Users with permission level of Quality Owner, Editor and Approver can create an NC. 

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

Create & Submit NC records

Access the NC module from the Navbar under Improvement

Click on the +Add New Nonconformance button to open a new record.

Enter all information known at the time of opening 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: Based on the source type, you’ll be able to select the source of the NC. For example if the source type is audit, then in sources you can select the audit number with which this NC is associated.
  • Source (other): Type if there are any other sources of the NC.
  • Attachments: If needed uploaded any attachments to explain the NC
  • Defect Number: Select the defect number associated with the NC. The defect numbers are determined in the NC/CAPA settings by the Quality Owner.
  • Defect Codes: Select the defect codes associated with the NC. The defect codes are determined in the NC/CAPA settings by the Quality Owner.

​ You can add an NC for a product or a process, so select the tab that applies to the type of NC you are creating.

​If the NC pertains to a product, fill out the product tab. If the NC pertains to a process in your company or supplier, then fill out the process tab.

NC for a Product

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 set in the NC/CAPA settings by the Quality Owner.
  • Severity/Occurrence/Risk associated with the NC. These are set in the NC/CAPA settings by the Quality Owner.
  • You can add a risk rationale.

Then select if you want the NC escalated to a CAPA or not. If escalating to a CAPA, enter the Phase 1 due date of the CAPA and the CAPA owner.

Once you Save Changes then you’ll be able to select the NC approvers. The approvers are populated based on the Approval Settings determined by the Quality Owner. Also if the person who initiated the NC is a Quality Owner or Approver permission level, they will always have to approve the NC record.

If the NC was not escalated to a CAPA, then enter

  • If an investigation is needed or not and the reason
  • Select the Root Cause code(s) for the NC. These are set by the Quality Owner in the NC/CAPA settings.
  • If Interim Action is needed or not.
    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.
  • Select the Disposition of the NC
    Dispositions are the proposed actions taken to address the root cause of the NC. These must first be approved before an NC record can be closed by the approvers listed.

Save Changes and then first select the Approvers for the disposition. Once the disposition (and/or interim actions are approved), it will be displayed in the record.

When you are ready to close the NC, open the record and then select the approvers to close the NC.

Things to remember are:
- The Approvers populated are based on the Approval Settings determined by the Quality Owner.
- If the initiator of the NC has Quality Owner or Approver permission level, they will have to approve the NC as well.
- Approvers listed in bold must approve the NC.

Once the NC closure has been approved, you’ll see it displayed in the module.

Process

If the NC resulted due to a process then select the Process tab and enter:

Details:

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

Indicate if the NC is escalated to a CAPA, then 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 enter

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

Things to remember are:
- The Approvers populated are based on the Approval Settings determined by the Quality Owner.
- If the initiator of the NC has Quality Owner or Approver permission level, they will have to approve the NC as well.
- Approvers listed in bold must approve the NC.

Note: If the creator of the NC is no longer available to approve, the Admin (Quality Owner) can set the permission of the NC Initiator to ‘Editor’ or 'Viewer'. As a result the initiator of the NC will no longer be required to approve it.

Approving the NC

The notification will show in the Dashboard notification, notification bell and Approvals Module. All approvers can approve the NC from either of these three notifications. Upon approval the NC will display as 'closed' in the NC module.

Edit Closed NC

To edit an NC that has been closed (and does not have a CAPA associated with it), click on the Edit icon and make your edits. Once you hit Save, this puts the NC back in draft mode and you will have to resubmit the NC for approval.


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

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