System Safety in Healthcare: The Right and Wrong Ways to Perform Failure Mode and Effects Analysis (FMEA)

Dev Raheja; Maria Escano

doi:10.56094/jss.v53i3.107

Authors

Dev Raheja
Maria C. Escano, M.D.

DOI:

https://doi.org/10.56094/jss.v53i3.107

Keywords:

FMEA, ROI, medical, risk assessment

Abstract

The objective of performing Failure Mode and Effects Analysis (FMEA) is to use sound risk management principles, coupled with innovative solutions that can assure high return on investment (ROI). Quality Guru Philip Crosby wrote in his book, Quality is Free, that quality is free if you do the right things at the right time. Essentially, the savings from avoiding fixes, process changes and lawsuits are much higher than the cost of doing things right. The principles of sound risk management, experienced by this paper’s co-author Dev Raheja as an international engineering management consultant over 30 years, include:

Identifying risks
Assessing risks
Mitigating risks
Orchestrating risk management
Aiming at high ROI without compromising safety

Author Biographies

Dev Raheja

Mr. Dev Raheja has been a System Safety and System Reliability Engineering consultant for over 25 years. His range of consulting encompasses transportation systems, electric power systems, high tech industry, aerospace, defense systems, medical systems, and consumer products. He has conducted training in several countries including Sweden, Australia, Japan, UK, Turkey, Germany, Poland, Singapore, Brazil, South Africa, and Canada. He has done training and consulting work with NASA, U.S. Army, GM, Boeing, Eaton, Nissan Aerospace, Litton, General Dynamics, ITT, BAE Systems, Lockheed-Martin, Harley-Davidson, and United Technologies.

Prior to consulting, Mr. Raheja worked at General Electric, Cooper Industries, and at Booz-Allen & Hamilton. He is the author of several books including Assurance Technologies Principles and Practices (Second Edition, Wiley 2006), and Design for Reliability (Wiley, 2012). A Fellow of the System Safety Society, he has a received Scientific Achievement Award and the Educator-of the-Year Award from the society.

Mr. Raheja serves on the Patient and Families Advisory Council at Johns Hopkins Hospital as a patient safety advocate. He is Associate Editor for Healthcare Safety for The Journal of System Safety and an Associate Professor at University of Maryland where he teaches the “Design For Reliability” course which includes design for safety and trustworthiness.

Maria C. Escano, M.D.

Dr. Maria C. Escano completed her medical degree at University of Miami School of Medicine. She received her post-graduate training at Columbia University/New York Presbyterian Hospital in New York City and St. Agnes Hospital in Baltimore, Maryland. She completed her advanced trauma surgery fellowship at R. Adams Cowley Shock Trauma Center at the University of Maryland.

She has been a regular contributor to scholarly journals for many years and has presented across the country on various topics advocating systems and patient safety initiatives. Dr. Escano is also an extensive traveler, having forged friendships across six continents.