I always like to give my suppliers the benefit of the doubt, I wouldn’t assume it’s an ethics issue.

An NCMR is a Non-Conforming Material Report and it would be opened for anytime a material related non-conformance is found. This could be in receiving inspections of the raw materials and components, on the manufacturing line, during in-process inspections or final inspection. The report would include a description of the non-conformance, bounding information (this means how much material is affected), and an escalation decision. The escalation decision is generally made by the MRB after reviewing the other information. An NCMR can be escalated to created a CAPA. If the non-conforming material is received from a supplier it might be escalated to a SCAR (Supplier Corrective Action Request). In the case of this simulation a Supplier Corrective Action Request could have been issued except that this supplier was completely unreponsive and not familiar with requirements of the medical device industry.