Context
Completing the Quality Plan meant reconciling its recall status report and CAPA form with each other before treating either as closed.
Quality Assurance • ISO 13485
ISO 13485 Recall & CAPA Record Update
Duration: 1 months • Role: Quality Assurance Specialist
Recall status reporting and CAPA form completion have to reconcile with each other, a recall record that doesn't match its CAPA closure creates a traceability gap an auditor will find.
Primary Risks Identified
- A quality record (change control, recall, CAPA) that doesn't reconcile with its related documents, creating a traceability gap during an audit
Testing Approach
Traced the change/record through every referencing document (manual, CAPA, recall record), confirming consistency against ISO 13485 and the current QMS procedure before closing the item.
Change Control Traceability
QMS Procedure Verification
Outcome
Completed the recall status report and CAPA form, reconciling the recall record with its corrective action closure.
Key Lessons
Recall status reporting and CAPA form completion have to reconcile with each other, a recall record that doesn't match its CAPA closure creates a traceability gap an auditor will find.
Have a system like this?
If you have no idea of testing your current system, let's talk through what's actually going on.
Contact me