The validation vex
To clarify its validation expectations, FSIS is issuing additional directives for inspectors and guidance materials for industry. Collectively, these materials will better define existing requirements relating to whether an establishment has appropriately validated its HACCP plan.
Validation under 9 CFR 417.4(a)(1) requires that an establishment rely upon scientific or technical support for its HACCP plan, and direct operational evidence, which demonstrates that the establishment satisfying the critical operational parameters necessary to achieve the goals of the plan. The underlying scientific or technical support can include: (1) published processing guidelines; (2) scientific articles from a peer-reviewed journal; (3) challenge or inoculated pack studies designed to determine the lethality or stabilization of a process; (4) data gathered in-house; and/or (5) regulatory performance standards. In turn, an establishment must also produce operational data which demonstrates it is meeting each of the critical operating parameters on an on-going basis.
From a regulatory standpoint, it has been less than clear how establishments were expected by FSIS to demonstrate that their HACCP plans had been appropriately validated. Although FSIS defines validation as the process of demonstrating that a HACCP system, if operating as designed, can adequately control identified hazards and consistently produce a safe product, even this simple definition is less than clear. When federal regulations, rules and policy statements are indefinitely worded (such as is the case here), confusion often results. This, of course, has proven true with FSIS’ less-than-uniform efforts, at least in the past, to effectively enforce existing validation and verification standards.
In any event, to enhance the effectiveness of HACCP generally, and to avoid inconsistent enforcement (for which the agency should be applauded), FSIS is now working to better instruct and train FSIS field personnel to interpret and enforce the agency’s emerging validation and verification standards in an accurate and consistent manner. So, while the agency struggles to eliminate confusion, and begins to focus more attention on the technical aspects of HACCP, rest assured that you will survive if you can show that your system is — at its most basic level — controlling hazards and producing a safe product.