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.