Q08-0200 Evaluation Activities - Control of Non-Conforming Product

This sub-category includes all the processes in regard to reporting, handling, monitoring and control of any DEVIATION to the manufacturing process affecting Product Quality.

• The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery.
• A documented procedure shall be established to define the controls and related responsibilities and authorities for dealing with nonconforming product.

Where applicable, the organization shall deal with nonconforming product by one or more of the following ways:

• by taking action to eliminate the detected nonconformity;
• by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer;
• by taking action to preclude its original intended use or application;
• by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started.

When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements.

Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained.

Q08-0000 Product Evaluation Activities in QMS