What the inspector wrote
Of 40 deviations reviewed, 11 had been closed on or before the 30-day target with investigation sections marked 'to be completed'. In 6 cases the investigation was completed after closure and appended without re-approval. No extension requests were on file. The site's deviation metric reported 100% on-time closure for the period.
Why it was cited
A closure target is a management tool. When it becomes the thing being managed, records get closed before they are finished and the metric stops meaning anything. Inspectors know this and look for the pattern in exactly this way: sample the on-time closures and read the investigation section.
Appending work after approval, without re-approval, is also a data integrity issue: the approved record is no longer the record.
What would have prevented it
- Build a documented extension step into the procedure with a rationale and a new target date, approved by QA. Late with an extension is controlled; late without one is not.
- Report the metric honestly, including extensions, and review the reasons for extensions at management review.
- Any content added after approval invalidates the approval. The system, paper or electronic, should make re-approval unavoidable.