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Failure mode and effects analysis: too little for too much?

Bryony Dean Franklin1, Nada Atef Shebl, Nick Barber

  • 1Director, Centre for Medication Safety and Service Quality, UCL School of Pharmacy and Imperial College Healthcare NHS Trust, Pharmacy Department, Charing Cross Hospital, London, UK. bryony.deanfranklin@imperial.nhs.uk

BMJ Quality & Safety
|March 27, 2012
PubMed

Insights

Failure Mode and Effects Analysis (FMEA) is a popular healthcare risk assessment tool. However, current evidence shows FMEA lacks reliability and validity for prioritizing patient safety interventions.

Area of Science:

  • Healthcare Risk Management
  • Patient Safety
  • Quality Improvement

Background:

  • Failure Mode and Effects Analysis (FMEA) is a widely adopted prospective risk assessment method in healthcare.
  • FMEA utilizes multidisciplinary teams to identify potential process failures, their likelihood, severity, and detectability.
  • The goal is to calculate a Risk Priority Number (RPN) to guide interventions.

Purpose of the Study:

  • To evaluate the evidence base for the reliability and validity of FMEA outputs in healthcare.
  • To examine the mathematical principles underlying FMEA's Risk Priority Number (RPN) calculation.
  • To assess the practical application and time investment of FMEA in clinical settings.

Main Methods:

  • Systematic review of existing literature on FMEA in healthcare.
  • Analysis of the methodologies and reported outcomes of FMEA studies.
  • Critical appraisal of the quantitative aspects and practical utility of FMEA.

Main Results:

  • Despite widespread use, there is limited empirical evidence supporting FMEA's reliability and validity for quantitative risk prioritization.
  • The mathematical basis for RPN calculation is questionable, and its application varies significantly in practice.
  • FMEA is resource-intensive, requiring substantial healthcare professional time.

Conclusions:

  • FMEA is not recommended as a quantitative tool for prioritizing patient safety interventions due to lack of evidence.
  • The process mapping and multidisciplinary team engagement stages of FMEA are valuable.
  • Further research is needed to develop effective methods for translating FMEA's process mapping into actionable patient safety plans.

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