Abstract

AbstractDesign Failure Mode and Effects Analysis (DFMEA) is a process to identify and mitigate risks of failure of a product to perform the intended function(s) for the customer. DFMEAs can be performed at all stages of design from product concept to system to component. Several issues with concept level design FMEAs have been identified by Henshall, et al in 2014: large documents, focus on components with poorly defined connections, focus on hardware rather than integrated electro‐mechanical systems. As a result of these challenges, improvements to the system‐level product concept are unlikely. In 2023 Genter and Bauer described a novel approach to eliciting design considerations representing the needs of both the customer and business using System Level Assessment. These design considerations form the basis for a concept level design FMEA. This approach was applied to a design concept for a technology that had not been previously developed. When compared to a concept DFMEA approach as part of Inclusive Customer Driven Conceptual Design defined by Hari and Weiss, the System Level Assessment based approach took 4.5 hours for the Critical System compared to 8 hours per concept for Inclusive Customer Driven Conceptual Design. When compared to a traditional Concept FMEA yielding 67% prevention tasks, the System Level Assessment Concept FMEA yielded 95% prevention tasks.

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