In the Quality menu click Nonconformances.
If necessary, use the provided fields and views to filter the list. Click a link to edit a record, or click New.
On the Nonconformance tab, complete the following:
Enter a Short Description and Date, and select the Source, Nonconformance Category, Nonconformance Type, Manufacturer, and the person Assigned To resolve this issue (referred to as “NC Assigned To” in later procedures).
Click Save. The NC record’s status is set to “Initiated” and the Due Date is set for 30 days from now.
Optionally, select the Product(s) that triggered the nonconformance. These products will also be listed on the Products tab; conversely, any products added on the Products tab will be displayed on the main form.
If you have to record multiple nonconformances that have similar issues, you can link the records (on the Linked Records tab), so that you only need to perform one set of investigations and CAPAs. The Investigations list view shows the Parent Number for easy access to an investigation’s parent nonconformance record.
The Linked Records tab also displays any Quality events posted to create the nonconformance record.
The Forms tab displays all forms in the PDFForm look-up table that have been linked to Nonconformance. Open and complete these as required.
To alert the Assigned To user and set the NC status to “Investigate”, choose Actions»Investigate. This user will be alerted and will complete the remaining tabs as required to resolve the nonconformance, as described in Investigating and Resolving a Nonconformance.
At any stage, you can use the Documents tab to link external documents to the nonconformance record to provide easy access to the file (for more information, see “Linking or Importing a Document” on page 14-2).
When a nonconformance record is closed, all tabs become locked. You can choose Actions»Reopen to unlock all tabs except CAPA and Investigation, which must be unlocked separately.