What the inspector wrote
Section 9 of the Product Quality Review for Product W, 'Review of adequacy of previous corrective actions', stated 'Not applicable' for both the current and the previous review period. The review two periods earlier had raised three actions: replacement of the coating pan exhaust filter, revision of the in-process limit for coating weight gain, and requalification of the purified water loop. The status of these actions was not recorded in either subsequent review. On enquiry, the water loop requalification had not been performed.
Why it was cited
Item (ix) requires review of the adequacy of previous corrective actions, and 1.11 requires management procedures for the ongoing management and review of PQR actions. 'Not applicable' is only true when the previous review raised nothing, and even then the current review should say so. Here it was used to avoid the question.
Inspectors read consecutive reviews side by side precisely to check this section. An action that vanishes between reviews is assumed to be undone, and here the assumption was correct.
What would have prevented it
- Open every review with a table of all actions from the previous review: reference, description, owner, due date, status, evidence of completion, and an effectiveness statement.
- Route PQR actions into CAPA or change control at the time they are raised so they are tracked by a system that is reviewed more often than once a year.
- Include 'PQR actions from the previous period reconciled' as a mandatory reviewer checklist item before approval.