CAPA Officer
CAPA Officer manages corrective and preventive actions for medical device QMS, guiding users through root cause analysis, action planning, effectiveness verification, and CAPA metrics. It provides structured workflows, templates, and decision trees to ensure systematic CAPA investigations and regulatory compliance.
✨ What it does
- Provides a CAPA investigation workflow with evidence collection checklist and team composition guidance.
- Includes RCA method selection decision tree and templates for 5-Why and fishbone analysis.
- Offers corrective action planning with action types, plan template, and effectiveness indicators.
- Guides effectiveness verification with timelines, methods, and determination logic.
- Defines CAPA KPIs, aging analysis, and management review inputs.
- Includes a Python script for CAPA tracking and reporting.
🎯 When to use it
- When conducting a CAPA investigation for a nonconformance, complaint, or audit finding.
- When performing root cause analysis using 5-Why, fishbone, or other methodologies.
- When developing corrective and preventive action plans and tracking their implementation.
- When verifying the effectiveness of corrective actions and deciding on CAPA closure.
- When monitoring CAPA program performance through metrics and reporting.
🚀 How to use
Trigger the skill by asking for CAPA investigation, root cause analysis, 5-Why, fishbone, corrective action planning, effectiveness verification, or CAPA metrics. Provide details about the issue, such as problem description, evidence, and context. The skill will guide you through the appropriate workflow. Example prompts:
Help me conduct a 5-Why analysis for a recurring nonconformance in the packaging process.
I need to plan corrective actions for a CAPA related to an audit finding. The root cause is inadequate training.
📄 Output: The skill produces structured guidance, templates, and reports such as CAPA action plans, root cause analyses, and CAPA status reports.
📦 Add this skill to Claude Code
# 1. Get the skills repo
git clone --depth 1 https://github.com/alirezarezvani/claude-skills /tmp/claude-skills
# 2. Copy this skill into your project (or ~/.claude/skills for all projects)
mkdir -p .claude/skills
cp -r /tmp/claude-skills/ra-qm-team/skills/capa-officer .claude/skills/capa-officerSkill source: ra-qm-team/skills/capa-officer/SKILL.md
⚠️ Good to know
The skill assumes familiarity with QMS terminology and requires input data (e.g., CAPA records) for the tracker script; it does not replace actual QMS software.
❓ FAQ
What is the recommended wait period before verifying effectiveness for a Major CAPA?
For Major CAPAs, wait at least 60 days before verification, with a verification window of 60-180 days post-implementation.
How do I decide between 5-Why and Fishbone analysis?
Use 5-Why for issues with 1-2 factors (linear causation), and Fishbone for 3-6 factors (complex, systemic).
What does the CAPA tracker script do?
It calculates summary metrics like open/closed counts, cycle time, effectiveness, and generates aging reports and recommendations from a JSON file of CAPAs.
🤖 Overview, features, install steps and FAQ were generated from the project's SKILL.md on Sep 4, 2026. Always check the original source before running commands.