Nonconformances

This page lists the nonconformances (NC) that are created in your company. You can also perform some actions based on your role.

To access this page:

  1. From the Compass, click Social and Collaborative Apps and select My Social And Collaborative AppsComplaints and Nonconformance.

    The Complaints List page appears.

  2. Click the NCs tab.

This topic describes:

This page discusses:

Columns

Column Name Description
Number Name of the nonconformance(NC). Click to view its details.
Type Type of the object. In this case, NC.
Status State of the NC. Possible states are Create, Review, Closed, and Invalid.
OwnerName of the NC owner.
Customer SeveritySeverity of the NC.

  • denotes severity is low.
  • denotes severity is medium.
  • denotes severity is high.
  • denotes severity is urgent.

Receipt DateDate the NC was created.
CategoryHigh level classification of the nonconformance.
NC TypeType of nonconformance.
Site FoundSite or location where the nonconformance was detected.
Functional AreaThe functional area in the location or site where the nonconformance was detected.
ProcessThe process during which the nonconformance was detected.
Product LineName of the product line of the model.
Impacted ItemName of the impacted item.
Important: The user assigned with the Administrator role can configure a display value for the name of item. For more information, see Customizing NC Impacted Items.
Investigation Status

: NC is under investigation

: NC investigation is complete or not required

Blank: investigation not started for NC

Point to view the status of the investigation. Click to view the details of the investigation.
Investigation SeveritySeverity of the investigation.

  • denotes severity is low
  • denotes severity is medium
  • denotes severity is high
  • denotes severity is urgent

CreateNumber of days the NC is in the Create state.
ActiveNumber of days the NC is active.
AgeAge of the NC in days.
Attachments

Shows if a file is attached

Click to view the details of the attached file and download it.

Filters

Based on your role, you can filter the NCs by states or statuses.

  • Assigned: NCs (of any state) assigned to the user are listed
  • Unassigned: NCs that are not assigned to anyone and are in the Review state are listed
  • Create: NCs that are in the Create state are listed
  • Review: NCs that are in the Review state are listed

Actions

Action DescriptionFor More Information
Add Assignee Adds an assignee to the selected NC.See Adding Assignees.
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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AcceptAssigns you the selected NCs.
Note: You must be a Complaint Investigator.
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Transfer Ownership Transfers the selected NCs to the required user.See Transferring a NC.
Complete InvestigationCompletes the investigation on the NC.
Note: Ensure the following:
  • You must be a Quality Manager or a Complaint Investigator.
  • The selected NCs must be in the Review state.
  • Provide necessary information in the Method, Results, Conclusion Code, Rationale, Responsible Investigator, and Completion Date fields.
See Investigation.
Invalidate Invalidates the selected NCs. 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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ClosePromotes the selected NC to the Closed state. When the review task for an NC is approved, the NC is automatically promoted to Closed.

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.

--
DeleteDeletes the selected NCs. Click OK to confirm.
Note: Ensure the following:
  • You must be a Quality Manager or the owner of the NC.
  • The selected NCs must be in the Create state.
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Actions > CAPA > Create CAPA RequestCreates a CAPA request using the NC.See Creating a CAPA Request in the CAPA and Audit Management User's Guide.
Actions > CAPA > Add To Existing CAPAAdds the NC to a CAPA project or a CAPA request as a data source. From the Search Results page that appears, select the required objects and click Submit.--
Create NC Creates an NC.See Creating a Nonconformance.
Enable EditActivates edit mode in which you can modify the NC Type field. Click Save when done.--