HACCP Introduction-Refresher Training

HACCP Introduction 7 Principles
HACCP Introduction - 7 Principles
VERSION 2, June 2008
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HACCP Introduction The History of HACCP

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
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VERSION 1 : November 2010
HACCP Introduction US Space Agency - NASA
HACCP Introduction
HACCP Introduction US Space Agency - NASA

How did they know that the Food is Safe? Is End Product Testing Sufficient? How Many Samples to Test? 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
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HACCP Introduction
Example If 1 of 1000 batches was defective (0.1%).. If test 60 batches.. If we say Yes for release.>94% chance for release Then still would miss defective batches! How many finished batches do you test?
!
Storage & Transport
Raw Material
Processing
Finished Product
QC?
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QC ?
QC ? VERSION 1 :
QC?
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HACCP Introduction HACCP Introduction

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. 1980s 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
HACCP Introduction CAC ( FAO + WHO) VERSION 1 : November 2010 6
National Advisory Committee on Microbiological Criteria for Foods
HACCP Introduction HACCP

Systematic Approach for:
Identification and assessment of Hazards associated with Manufacturing, Distribution, and use of Food Products as well as the definition of Preventative Measures for their Control HACCP focuses solely on Significant Hazards that are Reasonably Likely to result in unacceptable health risk to consumers
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HACCP Introduction 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.
HACCP Introduction
HACCP Introduction 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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HACCP Introduction 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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Module 2
1.
Introduction to HACCP
2.
3. 4.
Pre-requisite Programmes
Developing a HACCP System What are the Hazards
5.
6. 7. 8.
Assessing the Risk

Critical Control Points (CCPs) Validation, Verification and Review Implementation, Communications and Maintenance
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IPS
HACCP Introduction
HACCP Introduction
Prerequisite Programs 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.
HACCP Introduction
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.

HACCP Introduction
Prerequisite Programs
Prerequisite Programs address operational conditions providing a foundation of a HACCP System Manufacturing Facility Design Receiving and Storage Equipment Performance and Maintenance Sanitation and Pest Control Recall and Traceability Personnel Training
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Prerequisite Programs
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 effectiveness 4. Corrective action must be taken when problems are identified 5. Records kept of monitoring & corrective action
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Pre-requisite Programmes Systems that are normally in place before the HACCP plan is developed to ensure the business is operating according to: Codex General Principles of Food Hygiene Relevant Codes of Practice Relevant Food Safety Legislation
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Food Safety Pre-requisite Programmes 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
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HACCP Introduction
Food Safety Programmes
What programmes do we have?
CROP to CONSUMER
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AIB and Internal Audits
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Other Pre-requisites Vendor Assurance All raw materials
People Programmes
Hygiene Training Site Experts and Trainers
Quality Management
QA systems
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QAS
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HACCP and Quality Management
Quality Management ensures the level of QUALITY is consistently met
Document control Record keeping Traceability
HACCP & CRP ensures the manufacture of SAFE products
Plant Quality Systems (IPS)
Calibration
Plant Food Safety Systems (CRP)

HACCP Introduction
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!
HACCP Introduction
Pre-requisite Programmes
Evaluation of Pre-requisites in place 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 Effectiveness of Pre-requisites 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
HACCP Introduction
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
HACCP Introduction
What is HACCP?
Hazard Analysis & Critical Control Point Structured, preventative system Achieves Food Safety through: Hazard Identification Control of Hazards
HACCP Introduction
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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HACCP Introduction Seven Principles of HACCP
Principle 1 Principle 2 Principle 3 Principle 4
Hazard Analysis Identified CCPs Establish Critical Limits Monitor CCPs
Principle 5
Principle 6 Principle 7
Establish Corrective Action

Verification Record Keeping
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HACCP Introduction 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 dont know what the hazards are, then find out !
HACCP Introduction Principle 2 - Identified CCPs

Determine the points, procedures or operational steps that can be controlled to eliminate the hazard(s) or minimize its (their) likelihood of occurrence. A "step" 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 direct impact on food safety !

HACCP Introduction 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 cant control!

HACCP Introduction Principle - 4 Monitor CCPs

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!

HACCP Introduction
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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HACCP Introduction 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 effective and product is safe!

HACCP Introduction 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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HACCP Introduction 7 Principles Summary

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
Raw Material
Processing
Processing Heat Treatment
Filling
Transportation and Storage
Shelf life/ Consumption
Farm
HACCP Introduction
Fork
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12 Codex steps & 7 principles
7 6 5 4 3 2 1 5. 4. 7. 8. 9. 10. 11. 12. Establish documentation & record keeping Establish verification procedures
Establish corrective actions
Establish monitoring system for CCPs
Establish critical limits for CCPs
Determine Critical Control Points (CCPs)
6. List hazards, conduct hazard analysis, consider control measures

On-site confirmation of flow diagram
Construct flow diagram
3.
2. 1.
Identify intended use
Describe product
Assemble HACCP Team

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Codex step 1
Multi-disciplined Individual Expertise HACCP-Trained Familiar with Process
1.
Assemble HACCP Team

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HACCP Introduction
The HACCP team Process line representative(s) Packaging representative Support services (Engineers) Production management representative (e.g. FLM) Who needs to be part of the HACCP team? HACCP Project Leader Subject Specialist (Microbiologist, Regulatory affairs)
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Codex steps 2 to 4
Describe Product Intended Use Process Flow
Specification
Ingredients (incl. Allergens)

Processing requirements Labelling requirements
4.
Construct flow diagram
3.
2. 1.
Identify intended use
Describe product
Assemble HACCP Team

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Process Flow Charts
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Process Flow Charts
1.
2.
Peeling
3.
Peel
Slicing
4.
5.
6.
Oil
Frying
7.
Waste oil
Flow Charts Simple All inputs All outputs All process steps Numbered steps Describe process Not equipment
Seasoning
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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
HACCP Introduction
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?
There are 3 main types of Hazard
Chemical Physical Biological

HACCP Introduction
Identify the Hazards at each step in the process
1.
2.
Peeling
3.
Peel
Slicing
4.
5.
6.
Oil
Frying
7.
Waste oil
Seasoning
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HACCP Introduction
3.
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HACCP Introduction
Hazard Analysis
The process of hazard analysis is the result of:
collecting information on hazards

evaluating their significance
Using a Risk Assessment Model to determine what goes into the HACCP plan
HACCP Introduction
Risk assessment
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 = Severity x Frequency

HACCP Introduction
Is the Hazard significant? 1. Ask yourself:
What will be the severity of the outcome? 2. Ask yourself:

How often does it happen, what is the frequency?
These two together = Significance or RISK

HACCP Introduction
Risk Assessment Model - Severity RISK = Severity x Frequency Severity
Severity if controls fail Little Damage Damage Serious Damage Very Serious Damage Disaster Serious Illness Catastrophic
Severity of affect if Hazard Occurs

Mild disappointment to the consumer. May lead to a complaint, no business interruption. Minor consequences. Very minor medical treatment, (for example a broken tooth). Consumer disappointed and likely to lead to a complaint to the Company. Illness at home. Medical treatment not necessary. A disappointed consumer very likely to lead to a complaint to a regulatory authority. Illness at home with medical treatment necessary. A very disappointed consumer. A significant risk of proscecution. Hospitalization required. Significant risk of proscecution. Media coverage. Intervention by Crisis management team. Damage to branded image. Death. Top level crisis management Certain risk of proscecution. Destruction of brand
Multipl ier
1 2 3 4 5 6
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HACCP Introduction
Risk Assessment Model - Frequency
Frequency
Probability of hazard occurring if process fails
RISK = Severity x Frequency

Multipl ier
Frequency That Hazard Could Occur
Almost Impossible Un-Likely Small Risk Likely Certain
Less than once a year, no history of it occurring Very occasional, has been known to occur Isolated event that result after manual operations Product or operational factors that can be expected to be present Product or operational factors that the process is expected to control
1 2 3 4 5
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Guideline Actions from the Risk Assessment
1 5
Probably controlled by a Good Manufacturing Practice (GMP). Check nature of problem against existing pre-requisite programmes A consumer issue. With some risk to consumer safety. Certainly needs control by a GMP, could be a Specific Control Point (SCP) Use 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 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.
69
10 16
16 +
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GMPs, SCPs and CCPs
CCP
Critical Control Point
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.
SCP
Specific 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.
Magnets
GMP
Good Manufacturing Practice HACCP Introduction
Also called Pre-Requisites

Provide a sound foundation for HACCP Control Low Risk hazards
METAL METAL
Contact
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Engineering out hazards - examples... Making alterations to equipment to prevent metal-tometal contact Modifying equipment to prevent Allergen crosscontamination 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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What is a CCP?
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
CCPs should be identified with the aid of a Decision Tree and/or Risk Assessment Matrix
HACCP Introduction
CCP Decision Tree
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: Q1. Are the control measures in place for the hazard? YES NO
Modify process or product YES Is the control at this step necessary for food safety? NO Not a CCP Stop
Q2. Is the process step specifically designed to eliminate or reduce the hazard to an acceptable level? NO
*
YES
NO
Q3. Could contamination with YES the hazard occur at unacceptable level(s) or increase to unacceptable level(s)? Not a NO Stop CCP
HACCP Introduction
CRITICAL CONTROL POINT
Q4. Will a subsequent process step eliminate or reduce the hazard to an acceptable level? YES Not a CCP Stop
* = Proceed to next hazard or step in the described

process
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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?
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CCP: Filtration
Critical Control Limit: Process Step: Inline filtration at closest point prior to filling.
Present and intact filters/screens that prevent passage of objects >7mm.
PepsiCo Operational Target:

Gatorade Clear: Gatorade Cloudy: m Juices without added pulp: 2.4 mm Juices with added pulp: mm 15 m 25-40
Hazard: Foreign objects > 7mm*
6.4
Monitoring: Documentation:
Filter/Screen Inspection Log Extraneous Material Log Hold and Release Records Corrective Action Records Verification Records 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.
*FDA Compliance Policy Guide

#555.425 (FDA, 2001a). HACCP Introduction
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Validation:
verb; to validate, ratify; valid, sound, defensible of reasonable objection
Which means.. (Oxford English Dictionary)
Obtaining evidence that the elements of the HACCP plan are effective
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
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Verification:
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.
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HACCP Introduction Ten point Checklist for HACCP

HACCP Control Plan
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?)?
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HACCP Introduction 7 Principles

HACCP Introduction - 7 Principles

VERSION 2, June 2008

HACCP Introduction The History of HACCP

VERSION 1 : November 2010

HACCP Introduction US Space Agency - NASA

VERSION 1 : November 2010

HACCP Introduction US Space Agency - NASA

Our present QC system is testing Raw Material and Finished Product

HACCP Introduction HACCP Introduction

National Advisory Committee on Microbiological Criteria for Foods

HACCP Introduction HACCP

VERSION 1 : November 2010

HACCP Introduction HACCP is a Tool

VERSION 1 : November 2010

HACCP Introduction Why is Food Safety so Important ?

VERSION 1 : November 2010

HACCP Introduction Roles & Responsibilities

VERSION 1 : November 2010

Assessing the Risk

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

VERSION 1 : November 2010

VERSION 1 : November 2010

VERSION 1 : November 2010

Give a formal support network for HACCP team

VERSION 1 : November 2010

Food Safety Programmes

What programmes do we have?

AIB and Internal Audits

VERSION 1 : November 2010

Document control Record keeping Traceability

HACCP & CRP ensures the manufacture of SAFE products

Plant Quality Systems (IPS)

Plant Food Safety Systems (CRP)

VERSION 1 : November 2010

VERSION 1 : November 2010

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

A HACCP plan must stick to its scope:

VERSION 1 : November 2010

HACCP Introduction Seven Principles of HACCP

Principle 1 Principle 2 Principle 3 Principle 4

Hazard Analysis Identified CCPs Establish Critical Limits Monitor CCPs

Establish Corrective Action

VERSION 1 : November 2010

HACCP Introduction Principle 1 - Hazard Analysis

HACCP Introduction Principle 2 - Identified CCPs

Failure at a CCP has a direct impact on food safety !

HACCP Introduction Principle 3 - Establish Critical Limits

Unless you can MEASURE, you cant control!

HACCP Introduction Principle - 4 Monitor CCPs

Monitoring is effective data collection to enable decision making!

VERSION 1 : November 2010

HACCP Introduction Principle - 6 Verification

Proving the system is effective and product is safe!

HACCP Introduction Principle - 7 Record Keeping

VERSION 1 : November 2010

HACCP Introduction 7 Principles Summary

Processing Heat Treatment

Transportation and Storage

Shelf life/ Consumption

Establish corrective actions

Establish monitoring system for CCPs

Establish critical limits for CCPs