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CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics.
Passed 10 of 23 test cases with the skill, and 0 of 23 without it.
10 fixed0 passed either way13 still failing0 broke
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Corrective and Preventive Action (CAPA) management within Quality Management Systems, focusing on systematic root cause analysis, action implementation, and effectiveness verification.
Conduct systematic CAPA investigation from initiation through closure:
| Trigger Type | CAPA Required | Criteria |
|---|---|---|
| Customer complaint (safety) | Yes | Any complaint involving patient/user safety |
| Customer complaint (quality) | Evaluate | Based on severity and frequency |
| Internal audit finding (Major) | Yes | Systematic failure or absence of element |
| Internal audit finding (Minor) | Recommended | Isolated lapse or partial implementation |
| Nonconformance (recurring) | Yes | Same NC type occurring 3+ times |
test cases passed, vs 0 / 23 without
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