capa-officer

Corrective and Preventive Action (CAPA) management within Quality Management Systems, focusing on systematic root cause analysis, action implementation, and effectiveness verification. Conduct systematic CAPA investigation from initiation through closure: Select and apply appropriate RCA methodology based on problem characteristics. Use when: Single-cause issues with linear causation, process deviations with clear failure point. Template: Example - Calibration Overdue: See references/rca-methodologies.md for complete method details and templates. Before proceeding to action planning, validate root cause: Develop effective actions addressing identified root causes: Verify corrective actions achieved intended results: See references/effectiveness-verification-guide.md for detailed procedures. Monitor CAPA program performance through key indicators. Monthly CAPA status report includes: references/rca-methodologies.md contains: references/effectiveness-verification-guide.md contains: Calculates and reports: Required CAPA elements: - CAPA Investigation Workflow - Root Cause Analysis - Corrective Action Planning - Effectiveness Verification - CAPA Metrics and Reporting - Reference Documentation - Tools - Document trigger event with objective evidence - Assess significance and determine CAPA necessity - Form investigation team with relevant expertise - Collect data and evidence...