The seventh HACCP principle is verification -- ensuring that the system works. The verification principle encompasses four distinct processes. The establishment is responsible for the first three and FSIS, the fourth.

The first verification process is initial validation of the HACCP plan. Validation is the responsibility of the establishment; FSIS will not pre-approve the plan. Validation looks to whether the HACCP plan, as written, has the capacity to prevent, eliminate or reduce food safety hazards. In making this determination, the establishment's HACCP-trained individual(s), whether a consultant or company employee, reviews the scientific basis for the plan, as supplemented by specific company-generated data. In the Mega-reg preamble, FSIS indicated that all plans must be supported by at least some company-generated data.

The second verification process is ongoing verification activities. Under this process, the plant assures that the system is being implemented as designed; such activities include calibration of process-monitoring equipment, direct observation of monitoring activities/corrective actions, and records review.

The single most important ongoing verification activity is the records review. Records review provides a company with immediate feedback so as to identify a trend before it becomes a problem. Records review is also essential for regulatory compliance. The regulation requires a HACCP records review prior to shipment. Recently, FSIS officials have indicated that shipping/storing product off-site prior to the review may be permitted, provided the product remains within the company's control and this is addressed in the HACCP plan.

The third verification process is reassessment of the HACCP plan. Under this process, the company's HACCP trained individual reviews the HACCP plan to determine its continued adequacy whenever there is any change -- such as a new product or process -- or annually, whichever occurs first.

The fourth and final verification process is government verification. FSIS will use two different approaches in verifying compliance, referred to in the agency's "HACCP Guide" as Procedures 01 and 02. The frequency of FSIS's activities will depend, in large part, on the establishment's prior history and the risks posed by the operation.

The 01 procedure randomly focuses on one discreet aspect of the plan, such as monitoring of a Critical Control Point (CCP), determining the adequacy of corrective actions, and sampling. The 02 procedure focuses on whether all aspects of the plan were followed in connection with a particular lot of product. If the inspector detects an incident of noncompliance with the 01 procedure, he/she will also conduct an 02 procedure to determine if the plant discovered the noncompliance or shipped the product.

Noncompliance using an 01 procedure will constitute a "system failure" and trigger FSIS enforcement action if there is repeated noncompliance with the "same root cause." Even if the establishment discovered and corrected the noncompliance on its own, the inspector will issue a Noncompliance Record which can be used later to justify a finding of repeated noncompliance.

If the inspector performs an 02 procedure and either determines that an establishment did not perform a record review or failed to detect a deviation prior to shipment, there would be an automatic "system failure" and subsequent enforcement action.