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Failure Mode and Effects Analysis (FMEA), including design (DFMEA) and process (PFMEA), is an important part of advanced quality planning (AQP) or Advanced Product Quality Planning (APQP). The latter activities may be required by customers, especially in the automotive industry. FMEA also supports the new ISO 9001:2015 requirement for "Actions to Address Risks and Opportunities," although it played an important role in product and process planning under previous versions of ISO 9001 and also the corresponding automotive ISO/TS 16949 standard.
William A. Levinson, P.E., is the principal of Levinson Productivity Systems, P.C. He is an ASQ Fellow, Certified Quality Engineer, Quality Auditor, Quality Manager, Reliability Engineer and Six Sigma Black Belt. He is also the author of several books on quality, productivity and management, of which the most recent is The Expanded and Annotated My Life and Work: Henry Ford's Universal Code for World-Class Success.