DFMEA

Design Failure Mode and Effects Analysis (DFMEA) is a structured proactive risk assessment used in product development to identify potential failure modes in a design, assess their effects on customers and system performance, and identify actions to mitigate risk before production. The objective is to improve reliability, safety, quality, and manufacturability by evaluating how design decisions could fail and prioritizing corrective measures.

DFMEA is typically conducted by a cross-functional team early in the development lifecycle. The process includes planning, function analysis, identifying potential failure modes for each function, describing the effects of those failures, determining root causes, listing current design controls, and assigning risk ratings for severity, occurrence, and detection. The Risk Priority Number (RPN) is calculated as the product of these factors and is used to prioritize actions. Actions may include design changes, added tolerances, material changes, or robustness tests. The design is iteratively updated and re-evaluated, and outputs feed into the Design Verification Plan and Report (DVP&R) and the design controls.

DFMEA outputs include the DFMEA document, action items, updated risk ratings, and links to the control plan and DVP&R. It is distinct from Process FMEA (PFMEA), which analyzes potential failures in manufacturing and assembly processes. DFMEA is often aligned with industry standards such as the AIAG and VDA FMEA handbooks to promote consistency.

Limitations include reliance on team judgment and data availability, and it should be updated whenever designs change or new failure data emerges. DFMEA remains a preventive tool to reduce design-related risks before products reach the market.