Module 16 2024

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Corrective and preventative action

The PMS CAPA workflow:

TRACEABILITY

CAPA Verification

CAPA Plan

Change Note

Complaint

Risk Eval.

Report

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Corrective and preventative action

CAPA form contents:

• Unique ID, Date, Initiator/Owner

• Reason/background for the CAPA

• Scope, devices, processes affected

• Root cause investigation, the five Why’s

• Risk assessment

• Immediate action taken

• CAPA plan and due date

• Verification plan and due date

• Evidence of successful verification

• Resource assignment

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