CFR 820.90 for Nonconforming Product mandates that the company have procedures in place to control non-conforming product. Control includes:
- Identification of the affected product.
- Documentation of the non-conformance.
- Evaluation of potential remedies.
- Segregation of non-conforming product.
- Disposition of nonconforming product.
- Determination of the necessity for an investigation.
- A process for notifying anyone responsible for the nonconformance.
- Documentation of the product evaluation and investigation.
