capa-officer

原文涵盖的主题

• CAPA Officer
• Table of Contents
• CAPA Investigation Workflow
• CAPA Necessity Determination
• Investigation Team Composition
• Evidence Collection Checklist
• Root Cause Analysis
• RCA Method Selection Decision Tree

Corrective and Preventive Action (CAPA) management within Quality Management Systems, focusing on systematic root cause analysis, action implementation, and effectiveness verification. -- CAPA Investigation Workflow Root Cause Analysis Corrective Action Planning Effectiveness Verification CAPA Metrics and Reporting Reference Documentation Tools -- Conduct systematic CAPA investigation from initiation through closure: 1. Document trigger event with objective evidence 2. Assess significance and determine CAPA necessity 3. Form investigation team with relevant expertise 4. Collect data and evidence systematically 5. Select and apply appropriate RCA methodology 6. Identify root cause(s) with supporting evidence 7. Develop corrective and preventive actions 8. Validation: Root cause explains all symptoms; if eliminated, problem would not recur | Trigger Type | CAPA Required | Criteria | |--------------|---------------|----------| | Customer complaint (safety) | Yes | Any complaint involving patient/user safety | | Customer complaint (quality) | Evaluate | Based on severity and frequency | | Internal audit finding (Major) | Yes | Systematic failure or absence of element | | Internal audit

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