How does it track CAPA effectiveness?

The skill includes specialized scripts and guides for defining success criteria, collecting data, and performing systematic effectiveness verification before CAPA closure.

Can it help with Root Cause Analysis (RCA)?

Yes, it provides structured protocols for 5 Whys, Fishbone diagrams, Fault Tree Analysis, and Failure Mode and Effects Analysis (FMEA).

What regulatory standards does this skill support?

The Senior CAPA Officer skill is designed to align with ISO 13485, FDA 21 CFR 820.100, and EU MDR Article 10.9 requirements.

Is this suitable for safety-critical industries?

Absolutely. It includes specific investigation guides for safety, quality, and process-related issues, making it ideal for medical devices, aerospace, and pharmaceutical sectors.

Senior CAPA Officer

Name: Senior CAPA Officer
Author: davila7

bydavila7

•

12,827

生産性とワークフロー

Manages Corrective and Preventive Actions (CAPA) within Quality Management Systems using systematic root cause analysis and compliance-driven workflows.

概要

The Senior CAPA Officer skill equips Claude with specialized expertise in Quality Management Systems (QMS) to lead the end-to-end CAPA lifecycle. It provides frameworks for systematic root cause analysis (RCA) using methodologies like 5 Whys and Fishbone diagrams, facilitates corrective and preventive action planning, and ensures adherence to regulatory standards such as ISO 13485 and FDA 21 CFR 820.100. This skill is essential for quality assurance teams needing to automate trend analysis, track CAPA performance metrics, and maintain rigorous documentation for regulatory compliance and continuous process improvement.

主な機能

Automated trend analysis and quality performance metric reporting
Regulatory compliance alignment with ISO 13485 and FDA 21 CFR 820 standards
Standardized templates for investigation reports, action plans, and effectiveness verification
Comprehensive CAPA lifecycle management from initiation to closure
Multi-methodology Root Cause Analysis (RCA) framework including 5 Whys and Fishbone
12,827 GitHub stars

ユースケース

Investigating quality deviations and conducting deep-dive root cause analysis
Developing and tracking corrective action plans for regulatory compliance audits
Automating the generation of monthly CAPA status and trend reports for management reviews

概要

主な機能

Automated trend analysis and quality performance metric reporting
Regulatory compliance alignment with ISO 13485 and FDA 21 CFR 820 standards
Standardized templates for investigation reports, action plans, and effectiveness verification
Comprehensive CAPA lifecycle management from initiation to closure
Multi-methodology Root Cause Analysis (RCA) framework including 5 Whys and Fishbone
12,827 GitHub stars

ユースケース

Investigating quality deviations and conducting deep-dive root cause analysis
Developing and tracking corrective action plans for regulatory compliance audits
Automating the generation of monthly CAPA status and trend reports for management reviews