Complaint records can be created by Quality Owners, Editors and Approvers.
Note: This video was created using V1.24.2. Enzyme is updated weekly so some elements may change.
Access Complaints module under Improvement in the navigation menu.
Create New Complaint Record
To create a new complaint, click on the + Create New Complaint Record. This will open up a form where you can enter detailed information.
Enter information about the date when the procedure occurred, when the complaint occurred and when your company became aware of it.
Enter information about the person or entity who has reported the complaint to the company.
Describe where, when and all other provided details of the complaint event. Also indicate if the complaint resulted in an injury. If your company is using codes to categorize complaints, you can select one. Codes can be determined by the Admins under Complaint Settings.
Enter any additional information (emails, pictures, video files, MDR data) you want to capture about the complaint.
Indicate if there was a clinical injury outcome associated with the complaint and information about the patient.
Complaint Triage Assessment
Asses if the complaint needs further action and if an investigation needs to be opened.
Once you have entered all the information, click Save Changes at the top of the form.
Depending on your Compliant Triage Assessment you will see the Reportability and Investigation tabs.
Enter information about the reportability decision.
Enter information about the investigation such as
- Investigation details
Dates of investigation, product analysis information, shipping history, complaint, labeling review, root cause investigation, risk analysis and escalation statement. details of the investigation and any information about the product return.
- Product Return
Product return dates, description, and any associated files.
Be sure to Save Changes when you are done. When ready you can choose approvers and submit the complaint for approval or approval & closure.
Review the history of the compliant record from creating to closed.
Submit for Approval
If you are ready to submit the complaint then select Choose Approvers.
Then you will be able to select the approvers for this complaint which will populate based on the approvals set by the Admin. You will be able to Submit for Approval or Submit for Approval & Closure.
Individual approvers in bold are required and cannot be removed from the Complaint. Roles in bold must have at least one user approving for that role. Individual approvers and roles that are not bold are optional and can be removed. At least one approver (other than yourself) is required.
Once approvers are finalized and when the Complaint is submitted, all listed approvers will receive a notification and must approve. Any single approver (or role) can deny the request.
Click on Submit for approval and closure button and it will be routed to the approvers you specified.
Before the complaint is approved, you can always pullback to make changes to it.
To make changes to a complaint once it's approved, click Reopen Complaint to make changes.
Edit Complaint Records
If you edit a complaint record that was previous approved, it will return to draft state.
To edit a closed complaint record, you must first reopen it. Once you reopen and make changes, it will have to be rerouted for approval again.
At any time you can export the complaint record which will be emailed to you and be accessible through the notification bell in Enzyme.
If you have any questions, you can reach us through the in-app chat or email us at email@example.com.