Failure Mode and Effect Analysis in the Health Care System

Background Information

Organizations often experience some hold-ups in the systems. Therefore, leaders of an organization usually devise or employ some tools to address this problem in the system. Failure mode and effect analysis is one such a device. This essay discusses the application of FMEA by healthcare organization to establish its appropriateness in health care system.

Certain authors have attempted to define Failure mode and effects analysis (FMEA) tool. According to Dong (2007), FMEA is a device popularly used in “electronic, aerospace, and automotive industries to identify, prioritize, and remove known potential failures, challenges, and errors from systems under development prior to the release of the product” (958). FMEA essentially involves brainstorming of the potential failure modes and their effects. Certain variables are crucial in FMEA including severity of the impact of failure mode, the incidence of failure mode, and identification of the failure using a scale of 1 to 10. The inspectors of the system quantify risks using risk priority number (RPN) which represents the product occurrence, detection, and severity. A large RPN signifies a higher risk and vice versa.

The most serious setback of traditional FMEA lies in the variables used for RNP determination. These three indices are ordinal scale variables, and they cannot define the cost of failure. Therefore, the product of ordinal indices is not relevant. This setback has triggered various researches on alternative FMEA strategies.

FMEA application in healthcare management

How can FMEA tool work in a health care process management context? Reiley (2002) states that, FMEA is performed by a team of experts whose objective is to search for all possible means by which a product or procedure can fail. Clinical errors can arise due to medication or process failure. Failure modes represent ways in which a process or product can fail. Distinct failure modes may have effects that have more chance of occurring than others do. Each effect has its unique risk and prospective for severity. The FMEA affords a means of detecting potential failures, the impact of those failures and connected risks of a product or process, to eradicate or minimize them.

A system inspector may modify an FMEA process to suit the context of the problem. However, an overall set of steps followed by a well- coordinated FMEA team is as follows (Reiley, 2002, p. 660):

  1. Process review: this process is typically achieved through flow-charting the process of interest.
  2. Brainstorm and document all possible failure modes.
  3. Brainstorm and catalog the impact of each distinct failure mode.
  4. Allot severity rating to every unique effect.
  5. Allot occurrence rating for every mode.
  6. Allot a detection rating for every effect and/or effect.
  7. Compute the critical score for all modes and effect. Note that the cumulative criticality score for every mode can be computed from the addition of criticality scores for all the effect associated with a mode and acts as a baseline measure for association on re-measurement.
  8. Order the failure modes based on priority for action. This process is achieved by a performing a Pareto analysis, prioritizing the most serious failures regardless of the criticality score.
  9. Undertake a cause analysis of reason for occurrence of failure modes.
  10. Undertake strict actions to prevent those failure modes with the highest severity.
  11. Compute consequential critical scores as with reduction of failure modes.

Requirement by the Joint Commission on Accreditation of Health Organization (JCAHO)

JCAHO is a forefront force behind the application of FMEA in a healthcare setting. In 2001, the JCAHO amended its accreditation standards to incorporate a requirement that healthcare organization undertake yearly, one proactive risk evaluation at least on a high-risk process. Although the standard, LD 5.2, does not sanction a particular proactive assessment procedure be applied, like FMEA, it underscores a generic process for detecting and tackling failure modes pertaining to health care process.

The following JCAHO requirements are intended for application of FMEA in a healthcare setting (American Society for Healthcare Risk Management, 2002, p. 2-3):

  1. In determining the process for risk assessment, the healthcare organization should take into account occurrence reports, claims data, employee’s reimbursement reports, the literature, or any cues of analysis. In addition, the organization should regard accidents of high severity or those that occur with considerable frequency. Organization must regard any catastrophic incidence as a sentinel event and whatever sentinel alert reported by JACHO can present opportunities for prospective analysis.
  2. JCAHO standards require that any health organization to undertake at least one risk assessment annually. However, a health organization may benefit from performing as many risk assessment as possible predetermine limit on organizational resource utility.


Researchers have proven the potential of FMEA to boost the safety of non-healthcare sector by a great margin. Nevertheless, there is no contemporary research evidence on the effectiveness of FMEA in the context of healthcare errors (Reiley, 2002, p. 663); the effectiveness of FMEA in enhancing the safety of other sectors may prospect success when employed appropriately in a medical context.

Reference list

American Society for Healthcare Risk Management. (2002). strategies and tips for amximizing failure mode efffect analysis in your organization. Chicago: American Hospital Association. Web.

Dong, C. (2007). Failure mode and effects analysis based on fuzzy utility cost estimation. Innternational Journal of Quality Reliability Mangement , 24(9), 958-973.

Reiley, T. T. (2002). FMEA in preventing medical accidents. ASQ World Conference on Quality and Improvement Proceedings (pp. 657-664). Colorado: American Society for Quality.

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