3 replies to this topic

[priya2803]

One of the tools to conduct the vulnerability assessment mitigation strategies, monitoring procedure, corrective action and verification is Food Defense Plan Builder. I have tried to use the tool and my question is it mandatory to have records at monitoring procedures and corrective action step in the builder for each identified APS (actionable process step)? The reason is some monitoring procedures are actions by visual observation, by locking, etc so is it mandatory to have documented records for each and every method of doing? Eg if a monitoring procedure for a blending tank secured with lock is to lock the tank after blending is done, does the "activity of locking" need to have record to prove it is locked?

[G M]

The specifics will depend on which regulatory body and standards you operate under, but generally speaking no, individual records for each and every action taken in furtherance of food defense do not need to be written.

 

We only operate with two records that explicitly reference food defense, and each of them cover large areas of the facility and a long lists of items to be observed with a single "did you observe any non-compliances" pass/fail type of record.

[Fishlady]

If you have determined that you have an actionable process step, there must be monitoring of your mitigation strategy, according to the US FDA regulation (I assume you are exporting to the US).  If your mitigation strategy says a blending tank must be secured with a lock, then you should monitor at a sufficient frequency that the tank is locked and take action if it isn't locked.  The monitoring can be part of your daily QC inspections and can be recorded on forms you are already using for other purposes, such as your pre-operational inspection report.

[Julie T]

Records are required to ensure effectiveness of the mitigation strategy. A simple sign off from the Shift Supervisor / QC whoever monitors the process will suffice.