About Nonconformances

A nonconformance (NC) is used to identify and manage non-conformance in products, processes, and solutions. An NC is created when a product does not conform with the defined requirements, specification, or standards.

This page discusses:

Nonconformances

A nonconformance(NC) is used to identify non-conformance in a product, when the product does not conform with the requirements defined by the organization, customers, or regulatory authorities.

When a non-conformance is identified in a product, the issue is registered and sent for investigation. After the investigation is completed, the investigator recommends the necessary actions to be performed to fix the non-conformance. These actions may include changes to the manufacturing processes.

Product Controls

A Product Control object is a part of the NC management process that is used to manage the disposition of the non-conforming products.

A Product Controls is used to detect the amount of nonconforming products and propose a method to dispose the non-conforming products. Multiple Product Controls can be created for an NC to identify separate processes for disposing the nonconforming products.

Lifecycle

Lifecycle of NCs

The lifecycle of an NC consists of four states.

  • Create: In this state, you can transfer, invalidate, or submit the NC for review.
  • Review: In this state, you can investigate the NC, create product control objects, and close the NC.
  • Closed: A completed NC is moved to this state.
  • Invalid: An invalidated NC is moved to this state.

Lifecycle of Product Controls

The lifecycle of a Product Control consists of four states.

  • In Process: In this state, you can modify the details of the product control, submit it for review, or delete it.
  • Review: In this state, you can review and verify the product control.
  • Verified: In this state, you can complete the verified product control.
  • Complete: A completed product control is moved to this state.