capa-officer

---
name: "capa-officer"
description: CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use for CAPA investigations, 5-Why analysis, fishbone diagrams, root cause determination, corrective action tracking, effectiveness verification, or CAPA program optimization.
triggers:
  - CAPA investigation
  - root cause analysis
  - 5 Why analysis
  - fishbone diagram
  - corrective action
  - preventive action
  - effectiveness verification
  - CAPA metrics
  - nonconformance investigation
  - quality issue investigation
  - CAPA tracking
  - audit finding CAPA
---

# 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 |
|--------------|---------------|----------|
| Customer complaint (safety) | Yes | Any complaint involving patient/user safety