The user assigned to the complaint record (the “Complaint Assigned To”) (see Recording a Complaint) will be alerted at each change of status and will complete the investigation and record the CAPAs as required.
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.
If no investigation is required, select the No Investigations Required check box on the Quality Customer Complaint tab and save the record.
If investigation is required:
On the Investigations tab click New to create an investigation record. A complaint may require multiple investigations. Enter the details of the investigation, including who it is Assigned To, and click Save.
To alert the Assigned To user, choose Actions»Investigate. This user will be alerted to complete the investigation record.
Each investigation’s Assigned To user will review the investigation record, enter the Investigation Results and select the Closed check box.
Once all investigations are complete, the Complaint Assigned To user completes the Complaint Analysis and Post Investigation sections on the Quality Customer Complaint tab, selects the Investigation Complete check box and saves the record. The complaint status is changed to “CAPA Creation”.
If no corrective actios are required, select the No CAPAs Required check box on the Quality Customer Complaint tab and save the record. The complaint status is changed to “Review”.
If corrective actions are required:
On the CAPA tab, click New to record a finding and corresponding action (a complaint may involve multiple finding/actions).
Change the Finding Date if necessary and enter the Finding Details. If necessary, attach any documents related to the finding, such as an image.
Record the employee’s GDDLOFB and the action required, including who it has been Assigned To, the Reviewer, Priority, and Due Date.
To alert the Assigned To user, choose Actions»Address. This user will be alerted to complete the action and the status is set to “Work In Progress”.
When the CAPA Assigned To user has completed the action, they will enter any Completion Comments and Objective Evidence, and then choose Actions»CAPA Complete. The Reviewer is alerted and the status is set to “Pending Quality Review”.
If the Reviewer does not approve:
They will choose Actions»Reject and the status changes to “Requires Update”.
The Assigned To updates the record and chooses Actions»CAPA Update Complete; the status is set to “Pending Quality Review” again.
When the CAPA Reviewer approves, they will select the Closed check box and save the record. The status changes to “Closed-Done”.
Once all CAPA records are closed, the complaint record is in “Review” status.
The Complaint Assigned To user can record any costs related to the complaint, e.g. to rework the product, on the Quality Costs tab.
To close the complaint record, select “Approved” beside Approved/Requires Update and click Save.
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).