A complaint may have been created from a Quality Event record (see Reviewing Events). In this case some fields will be populated from the event record. The event record will be listed on the Related Quality Event tab so you can view the event that triggered the complaint. Any linked documents and/or products from the event record will be listed on their respective tabs in the complaint record. Retrieve the complaint and complete it as usual.
In the Quality menu click Complaints.
If necessary, use the provided fields and views to filter the list. Click a link to edit a record, or click New.
On the Quality Customer Complaint tab, complete the following:
Enter a Short Description, a longer Description, and the Awareness Date (when you received the complaint), and any other fields that you are able to capture at this time.
Select the person Assigned To resolve this issue (referred to as “Complaint Assigned To” in later procedures).
Click Save. The 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 complaint. 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 received multiple complaints, you can link the complaint 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. If you identified a related Supplier, the complaint will also be listed on the Linked Records tab of the Supplier record.
The Forms tab displays all forms in the PDFForm look-up table that have been linked to Quality Complaints. Open and complete these as required.
To alert the Assigned To user and set the complaint status to “Investigate”, choose Actions»Investigate. This user will be alerted and will complete the remaining tabs as required to resolve the complaint, as described in Investigating and Resolving a Complaint.
At any stage, you can use the Documents tab to link external documents to the complaint record to provide easy access to the file (for more information, see “Linking or Importing a Document” on page 14-2).
When a complaint 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.