Principle

There should be a comprehensive food safety management system (FSMS), so designed, documented, implemented and reviewed, and so furnished with personnel, equipment and resources, as to ensure that critical limits set to achieve the intended food safety standards are not exceeded. The attainment of this food safety objective requires the design, development and implementation of a hazard analysis critical control point (HACCP) system specific to the manufacturing process and the commitment of all staff to its adoption at all stages of manufacture.

Hazard

3.1 A food safety hazard is an agent or material with the potential to cause harm to the consumer. Classic hazard analysis defines three types of food safety hazard: biological (otherwise called microbiological), chemical and physical. This basic classification of food safety hazards needs to be set in the context of emerging hazards and further hazard types being identified in the future which do not fit easily into this classification, which was developed over half a century ago. Food allergens are constituents of a given food, such as inherent proteins, that have the potential to cause an allergic reaction when handled or consumed by an individual who is sensitive to the said agent (see Chapter 8). In some reference and private system standards, allergens are defined as a separate category of food safety hazard whilst in other documents they are included within the category of a biological hazard. Intrinsic food safety hazards arise from the product itself, for example fruit stones, fish bones, bone fragments in meat, or as previously described proteins that can cause an allergenic reaction and so forth. Extrinsic food safety hazards arise from people, the manufacturing environment, waste and/or other products being manufactured such as glass, metal, wood, ceramic etc.

Hygienic Practice and Prerequisite Programmes

3.2 The ‘hygiene package’ of five laws adopted by the European Union (EU) in 2004 aimed to merge, harmonise and simplify the complex hygiene requirements that were hitherto contained within 17 EU Directives. The aim was to create a simple, transparent hygiene policy applicable to all food and all food operators together with effective instruments to manage food safety and food safety management throughout the supply chain. The new hygiene law has applied in member states since 1 January 2006.

Good hygienic practice (GHP) is critical to every aspect of good manufacturing practice (GMP), and throughout this Guide it has been treated as a continuous theme and has deliberately not been made the subject of a separate chapter. The Codex Alimentarius Commission (CAC) recommended international code of practice General Principles of Food Hygiene CAC/RCP 1‐1969 (2003; Rev 4) lays down the foundation for ensuring GHP, and key aspects are addressed in this Guide. The term for prerequisite programmes (PRP) is often used to identify the procedures, policies and protocols that need to be in place within a food organisation before a HACCP plan can be designed and implemented. A number of these requirements are detailed in the previously mentioned CAC/RCP. Examples of PRPs include GHP, GMP, good agricultural practice (GAP), good distribution practice (GDP) etc. These PRPs contain a number of protocols and standards that define best practice for the construction and layout of buildings, premises, workspaces, storage and transport, personal hygiene protocols, premises hygiene and sanitation procedures, maintenance programmes, calibration, training and pest control programmes, procurement procedures and so forth. The ISO/TS 22002‐1:2009 Prerequisite programmes on food safety – Part 1: food manufacturing specifies requirements for establishing, implementing and maintaining PRP to controlling food safety hazards. The standard was designed to assist organisations seeking to establish, implement and maintain PRP in order to meet the elements of BS EN ISO 22000:2005 Food safety management systems: Requirements for any organisation in the food chain. For further details, consult the Campden BRI Guidelines Food safety plans: principles and basic system requirements (2016, Guideline 76, ISBN 978090750388). It is essential that the food business operator or their designate is fully conversant with the requirements of PRP establishment, implementation and verification as they underpin the development of food safety management systems (FSMSs) and good integrity management systems (FIMSs). Whilst the senior management team may delegate the day‐to‐day operations of FSMSs and FIMSs, they ultimately have the responsibility to ensure they are appropriate for the products manufactured and have been suitably, consistently and effectively implemented. The use of HACCP as a risk assessment tool is only the first step to developing an effective FSMS.

HACCP

3.3 With regard to current legislation in the EU, during the design and implementation of manufacturing operations and control procedures, HACCP principles must be applied as defined in the EU Regulation (EC) No. 852/2004 of the European Parliament and of The Council, in which Regulation 1 requires:

• general implementation of procedures based on the HACCP principles, together with the application of good hygiene practice, should reinforce food business operators’ responsibility;
• guides to good practice are a valuable instrument to aid food business operators at all levels of the food chain with compliance with food hygiene rules and with the application of the [seven] HACCP principles.

Regulation 2 (a) to (g) defines those [seven] HACCP principles. An EU Regulation has immediate force on the due date in all Member States. Provisions for enforcement and penalties in the UK are contained in the Food Hygiene (England) Regulations 2005 and similar Regulations for Scotland, Wales and Northern Ireland (as amended).

3.4 It takes more than common sense or business acumen to be able to comply with these legal requirements. In large‐ and medium‐sized food business establishments, it requires suitable numbers of appropriately qualified and experienced personnel. Even in the smallest food business, it is extremely important that the proprietor or some other responsible person has been trained in the principles of food hygiene and food safety, at least to Level 3 standard. There must be senior management commitment to utilising HACCP, which will be implemented through the operation of the FSMS. This means that senior management must commit the resources required to ensure a FSMS is appropriately developed and implemented, and is effective.

Although food safety is the most important factor considered here, the planning and control principles outlined in this chapter are also applicable to preventing or minimising defects during the quality planning process in respect of intrinsic and extrinsic quality attributes too (see Chapter 12).

3.5 The HACCP system and guidelines for its application is published in the Codex Alimentarius Commission Food Hygiene Basic Texts (ISBN 9251040214) and identifies seven principles of HACCP:

1. Conduct a hazard analysis. Prepare a list of steps in the process where significant hazards can occur and describe the preventive measures.
2. Identify the critical control points (CCPs) in the process.
3. Establish critical limits for preventive measures associated with each identified CCP.
4. Establish CCP monitoring requirements. Establish procedures for using the results of monitoring to adjust the process and maintain control.
5. Establish corrective actions to be taken when monitoring indicates that there is a deviation from an established critical limit.
6. Establish effective record‐keeping procedures that document the HACCP system.
7. Establish procedures for verification that the HACCP system is working correctly.

3.6 In order to undertake HACCP a multi‐disciplinary team should be drawn together. The HACCP team needs to contain personnel who have expertise in areas such as production, engineering, quality control, product technology and procurement. The team members need to have relevant practical experience, knowledge of the products and processes within the study and suitable training on how to undertake a HACCP study and the implementation of HACCP principles. At least one member of the team should have formal HACCP training, but all team members need to be trained on how to utilise HACCP principles in assessing how a food product should be manufactured in order to minimise the potential for a food safety incident occurring. The team is also responsible for ongoing review and management of the HACCP system. In the event that external expertise is sourced to assist with either the development or the maintenance of the HACCP system, it is critical that the management team should not delegate responsibility to the external resource. The management of the HACCP system and the development and implementation of the food safety control system remain the responsibility of the manufacturing organisation. The quality of the external expertise should be formally assessed, including the amount of experience in the food industry and the provision of appropriate references from current clients.

3.7 The scope of the HACCP plan(s), that is, the products produced and processes undertaken at the manufacturing site, should be detailed. Relevant information about food products is usually recorded in a product specification. Product specifications should be reviewed to ensure that they contain the relevant information before the start of the HACCP process and if required should be updated. Relevant information includes:

1. product composition in terms of ingredients, including the origin of ingredients, nature of the item in the case of fruit or vegetables, whether or not the ingredients or the product itself are, or contain allergens;
2. the physical and chemical attributes of the food, including those that might limit microbial growth, e.g. salt or sugar content, pH or water activity;
3. packaging type and standards, e.g. gas modified atmosphere, aseptic packaging or vacuum packed;
4. storage and distribution requirements;
5. instructions for use;
6. intended consumer target group, e.g. the general population or a specific group that may be more vulnerable to the food safety hazards being assessed; and
7. shelf life and nutrition information.

The nature of the treatment and processing of the ingredients and final product undertaken (e.g. cooking or other heat treatment, chlorine washing, blanching, cooling, freezing, metal detection etc.) may also be defined in the product specification, or an alternative document. This information is especially critical where process activities are specifically designed to reduce the likelihood of a food hazard occurring or surviving the processing treatment, for example heat treatment and foreign body detection.

3.8 HACCP is essentially a preventive methodology that needs to be exercised not only within the confines of the in‐factory manufacturing process. It should also be applied to the sourcing and intake of the starting materials and packaging materials, and to the post‐process packaging, handling and distribution, and indeed, as far as possible, via appropriate storage, preparation and use instructions on the label, as far as the consumer.

3.9 A process flow diagram needs to be developed to identify each step within the manufacturing process. BS EN ISO 22000:2005 describes a flow diagram as a ‘schematic and systematic presentation of the sequence of, and interaction of steps’ and states that flow diagrams should be prepared for the process(es) and product(s) within the scope of the HACCP or FSMS. Flow diagrams should include, as applicable, the sequence of process steps from intake through each definable stage, to intermediate and finished products, despatch and delivery to the consumer, to stages where reworking, regrading or recycling takes place and where waste is produced, the introduction of packaging and water (whether as an ingredient or a processing aid, e.g. transport), outsourcing of steps or processes, and sequence of events for finished products, semi‐finished materials that go into storage awaiting further processing, by‐products (e.g. for animal feed) and waste. Recycling or feedback loops should be included on the flow diagram to aid the determination of potential food safety hazards. Process steps should be numbered, again to aid analysis and development of associated food safety control programmes and, where this is applicable, to indicate segregation of areas on the diagram, that is, which process steps occur in low‐ or high‐risk areas (see 3.10 and Chapter 44).

Verifying the flow diagram involves physically walking the flow diagram in the manufacturing premises. The ‘walking’ of the process flow diagram is important to identify potential hazards that have not been identified in the initial review stages, to determine the degree of implementation of PRPs and preventive (control) measures in practice, to identify areas of potential cross‐contamination, to determine holding periods for a product, especially as a result of equipment breakdown and if these could be to the detriment of the product, and to determine whether all process steps (both forward and back in the case of rework loops) have been included in the flow diagram. This verification activity will also aid the determination of realistic food safety hazards. Verification of the site layout plan should also be undertaken at the same time, especially people, product and process flow. Records of flow diagram verification should be maintained and the frequency of verification should also be agreed based on risk assessment, for example those processes that may be seasonal, subject to equipment substitution etc. Reverification activities ensure that any changes to the process flow diagram or the site layout plan have been adequately recorded, and reverification activities should be scheduled at designated intervals.

3.10 As well as the development of a schematic flow diagram that outlines the individual process steps in preparing, storing, manufacturing and despatching the product, further factors should also be considered. A site layout plan for the site as a whole, and the manufacturing areas specifically, should be developed. This plan should cover internal and external areas. It should identify people, product and process flow, especially where there is the potential for delay, rework or recycling. It should also include the availability of and access to utilities such as water, ice and air, especially in the instance where there may be both a potable and non‐potable supply of water. This plan should also identify segregation by area, for example allergen control, low‐care/high‐care areas or low‐risk/high‐risk areas, temperature‐controlled and ambient areas, and areas of the process where the product is fully enclosed or alternatively where the product may be vulnerable to contamination, depending on the products being handled and stored and the nature of the manufacturing process being undertaken. This means that the site layout plan will vary in complexity between, for example, a sandwich manufacturer with multiple zones within their manufacturing process and an ambient long shelf life product manufacturing business where the product arrives on the premises fully enclosed in its final retail packaging.

Personnel facilities such as toilets, changing rooms, smoking areas, rest rooms and location of hand‐washing and sanitation points should be included on the site plan (whether internal or external to the main manufacturing building(s). The location of waste systems, drainage systems and cleaning chemical storage should also be identified as well as the flow of waste to external storage. On a complex manufacturing site this may lead to a number of interconnecting site plans being required. The site plan(s) should be used when considering the potential for contamination with extrinsic food safety hazards (see 3.1). Process design should be reviewed to ensure there is the minimum potential for cross‐contamination of this nature. This review should also consider external access and the security requirements in terms of product risk, especially where items are stored in external locations.

As well as routes of movement for materials, personnel, reworked material and waste, the site map should also define internal and external access points for personnel, vehicles, visitors, materials and services (see Chapter 7).

3.11 The hazard analysis should consider all realistic potential hazards that could occur at each stage of the manufacturing process and the potential cause. The CAC Guidelines for the Validation of Food Safety Control Measures (CAC/GL 69, 2008) state that the control of hazards potentially associated with foods usually involves the application of control measures in the food chain, from primary production, through processing, to consumption. The guidelines describe a control measure as any action and activity that can be used to prevent or eliminate a food safety hazard or reduce it to an acceptable level. In this context the terms preventive measure and control measure can be considered to be interchangeable. For a given food safety hazard, there may be one or more control measures that have influence on the likelihood of a hazard occurring and the degree of severity should it occur.

BS EN ISO 22000:2005 states that when selecting control measures, they should be categorised as to whether they are, firstly, elements of the operational PRP(s), that is, procedural or policy based, or, secondly, elements of the HACCP plan, that is, the control measures are product or process based. The standard states that both PRPs and the HACCP plan need to have specific monitoring and verification programmes in place. For each realistic hazard, analysis is required to take account of the severity of the hazard and the likelihood of it occurring and whether elimination or reduction to an acceptable level is critical to ensure food safety. Account should be taken of subsequent stages in the production process and their potential impact on eliminating or reducing the hazard to an acceptable level and hence the impact any deviation is likely to have on the consumer. Realistic food safety hazards are those that are reasonably expected to occur at any step in the process from the raw material, product, people, premises and wider manufacturing facilities.

Existing processes for determining likelihood and severity can be qualitative (Q) based on subjective knowledge of the products and processes, semi‐quantitative (SQ), where numbers are assigned to qualitative parameters, or fully quantitative (QRA) as in the use of microbiological risk assessment (MRA) methods.

1. Traditionally in the Codex Alimentarius guidelines a decision tree tool is used that, through a set sequence of questions, identifies whether a hazard could occur at unacceptable levels or increase to unacceptable levels. However, this approach requires a manufacturing business to be able to quantify what is deemed acceptable. The use of SQ risk assessment matrices is widespread in the food manufacturing industry for determining risk. In SQ risk assessment processes numbers are assigned to qualitative terms for the parameters being used, for example the use of the numbers one, two and three to represent low, medium and high as risk rankings. Commonly in food safety risk assessment the two risk parameters chosen are severity (the degree of harm should a hazard be realized) and likelihood (the probability that the hazard should be realized). Numbers are assigned based on a low, medium or high rating for each and these are multiplied for both criteria to give a risk ranking for that hazard or ‘score’. It should be remembered that this is largely a qualitative approach and requires a high level of knowledge and information to be effective. The types of information that could be of value include:
   1. the last risk assessment and rationale for why the hazards were risk ranked as they were by the HACCP team;
   2. historical data and information about known food safety hazards associated with the specific ingredients used or products manufactured;
   3. recognised guidelines and codes of practice related to the products manufactured and processes undertaken;
   4. relevant legislation in the country of manufacture and the countries to which the products could be exported;
   5. market/customer requirements for risk assessment;
   6. influence of target market for the food product(s), e.g. vulnerable groups such as babies and small children, the elderly, the immune‐compromised and those who have food allergies; and
   7. the latest scientific literature and research.

When undertaking hazard analysis consideration should be given to realistic biological hazards and the potential for contamination and multiplication and for survival of any heat treatment (e.g. the ability to form spores) and the individual organism’s propensity to produce toxins. With chemical and physical hazards again the potential for contamination and the likelihood of being undetected should be considered and where possible eliminated by the controls in the FSMS.

The World Trade Organisation (WTO) Sanitary and Phytosanitary (SPS) Agreement introduced the term ‘appropriate level of sanitary or phytosanitary protection’ (ALOP), that is, the level of protection deemed appropriate by a country or Member State establishing an SPS measure to protect human, animal or plant life or health within its borders. The 20th edition of the Procedural Manual of Codex Alimentarius Commission defined a food safety objective (FSO) as the maximum frequency and/or concentration of a hazard in a food at the time of consumption that provides or contributes to the ALOP. This definition recognised that the acceptable level of a hazard may vary at different points in the production, supply and consumption of a food product.

Great care must be applied to the decision process of assessing the severity of a hazard and the likelihood of it occurring, particularly in relation to ensuring all of the requisite information and all of the relevant expertise is available (see above).

For food safety hazards where control is deemed to be critical at a given point in the supply chain then this process step is termed a CCP for that hazard (HACCP Principle 2). CCPs are those control points in the process where control at that point will eliminate a food safety hazard or control that hazard to an acceptable level. It is important that all those staff working at process steps that are deemed to be CCPs in the manufacturing process are fully aware of this determination and have been sufficiently instructed and trained to be clear on their role in ensuring the food safety hazard in question is adequately controlled and all associated procedures are fully adopted and effectively implemented. Examples of these process points which may be deemed CCPs are sieves, in‐line filters, X‐ray machines, metal detectors etc.

A decision to incorrectly discard control of a hazard at a specific process step could mean that a substantive CCP is not identified or is now no longer adequately controlled as per HACCP Principle 2. The Codex publication Principles and Guidelines for the Conduct of Microbiological Risk Assessment CAC/GL‐30 (1999) provides relevant guidance on this.

3.12 Validation is defined in the CAC Guidelines for the Validation of Food Safety Control Measures¹(CAC/GL 69‐2008) as being the obtaining of evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome. Validation can also be described as the process of ensuring that the process and procedural controls in place within a manufacturing operation are capable of effectively managing potential food safety hazards should they occur and eliminating them or reducing them to a safe level. Therefore, effective validation of control measures is a critical element of the ‘due diligence’ defence (see 1.10). Validation is an activity undertaken at pre‐FSMS design, implementation and as a post‐FSMS implementation activity. Ensuring that the design of the FSMS remains valid over time may require revalidation activities to be undertaken. The process of validation is therefore the assimilation and evaluation of data to demonstrate that the critical limit determined and/or the target level and tolerances defined are appropriate to control the hazard (see HACCP Principle 3). These data can include, but are not limited to, reference to legislation, scientific data, guidelines, codes of practice or technical information, results from validation studies, historical data arising from monitoring and verification activities or data from similar processes, data from mathematical modelling activities and the use of risk assessment models. Risk assessment models, as previously described in 3.11, can be used to determine whether a specific control measure or a combination of control measures, which may be enforced at different stages of manufacture, is capable of consistently controlling a food safety hazard or reducing a food safety hazard to an acceptable level. Revalidation may be required as a result of system or product failure, process or procedural changes, new scientific or regulatory information or evidence of emergent hazards previously unrecognised in the food industry.

The Food Standards Agency (FSA) publication E. coli O157 – Control of cross‐contamination: Guidance for food business operators and enforcement authorities (2014)² stresses the importance of not only validating the HACCP plan, but also focusing on validating the control measures in place to ensure, for example, bacterial loading on fresh produce is reduced on receipt, that physical separation of materials is effective and that disinfectants are purchased and used in compliance with validated dilution levels and contact times. The scope of activities required for full validation of a HACCP plan go well beyond the several examples required here. The validation of a HACCP plan at preproduction stages for a new product is essential and routine revalidation activities should be undertaken within the food manufacturing business at a frequency determined by risk assessment.

3.13 As previously described, CCPs should be determined where control is necessary to eliminate or reduce the risk of an unacceptable level of hazard occurring. In determining CCPs, account should be taken of the intended circumstances of use of the product by the customer or consumer. This should include both normal intended use and realistic deviations from this. Intended use could include temperature‐controlled storage, cooking or reheating of the food product. Measurable critical limits need to be established at each CCP. These are values that separate acceptability from unacceptability in terms of food safety. Target levels and tolerances may also be set that take into consideration the potential fluctuations within the process and/or provide opportunity to take action before the product is deemed unacceptable (unsafe and therefore rejected).

3.14 At each CCP, a monitoring system must be developed, and appropriate corrective action needs to be determined in the instance that control is lost at a CCP and a target level or critical limit is exceeded (see HACCP Principles 4 and 5). In the instance of a manufacturer using both target levels, designed to give an early warning so the product is brought back under control before it becomes unsafe, and critical limits which if breeched the product is deemed unsafe, two levels of corrective action will be required. In some manufacturers these are described as ‘amber’ actions and ‘red’ actions to help to differentiate their severity to staff working at CCPs. Whatever system is adopted by the manufacturer the staff working at the CCP and monitoring activities associated with the CCP must have a clear, unambiguous understanding of the difference between target levels and critical limits.

The activities undertaken in monitoring a CCP should be clearly identified in specific work instructions or similar equivalent document. Personnel working at CCPs should be able to demonstrate their appropriate level of competence. The training undertaken and the formal assessment of competence should be recorded. The corrective actions determined must be capable of bringing both the product and the process back under control, where possible before unsafe food is produced. These actions must ensure that any product or material that may have been produced while the CCP was not in control is suitably identified, controlled and adequately assessed to determine appropriate disposition.

3.15 Records need to be maintained at each CCP to demonstrate that measurements were undertaken on a routine basis to ensure that CCPs are under control (see HACCP Principle 6). In the event of a loss of control at a CCP, the resultant actions taken also need to be recorded. These records form part of the manufacturer’s due diligence defence and should demonstrate that only competent personnel have been engaged in CCP operational and monitoring activities. Where records are in electronic form, suitable evidence should be available as to how the checks have been undertaken and how the records have been verified.

The HACCP plan will contain details of the CCP monitoring programme that has been developed. This may include in‐line continuous measurement by processing equipment, on‐line measurement at designated intervals by staff reading electronic displays and recording information on a separate paper‐based form or hand‐held device, and off‐line measurement at designated intervals where samples of product, packaging and other materials are taken to a workstation or laboratory. It is important to ensure that when undertaking monitoring activities the sample taken is representative of the batch being assessed (see Chapter 35).

Corrective action must be defined in the event of non‐compliance being identified at a CCP or when monitoring a PRP. Monitoring of PRP(s) must be formally defined and staff who undertake such monitoring, for example glass and brittle material audits, hygiene audits, glove audits, knife audits, hand‐washing standards etc., need to be aware of the compliance standards required and the actions to take in the event of non‐compliance. All instances of non‐compliance must be recorded along with the associated required corrective action that has been determined, together with evidence that the corrective action has been completed and then verified to ensure it is effective.

3.16 Verification is the activities undertaken in addition to monitoring to determine if the HACCP system is capable of delivering safe food, whether the manufacturing operation is in compliance with the HACCP plan and/or whether the HACCP plan needs modification and review (see HACCP Principle 7). The HACCP plan should be audited and reviewed at least annually to ensure continuing suitability. CCP records should be verified at intervals defined by the manufacturer to ensure that the HACCP system is implemented and effective. Verification should be undertaken by different personnel to those who undertake the monitoring activities prescribed for PRP(s) and/or the HACCP plan. It is important that verification activities should not just address the HACCP plan, but also PRPs and their continued effectiveness. The key tool for verification is the audit (see Chapter 11). The results of internal audits, complaint data, product withdrawal and recall data, and data on service levels as well as internal records of rework or rejection and microbiological and chemical analysis should also be considered in this process. Any trends should be identified, especially where they indicate a loss of control that has not been suitably managed, and a corrective action programme must be implemented. The frequency of verification should be based on risk assessment.

3.17 The FSMS should be reviewed at least annually. In the event of changes to the product (including formulation and recipes), procedures, processes, site plans and people, product and process flow and processing conditions, responsibilities of personnel, supply or composition of raw materials, packaging and ingredients/recipe, consumer use, packaging, storage or distribution activities, emergence of new knowledge, information or data concerning materials, products, processes or processing conditions, emergence of a new food safety hazard, or determination of a change in risk profile, following a food safety incident, withdrawal or recall, or any other factor deemed necessary, a review should be undertaken. In the event of non‐conformity, as described in 3.15, a review should also be undertaken. Depending on the characteristics of the product, there is the potential for a new, emergent food safety hazard to occur. In this circumstance, a full review should be undertaken, and this may require a reconsideration of all aspects to ensure that the FSMS is still capable of consistently delivering safe products. For further details, consult Campden BRI HACCP: A practical guide (5th edition, 2015, Guideline 42, ISBN 9780907503828) and the Campden BRI HACCP auditing standard (3rd edition, 2015, ISBN 9780907503835).

3.18 In 2016, the European Commission issued a Commission Notice (2016/C 278/01) on the implementation of FSMSs covering prerequisite programs (PRPs) and procedures based on the HACCP principles, including the facilitation/flexibility of the implementation in certain food businesses. The aim of the explanation here is not to give a detailed explanation of its contents, but instead to highlight some of the key themes in terms of how they may affect the implementation of a HACCP system on a manufacturing site. The notice provides clear links between the FSMS, HACCP and PRPs as already outlined in this chapter (see 3.2) and gives further detail on how HACCP can be used to develop a FSMS. More details can be found at http://eur‐lex.europa.eu/legal‐content/EN/TXT/?uri=uriserv:OJ.C_.2016.278.01.0001.01.ENG.

Hazard Analysis and Operability Study

3.19 HACCP is just one of a number of recognised methods of hazard analysis including failure mode and effects analysis (FMEA) and hazard analysis and operability study (HAZOP). FMEA seeks to identify which failures in an electrical, mechanical or manufacturing process or system can lead to undesirable situations and the means of detection, safeguards that can be implemented and the required actions. HAZOP is a systematic structured approach questioning the sequential stages of a proposed operation/manufacturing process in order to optimise the efficiency and the management of risk. Thus, the application of HAZOP is most effective when used to assess the design of a proposed food‐related operation or for existing processes where there are planned modifications to the current design. HAZOP is therefore used to identify both food safety hazards and potential operational issues that could lead to food safety or environmental hazards and also the impact on manufacturing. This approach should result in a system in which as many CCPs as possible have been eliminated, making HACCP during subsequent operations much easier to carry out.

3.20 HAZOP was developed in the 1960s and was a precursor for the development of HACCP as a means of hazard analysis. The HAZOP approach uses guide words and parameters and identifies potential deviations that could lead to problems such as contamination, filter blockage, corners, bends and dead spaces (which might prove difficult to clean effectively), seal or gasket failure, corrosion or stress fractures.