capa-officer
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.
Profile →npx skills add alirezarezvani/claude-skills --skill capa-officer --agent claude-code
Same command for any agent — swap --agent for codex, cursor, copilot.
Weekly change comes from our own snapshots, not the repository page — it measures attention, not adoption.
# 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](#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) - [Tools](#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 |
- Table of Contents
- CAPA Investigation Workflow
- CAPA Necessity Determination
- Investigation Team Composition
- Evidence Collection Checklist
- Root Cause Analysis
- RCA Method Selection Decision Tree
- 5 Why Analysis
- Fishbone Diagram Categories (6M)
- Root Cause Validation
- Corrective Action Planning
- Action Types
- Action Plan Components
- Action Effectiveness Indicators
Generate CAPA status report python scripts/capa_tracker.py --capas capas.json Interactive mode for manual entry python scripts/capa_tracker.py --interactive JSON output for integration python scripts/capa_tracker.py --capas capas.json --output json Generate sample data file python scripts/capa_tracker.py --sample > sample_capas.json
What does the capa-officer skill do?
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.
How do I install it?
Run `npx skills add alirezarezvani/claude-skills --skill capa-officer --agent claude-code` — it drops the skill into your project so the agent can pick it up. Swap the --agent value for codex, cursor or copilot if you use one of those.
Where does this skill come from?
From alirezarezvani/claude-skills, a repository with 23,791 stars. We read it straight from the repository tree rather than a submitted listing, so what you see here is what is actually published.
Is a popular skill a good skill?
Not necessarily. Stars measure attention, not adoption — a repository can trend for a week and be abandoned. That is why we show the weekly change from our own snapshots next to the total, instead of a single flattering number.