Capa Officer
Skill Verifiziert AktivCAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use for CAPA investigations, 5-Why analysis, fishbone diagrams, root cause determination, corrective action tracking, effectiveness verification, or CAPA program optimization.
To streamline and standardize CAPA investigations, root cause analysis, and effectiveness verification for medical device manufacturers, ensuring regulatory compliance and improving product quality.
Funktionen
- Systematic CAPA investigation workflow
- Multiple Root Cause Analysis methodologies (5-Why, Fishbone, Fault Tree)
- Action planning and effectiveness verification guidance
- CAPA metrics calculation and reporting
- Adherence to ISO 13485 and FDA 21 CFR 820.100 standards
Anwendungsfälle
- Conducting thorough CAPA investigations for quality issues.
- Performing detailed root cause analysis using structured techniques.
- Planning and verifying corrective and preventive actions.
- Generating CAPA status reports and analyzing program metrics.
Nicht-Ziele
- Directly interfacing with regulatory bodies or submitting reports externally.
- Automated CAPA initiation based on raw data without user review.
- Managing other aspects of the QMS not directly related to CAPA.
Installation
Zuerst Marketplace hinzufügen
/plugin marketplace add alirezarezvani/claude-skills/plugin install ra-qm-team@claude-code-skillsQualitätspunktzahl
VerifiziertVertrauenssignale
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