Failure Modes and Effects Analysis (FMEA) is a methodology that may contribute to identify and reduce risks during the product design phase. Although this is a widely used methodology within several fields; it has nevertheless many limitations and challenges. Traditional FMEA process was applied during the design phase of the company involved in this study. The FMEA methodology is discussed and evaluated and an evolved method to improve problem solving and root cause detection is proposed. The results show that the formal fulfillment of the method is not sufficient by itself to achieve efficiently quality and reliability improvement on the product design. Consequently, to succeed with the FMEA methodology it is proposed to combine it with the A3 problem solving methodology for a deeper analysis of the root causes for the prioritized issues during the risk reduction process.
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