What root cause analysis methodologies does the CAPA Officer skill support?

The skill supports a wide range of methodologies including 5 Whys Analysis, Fishbone (Ishikawa) Diagrams, Fault Tree Analysis, Human Factors Analysis, and Failure Mode and Effects Analysis (FMEA).

Does this skill help with regulatory compliance for medical devices?

Yes, it specifically integrates requirements from ISO 13485, FDA 21 CFR 820.100, and EU MDR Article 10.9 to ensure your CAPA process is audit-ready.

How does this skill handle preventive actions?

It uses systematic trend analysis of quality data and risk assessment outcomes to identify potential issues and implement proactive measures before they occur.

Can the CAPA Officer skill track quality metrics?

Yes, it provides frameworks and scripts for tracking key performance indicators such as CAPA Cycle Time, First-Time Effectiveness, and Overdue CAPA Rates.

CAPA Officer

Name: CAPA Officer
Author: alirezarezvani

byalirezarezvani

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1,039

생산성 및 워크플로

Manages the full Corrective and Preventive Action (CAPA) lifecycle within Quality Management Systems using systematic root cause analysis and compliance frameworks.

소개

The Senior CAPA Officer skill equips Claude with expert-level knowledge of Quality Management Systems (QMS), enabling it to lead complex investigations, perform thorough root cause analysis (RCA), and implement sustainable corrective and preventive actions. It is designed for quality professionals and engineers who need to manage the end-to-end CAPA process—from initiation and data collection to effectiveness verification and regulatory compliance (e.g., ISO 13485, FDA 21 CFR 820.100). By integrating sophisticated RCA methodologies like 5 Whys and Fishbone diagrams with automated metrics tracking, this skill ensures that systemic issues are resolved permanently and documented for regulatory audit readiness.

주요 기능

Regulatory alignment with ISO 13485, FDA 21 CFR 820.100, and EU MDR standards.
End-to-end CAPA lifecycle management from initiation to effectiveness verification.
Specialized investigation protocols for quality, safety, and process deviations.
1,039 GitHub stars
Multiple RCA methodologies including 5 Whys, Fishbone, and Human Factors Analysis.
Automated trend analysis and performance metrics like Cycle Time and Recurrence Rate.

사용 사례

Conducting proactive trend analysis on quality data to trigger preventive actions before issues impact production.
Preparing for regulatory inspections by automating CAPA tracking and ensuring documentation compliance.
Investigating a recurring product defect to identify systemic root causes and design effective corrective actions.

소개

주요 기능

Regulatory alignment with ISO 13485, FDA 21 CFR 820.100, and EU MDR standards.
End-to-end CAPA lifecycle management from initiation to effectiveness verification.
Specialized investigation protocols for quality, safety, and process deviations.
1,039 GitHub stars
Multiple RCA methodologies including 5 Whys, Fishbone, and Human Factors Analysis.
Automated trend analysis and performance metrics like Cycle Time and Recurrence Rate.

사용 사례

Conducting proactive trend analysis on quality data to trigger preventive actions before issues impact production.
Preparing for regulatory inspections by automating CAPA tracking and ensuring documentation compliance.
Investigating a recurring product defect to identify systemic root causes and design effective corrective actions.