Journal of The Japanese Society for Quality Control
Online ISSN : 2432-1044
Print ISSN : 0386-8230
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Practical Proposals Based on a Rational New Approach to Failure Mode and Effects Analysis(FMEA)
Shuhei IIDA
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2025 Volume 55 Issue 3 Pages 150-157

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Abstract
 Failure Mode and Effects Analysis ( FMEA ) is widely used across various fields as a proactive risk management tool. The author has implemented quality management ( QM ) tools as part of Total Quality Management ( TQM ) in the healthcare field. When FMEA was introduced to Nerima General Hospital (1998), there were no reported use cases in healthcare, so references from industrial applications were used. However, certain terms and concepts were unacceptable for healthcare professionals. Therefore, I developed a healthcare-adapted training material, and tested in workshops with our employee and those from other hospitals, and refined accordingly. Through the “ Total Quality of Healthcare Management Study Group ” of this academic society, we developed and published the “Seven TQM Tools for Healthcare,” which was also presented at the this society’s conference. While FMEA is useful for safety management and often accepted uncritically, this paper highlights its issues and proposes revised concepts and practices.
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© 2025 The Japanese Society for Quality Control
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