What is a Supplier Corrective Action Request (SCAR)?Ā
A Supplier Corrective Action Request (SCAR) is a formal request issued by a medical device manufacturer to a supplier to address and rectify a quality issue or non-conformance. It is closely linked to Non-Conforming Material Reports (NCMR), which document materials or components that fail to meet specified requirements. When a non-conformance is identified, an NCMR can trigger a SCAR, prompting the supplier to investigate and resolve the issue. Corrective and Preventive Actions (CAPA) are then implemented to identify the root cause, correct the problem, and prevent its recurrence. This integrated approach ensures that quality issues are effectively managed and prevented in the future.
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Tips on completing a SCAR:
Completing a SCAR for a medical device typically overlaps with a nonconforming materials report (NCMR) and corrective actions/ preventive actions (CAPA). Here are three tips to keep in mind:
- Clearly define the issue and gather evidence such as inspection reports, test results and photographs to support your findings.
- Engage the supplier to ensure they understand the issue and are committed to resolving it. Work with the supplier to develop the corrective action plan, ensuring that the root cause is addressed.
- Monitor the progress of corrective actions and verify their effectiveness through re-inspection, testing or audits.
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FAQ About Supplier Corrective Action Requests (SCAR)
Here are some answers to frequently asked questions about Supplier Corrective Action Requests.
How is SCAR different from CAPA?
What are common pitfalls of SCAR?
How can manufacturers ensure the effectiveness of corrective actions taken by suppliers?
How does SCAR contribute to continuous improvement in medical device development?
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