HACCP Principles - Food Safety Management Lecture PDF

HACCP Principles – Food Safety Management Lecturer: Michael King Module Learning Outcomes The Learning Outcomes for this modules are LO 1: State the principles of HACCP as part of GMP in the food industry. LO 2: Identify the relevant elements of a HACCP programme. LO 3: Identify the re...

HACCP Principles – Food Safety Management Lecturer: Michael King Module Learning Outcomes The Learning Outcomes for this modules are LO 1: State the principles of HACCP as part of GMP in the food industry. LO 2: Identify the relevant elements of a HACCP programme. LO 3: Identify the regulatory agencies and requirements for a HACCP programme. LO 4: Evaluate and audit a HACCP system 2 Module Learning Outcomes The Learning Outcomes for this modules are 4: Design protocols and procedures for food hygiene and contamination controls in a food production facility and the levels of control required in low risk, high risk and high care production facilities. 5: Design and recommend a documented HACCP system using appropriate control measures at identified critical control points. 6: Identify and prescribe corrective actions for failures at identified critical control points. 3 Learning Outcomes – Lecture 1 After Today's Lecture 1. Understand the legal framework and international best practice for HACCP based food safety management systems 2.Understand the functions of the HACCP Food Safety Team. 3. Understand the importance of production description and product intended use in the design of a HACCP system 3. Understand the importance of and how to design a pre-requisite programme for a HACCP system. 4.Be able to draw up a process flow diagram for a simple food production process. 4 Learning Outcomes – Lecture 1 5. Understand the principles of hazard analysis and how to carry out this analysis on a simple food process. 6. Understand the process for the identification critical control points in a food process. 7. Understand the importance of critical limits in a food safety HACCP system. 8. Understand the need for a monitoring programme at critical limits. 9. Understand the corrective actions plans in a HACCP system 5 Learning Outcomes – Lecture 1 10. Understand the need for and mechanisms to carry out verification of the HACCP system including internal auditing. 11. Understand the needs for documentation and record keeping in a HACCP system. 12. Understand the need for ongoing review of a food company’s HACCP system 6 Assessment of the Module Continuous Assessment = 40% of overall marks will take place online on 06/3/2025 Final Exam in May 2025 will be worth the remaining 60% Remember that a minimum of 30% must be achieved in both the final exam and in the continuous assessment overall. The pass grade is 40% overall 7 Background to HACCP Chronology of its development: 1958 - Concept discussions at NASA (National Aeronautics and Space Administration) Administration) 1959 - Development of the HACCP concept to assure one hundred percent safety of food to be used in space 8 Background to HACCP 1971- The HACCP system was published and documented in the USA. 1985 - The National Academy of Science (NAS) recommended the use of the system. Worldwide the system became used and the FAO/WHO Codex Alimentarius cited the system in the Codex 9 What does HACCP for Hazard Analysis Critical Control Point 10 What is Hazard Analysis The Food Safety Authority of Ireland define Hazard Analysis as A procedure for looking at a specific food process, identifying all hazards associated with that process and deciding which are significant to food safety and as such should be included in a HACCP plan e.g. the cross-contamination of a cooked chicken breast with Campylobacter bacteria from raw chicken is identified as a hazard due to poor hygiene practice 11 What is Hazard Analysis? The Food Safety Authority of Ireland define Hazard Analysis as A procedure for looking at a specific food process, identifying all hazards associated with that process and deciding which are significant to food safety and as such should be included in a HACCP plan e.g. the cross-contamination of a cooked chicken breast with Campylobacter bacteria from raw chicken is identified as a hazard due to poor hygiene practice 12 What is a Critical Control Point? Food Safety Authority of Ireland define a Critical Control Point as; A step in which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level, e.g. thorough cooking of a raw chicken product such that the core temperature reaches 75°C or equivalent, e.g. 70°C for two minutes. Usually it is the last step in the process where control can be applied 13 Legislative basis for HACCP in the Food Industry Article 4 of EC Directive 852/2004 on the hygiene of foodstuffs 1. Food business operators shall put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles. 2. The HACCP principles referred to in paragraph 1 consist of the following: (a) identifying any hazards that must be prevented, eliminated or reduced to acceptable levels; (Hazard Analysis) (b) identifying the critical control points at the step or steps at which control is essential to prevent or eliminate a hazard or to reduce it to acceptable levels; (Critical Control Point) 14 Article 4 of EC Directive 852/2004 (continued) (c) establishing critical limits at critical control points which separate acceptability from unacceptability for the prevention, elimination or reduction of identified hazards; (d) establishing and implementing effective monitoring procedures at critical control points; (e) establishing corrective actions when monitoring indicates that a critical control point is not under control; 15 Article 4 of EC Directive 852/2004 (continued) (f) establishing procedures, which shall be carried out regularly, to verify that the measures outlined in subparagraphs (a) to (e) are working effectively; (eg Internal Audits) and (g) establishing documents and records commensurate with the nature and size of the food business to demonstrate the effective application of the measures outlined in subparagraphs (a) to (f). When any modification is made in the product, process, or any step, food business operators shall review the procedure and make the necessary changes to it. 16 Article 4 of EC Directive 852/2004 (continued) 3. Paragraph 1 shall apply only to food business operators carrying out any stage of production, processing and distribution of food after primary production and those associated operations listed in Annex I. (Not primary agriculture) 4. Food business operators shall: (a) provide the competent authority with evidence of their compliance with paragraph 1 in the manner that the competent authority requires, taking account of the nature and size of the food business; 17 Article 4 of EC Directive 852/2004 (continued) (b) ensure that any documents describing the procedures developed in accordance with this Article are up-to-date at all times; (c) retain any other documents and records for an appropriate period. A legal food safety record must be – Dated and timed – Record the actual reading taken – Signed by the person taking the reading at that date/time – Ideally, verified by somebody in a senior/management role 18 Article 4 of EC Directive 852/2004 (continued) (b) ensure that any documents describing the procedures developed in accordance with this Article are up- to-date at all times; (Standard Operating Procedures – SOPs) (c) retain any other documents and records for an appropriate period. 19 Article 4 of EC Directive 852/2004 (continued) 5. Detailed arrangements for the implementation of this Article may be laid down in accordance with the procedure referred to in Article 14(2). Such arrangements may facilitate the implementation of this Article by certain food business operators, in particular by providing for the use of procedures set out in guides for the application of HACCP principles, in order to comply with paragraph 1. Such arrangements may also specify the period during which food business operators shall retain documents and records in accordance with paragraph 4(c). 20 Good Manufacturing Basis for HACCP BRC Global Food Safety Standard Issue 9 – Section 2 HACCP – Fundamental Clause STATEMENT OF INTENT The company shall have a fully implemented and effective food safety plan based on Codex Alimentarius HACCP principles. 21 Developing a HACCP Plan – The HACCP team Clause 2.1.1 - Multi-Disciplinary Team – Aligned with Codex Alimentarius Step 1 The HACCP plan must be developed and managed by a multi- disciplinary food safety team that includes those responsible for quality/technical, production operations, and other relevant functions(engineering, hygiene). (Though not specified many companies add a NPD team member also) The team leader must have an in-depth knowledge of HACCP and be able to demonstrate competence and experience. The team members must have specific knowledge of HACCP and relevant knowledge of product, process and associated hazards. 22 Developing a HACCP Plan – The HACCP team The team leader (normally Technical/QA Manager) manages the team, has a good understanding of food safety risks identification, CCP identification along with technical and legal requirements. (S)he organisers the HACCP meetings and reviews and ensures that the HACCP team are kept up to date with a relevant legal or technical changes. 23 Developing a HACCP Plan – The HACCP team The Production representative is the process expert and is normally responsible for the day to day functioning of the HACCP system on the factory floor. Best practice is that this team member verifies the accuracy of the Process Flow Diagram 24 Developing a HACCP Plan – The HACCP team The Engineering representative is the equipment and process expert. They contribute significantly to the identification of food safety risk (physical and chemical) during Hazard Analysis. They also ensure the integrity of the process equipment, preventative maintenance systems and are involved in the introduction of new equipment. 25 Developing a HACCP Plan – The HACCP team The New Product Development (NPD) representative will inform the team 1. of new product development projects, 2. of the introduction of new suppliers 3. of the potential introduction of new allergens. The presence of this individual on the team should make the team more proactive and less reactive to changes. 26 Developing a HACCP Plan – The Scope of the HACCP Plan Clause 2.1.2 - The scope of each HACCP or food safety plan, including the products and processes covered, shall be defined. The scope should describe all the products and processes to be included within the study. In sites with a small range of similar products, it may be possible to incorporate all of the products and processes into a single HACCP 27 Developing a HACCP Plan – The Scope of the HACCP Plan however, where there is a wide range of different products or processes with different hazards, it is likely that the site will need to use more than one plan. The format of these plans is not prescribed by the Standard; various formats are acceptable as long as the scope for each plan is clearly defined and all activities and products are covered within the processes. – Product based – Product Family based – Process Based – Key process with supporting subprocesses 28 Developing a HACCP Plan – 2.2 Pre-requisite Programme Clause 2.2.1 The site shall establish and maintain environmental and operational programmes necessary to create an environment suitable to produce safe and legal food products (prerequisite programmes). As a guide these may include the following, although this is not an exhaustive list: 29 Developing a HACCP Plan – 2.2 Pre-requisite Programme cleaning and disinfection pest management maintenance programmes for equipment and buildings personal hygiene requirements staff training supplier approval and purchasing transportation arrangements processes to prevent cross-contamination allergen management. 30 Developing a HACCP Plan – 2.2 Pre-requisite Programme The prerequisite programmes for the particular areas of the site shall take into account the production risk zoningThe control measures and monitoring procedures for the prerequisite programmes must be clearly documented and shall be included within the development and reviews of the HACCP or food safety plan. Think of a pre-requisite programme as the basis required to produce any food product 31 2.2 Pre-requisite Programme - Interpretation The prerequisites are the basic environmental and production conditions necessary for the manufacture of safe food and the control of generic hazards. Although the prerequisites are usually covered by day-to-day activities such as good manufacturing or hygiene practices, it is vital that they work effectively and to the correct standards 32 2.2 Pre-requisite Programme - Interpretation the prerequisite programme needs to provide a solid base on which the rest of the HACCP or food safety plan can be developed the company is relying on the prerequisite activities to mitigate the identified hazards and deliver safe product (e.g. if a site identifies cleaning as a prerequisite, then it relies on the cleaning activities to adequately remove food residues and dirt that might otherwise result in hazards such as allergen cross-contamination or microbiological contamination). 33 2.2 Pre-requisite Programme - Interpretation Therefore there should be a whole work-stream behind each identified prerequisite to ensure that the relevant activity, procedures and policies are in place, that they are working correctly and that they continue to deliver the level of control required. Although the prerequisite programme is expected to be effective in achieving the level of control required to ensure food safety, it is not a requirement that a documented validation of every prerequisite is undertaken, as prerequisite programmes typically cover a wide range of general environmental controls, often with results that are not quantifiable. 34 2.2 Pre-requisite Programme - Interpretation However, where a prerequisite programme is used to manage a specific hazard (e.g. cleaning regimes used to prevent allergen cross- contamination), there needs to be a documented validation that the prerequisite controls the identified hazard (see clause 2.7.3for further details regarding the validation). Some companies prefer to differentiate these prerequisites that manage specific hazards from other prerequisites by referring to them as operational prerequisites (oPRPs). 35 2.2 Pre-requisite Programme - Interpretation Sites that need to meet the requirements of the US Food Safety Modernization Act (FSMA) should note that they must ensure that preventive controls are subject to validation and verification. Some of these controls may cover activities that have traditionally formed part of the prerequisite programme. Later sections of the Standard provide detail on the requirements for effective management of some specific prerequisites, including cleaning (section 4.11), pest management (section 4.14) and training (section 7.1). 36 2.2 Pre-requisite Programme - Interpretation Good practice is to review the prerequisite programmes and their management. The frequency of this review should be based on risk, but it could be included, for example, in the annual review of the HACCP or food safety plan. 37 2.3 Describe the Product – Aligned with Codex Alimentarius Step 2 Clause 2.3.1 - A full description for each product or group of products shall be developed, which includes all relevant information on food safety. As a guide, this may include the following, although this is not an exhaustive list: composition (e.g. raw materials, ingredients, allergens, recipe) origin of ingredients physical or chemical properties that impact food safety (e.g. pH, aw) treatment and processing (e.g. cooking, cooling) packaging system (e.g. modified atmosphere, vacuum) storage and distribution conditions (e.g. chilled, ambient) maximum safe shelf life under prescribed storage and usage 38 conditions. 2.3 Describe the Product – Aligned with Codex Alimentarius Step 2 A full description of the product is required to ensure that all aspects that could potentially affect food safety are considered. The Standard gives guidance on the factors that may be considered and these are listed in the previous slide. Product groups can be used where the products are similar (e.g. different pack sizes). However, where significantly different products (e.g. coated and non- coated meat products) are manufactured, these are to be treated as separate products or groups. 39 2.3 Describe the Product – Aligned with Codex Alimentarius Step 2 Clause 2.3.2 - All relevant information needed to conduct the hazard analysis shall be collected, maintained, documented and updated. The company will ensure that the HACCP or food safety plan is based on comprehensive information sources, which are referenced and available on request. As a guide, this may include the following, although this is not an exhaustive list: 40 2.3 Describe the Product – Aligned with Codex Alimentarius Step 2 Clause 2.3.2 (contin.) the latest scientific literature historical and known hazards associated with specific food products relevant codes of practice recognised guidelines food safety legislation relevant for the production and sale of products 41 2.3 Describe the Product – Aligned with Codex Alimentarius Step 2 Clause 2.3.2 (contin.) customer requirements a copy of any existing site HACCP plans (e.g. for products already in production at the site) a map of the premises and equipment layout a water distribution diagram for the site indication of any areas (zones) where high-risk, high-care or ambient high-care production facilities are required. 42 2.3 Describe the Product – Aligned with Codex Alimentarius Step 2 Sources of Information Up-to-date background information must be taken into account when preparing the HACCP or food safety plan. Therefore, suitable information must be collated and maintained. 43 2.3 Describe the Product – Aligned with Codex Alimentarius Step 2 Many membership organisations (Campden BRI, Leatherhead etc) provide useful information. Where membership information is referenced, this also needs to be available on site (either electronically or as hard copy). The Standard gives some guidance on the types of information that may be considered in developing the HACCP or food safety plan. These include: the latest scientific literature 44 2.3 Describe the Product – Aligned with Codex Alimentarius Step 2 historical and known hazards associated with specific food products (good practice is to be as specific as possible, giving, for example, the name of the micro- organism(s) that are known hazards to the product, rather than just listing ‘bacteria’) relevant codes of practice recognised guidelines food safety legislation relevant for the production and sale of products in destination countries, states or territories customer requirements. 45 2.4 Identify Intended Use – Aligned with Codex Alimentarius Step 3 Clause 2.4.1 The intended use of the product by the customer, and any known alternative use, shall be described, defining the consumer target groups, including the suitability of the product for vulnerable groups of the population (e.g. infants, elderly, allergy sufferers). 46 2.4 Identify Intended Use – Aligned with Codex Alimentarius Step 3 Identify the use The HACCP food safety team needs to consider and document the intended use of the products by the customer and the ultimate consumer to ensure all the risks have been assessed. For example, the team should consider: the target population (e.g. does this include high-risk groups such as infants, elderly people or allergy sufferers?) handling and preparation (e.g. will the product be consumed without further cooking?) the customer supply chain storage (e.g. frozen, or the requirement for chilled storage after opening the pack). 47 2.4 Identify Intended Use – Aligned with Codex Alimentarius Step 3 Where there is a known alternative use for a product, including the potential for a customer or consumer to misuse or mistreat the product in a way not intended by the manufacturer, this information should be included in the description in the HACCP assessment so that any implications can be considered as part of the subsequent hazard analysis. For example, where a product looks ready to eat (but requires cooking) there is the potential for a consumer to insufficiently cook the product. 48 2.5 Construct a Process Flow Diagram – Aligned with Codex Alimentarius Step 4 A flow diagram shall be prepared to cover each product, product category or process. This shall set out all aspects of the food process operation within the HACCP or food safety plan scope, from raw material receipt through to processing, storage and distribution. As a guide, this should include the following, although this is not an exhaustive list: 49 2.5 Construct a Process Flow Diagram – Aligned with Codex Alimentarius Step 4 plan of premises and equipment layout raw materials, including introduction of utilities and other contact materials (e.g. water, packaging) sequence and interaction of all process steps outsourced processes and subcontracted work potential for process delay rework and recycling low-risk/high-risk/high-care area segregation finished products, intermediate/semi-processed products, by- products and waste. 50 2.5 Construct a Process Flow Diagram – Aligned with Codex Alimentarius Step 4 - Interpretation raw materials – it should be clear where raw materials are stored and the routes they take into the production area; this includes the introduction of utilities and other contact materials (e.g. water or packaging) sequence and interaction of all process steps (e.g. method of transportation between each step) outsourced processes and subcontracted work potential for process delay (i.e. how products or ingredients will be handled if a delay occurs) rework and recycling low-risk/high-risk/high-care segregation (i.e. clearly indicating where the different production zones are located) 51 2.5 Construct a Process Flow Diagram – Aligned with Codex Alimentarius Step 4 - Interpretation finished products, intermediate/semi-processed products, by-products and waste (e.g. where waste products leave the production process and the storage of intermediates and finished products). Clause 3.2.1 of the Standard requires the site to have an effective document control system. Signing and dating the approved process flow diagram is one method of demonstrating that this is occurring. (Usually signed off annually by the production rep on the HACCP team) 52 2.6 Verify the Process Flow Diagram – Aligned with Codex Alimentarius Step 5 Clause 2.6.1 The HACCP food safety team shall verify the accuracy of the flow diagrams by on-site audit and challenge at least annually at least annually, and whenever there are changes to the process, to ensure any changes have been considered as a part of the HACCP or food safety plan. 53 2.6 Verify the Process Flow Diagram – Aligned with Codex Alimentarius Step 5 –Interpretation Verifying the flow diagram The flow diagram shall be verified as accurate. A member of the HACCP food safety team who is based at the site, part of the team or the whole team must check that the flow diagram is accurate ‘by on-site audit and challenge’. This may be achieved using a physical walk-through of the process within the production area. A report of the activity and any findings will help to demonstrate that this has been completed. During the BRC Global Standards audit, the auditor will undertake part or all of this process to confirm the accuracy of the documented process flow diagram. 54 2.6 Verify the Process Flow Diagram – Aligned with Codex Alimentarius Step 5 –Interpretation It is vital that the process flow diagram remains up to date; therefore verification should occur whenever there is a review of the HACCP or food safety plan (e.g. whenever there is a change to the plan or operational activity) and at least once per year. It is important that any daily or seasonal variations are considered during the verification process (e.g. the production of a Christmas range that uses ingredients or processes not used during the rest of the year). 55 2.6 Verify the Process Flow Diagram – Aligned with Codex Alimentarius Step 5 – Quick Tips Ensure all relevant information is incorporated in the diagram. Ensure all ingredients are incorporated, including water, additives and packaging. Consider all shifts worked, including night or weekend production. Consider seasonal or occasional production activities. 56 2.6 Verify the Process Flow Diagram – Aligned with Codex Alimentarius Step 5 – Verification Records The importance of keeping good records Your site should maintain full records of the diagrams and all verification activities. A verification record could include a fully annotated diagram showing, for example: the date and time of the verification the product(s) being manufactured at the time the activity was observed any amendments or alterations that were noted. Alternatively, a separate report could be produced in the format of an internal audit. The records should also be signed to confirm who completed the verification. 57 2.7 – Hazard Analysis – Aligned to Codex Alimentarius Step 6, Principle 1 2.7 LIST ALL POTENTIAL HAZARDS ASSOCIATED WITH EACH PROCESS STEP, CONDUCT A HAZARD ANALYSIS AND CONSIDER ANY MEASURES TO CONTROL IDENTIFIED HAZARDS (EQUIVALENT TO CODEX ALIMENTARIUS STEP 6, PRINCIPLE 1) 58 2.7 – Hazard Analysis – Aligned to Codex Alimentarius Step 6, Principle 1 Clause 2.7.1 The HACCP food safety team shall conduct a hazard analysis to identify the significant hazards (i.e. those hazards that are reasonably likely to occur at an unacceptable level), which need to be prevented, eliminated or reduced to acceptable levels. This shall include hazards present in raw materials, those introduced during the process or surviving the process steps, and consideration of 59 2.7 – Hazard Analysis – Aligned to Codex Alimentarius Step 6, Principle 1 microbiological physical contamination chemical and radiological contamination fraud (e.g. substitution or deliberate/intentional adulteration) malicious contamination of products allergen risks (see section 5.3). It shall also take account of the preceding and following steps in the process chain. 60 2.7 – Hazard Analysis – Aligned to Codex Alimentarius Step 6, Principle 1 List of potential hazards It is expected that the list will include specific hazards. The Standard provides examples of those that should be considered, including: specific micro-organisms (e.g. E. coli or Salmonella) specific chemicals (e.g. veterinary residues, pesticides or radiological contaminants) cleaning chemicals machinery lubricants specific foreign bodies (e.g. glass, metal or plastic) specific allergens (e.g. peanuts or egg) the potential for fraud and/or adulteration malicious tampering with the product or processes. 61 2.7 – Hazard Analysis – Aligned to Codex Alimentarius Step 6, Principle 1 Clause 2.7.2 The HACCP food safety team shall conduct a hazard analysis to identify the significant hazards (i.e. those hazards that are reasonably likely to occur at an unacceptable level), which need to be prevented,eliminated or reduced to acceptable levels. Consideration shall be given to the following: likely occurrence of hazard severity of the effects on consumer safety vulnerability of those exposed survival and multiplication of micro-organisms of specific 62 2.7 – Hazard Analysis – Aligned to Codex Alimentarius Step 6, Principle 1 Clause 2.7.2 contamination of raw materials, intermediate/semi- processed product, or finished product. Where elimination of the hazard is not practical, justification for acceptable levels of the hazard in the finished product shall be determined and documented. 63 2.7 – Hazard Analysis – Aligned to Codex Alimentarius Step 6, Principle 1 -Interpretation Where this information is not available at the site, it may be necessary for the site to obtain it from suppliers or reputable external sources to establish the likelihood or severity of the specific hazards. Where elimination of a hazard is not possible, acceptable levels need to be defined. Reference should be made to legal requirements or scientific evidence to justify the acceptable levels (e.g. microbiological standards or presence of mycotoxins). 64 2.7 – Hazard Analysis – Aligned to Codex Alimentarius Step 6, Principle 1 Clause 2.7.3 The HACCP food safety team shall consider the control measures necessary to prevent or eliminate a food safety hazard or reduce it to an acceptable level. 65 2.7 – Hazard Analysis – Aligned to Codex Alimentarius Step 6, Principle 1 Clause 2.7.4 Where the control is achieved through existing prerequisite programmes, this shall be stated and the adequacy of the programme to control the specific hazard validated. Consideration may be given to using more than one control measure. 66 2.7 – Hazard Analysis – Aligned to Codex Alimentarius Step 6, Principle 1 -Interpretation Control measures Control measures required to reduce or eliminate the specific hazards (i.e. each hazard identified in clause 2.7.1) must be established. Any hazard that cannot be eliminated must have control measures designed to reduce it to an acceptable level of presence. This acceptable level (e.g. setting a target of