JPO, on 24 January 2012 - 02:48 PM, said:
We were recently FDA audited and the inspector did exactly as was noted in the above post. They watched several work stations, for about 1 hour at a crack. They also made the point to come in and observe sanitation after we had completed operations for the day.
Additionally, we DID do paperwork review, primarily training records as well as performing a mock recall-traceability exercise.
The inspector walked by a pallet of raw materials and essentially said "tell me when this came in, how much there was initially, how much you show now (and it had better match the physical stock on the floor), and where it went."
We counted the pallet of stuff, went to my office and checked out inventory on the computer and noted arrival date, shipper information, etc. then we found where the product was used, reconciled the amounts to come up with all the product, and off we went.
It's a bunch like a GFSI compliant inspection, with significantly more emphasis spent observing employees and employee practices.
Pray nobody decides today is the day to itch their nose, then not wash hands and change gloves.
I think just following the proper sanitation and procedure it will be fine. Although, I do hope that nobody will do something... :)
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