Design Risk Assessment

Definition of Design Risk Assessment:

A design risk assessment is the act of determining potential risk in a design process, either in a concept design or a detailed design. It provides a broader evaluation of your design beyond just CTQs, and will enable you to eliminate possible failures and reduce the impact of potential failures. This ensures a rigorous, systematic examination in the reliability of the design and allows you to capture system-level risk.

Additionally, a DFMEA would be a quantified estimate of the criticality of CTQ internal failures and CTC performance factors using the classic FMEA form but for design reviews and technology transfers. Performance to customer needs uses CTCs, design parameters to help meet those requirements and also the manufacturability requirements might be called CTQs. Both would be appraised in the DFMEA document and then updated as the product moves into production, based on real failure frequencies and severities, becoming a living risk-management and design feedback document.

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