A non-conforming material report (NCMR) is something that must get taken up with the current vendor to prevent the incorporation of defective equipment into a medical device project. An NCMR is generated by either the quality department or during a warehouse inspection and requires identification inputs regarding its condition. This requires mentioning 1) the defect at hand and how it negatively impacts the product/project, 2) the lot number that the defective material was manufactured, and 3) the identity of the on-site investigator carrying out the examination. Once the NCMR is submitted, a course of action is taken to address the issue, which includes refunding the material to the vendor, scrapping the material to prevent its further use, use it as is and accept its risk, reclassify the material and rework it to another project/product, or repair it so that it is compliant with manufacturing standards.

There was a situation at my company where a cell bag that holds cell culture/medium would leak during processing, which ultimately contaminated and compromised the product. If one material in a lot shows fault, then how would the remaining materials in that lot be treated? Would the size of the lot determine how the potential defects will be handled? Would defective materials in this nature also be treated differently if being applied to a Class I project as opposed to a Class III?