated rework area.1.6.1.2 The rework area is segregated from usable materials.1.6.1.3 Rework is processed weekly or often enough to keep rework

    quantities at minimal levels.1.6.1.4 Rework is identified for traceability purposes.

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    Consolidated Standards for Inspection

    Minor Requirements1.6.2.1 A break in the rework process is defined. Records

    demonstrate that the break and clean process is followed.

    1.7. Release.ProceduresReleaseproceduresensurethatmaterialsarecheckedfordefinedfoodsafetyhazardsbeforebeingreleasedintothefacility,orshippedtoacustomer.

    Critical Requirements 1.7.1.1 The facility follows release procedures. 1.7.1.2 Products are not released unless all release procedures have

    been followed.1.7.1.3 Raw materials, work-in-progress, and/or finished product is

    only released by authorized personnel.

    1.8. Dust.Collection.and.Filtering.DevicesIfnotmaintained,filters,screens,andsocksmaycontributetofoodsafetyissues.

    Critical Requirements1.8.1.1 Dust collection and filtering devices are stored in a dust-free

    environment.1.8.1.2 Dust collection and filtering devices are clean.1.8.1.3 Dust collection and filtering devices are designed to

    prevent possible contamination from threads, lint and fibers.

    1.9. Bulk.Material.HandlingBulksystemsandunloadingareasarehigh-activitylocationsthatcouldintroduceexternalcontaminantsintothefacility.Properreceivingpracticesensureprotectionduringunloading.

    Critical Requirements1.9.1.1 Bulk systems and unloading areas are installed and

    maintained to prevent adulteration of raw materials and finished product.

    1.9.1.2 Outside receiving lines or caps to bulk dry and liquid ingredients are locked and identified, or otherwise secured.

    1.9.1.3 Air is filtered or inspection hatches are covered when bulk materials are unloaded to eliminate the potential for foreign material contamination during the process.

  • AIB International21

    Operational Methods and Personnel Practices

    1.9.1.4 If present, security seals on bulk container hatches or other shipping containers are checked against the seal number on the bill of lading to verify that the numbers match.

    1.9.1.11 Tanker wash tags verify that each milk delivery tanker has

    been washed and sanitized to meet federal, state, county or municipal requirements.

    1.9.1.12 Receiving temperatures for raw milk do not exceed 45F (7C). Temperatures are documented for each load of raw milk received.

    1.9.1.13 Raw milk is tested upon receipt. This includes certification that the milk is not in excess of pesticide and antibiotic residues as defined the by the FDA or country requirement. Milk that does not meet testing requirements is rejected and documentation of the rejection is maintained.

    Minor Requirements1.9.2.1 Security seals or padlocks are provided, and their use is

    documented as per facility or customer requirements.

    1.10. Sampling.ProceduresBecausesamplinginvolvesdirectcontactwithrawmaterials,finishedproduct,orwork-in-progress,ifsamplingisusedinafacility,proceduresaredefinedtopreventproductcontamination.

    Critical Requirements1.10.1.1 The facility has documented aseptic sampling procedures in

    place for obtaining samples of incoming raw materials.1.10.1.2 All openings created for sampling in bags, boxes or

    containers are properly resealed and identified as such.1.10.1.3 Staples and other items likely to cause product

    contamination are not used to reseal packaging materials.

    1.11. Processing.AidsProcessingaidsarefoodcontactmaterials,andarethereforemanagedasingredientsinordertopreventcontaminationofproduct.

    Critical Requirements1.11.1.1 All food contact processing aids, such as antifoam and

    release agents, are segregated from nonfood materials. 1.11.1.2 Processing aids are labeled for their intended use.1.11.1.3 Food approval documentation for food contact processing

    aids is on file.

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    Consolidated Standards for Inspection

    1.12. Raw.Material.Transfer Oncereceived,rawmaterialsaretransferredtopointsofusewithinthefacility.Sometimes,therawmaterialsareputintosmallercontainerstofacilitatehandling.Thetransferofrawmaterialsshouldbecarefullymanagedtoavoidintroductionofcontaminants.

    Critical Requirements1.12.1.1 The facility follows procedures for transferring and

    handling food materials.1.12.1.2 Containers are kept off the floor at all times and covered

    when not in use.1.12.1.3 Ingredient storage containers are properly identified to

    maintain ingredient integrity and traceability.

    Minor Requirements 1.12.2.1 Personnel quickly address spills, leaks and waste caused

    by transfer of raw materials.1.12.2.2 Materials selected for transport to processing areas are

    visually inspected and cleaned prior to transport.1.12.2.3 Drums and barrels are wiped clean.1.12.2.4 Packaging material is removed from the protective outer

    package outside of production areas to eliminate potential contamination.

    1.13 Ingredient SiftingDryingredientsaresiftedtoidentifyandeliminateforeignmaterialorinsects.

    Critical Requirements 1.13.1.9 Documentation from the supplier states that bag or box

    materials were sifted prior to packaging or bag dumps and/or other devices are provided at the facility to remove foreign material prior to use.

    Minor Requirements 1.13.2.1 Fruits, nuts, coconut, and similar materials are visually

    examined before use.

  • AIB International23

    Operational Methods and Personnel Practices

    1.14. Bulk.Liquid.Ingredients.Liquidingredients(includingprocessingaids)arestrained,andstrainersareregularlycheckedtoidentifyforeignmaterialandpreventcontaminationofliquids.

    Critical Requirements1.14.1.1 All bulk liquid ingredients are filtered with inline receiving

    strainers. 1.14.1.2 Strainers are cleaned and inspected for integrity after each

    load.1.14.1.3 Strainer mesh sizes are sufficiently restrictive to remove

    foreign material from liquid ingredient deliveries. 1.14.1.4 Strainer inspections, findings, and Corrective Actions are

    documented and kept on file.1.14.1.5 If strainers are provided on the truck, or portable strainers

    are used at the site, the presence of a clean and intact strainer is verified prior to pumping of material.

    1.15. Foreign.Material.Control.DevicesSifters,magnets,strainers,Xraymachinesandmetaldetectorsareinstalledatappropriatelocationstopreventtheinclusionofmetal,wood,glassandotherforeignmaterials.

    Critical Requirements 1.15.1.1 Precautions are taken to minimize product contamination

    when staples or similar items are used in packaging materials.

    1.15.1.2 Foreign material control devices are located at the last possible point on all production lines.

    1.15.1.3 Metal detectors or Xray machines either contain an alarm and an automatic rejection device that diverts contaminated product into a locked box accessible only to authorized personnel, or otherwise maintain control of the rejected product.

    1.15.1.4 Product rejections or unusual foreign materials finds are investigated and Corrective Actions are taken to identify and eliminate contamination sources.

    1.15.1.5 Foreign material control devices are appropriate to the product or process, and detect metal wear or contamination from the processing equipment.

    1.15.1.7 The facility follows procedures to operate, monitor and

    test foreign material control devices.

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    Consolidated Standards for Inspection

    1.15.1.8 Foreign material control devices are regularly monitored and documented.

    1.15.1.9 The facility follows Corrective Action and reporting procedures to respond to foreign material control device failures. These procedures may address: Isolating Quarantining Re-testing all food produced since the last acceptable

    test of the device

    1.16. Waste.Material.DisposalWastematerialsandtheirremovalaremanagedtoavoidcontamination.

    Critical Requirements1.16.1.1 Trash or inedible waste is stored in properly covered,

    labeled containers.1.16.1.2 Waste containers are emptied at least daily.1.16.1.3 Trash or inedible waste does not come in contact with raw

    materials, work-in-progress or finished product at any time.1.16.1.4 Licensed contractors remove waste, where required.1.16.1.5 Waste disposal meets regulatory requirements.

    1.17. Ingredient.ScoopsIngredientscoopsmaycausecrosscontaminationiftheyareusedformultipleingredients.

    Critical Requirements1.17.1.1 All in-use ingredient containers have individual transfer

    scoops (where needed) to prevent cross contamination.

    1.18. Product.IdentificationIfwork-in-progressandrawmaterialsarenotidentified,theycouldbemisusedandcausefoodsafetyproblems.

    Critical Requirements 1.18.1.1 Carry-over product, work-in-progress, rework and raw

    materials are properly identified and dated.1.18.1.2 Carry-over is minimal and used at the first opportunity

  • AIB International25

    Operational Methods and Personnel Practices

    1.18.1.5 Rerun, reclaimed and returned milk, cream, ice milk mix and milk products are not used unless they comply with federal, state, county, or municipal regulations.Minimum requirements include, but are not limited to, proper storage temperatures, filtering, and reprocessing to ensure product safety.

    1.19. Workspace.ArrangementAneat,efficientworkspacepromotescleanlinessandmaintainabilitybothessentialforfoodsafety.

    Critical Requirements1.19.1.1 Routine housekeeping activities are ongoing throughout

    operating hours in production and support areas to maintain a sanitary environment.

    Minor Requirements 1.19.2.1 Production equipment and supplies are neatly arranged

    and installed.1.19.2.2 Portable, infrequently used equipment is not stored in

    production or raw material storage areas.1.19.2.3 Adequate workspace and storage are provided to enable

    operations to be performed in safe, hygienic conditions.1.19.2.4 Operational debris is kept at a minimum.

    1.20. Single-Service.ContainersResiduecancontaminateanynewmaterialsorproductsaddedtoanoldcontainer.

    Critical Requirements1.20.1.1 Single-service containers are not reused. 1.20.1.2 All single-service containers are crushed, punctured or

    otherwise disposed of so that they cannot be reused. 1.20.1.3 Seamed egg containers are not reused under any

    circumstances and are not washed in sinks or other equipment used to wash utensils or production equipment.

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    Consolidated Standards for Inspection

    1.21. Hand.ContactAfacilitycaneliminate,wherepossibleandpractical,potentialsourcesofcontaminationbyminimizingtheneedfordirecthumanhandlinginfoodprocessing.

    Critical Requirements 1.21.1.1 Production facilities, equipment and accessories are

    designed so that minimum hand contact is made with raw materials, work-in-progress and finished product, where possible and practical.

    1.22. Temperature-Sensitive.MaterialsTemperaturecontrolspreventthegrowthofpathogensinsusceptiblematerials.

    Critical Requirements 1.22.1.1 Raw materials, work-in-progress and finished product

    capable of supporting the rapid growth of pathogenic microorganisms are properly stored.

    1.22.1.2 Temperature-sensitive materials are stored to maintain appropriate internal temperatures:40F or 4C or below Finished product is stored between 34F (1C) and 40F

    (4C)Or in accordance with country-specific regulation

    1.23. Cross.Contamination.PreventionIncompatibleorhazardousmaterialsrequireseparatehandlingtopreventcontamination.

    Critical Requirements1.23.1.1 Incompatible materials (such as raw and pasteurized

    products) are stored under conditions that prevent cross contamination.

    1.23.1.2 Measures are taken to prevent cross contamination by hazardous ingredients, such as allergens.

    1.23.1.3 Systems are set up to reduce any potential physical, chemical or microbiological contamination risks.

    1.23.1.15 Where required, foot baths or automatic floor

    sanitizer sprays are provided to prevent microbiological contamination of product and processing areas.

  • AIB International27

    Operational Methods and Personnel Practices

    1.23.1.16 When used, verification of effective concentration of the foot bath or sanitizers is monitored and documented, including Corrective Action and re-verification of concentration as required.

    Minor Requirements1.23.2.1 Measures are taken to prevent cross contamination that can

    cause customer complaints such as non-organic ingredients in organic foods.

    1.24. Containers.and.UtensilsIfnotmanaged,anyfoodcontactcontainersorutensilshavethepotentialtocreatefoodsafetyhazards.

    Critical Requirements1.24.1.1 Containers and utensils used to transport, process, hold or

    store raw materials, work-in-progress, rework or finished products are constructed, handled and maintained in a way that prevents contamination.

    1.24.1.2 Containers for work-in-progress or finished products are only used for their designated purposes.

    1.24.1.3 Containers are legibly labeled with contents.1.24.1.4 Snap-off blades are not used in production, packaging, or

    raw material storage areas.

    1.25. Cans,.Bottles,.and.Rigid.PackagingIfused,cans,bottles,andothercontainersforpackagingrequireextracleaningandstoragestepstopreventforeignmaterialcontamination.

    Critical Requirements1.25.1.4 Rigid packaging is maintained in an inverted position or

    covered to prevent foreign material contamination until filled and capped.

    1.25.1.5 Boxes, bagged containers, and other liners used in product containers or packaging materials are suitably durable to prevent risk of product contamination.

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    Consolidated Standards for Inspection

    1.26. Finished.Product.TransportationFinishedproductiscodedfortraceability,andshippingrequirementsareinplacetopreventproductcontamination.

    Critical Requirements 1.26.1.1 Legible code marks that are easily seen by consumers are

    placed on all finished products.1.26.1.2 Code marks satisfy regulatory packaging requirements

    and lot definitions, and are used in the Recall Program. 1.26.1.3 Distribution records identify the initial point of

    distribution as per regulatory requirements.1.26.1.4 Finished products are handled and transported in a way

    that prevents actual or potential contamination.1.26.1.5 Finished products are loaded or transferred in covered

    bays or canopies to protect the product from weather damage.

    1.26.1.6 Temperatures of perishable and frozen products are taken and recorded upon loading.

    1.26.1.7 Documentation validates that temperature-sensitive products are loaded into vehicles that are designed to sustain required temperatures during delivery.

    1.26.1.8 Temperatures of vehicles are checked and recorded before loading.

    1.26.1.9 The facility enforces transportation breakdown procedures.

    1.26.1.10 Prior to loading, all shipping vehicles are inspected for cleanliness and structural defects that could jeopardize the product.

    1.26.1.11 Shipping vehicle inspections are documented.1.26.1.12 Local delivery trucks and route trucks are inspected

    and cleaned at least weekly to identify potential sources of foreign material contamination.

    Minor Requirements 1.26.2.1 Common carriers and customers are encouraged to

    maintain their delivery vehicles in sanitary condition, and in good repair.

    1.26.2.2 Security seals or padlocks are provided, and their use is documented as per facility or customer requirements.

  • AIB International29

    Operational Methods and Personnel Practices

    1.27. Hand.Washing.FacilitiesPersonnelareprovidedtheequipmenttoeffectivelyremovecontaminantsfromtheirhands.

    Critical Requirements 1.27.1.1 Suitable and properly maintained hand washing facilities

    are located at the entrance to production areas, and at other appropriate sites.

    1.27.1.2 Single use towels or air dryers are provided at hand washing stations.

    1.27.1.3 Hand sanitizing stations are provided, where appropriate.1.27.1.4 Hand sanitizers are regularly monitored for proper

    concentration to ensure effectiveness.1.27.1.5 Wash hands signs appear above sinks and entries to

    production areas, where appropriate.

    Minor Requirements 1.27.2.1 Dispensers for disposable paper towels are covered.

    Hands-free design is desirable.

    1.28. Washrooms,.Showers.and.Locker.RoomsCleanlinessdiminisheschancesofcontaminationbeingspreadfrompersonnelareas.

    Critical Requirements1.28.1.1 All washrooms, showers and locker rooms are maintained in

    a sanitary condition. 1.28.1.2 No pests or mold are present.1.28.1.3 There are no open food or drinks in lockers or locker

    rooms.1.28.1.4 Wash hands signs are displayed in all restrooms,

    lunchrooms, and smoking areas.

    Minor Requirements 1.28.2.1 Company-owned personnel lockers are inspected on a

    defined frequency.

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    Consolidated Standards for Inspection

    1.29. Personal.HygienePersonnelconformtohygienepracticestoavoidbecomingasourceofcontamination.

    Critical Requirements 1.29.1.1 Trained supervisors are responsible for ensuring that all

    personnel are complying with facility policies regarding personnel practices.

    1.29.1.2 Personnel wash hands before beginning work, and after eating, drinking, smoking, using the restroom, or otherwise soiling hands.

    1.29.1.3 Personnel are encouraged to practice good personal hygiene at all times.

    Minor Requirements1.29.2.1 Hand washing practices are checked periodically for

    effectiveness.

    1.30. Work.Clothes,.Changing.Facilities,.and.Personnel.AreasClothingmaycontaminatefoodproductsiftheclothingisdirtyormadeofunsuitablematerial.Changingfacilitiesareprovidedtoallowpersonneltokeepworkclothesclean.

    Critical Requirements .1.30.1.1 Personnel wear suitable, clean outer garments or

    uniforms.1.30.1.2 Personnel wear suitable footwear.1.30.1.3 Personnel wear effective hair restraints to fully contain

    hair, if applicable. Hair restraints may include head, beard or moustache covers.

    1.30.1.4 If worn, gloves are adequately controlled to avoid product contamination.

    1.30.1.5 Items such as pens, pencils and thermometers are carried in pockets or pouches below the waist in production areas.

    1.30.1.6 Changing facilities are provided for all employees, visitors and contractors to allow personnel to change clothes before entering food-processing areas, if necessary.

    1.30.1.7 Work clothes are stored separately from outdoor clothing and personal items in changing facilities.

    Minor Requirements 1.30.2.1 There are no pockets above the waist on outer garments.1.30.2.2 Suitable breakrooms and dining facilities are provided for

    all personnel.

  • AIB International31

    Operational Methods and Personnel Practices

    1.31 High-Risk.Clothing.ManagementSpecialhandlingisrequiredinhigh-riskoperationstoassurethatworkclothingisdistinctivefordifferentprocesses,andmanagedtopreventproductcontamination.

    Critical Requirements1.31.1.1 Personnel in high-risk operations follow specified

    procedures for dressing in visually distinctive clean outer garments, headwear and footwear.

    1.31.1.2 Personnel enter high-risk operations through specially designated changing areas.

    1.31.1.3 Changing facilities are located to allow direct access to production, packaging and storage areas.

    1.31.1.4 High-risk work clothing is only removed in a specially designated changing area.

    Minor Requirements1.31.2.1 Personal clothing above the knee is completely covered by

    work clothes (e.g., smocks).1.31.2.2 All protective clothing is regularly cleaned on-site or by a

    contract laundry.

    1.32. Personal.Items.and.Jewelry.ControlPersonalitemsandjewelrypresentproductcontaminationrisksifnotcontrolled.

    Critical Requirements1.32.1.1 Personnel in contact with food products remove jewelry

    and cosmetic items including but not limited to: Visible or exposed piercings Watches Earrings Necklaces Bracelets Rings with settings False fingernails False eyelashes Fingernail polish

    1.32.1.2 Plain wedding bands are acceptable if permitted by the Personnel Practices Program.

    1.32.1.3 Personnel eat, drink, chew gum, and use tobacco products only in designated areas.

    1.32.1.4 Personal food and belongings are not brought into production or storage areas.

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    Consolidated Standards for Inspection

    1.32.1.5 All personal property is stored in a designated area.1.32.1.6 The facility Personnel Practices Program defines and

    explains any exceptions to personal items and jewelry control.

    Minor Requirements1.32.2.1 Personnel in contact with food products avoid wearing

    perfume and aftershave.

    1.33. Health.ConditionsFacilitypoliciesareinplaceandenforcedtopreventdisease,illnessorinfectionfromcontaminatingproduct.

    Critical Requirements1.33.1.1 No person with boils, sores, infected wounds or any other

    infections or communicable disease is permitted to contact food as defined by local or national law.

    1.33.1.2 All exposed cuts and grazes are covered by a facility-issued detectable metal strip bandage.

    1.33.1.3 All personnel health cards are current and properly posted if required by local regulations.

    1.33.1.4 The facility follows procedures requiring personnel, including temporary workers, to notify supervisory personnel of any relevant infectious disease or conditions to which they may have been exposed.

    Minor Requirements1.33.2.1 Bandages are regularly tested in the metal detector.1.33.2.2 If appropriate, the facility uses detectable gloves, earplugs,

    or other detectable protective equipment. If used, detectable equipment is regularly tested and documented.

  • AIB International33

    Operational Methods and Personnel Practices

    1.34. Non-Facility.PersonnelVisitorsandcontractorsarerequiredtocomplywithfacilitypoliciestoprotectproductfromcontamination.

    Critical Requirements1.34.1.1 Non-facility personnel conform to the facility Personnel

    Practices Program. Non-facility personnel include but are not limited to: Visitors Temporary personnel Regulatory authorities Outside contractors Tour groups Family and friends of personnel

    1.34.1.2 Where appropriate, visitors and contractors undergo medical screening and appropriate training before entering raw material, preparation, processing, packaging and storage areas.

    1.35..Cleaning.of.Multiple-Service.Cans,.Bottles.and.Rigid.PackagingIfused,cans,bottlesandotherpackagingcontainersrequireextracleaning,storageandinspectiontopreventforeignmaterialcontamination.

    Critical Requirements1.35.1.1 Refillable or multiple-service primary containers are

    cleaned, sanitized and inspected before filling, capping and sealing.

    1.35.1.2 Containers that are determined to be unsanitary or defective after inspection are reprocessed or discarded.

    1.35.1.3 All multiple-service primary containers are washed, rinsed and sanitized by a mechanical washer or other method that will adequately clean and sanitize the container for use.

    1.35.1.4 The cleaning process is validated by testing for chemical residue on a defined frequency.

    1.35.1.5 Mechanical washers are regularly monitored and maintained as part of the Preventive Maintenance Program.

    1.35.1.6 A functional indicating thermometer is installed on the mechanical washer to record the temperature of the caustic wash solution.

  • 34AIB International

    1.35.1.7 Records of the mechanical wash system are current and include the following: Physical maintenance Inspection Conditions found Corrective Actions Performance of the mechanical washer

    1.36..Multiple-Service.Shipping.ContainersMultiple-serviceshippingcontainersarecleanedandmaintainedsothattheydonotcontaminatetheprimaryproductcontainerortheproduct.

    Critical Requirements1.36.1.1 Dry or wet cleaning processes are in place to remove

    contaminants so that the cases are maintained in a clean and satisfactory condition.

    1.37..Glass.Container.BreakageProceduresareinplacetoaddressglasscontainerbreakageatreceiving,storage,depalletizing,washing,rinsing,filling,andcappingstagestopreventproductcontamination.

    Critical Requirements1.37.1.1 Procedures are defined to address glass container

    breakage in the following areas: Receiving Storage Depalletizing Washing Rinsing Filling Capping

    1.37.1.2 Records are current and document that procedures for glass breakage clean up in receiving, storage, depalletizing, washing, rinsing, filling and capping areas are followed.

    Consolidated Standards for Inspection

  • AIB International35

    1.38..Filling,.Capping.and.SealingFilling,cappingandsealingofsingleormultiple-servicecontainersismonitoredtomeetspecifications.

    Critical Requirements1.38.1.1 Performance of the filling, capping and sealing operations is

    monitored visually or electronically. Visual or electronic inspections indicate that filled containers are sound and properly sealed.

    1.38.1.2 Sealed and filled containers that do not meet specifications are reprocessed or rejected.

    1.39 .Processing.Water.TreatmentTreatmentofwaterusedasaningredientforprocessingorcleaningprimarycontainersiseffectiveandmeetsdefinedrequirements.

    Critical Requirements1.39.1.1 Water treatment may include, but is not limited to the

    following methods: Distillation Chlorination Ion exchange Filtration Ultra-violet treatment Reverse osmosis Carbonation Mineral addition

    1.39.1.2 The treatment process is verified as effective for the defined purpose.

    1.39.1.3 Records demonstrate that the treatment process is effective and current.

    1.39.1.4 When used, chlorine residue levels are regularly monitored. Records that demonstrate compliance with the defined residue levels are maintained.

    1.40..Pasteurized.BeveragesPasteurizationofbeverageseffectivelyeliminatesorreducespathogenicand/ornon-pathogenicmicroorganisms.

    Critical Requirements1.40.1.1 Time and temperature parameters are established using

    scientific criteria.1.40.1.2 The effectiveness of the pasteurization process is verified.

    Operational Methods and Personnel Practices

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    1.40.1.3 Pasteurization records demonstrate that time and temperature parameters have been met and are maintained on file.

    1.41..Unpasteurized.BeveragesMethodsotherthanpasteurizationareusedtoreducepathogenicandnon-pathogenicmicroorganismstoensurethemicrobiologicalintegrityoffinishedproducts.

    Critical Requirements1.41.1.1 Methods to reduce or eliminate microorganisms and

    prevent spoilage or pathogen development are defined and in place.

    1.41.1.2 Records that demonstrate effective reduction or elimination of microorganisms are maintained and current.

    Minor Requirements1.41.2.1 Control measures may include but are not limited to:

    Preservatives Carbonation Acidification Disinfection of produce prior to extraction

    1.54 .Pasteurization.of.Dairy.ProductsPasteurizationofdairyproductseffectivelyeliminatespathogenicmicroorganismstomeetregulatoryrequirements.

    Critical Requirements1.54.1.1 The facility has a High Temperature Short Time (HTST)

    installation flow diagram that meets 3A Dairy Standards or regulatory requirements, as applicable.

    1.54.1.2 Documentation demonstrates the required temperature accuracy checks and six month holding time checks by the appropriate regulatory authority. Recording charts demonstrating the checks are on file and current.

    Consolidated Standards for Inspection

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    1.54.1.3 Pasteurization charts are maintained for 3 months and include the following information: Date Name of milk plant Number or location of the recorder Indicating thermometer reading at a given time Volume and name of pasteurized product Record of unusual occurrence Cut-in and cut-out temperatures recorded daily by the

    operator at the beginning of the product run Signatures or initials of operator

    1.54.1.4 Ultra High Temperature (UHT) pasteurization systems meet requirements for culinary steam. Food-grade boiler additives are used for cleaning and maintenance of this equipment.

    1.54.1.5 Retesting procedures are defined for batch processing when adjustments are made to the process. Documentation is current.

    1.54.1.6 Pasteurization meets the following minimum time and temperature requirements: 145F (63C) for 30 minutes 161F (72C) for 15 seconds 191F (89C) for 1 second 194F (90C) for 0.50 second 201F (94C) for 0.10 second 204F (96C) for 0.05 second 212F (100C) for 0.01 second All products containing more than 10% fat, or total

    solids of 18% or greater, or that have added sweeteners, or are concentrated (condensed), are increased by a miminum 5F (3C)

    1.54.1.7 Pasteurization of eggnog meets the following requirements: 155F (69C) for 30 minutes 175F (80C) for 25 seconds 180F (83C) for 15 seconds

    Operational Methods and Personnel Practices

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    2. Maintenance for Food Safety

    The design, upkeep and management of equipment, buildings and grounds to provide a sanitary, efficient, and reliable manufacturingenvironment.

    Maintenance for Food Safety

    2.1. Facility.LocationSelectionandmanagementofthefacilitylocationwillallowpersonneltoidentifyandcontrolpotentiallynegativeimpactsofsurroundingoperations.

    Critical Requirements2.1.1.1 The facility identifies and takes measures to prevent product

    contamination from local activities that could have adverse impacts.

    Minor Requirements2.1.2.1 Facility boundaries are clearly defined and controlled.2.1.2.2 Effective measures are in place to prevent product

    contamination from neighboring properties. These measures are periodically reviewed.

    2.2. Outside.GroundsThefacilitygroundsaremaintainedinawaythatpreventsfoodadulteration.

    Critical Requirements2.2.1.1 Equipment stored outside is placed to prevent pest

    harborage, to make the inspection process easier, and to protect equipment from deterioration and contamination.

    2.2.1.2 Litter and waste are removed from the property.2.2.1.3 Weeds and tall grass are not near the building.2.2.1.4 Roads, yards and parking areas are maintained to be free

    of dust, standing water and other potential contaminants.2.2.1.5 Adequate drainage is provided for grounds, roofs and other

    areas.2.2.1.6 Outside wet and dry waste or scrap compactors, modules

    and containers are installed in a way that prevents product contamination. Containers are maintained to minimize and contain leakage, and are removable so that the area can be cleaned.

    2.2.1.7 Waste containers and compactors are closed or covered, and located on a concrete pad or in a manner to minimize pest attraction and harborage.

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    Consolidated Standards for Inspection

    Minor Requirements2.2.2.1 Outdoor equipment storage is minimal.

    2.3. Security.EquipmentInstallingandmaintainingtheequipmentandstructuresthatsupportaFoodDefenseProgramhelpguardagainstintentionalproductcontamination.

    Minor Requirements2.3.2.1 Physical security measures that require maintenance or

    design can include: Perimeter fences Surveillance cameras Locked doors Security guard stations Controlled access Controlled bulk storage areas

    2.4. LayoutSpaciouslayoutandplacementofequipment,materialsandstructuresfacilitatesinspection,cleaningandmaintenanceactivities.

    Critical Requirements2.4.1.1 Space is maintained between equipment and structures to

    enable cleaning and maintenance.

    Minor Requirements2.4.2.1 There is adequate space to place equipment and raw

    materials.

    2.5. Floors,.Walls.and.CeilingsThefloors,wallsandceilingsofthefacilityaredesignedandmaintainedtoprovidestructuralintegrity,facilitatecleaning,preventcontaminationandeliminatepestharborageorentry.

    Critical Requirements2.5.1.1 Floors, walls and ceilings are made of materials that are

    easily cleaned and kept in good repair.2.5.1.2 Floor drains with grates are installed, maintained and

    operational in all wet processing or wash areas.2.5.1.3 Floor drain grates are easily removable for cleaning and

    inspection.2.5.1.4 Drainage is designed and maintained to minimize the risk of

    product contamination.

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    Maintenance for Food Safety

    2.5.1.5 For high-risk operations, drainage flows away from high-risk areas (e.g., raw vs. pasteurized).

    2.5.1.6 Access to the void in hollow or suspended ceilings is provided to facilitate cleaning, maintenance and inspection activities.

    2.5.1.7 Roof leaks are promptly identified, controlled and repaired.

    Minor Requirements 2.5.2.1 Ceilings, overheads and walls are designed, constructed,

    finished and maintained to: Prevent dirt accumulation Reduce condensation and mold growth Facilitate cleaning

    2.5.2.2 Wall/floor junctions and corners are coved to facilitate cleaning.

    2.5.2.3 Holes in wall and floor surfaces are repaired to prevent debris from lodging and to avoid pest harborage.

    2.5.2.4 Floors are designed to meet the demands of facility operations, and withstand cleaning materials and methods.

    2.5.2.5 Floors are impervious.2.5.2.6 Floors are sloped to direct the flow of water or effluent

    toward drains.2.5.2.7 Floor drains can be easily accessed for cleaning and

    inspection.2.5.2.8 Equipment and drains should be placed in a way that any

    processing discharge or overspill goes directly into a drain rather than on the floor.

    2.6 Overhead.StructuresStructuralelementssuchasbeams,supports,fixtures,ducts,pipes,orequipmentdonotthreatenfoodproductwithleaking,loose,chipping,flaking,orpeelingmaterial.

    Critical Requirements2.6.1.1 Fixtures, ducts, pipes and overhead structures are installed

    and maintained so that drips and condensation do not contaminate foods, raw materials or food contact surfaces.

    2.6.1.2 There is no flaking paint or rust on equipment or structures. Only normal mild oxidation on nonfood contact surfaces is acceptable.

    2.6.1.3 Other materials (such as loose insulation) do not threaten food products or food contact surfaces.

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    Consolidated Standards for Inspection

    2.7. Glass,.Brittle.Plastics,.and.Ceramics.ControlTheGlass,BrittlePlastics,andCeramicsProgrammanagesnotonlylightingtoensurethatitisadequateforthesafeproductionoffoodproducts,buttheProgramalsotakesintoconsiderationbreakablematerialsthatareusedforotherpurposeswithinthefacility.

    Critical Requirements2.7.1.1 Adequate lighting is provided in all areas.2.7.1.2 Light bulbs, fixtures, windows, mirrors, skylights and

    other glass suspended over product zones, product areas, ingredients, or packaging supplies are of the safety type, or are otherwise protected to prevent breakage.

    2.7.1.3 Light fittings and glass are replaced in a way that minimizes the potential for product contamination.

    2.7.1.4 Glass that cannot be fully protected is addressed in the Glass, Brittle Plastics, and Ceramics Program.

    2.7.1.5 Only essential glass is present in the facility. If glass must be used, it is addressed by the Glass, Brittle Plastics, and Ceramics Program.

    2.8. Air.Makeup.UnitsAirusedinthefacilityisfilteredorscreened,andfiltersandscreensaremaintainedtopreventproductcontamination.

    Critical Requirements 2.8.1.1 Air makeup units are fitted with clean filters and are free of

    mold and algae.2.8.1.2 Air return ducts for HVAC systems and air makeup units are

    fitted with cleaning and inspection hatches.2.8.1.3 Fans, blowers, filters, cabinets and plenums are on

    the Preventive Maintenance Schedule to prevent mold, the development of microbes, insect activity, and foreign material collection.

    2.8.1.4 Windows and doors that must be kept open for ventilation are screened to prevent pest entry.

    2.8.1.5 Air blowing equipment is located, cleaned and operated in a way that does not contaminate raw materials, work-in-progress, packaging materials, food contact surfaces, and finished products.

    2.8.1.6 Filters are capable of removing particles of 50 microns or larger.

    2.8.1.7 Positive air pressure is maintained in production areas.

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    Maintenance for Food Safety

    Minor Requirements2.8.2.1 If unscreened, windows and skylights are non-opening.2.8.2.2 Dust extraction equipment for dry powder handling

    equipment is installed.2.8.2.3 Ventilation is provided in product storage and processing

    areas to minimize odors, fumes and vapors.

    2.9. Pest.PreventionThematerials,structureandmaintenanceofthebuildingandequipmentsupporttheIntegratedPestManagementProgram.

    Critical Requirements2.9.1.1 The building has barriers in place to protect against birds,

    rodents, insects and other pests. 2.9.1.2 The structures are free from cracks, crevices and pest

    harborages.2.9.1.3 External doors, windows or other openings are close-

    fitting or otherwise pest-proofed to less than in or 6 mm.

    2.10. Leaks.and.LubricationLeaksandlubricationaremanagedsotheydonotcontaminatefoodproducts.

    Critical Requirements 2.10.1.1 The facility prevents, identifies and eliminates leaks and

    excessive lubrication.2.10.1.2 Catch pans or deflector plates are installed in areas where

    drive motors and gearboxes are mounted over product zones, and where conveyors cross or run parallel at different levels.

    2.11. LubricantsLubricantsthatareessentialforeffectiveequipmentoperationaremanagedtoensuretheydonotgetintofoodproducts.

    Critical Requirements 2.11.1.1 Only food-grade lubricants are used on food processing

    and packaging equipment, or on any other equipment where incidental food contact may occur.

    2.11.1.2 Lubricants are labeled, segregated and stored in a designated, secure area. Food-grade and non food-grade lubricants are kept separate from each other.

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    Consolidated Standards for Inspection

    2.12. Cross.Contamination.PreventionDifferentstepsintheproductionoffoodproductscannegativelyimpactprocessinginotherareas.Segregationofoperationsminimizesopportunitiesforfoodhazardstoarise.

    Critical Requirements2.12.1.1 Operations are separated based on process flow, material

    types, equipment, personnel, airflow, air quality and services needed.

    2.12.1.2 The process flow, from receiving to shipping, is arranged to prevent product contamination. High- and low-risk operations are segregated to minimize product cross contamination.

    2.12.1.3 Areas for washing and cleaning are located away from production activities, where appropriate.

    2.12.1.4 Toilet rooms do not open directly into production, packaging or raw materials storage areas.

    2.12.1.7 The angle of the HTST holding tubes is checked and

    verified on a scheduled frequency.2.12.1.8 The operation of the flow diversion valve is checked and

    verified on a scheduled frequency.2.12.1.9 Regulatory seals are provided on pasteurization equipment.

    Where seals have been broken for repair, documentation is provided to indicate notification of the regulatory authority.

    Minor Requirements 2.12.2.1 Cleaning and production areas are segregated with air

    curtains, partitions, doors or other exclusionary systems.

    2.13. Design.StandardsStructuralandequipmentdesignstandardsofferaconsistentapproachtodesigns,repairs,modifications,andpurchases,andtakeintoaccountPrerequisiteandFoodSafetyPrograms.

    Critical Requirements 2.13.1.1 The facility has design standards that apply to all

    structural and equipment designs, repairs, modifications, or purchases to reduce the potential for contamination and pest infestations, and make cleaning easier.

    2.13.1.3 Equipment complies with 3A Dairy Standards.

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    Maintenance for Food Safety

    2.14. Equipment.and.Utensil.ConstructionEquipmentandutensilsdesignedforeasymaintenanceensurecompliancewithPrerequisiteandFoodSafetyPrograms.

    Critical Requirements 2.14.1.1 All utensils are designed and made of materials that are

    easily cleaned and maintained. 2.14.1.2 Ingredient, product-holding, packaging, conveying,

    processing and bulk equipment are designed and made of materials that are easily cleaned, inspected, and maintained.

    2.14.1.3 Equipment is installed in a way that provides access for cleaning.

    Minor Requirements2.14.2.1 Processing equipment for exposed raw materials, work-

    in-progress and unwrapped finished product is not made of wood, wherever possible and practical. If processing equipment is made of wood, it is maintained.

    2.15. Temporary.Repair.MaterialsTemporaryrepairsaresometimesneededorunavoidable.Procedurestoensurethattheydonotbecomeacontaminationhazardaredefined.

    Critical Requirements 2.15.1.1 Tape, wire, string, cardboard, plastic and other

    temporary materials are not used for permanent repairs. If used for emergency repairs, they are dated and replaced with a permanent repair as soon as possible.

    2.15.1.2 Any temporary repairs on food contact surfaces are constructed of food-grade material.

    2.15.1.3 The facility maintains a record of work orders or repair requests.

    2.15.1.4 The facility follows temporary repair procedures.

    Minor Requirements2.15.2.1 Temporary repair issues are resolved as soon as possible

    and practical.

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    Consolidated Standards for Inspection

    2.16. Food.Contact.Surface.Construction.Surfacesthatdeteriorate,orcannotbecleanedormaintainedmaypresentproductcontaminationhazards.

    Critical Requirements2.16.1.1 Food contact surfaces are corrosion-free, durable, and

    made of non-toxic materials. 2.16.1.2 Seams on food contact surfaces are smooth, and free of

    spot or tack welds.

    Minor Requirements2.16.2.1 Food contact surfaces are constructed of stainless steel.

    2.17. Temperature.Measuring.DevicesProcessesthatrequiretemperaturecontrolsneedmeasuringdevicesthatarefunctioningandaccurate.

    Critical Requirements2.17.1.1 Temperature measuring devices, including thermometers,

    regulating, and recording controls, are installed on any equipment that sterilizes, pasteurizes or otherwise prevents pathogenic microorganism growth. These devices are routinely calibrated.

    2.17.1.2 If used in a process critical to food safety, temperature measuring devices are calibrated to a national standard.