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capa-officer v1

CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use when running CAPA investigations, 5-Why analysis, fishbone diagrams, root cause determination, corrective action tracking, effectiveness verification, or CAPA program optimization.

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SHA-25669be3a09586691182858834c385d139aab4f4546d2b1e64e39b9fb7a859a3e94
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5 files

CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use when running CAPA investigations, 5-Why analysis, fishbone diagrams, root cause determination, corrective action tracking, effectiveness verification, or CAPA program optimization.

Manifest SHA-25624e796c8c57624085be148abdd7749354a3380e2759ea0302ed024dd5e359449
  • SKILL.md16,134 bytes
  • references/effectiveness-verification-guide.md13,611 bytes
  • references/rca-methodologies.md15,808 bytes
  • scripts/capa_tracker.py20,986 bytes
  • scripts/root_cause_analyzer.py17,812 bytes