Chapter 3, Subject 4
QMP Reference Standard and Compliance Guidelines
Section 5

5. The Hazard Analysis Critical Control Point (HACCP) Plan

Reference Standard Requirement:

5.1 Processors must develop, document and implement a HACCP Plan to control any health and safety hazards related to the product or process. The processor must apply the seven principles of HACCP to identify any significant hazards and for those significant hazards identified, develop a HACCP Plan to prevent, eliminate or reduce the hazard to an acceptable level.

The HACCP system consists of the following seven principles:

• 5.1.1 Principle 1 – Conduct a hazard analysis.
• 5.1.2 Principle 2 – Determine the Critical Control Points (CCPs).
• 5.1.3 Principle 3 – Establish critical limit(s).
• 5.1.4 Principle 4 – Establish a system to monitor control of the CCP.
• 5.1.5 Principle 5 – Establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control.
• 5.1.6 Principle 6 – Establish procedures for verification to confirm that the HACCP system is working effectively.
• 5.1.7 Principle 7 – Establish documentation concerning all procedures and records appropriate to these principles and their application.

Intent:

Every processor must analyse their products and processes to determine if any health and safety hazards are present and, where significant hazards are identified, appropriate controls are put in place. The application of the HACCP principles must be consistent with the Recommended International Code of Practice – General Principles of Food Hygiene, CAC/RCP 1-1969, Rev.3 (1997), Amd. (1999).

Compliance Guidelines:

1. Conduct a Hazard Analysis

1. The hazard analysis and the development of the HACCP Plan is conducted by a HACCP team, including at least one member who has knowledge of HACCP from either formal training or experience.
2. The hazard analysis is conducted at each process step for every product type. Process steps where a significant hazard may be introduced or where a hazard may increase to an unacceptable level must be identified.
3. The hazard analysis includes the identification of all potential hazards (biological, chemical, physical), the determination of the significance of the hazard identified, i.e., consideration of its severity and the likelihood of occurrence and, if applicable, justification for a determination of non-significance of a hazard.
4. The processor demonstrates that they have considered all process steps in conducting their hazard analysis. A Hazard Analysis Worksheet, or equivalent, is used to organise and document the hazard analysis.
5. The processor considers all activities and materials in the establishment, including incoming fish, ingredients, packaging materials, establishment personnel, the establishment itself, product descriptions, the process flow diagram documented in the Background Product and Process Information section, as well as consumer complaint information, and epidemiological and technical literature available when conducting the hazard analysis.
6. For some establishments, the hazard analysis will not identify any significant hazards. The HACCP component of the QMP Plan would therefore only include the hazard analysis and other applicable documentation (examples are given in number 7 below Establish a Documentation and Record-Keeping System.) The determination of CCPs and associated controls would not be applicable.

2. Determine Critical Control Points (CCPs)

1. For each significant hazard identified in the first step, there is an appropriate preventive measure in place to prevent or eliminate the hazard or reduce it to an acceptable level.
2. The method and results of the CCP determination are documented and CCPs are indicated on the process flow diagram.

3. Establish Critical Limits

1. Critical limits are established for each CCP identified. A critical limit means the maximum or minimum value to which a hazard must be controlled at a critical control point. For example, a temperature or time which must be achieved to ensure destruction of a pathogenic bacteria, a specific pH to prevent the growth of bacteria, a level of a preservative, a size of detectable shell pieces, or the presence of acceptable product analysis documentation from a SQA supplier of raw materials.
2. The critical limits are validated to demonstrate that they are effective and the validation is documented.

4. Establish Monitoring Procedures

1. At each CCP, the processor has established monitoring procedures to determine that the system is operating within the critical limits identified. It is important to have monitoring procedures which produce immediate measurable results to which action can be initiated since there may be potential food safety implications.
2. The monitoring procedures include what will be monitored, if applicable how the critical limits and preventive measures will be monitored, how frequently monitoring will be performed, and who will perform the monitoring.
3. For each monitoring activity, the processor has established that personnel performing the monitoring have the knowledge and ability to conduct the procedure. Where specialised skills are required in order to adequately monitor a process or perform an activity which is critical to ensure product safety, appropriate training requirements, experience, and/or skills are identified. For example, the following positions are recognised as requiring specialised skills: retort operator, can closing machine operator, can screening machine operator, and container integrity inspector. Personnel in these positions require special knowledge and experience.

5. Establish a Corrective Action System

1. Corrective action procedures are established to be initiated when monitoring indicates that the process is operating outside the defined critical limits. The corrective action procedures are established in advance so the personnel conducting the monitoring will have direction on the steps to take when a deviation is identified.
2. The corrective action procedures address: the correction of the deficiency that gave rise to the problem; the identification and segregation of all affected product; the culling, re-working, and/or disposition of affected product in an appropriate manner.
3. The corrective action procedures address: the prevention or reduction in likelihood of reoccurrence of the problem (e.g., by investigating how the problem developed); if a review of the QMP Plan (e.g., to determine where changes of procedures, control measures, standards, etc., are needed) is needed; the implementation of necessary changes; identification of changes in the QMP amendment log.
4. The corrective action procedures include a record system to document at least the details of the problem, including the date the problem was identified, the corrective action taken, the person(s) responsible for the action, the date the action was taken and the changes needed to eliminate or prevent re-occurrence of the problem.

6. Establish Verification Procedures

1. Verification activities are an additional level of control and monitoring to ensure the HACCP Plan is operating as it was designed. The verification activities are conducted in addition to the CCP monitoring, but on a less frequent basis, in order to review the implementation of the plan through the records or through additional tests or analysis. For each monitoring activity, the processor must establish and document verification procedures to ensure that the CCP is working as designed.
2. The verification procedures include what will be verified, how it will be verified, how frequently verification will be performed, and who will perform the verification.
3. Verification activities are performed by qualified personnel and usually by personnel not associated with monitoring of the CCP.

7. Establish Documentation and Record Keeping

1. Processors keep two types of records associated with HACCP, "documentation" and "records". Documentation refers to those records which are created as a result of the development of the HACCP Plan, and records, which are created as a result of the implementation of the HACCP Plan.
2. Documentation is maintained as a record of HACCP Plan development, recognising the support and input from many individuals and usually over a considerable period of time. During this phase there are numerous decisions taken and authorities referenced. This information is essential to justify, if necessary, to regulatory agencies or customers why certain actions or activities are taken and also to assist in future development and evolution of the plan. Documentation includes the QMP and HACCP Plans as well as component parts such as SOPs. It also includes the hazard analysis, product attribute data, CCP determination, critical limit validation data, personnel training records, and manufacturer specifications for operation and maintenance of specialised equipment.
3. Records are generated by the procedures or activities performed and any corrective actions taken. The processor establishes a record-keeping system that ensures that CCP monitoring records, corrective action records and verification records are complete, accurate, legible, and available for review. These records include all information required in the QMP Plan and are initialled or signed and dated by the person responsible for monitoring and by the person responsible for reviewing to verify the monitoring or corrective actions where this review is identified in the QMP Plan as a verification activity. A copy of each record is included in the HACCP Plan.

Additional guidance on electronic records system can be found in the Appendices of this document.

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