Are you keeping a log of the documents that are being destroyed?
A company recently received this 483 observation:
…..The responsibilities and procedures applicable to the quality control unit are not fully followed.
Specifically, your QA technicians and other individuals were recorded destroying and altering records pertaining to commercial batch manufacturing immediately prior to this regulatory inspection. The loss of data and documents are evidenced by a review of your firm’s Closed Circuit TV. We identified the following …..
Your firm’s Quality Manager stated that your firm has failed to maintain a log of what documents had been shredded.
For more details on this observation as well as other observations pertaining to Manufacturing Controls see Issue 1017 available today. It features observations pertaining to Packaging and Labeling on our rotating page 3 topic as well as Laboratory Controls and Manufacturing Controls.