Revised Risk Priority Number in Failure Mode and Effects Analysis Model from the Perspective of Healthcare System

Fatemeh Rezaei, Mohmmad H. Yarmohammadian, Abbas Haghshenas, Ali Fallah, Masoud Ferdosi


Background: Methodology of Failure Mode and Effects Analysis (FMEA) is known as an important risk assessment tool and accreditation requirement by many organizations. For prioritizing failures, the index of “risk priority number (RPN)” is used, especially for its ease and subjective evaluations
of occurrence, the severity and the detectability of each failure. In this study, we have tried to apply FMEA model more compatible with health‑care systems by redefning RPN index to be closer to reality.

Methods: We used a quantitative and qualitative approach in this research. In the qualitative domain, focused groups discussion was used to collect data. A quantitative approach was used to calculate RPN score.

Results: We have studied patient’s journey in surgery ward from holding area to the operating room. The highest priority failures determined based on (1) defning inclusion criteria as severity of incident (clinical effect, claim consequence, waste of time and fnancial loss), occurrence of incident (time ‑ unit occurrence and degree of exposure to risk) and preventability (degree of preventability and defensive barriers) then, (2) risks priority criteria quantifed by using RPN index (361 for the highest rate failure). The ability of improved RPN scores reassessed by root cause analysis showed some variations.

Conclusions: We concluded that standard criteria should be developed inconsistent with clinical linguistic and special scientifc felds. Therefore, cooperation and partnership of technical and clinical groups are necessary to modify these models.

Keywords: Failure Mode and Effects Analysis, health system, risk assessment, risk priority number

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Rezaei F, Yarmohammadian MH, Ferdosi M, Haghshenas A.

Developing an integrated clinical risk management model for

hospitals. Int J Health Syst Disaster Manage 2013;1:221.

Chan D, Ng SS, Chong YH, Wong J, Tam YH, Lam YH, et al.

Using ‘failure mode and effects analysis’ to design a surgical

safety checklist for safer surgery. Surg Pract 2010;14:53‑60.

Chiozza ML, Ponzetti C. FMEA: A model for reducing medical

errors. Clin Chim Acta 2009;404:75‑8.

Senders JW. FMEA and RCA: The mantras of modern risk

management. Qual Saf Health Care 2004;13:249‑50.

Lu Y, Teng F, Zhou J, Wen A, Bi Y. Failure mode and effect

analysis in blood transfusion: A proactive tool to reduce risks.

Transfusion 2013;53:3080‑7.

Thornton E, Brook OR, Mendiratta‑Lala M, Hallett DT,

Kruskal JB. Application of failure mode and effect analysis in a

radiology department. Radiographics 2011;31:281‑93.

Lago P, Bizzarri G, Scalzotto F, Parpaiola A, Amigoni A,

Putoto G, et al. Use of FMEA analysis to reduce risk of errors

in prescribing and administering drugs in paediatric wards: A

quality improvement report. BMJ Open 2012;2. pii: E001249.

Shebl NA, Franklin BD, Barber N. Failure mode and effects

analysis outputs: Are they valid? BMC Health Serv Res


Sellappan N, Palanikumar K. Modified prioritization

methodology for risk priority number in failure mode and effects

analysis. Int J Appl Sci Technol 2013;3:27‑36.

Yeh TM, Chen LY. Fuzzy‑based risk priority number in

FMEA for semiconductor wafer processes. Int J Prod Res


Xiao N, Huang HZ, Li Y, He L, Jin T. Multiple failure modes

analysis and weighted risk priority number evaluation in FMEA.

Eng Fail Anal 2011;18:1162‑70.

Liu HC, Liu L, Liu N. Risk evaluation approaches in failure

mode and effects analysis: A literature review. Expert Syst Appl


Mengis J, Nicolini D. Root cause analysis in clinical adverse

events. Nurs Manag (Harrow) 2010;16:16‑20.

Smith IJ. Failure Mode and Effects Analysis in Health Care:

Proactive Risk Reduction. Oakbrook Terrace, IL, United States:

Joint Commission Resources; 2005.

Guida E, Rosati U, Pini Prato A, Avanzini S, Pio L, Ghezzi M,

et al. Use of failure modes, effects, and criticality analysis

to compare the vulnerabilities of laparoscopic versus open

appendectomy. J Patient Saf 2015;11:105‑9.

van Wagtendonk I, Smits M, Merten H, Heetveld MJ, Wagner C.

Nature, causes and consequences of unintended events in surgical

units. Br J Surg 2010;97:1730‑40.

Walker IA, Reshamwalla S, Wilson IH. Surgical safety checklists:

Do they improve outcomes? Br J Anaesth 2012;109:47‑54

de Vries EN, Eikens‑Jansen MP, Hamersma AM,

Smorenburg SM, Gouma DJ, Boermeester MA. Prevention of

surgical malpractice claims by use of a surgical safety checklist.

Ann Surg 2011;253:624‑8.

Quigley PA, White SV. Hospital‑based fall program measurement

and improvement in high reliability organizations. Online J

Issues Nurs 2013;18:5.

Zegers M, de Bruijne MC, de Keizer B, Merten H,

Groenewegen PP, van der Wal G, et al. The incidence,

root‑causes, and outcomes of adverse events in surgical units:

Implication for potential prevention strategies. Patient Saf Surg


Cydulka RK, Tamayo‑Sarver J, Gage A, Bagnoli D. Association

of patient satisfaction with complaints and risk management

among emergency physicians. J Emerg Med 2011;41:405‑11.

Warburton KD, Scott CL. Violence risk assessment and

treatment. CNS Spectr 2014;19:366‑7.

Manuj I, Esper TL, Stank TP. Supply chain risk management

approaches under different conditions of risk. J Bus Logist


Ding Q, Schenk L, Hansson SO. Setting risk‑based occupational

exposure limits for no‑threshold carcinogens. Hum Ecol Risk

Assess 2014;20:1329‑44.

Chang Y. Risk analysis of cargos damages for aquatic products

of refrigerated containers: Shipping operators’ perspective in

Taiwan. Risk Anal 2012;4:86‑94.

Bas E. An investment plan for preventing child injuries using

risk priority number of failure mode and effects analysis

methodology and a multi‑objective, multi‑dimensional mixed 0‑1

knapsack model. Reliab Eng Syst Saf 2011;96:748‑56.

Zammori F, Gabbrielli R. ANP/RPN: A multi criteria

evaluation of the risk priority number. Qual Reliab Eng Int


Hayes W, Cohen J, Ferguson B, editors. A Defect Prioritization

Method Based on the Risk Priority Number. Software Solutions

Conference. U.S: Carnegie Mellon University; 2015.

DeRosier J, Stalhandske E, Bagian JP, Nudell T. Using health

care failure mode and effect analysis™: The VA national center

for patient safety’s prospective risk analysis system. Jt Comm J

Qual Patient Saf 2002;28:248‑67.

Yarmohammadian MH, Rezaei F, Ferdosi M, Haghshenas A.

Healthcare incident reporting system in several countries:

Concepts, infrastructure and features. Int J Health Syst Disaster

Manage 2013;1:143.