WI-07 Complaint
Work Instruction for Complaint configuration items
1. Introduction
1.1. Purpose
This Work Instruction provides the tasks required to be performed as part of the Complaint configuration item lifecycle.
1.2. Scope
This Work Instruction covers the complete Complaint lifecycle.
1.3. Records and evidence
Records for each Complaint will be held based on the records and retention policy. Complaints are used to generate the following artifacts:
Change management file
Change request verification report
1.4. Responsibilities
As listed in the procedure description, each task in the Complaint item’s lifecycle will be completed by a member that is part of one of the following approval groups. When any of these approval group members can perform the task, Anyone is listed.
Item Assignee: The person responsible for the Complaint. This organization member is responsible for managing/completing the Complaint lifecycle activities. This Item Assignee can change from time to time.
Quality Manager: The person that verifies the Complaint is correctly documented, investigated, and completely tested. The Quality Manager is consulted to approve the Complaint.
R&D Lead: The person that is accountable for the Complaint. The R&D Lead is consulted to investigate, resolve, and approve the fix for the Complaint.
Product Manager: This organization member leads the product development, defines requirements, and ensures that the product meets customer demands. The Product Manager is accountable for the Complaint being investigated and resolved.
2. Procedure description
2.1. Step 1: Log into Jira
Anyone
Log into your Jira organization, e.g., your-company.atlassian.net.
2.2. Step 2: Create
Anyone
Define an appropriate title in the Summary field.
Define an appropriate Assignee (the Item Assignee).
Provide additional preliminary information in the extra fields. (All fields can still be edited later.)
2.3. Step 3: Navigate to the issue page
Anyone
Using the popover shown by Jira or through the Jira issue link, navigate to the Jira page of the Complaint.
2.4. Step 4: Change status to In Progress
Anyone
2.5. Step 5: Describe the complaint
Item Assignee
2.6. Step 6: Add a complaint type
Item Assignee
The complaint type helps to categorize the type of complaint. Select a complaint type:
Product Feedback: the complaint is about feedback about the product itself that is not necessarily an adverse event.
Adverse Event: the complaint is about an undesirable experience associated with the use of a medical product.
Severe Adverse Event: an event that results in serious injury (or even death).
Other
2.7. Step 7: Document the original customer complaint
Item Assignee
Information about the original customer complaint can be filled in in different fields.
Complaint received data: within the Original customer complaint field, describe the actual complaint.
2.8. Step 8: Document the complainant's contact information
Item Assignee
The contact information about the complainant can be added under the Complainant contact information field.
2.9. Step 9: Perform investigation, if required
Item Assignee
1. Select whether an investigation is Required or Not required.
Depending on whether an investigation is required or not, choose Required or Not required for the field Investigation required.
2. Perform the complaint investigation
Perform the required investigation to understand and solve the complaint. Document it under the Investigation field.
3. Fill in the date on which the complaint investigation was completed
After the investigation, choose the date on which the investigation was completed.
2.10. Step 10: Select configuration items and document found anomalies.
Item Assignee
Select which configuration items are affected by this complaint
Select which anomalies were found as part of the complaint investigation
Select which configuration items resolve this complaint
2.11. Step 11: Resolve and fix anomalies reported as part of this complaint. As needed, verify that all resulting anomalies are corrected.
Item Assignee
After identifying anomalies during the investigation, all anomalies should be fixed and resolved. All necessary tests and results should be documented.
2.12. Step 12: Fill in the final response to the complainant
Item Assignee
After the investigation was completed and found anomalies were fixed, fill in reply to the complainant.
2.13. Step 13: Change status to Resolved (Ready for Review)
Anyone
Once the Complaint is completed and ready for verification, change its status to Resolved.
2.14. Step 14: Review as Owner
Item Assignee
Review the Complaint to verify:
The Complaint is traceable to all other needed items.
The Complaint investigation has been correctly documented and concluded.
If the verification fails, reopen the ticket and, if needed, provide a comment on the reason it failed, then go to Step 5. If verification passes, approve the Complaint.
2.15. Step 15: Review as R&D Lead
R&D Lead
Review the Complaint to verify:
The Complaint is traceable to all other needed items.
The Complaint investigation has been correctly documented and concluded.
If the verification fails, reopen the ticket and, if needed, provide a comment on the reason it failed, then go to Step 5. If verification passes, approve the Complaint.
2.16. Step 16: Review as Quality Manager
Quality Manager
Review the Complaint to verify:
The Complaint is traceable to all other needed items.
The Complaint investigation has been correctly documented and concluded.
If the verification fails, reopen the ticket and, if needed, provide a comment on the reason it failed, then go to Step 5. If verification passes, approve the Complaint.
2.17. Step 17: Review as Product Manager
Product Manager
Review the Complaint to verify:
The Complaint is traceable to all other needed items.
The Complaint investigation has been correctly documented and concluded.
If the verification fails, reopen the ticket and, if needed, provide a comment on the reason it failed, then go to Step 5. If verification passes, approve the Complaint.
2.18. Step 18: Transition to a controlled state
Ketryx
Only Ketryx can move a Complaint to a controlled and effective state by transitioning its status to Closed. Ketryx moves the Complaint to a Closed state after all approval rules have been passed, i.e., all required groups have approved the Complaint.
Ketryx automatically adds a comment to the Jira issue with a link to the effective controlled record in Ketryx.
2.19. Step 19: Re-Open the complaint
Anyone
If a Complaint needs to be reopened, change its status to Reopen.
3. Procedure flow diagram
4. Item schema
Complaint Type: The nature of the complaint
Severe Adverse Event
Adverse Event
Product Complaint
Other
Description (rich text): Description of the complaint
Original customer complaint (rich text): The customer's original complaint
Affected items (-> Requirement, Software Item Spec, Hardware Item Spec, Test Case, Risk, Configuration Item, CAPA, Anomaly, Change Request): Items affected by the complaint
Introduced in version: What version this complaint is about
Name of medical device (short text): The official product name
Date complaint received (date): The date of when the complaint was received
Complainant contact information (rich text): Contact information of the complainant
Investigation required: Whether the complaint necessitates an investigation
Required
Not required
Date of investigation (date): The date when the investigation begun
Investigation (rich text): Details about the investigation
Reply to the complainant (rich text): Response of the product company to the client
Found anomalies (-> Anomaly): Anomalies that were discovered as a result of this complaint
Resolved by (-> Requirement, Software Item Spec, Hardware Item Spec, CAPA, Change Request)
5. Traceability to other configuration items
The following relations can be defined from a Complaint to other configuration items:
Complaint finds Anomaly
Complaint relates to Anomaly
Complaint relates to and is resolved by Hardware Item Spec, Requirement, Change Request
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