When Recording a Complaint, a Customer Service Representative–or CSR–enters essential information about the complaint in the Overview tab. This includes the date the complaint was initiated, the nature of the complaint, a brief description, and a summary of any progress made to date. In the Pertains To section, a CSR can indicate any products, orders, patients, Bulk Lots, or Packaging Runs relevant to the complaint. This is useful if a complaint initiates a product recall.
If the complaint's status is Open it means the licence holder's QA Technicians are still investigating the issue and/or performing corrective actions. If these processes are complete and the licence holder has addressed the complaint, the CSR can Close the Complaint.
If the complaint requires an investigation, QA Technicians should use the Investigation tab to document the details of the investigation. Click the icon to unlock editing capabilities.
By default, an investigation's status is Open. Once the investigation is complete, click the icon to unlock editing capabilities, and click Close Investigation.
If the complaint requires corrective actions, QA Technicians should use the Corrective Actions tab to track any steps taken to rectify the issue. The Assigned To, Implemented By, and QA Approved By sections allow the QA team to identify the staff members tasked with corrective actions, implementation, and QA approval.
By default, the Corrective Actions status is Open. Once corrective actions are complete, click the icon to unlock editing capabilities, and click Close Corrective Actions.