3 Document Corrective Actions Properly: Ensure that in the event there is a deviation, you are documenting all corrective actions correctly.
Environmental Monitoring solutions like Matrix Gemini allow investigators to quickly focus on sample point failures and the ‘out-of-specification’ actions that were initiated to investigate and resolve these failures. Typically three months of data is requested around these sample points, though up to two years’ worth of data could be requested. This data can be instantly pulled from the database as a report for further investigation.
FDA investigators will be most interested in what happens in the event of a failure and what learning gets incorporated into your regular regime. What happens when an ‘out-of-specification’ result is obtained is the crux of preventive testing regimes. Actions might include changing sanitation methods, increasing test frequency or locations in areas of concern, segregating traffic patterns, re-training staff and so forth. Some of these actions, such as increasing test frequency, can be automated. All actions must be clearly documented, which can be done by adding appropriate records directly into the Matrix Gemini Environmental Solution. This captures the actions that each quality improvement cycle needs to discover the likely root cause of any problems and how they may be avoided in the future.
All corrective actions should identify the root cause of the deviation, actions are taken to prevent recurrence and, if product safety is not affected, a written conclusion (supported by factual and scientific data) that the deviation “does not create an immediate food safety issue.”
The emphasis should always be on preventive actions to remove potential points of failure before issues get into the final delivered products causing stock loss and costly recalls.
The FDA Inspection Checklist is a valuable aid to all food and drinks sanitation experts. Many of the points it makes just follow best practices. The Matrix Gemini Environmental Solution provides a practical way for food and drinks companies to document their sanitation/safety programs and instantly show written evidence of both testing and corrective actions when the FDA comes knocking.