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HACCP Introduction - 7 Principles VERSION 2, June 2008

HACCP Introduction – 7 Principles

HACCP Introduction VERSION 1 : November 2010

HACCP Introduction

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• The most common template (tool) for a food safety plan follows principles laid out under a program called HACCP

• Back in 1959, the US space agency NASA faced a simple but mundane problem when planning its first manned space flights: How and what was it going to feed astronauts ?

• The American food company Pillsbury (now part of General Mills) was called into help.

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 and Finished Product”

“Sampling and testing of each batch of food is impractical”

• How did they know that the Food is 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 & TransportQC?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 of safe 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.• 1980’s – major food companies began to utilize HACCP Principles• 1993 the Codex Alimentarius Commission adopted Guidelines for the

application of the Hazard Analysis Critical Control Point (HACCP) system – to 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 Advisory Committee on Microbiological Criteria for Foods CAC ( FAO + WHO)

HACCP Introduction


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Systematic Approach for:Identification Identification and assessment of Hazards assessment of Hazards associated with Manufacturing, Distribution, and use of Food Products as well as the definition of Preventative Measures Preventative Measures for theirControl

HACCP focuses solely on Significant Hazards Significant Hazards that are Reasonably Likely Reasonably 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 and is not designed to be a stand alone program.

• To be effective, other tools must include: adherence to good manufacturing practices, sanitation standard operating procedures, and a personal hygiene program.


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Why is Food Safety so Important ?

• More countries will incorporate Food Safety principles into their food legislations

• Food Safety Plans will be made mandatory for more categories of products

• In the long run, food business operations not based on 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 of

Food Safety system• Provide for sufficient resources for

training• Allocate resources for implementation• Take ownership of the Food Safety

system• The need to share experiences with other

sectors to ensure that adequate provision is made for food safety.


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1. Introduction to HACCP

2. Pre-requisite Programmes3. Developing a HACCP System4. What are the Hazards5. Assessing the Risk6. Critical Control Points (CCPs)7. Validation, Verification and Review8. Implementation, Communications and

Maintenance

Module 2

IPS


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Steps or procedures that control the operational conditions within the food establishment, allowing for environmental conditions that are favorable for safe and wholesome food manufacturing

Prerequisite programs are the foundation for establishment of HACCP and guidelines for production of safe products.

Prerequisite Programs


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How Do These Programs Fit Together ?

The Umbrella shows the programs and how they link together -now we will look at some of these programs in more detail

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


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Prerequisite Programs address operational conditions providing a foundation of a HACCP System

Manufacturing Facility DesignReceiving and StorageEquipment Performance and MaintenanceSanitation and Pest ControlRecall 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 and supervised

3. Assessed for effectiveness4. Corrective action must be taken when

problems are identified5. Records kept of monitoring & corrective action


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• Codex General Principles of Food Hygiene

• Relevant Codes of Practice• Relevant Food Safety

Legislation

Pre-requisite Programmes

Systems that are normally in place before the HACCP plan 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 HACCP

team• 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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GMPsHA

CCP

Expe

rt sit

es

AIB and Internal Audits


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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 Management ensures the level of QUALITY is consistently met

Plant Quality Systems (IPS)

Traceability

Calibration

Document control

Record keeping

HACCP and Quality Management

Plant Food Safety

Systems (CRP)

HACCP & CRP ensures the manufacture of SAFE products


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Document Control

• Many documents in a HACCP system

• Need to keep updated and current

• Methods for withdrawal and destruction of obsolete/out of date documents

• Vital to ensure correct records kept


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Record-keeping

• All monitoring forms for CCPs or SCPs need to be maintained in retrievable format for 3 years (see local requirements)

• Some records need only be kept for shelf life + 6 months


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Traceability

• Ability to track where materials have come from, and go to

• ‘One step up and one step down’• All materials labelled by batch and

lot• Segregate each batch and lot from

similar materials• Trail to link raw material batches and

final product codes


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Calibration• Not all technical equipment

electronically controlled• Other equipment needs to be

calibrated by trained staff, e.g. : Laboratory analytical equipment On-line moisture meters Metal detectors Hand-held engineering test apparatus

• Without calibration, information given may be inaccurate and our records 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 be identified• “Gap Analysis” will help to identify these so that a complete

framework exists on which to build the HACCP system

Evaluation of Pre-requisites in place

• Completed pre-requisite programmes need to be validated in the 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 to ensure 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 food

legislation applied from 1 January 2006)• PepsiCo chosen system for Food Safety and Risk

Assessment:• Simple • Effective• Understandable


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Seven Principles of HACCP

Principle 1 Hazard AnalysisPrinciple 1 Hazard AnalysisPrinciple 2 Identified CCP’sPrinciple 2 Identified CCP’sPrinciple 3 Establish Critical LimitsPrinciple 3 Establish Critical LimitsPrinciple 4 Monitor CCP’sPrinciple 4 Monitor CCP’sPrinciple 5 Establish Corrective ActionPrinciple 5 Establish Corrective ActionPrinciple 6 Verification Principle 6 Verification Principle 7 Record KeepingPrinciple 7 Record Keeping


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Principle 1 - Hazard Analysis

• Identify the potential hazard(s) associated with food production at all stages, from primary production, processing, manufacture and distribution until the point of consumption.

• A flow diagram of the complete process is important in conducting the hazard analysis. The significant hazards associated with each specific step of the manufacturing process are listed.

If you don’t know what the hazards are, then find out !


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Principle 2 - Identified CCP’s

• Determine the points, procedures or operational steps that can be controlled to eliminate the hazard(s) or minimize its (their) likelihood of occurrence.

• A "stepstep" means any stage in food production and/or manufacture including the receipt and/or production of raw materials, transport, formulation, processing, storage, etc.

Failure at a CCP has a directimpact on food safety !


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Principle 3 - Establish Critical Limits

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

• Critical limits are the operational boundaries of the CCPs which control the food safety hazard(s).

• All CCP's must have preventive measures which are measurable!

• The criteria for the critical limits are determined ahead of time in consultation with competent authorities.

Unless you can MEASURE, you can’t control!


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Principle - 4 Monitor CCP’s

• Establish a system to monitor control of the CCP by scheduled testing or observations.

• It allows processors to assess trends before a loss of control occurs. Adjustments can be made while continuing the process.

• The monitoring interval must be adequate to ensure reliable control of the process.

Monitoring is effective data collection to enable decision making!


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Principle - 5 Establish Corrective Action• Establish the corrective action to be taken

when monitoring indicates that a particular CCP is not under control.

• HACCP is intended to prevent product or process deviations. However, should loss of control occur, there must be definite steps in place for disposition of the product and for correction of the process.

• These must be pre-planned and written

Failure requires: stopping the process, hold the products, correcting the problem

and recording the action!


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Principle - 6 Verification

• Establish procedures for verification to confirm that the HACCP system is working effectively

• The system should be subject to periodic revalidation using independent audits or other verification procedures.

Proving the system is effectiveand product is safe!


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Principle - 7 Record Keeping

• The HACCP system requires the preparation and maintenance of a written HACCP plan together with other documentation.

• Usually, the simplest record keeping system possible to ensure effectiveness is the most desirable.

“Not documented, it did not happen”Not documented -it did not happen!


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RawMaterial Processing Heat Treatment Filling

Processing Transportation and Storage

Shelf 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 system for CCP’s

8. Establish critical limits for CCP’s

7. Determine Critical Control Points (CCP’s)

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

712 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 of collecting and evaluating information on

hazards and conditions leading to their presence to decide

which are significant for food safety 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 SOS audits)• 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 product to 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.


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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 Assessment Model to determine what goes into the HACCP

plan


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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


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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?”


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Risk Assessment Model - SeverityRISK = Severity x Frequency

Severity

if controls

fail Severity of affect if Hazard Occurs Multipl

ier

Little Damage

Mild disappointment to the consumer. May lead to a complaint, no business interruption. Minor consequences. 1

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

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

Serious Damage

Illness at home. Medical treatment not necessary. A disappointed consumer very likely to lead to a complaint to a regulatory authority. 3

Very Serious Damage

Illness at home with medical treatment necessary. A very disappointed consumer. A significant risk of proscecution. 4

Disaster Serious Illness

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 ‘brand’ 6

Severity


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Probability of

hazard occurring if

process fails Frequency That Hazard Could Occur Multipl

ier

Almost Impossible 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


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6 – 9A consumer issue. With some risk to consumer safety. Certainly needs control by a GMP, could be a Specific Control Point (SCP)

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

1 –5 Probably controlled by a Good Manufacturing Practice (GMP). Check nature of problem against existing pre-requisite programmes

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

Guideline Actions from the Risk Assessment


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GMPs, SCPs and CCPs

• A step in the food production process where a control measure can be applied• Must control the hazard to a safe level, or eliminate it completely.

CCP

Critical Control Point

MagnetsSpecific Control Point

• May occur at several points in the process• Do not give complete control of a Hazard• Will need a high level of checking.

SCP

Good Manufacturing Practice

METALMETAL

Contact

• Also called “Pre-Requisites”

• Provide a sound foundation for HACCP

• Control ‘Low Risk’ hazards

GMP


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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


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Preventing or reducing hazards - key questions

• Is this controlled by a pre-requisite GMP programme?

• Is there equipment or processing which prevents the hazards being present at later stages?

• If we cannot prevent the hazard occurring, is our only option to monitor potential contamination to ensure that unsafe product cannot leave our factory?


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CCP’s should be identified with the aid of a Decision Tree and/or Risk Assessment Matrix

Critical Control Points – CODEX definition

“A step where control can be applied and is essential to

prevent, eliminate or reduce a food safety hazard to acceptable

levels”

What is a CCP?


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CRITICAL CONTROL POINT

* = Proceed to next hazard or step in the described process

Q1. Are the control measures in place for the hazard?

Q2. Is the process step specifically designed to eliminate or reduce the hazard to an acceptable level?

YES

Q3. Could contamination with the hazard occur at unacceptable level(s) or increase to 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 step necessary for food safety?

Modify process or product

YESNot a CCP Stop

*NO

Not a CCP Stop

*NO

YES Q4. Will a subsequent process step eliminate or reduce the hazard to an acceptable level?

Not a CCP Stop

*YES

NO

CCP Decision Tree


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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?

Portfolio Risk Table


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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 prevent passage of objects >7mm.

PepsiCo Operational Target:Gatorade “Clear”: 15 µmGatorade “Cloudy”: 25-40 µmJuices without added pulp: 2.4 mmJuices 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 if correctly 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 correctly according to the seven Codex principles. To ensure that any changes to the process, product or equipment have 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 the HACCP 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 records has been trained. To check that any equipment used for monitoring CCPs has been calibrated. To check that appropriate corrective action has been taken where any of the CCP checks have failed.

Verification:


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Ten point Checklist for HACCP

1. Was a multi-disciplined team used for the HACCP study? 2. Are Product descriptions and intended use details available for all products? 3. Is the Process Flow Diagram up to date and signed off as correct? 4. Are all hazards listed including: Biological, Physical and Chemical (including Allergens)? 5. Have Hazards been risk assessed? 6. Have CCPs been identified using a decision tree or expert panel? 7. Are all CCPs controlled to within the Critical limits and monitored frequently? 8. Have corrective actions been taken for any CCP failures? 9. Are verification/validation procedures completed frequently (at last annually)? 10. Is the HACCP plan up to date (reviewed annually?)?

HACCP Control Plan

Science

Haccp introduction refresher training لكل مهندسين الجودة