The Nonconformance module (NC) helps companies capture and manage all NC incidents that occur, may have occurred (not sure of but noteworthy), or may occur (possible future NC for which action seems warranted) in a service, product, process, from a supplier, or in the QMS itself. An NC occurs when specifications or requirements were not met and that were (or should have been) defined by company procedures. 

Access the Nonconformance module from the  Navbar under Improvement

In the module, you will see all of the NCs that have been initiated, their status (draft, pending, closed, cancelled), the days they have been (or were open), the source to which they are linked and the risk associated with the NC. 

To sort the table, click on Add Filter and selection how you want to sort the table. Click Remove to remove any filters.

Turn the Show Cancelled toggle on and you will also be able to see the NC’s that were cancelled.

To view a nonconformance, hover over and click on the NC in which you are interested. 

In the header you will see its status, days it has been open (or if it is closed), and any items within the QMS to which it’s linked. You also have the option to Cancel the NC or close out of it and return to the module. If the NC is closed, you can edit it and will have to re-submit it for approval. 

If the NC is pending approval and you submitted it, then you (or a Quality Owner) can pull it back. Pulling it back, puts the NC once again in a draft state.  

You can also see the source, defect number (if applicable) and any defect codes. The defect codes list is managed by a Quality Owner under the NC/CAPA setting in their Settings menu. 

NC’s can be created for either a product or a process. 

Under the Product tab, you can view:

  • Details of the product including its version/batch number, anomaly description, any defect types and its risk assessment
  • If it was escalated to CAPA, the CAPA phase 1 due date and CAPA owner
  • If not escalated to CAPA, whether an investigation was needed, its disposition and information about the disposition
  • Approvers of the nonconformance

Under the Process tab, you can view:

  • Details of the process including the requirement to which it’s traced, NC description and its risk assessment
  • If it was escalated to CAPA, CAPA phase 1 due date and CAPA owner
  • If not escalated to CAPA, whether an investigation was needed, information about the resolution
  • Approvers of the nonconformance

Once done viewing the NC, click on the X to close it and return to the NC module. 

If you have any questions, you can reach us through the chat or email us at support@enzyme.com. 

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