What problem does it solve? Quality teams struggle to run consistent CAPA processes—from investigation and root cause analysis through effectiveness verification—while staying compliant with ISO 13485, FDA 21 CFR 820.100, and EU MDR requirements. ## Core Features & Use Cases - CAPA Lifecycle Management: Guides initiation, investigation, action planning, implementation monitoring, and effectiveness verification with structured workflows. - Root Cause Analysis: Applies 5 Why, Fishbone, Fault Tree, Human Factors, and FMEA methodologies with decision points for method selection. - Metrics and Trend Analysis: Tracks CAPA cycle time, first-time effectiveness, recurrence rate, and generates monthly, quarterly, and annual reports. - Use Case: A medical device company receives a complaint trend; use this Skill to scope the investigation, select an RCA method, build a corrective action plan with owners and milestones, and verify effectiveness before closure. ## Quick Start Ask the assistant to initiate a CAPA investigation for a recurring nonconformance and produce a root cause analysis with a corrective action plan.
