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.

Note: This video was created using V1.26.0. Enzyme is updated weekly so some elements may change.  

Access the Nonconformance module from the Navigation menu under Improvement

In the module, you will see all of the NCs that have been initiated. You will see their

  • Status: open & days if open, NC number, approval state (draft, pending, closed, cancelled)
  • Description of the NC
  • Person who Initiated the NC and the date it was initiated
  • Date NC was closed
  • Link to the source of the NC
  • Risk Level
  • Disposition of the NC

You can add filters to view specific NC’s by Status or Risk. You can also turn the Show Cancelled toggle on to view the cancelled NC.

Hover over and click on the NC you’d like to view.

In the header you will see the NC number, its status and days it has been open (or if it is closed), the person who initiated the NC and the date it was initiated. You also have the option to edit the NC if it’s not associated with a CAPA, print the NC record or close out of it and return to the module.

If the NC is closed and it is not associated with a CAPA, you can click on the Edit icon to cancel it or reopen it and make changes.

If the NC is pending approval and you initiated it, then you (or a Quality Owner) can pull it back. Pulling it back, puts the NC once again in a draft state. The Initiator of the NC must approve it as well in addition to other approvers.

History

At any time you can view the approval and change history of the NC. Here you can also view the draft change history of the NC record by turning Show Draft Changes toggle ON.

Entry

In the Entry tab you can view information about the source of the NC.

  • Source Type: Reason(s) for the NC such as Audits, Complaints, Suppliers, Documentation Review, Inspections etc. You can select multiple source types.
  • Sources: The specific sources that are based on the Source Type. For example if the source type is audit, then the source can be the audit number with which this NC is associated.
  • Source (other): Any other sources of the NC.
  • Attachments:Any attachments to explain the NC
  • Defect Number: The defect number(s) associated with the NC. The defect numbers are determined in the NC/CAPA settings by the Quality Owner.
  • Defect Codes: The defect codes associated with the NC. The defect codes are determined in the NC/CAPA settings by the Quality Owner.

An NC record can be related to either a product or a company process.

Product

Under the Product tab, you can view:

Details:

  • Product(s) the NC is associated with.
  • Specific parts/assemblies that resulted in the NC.
  • Description of the NC
  • Defect Types associated with the NC. The defect types are determined in the NC/CAPA settings by the Quality Owner.
  • Severity/Occurrence/Risk associated with the NC. These are determined in the NC/CAPA settings by the Quality Owner.
  • Risk rationale behind the Severity/Occurrence selected.

Then you can view if the NC was escalated to a CAPA or not. If it was escalated to a CAPA, you’ll see the Phase 1 due date of the CAPA and the CAPA owner. You can also view the approvers of the NC.

If the NC was not escalated to a CAPA (and why), then you can view

  • If an investigation was needed and the reason
  • Root cause code of the NC. These are determined by the Quality Owner in the NC/CAPA settings.
  • If an interim action is needed and the corresponding disposition. Interim actions are steps (i.e. temporary dispositions) taken while the disposition is being addressed long term. Interim actions can be approved either before or along with the disposition.
  • Dispositions which are the proposed actions taken to address the root cause of the NC. These (along with interim action dispositions) must first be approved before an NC record can be closed by the approvers listed.
  • Approvers of the NC

Process

Under the Process tab, you can view:

Details:

  • Process requirement where the NC was generated.
  • Any other process requirements.
  • Description of why the process NC occurred.
  • Severity and corresponding Risk of the NC. These can be defined by the Quality Owner in the NC/CAPA Settings.

If the NC is escalated to a CAPA, you will see the Phase 1 due date and the CAPA Owner as well as the approvers.

If the NC was not escalated to a CAPA (and why), then you can view

  • If an investigation was needed and the reason.
  • Root cause code of the NC. These are determined by the Quality Owner in the NC/CAPA settings.
  • Resolution description of the NC.
  • Approvers of the NC.

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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