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10. Improvement

10.1 General

The Organization uses the management system to improve its processes, products and services. Such improvements aim to address the needs and expectations of customers as well as other interested parties, to the extent possible.

Improvement shall be driven by an analysis of data related to:

The results of analysis shall be used to evaluate:

a) conformity of products and services;

b) the degree of customer satisfaction;

c) the performance and effectiveness of the management system;

d) the effectiveness of planning;

e) the effectiveness of actions taken to address risks and opportunities;

f) the performance of external providers;

g) other improvements to the management system.

10.2 Nonconformity & Corrective Action

The organization ensures that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. A documented procedure is established to define the controls and related responsibilities and authorities for dealing with nonconforming products. The term "nonconforming product" includes nonconforming product returned from a customer.

The documented procedure (Control of Nonconforming Product) defines the responsibility for review and authority for the disposition of nonconforming product and the process approving personnel making these decisions.

Where applicable, the organization deals 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, and
  • 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.
Disposition of nonconforming product is limited to:

  • Scrap: Products dispositioned for scrap is conspicuously and permanently marked, or positively controlled, until physically rendered unusable (see Scrap Procedure)
  • Rejection for return to supplier,
  • Rejection for revalidation by the manufacturer,
  • Submittal to design authority and customer for "Use-As-Is" disposition.
The organization does not use dispositions of use-as-is or repair, unless specifically authorized by the customer,

  • if the product is produced to customer design, or
  • the nonconformity results in a departure from the contract requirements
  • if applicable, unless otherwise restricted in the contract, organization-designed product which is controlled via a customer specification is dispositioned by the organization as use-as-is or repair, provided the nonconformity does not result in a departure from customer-specified requirements.
When nonconforming product is corrected the product is subject to re-verification to demonstrate conformity to the requirements.

Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, are maintained (see 4.2.4)

When nonconforming product is detected after delivery or use has started, appropriate actions are taken to the effects or potential effects of the nonconformity.

In addition to any contract or regulatory authority reporting requirements, the organization provides for timely reporting of delivered nonconforming product that may affect reliability or safety. Notification includes a clear description of the nonconformity, which includes as necessary parts affected, customer and/or organization part numbers, quality, and date(s) delivered.

Note: Parties requiring notification of nonconforming product may include suppliers, internal organizations, customers, distributors, and regulatory authorities.

The organization takes action to eliminate the causes of nonconformities in order to prevent recurrence. Corrective actions are appropriate to the effects of the nonconformities encountered.

A documented procedure is established to define requirements for:

  • reviewing nonconformities (including customer complaints),
  • determining the causes of nonconformities,
  • evaluating the need for action to ensure that nonconformities do not recur,
  • determining and implementing action needed,
  • records of the results of action taken (see 4.2.4), and
  • reviewing the effectiveness of the corrective action taken.
  • flow down of the corrective action requirement to a supplier, when it is determined that the supplier is responsible for the root cause, and
  • specific actions where timely and/or effective corrective actions are not achieved.
Supporting Documentation
Preventive action

The organization determines actions to eliminate the cause of potential nonconformities in order to prevent their occurrence. Preventive actions are appropriate to the effects of the potential problems. When anticipated, a documented procedure is established to define requirements for:

  • determining potential nonconformities and their causes,
  • evaluating the need for action to prevent occurrence of nonconformities,
  • determining and implementing action needed,
  • records of results of action taken (see 4.2.4), and
  • reviewing the effectiveness of the preventive action taken,
  • the withdrawal of product(s) from stock that are suspected of a noncompliance, including notification of customer of the actions taken who have purchased the product from the same lot.
Supporting Documentation

10.3 Continual improvement

The organization continually improves the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management reviews.

Supporting Documentation:

Topic revision: r3 - 10 Apr 2019 - SteveKreis
 
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