HACCP Introduction 7 Principles HACCP Introduction 7 Principles

HACCP Introduction – 7 Principles HACCP Introduction - 7 Principles VERSION 2, June 2008 Page 1

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 HACCP Introduction VERSION 1 : November 2010 2

HACCP Introduction US Space Agency - NASA HACCP Introduction VERSION 1 : November 2010 3

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” HACCP Introduction VERSION 1 : November 2010 4

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? Raw Material QC? HACCP Introduction Processing Finished Product QC ? QC? Storage & Transport VERSION 1 : November 2010 QC? 5

HACCP Introduction • HACCP was developed by Pillsbury Company (USA) in 1959 • The HACCP concept was pioneered in the 1960 s 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 Pepsi. Co 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 HACCP Introduction VERSION 1 : November 2010 7

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 VERSION 1 : November 2010 8

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 HACCP Introduction VERSION 1 : November 2010 9

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. HACCP Introduction VERSION 1 : November 2010 10

HACCP Introduction Module 2 1. Introduction to HACCP 2. Pre-requisite Programmes 3. Developing a HACCP System 4. What are the Hazards 5. Assessing the Risk 6. Critical Control Points (CCPs) 7. Validation, Verification and Review 8. Implementation, Communications and Maintenance HACCP Introduction VERSION 1 : November 2010 IPS 11

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 VERSION 1 : November 2010 12

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 VERSION 1 : November 2010 13

HACCP Introduction Prerequisite Programs address operational conditions providing a foundation of a HACCP System q. Manufacturing Facility Design q. Receiving and Storage q. Equipment Performance and Maintenance q. Sanitation and Pest Control q. Recall and Traceability q. Personnel Training HACCP Introduction VERSION 1 : November 2010 14

HACCP Introduction 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 HACCP Introduction VERSION 1 : November 2010 15

HACCP Introduction 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 HACCP Introduction VERSION 1 : November 2010 16

HACCP Introduction 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 HACCP Introduction VERSION 1 : November 2010 17

HACCP Introduction Food Safety Programmes What programmes do we have? CROP to CONSUMER HACCP Introduction VERSION 1 : November 2010 18

HA CC P Ex pe rt sit e s HACCP Introduction GM Ps AIB and Internal Audits HACCP Introduction VERSION 1 : November 2010 19

HACCP Introduction Other Pre-requisites Vendor Assurance • All raw materials People Programmes • Hygiene Training • Site Experts and Trainers Quality Management • QA systems HACCP Introduction QAS VERSION 1 : November 2010 20

HACCP Introduction HACCP and Quality Management ensures the level of QUALITY is consistently met Document control Record keeping Traceability HACCP & CRP ensures the manufacture of SAFE products Plant Food Safety Systems (CRP) HACCP Introduction Plant Quality Systems (IPS) VERSION 1 : November 2010 Calibration 21

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 HACCP Introduction VERSION 1 : November 2010 22

HACCP Introduction 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 HACCP Introduction VERSION 1 : November 2010 23

HACCP Introduction 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 HACCP Introduction VERSION 1 : November 2010 24

HACCP Introduction Calibration • Not all technical equipment electronically controlled • Other equipment needs to be calibrated by trained staff, e. g. : ü Laboratory analytical equipment ü On-line moisture meters ü Metal detectors ü Hand-held engineering test apparatus • Without calibration, information given may be inaccurate and our records are worthless! HACCP Introduction VERSION 1 : November 2010 25

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 VERSION 1 : November 2010 26

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 VERSION 1 : November 2010 27

HACCP Introduction What is HACCP? Hazard Analysis & Critical Control Point • Structured, preventative system • Achieves Food Safety through: q Hazard Identification q Control of Hazards HACCP Introduction VERSION 1 : November 2010 28

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) • Pepsi. Co chosen system for Food Safety and Risk Assessment: • Simple • Effective • Understandable HACCP Introduction VERSION 1 : November 2010 29

HACCP Introduction Seven Principles of HACCP Principle 1 Principle 2 Hazard Analysis Identified CCP’s Principle 3 Principle 4 Establish Critical Limits Monitor CCP’s Principle 5 Principle 6 Establish Corrective Action Verification Principle 7 Record Keeping HACCP Introduction VERSION 1 : November 2010 30

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 don’t know what the hazards are, then find out ! HACCP Introduction VERSION 1 : November 2010 31

HACCP Introduction 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 "step" 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 VERSION 1 : November 2010 32

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 can’t control! HACCP Introduction VERSION 1 : November 2010 33

HACCP Introduction 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! HACCP Introduction VERSION 1 : November 2010 34

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! HACCP Introduction VERSION 1 : November 2010 35

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 VERSION 1 : November 2010 36

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 notnot happen! “Not documented, it did happen” HACCP Introduction VERSION 1 : November 2010 37

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 “Farm HACCP Introduction Processing Heat Treatment Filling Transportation and Storage Shelf life/ Consumption Fork” VERSION 1 : November 2010 38

HACCP Introduction 12 Codex steps & 7 principles 7 6 5 4 3 2 5. 3. 2. 1. 11. Establish verification procedures Establish corrective actions Establish monitoring system for CCP’s Establish critical limits for CCP’s Determine Critical Control Points (CCP’s) 6. List hazards, conduct hazard analysis, consider control measures 1 4. 7. 8. 9. 10. 12. Establish documentation & record keeping On-site confirmation of flow diagram Construct flow diagram Identify intended use Describe product Assemble HACCP Team HACCP Introduction VERSION 1 : November 2010 39

HACCP Introduction Codex step 1 • • 1. Multi-disciplined Individual Expertise HACCP-Trained Familiar with Process Assemble HACCP Team HACCP Introduction VERSION 1 : November 2010 40

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) HACCP Introduction VERSION 1 : November 2010 41

HACCP Introduction Codex steps 2 to 4 Describe Product Intended Use Process Flow • Specification • Ingredients (incl. Allergens) • Processing requirements • Labelling requirements 4. 3. 2. 1. Construct flow diagram Identify intended use Describe product Assemble HACCP Team HACCP Introduction VERSION 1 : November 2010 42

HACCP Introduction Process Flow Charts HACCP Introduction VERSION 1 : November 2010 43

HACCP Introduction Process Flow Charts 1. 2. Peeling Peel 3. Slicing 6. 5. 4. Frying Oil 7. Seasoning HACCP Introduction Waste oil Flow Charts • Simple • All inputs • All outputs • All process steps • Numbered steps • Describe process • Not equipment VERSION 1 : November 2010 44

HACCP Introduction 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 VERSION 1 : November 2010 45

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 HACCP Introduction VERSION 1 : November 2010 46

HACCP Introduction What is a Hazard? A HAZARD is. . . A property which may cause a product to be unsafe for consumption HACCP Introduction VERSION 1 : November 2010 47

HACCP Introduction What are three types of Hazard? There are 3 main types of Hazard……… • Chemical • Physical • Biological HACCP Introduction VERSION 1 : November 2010 48

HACCP Introduction Identify the Hazards at each step in the process 1. 2. Peeling Peel 3. Slicing 6. 5. 4. Frying Oil Waste oil 7. Seasoning HACCP Introduction VERSION 1 : November 2010 49

HACCP Introduction 3. HACCP Introduction VERSION 1 : November 2010 50

HACCP Introduction Hazard Analysis The process of hazard analysis is the result of: þ collecting information on hazards ¨ evaluating their significance Using a Risk Assessment Model to determine what goes into the HACCP plan HACCP Introduction VERSION 1 : November 2010 51

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 VERSION 1 : November 2010 52

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 VERSION 1 : November 2010 53

HACCP Introduction Risk Assessment Model - Severity RISK = Severity x Frequency Severity HACCP Introduction VERSION 1 : November 2010 54

HACCP Introduction Risk Assessment Model - Frequency HACCP Introduction RISK = Severity x Frequency VERSION 1 : November 2010 55

HACCP Introduction Guideline Actions from the Risk Assessment Probably controlled by a Good Manufacturing Practice (GMP). Check nature of problem against existing pre-requisite programmes 1 – 5 A consumer issue. With some risk to consumer safety. Certainly needs control by a GMP, could be a Specific Control Point (SCP) 6– 9 10 – 16 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 16 + HACCP Introduction 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. VERSION 1 : November 2010 56

HACCP Introduction GMPs, SCPs and CCPs CCP Critical Control Point SCP • 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. • May occur at several points in the process • Do not give complete control of a Hazard Specific Control Point GMP Good Manufacturing Practice HACCP Introduction • Will need a high level of checking. Magnets • Also called “Pre-Requisites” • Provide a sound foundation for HACCP • Control ‘Low Risk’ hazards VERSION 1 : November 2010 METAL Contact 57

HACCP Introduction ‘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 HACCP Introduction VERSION 1 : November 2010 58

HACCP Introduction 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? HACCP Introduction VERSION 1 : November 2010 59

HACCP Introduction 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” CCP’s should be identified with the aid of a Decision Tree and/or Risk Assessment Matrix HACCP Introduction VERSION 1 : November 2010 60

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: Q 1. Are the control measures in place for the hazard? YES NO Modify process or product Is the control at this step necessary for food safety? Q 2. Is the process step specifically designed to eliminate or reduce the hazard to an acceptable level? NO Not a CCP Stop * YES NO NO Q 3. Could contamination with YES the hazard occur at unacceptable level(s) or increase to unacceptable level(s)? Not a NO Stop CCP HACCP Introduction YES * CRITICAL CONTROL POINT Q 4. Will a subsequent process step eliminate or reduce the hazard to an acceptable level? YES Not a CCP * = Proceed to next hazard or step in the described Stop * VERSION 1 : November 2010 process 61

HACCP Introduction 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 VERSION 1 : November 2010 62

HACCP Introduction 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 >7 mm. Pepsi. Co Operational Target: Gatorade “Clear”: Gatorade “Cloudy”: µm Juices without added pulp: 2. 4 mm Juices with added pulp: mm Hazard: Foreign objects > 7 mm* 15 µm 25 -40 6. 4 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) Documentation: • Filter/Screen Inspection Log • Extraneous Material Log • Hold and Release Records • Corrective Action Records • Verification Records *FDA Compliance Policy Guide #555. 425 (FDA, 2001 a). HACCP Introduction 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. VERSION 1 : November 2010 63

HACCP Introduction 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: Ø To ensure the scope of the HACCP is correct and still valid. Ø To ensure the HACCP study has been completed correctly according to the seven Codex principles. Ø To ensure that any changes to the process, product or equipment have been reflected in the HACCP study HACCP Introduction VERSION 1 : November 2010 64

HACCP Introduction 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: Ø To check that monitoring records are complete for each CCP. Ø To check that the person completing the CCP checks and records has been trained. Ø To check that any equipment used for monitoring CCPs has been calibrated. Ø To check that appropriate corrective action has been taken where any of the CCP checks have failed. HACCP Introduction VERSION 1 : November 2010 65

HACCP Introduction Ten point Checklist for HACCP Control Plan q 1. Was a multi-disciplined team used for the HACCP study? q 2. Are Product descriptions and intended use details available for all products? q 3. Is the Process Flow Diagram up to date and signed off as correct? q 4. Are all hazards listed including: Biological, Physical and Chemical (including Allergens)? q 5. Have Hazards been risk assessed? q 6. Have CCPs been identified using a decision tree or expert panel? q 7. Are all CCPs controlled to within the Critical limits and monitored frequently? q 8. Have corrective actions been taken for any CCP failures? q 9. Are verification/validation procedures completed frequently (at last annually)? q 10. Is the HACCP plan up to date (reviewed annually? )? HACCP Introduction VERSION 1 : November 2010 66