What the inspector wrote
The site's deviation system contained 40 deviations from packaging line 2 in the review period, of which 14 related to label reconciliation. Each had been investigated individually and closed as minor. No trend analysis by failure mode had been performed. The product quality review recorded the count of deviations but did not identify the recurrence.
Why it was cited
A deviation system that closes records individually and never looks across them cannot learn. Fourteen label reconciliation events is a system problem hiding in plain sight, and the PQR's job is to find it.
Trending is an explicit expectation of Chapter 1 and ICH Q10, and the absence of it usually appears in a finding alongside whichever recurring failure the inspector found by doing the trend themselves.
What would have prevented it
- Categorise every deviation by failure mode and area at closure, using a controlled list, so trending is a query rather than a project.
- Review trends monthly at site level and at management review, and record the decisions taken.
- Escalate the classification automatically on recurrence within a defined window.