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Evaluating inputs of failure modes and effects analysis in identifying patient safety risks

Mecit Can Emre Simsekler (Department of Industrial and Systems Engineering, Khalifa University of Science Technology, Abu Dhabi, United Arab Emirates) (School of Management, University College London, London, UK)
Gulsum Kubra Kaya (Department of Engineering, University of Cambridge, Cambridge, UK)
James R. Ward (Department of Engineering, University of Cambridge, Cambridge, UK)
P. John Clarkson (Department of Engineering, University of Cambridge, Cambridge, UK)

International Journal of Health Care Quality Assurance

ISSN: 0952-6862

Article publication date: 11 February 2019



There is a growing awareness on the use of systems approaches to improve patient safety and quality. While earlier studies evaluated the validity of such approaches to identify and mitigate patient safety risks, so far only little attention has been given to their inputs, such as structured brainstorming and use of system mapping approaches (SMAs), to understand their impact in the risk identification process. To address this gap, the purpose of this paper is to evaluate the inputs of a well-known systems approach, failure modes and effects analysis (FMEA), in identifying patient safety risks in a real healthcare setting.


This study was conducted in a newly established adult attention deficit hyperactivity disorder service at Cambridge and Peterborough Foundation Trust in the UK. Three stakeholders of the chosen service together with the facilitators conducted an FMEA exercise along with a particular system diagram that was initially found as the most useful SMA by eight stakeholders of the service.


In this study, it was found that the formal structure of FMEA adds value to the risk identification process through comprehensive system coverage with the help of the system diagram. However, results also indicates that the structured brainstorming refrains FMEA participants from identifying and imagining new risks since they follow the process predefined in the given system diagram.


While this study shows the potential contribution of FMEA inputs, it also suggests that healthcare organisations should not depend solely on FMEA results when identifying patient safety risks; and therefore prioritising their safety concerns.



The authors acknowledge all the hospital staff who voluntarily participated in this study at the Adult ADHD Service at the Cambridge Peterborough Foundation Trust. The system diagram used throughout the FMEA exercise was generated by using Cambridge Advanced Modeller (CAM) (Wynn et al., 2010). The authors also thank Dr Jieling Long for his substantial support and collaboration in modelling SMAs. The authors declared no potential conflicts of interests with respect to the authorship and/or publication of this paper. This work was partly supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) East of England, at Cambridgeshire and Peterborough NHS Foundation Trust. Provenance and peer review: not commissioned; externally peer reviewed.


Simsekler, M.C.E., Kaya, G.K., Ward, J.R. and Clarkson, P.J. (2019), "Evaluating inputs of failure modes and effects analysis in identifying patient safety risks", International Journal of Health Care Quality Assurance, Vol. 32 No. 1, pp. 191-207.



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