Yes, it is recognized that as part of Hazard Analysis Critical Control Point (HACCP) verification, a responsible plant person is “reviewing records generated” as part of the HACCP program. In addition, the plant has someone that conducts pre-shipment review of records prior to product leaving the facility. However, the question remains – do you take time to truly review your records?
As part of a Food Safety Assessment, the Food Safety and Inspection Service (FSIS) will review random records from the previous sixty days. Do you know what they will find? Are there records that have not been completed? Are there records that have not been signed or dated? Do any records include a deviation from a critical limit? Was a corrective action taken in response to the deviation? Can you easily find the corresponding corrective action record? Are actual values documented for each check or have personnel included “dittos” or drawn lines to indicate the same value as the “check above?”
FSIS often relies on documentation mistakes in enforcement actions (and even recalls) that have been discovered from reviewing the establishment records. It is wise for the establishment to have a system for reviewing their own records and discovering (and ultimately minimizing) any mistakes. If mistakes are discovered during a records review, the establishment should take action to correct to the extent they are able to do so at the time the mistake is discovered.
For example, if “dittos” or a line was drawn, the establishment can interview the employee. If the employee indicates that they took the measurement and it was the same as the previous, the establishment can add a notation on the bottom of the record with the date the situation was discovered, the fact the employee was interviewed and attested to the fact the measurement was identical to the previously recorded measurement, initials for this entry, and comments on measures taken to prevent reoccurrence.
The key to correcting record discrepancies is that any new documentation must include the actual date of the correction. If a deviation without corrective actions is discovered, the establishment will be responsible for determining if they have other evidence to demonstrate the safety of the product (e.g., other production records), as well as the current location of the product. If the establishment is unable to demonstrate the safety of the product, it could result in a recall of the product if already distributed in commerce.
Do you take time to review your records? It should not be thought of as a paperwork review, but more as a review of whether you are able to demonstrate your system is being implemented. You often have the opportunity to make corrections on findings and use them to make program improvements before FSIS identifies an issue and takes action based on such finding. Perhaps the question should be, how can you not find the time?
About “Dr. Doom”
Mixed in with the attorneys at OFW Law is the former USDA Food Safety Inspection Service’s (FSIS) Administrator, Dr. Barbara Masters. Dr. Masters is a veterinarian who spent eighteen years with FSIS – the final three years as Acting Administrator and Administrator. During her rise to the Administrator’s position, Dr. Masters served as the Deputy Assistant Administrator for Office of Field Operations. While in these key leadership positions at FSIS, Dr. Masters’ primary focus was on the implementation of science-based policies for the protection of public health. Dr. Masters issued the initial Federal Register Notices for a systematic approach to humane treatment of livestock and poultry.
Dr. Masters was involved in the drafting of the training of inspection personnel on the Hazard Analysis and Critical Control Points (HACCP) and Sanitation Standard Operating Procedures (SSOP) regulations. She was the lead of the FSIS HACCP Hotline. In addition, Dr. Masters provided technical review for establishment’s hazard analysis, HACCP plans and supporting documentation. She started her career at FSIS as a public health veterinarian that had responsibilities for ante-mortem inspection, sanitation inspection and all post-mortem inspection responsibilities. She has a good understanding of what happens at the in-plant location, because she has spent many of long days working there.