Nonconformances Properties

This page displays the details of the nonconformances (NC). In this page, you can modify the details of the NC. You can also close, invalidate, or transfer the NC.

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This topic describes:

This page discusses:

Fields

Section Name Field Name Description
Owner Name of the NC owner.
Originator Name of the NC creator.
Receipt Date Date the NC was created.
Modification DateDate the NC was last modified.
Status State of the NC. Possible states are Create, Review, Closed, and Invalid.
Investigation RequiredShows Yes if the NC must be investigated. Otherwise, shows No. This field appears only when the NC is in the Review or the Closed state.
Description Description of the NC.
Reassign RationaleReason why the NC was transferred.
Category High level classification of the nonconformance.
NC TypeType of nonconformance.
Severity Severity of the NC.
Functional AreaThe functional area in the location or site where the nonconformance was detected.
Process The process during which the nonconformance was detected.
Defect TypeType of the defect identified.
Site Found Site or location where the nonconformance was detected.
Supplier InformationNameName of the supplier that provided the material for the product.
Site Site of the supplier that provided the material for the product.
Lot NumberLot code assigned to the supplier for the material.
Invalidation DetailsRationale Reason why the NC was invalidated.
NameName of the person that invalidated the NC.
DateDate the NC was invalidated.
Closure Details Closure Type Whether a CAPA and Change are required to close the NC.
Note: If you selected the value as No for the Investigation option, the closure type is not required. Also closure type is selected as CAPA and Change, the data source need to be connected to the NC before closing it.
Closed RationaleReason why the NC was closed.
Closed DateDate the NC was closed.
Custom Attributes Name of attribute Custom attributes that are connected with the type and subtype of the nonconformance.

Actions

Action DescriptionFor More Information
Submit To Review Promotes the NC to the Review state.
Note: You must be a Quality Manager or the owner of the selected NC.
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Close Promotes the NC to the Closed state. In the Close NC page, type the reason for closing the NC and click Done.
Note: Ensure the following:
  • You must be a Quality Manager or a Complaint Investigator.
  • All objects associated with the NC must be closed or completed.
  • The associated CAPA requests must be in the Committed state.
  • The associated CAPA projects must be in the Complete state.
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Invalidate Invalidates the NC. In the Invalidate NC page that appears, type your user name and the password, type the reason for invalidating the NC, and click Done.
Note: Ensure the following:
  • The NC must be in the Create or the Review state.
  • If you are an NC User, you can invalidate the NC in the Create state.
  • If you are a Complaint Investigator, you can invalidate the NC in the Review state.
  • If you are a Quality Manager , you can invalidate the NC in the Create and the Review states.
  • All associated product control objects must be in the In Process or the Complete state.
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Transfer OwnershipTransfers the NC to the required user.See Transferring a NC.
EditActivates edit mode in which you can modify the Description, Category, NC Type, Severity, Functional Area, Process, Defect Type, Site Found, Supplier Name, Site, Lot Number, and Closure Type fields. Click Done to save the changes.--
Open NC ReportGenerates the NC summary report.See Nonconformance Summary Report.