QUERI – Quality Enhancement Research Initiative

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Quality Improvement Methods

14.Failure Mode and Effects Analysis

a. Definition: Failure Mode and Effects Analysis (FMEA) considers the ways or modes in which something might fail, or an error occur and then doing a structured study of the causes of the failure, the effect of each cause and how best to deal with the causes of failure. By breaking down the causes and relationships, this method results in a better understanding of the processes involved and where best to prevent future failures or reduce risk. It identifies actions to reduce or eliminate causes and documents the entire process. It was initially developed in the 1950s for the analysis of military equipment malfunctions. Where clinical quality is concerned, FMEA can be used to develop an improved design, to better understand an error, or to avoid a failure before it occurs. In planning a QUERI research intervention, it could be used to reduce the chances of adverse results. Worksheets and software exist to manage the information and present it in a standardized way.

Healthcare Failure Mode and Effect Analysis (HFMEA) is FMEA specifically for healthcare. VA documents describe it as: HFMEA streamlines the hazard analysis steps found in the traditional Failure Mode and Effect Analysis process by combining the detectability and criticality steps into an algorithm presented as a "Decision Tree." See DeRosier, Joseph, et al. "Using health care failure mode and effect analysis: the VA National Center for Patient Safety's prospective risk analysis system." The Joint Commission Journal on Quality and Patient Safety 28.5 (2002): 248-267.

a. Literature:

  • Brooks, Frederick P. The mythical man-month. Vol. 1995. Reading: Addison-Wesley, 1975. (Not about FMEA expressly but this popular book provides a foundation for it.)
  • Stamatis, Dean H. Failure mode effect analysis: FMEA from theory to execution. ASQ Quality Press, 2003.
  • DeRosier, Joseph, et al. "Using health care Failure Mode and Effect Analysis: the VA National Center for Patient Safety's prospective risk analysis system." Joint Commission Journal on Quality and Patient Safety 28.5 (2002): 248-267.
  • Spath, Patrice L. "Using failure mode and effects analysis to improve patient safety." AORN journal 78.1 (2003): 15-37.
  • Reiling, John G., Barbara L. Knutzen, and Mike Stoecklein. "FMEA—the cure for medical errors." Quality Progress 36.8 (2003): 67-71.

c. Example: A hospital performed a FMEA on its electronic health record system. The hospital identified the various scenarios which could result in wrong information being stored in a patient's records. This analysis identified what specific actions the hospital should take in the near term in order to reduce the likelihood of the most important problems related to its quality of care. The cross-functional team used their experience and judgment to determine appropriate priorities for action based on a study of the possible failures, impacts, causes and ability to detect each failure. These factors can be scored and a combined score used to set priorities, such as:


d. Steps:

1) Define the objective and scope of the FMEA.

2) Assemble a multidisciplinary team

3) Graphically describe the processes and sub processes. For each function involved, identify the ways in which failure could occur.

4) Conduct a hazard analysis; including determining how serious each failure mode impact is and its likelihood. Often these are given a numerical value.

5) For each failure mode define the detection mode and how likely it is to detect a failure.

6) Determine priorities based on the aforementioned impact, likelihood and detection scores.

7) Develop and implement a mitigation plan of actions based on the information from the analysis as well as outcome measures to evaluate the results.