What problem does it solve? Quality teams struggle to run disciplined CAPA processes—investigations stall, root causes are misidentified, and corrective actions fail effectiveness checks, leading to recurring nonconformances and audit findings. ## Core Features & Use Cases - CAPA Lifecycle Management: Guides the full workflow from initiation and investigation through action planning, implementation, and effectiveness verification. - Root Cause Analysis: Applies structured RCA methodologies including 5 Why, Fishbone, Fault Tree Analysis, and FMEA based on problem type. - Trend Analysis & Metrics: Tracks CAPA cycle time, recurrence rate, and first-time effectiveness for management review and continuous improvement. - Use Case: A medical device quality engineer receives a customer complaint about a labeling defect. Use this Skill to scope the investigation, select an RCA method, build a corrective action plan with owners and timelines, and verify effectiveness before closure. ## Quick Start Ask the assistant to initiate a CAPA investigation for a recent nonconformance and guide you through root cause analysis and corrective action planning.
