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
