8.7.1、The organization shall ensure that outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery.
NOTE: The term “nonconforming outputs” includes nonconforming product or service generated internally, received from an external provider, or identified by a customer.
The organization shall take appropriate action based on the nature of the nonconformity and its effect on the conformity of products and services. This shall also apply to nonconforming products and services detected after delivery of products, during or after the provision of services.
The organization’s nonconformity control process shall be maintained as documented information including the
—— defining the responsibility and authority for the review and disposition of nonconforming outputs and the process for approving persons making these decisions;
—— taking actions necessary to contain the effect of the nonconformity on other processes, products, or services;
timely reporting of nonconformities affecting delivered products and services to the customer and to relevant
—— defining corrective actions for nonconforming products and services detected after delivery, as appropriate to their impacts (see 10.2).
NOTE: Interested parties requiring notification of nonconforming products and services can include external providers, internal organizations, customers, distributors, and regulatory authorities.
The organization shall deal with nonconforming outputs in one or more of the following ways:
b. segregation, containment, return or suspension of provision of products and services;
c. informing the customer;
d. obtaining authorization for acceptance under concession by a relevant authority and, when applicable, by the customer.
Dispositions of use-as-is or repair for the acceptance of nonconforming products shall only be implemented:
—— after approval by an authorized representative of the organization responsible for design or by persons having delegated authority from the design organization;
—— after authorization by the customer, if the nonconformity results in a departure from the contract requirements.
Product dispositioned for scrap shall be conspicuously and permanently marked, or positively controlled, until physically rendered unusable.
Counterfeit, or suspect counterfeit, parts shall be controlled to prevent reentry into the supply chain.
Conformity to the requirements shall be verified when nonconforming outputs are corrected.
8.7.2、The organization shall retain documented information that:
a. describes the nonconformity;
b. describes the actions taken;
c. describes any concessions obtained;
d. identifies the authority deciding the action in respect of the nonconformity.