Retention of Quality Records - NC for "access and disposal of quality records"



In our most recent surveillance audit, we received a minor for "Level I and II documents do not adequately address requirements" One requirement that was not addressed was for "access and disposal of quality records" However, our instructions do state that we properly maintain, make accessible and discard of documents at perscribed intervals. How detailed does one have to get. The auditor stated that it must say how we dispose (shred, rip up, burn) and that we must say who can access these records. Is this really necessary?? I am very reluctant at giving in to this. Any comments or suggestions would be greatly appreciated.

Laura M

I had the exact same NC once - retentions were specified, but not how to dispose. We specified that confidential records needed to be shredded and that others would follow office paper disposal procedures...or something like that. Didn't get into who was supposed to do it tho, beyond "the organization responsible for creating/storing.." which is how it worked.


My quality records table has a field for disposal on the very end which states they are burned (everything). Auditor was happy with this. It was simple to do and worked.
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