Ask three standards what a risk is, and none tells you what to do tomorrow morning. This article defines risk operationally as a knowledge gap and shows how Step 6 of the FMEA minimises the risk: through knowledge that is generated and applied in the design. This turns the action list into a plan that creates robustness instead of documenting confidence.

SAE 1025 arrived in January 2026 as a new FMEA standard. Do you now need a second FMEA organisation? No. Both standards share the same method core, only the configuration follows the supplier regime.

In the FMEA, a single question decides which control actually works: can you set the parameter, or do you only get it? Anyone who cleanly separates control parameters (Cᵢ) and noise factors (Nᵢ) chooses between a prevention and a detection control not by gut feeling but by a test criterion. This article shows the decisive cut, the mandatory criteria and a concrete worked example.

Author: Dr. Saéd Ehsani System-based Design FMEA combines the thinking behind systems engineering with classic FMEA, thereby creating a clear, logically structured basis for risk analyses of complex mechatronic products. This approach reduces ffailure propagation paths, increases the robustness of product functions, and enables more efficient development processes. It is a modern way of improving product reliability in a structured and sustainable manner.

Lessons Learned develop solutions for specific problems and make them available for future applications. They are a central success factor for the future viability of companies.