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CAPA investigation for ISO 13485 involves documenting trigger events, performing root cause analysis, and planning corrective actions. This workflow structures the process from initiation through closure with evidence collection to satisfy regulatory compliance requirements.

Root cause analysis for medical device quality management is best performed using structured methods like 5-Why, Fishbone, or Fault Tree Analysis. These techniques isolate underlying factors to ensure corrective action effectiveness and prevent issue recurrence.

Corrective action plans and effectiveness verification are tracked by defining containment actions, assigning owners, setting timelines, and documenting verification plans. This ensures CAPA closure criteria are met and recurrence is prevented within the QMS.

This CAPA workflow supports FDA regulatory audits by documenting root causes, corrective actions, and verification plans. It aligns with FDA CAPA expectations for medical device quality management, ensuring structured evidence collection during inspections.

CAPA management reviews should report metrics tracking CAPA aging, cycle time, and effectiveness verification results. These metrics demonstrate regulatory compliance and quality management performance to stakeholders during audits.

A fishbone diagram is needed when exploring multiple potential causes of a CAPA issue, while 5-Why is used for sequential drilling into a single problem thread. Both root cause analysis methods support structured corrective action planning.