Agent skill · research science · alirezarezvani
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.
Why this skill is useful
Provides specific methodologies and templates for CAPA investigations that the AI wouldn't reliably generate on its own.
What it needs
About 9k tokens when loaded. Last updated 2026-08-05. 23,939 stars on the source repository.
What this skill does
CAPA Officer Corrective and Preventive Action (CAPA) management within Quality Management Systems, focusing on systematic root cause analysis, action implementation, and effectiveness verification. --- Table of Contents CAPA Investigation Workflow Root Cause Analysis Corrective Action Planning Effectiveness Verification CAPA Metrics and Reporting Reference Documentation Tools --- CAPA Investigation Workflow Conduct systematic CAPA investigation from initiation through closure: 1. Document trigger event with objective evidence 2. Assess significance and determine CAPA necessity 3. Form investigation team with relevant expertise 4. Collect data and evidence systematically 5. Select and apply appropriate RCA methodology 6. Identify root cause(s) with supporting evidence 7. Develop corrective and preventive actions 8. Validation: Root cause explains all symptoms; if eliminated, problem would not recur CAPA Necessity Determination 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 Nonconformance (isolated) Evaluate Based on severity and risk External audit finding Yes All Major and Minor findings Trend analysis Evaluate Based on trend significance Investigation Team Composition CAPA Severity Required Team Members --------------- ---------------------- Critical CAPA Officer, Process Owner, QA Manager, Subject Matter Expert, Management Rep Major CAPA Officer, Process Owner, Subject Matter Expert Minor CAPA Officer, Process Owner Evidence Collection Checklist [ ] Problem description with specific details (what, where, when, who, how much) [ ] Timeline of events leading to issue [ ] Rel …
How to use it
Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:
@skills alirezarezvani/capa-officer--983b9b