Course Code: ELM-802-03

How to Handle Medical Device Non-Conformances [Video]

Typically, a process will be created with a title such as “Control of Nonconforming Materials”.

Non Conformance Report

The acronym for nonconformances varies, and includes, Nonconformance Report (NCR), Nonconforming Materials Report (NCMR, or rarely NMR which gets confused with nuclear magnetic resonance) or just an NC.

For our purposes we’re going to go with NCR for the general acronym.

NCR Process

The NCR process should cover product from the moment material is received through the commercial product realization process and it’s typically the production personnel and the quality personnel who initiate an NCR.

The NCR process is typically done in stages, with the first stage identifying the issue, lots and part numbers impacted and labelling and segregating the material.

Nonconforming product may be dispositioned as:

  • “Rework” whereas the material is reworked to bring it back into conformity
  • “Accepted Use As Is” (UAI), also sometimes referred to as “concession”, this is where the nonconformance must be evaluated as to ensure it is still suitable for its intended use
  • “Scrapped” whereas the product is scrapped and removed from the production area
  • “Convert to Development”, whereas material is essentially scrapped but handed directly to the development team for product development studies

Author

Don Rackham

Associate Director QA Asterias Biosciences