Failure Mode and Effects Analysis (FMEA) is to prevention and proactive risk management as Root Cause Analysis is to occurrence of adverse events. Root Cause Analysis is a structured analytic methodology used primarily to examine the underlying contributors to an adverse event or condition. Failure Mode and Effects Analysis (FMEA) differs from this in that it is a structured analytic methodology used primarily to evaluate a process prior to its implementation. Its purpose is to identify on an a priori basis the ways in which that process might potentially fail, with the goal in mind being to eliminate or reduce the likelihood and/or outcome severity of such a failure.

Healthcare organizations accredited by JCAHO are required to conduct a root cause analysis (RCA) in response to any sentinel event. Such organizations are also required to conduct at least one failure mode & effects analysis (FMEA) or similar proactive analysis annually.

The HFMEA process may be reviewed at Steps in the FMEA process.

Healthcare Failure Mode and Effects Analysis (HFMEA^®) is the modified form of FMEA that we have developed for specific application to the healthcare environment. HFMEA is a registered trademark of Medical Risk Management Associates, LLC.