Failure Mode and Effects Analysis

April 11, 2019 | Healthcare Risk, Quality, & Safety Guidance

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FMEA—a proactive, systematic method of identifying ways in which a process can go wrong and actions to address them—has been around for several decades. A military manual outlined an FMEA procedure in 1949, and the National Aeronautics and Space Administration began using it for missions as early as Apollo, bringing attention to the approach. Faced with a host of safety concerns and controversy regarding its beleaguered Pinto, Ford Motor Company introduced the approach to the auto industry. FMEA is now in widespread use in manufacturing and is becoming more common in service-based industries. The method has been successfully adapted for use in healthcare. (Stalhandske et al.)

A few features distinguish FMEA from other analytical techniques that patient safety, risk, and quality professionals may be familiar with and illustrate its utility.

FMEA is proactive. The approach focuses on identifying and addressing vulnerabilities before harm occurs. Although previous adverse events or near misses can inform the selection of processes to analyze and may inform the analysis itself, an adverse event or near miss related to the process need not have happened. The process supports a "preoccupation with failure," or continual vigilance against possible failures, which is one of the hallmarks of high-reliability organizations (Weick and Sutcliffe). It also supports the risk management process in that it allows organizations to proactively apply loss control techniques (e.g., loss prevention, loss reduction) to vulnerabilities rather than just react after an event occurs. (ASHRM)

FMEA is systematic. During the analytical phase, the team typically does the following (NCPS "Basics"; Williams):

The process also involves testing proposed actions on a small scale before widespread implementation and then monitoring outcomes to ensure effectiveness.

FMEA is flexible. It is especially useful for evaluating and improving high-risk or problematic processes that are currently in place, proposed changes to existing processes, and new processes. However, FMEA can also be used to analyze systems, products, or technology. Further, the approach can be applied not just to patient safety concerns but to issues relating...

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