Prerequisites

• Access the Management > FMEA (FM012) menu.
• FMEA previously registered.
• To be part of the team responsible for FMEA.

Presentation

The FMEA framework represents the heart of the analysis; it is where failure modes, their effects, causes, and controls are recorded, forming the logic that will allow for risk assessment and the definition of recommended actions.

In SoftExpert FMEA, this structure can vary depending on the version used (4th Edition or AIAG & VDA), and in the case of process FMEAs, a specific wizard assists in assembling the elements according to the process flow.

Properly setting up this structure ensures that the analysis is complete, accurate, and adheres to the methodology defined by the organization.

Setting up the FMEA structure

1. Access the Management > FMEA (FM012) menu, select the desired FMEA and click .

2. On the FMEA data screen, open the Structure option according to the type of control configured.

3. The structure screen will be displayed, containing:

• At the top, the toolbar, with options for manipulating the structure.
• At the bottom, the areas are designated for including and configuring the FMEA elements.

4. In the toolbar, use the options as needed:

• Include: Use this option to select and include objects that will be part of the FMEA structure. Depending on the FMEA object, the structure may consist of items, assets, process activities, or project activities.
• Delete: Use this option to remove the selected object from the structure navigation.
• Data: Use this option to view FMEA data, review data, or structure object data.
• Action plan: Use this option to associate and configure actions linked to the FMEA structure, when integration with SoftExpert Action Plan is enabled.
• Copy data: Use this option to copy the structure from another FMEA to the current FMEA.

5. To begin the analysis, click on New failure mode and associate a failure mode with the structure object.

6. In Failure Mode, report:

• The failure mode.
• The associated characteristic.
• The related function.
• The corresponding requirement.
  If the failure mode has already been used in other FMEAs, the system will display a warning with access to lessons learned.

7. After adding the failure mode, click on New failure effect and enter the following information:

• The failure effect.
• The severity criterion.
• The classification, which can be automatically filled in according to the FMEA type rules.
• Secondary failure effects, if applicable.

8. Next, click on New failure cause to register it:

• The potential cause of the failure.
• The criteria for occurrence and detection.
• The NPR or AP field will be automatically filled in.
• For Design FMEAs, the lower element, when applicable.

9. After identifying the causes, click on New failure action to define the recommended action, specifying:

• The action to be performed.
• The person responsible for the action, when applicable.
• The type of action (preventive or corrective), if integration with the Action Plan component is not enabled.
• The deadline for execution.
• There will be approval after execution.

10. Repeat the process until all modes, effects, causes, and actions are properly recorded.

11. Changes made to the FMEA structure are saved automatically by the system.

Conclusion

Setting up the FMEA framework is an essential step to ensure that risks are correctly identified, assessed, and addressed. 

By structurally recording failure modes, their effects, causes, and recommended actions, SoftExpert FMEA enables a complete, consistent analysis aligned with the methodology's best practices. 

With the structure properly assembled, FMEA becomes a reliable basis for decision-making and continuous improvement of the processes, products, or projects analyzed.