Users with permission level of Quality Owner, Editor and Approver can create an NC.
Access the Nonconformance module from the Navbar under Improvement.
Click on the +Add New Nonconformance button which will open up a new form.
Enter all information known at the time of opening the NC.
The defect codes list is managed by the Admin (Quality Owner) under the NC/CAPA settings in their User Settings menu.
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
Under the Product tab, enter:
- Details of the product including its version/batch number, anomaly description, any defect types and its risk assessment
- If it was escalated to CAPA, enter the CAPA phase 1due date and CAPA owner
- If not escalated to CAPA, enter whether an investigation is needed, its disposition and information about the disposition
- Save changes
NC for a Process
Under the Process tab, enter:
- Details of the process including the requirement to which it’s traced, NC description and its risk assessment
- Enter it is escalated to CAPA, CAPA phase 1 due date and CAPA owner
- If not escalated to CAPA, enter whether an investigation was needed, information about the resolution
- Save Changes
Escalating to CAPA
When it is determined that an NC is escalating to CAPA, you must enter a CAPA Phase 1 Due Date and a CAPA Owner. Escalating to CAPA is mandatory for all High risk NCs and is optional for all Low risk NCs. Click on the Save button.
You will then be taken to the form again, and when you scroll down you will be able to select approvers of the NC. Once the NC is approved, it will automatically close the NC as it’s been escalated to CAPA.
NC Approver Selection, Approval and Closure
Once the changes are saved, the approvers and roles that populate are based on the settings managed by the Quality Owner under the Approval Settings within their Settings menu.
As the individual who created the NC, you must also approve it, and at least one other person must approve it as well. It’s required to add at least one approver from each Role in bold, and it’s required to add each Individual Approver in bold. Once approvers are selected, click on Save and Submit. Those approvers will be notified of the NC approval request.
Note: If the creator of the NC is no longer available to approver, the Admin (Quality Owner) can set the permission of the creator to 'Viewer'. As a result the creator of the NC will no longer be required to approve it.
Approving the NC
The notification will show in the Dashboard notification list as well as the notification bell. All approvers can approve the NC from either of these two 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 an open CAPA associated with it), click on the Edit icon and make your edits.
Once you hit Save, this is put the NC back in draft mode and you will have to resubmit the NC for approval.
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