近年發生多起事故，如三星電池爆炸事件、高田安全氣囊因存缺陷召回數萬車輛，現今環境充滿風險，而失效模式與效應分析（FMEA , Failure Mode and Effects Analysis）正是一個預防性的風險管理工具；FMEA針對失效風險逐一檢討其嚴重度、發生度、偵測度。FMEA的價值是從產品最初的設計階段，一直到量產時的製程改善，將失效風險降至最低，提高品質預防失效。
IATF 16949是生產車用產品必要通過的稽核條文，IATF 16949有五大核心工具，分別是PPAP、APQP、FMEA、SPC、MSA。ISO 9001:2008改版至ISO 9001:2015，將風險管理列入重要稽核項目中，因產品架構越來越複雜，失效風險也越來越高。當中最常被稽核缺失的項目為FMEA，因它是從設計階段一直到量產都需要一直更新，持續使用的工具，而FMEA通常又是由單一工程師撰寫，全憑主觀想法或是將結果導向自己有利之項目進行撰寫，因此無法找到真正風險最高且最需被改善之項目；計算風險優先值（RPN , Risk Priority Number)時，因存在嚴重度、發生度、偵測度的權重一致等缺點，導致傳統RPN排序無法真實反映實際狀況，無法找出真正高風險之項目。
本研究嘗試將模糊理論(Fuzzy)中的模糊規則庫導入於FMEA中，利用問卷評分的方式讓公司的各部門專家參與FMEA的撰寫，最後Fuzzy FMEA與傳統FMEA做比較，結果找出工程師評分問題以及找到最合適的風險優先項目進行改善，呈現顧客較重視嚴重度風險的結果，達到顧客要求。顧客稽核本研究Fuzzy FMEA文件給予正面評價，並建議未來可以將該方法建立系統化管理。

Nowadays, customers are paying increasing attention re risk of product. FMEA (Failure Mode and Effects Analysis) is a preventive tool for risk which is widely-used in each stage of product life cycle in manufacturing industry in order to assess failure risk and corresponding actions to implement risk management for product failures. Furthermore, for customer or third-party audits, FMEA is a must-read type of document.
FMEA is usually prepared by a product engineer who writes the FMEA based on his own subjective ideas or drives the result of FMEA favorable to his enterprise or department. These reasons will mislead the result from finding the critical risky items requiring for improvement. Therefore, it is impossible to find the item that has the highest risk and needs improvement the most. Many customers of automobile factory learned about the shortcomings of traditional FMEA and now skips risk ranking result of traditional RPN (Risk Priority Number).
This study attempts to introduce the fuzzy rules in fuzzy theory into FMEA. The study arranges experts from various departments to participate in the FMEA evaluation and finally compare the Fuzzy FMEA with the traditional FMEA to find out the engineers' evaluation problems, as well as, the most suitable risk prioritization to present and improve the truly high-risk items so as to improve customer satisfaction.

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