Summer 2026 Help

Adding Design FMEAs to Design Files

Overview

Creating Design FMEAs from the Design File embeds risk-by-design into your development workflow. It lets you initiate the DFMEA where the product’s records live, then populate structure, failure modes, effects, detections, and risk controls with full traceability to related design artifacts supporting proactive risk reduction, collaboration, and audit-ready documentation. Best practice in ComplianceQuest is to create the DFMEA directly from the Design File rather than from the standalone FMEA tab.

Prerequisites


Available in: CQ Design

Installed Package(s): CQ Core, CQ Design Extension & CQ Process Extension - Winter 2025

Optional Extension Packages: myCQ & CQ PLM- Winter 2025

User Profile: Standard User

Permissions: CQ Base User PSG, CQ Design Owner PSG, and CQ Design Team Member PSG

Instructions


Linking or Creating Design FMEAs

  1. From the Design File record, Risk tab, Design FMEA section, click the Add button.

design fmea add.PNG
  1. From the Design File record, Risk tab, Design FMEA section, click the Create Design FMEA button. (If no Design FMEAs existed in the system.

created design fmea design file.PNG
  1. See the Adding or Creating Design FMEA specific to the Design FMEAs to be Added or Created.

:check_mark:

Results

  • The Design FMEAs record is added/created in the Design File record.

  • Edit and Delete options are available from the drop-down arrow at the end of each Product Risk row.

  • Click View All to see all Design FMEAs.

Troubleshooting

  • Check back for new articles