Adding Product Defects / Failures

Purpose

As a Record Owner, you add product defects or failures to document issues confirmed during the complaint investigation. You record the defect details so reviewers can reference them when assessing the complaint and determining any follow‑up actions.

Prerequisites

Installation Package: CQ Core, CQ Regulatory Reports Extension, CQ AS2 Gateway Extension, myCQ Extension, and CQ AI Extension

Product: QualityQuest and Platform Apps

Function: CQ Product Defect/Failure Addition

User Profile: Standard User

Permissions: CQ Base User PSG, CQ Complaint Owner PSG

Configurations: CQ Tasks

Steps

1. From the Complaint record, Evaluation tab, Defect / Failure section, click the New button.

2. Failure Type defaults to Product. If applicable, select Process from the drop-down.

3. Source is a read-only field that defaults to As Reported.

4. Enter or select the Part (Required if Failure Type selected is Product).

5. Enter the Lot Number.

6. Enter the Defective Quantity.

7. Optionally, enter the No. of Defects / Failure.

8. Optionally, enter the Cost of Defect / Failure.

9. Either select the Failure Code or enter the Defect / Failure and Failure Category.

10. Optionally, select the Defect / Failure Severity.

11. Optionally, enter the Defect / Failure Description.

12. Optionally, select the Cause Code.

13. Cause Code Category is a read-only field that autopopulates based on the selected Cause Code.

14. Cause Code Sub Category read-only field that autopopulates based on the selected Cause Code.

15. Optionally, enter the Cause Description.

16. Optionally, select the Controlled Document for reference.

17. Optionally, select the Equipment for reference.

18. Optionally, drop/Upload Files associated with the Defect / Failure.

19. Click the Save button or Save & New for additional Defects / Failures.

Example:

Expected Outcome

• The Defect record is created and assigned a unique number.

• Click View All to see all Defects / Failures.

• Edit and Delete options are available from the drop-down arrow at the end of each Defect / Failure row.

• The Defect / Failure link under the Related List Quick Links section displays the total count of defective parts.

Additional Resources

ComplianceQuest

• Adding Associated Items

• Adding Product History Reviews

• Reopening Complaint Investigations

• Redoing Complaint Investigations

• Escalating Complaints to CAPA

• Creating New CAPAs

• Linking Existing CAPAs