R
Small Medical Device instrument manufacturer. Just passed our Audit but the Auditor missed items that I thought we would be written up. We ended up with one minor and a few observations. The minor was for doc control (mixed revisions) of documents in a Device History Record. I looked back on the Internal Audits and found nine incidents of minors written for doc control. Training was also an issue, with people selectively picking and creating training records at the last second.The internal audit corrective actions were not effective for doc control and we missed being bagged for training. Granted I'm not complaining but this was a gift that needs to be fixed. My opinion is we should double our auditing efforts in a few of these lacking areas and add some sort of process type audit for random checking. Any suggestions would be appreciated. Great Thanks