capa-officer

# 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)
- [Tools](#tools)

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## 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 Offi...