CAPA That Closes: Reducing Repeat Deviations With Root-Cause Discipline

Summary

Repeat deviations usually mean the root cause was never found. This paper describes a root-cause standard, effectiveness checks and the governance that keeps CAPA from becoming paperwork.

Key takeaways

1. 01Why "human error" is rarely a root cause
2. 02Effectiveness checks that prove a CAPA worked
3. 03Trending deviations to find systemic issues
4. 04Governance and metrics for the CAPA board

Written for

• QA heads
• Operational excellence
• Site quality heads