Edited by Jeremy Russell

January 18, 2000


By Robert A. Savage, President, HACCP Consulting Group

The Food Safety and Inspection Service (FSIS) Pathogen Reduction/HACCP regulations, published in July 1996, require that each official establishment reassess its HACCP plans at least annually. Section 417.4 (a)(3) requires:

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

Establishments should take this requirement very seriously and utilize the time to conduct a thorough reassessment of their HACCP plans (written plans) and HACCP system (implementation of the written plans) to ensure compliance with the FSIS, HACCP regulations. This is an opportunity to make any necessary changes, additions or deletions in the HACCP plans based on the previous year's experiences with the plans. Any changes made to the HACCP plans must be supported by data and that data maintained on file.

It is important during reassessment to differentiate between validation, verification and reassessment. Validation of the HACCP plan is the initial review of the HACCP plan to ensure that all elements of the HACCP plan are effective. During validation, the HACCP team asks the question "Is it the right thing to do?" During verification of the HACCP plan, the question asked is "Do we say what we do, and do we do what we say"? During reassessment, the question asked is "Is it STILL the right thing to do?" Reassessment therefore goes beyond verification because a complete reassessment involves a review of the Hazard Analysis, Control Methods, CCP selection, Critical Limits, CCP Monitoring activities, Corrective Actions, Verification and Record Keeping procedures. During reassessment, it is also critically important to ensure that documentation is on file to support ALL decisions made in the hazard analysis, selection of CCPs and critical limits. Reassessment also provides the opportunity to ensure that all information (e.g., HACCP plans, HACCP records, supporting documentation, etc.) are properly filed and maintained. This will help ensure that your plant is adequately prepared for a possible FSIS, in-depth verification review (audit).

Reassessment of the HACCP plan and system should be conducted by the plantís HACCP team or a reassessment team with the appropriate expertise to conduct a complete reassessment. Section 417.7(b) of the FSIS HACCP regulations require that a HACCP trained individual must perform the reassessment. In some cases, an outside consultant can examine the process with "fresh eyes" and may discover deficiencies that internal team members failed to notice or did not consider. Reassessment must be documented and made part of the HACCP file and the HACCP plan(s) signed again and dated following the completion of the reassessment. Optimally, a reassessment report should contain: the identity of the HACCP plan reviewed; the date of review and the members of the review team; the reason for the reassessment; the scope of the review; a list of all changes to the HACCP plan as a result of the reassessment along with ALL supporting documentation; the date when any changes were implemented; and a signature and date indicating that the changes were reviewed and approved by management.

FSIS inspection personnel will be assigned a 0301 procedure and will use the Basic Compliance Checklist to ensure that the HACCP plans have been reassessed.