The Hazard Analysis and Critical Control Point System(HACCP) Guidelines for its Application Principles The HACCP system consists, of the following seven principles Principle 1 Conduct a hazard analysis Principle 2 Determine the Critical Control Points(CCPs) Principle 3 Establish critical limit(s) Principle 4 Establish a system to monitor control of the CCP Principle 5 Establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control Principle 6 Establish procedures for verification to confirm that the HACCP system is working effectively Principle 7 Establish documentation concerning all procedures and records appropriate to these principles and their application Guidelines for the Application of the HACCP System Prior to application of HACCP to any sector of the food chain, that sector should be operating according to the Codex General Principles of Food Hygiene, the appropriate Codex Codes of Practice, and appropriate food safety legislation. Management commitment is necessary for implementation of an effective HACCP system. During hazard identification, evaluation, and subsequent operations in designing and applying HACCP systems, consideration must be given to the impact of raw materials, ingredients food manufacturing practices, role of manufacturing processes to control hazards, likely end-use of the product, categories of consumers of concern, and epidemiological evidence relative to food safety
The Hazard Analysis and Critical Control Point System(HACCP) – Guidelines for its Application Principles The HACCP system consists, of the following seven principles: Principle 1 Conduct a hazard analysis. Principle 2 Determine the Critical Control Points (CCPs). Principle 3 Establish critical limit(s). Principle 4 Establish a system to monitor control of the CCP. Principle 5 Establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control. Principle 6 Establish procedures for verification to confirm that the HACCP system is working effectively. Principle 7 Establish documentation concerning all procedures and records appropriate to these principles and their application. Guidelines for the Application of the HACCP System Prior to application of HACCP to any sector of the food chain, that sector should be operating according to the Codex General Principles of Food Hygiene, the appropriate Codex Codes of Practice, and appropriate food safety legislation. Management commitment is necessary for implementation of an effective HACCP system. During hazard identification, evaluation, and subsequent operations in designing and applying HACCP systems, consideration must be given to the impact of raw materials, ingredients, food manufacturing practices, role of manufacturing processes to control hazards, likely end-use of the product, categories of consumers of concern, and epidemiological evidence relative to food safety
The intent of the HACCP system is to focus control at CCPs Redesign of the operation should be considered if a hazard which must be controlled is identified but no ccPs are found. HACCP should be applied to each specific operation separately. CCPs identified in any given example in any Codex Code of Hygienic Practice might not be the only ones identified for a specific application or might be of a different nature The HACCP application should be reviewed and necessary changes made when any modification is made in the product, process, or any step It is important when applying HACCP to be flexible where appropriate, given the context of the application taking into account the nature and the size of the operation Application The application of HACCP principles consists of the following tasks as identified in the Logic Sequence for Application of HACCP(Diagram 1) Assemble haccp team The food operation should assure that the appropriate product specific knowledge and expertise is available for the development of an effective HACCP plan. Optimally, this may be accomplished by assembling a multidisciplinary team. Where such expertise is not available on site, expert advice should be obtained from other sources. The scope of he HACCP plan should be identified. The scope should describe which segment of the food chain is involved and the general classes of hazards to be addressed(e.g. does it cover all classes of hazards or only selected classes) Describe product A full description of the product should be drawn up, including relevant safety information such as: composition, physical/chemical structure(including Aw. pH, etc. ) microcidal/static treatments( e.g. heat-treatment, freezing, brining, smoking, etc. ) packaging, durability and storage conditions and method of distribution Identify intended use The intended use should be based on the expected uses of the product by the end user or consumer. In specific cases, vulnerable groups of the population, e.g. institutional feeding, may have to be considered Construct flow diagram The flow diagram should be constructed by the HACCP team. The flow diagram should consideration should be given to steps preceding and following the specified operation cover all steps in the operation. When applying HACCP to a given operatic
The intent of the HACCP system is to focus control at CCPs. Redesign of the operation should be considered if a hazard which must be controlled is identified but no CCPs are found. HACCP should be applied to each specific operation separately. CCPs identified in any given example in any Codex Code of Hygienic Practice might not be the only ones identified for a specific application or might be of a different nature. The HACCP application should be reviewed and necessary changes made when any modification is made in the product, process, or any step. It is important when applying HACCP to be flexible where appropriate, given the context of the application taking into account the nature and the size of the operation. Application The application of HACCP principles consists of the following tasks as identified in the Logic Sequence for Application of HACCP (Diagram 1). 1. Assemble HACCP team The food operation should assure that the appropriate product specific knowledge and expertise is available for the development of an effective HACCP plan. Optimally, this may be accomplished by assembling a multidisciplinary team. Where such expertise is not available on site, expert advice should be obtained from other sources. The scope of the HACCP plan should be identified. The scope should describe which segment of the food chain is involved and the general classes of hazards to be addressed (e.g. does it cover all classes of hazards or only selected classes). 2. Describe product A full description of the product should be drawn up, including relevant safety information such as: composition, physical/chemical structure (including Aw, pH, etc.), microcidal/static treatments (e.g. heat-treatment, freezing, brining, smoking, etc.), packaging, durability and storage conditions and method of distribution. 3. Identify intended use The intended use should be based on the expected uses of the product by the end user or consumer. In specific cases, vulnerable groups of the population, e.g. institutional feeding, may have to be considered. 4. Construct flow diagram The flow diagram should be constructed by the HACCP team. The flow diagram should cover all steps in the operation. When applying HACCP to a given operation, consideration should be given to steps preceding and following the specified operation
5. On-site confirmation of flow diagram The HACCP team should confirm the processing operation against the flow diagram during all stages and hours of operation and amend the flow diagram where appropriate 6. List all potential hazards associated with each step, conduct a hazard analysis, and consider any measures to control identified hazards(see Principle 1) The HACCP team should list all of the hazards that may be reasonably expected to occur at each step from primary production, processing, manufacture, and distribution until the point of consumption The HACCP team should next conduct a hazard analysis to identify for the HACCP plan which hazards are of such a nature that their elimination or reduction to acceptable levels is essential to the production of a safe food In conducting the hazard analysis, wherever possible the following should be included the likely occurrence of hazards and severity of their adverse health effects the qualitative and/or quantitative evaluation of the presence of hazards survival or multiplication of microorganisms of concern production or persistence in foods of toxins, chemicals or physical agents; and conditions leading to the above The team must then consider what control measures, if any, exist which can be applied for each hazard More than one control measure may be required to control a specific hazard(s)and more han one hazard may be controlled by a specified control measure Determine Critical Control Points(see Principle 2)" There may be more than one CCP at which control is applied to address the same hazard. The determination of a CCP in the HACCP system can be facilitated by the application of a decision tree, e.g. Diagram 2, which indicates a logic reasoning approach. Application of a decision tree should be flexible, given whether the operation is for production, slaughter, processing storage, distribution or other. It should be used for guidance when determining CCPs. This example of a decision tree may not be applicable to all situations. Other approaches may be used. Training in the application of the decision tree is recommended 1 Since the publication of the decision tree by Codex, its use has been implemented many times for training purposes. In many instances, while this tree has been useful to explain the logic and depth of understanding needed to determine CCPs, it is not specific to all food operations, e.g. slaughter, and therefore it should be used in conjunction with professional judgement, and modified in some cases
5. On-site confirmation of flow diagram The HACCP team should confirm the processing operation against the flow diagram during all stages and hours of operation and amend the flow diagram where appropriate. 6. List all potential hazards associated with each step, conduct a hazard analysis, and consider any measures to control identified hazards (see Principle 1) The HACCP team should list all of the hazards that may be reasonably expected to occur at each step from primary production, processing, manufacture, and distribution until the point of consumption. The HACCP team should next conduct a hazard analysis to identify for the HACCP plan which hazards are of such a nature that their elimination or reduction to acceptable levels is essential to the production of a safe food. In conducting the hazard analysis, wherever possible the following should be included: • the likely occurrence of hazards and severity of their adverse health effects; • the qualitative and/or quantitative evaluation of the presence of hazards; • survival or multiplication of microorganisms of concern; • production or persistence in foods of toxins, chemicals or physical agents; and, • conditions leading to the above. The team must then consider what control measures, if any, exist which can be applied for each hazard. More than one control measure may be required to control a specific hazard(s) and more than one hazard may be controlled by a specified control measure. 7. Determine Critical Control Points (see Principle 2)'1 There may be more than one CCP at which control is applied to address the same hazard. The determination of a CCP in the HACCP system can be facilitated by the application of a decision tree, e.g. Diagram 2, which indicates a logic reasoning approach. Application of a decision tree should be flexible, given whether the operation is for production, slaughter, processing, storage, distribution or other. It should be used for guidance when determining CCPs. This example of a decision tree may not be applicable to all situations. Other approaches may be used. Training in the application of the decision tree is recommended. 1 Since the publication of the decision tree by Codex, its use has been implemented many times for training purposes. In many instances, while this tree has been useful to explain the logic and depth of understanding needed to determine CCPs, it is not specific to all food operations, e.g. slaughter, and therefore it should be used in conjunction with professional judgement, and modified in some cases
If a hazard has been identified at a step where control is necessary for safety, and no control measure exists at that step, or any other, then the product or process should be modified at that step, or at any earlier or later stage, to include a control measure 8. Establish Critical Limits for each CCP (see Principle 3) Critical limits must be specified and validated if possible for each critical control point. In some cases more than one critical limit will be elaborated at a particular step. Criteria often used include measurements of temperature, time, moisture level, pH, Aw, available florine, and sensory parameters such as visual appearance and texture 9. Establish a Monitoring System for Each CCP(see Principle 4) Monitoring is the scheduled measurement or observation of a CCP relative to its critical limits. The monitoring procedures must be able to detect loss of control at the CCP Further, monitoring should ideally provide this information in time to make adjustments to ensure control of the process to prevent violating the critical limits. Where possible process adjustments should be made when monitoring results indicate a trend towards loss of control at a CCP. The adjustments should be taken before a deviation occurs Data derived from monitoring must be evaluated by a designated person with knowledge and authority to carry out corrective actions when indicated. If monitoring is not continuous, then the amount or frequency of monitoring must be sufficient to guarantee the CCP is in control. Most monitoring procedures for CCPs will need to be done rapidly because they relate to on-line processes and there will not be time for lengthy analytical testing. Physical and chemical measurements are often preferred to microbiological testing because they may be done rapidly and can often indicate the microbiological control of the product. All records and documents associated with monitoring CCPs must be signed by the person(s) doing the monitoring and by a responsible reviewing official(s) of the company 10 Establish Corrective Actions(see Principle 5) Specific corrective actions must be developed for each CCP in the HACCP system in order to deal with deviations when they occur The actions must ensure that the CCP has been brought under control. Actions taken must also include proper disposition of the affected product. Deviation and product disposition procedures must be documented in the HACCP record keeping 11. Establish Verification Procedures(see Principle 6) Establish procedures for verification Verification and auditing methods, procedures and tests, including random sampling and analysis, can be used to determine if the HACCP system is working correctly. The frequency of verification should be sufficient to confirm that the HACCP system is working effectively. Examples of verification activities include Review of the hacCP system and its records eview of deviations and product dispositions
If a hazard has been identified at a step where control is necessary for safety, and no control measure exists at that step, or any other, then the product or process should be modified at that step, or at any earlier or later stage, to include a control measure. 8. Establish Critical Limits for each CCP (see Principle 3) Critical limits must be specified and validated if possible for each critical control point. In some cases more than one critical limit will be elaborated at a particular step. Criteria often used include measurements of temperature, time, moisture level, pH, AW, available chlorine, and sensory parameters such as visual appearance and texture. 9. Establish a Monitoring System for Each CCP (see Principle 4) Monitoring is the scheduled measurement or observation of a CCP relative to its critical limits. The monitoring procedures must be able to detect loss of control at the CCP. Further, monitoring should ideally provide this information in time to make adjustments to ensure control of the process to prevent violating the critical limits. Where possible, process adjustments should be made when monitoring results indicate a trend towards loss of control at a CCP. The adjustments should be taken before a deviation occurs. Data derived from monitoring must be evaluated by a designated person with knowledge and authority to carry out corrective actions when indicated. If monitoring is not continuous, then the amount or frequency of monitoring must be sufficient to guarantee the CCP is in control. Most monitoring procedures for CCPs will need to be done rapidly because they relate to on-line processes and there will not be time for lengthy analytical testing. Physical and chemical measurements are often preferred to microbiological testing because they may be done rapidly and can often indicate the microbiological control of the product. All records and documents associated with monitoring CCPs must be signed by the person(s) doing the monitoring and by a responsible reviewing official(s) of the company. 10 Establish Corrective Actions (see Principle 5) Specific corrective actions must be developed for each CCP in the HACCP system in order to deal with deviations when they occur. The actions must ensure that the CCP has been brought under control. Actions taken must also include proper disposition of the affected product. Deviation and product disposition procedures must be documented in the HACCP record keeping. 11. Establish Verification Procedures (see Principle 6) Establish procedures for verification. Verification and auditing methods, procedures and tests, including random sampling and analysis, can be used to determine if the HACCP system is working correctly. The frequency of verification should be sufficient to confirm that the HACCP system is working effectively. Examples of verification activities include: Review of the HACCP system and its records Review of deviations and product dispositions
Confirmation that CCPs are kept under control Where possible, validation activities should include actions to confirm the efficacy of all elements of the HACCP plan 12. Establish Documentation and Record Keeping(see Principle 7) Efficient and accurate record keeping is essential to the application of a HACCP system HACCP procedures should be documented. Documentation and record keeping should be appropriate to the nature and size of the operation
Confirmation that CCPs are kept under control Where possible, validation activities should include actions to confirm the efficacy of all elements of the HACCP plan. 12. Establish Documentation and Record Keeping (see Principle 7) Efficient and accurate record keeping is essential to the application of a HACCP system. HACCP procedures should be documented. Documentation and record keeping should be appropriate to the nature and size of the operation
Diagram 1 Logical Sequence for Application of HACCP 1 Assemble the HACCP team Describe the product Identify Intended U 5 On-site Confirmation of Flow Diagram List All Potential Hazards Conduct a Hazard Analysis Determine Control Measures Determine CCCPs See Diagram 2 8 Establish Critical Limit for each 9 Establish a Monitoring System for each CCP 10 Establish Corrective Action Deviation that may occur 11 Establish Verification Procedures 12 Establish Documentation and Red
Diagram 1 Logical Sequence for Application of HACCP 1 Assemble the HACCP team 2 Describe the Product 3 Identify Intended Use 4 Construct Flow Diagram 5 On-site Confirmation of Flow Diagram 6 List All Potential Hazards Conduct a Hazard Analysis Determine Control Measures 7 Determine CCCPs See Diagram 2 8 Establish Critical Limit for each CCP 9 Establish a Monitoring System for each CCP 10 Establish Corrective Action for Deviation that May Occur 11 Establish Verification Procedures 12 Establish Documentation and Record Keeping
Diagram 2 Example of Decision Tree to Identify CCPs (answer questions in sequence Do control measure(s)exist Ye i Modify step, process or produ Is control at this step necessary Yes for safety Not a CCP s the step specifically designed to eliminate or reduce Yes the likely occurrence of a hazard to an acceptable leve Could contamination with identified hazard(s)occur in excess of acceptabl level(s)or could these increase to unacceptable levels Yo Not a CCP Will a subsequent step eliminate identified hazard(s )or reduce likely accurence to an acceptable level? → CRITICAL CONTROL POI Not a ccp Proceed to next identified hazard in the described process Acceptable and unacceptable levels need to be defined within the overall objectives in identifying the CCPs of the HACCP plan
Diagram 2 Example of Decision Tree to Identify CCPs (answer questions in sequence) Q1 Do control measure(s) exist Yes No Modify step, process or product Is control at this step necessary for safety Yes No Not a CCP Stop* Q2 Is the step specifically designed to eliminate or reduce the likely occurrence of a hazard to an acceptable level Yes No Q3 Could contamination with identified hazard(s) occur in excess of acceptable level(s) or could these increase to unacceptable levels2 Yes No Not a CCP Stop* Q4 Will a subsequent step eliminate identified hazard(s) or reduce likely accurence to an acceptable level? Yes No CRITICAL CONTROL POINT Not a CCP Stop* * Proceed to next identified hazard in the described process 2Acceptable and unacceptable levels need to be defined within the overall objectives in identifying the CCPs of the HACCP plan
Diagram 3 Example of HACCP Worksheet Describe product Diagram Process Flow List Step Hazard(s) Control CCPs Critical Monitoring Correcti Limits Procedure(s)I Action(s) Record(s)
Diagram 3 Example of HACCP Worksheet 1. Describe Product 2. Diagram Process Flow 3. List Step Hazard(s) Control Measure(s) CCPs Critical Limits Monitoring Procedure(s) Corrective Action(s) Record(s) 4. Verification