capa-officer

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---
name: "capa-officer"
description: 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.
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 |
| 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
- [ ] Relevant records and documentation
- [ ] Interview notes from involved personnel
- [ ] Photos or physical evidence (if applicable)
- [ ] Related complaints, NCs, or previous CAPAs
- [ ] Process parameters and specifications

---

## Root Cause Analysis

Select and apply appropriate RCA methodology based on problem characteristics.

### RCA Method Selection Decision Tree

```
Is the issue safety-critical or involves system reliability?
├── Yes → Use FAULT TREE ANALYSIS
└── No → Is human error the suspected primary cause?
    ├── Yes → Use HUMAN FACTORS ANALYSIS
    └── No → How many potential contributing factors?
        ├── 1-2 factors (linear causation) → Use 5 WHY ANALYSIS
        ├── 3-6 factors (complex, systemic) → Use FISHBONE DIAGRAM
        └── Unknown/proactive assessment → Use FMEA
```

### 5 Why Analysis

Use when: Single-cause issues with linear causation, process deviations with clear failure point.

**Template:**

```
PROBLEM: [Clear, specific statement]

W