What is the CAPA Officer skill?

The CAPA Officer skill is a specialized tool for Claude Code designed to guide users through the Corrective and Preventive Action (CAPA) process, ensuring systemic issues are identified and resolved within a Quality Management System.

Which Root Cause Analysis (RCA) methods does it support?

It provides structured templates and logic for 5 Whys, Fishbone (Ishikawa) diagrams, Fault Tree Analysis (FTA), and Human Factors Analysis.

How does it handle effectiveness verification?

The skill provides a framework for defining verification timelines, methods (such as trend analysis or process audits), and measurable success criteria to ensure actions prevented recurrence.

Can this skill help with regulatory audit findings?

Yes, it is designed to address triggers from external and internal audits, customer complaints, and nonconformance reports by generating audit-ready documentation and evidence trails.

CAPA Officer & Quality Management

Name: CAPA Officer & Quality Management
Author: borghei

byborghei

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Productivity & Workflow

Manages Corrective and Preventive Action (CAPA) workflows and root cause analysis for regulated Quality Management Systems.

The CAPA Officer skill empowers Claude to act as a specialized Quality Management Systems (QMS) assistant, specifically designed for the rigorous requirements of medical device manufacturing and ISO compliance. It provides structured frameworks for conducting deep-dive root cause investigations using methodologies like 5 Whys and Fishbone diagrams, developing robust action plans, and establishing measurable effectiveness verification criteria. This skill is essential for RA/QA professionals and engineers who need to ensure investigations are systematic, evidence-based, and regulatory-ready.

Key Features

01Quantitative effectiveness verification protocols and success criteria

0250 GitHub stars

03Quality metrics tracking for cycle time, recurrence, and aging analysis

04Categorized action planning for containment, correction, and prevention

05Guided Root Cause Analysis (RCA) using 5 Whys and Fishbone (6M) frameworks

06Standardized CAPA investigation workflows from initiation to closure

Use Cases

01Defining effectiveness verification windows and criteria for safety-critical CAPAs

02Conducting a 5-Why analysis for a recurring manufacturing nonconformance

03Developing a corrective action plan following a major internal audit finding

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add borghei/claude-skills capa-officer

For use in Claude.ai and ChatGPT

Download Skill