Deviation and CAPA metrics introduced into management review
Ergopharm has introduced a formal set of quality metrics into its management review, so that deviation, CAPA, complaint and change-control performance is reported to senior management on a fixed cycle rather than on request.
ICH Q10 places responsibility for the quality system with senior management, and that responsibility is discharged through review of data, not through statements of commitment. The metrics chosen matter: counting deviations rewards not recording them, so the set deliberately includes indicators that get worse when the system is working — the proportion of deviations found by the organisation itself, for instance.
“Count deviations and you will get fewer deviations recorded. Choose the metric carefully.”
Reported measures cover deviation ageing and recurrence, CAPA closure against due date and effectiveness-check outcomes, complaint categories and trends, change-control cycle time, training compliance, and environmental monitoring excursions. Each is trended over time rather than presented as a single period's number.
The review produces decisions with owners and dates, recorded in the same system as any other quality action, and the previous review's actions are checked before new ones are added.
Key facts
- Framework
- Management review under ICH Q10
- Measures
- Deviations, CAPA, complaints, change control, training, EM
- Designed against
- Metrics that reward under-reporting
- Output
- Actions with owners and dates; prior actions checked first