Jan S Krouwer1. 1. Krouwer Consulting, Sherborn, Mass 01770, USA. info@krouwerconsulting.com
Abstract
OBJECTIVE: To review the Failure Mode Effects Analysis (FMEA) process recommended by the Joint Commission on Accreditation of Health Organizations and to review alternatives. This reliability engineering tool may be unfamiliar to hospital personnel. DATA SOURCES: Joint Commission on Accreditation of Health Organizations recommendations, Mil-Std-1629A, and other articles about FMEA were used. STUDY SELECTION: The articles were selected by a literature search that included Web site-accessible material. DATA EXTRACTION: All articles found were used. DATA SYNTHESIS: The results are based on the articles cited and the author's experience in conducting FMEAs in the medical diagnostics industry. CONCLUSIONS: Fault trees and a list of quality system essentials are recommended additions to the FMEA process to help identify failure mode effects and causes. Neglecting mitigations for failure modes that have never occurred is a possible danger when too much emphasis is placed on improving risk priority numbers. A modified Pareto, not based on the risk priority number, is recommended when there are qualitatively different failure mode effects with different severities. Performing a FMEA that both meets accreditation requirements and reduces the risk of medical errors is an attainable goal, but it may require a different focus.
OBJECTIVE: To review the Failure Mode Effects Analysis (FMEA) process recommended by the Joint Commission on Accreditation of Health Organizations and to review alternatives. This reliability engineering tool may be unfamiliar to hospital personnel. DATA SOURCES: Joint Commission on Accreditation of Health Organizations recommendations, Mil-Std-1629A, and other articles about FMEA were used. STUDY SELECTION: The articles were selected by a literature search that included Web site-accessible material. DATA EXTRACTION: All articles found were used. DATA SYNTHESIS: The results are based on the articles cited and the author's experience in conducting FMEAs in the medical diagnostics industry. CONCLUSIONS: Fault trees and a list of quality system essentials are recommended additions to the FMEA process to help identify failure mode effects and causes. Neglecting mitigations for failure modes that have never occurred is a possible danger when too much emphasis is placed on improving risk priority numbers. A modified Pareto, not based on the risk priority number, is recommended when there are qualitatively different failure mode effects with different severities. Performing a FMEA that both meets accreditation requirements and reduces the risk of medical errors is an attainable goal, but it may require a different focus.