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

Franklin, B.D., Shebl, N.A. and Barber, N. (2012) Failure mode and effects analysis: too little for too much? BMJ Quality & Safety, 23rd March . 10.1136/bmjqs-2011-000723.

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DOI: 10.1136/bmjqs-2011-000723


Failure mode and effects analysis (FMEA) is a structured prospective risk assessment method that is widely used within healthcare. FMEA involves a multidisciplinary team mapping out a high-risk process of care, identifying the failures that can occur, and then characterising each of these in terms of probability of occurrence, severity of effects and detectability, to give a risk priority number used to identify failures most in need of attention. One might assume that such a widely used tool would have an established evidence base. This paper considers whether or not this is the case, examining the evidence for the reliability and validity of its outputs, the mathematical principles behind the calculation of a risk prioirty number, and variation in how it is used in practice. We also consider the likely advantages of this approach, together with the disadvantages in terms of the healthcare professionals' time involved. We conclude that although FMEA is popular and many published studies have reported its use within healthcare, there is little evidence to support its use for the quantitative prioritisation of process failures. It lacks both reliability and validity, and is very time consuming. We would not recommend its use as a quantitative technique to prioritise, promote or study patient safety interventions. However, the stage of FMEA involving multidisciplinary mapping process seems valuable and work is now needed to identify the best way of converting this into plans for action

Item Type:Article
Departments, units and centres:Department of Practice and Policy > Department of Practice and Policy
ID Code:3167
Journal or Publication Title:BMJ Quality & Safety
Deposited By:Library Staff
Deposited On:04 May 2012 14:40
Last Modified:04 May 2012 14:40


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