What the inspector wrote
Site procedure QA-SOP-042 requires the approved Product Quality Review to be issued within six months of the end of the review period. At the time of inspection, the reviews for four of the site's eleven products for the period ending 31 December of the previous year had not been approved, the latest being nine months beyond the procedural deadline. No deviation, extension or risk assessment had been raised for any of the four. The QP responsible for certification of these products was not aware that the reviews were outstanding.
Why it was cited
The regulation does not fix a deadline after period end, but the site's procedure does, and the site is inspected against its own procedure. Paragraph 1.11 makes the QP, together with the MAH, responsible for ensuring the review is performed in a timely manner; a QP who does not know the review is late cannot be discharging that duty.
The absence of any documented extension is what turns a late report into a quality system finding. It shows there is no schedule being tracked, and that the review is treated as an artefact to be produced eventually rather than a control that feeds certification and management review.
What would have prevented it
- Publish an annual PQR schedule with milestone dates per product and review it at the monthly quality meeting; report PQR status to the QP as part of the certification information flow.
- Require a documented extension, approved by the head of QA before the due date, with a reason and a new date, for any review that will be late.
- Stagger review periods across the year so that all reviews do not fall due in the same quarter.