ISO 9001:2008, Clause 8.3 “Control of nonconforming product”

When one or more characteristics of a product fail to meet specified requirements, it is referred to as a nonconforming product.
When a product deviates from specified product requirements, it fails to conform. Nonconforming products must be identified and controlled to prevent unintended use or delivery.

Nonconforming product is defined as product that does not conform to customer requirements; applicable regulatory requirements or your own organization requirements. The definition may also apply to nonconforming processes and services. Nonconformities may relate to suppliers and outsourced work; your own organizational activities or product shipped to customers.

Your documented procedure for nonconforming product must include controls and responsibilities to – identify; contain,(i.e. prevent further processing or use); keep records of the nature and other details of the nonconformity; notify appropriate personnel and customer, where appropriate; evaluate what disposition action needs to be taken; carry out timely disposition; determine policies for release for further processing or shipment to the customer; obtain customer concessions; rework and re-verification; establish performance indicators to measure the effectiveness of the control of nonconformance process; etc.

Product or material found with no identification or its quality status is not known, should be treated as nonconforming product and controlled by the above procedure.

If you find that nonconforming product has been shipped, without a customer concession, you must take appropriate action to reduce the immediate and consequential effect of the nonconformity. Depending upon the seriousness and scope of the nonconformity, you might consider taking action to eliminate the nonconformity as well as corrective action (see clause 8.5.2) to eliminate the root causes of the nonconformity. While there is no requirement to notify the customer (unless contractually required), it might be appropriate in specific circumstances to notify the customer and resolve the situation to your customer’s satisfaction.

A similar rationale may be applied where product has been shipped that does not meet regulatory requirements. Depending upon the seriousness and scope of the nonconformity, you might consider taking action to eliminate the nonconformity as well as corrective action (see clause 8.5.2) to eliminate the root causes of the nonconformity. You need to be aware of any reporting requirements imposed by regulatory bodies and comply with them.

A concession authorization allows you to ship nonconforming product, under controlled conditions. A deviation authorization allows you to manufacture product different from the original specification, under controlled conditions. In both these situations, make sure that you obtain these authorizations in writing prior to shipping or manufacturing nonconforming product.

All product realization processes (see clause 7.1) must show the interaction with your process for nonconforming product.