Reasonable Probability in Your Records

In the food safety world, we have several catch phrases. I wanted to take this opportunity to explore what a couple of them mean when they are paired together.

One such phrase that has been around for a very long time is:“If it isn’t documented, it didn’t happen.” A newer phrase that has been highlighted by FSMA (Food Safety Modernization Act) is: “Reasonable Probability.” Under Section 102 of FSMA, if there is reasonable probability that a food may cause harm, the FDA (Food and Drug Administration) can suspend the facility registration (close the plant). The FDA first exercised this right with Sunland, Inc., when the company failed to provide evidence of proper sanitation of the lines after the product tested positive for Salmonella.

Let’s consider some gaps in documentation that may lead to a reasonable probability conclusion by the FDA. Perhaps after an allergen clean-up, the line is subjected to a pre-op inspection. The pre-op inspection is effective in identifying an area of the line that still has residue, and this is documented. However, if the re-cleaning of that area is done, but not documented, there is now reasonable probability that the subsequent product may cause harm. It is common that the activity of cleaning, inspecting, and restarting the line involves multiple departments including sanitation, quality, production, and sometimes maintenance. It can be difficult to coordinate all the activities that need to happen, and in the flurry, documentation is missed.

Let’s also consider HACCP documentation. If there is a failure of a CCP to meet the defined critical limits, the product is considered suspect. In other words, there is reasonable probability that the food may cause harm. HACCP requires action and documentation demonstrating that all suspect products have been captured and they have either been destroyed or reprocessed through a functioning CCP. With this event, there are multiple places in the documentation where gaps may give way to reasonable probability that the suspect products were released. One should question if hold records would clearly identify what product was held and that this held product corresponds to the time during which the CCP could not be considered in control. A statement that “all products held since last good check” does not provide this assurance. Specific product codes must align with the processing records during the suspect period. There may also be gaps in the documentation that provides evidence of the disposition of the product. Are product destruction records detailed enough to match the suspect product codes with the product that was destroyed? If the product is re-run, is there documentation of where, when, and by whom each and every suspect unit (bag, case, drum) was reprocessed?

If it isn’t documented, it isn’t done. If it isn’t done there is reasonable probability that the product will cause harm. If there is reasonable probability that the product will cause harm, the FDA has met the threshold to exercise its authority to initiate a recall or suspend the facility’s registration.

With so much at stake based on the records, what is a company to do? The answer is the same approach we take with most food safety practices: Education and Verification. Employees who are responsible for completing records must not only be trained on how to complete the records, but educated about the implications of falsified or incomplete records. Companies should also be implementing verification of records. This includes a review of records to ensure they are complete, legible, and genuine.

Perhaps the new catch phrase will be: If it isn’t documented, we’re out of business.

The author is Vice President of Food Safety Education, AIB International.