What is the CAPA Officer skill?

It is a specialized Claude Code capability designed to guide quality professionals through the Corrective and Preventive Action (CAPA) process within a Quality Management System.

Is this skill restricted to medical devices?

While optimized for medical device QMS (like ISO 13485), the systematic investigation and tracking logic is applicable to any industry requiring rigorous quality control.

Can this help with regulatory audit findings?

Yes, it helps structure responses to audit findings by ensuring root causes are validated and that corrective actions directly address those causes with measurable success criteria.

Which RCA methods does the skill support?

The skill provides frameworks for 5-Why analysis, Fishbone (Ishikawa) diagrams, Fault Tree Analysis (FTA), and Human Factors Analysis.

CAPA Officer

Name: CAPA Officer
Author: zhangzhang-111-i

byzhangzhang-111-i

0•

生産性とワークフロー

Manages Corrective and Preventive Action (CAPA) workflows within medical device Quality Management Systems to ensure systematic problem resolution.

The CAPA Officer skill empowers Claude to act as a quality assurance specialist, guiding users through the end-to-end CAPA lifecycle. It provides structured frameworks for conducting rigorous root cause analyses using methodologies like 5-Why and Fishbone diagrams, developing data-driven corrective action plans, and establishing robust effectiveness verification protocols. Ideal for quality managers and engineers, this skill ensures that investigations are thorough, evidence-based, and meet the high standards required for medical device QMS compliance and regulatory audits.

主な機能

01Effectiveness verification protocols with measurable success criteria

02Standardized CAPA investigation workflows from initiation to closure

03Comprehensive action planning for containment, correction, and prevention

04Structured Root Cause Analysis (RCA) using 5-Why and Fishbone methodologies

050 GitHub stars

06QMS performance monitoring through CAPA metrics and aging analysis

ユースケース

01Addressing internal and external audit findings with documented action plans

02Establishing effectiveness verification windows for high-severity quality issues

03Investigating recurring product nonconformances to identify systemic failures

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add zhangzhang-111-i/claude-skills111 capa-officer

For use in Claude.ai and ChatGPT

主な機能

01Effectiveness verification protocols with measurable success criteria

02Standardized CAPA investigation workflows from initiation to closure

03Comprehensive action planning for containment, correction, and prevention

04Structured Root Cause Analysis (RCA) using 5-Why and Fishbone methodologies

050 GitHub stars

06QMS performance monitoring through CAPA metrics and aging analysis

ユースケース

01Addressing internal and external audit findings with documented action plans

02Establishing effectiveness verification windows for high-severity quality issues

03Investigating recurring product nonconformances to identify systemic failures

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add zhangzhang-111-i/claude-skills111 capa-officer

For use in Claude.ai and ChatGPT