capa-officer

CAPA investigation for ISO 13485 requires documenting issues, forming teams, and collecting evidence. This Skill guides you through the entire Corrective and Preventive Action lifecycle to ensure systematic resolution of quality non-conformances.

Root cause analysis for FDA 21 CFR 820.100 is best performed using 5-Why and Fishbone diagram methodologies. This Skill facilitates identifying underlying causes of quality issues to ensure robust corrective action planning.

Track CAPA metrics and effectiveness verification by monitoring cycle time and generating management reports. This Skill provides tools to define effectiveness verification procedures and track ongoing action implementation within your Quality Management System.

Yes, you can manage both corrective action and preventive action workflows. The Skill facilitates the creation of action plans, guides implementation, and defines effectiveness checks for robust quality management system compliance.

Yes, python-dateutil is required as a dependency to run the CAPA lifecycle management scripts. It supports the internal processing logic needed for tracking dates and generating quality management reports.

You need to initiate a CAPA process when a recurring non-conformance is identified in your quality system. This Skill helps start a new investigation, perform root cause analysis, and define corrective actions for critical quality issues.