8.7 Control of Nonconforming Outputs

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 provisions for:

− 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 interested parties;

− 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:

a. correction;

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.

10. IMPROVEMENT

10.1 General

The organization shall determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction.

These shall include:

a. improving products and services to meet requirements as well as to address future needs and expectations;

b. correcting, preventing, or reducing undesired effects;

c. improving the performance and effectiveness of the quality management system.

NOTE: Examples of improvement can include correction, corrective action, continual improvement, breakthrough change, innovation, and re-organization.

10.2 Nonconformity and Corrective Action

10.2.1 When a nonconformity occurs, including any arising from complaints, the organization shall:

a. react to the nonconformity and, as applicable:

1. take action to control and correct it;

2. deal with the consequences;

b. evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by:

1. reviewing and analyzing the nonconformity;

2. determining the causes of the nonconformity, including, as applicable, those related to human factors;

3. determining if similar nonconformities exist, or could potentially occur;

c. implement any action needed;

d. review the effectiveness of any corrective action taken;

e. update risks and opportunities determined during planning, if necessary;

f. make changes to the quality management system, if necessary;

g. flow down corrective action requirements to an external provider when it is determined that the external provider is responsible for the nonconformity;

h. take specific actions when timely and effective corrective actions are not achieved.

Corrective actions shall be appropriate to the effects of the nonconformities encountered.

The organization shall maintain documented information that defines the nonconformity and corrective action management processes.

10.2.2 The organization shall retain documented information as evidence of:

a. the nature of the nonconformities and any subsequent actions taken;

b. the results of any corrective action.

10.3 Continual Improvement

The organization shall continually improve the suitability, adequacy, and effectiveness of the quality management system.

The organization shall consider the results of analysis and evaluation, and the outputs from management review, to determine if there are needs or opportunities that shall be addressed as part of continual improvement.

The organization shall monitor the implementation of improvement activities and evaluate the effectiveness of the results.

NOTE: Examples of continual improvement opportunities can include lessons learned, problem resolutions, and the benchmarking of best practices.