How does it improve CAPA effectiveness?

By providing structured investigation checklists, automated performance dashboards, and clear verification protocols to ensure that corrective actions address root causes rather than just symptoms.

Which RCA methodologies does this skill support?

The skill supports several industry-standard methodologies including 5 Why Analysis, Fishbone Diagrams (Ishikawa), Fault Tree Analysis (FTA), and Failure Mode and Effects Analysis (FMEA).

What is the Senior CAPA Officer skill?

It is a specialized Claude Code skill designed to help quality professionals manage Corrective and Preventive Actions (CAPA) and conduct deep-dive root cause investigations within a Quality Management System.

Can this skill help with regulatory compliance?

Yes, it is specifically designed to align with major regulatory requirements such as ISO 13485 Clause 8.5.2/8.5.3, FDA 21 CFR 820.100, and EU MDR Article 10.9.

Senior CAPA Officer Specialist

Name: Senior CAPA Officer Specialist
Author: BbgnsurfTech

byBbgnsurfTech

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생산성 및 워크플로

Manages end-to-end Corrective and Preventive Action (CAPA) processes, root cause analysis, and regulatory compliance within Quality Management Systems.

소개

The Senior CAPA Officer skill equips Claude with expert-level knowledge for managing Quality Management Systems (QMS), focusing on systematic problem-solving and sustainable corrective action implementation. It provides structured frameworks for the entire CAPA lifecycle—from initial investigation and multi-methodology root cause analysis (such as 5 Whys, Fishbone, and FMEA) to effectiveness verification and long-term trend reporting. This skill is indispensable for professionals looking to maintain high quality standards, ensure regulatory compliance with ISO 13485 or FDA guidelines, and foster a culture of continuous improvement through data-driven insights.

주요 기능

End-to-end CAPA lifecycle management from initiation to closure
Regulatory alignment with ISO 13485 and FDA 21 CFR 820.100
Advanced Root Cause Analysis (RCA) using 5 Whys, Fishbone, and FMEA
3 GitHub stars
Structured investigation protocols for quality, safety, and process issues
Automated trend analysis and QMS performance metric tracking

사용 사례

Generating automated trend reports for management reviews and QMS oversight
Investigating product defects or process deviations to prevent recurrence
Preparing for quality audits and ensuring regulatory inspection readiness

소개

주요 기능

End-to-end CAPA lifecycle management from initiation to closure
Regulatory alignment with ISO 13485 and FDA 21 CFR 820.100
Advanced Root Cause Analysis (RCA) using 5 Whys, Fishbone, and FMEA
3 GitHub stars
Structured investigation protocols for quality, safety, and process issues
Automated trend analysis and QMS performance metric tracking

사용 사례

Generating automated trend reports for management reviews and QMS oversight
Investigating product defects or process deviations to prevent recurrence
Preparing for quality audits and ensuring regulatory inspection readiness