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CAPA Officer

Runs medical-device CAPA investigations end to end: root cause analysis, action planning, effectiveness verification and program metrics.

Docs & OfficeIntermediate★ 24,151⑂ 3,405AI score 8/10Last updated: Aug 9, 2026

What it does

Guides the full Corrective and Preventive Action (CAPA) lifecycle inside an ISO 13485 quality management system.

  • CAPA necessity matrix (complaints, audit findings, recurring NCs, trends) plus investigation team composition by severity
  • Decision tree for picking the right RCA method: 5 Why, 6M fishbone, Fault Tree Analysis, Human Factors Analysis, FMEA
  • 5 Why template with a fully worked example (overdue pH meter calibration) and a root-cause validation checklist
  • Action plan template separating Containment / Correction / Corrective / Preventive with owners, dates, success criteria and sign-off blocks
  • Severity-based wait periods and verification windows, plus an effectiveness determination decision tree
  • CAPA KPIs (cycle time, overdue rate, first-time effectiveness, recurrence), aging buckets, and management review report contents
  • scripts/capa_tracker.py for generating status reports from a JSON CAPA file
  • Current regulatory framing: ISO 13485 §8.5.2/8.5.3, FDA QMSR transition (effective 2026-02-02), common 483 observations

Who it's for

  • QA and CAPA officers at medical device manufacturers
  • Teams preparing for ISO 13485 certification or an FDA inspection
  • Quality managers converting audit findings into tracked CAPAs
  • Regulated-industry practitioners standardizing root cause analysis practice

Examples

  1. "Run a 5 Why on the pH meter that was 2 months overdue for calibration" → evidence-backed 5 Why chain ending in a validated systemic root cause
  2. "Draft a CAPA action plan for this Major external audit finding" → containment/corrective/preventive actions with owners, due dates and measurable success criteria
  3. "Generate this month's CAPA metrics from capas.json" → cycle time, overdue list, aging analysis and improvement recommendations

· · · Install guide · · ·

Install in the Claude app (no terminal)
  1. Download the ZIP with the button below.
  2. In Claude, open Settings → Capabilities and turn on 'Code execution and file creation'. (one time)
  3. Go to Customize → Skills → + → 'Upload a skill' and upload the ZIP.
↓ Download ZIP
Install in Claude Code

Let Claude do it — paste this into Claude Code

Install the skill I found on Claude Skill Mart.
Copy the .gemini/skills/capa-officer folder from the GitHub repo alirezarezvani/claude-skills into my ~/.claude/skills/capa-officer/.
When it's done, tell me in one line what this skill can do.

Install with a command instead

git clone https://github.com/alirezarezvani/claude-skills.git /tmp/claude-skills && mkdir -p ~/.claude/skills && cp -r /tmp/claude-skills/.gemini/skills/capa-officer ~/.claude/skills/

⚠ This is a third-party skill. Check the source repository before installing.

  1. Open a terminal (Terminal on macOS/Linux, Git Bash on Windows).
  2. Clone the repository: git clone https://github.com/alirezarezvani/claude-skills.git
  3. Create the skills folder if needed: mkdir -p ~/.claude/skills
  4. Copy the skill: cp -r claude-skills/.gemini/skills/capa-officer ~/.claude/skills/
  5. Confirm the references/ and scripts/ subfolders came along: ls ~/.claude/skills/capa-officer
  6. To use the tracker script, verify Python 3 is available: python3 --version
  7. Restart Claude Code and type something like "start a CAPA investigation" or "help me with root cause analysis" to trigger the skill.
View source on GitHub ↗License: MIT