Validating, verifying, and reassessing your HACCP plan

Hazard Analysis and Critical Control Points (HACCP) requires procedures, other than monitoring activities, be established to determine if your HACCP plan is adequate to control food safety hazards reasonably likely to occur, and that the overall HACCP system is operating as intended. These procedures also provide the opportunity for identifying and introducing improvements to the system. After your HACCP plan has been written, your company needs to confirm the HACCP system’s effectiveness by performing validation, verification, and reassessment activities.

Validation
You must first validate the plan before final implementation to determine that all hazards have been identified and that if the HACCP plan is properly implemented these hazards will be effectively controlled. During this initial HACCP plan validation phase, your company must test the adequacy of the CCPs, scientific and technical soundness of established critical limits, monitoring and recordkeeping procedures, and corrective actions set forth in the written HACCP plan. A review of the critical limits is necessary to ensure they will effectively control the identified hazards at each CCP. This process can be complex and may require intensive involvement of highly skilled professionals from a variety of disciplines.

Verification
The verification phase ensures, both initially and on an ongoing basis, that the entire HACCP system is operating according to the written plan. An effective system requires little end-product sampling, since appropriate safeguards are built into the production process in the early stages. Therefore, rather than relying on end-product sampling, your company must rely on methods, procedures, and/or tests — in addition to those used for monitoring — to determine whether the HACCP system is in compliance with the written plan. Ongoing verification activities include, but are not limited to:

• Calibrating process monitoring equipment used at CCPs such as thermometers and metal detectors;
• Reviewing customer complaints to determine whether they relate to the performance of the HACCP plan or reveal the existence of unidentified CCPs;
• Observing monitoring activities to ensure the records are complete and to verify that the documented values are within the established critical limits;
• Reviewing corrective actions to ensure that the records are complete and that the appropriate actions were taken in accordance with the written HACCP plan; and
• Reviewing records generated by the HACCP system to verify signatures and dates for completeness.

Reassessment
The reassessment phase consists of documented periodic reassessments—independent of audits or other verification procedures—to evaluate the adequacy of the HACCP plan.  FDA and USDA require that reassessment be performed at least annually and whenever there are significant changes in raw materials, product formulation, processing methods, production volumes, packaging, consumer use, distribution methods, or personnel that could affect the hazard analysis. Modifications of the HACCP plan must be made as necessary.

Documentation
Your company needs to document the steps it takes in completing the validation, verification, and reassessment phases. The record should include the specific results of all activities and procedures and a description of the sampling and testing methods employed. Also, the rationale for making any revisions to the HACCP plan needs to be documented.

Additionally, any other information that confirms the validity of the HACCP plan’s operations should be included. For example, consider inclusion of any certifications that attest that the monitoring equipment is properly calibrated and maintained in working order. The training of individuals who perform CCP monitoring activities should also be documented.  

Performing these steps will help ensure that your HACCP system is operating as intended.

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