About Creating a Non-Conformance

A non-conformance occurs when a serial/lot contains a defect (that is, it does not meet the specification or requirement of a process, system, internal policies and procedures, customer requirements, or regulatory body). Each non-conformance can be related to multiple defects.

You can create a non-conformance for the following types of products:
  • Serialized: You can create a non-conformance for multiple serialized products at the same time. Defects that are created as part of a non-conformance appear in Non Conformance, where they can be disposed.
    Note: The defects created for serialized products will be assigned to a default PLAN in the NCR tab. Irrespective of the number of defects in a serial/lot, all the defect(s) share the same plan number. This will allow you to search for all the non-conformances associated with the plan.
  • Non-serialized: You can create a non-conformance only for a single lot at a time. If only some quantity of the lot is defective, you can specify the quantity of the defective pieces. The lot is then split into sublots. This will allow you to continue working on the non-defective quantity, while the defective quantity is disposed using Non Conformance.
    Note:
    • The defects created for non-serialized products will not be assigned to a PLAN in the NCR tab.
    • For a non-serialized product, you need permission to modify the AFFECTED QUANTITY while creating a Non-conformance. This will split the defective items of a serial/lot. You must provide permission to split the serial/lot in the Security application.
      In the Security application:
      • Select the Roles tab.
      • Select Non Conformance Management from ROLE CATEGORY and ensure that Allow lot split during defect creation toggle is enabled.

      If the permission is not provided, the AFFECTED QUANTITY field is disabled, and you cannot modify the AFFECTED QUANTITY. Hence, you can create the defect only on the whole quantity.

      For more information on relevant permissions for a selected role category, refer to Create a Role.

The following conditions apply when you create a non-conformance:
  • You can create a non-conformance on a serial/lot only if you are clocked on to the serial/lot.
  • You can create a non-conformance only on the available quantity of a lot (that is, the quantity for which the operation is not yet complete).
  • The defective serial/lot and the operation are changed to the On Hold status. Depending on the configuration, you are clocked off the serial/lot and the operation.
  • You can complete the operation on the serial/lot only after the serial/lot is disposed in Non Conformance.