Individual skill
capa-officer
Use for CAPA work in a medical device QMS: root cause analysis (5-Why, fishbone), corrective action plans, effectiveness checks or CAPA metrics. Tracks CAPAs with capa_tracker.py and analyzes causes with root_cause_analyzer.py.
ra-qm-team/skills/capa-officer/SKILL.md
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- Last checked
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- MIT
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SKILL.mdcore · 16,030 bytesSKILL.mdcore · 16,030 bytesSKILL.mdcore · 16,030 bytesreferences/effectiveness-verification-guide.mddoc · 13,611 bytesreferences/rca-methodologies.mddoc · 15,808 bytesscripts/capa_tracker.pyruns · 20,986 bytesscripts/root_cause_analyzer.pyruns · 17,812 bytes
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# CAPA Officer
Corrective and Preventive Action (CAPA) management within Quality Management Systems, focusing on systematic root cause analysis, action implementation, and effectiveness verification.
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## Table of Contents
- [CAPA Investigation Workflow](#capa-investigation-workflow)
- [Root Cause Analysis](#root-cause-analysis)
- [Corrective Action Planning](#corrective-action-planning)
- [Effectiveness Verification](#effectiveness-verification)
- [CAPA Metrics and Reporting](#capa-metrics-and-reporting)
- [Reference Documentation](#reference-documentation)