Quality and Reliability Engineering International

A linguistic risk prioritization approach for failure mode and effects analysis: A case study of medical product development

Early View

Abstract Failure mode and effects analysis (FMEA) is a widely used risk management technique for identifying the potential failures from a system, design, or process and determining the most serious ones for risk reduction. Nonetheless, the traditional FMEA method has been criticized for having many deficiencies. Further, in the real world, FMEA team members are usually bounded rationality, and thus, their psychological behaviors should be considered. In response, this study presents a novel risk priority model for FMEA by using interval two‐tuple linguistic variables and an integrated multicriteria decision‐making (MCDM) method. The interval two‐tuple linguistic variables are used to capture FMEA team members' diverse assessments on the risk of failure modes and the weights of risk factors. An integrated MCDM method based on regret theory and TODIM (an acronym in Portuguese for interactive MCDM) is developed to prioritize failure modes taking experts' psychological behaviors into account. Finally, an illustrative example regarding medical product development is included to verify the feasibility and effectiveness of the proposed FMEA. By comparing with other existing methods, the proposed linguistic FMEA approach is shown to be more advantageous in ranking failure modes under the uncertain and complex environment.

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