Section 1.5 Follow-up
Verify and Assess CAPA Effectiveness
It is important to review CAPA to ensure:
a) all planned actions have been completed
b) for more significant or systematic deviations, review the effectiveness of CAPA implemented to determine whether the action has or has not eliminated the problem. Examples of CAPA effectiveness check include:
– Periodic checks to determine if there has been a recurrence of the same or similar incidents, this could be conducted as part of on-site or centralised monitoring.
– Trend analysis
Update Log and Close Deviation
This should include:
– Checking all aspects of the incident are complete and documented according to previous steps e.g. CAPA complete.
– Filing incident reports and associated documentation e.g. emails correspondence, evidence of review which could be included in meeting minutes.
