Failure Modes and Effects Analysis

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Definition and Utilization

The American Society for Quality (ASQ) defines Failure Mode Effects Analysis (FMEA) as a step-by-step approach for identifying all possible failures in a design, a manufacturing or assembly process, or a product or service. It also documents current knowledge and actions about the risks of failures, for use in continuous improvement. They further define “Failure modes” as the ways, or modes, in which something might fail. [1]

The Institute for Healthcare Improvement defines Failure Mode and Effects Analysis as a systematic, proactive method for evaluating a process to identify where and how it might fail and to assess the relative impact of different failures, in order to identify the parts of the process that are most in need of change. FMEA is systematic way to evaluate processes for possible failures and to prevent them by redesigning the processes proactively rather than reacting to adverse events after failures have occurred. It is a strong tool to deconstruct an activity system to understand where the weak parts of the process are. This emphasis on prevention may reduce risk of harm to both patients and staff. FMEA is particularly useful in evaluating a new process prior to implementation and in assessing the impact of a proposed change to an existing process. Once the process has been evaluated and the failure modes identified, then high risk errors are identified and either eliminated or mitigating actions defined. [2]


The Failure Mode and Effects Analysis process was developed by the U.S. military in the 1940s. The National Aeronautics and Space Administration (NASA) utilizes a variation of the FMEA process for failure identification, management and control of mission critical hardware and procedures. The civil aviation industry as well as the automotive and other industries maintain their own FMEA standards. Although FMEA methodology was developed outside of healthcare, it is now being used in healthcare. [3]

Motivation for FMEA process utilization in healthcare

The Joint Commission

The Joint Commission (formerly The Joint Commission on Accreditation of Healthcare Organizations, JCAHO), founded in 1951, is the nation’s oldest and largest standards-setting and accrediting body in health care. The Joint Commission accredits and certifies more than 20,500 health care organization in the United States. Their mission is: To continuously improve health care for the public, in collaboration with other stakeholders, by evaluating health care organizations and inspiring them to excel in providing safe and effective care of the highest quality and value. The Joint Commission’s standards focus on patient safety and quality of care. There are more than 250 hospital accreditation standards and they address many things including: patient rights and education, infection control, medication management, and preventing medical errors. The standards also address how a hospital verifies that its doctors, nurses and other staff are qualified and competent, how the hospital prepares for emergencies, and how it collects data on its performance as well as how it uses that data to improve itself. [4]
The Joint Commission is the driver behind FMEA utilization in healthcare organizations. To maintain The Joint Commission accreditation, healthcare organizations must meet standards. The Leadership Standards and Elements of Performance Guidelines in July 2002 requires healthcare facilities to meet Standard LD.5.2 to stay in compliance. LD.5.2 requires facilities to select at least one high-risk process for proactive risk assessment each year, and the selection should be based on information published by The Joint Commission that identifies the most frequently occurring types of sentinel events. [5][6]

Healthcare Models of FMEA Utilization

The Institute for Healthcare Improvement has a step-wise set of instructions of the process to conduct a FMEA. They also have an online, interactive FMEA tool to create a FMEA and automatically calculate the risk priority number (RPN) of a process, evaluate the impact of process changes that are being considered and track process improvement over time. The Joint Commission has a similar stepwise process for conducting a FMEA analysis as the IHF with a few differences found in determining criticality of the failure mode identified (what the Institute for Health calls a Risk Priority Number) as well as conducting a root cause analysis on the most critical modes of failure. The Veterans Administration National Center for Patient Safety (VA NCPS) has developed their own FMEA methodology called Healthcare Failure Mode Effect Analysis (HFMEA).

The Institute for Healthcare FMEA Analysis [7]:

The interactive Institute for Healthcare FMEA Analysis Tool [8]:

The Joint Commission FMEA Analysis [9]:

National Center for Patient Safety Analysis [6]:


  1. ASQ - a Global Leader in Quality Improvement & Standards. Failure Mode Effects Analysis (FMEA) - ASQ. Retrieved October 23, 2014, from
  2. IHI Home Page. Failure Modes and Effects Analysis (FMEA) Tool. Retrieved October 23, 2014, from
  3. Wikipedia, the free encyclopedia. Failure mode and effects analysis - Wikipedia, the free encyclopedia. Retrieved October 23, 2014, from
  4. The Joint Commission. The Joint Commission FAQ. Retrieved October 23, 2014, from
  5. Barker, D., Berry, M., Driver, J., Hopper, M., Santoro, M., & Sine, D. (2002). ASHRM - Healthcare Risk Management and Patient Safety programs, information and resources. Retrieved October 23, 2014, from
  6. 6.0 6.1 DeRosier, J., & Nudell, T. (2001). VA National Center for Patient Safety Home. The Basics of Healthcare Failure Mode and Effect Analysis. Retrieved October 23, 2014, from
  7. IHI Home Page. Failure Modes and Effects Analysis (FMEA) Tool. Retrieved October 24, 2014
  8. IHI Home Page. Institute for Healthcare Improvement: Failure Modes and Effects Analysis Tool Report. Retrieved October 24, 2014
  9. Rich, D. (2001). FMEA Info Centre Home Page Failure Mode and Effects Analysis Information Center. Complying with the FMEA Requirement of the New Patient Safety Standards. Retrieved October 24, 2014

Submitted by Elizabeth Youmans