haccp introduction-refresher training

8/4/2019 HACCP Introduction-Refresher Training

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HACCP Introduction - 7 Principles VERSION 2, June 2008

HACCP Introduction7 Principles


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HACCP Introduction VERSION 1 : November 2010

HACCP Introduction

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The most common template (tool) for afood safety plan follows principles laid outunder a program called HACCP

Back in 1959, the US space agency NASAfaced a simple but mundane problem whenplanning its first manned space flights:How and what was it going to feedastronauts ?

The American food company Pillsbury

(now part of General Mills) was called intohelp.

HACCP stands for Hazard Analysis & Critical Control Points

The History of HACCP


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US Space Agency - NASA


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NASA concluded..

With standard QC..No way we could be sure that there

would not be a problem

Our present QC system is testing Raw Material andFinished Product

Sampling and testing of each batch of food is impractical

How did they know that the Foodis Safe?

Is End Product Testing Sufficient? How Many Samples to Test?

US Space Agency - NASA
http://www.nasa.gov/home/index.html


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!

Finished ProductProcessingRaw Material

Example

If 1 of 1000 batches was defective (0.1%)..If test 60 batches..If we say Yes for release.>94% chance for releaseThen still would miss defective batches!

How many finished batches do you test?

QC ? QC

?

Storage & Transport

QC?QC?


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HACCP was developed by Pillsbury Company (USA) in 1959 The HACCP concept was pioneered in the 1960s by the Pillsbury Company,

the US Army and NASA as a collaborative development for the production ofsafe foods for the United States space program.

1973 Pillsbury published comprehensive document on Hazard Analysis

1974 - FDA used HACCP principles in development of low-acid regulations.

1980s major food companies began to utilize HACCP Principles

1993 the Codex Alimentarius Commission adopted Guidelines for theapplication of the Hazard Analysis Critical Control Point(HACCP) systemto include 7 Principles. Further updates were provided in 1997.

The HACCP system for food safety is now adopted as national guidelines or

required regulations in many countries.

This PepsiCo International HACCP Training is based on

1997 Codex and NACMCSF HACCP 1997 Guidelines

National Advisor Committee on Microbiolo ical Criteria for FoodsCAC FAO + WHO

HACCP Introduction


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Systematic Approach for:

Identification and assessment of Hazards associated withManufacturing, Distribution, and use of Food Products aswell as the definition of Preventative Measures for their

Control

HACCP focuses solely on Significant Hazards that areReasonably Likely to result in unacceptable health

risk to consumers

HACCP


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HACCP is a Tool

Hazard Analysis Critical Control Points (HACCP) is a tool andis not designed to be a stand alone program.

To be effective, other tools must include: adherence to goodmanufacturing practices, sanitation standard operatingprocedures, and a personal hygiene program.


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Why is Food Safety so Important ?

More countries will incorporate Food Safety principlesinto their food legislations

Food Safety Plans will be made mandatory for more

categories of products

In the long run, food business operations not basedon Food Safety will not be acceptable by the industry,consumers, government and other stakeholders


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Roles & Responsibilities

Management commitment

A clear understanding of the principles ofFood Safety system

Provide for sufficient resources for

training Allocate resources for implementation

Take ownership of the Food Safetysystem

The need to share experiences with othersectors to ensure that adequate provisionis made for food safety.


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1. Introduction to HACCP

2. Pre-requisite Programmes

3. Developing a HACCP System4. What are the Hazards

5. Assessing the Risk

6. Critical Control Points (CCPs)

7. Validation, Verification and Review

8. Implementation, Communications and Maintenance

Module 2

IPS


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Steps or procedures that control theoperational conditions within the foodestablishment, allowing for environmental

conditions that are favorable for safe andwholesome food manufacturing

Prerequisite programs are the foundation

for establishment of HACCP and guidelinesfor production of safe products.

Prerequisite Programs


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How Do These Programs Fit Together ?

The Umbrella shows theprograms and how they

link together -now we willlook at some of theseprograms in more detail

A common diagram of a quality /food safety system: the Umbrella.


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Prerequisite Programs address operationalconditions providing a foundation of a HACCPSystem

Manufacturing Facility Design

Receiving and Storage

Equipment Performance and Maintenance

Sanitation and Pest Control

Recall and TraceabilityPersonnel Training



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There are five (5) basic requirements :-

1. Documented all aspects written down(what, how, where, when, who)

2. Effectively implemented - monitored andsupervised

3. Assessed for effectiveness

4. Corrective action must be taken when

problems are identified5. Records kept of monitoring & corrective action


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Codex General Principlesof Food Hygiene

Relevant Codes of Practice

Relevant Food SafetyLegislation

Pre-requisite Programmes

Systems that are normally in place before the HACCPplan is developed to ensure the business is operating

according to:


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Also called Good Manufacturing Practices

Provides a sound foundation of HACCP

Covers Low Risk hazards

Allows the HACCP plan to be focused &specific

Give a formal support network for HACCPteam

Enables stream-lined HACCP plans

Food Safety Pre-requisite Programmes


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CROP to CONSUMER

Food Safety Programmes

What programmes do we have?


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AIB andInternalAudits


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Other Pre-requisites

People Programmes

Hygiene Training

Site Experts and Trainers

Quality Management

QA systems QAS

Vendor Assurance All raw materials


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Quality Managementensures the level ofQUALITY is consistentlymet

Plant

Quality

Systems

(IPS)

Traceability

Calibration

Document control

Record keeping

HACCP and Quality Management

Plant FoodSafety

Systems(CRP)

HACCP & CRPensures themanufacture ofSAFE products


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Document Control

Many documents in aHACCP system

Need to keep updated and

current Methods for withdrawal and

destruction of obsolete/out ofdate documents

Vital to ensure correctrecords kept


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Record-keeping

All monitoring forms forCCPs or SCPs need to bemaintained in retrievable

format for 3 years (see localrequirements)

Some records need only be

kept for shelf life + 6months


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Traceability

Ability to track where materials havecome from, and go to

One step up and one step down

All materials labelled by batch andlot

Segregate each batch and lot fromsimilar materials

Trail to link raw material batches andfinal product codes


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Calibration

Not all technical equipmentelectronically controlled

Other equipment needs to becalibrated by trained staff, e.g. :

Laboratory analytical equipment

On-line moisture meters

Metal detectors

Hand-held engineering test apparatus

Without calibration, informationgiven may be inaccurate and ourrecords are worthless!


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Pre-requisite Programmes

HACCP will work well if supported by other sound practices

Need to evaluate these practices and activities

Deficiencies and gaps in existing systems need to beidentified

Gap Analysis will help to identify these so that a completeframework exists on which to build the HACCP system

Evaluation of Pre-requisites in place

Completed pre-requisite programmes need to be validated inthe same way as HACCP to confirm their effectiveness

Procedures for verification will include audit, inspections,testing and analysis

Documentation and records are required

Effectiveness of Pre-requisites


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Role of Quality Pre-requisites

Key quality systems need to be in place toensure an effective HACCP system

HACCP plans should only cover food safety

not quality There is an essential relationship between

quality and food safety programmes, but..

A HACCP plan must stick to its scope:

FOOD SAFETY


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What is HACCP?

Structured, preventative system Achieves Food Safety through:

Hazard Identification

Control of Hazards

Hazard Analysis & Critical Control Point


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Why do we need HACCP?

To protect the consumers of our products Eliminate Food Safety Risk to the business

Legal Requirement in many countries (EU foodlegislation applied from 1 January 2006)

PepsiCo chosensystem for Food Safety and RiskAssessment: Simple

Effective

Understandable


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Seven Principles of HACCP

Principle 1 Hazard Analysis

Principle 2 Identified CCPs

Principle 3 Establish Critical Limits

Principle 4 Monitor CCPs

Principle 5 Establish Corrective Action

Principle 6 Verification

Principle 7 Record Keeping


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Principle 1 - Hazard Analysis

Identify the potential hazard(s) associated withfood production at all stages, from primaryproduction, processing, manufacture anddistribution until the point of consumption.

A flow diagram of the complete process isimportant in conducting the hazard analysis. Thesignificant hazards associated with eachspecific step of the manufacturing process arelisted.

If you dont know what the

hazards are, then find out !


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Principle 3 - Establish Critical Limits

Establish critical limit(s) which must be met toensure the CCP is under control.

Critical limits are the operational boundariesof the CCPs which control the food safetyhazard(s).

All CCP's must have preventive measureswhich are measurable!

The criteria for the critical limits aredetermined ahead of time in consultation withcompetent authorities.

Unless you can MEASURE,you cant control!


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Principle - 4 Monitor CCPs

Establish a system to monitor control of theCCP by scheduled testing or observations.

It allows processors to assess trends beforea loss of control occurs. Adjustments can bemade while continuing the process.

The monitoring interval must be adequate toensure reliable control of the process.

Monitoring is effective datacollection to enable decision making!


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Principle - 5 Establish Corrective Action

Establish the corrective action to be takenwhen monitoring indicates that a particularCCP is not under control.

HACCP is intended to prevent product orprocess deviations. However, should loss of

control occur, there must be definite steps inplace for disposition of the product and forcorrection of the process.

These must be pre-planned and written

Failure requires: stopping the process,

hold the products, correcting the problemand recording the action!


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Principle - 6 Verification

Establish procedures for verification toconfirm that the HACCP system is workingeffectively

The system should be subject to periodicrevalidation using independent audits orother verification procedures.

Proving the system is effectiveand product is safe!


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Principle - 7 Record Keeping

The HACCP system requires the preparationand maintenance of a written HACCP plantogether with other documentation.

Usually, the simplest record keeping systempossible to ensure effectiveness is the mostdesirable.

Not documented, it did not happenNot documented -it did not happen!


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RawMaterial

Processing Heat Treatment FillingProcessing Transportation

and StorageShelf life/Consumption

Farm Fork

Prevention rather than Inspection Systematic Approach Identifies Hazards in the Process Identifies Critical Points for Control and Monitoring

Focus is on Safety and not Quality

7 Principles Summary


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12. Establish documentation & record keeping

11. Establish verification procedures

10. Establish corrective actions

9. Establish monitoring systemfor CCPs

8. Establish critical limitsfor CCPs

7. Determine Critical Control Points(CCPs)

6. List hazards, conduct hazard analysis, consider control measures

5. On-site confirmation of flow diagram

4. Construct flow diagram

3. Identify intended use

2. Describe product

1. Assemble HACCP Team

1

2

3

4

5

6

7

12 Codex steps & 7 principles


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Codex step 1

Multi-disciplined Individual Expertise HACCP-Trained

Familiar with Process


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Who needs to be part of the HACCP team?

Process line representative(s)

Packaging representative

Support services (Engineers)

Production management representative (e.g. FLM)

HACCP Project Leader

Subject Specialist (Microbiologist, Regulatory affairs)

The HACCP team


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Codex steps 2 to 4

4. Construct flow diagram

Process Flow

3. Identify intended use

Intended Use

2. Describe product

Describe Product

Specification

Ingredients (incl. Allergens)

Processing requirements

Labelling requirements


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Process Flow Charts


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Flow Charts Simple

All inputs All outputs All process steps Numbered steps Describe process

Not equipment

Process Flow Charts

Peeling

Slicing

Frying

Seasoning

Peel

Waste oilOil

1.

3.

4.

7.

2.

6.5.


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Hazard Analysis

What does Codex say about Hazard Analysis ?

The process ofcollecting andevaluating information on

hazards and conditions leadingto their presence to decide

which are significant for foodsafety and therefore should be

addressed in the HACCP plan


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Collecting and evaluating information

Brainstorming (use the HACCP team) Research (R&D and scientific and trade literature,public health statistics)

Analysis of available data (AIB reports , internal SOSaudits)

Consumer complaints data

Consumer surveys and reports

Talking to people on the line

Practical observation

Shelf life and challenge studies

Consider users and abusers


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What is a Hazard?

A HAZARD is...

A property which may cause a productto be unsafe for consumption


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What are the three types of Hazard?

Chemical

Physical

Biological

There are 3 main types of Hazard


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Identify the Hazards at each step in the process

Peeling

Slicing

Frying

Seasoning

Peel

Waste oilOil

1.

3.

4.

7.

2.

6.5.


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3.

CC


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The process of hazard analysis is the result of:

collecting information on hazards

evaluating their significance

Hazard Analysis

Using a Risk AssessmentModel to

determine what goes into the HACCPplan

HACCP I d i


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A Risk Assessment Model should be used

so that the risk assessment can be as objective

as possible and to enable the ranking of

hazards as to their importance

Risk assessment

RISK = Severity x Frequency

HACCP I d i


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These two together = Significance or RISK

Is the Hazard significant?

2. Ask yourself:

How often does it happen, what is the frequency?

1. Ask yourself:

What will be the severity of the outcome?

HACCP I t d ti


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Risk Assessment Model - Severity

RISK = Severity x Frequency

Severityif

controlsfail

Severity of affect if Hazard OccursMultipl

ier

LittleDamage

Mild disappointment to the consumer. May lead to a complaint, no business

interruption. Minor consequences.1

DamageVery minor medical treatment, (for example a broken tooth). Consumer

disappointed and likely to lead to a complaint to the Company.2

SeriousDamage

Illness at home. Medical treatment not necessary. A disappointed consumer

very likely to lead to a complaint to a regulatory authority.3

Very

SeriousDamage

Illness at home with medical treatment necessary. A very disappointed

consumer. A significant risk of proscecution. 4

DisasterSeriousIllness

Hospitalization required. Significant risk of proscecution. Media coverage.

Intervention by Crisis management team. Damage to branded image.5

Catast-rophic

Death. Top level crisis management Certain risk of proscecution.

Destruction of brand6

Severity

HACCP I t d ti


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Probability ofhazard

occurring ifprocess fails

Frequency That Hazard Could OccurMultipl

ier

AlmostImpossible

Less than once a year, no history of it occurring 1

Un-Likely Very occasional, has been known to occur 2

Small Risk Isolated event that result after manual operations 3

Likely Product or operational factors that can be expected to be present 4

Certain Product or operational factors that the process is expected to control 5

Frequency RISK = Severity x Frequency

Risk Assessment Model - Frequency

HACCP I t d ti


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6 9

A consumer issue. With some risk to consumer safety.

Certainly needs control by a GMP, could be aSpecific Control Point (SCP)

10 16Use Codex decision tree for hazards. Implications for correctiveaction procedures. Report/resolve and record at next HACCP review.Definitely either a GMP or an SCP,may be a CCP

15Probably controlled by a Good Manufacturing Practice (GMP).Check nature of problem against existing pre-requisiteprogrammes

16 +Likely to be a Critical control point (CCP). Use Codex decision treefor hazards. Failure may result in food poisoning incidents orProduct Recall. Initiates special HACCP review.

Guideline Actions from the Risk Assessment

HACCP I t d ti


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GMPs, SCPs and CCPs

A step in the food production process wherea control measure can be applied

Must control the hazard to a safe level, oreliminate it completely.

CCP

Critical Control Point

MagnetsSpecific Control Point

May occur at several points in theprocess

Do not give complete control of a Hazard

Will need a high level of checking.

SCP

Good ManufacturingPractice

METAL

METAL

Contact

Also called Pre-Requisites

Provide a sound foundation for HACCP

Control Low Risk hazards

GMP

HACCP Introduction


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Engineering out hazards - examples...

Making alterations to equipment to prevent metal-to-metal contact

Modifying equipment to prevent Allergen cross-contamination

Re-designing equipment to make it easier to clean

HACCP Introduction


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Preventing or reducing hazards - key questions

Is this controlled by a pre-requisite GMPprogramme?

Is there equipment or processing whichprevents the hazards being present at later

stages? If we cannot prevent the hazard occurring, is

our only option to monitor potentialcontamination to ensure that unsafe productcannot leave our factory?

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CCPs should be identified with the aid of a

Decision Tree and/or Risk Assessment Matrix

Critical Control Points CODEXdefinition

A step where control can beapplied and is essential to

prevent, eliminate or reduce afood safety hazard to acceptable

levels

What is a CCP?

HACCP Introduction


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CRITICALCONTROL

POINT

*= Proceed to next hazard or step in the describedrocess

Q1. Are the controlmeasures in place for thehazard?

Q2. Is the process stepspecifically designed toeliminate or reduce the hazardto an acceptable level?

YES

Q3. Could contamination withthe hazard occur atunacceptable level(s) or increaseto unacceptable level(s)?

NO

Questions to be answered for each potential hazard at each process step. Do not proceed where

the hazard is managed by a pre-requisite or GMP programme:

YES

NO Is the control at this stepnecessary for food safety?

Modify process or product

YES

Not aCCP Stop

*

NO

Not aCCP

Stop

*

NO

YES Q4. Will a subsequent processstep eliminate or reduce thehazard to an acceptable level?

Not aCCP

Stop

*

YES

NO

CCP Decision Tree

HACCP Introduction


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What CCPs could we expect at suppliers?

Are the Metal Check Records completed fully?

Are the correct Test Pieces used by a trained person?

Is Corrective action taken if the test fails?

Is action taken for reject product?

HACCP Introduction


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CCP: Filtration

Process Step:Inline filtration at closest

point prior to filling.

Hazard:

Foreign objects > 7mm*

Critical Control Limit:

Present and intact filters/screens that preventpassage of objects >7mm.

PepsiCo Operational Target:Gatorade Clear: 15 m

Gatorade Cloudy: 25-40

m

Juices without added pulp: 2.4 mm

Juices with added pulp: 6.4

mm

Monitoring:Filters/Screens are inspected (i) present and (ii) intact, at a defined

frequency. Abnormal extraneous material with potential risks found on

intact screens are noted for root cause and investigative proposes (i.e.

gaskets, plastic, glass, or metal fragments)

Corrective Action: If filter/screen is not (i) present or (ii) intact during verification, put the

product produced since the last acceptable check on hold, stop the

process, and replace with functional filter/screen.

Notify designated quality employee to determine disposition of the

product. Establish statistical sampling plan to evaluate likelihood of

hazard in product and for the disposition of product. Corrective action

and disposition records must be documented.

Documentation: Filter/Screen Inspection Log

Extraneous Material Log

Hold and Release Records

Corrective Action Records Verification Records

*FDA Compliance Policy Guide#555.425 (FDA, 2001a).

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The HACCP team will check that the HACCP study is valid and that ifcorrectly followed will deliver safe food.

The aims of this audit are: To ensure the scope of the HACCP is correct and still valid.

To ensure the HACCP study has been completed correctlyaccording to the seven Codex principles.

To ensure that any changes to the process, product or equipmenthave been reflected in the HACCP study

verb; to validate, ratify; valid, sound, defensible of reasonable objection(Oxford English Dictionary)

Which means..

Obtaining evidence that the elements of theHACCP plan are effective

Validation:

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verb; to establish truth or correctness by examination or demonstration(Oxford English Dictionary)

Which means..

Monitoring and Evaluating compliance

with the HACCP plan

This is focussed on how well the CCPs are being controlled.

The aims of this audit are:

To check that monitoring records are complete for each CCP.

To check that the person completing the CCP checks and recordshas been trained.

To check that any equipment used for monitoring CCPs has beencalibrated.

To check that appropriate corrective action has been taken whereany of the CCP checks have failed.

Verification:

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Ten point Checklist for HACCP

1. Was a multi-disciplined team used for theHACCP study? 2. Are Product descriptions and intendeduse details available for all products? 3. Is the Process Flow Diagram up to dateand signed off as correct?

4. Are all hazards listed including:Biological, Physical and Chemical (includingAllergens)? 5. Have Hazards been risk assessed? 6. Have CCPs been identified using adecision tree or expert panel? 7. Are all CCPs controlled to within theCritical limits and monitored frequently?

8. Have corrective actions been taken forany CCP failures? 9. Are verification/validation procedurescompleted frequently (at last annually)? 10. Is the HACCP plan up to date (reviewedannually?)?

HACCP Control Plan

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