ELM-308-01

Your 1 Minute Guide to the NCR Process [Video]

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

“Rework” whereas the material is reworked to bring it back into conformity

Accepted Use As Is

“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

“Scrapped” whereas the product is scrapped and removed from the production area

Convert to Development

“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