What is the CAPA Officer skill?

It is a specialized capability for Claude Code designed to manage the Corrective and Preventive Action lifecycle within medical device Quality Management Systems.

Can this skill help with regulatory compliance?

Yes, it follows systematic QMS workflows to help ensure that investigations, action plans, and effectiveness verifications meet standard regulatory expectations for medical devices.

How does it measure CAPA effectiveness?

The skill provides frameworks for defining measurable success criteria, establishing verification windows, and monitoring post-implementation data for signs of recurrence.

What are the CAPA metrics supported?

It tracks key performance indicators such as cycle time, overdue rates, first-time effectiveness, and recurrence rates for management review reporting.

Does it support standard RCA methodologies?

Yes, it includes structured templates and decision logic for 5 Why analysis, Fishbone (Ishikawa) diagrams, and Fault Tree 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 and root cause analysis for medical device quality management systems.

The CAPA Officer skill provides a comprehensive framework for managing the complete Corrective and Preventive Action lifecycle within a Quality Management System (QMS). It enables Claude to guide users through systematic root cause analysis (RCA) using methodologies like 5 Whys and Fishbone diagrams, develop robust action plans, and establish rigorous effectiveness verification protocols. Designed for highly regulated environments such as medical device manufacturing, this skill helps ensure that quality issues are not only resolved but prevented from recurring through evidence-based investigation and data-driven metrics.

主な機能

01CAPA necessity determination and severity-based risk assessment.

02Systematic Root Cause Analysis (RCA) using 5 Whys and Fishbone (6M) frameworks.

03Structured effectiveness verification workflows with measurable success criteria.

04Action plan generation including containment, corrective, and preventive measures.

050 GitHub stars

06CAPA program performance tracking through KPIs and aging analysis.

ユースケース

01Conducting effectiveness verification audits to confirm that implemented actions successfully prevented recurrence.

02Investigating a major nonconformance or audit finding to identify underlying systemic causes.

03Designing a compliant CAPA action plan with assigned responsibilities and implementation milestones.

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

01CAPA necessity determination and severity-based risk assessment.

02Systematic Root Cause Analysis (RCA) using 5 Whys and Fishbone (6M) frameworks.

03Structured effectiveness verification workflows with measurable success criteria.

04Action plan generation including containment, corrective, and preventive measures.

050 GitHub stars

06CAPA program performance tracking through KPIs and aging analysis.

ユースケース

01Conducting effectiveness verification audits to confirm that implemented actions successfully prevented recurrence.

02Investigating a major nonconformance or audit finding to identify underlying systemic causes.

03Designing a compliant CAPA action plan with assigned responsibilities and implementation milestones.