Manages Corrective and Preventive Action (CAPA) workflows for medical device Quality Management Systems (QMS).
The CAPA Officer skill equips Claude with specialized knowledge for handling complex medical device quality investigations. It facilitates systematic root cause analysis (RCA) through methodologies like 5-Why and fishbone diagrams, assists in creating robust corrective and preventive action plans, and defines measurable effectiveness verification criteria. Designed for quality professionals and developers building compliance-heavy workflows, this skill ensures that quality issues are addressed at their source rather than just treating symptoms, maintaining alignment with regulatory standards and industry best practices.
主な機能
01CAPA necessity determination based on risk, severity, and recurrence frequency.
02Systematic Root Cause Analysis (RCA) using 5-Why, Fishbone (6M), and Fault Tree Analysis.
03Defined effectiveness verification protocols with specific wait periods and methods.
040 GitHub stars
05Structured action planning for containment, correction, and prevention.
06Comprehensive QMS metrics tracking including cycle time and first-time effectiveness.
ユースケース
01Establishing a KPI dashboard for management review of quality system performance.
02Performing root cause validation to ensure identified causes explain all symptoms.
03Investigating major internal audit findings or recurring nonconformances.
