Supplier Corrective Action Request (SCAR) - criteria

B

Bella65

#1
We currently raise a SCAR every time a product is rejected. We wish to review the criteria for when a SCAR is raised, e.g. 3rd time paperwork issue or 1st major problem - but then what is determined as major....

Would like some ideas on how other Medical Device Companies carry out this function
 
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A

arios

#2
We currently raise a SCAR every time a product is rejected. We wish to review the criteria for when a SCAR is raised, e.g. 3rd time paperwork issue or 1st major problem - but then what is determined as major....

Would like some ideas on how other Medical Device Companies carry out this function
Hi Bella65, its me again

You are correct, you could revise your criteria. For instance, by applying your risk management approach from ISO 14971, you could classify your raw material defects by categories depending on their impact on the finished product. If for instance a defect compromises sterility, safety, biocompatibility or performance, then a SCAR could be applied at first instance. For other less significant defects, it could be based on incidence and % detective per lot. Since it could be hard to specify or imagine all types of defects you could either have a qualified person make a determination and document the decision on the reject report as part of the failure investigation each time a defect occurs, or find a way to link the decision to your FMEA or risk analysis tool.

Once again, I hope this helps
 
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qusys

Trusted Information Resource
#3
We currently raise a SCAR every time a product is rejected. We wish to review the criteria for when a SCAR is raised, e.g. 3rd time paperwork issue or 1st major problem - but then what is determined as major....

Would like some ideas on how other Medical Device Companies carry out this function
Hi Bella65.

I do not work for medial Device sector, but we raise SCAR for each issue that caused a problem for product quality, not depending on our process.
The SCAR is then filled in by supplier according 8D method.
These SCARs are one of the tool for supplier performance monitoring. We also make supplier audit where we also verify the effectiveness of the corretive action directly on hteir premises.
hope this helps:bigwave:
 
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