What the inspector wrote
Minutes of the management review recorded eleven actions, of which seven had no named owner and nine had no due date. Four actions from the previous year's review were recorded as closed with no evidence of completion. The action 'improve CAPA effectiveness' had been carried forward unchanged for three consecutive reviews. No effectiveness of any completed action was reported.
Why it was cited
ICH Q10 4.3 defines the outputs of review as decisions on improvement and resources. An action that names no person and no date is not a decision; it is a note. When the same action is carried forward for three years the inspector concludes the review has no consequences.
Actions closed without evidence fail the same test as a CAPA closed without evidence. The review is a quality record and its actions are subject to the same discipline.
What would have prevented it
- Write every action with a specific change, a named owner, an agreed date, the resources attached and the metric that will show it worked.
- Track review actions in the CAPA system or a dedicated log with identifiers, extensions with rationale and closure with evidence.
- Report the effectiveness of each closed action at a subsequent review against the metric it was meant to move.