What the inspector wrote
The complaint rate for product X increased in each of the four quarters preceding the inspection and a confirmed root cause (closure supplier change) was identified by the complaints unit in month five. Neither the trend nor the root cause appeared in any management review record. The site head, when asked, was not aware of the trend. No decision on the supplier had been taken at the time of inspection.
Why it was cited
EU GMP 1.5 places ultimate responsibility for the quality system with senior management and expects their active participation. When a known, confirmed quality problem does not reach the people accountable, the inspector concludes that the escalation route to senior management does not work, whatever the procedure says.
The finding is against the quality system rather than the complaint procedure because the complaints unit did its job. The system failed at the point where information should have become a decision.
What would have prevented it
- Define trend rules for complaint, deviation and CAPA metrics that automatically place a triggered metric on the next review agenda.
- Hold an interim quarterly review of metrics and escalations so that a rising trend reaches senior management within the quarter, not at the annual review.
- Brief senior management on open significant issues before an inspection; they will be asked directly.