Food Safety Enhancement Program Manual

Chapter 2. - Developing a HACCP System

Section 5 - Validation and reassessment of the HACCP system

1) Validation

Every establishment shall validate the adequacy of the HACCP system in controlling the food safety hazards identified during the hazard analysis and shall verify that the system is being implemented effectively.

Upon completion of the hazard analysis and development of the HACCP plan, the establishment shall conduct activities designed to determine whether the HACCP plan is functioning as intended. During this HACCP plan validation period, the establishment shall repeatedly test the adequacy of the CCP's critical limits, the monitoring and record keeping procedures, and the corrective actions set forth in the HACCP plan. Validation also encompasses reviews of the records themselves, routinely generated by the HACCP system, in the context of other validation activities.

Validation of the prerequisites is accomplished through initial self-evaluation and ongoing reassessment of the HACCP system.

Validation of food hygiene control measures is different from both verification and monitoring. Validation focuses on the collection and evaluation of scientific, technical and observational information to determine whether the control measures are capable, if implemented, of controlling the hazard to the appropriate level and whether this level of control can be achieved consistently. This is in contrast to monitoring and verification, which both take place only after the validated control measures have been implemented.

Need for re-validation

There are many changes that could lead to a need to re-validate a control measure, a combination of control measures or the entire food safety control system.

For example, the introduction into the food control system of a new product line, process step, control measure, technology or piece of equipment that impacts the control of the hazard means that part or all of the system may need to be re-validated. Similarly, changes made in product formulation or the application of current control measures (e.g. temperature changes) may result in the need for re-validation of control measures. While minor changes are less likely to require re-validation of the control measures, multiple minor changes will almost certainly mean that re-validation is needed.

The hazard(s) associated with a food or ingredient change as a result of (i) higher concentrations of a pathogen or pathogens than originally encountered and accounted for in the design, (ii) a change in the response of a hazard to control (e.g. adaptation), (iii) the emergence of a previously unidentified hazard, or (iv) new information indicating that the hazard is not being controlled to the level specified (e.g. new epidemiological findings or new analytical technologies). Any of these changes may result in the need for re-validation.

If monitoring or verification identifies failures that are above a pre-established rate and for which a process deviation cause cannot be identified, re-validation may be needed. Non-compliance with monitoring or verification criteria may indicate a change in the parameters (i.e. the selection and specification of the control measures) on which the design of the food safety control system is based.

2) Reassessment of the HACCP system

Every establishment shall reassess the adequacy of the HACCP system at least annually and whenever any changes occur that could affect the hazard analysis or alter the HACCP system.

Your establishment must have in place written procedures that indicate how the company annually reviews and updates its entire HACCP system. These written reassessment procedures may specify that the company will conduct its required activities at various times over the course of a year.

Your reassessment plan must specify regular procedures for maintaining your HACCP system. In each case, specify the procedures (what) and how they will be applied (how), the frequency (when), the documents to be maintained (records) and the individual responsible (who) for these review procedures. As well, outline the procedures that the company will follow when a deviation is found during the review. Include actions to prevent reoccurrence of these deviations.

Reassessment procedures must include the following:

1. Procedures to ensure that all changes to the HACCP system are documented in a log book. The log book must describe the changes, state the location where they occurred in the HACCP system, and specify the date on which the changes were implemented. The log book must also identify the individual responsible for ensuring that the changes have been implemented and, if necessary, validated.
2. Procedures to review all sub-elements in the prerequisite program to ensure that the procedures reflect current processes and equipment at your establishment, as well as regulatory requirements, and that they continue to be effective.
3. Procedures to review the accuracy of the product descriptions, lists of incoming ingredients, process flow diagrams and schematic diagrams in your HACCP system.
4. Procedures to review all hazards identified in the HACCP system, in order to ensure that they are accurate and reflect your establishment's current processes, equipment and operating procedures. When new hazards are identified, your HACCP team must analyze them appropriately in accordance with to your HACCP system. Hazards that are not controlled by CCPs should continue to be controlled by other measures identified in the HACCP system (e.g. prerequisite programs, letters of guarantee, etc.).
5. Procedures to review each CCP (including validation studies such as microbiological sampling, challenge studies and process validation) to ensure that it continues to control the identified hazard(s).
6. Procedures to evaluate critical limits to ensure that they meet current program and regulatory requirements.
7. Procedures to review the monitoring, deviation and verification procedures for each CCP, in order to ensure that they continue to be implemented effectively.

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