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 steps. When any of these 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

1. Press the Create button in the top-level navigation to open the form to create a new Jira work item.

2. Ensure the desired space (formerly project) is selected, and select the Work type "Complaint". If that does not appear, check with your system administrator to ensure your space is connected to Ketryx.

1. Define an appropriate title in the Summary field.

2. Define an appropriate Assignee (the Item Assignee).

3. Provide additional preliminary information in the extra fields. (All fields can still be edited later.)

4. Press the Create button at the end of the form to finalize the creation of the new Jira work item.

2.3. Step 3: Navigate to the work item page

Anyone

Using the popover shown by Jira or through the Jira work item link, navigate to the Jira page of the Complaint.

2.4. Step 4: Change status to In Progress

Anyone

Change the work item status to In Progress using the work item status selector.

2.5. Step 5: Describe the complaint

Item Assignee

As possible, fill in the information and describe the complaint within the Description field. Be sure to press "Save" after entering new information or making changes.

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.

1. Complaint received data: within the Original customer complaint field, describe the actual complaint.

   
2. Name of medical device: describe the device that caused the complaint.

3. Date received: the date when the complaint was filed and received.

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

1. Select which configuration items are affected by this complaint

2. Select which anomalies were found as part of the complaint investigation

3. Select which configuration items resolve this complaint

4. Add related tasks if applicable

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 steps have approved the Complaint.

Ketryx automatically adds a comment to the Jira work item 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