On occasion there will be product that is nonconforming to the required product specification.

Product Realization

This may occur at any stage of product realization, from an incoming material to an in-process check, or finished product testing or inspection prior to entering the market, or in some cases, even after a product has entered into the market.

The organization must have a process to ensure that product which does not conform to the product requirements is identified and controlled to prevent its unintended use or delivery.

Process Requirements

This process must include definitions for authorities, or responsibilities, for identification, documentation, segregation, evaluation and ultimately disposition of nonconforming product.

In addition, this process must include an evaluation of the nonconformity and a determination for an investigation or notification to any external party responsible for the nonconformity.