A Practical Guide to Failure Mode and Effects Analysis in Health Care: Making the Most of the Team and Its Meetings

doi:10.1016/S1553-7250(10)36053-3

The Joint Commission Journal on Quality and Patient Safety

Volume 36, Issue 8, August 2010, Pages 351-358

https://doi.org/10.1016/S1553-7250(10)36053-3 Get rights and content

Article-at-a-Glance

Background

Failure Mode and Effects Analysis (FMEA) is a proactive risk assessment tool used to identify potential vulnerabilities in complex, high-risk processes and to generate remedial actions before the processes result in adverse events. FMEA is increasingly used to proactively assess and improve the safety of complex health care processes such as drug administration and blood transfusion. A central feature of FMEA is that it is undertaken by a multidisciplinary team, and because it entails numerous analytical steps, it takes a series of several meetings. Composing a team of busy health care professionals with the appropriate knowledge, skill mix, and logistical availability for regular meetings is, however, a serious challenge. Despite this, information and advice on FMEA team assembly and meetings scheduling are scarce and diffuse and often presented without the accompanying rationale.

The Multidisciplinary Team

Assemble an eight-member team composed of clinically active health care staff, from every profession involved in delivery of the process—and who regularly perform it; staff from a range of seniority levels; outsider(s) to the process—and perhaps even to health care; a leader (and facilitator); and researchers.

Scheduling

Plan for 10–15 hours of team meeting time for first-time, narrowly defined FMEAs, scheduled as four to six meetings lasting 2 to 3 hours each, spaced weekly to biweekly. Meet in a venue that seats the team around one table and is off the hospital floor but within its grounds.

Conclusions

FMEA, generally acknowledged to be a useful addition to the patient safety toolkit, is a meticulous and time- and resource-intensive methodology, and its successful completion is highly dependent on the team members’ aptitude and on the facility’s and team members’ commitment to hold regular, productive meetings.

Section snippets

Clinically Active Health Care Staff

The team must possess a highly detailed knowledge of the process under scrutiny to conduct FMEA. A successful FMEA team cannot, therefore, consist of only management and/or research staff. Although the inclusion of such staff can enhance the team, it is imperative that it centers around a core of clinically active health care staff who regularly perform the process. Furthermore, for the team to possess knowledge of the entirety of the process, it is vital that it contains health care staff from

How Many Team-Meeting Hours Are Required to Undertake FMEA?

Whereas numerous empirical articles highlight the time-consuming nature of FMEA, far fewer note the actual number of team hours needed to complete it. Practical-guidance articles also generally fail to provide estimates of, or even to discuss, the number of team hours needed for FMEA. However, to secure resources and executive backing for an FMEA study, recruit team members, and book meetings venues, it is vital to have an estimate of the requisite number of meeting hours at the study outset.

Conclusions

FMEA is generally acknowledged to be a useful addition to the tool kit available to health professionals for assessing and improving the safety of health care processes. Further, undertaking the FMEA procedure often serves to greatly increase staff members’ understanding of the process under scrutiny, particularly from the perspective of their colleagues, and thus to enhance multidisciplinary teamwork and communication. However, FMEA is a meticulous, time- and resource-intensive methodology,

References (24)

BurgmeierJ.
Failure Mode and Effect Analysis: An application in reducing risk in blood transfusion
Jt Comm J Qual Patient Saf
(Jun. 2002)
ColesG.
Using Failure Mode Effects and Criticality Analysis for high-risk processes at three community hospitals
Jt Comm J Qual Patient Saf
(Mar. 2005)
RobinsonD.L.
Using Failure Mode and Effects Analysis for safe administration of chemotherapy to hospitalized children with cancer
Jt Comm J Qual Patient Saf
(Mar. 2006)
Kimchi-WoodsJ.
Using HFMEA to assess potential for patient harm from tubing misconnections
Jt Comm J Qual Patient Saf
(Jul. 2006)
SaxenaS.
Critical laboratory value notification: A Failure Mode Effects and Criticality Analysis
Jt Comm J Qual Patient Saf
(Sep. 2005)
DeRosierJ.
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
(May 2002)
ApkonM.
Design of a safer approach to intravenous drug infusions: Failure mode effects analysis
Qual Saf Health Care
(Aug. 2004)
EsmailR.
Using healthcare failure mode and effect analysis tool to review the process of ordering and administering potassium chloride and potassium phosphate
Healthc Q
(Oct. 2005)
NickersonT.
Using ISMP Canada’s framework for failure mode and effects analysis: A tale of two FMEAs
Healthcare Q
(2008)
Van TilburgC.M.
Health care failure mode and effect analysis: A useful proactive risk analysis in a paediatric oncology ward
Qual Saf Health Care
(Feb. 2006)

KunacD.L.

Identification of priorities for medication safety in neonatal intensive care

Drug Saf

(2005)

KozakiewiczJ.M.

Safe chemotherapy administration: Using failure mode and effects analysis in computerized prescriber order entry

Am J Health Syst Pharm

(Sep. 2005)

Cited by (74)

Impact of risk mapping as a strategy for monitoring and improving patient safety in paediatric emergency care
2022, Anales de Pediatria
Diseñar un Mapa de Riesgos (MR) como herramienta para identificar y gestionar los riesgos en Urgencias Pediátricas y analizar el impacto de las acciones de mejora desarrolladas a partir de los riesgos identificados, en el nivel de riesgo para la Seguridad del Paciente (SP).
Un grupo de trabajo multidisciplinar revisó todo el proceso asistencial aplicando la herramienta Análisis Modal Fallos y Efectos (AMFE). Fases del proyecto: 1ª) MR 2017 y planificación acciones de mejora. 2ª) Desarrollo e implantación de acciones de mejora. 3ª) MR 2019. 4ª) Análisis: evolución del MR e impacto de las acciones de mejora.
En el MR 2017 se identificaron 106 modos de fallo (MF) (54,7% riesgo alto o muy alto). Se aplicaron criterios de priorización para seleccionar las acciones de mejora que debían planificarse. Se planificaron 19 acciones de mejora, con responsables y plazos, que permitían abordar 46 MF prioritarios. Se implantaron el 100%. En el MR 2019 se identificaron 110 MF (48,2% riesgo alto) y se objetivó una reducción global del nivel de riesgo del 20%. Analizando los 46 MF prioritarios que se habían abordado mediante las 19 acciones de mejora planificadas, se comprobó que el 60% habían pasado de nivel de riesgo alto a medio y que se había reducido el nivel de riesgo tanto a nivel global (-27,8%) como desglosado por procesos.
El AMFE es una herramienta útil para identificar riesgos, analizar el impacto de las estrategias de mejora y monitorizar el nivel de riesgo de un servicio clínico complejo. Las acciones de mejora desarrolladas han logrado reducir el nivel de riesgo de nuestros procesos, mejorando la SP.
To design a risk map (RM) as a tool for identifying and managing risks in the paediatric emergency department and to assess the impact of the improvement actions developed based on the identified risks in terms of the level of risk to patient safety.
A multidisciplinary working group reviewed the entire care process by applying the Failure Mode and Effects Analysis (FMEA) tool. Project phases: 1) RM 2017 and planning of improvement actions; 2) Development and implementation of improvement actions; 3) RM 2019; 4) Analysis: evolution of the RM and impact of improvement actions.
A total of 106 failure modes (FMs) were identified in the 2017 RM (54.7% high- or very high risk). We applied prioritization criteria to select the improvement actions to plan. Nineteen improvement actions were planned, with assigned responsible parties and deadlines, to address 46 priority FMs. One hundred percent were implemented. In the 2019 RM, we identified 110 FMs (48.2% high risk) and found an overall reduction of the risk level of 20%. Analysing the 46 priority FMs that had been addressed by the 19 planned improvement actions, we found that 60% had changed from high to medium risk level and that the risk level had decreased, both overall (–27.8%) and by process.
The FMEA is a useful tool to identify risks, analyse the impact of improvement strategies and monitor the risk level of a complex clinical care department. The improvement actions developed succeeded in reducing the level of risk in the processes in our unit, improving patient safety.
Failure mode and effects analysis of telehealth service of minority elderly for sustainable digital transformation
2022, Computers in Biology and Medicine
Citation Excerpt :
Signs and symptoms were categorized in accordance with the manual, and patients were informed whether they should visit a hospital through video consultations. Triage was performed according to frequently occurring signs and symptoms, and intervention strategies were used as classification criteria [16]. Fig. 2 shows the flow chart of telehealth services for minority older adults.
Telehealth services are time- and cost-saving solutions for disease management for older adults. Minority older individuals with multiple risk factors have an increasing demand for telehealth services. There are insufficient data on patient safety in telehealth services. This study aimed to enhance the quality of telehealth services by reducing errors and creating a safe user environment for low-income older adults. Failure mode and effects analysis tool (FMEA) was adopted to manage potential risks for sustainable digital transformation.
An eight-member multidisciplinary team conducted telehealth FMEA to determine risk priority numbers (RPNs). The process included identifying the potential cause and effect failure mode of each step; measuring severity, probability, and detectability scores for RPNs; and generating strategies to decrease potential failures.
This study identified 24 risk factors and 34 causes in four major phases with a mean RPN of 90.7: preparation to measure biosignals, measurement of biosignals following instructions from a personal device, confirmation of measurement results, and intervention based on disease or condition type. Risk prioritization revealed four high failure modes and a total RPN of 362.7. Based on fundamental causes, risks were categorized as oblivescence, economic issues, and technology literacy.
To correct these failure modes, stabilization of the platform, adding to the providers’ manpower, and support for government policies are recommended. FMEA identifies and evaluates the potential risks of telehealth services. The selected priorities reduce the clinical risks of low-income elders who use telehealth services by weighting clinical actions.
Implementation of the failure modes and effects analysis in a Hospital Radiopharmacy Unit
2022, Revista Espanola de Medicina Nuclear e Imagen Molecular
El objetivo de este estudio es la implementación en una Unidad de Radiofarmacia Hospitalaria de una metodología de análisis de riesgos para poder identificar de forma proactiva los posibles modos de fallo y priorizar medidas correctivas.
Mediante el análisis modal de fallos y efectos (AMFE) se identificaron los posibles modos de fallo de cada una de las etapas de los procesos de prescripción, preparación y administración de los radiofármacos de diagnóstico y de terapia. A partir de las variables de severidad, probabilidad y detectabilidad se cuantificó el riesgo mediante el número de prioridad de riesgo (NPR) para cada modo de fallo, subproceso y tipo de radiofármaco. Se establecieron medidas de mejora y se calculó la reducción en el NPR.
Se identificaron 96 modos de fallos (58 para los radiofármacos de diagnóstico y 38 para los de terapia). La identificación biunívoca del paciente con el radiofármaco es el modo de fallo con mayor NPR (60) y el subproceso de marcaje celular el que presenta mayor riesgo (NPR 286). Como resultado de las medidas de mejora se disminuyó el NPR global en un 22% para los radiofármacos de diagnóstico y 20% para los de terapia. Esta reducción sería del 46 y el 31%, respectivamente, si se implantara un software de radiofarmacia y tecnología de código de barras en la administración.
La aplicación de la metodología AMFE como herramienta de análisis de riesgos permite identificar los puntos críticos de los procesos relacionados con los radiofármacos y priorizar medidas para disminuir el riesgo.
The aim of this study is the implementation in a Hospital Radiopharmacy Unit of a risk analysis methodology in order to proactively identify possible failure modes and prioritize corrective measures.
By means of the failure modes and effects analysis (FMEA), the possible failure modes of each of the stages of the processes of prescription, preparation, and administration of radiopharmaceuticals for diagnostic and therapy were identified. From the variables of severity, probability and detectability, the risk was quantified using the Risk Priority Number (RPN) for each failure mode, sub-process, and type of radiopharmaceutical. Improvement measures were established and the reduction in the RPN value was calculated.
A total of 96 failure modes were identified (58 for diagnostic radiopharmaceuticals and 38 for therapy). Biunivocal identification of the patient with the radiopharmaceutical is the failure mode with the highest RPN (60) and the radiolabeling cell sub-process the one that has the highest risk (RPN 286). As a result of the improvement measures, the overall RPN was reduced by 22% for diagnostic radiopharmaceuticals and 20% for therapy. This reduction would be 46% and 31% respectively if radiopharmacy software and a barcode technology in the administration were implemented.
The application of the FMEA methodology as a risk analysis tool allows to identify the critical points of the processes related to radiopharmaceuticals and prioritize measures to reduce the risk.
Hemodialysis Centers Guide 2020
2021, Nefrologia
We present a new edition of the Hemodialysis Center Guide. It is part of the program of updating the Clinical Guides of the Spanish Society of Nephrology. It is a consensus document in which nephrologists with extensive experience in dialysis and experts in nephrological nursing have collaborated. The Guide has been corrected by a group of external evaluators. The opinion of the patients through the kidney diseases patient association (ALCER) has been reported and taken into consideration. This Guide includes in its ten chapters architectural, logistical and organizational aspects. It places special emphasis on human resources needs and their qualification. Review current hemodialysis modalities, dosage and adequacy, and intra and interdialysis monitoring. Hemodialysis is one of the forms of renal replacement therapy, so it mentions the need for transplant waiting list inclusion and the relationship with peritoneal dialysis units. The patient's quality of life on hemodialysis understands the need to relate and travel so care of transitory patients is reviewed and standardized. Quality management is a tool currently needed to achieve continuous improvement of any procedure such as hemodialysis. This Guide is intended to be an aid for the proper functioning of the Dialysis Units, for those responsible for them, as well as for health managers.
Presentamos una nueva edición de la Guía de Centros de Hemodiálisis. Se enmarca en el programa de actualización de las Guías Clínicas de la Sociedad Española de Nefrología. Es un documento de consenso en el que han colaborado nefrólogos con amplia experiencia en diálisis y expertos de la enfermería nefrológica. La Guía ha sido corregida por un grupo de evaluadores externos. Se ha informado y se ha tomado en consideración la opinión de los enfermos a través de la Asociación de Enfermos Renales (ALCER). Esta Guía incluye en sus diez capítulos aspectos arquitectónicos, logísticos y organizativos. Hace especial énfasis en las necesidades de recursos humanos y su cualificación. Revisa las modalidades actuales de hemodiálisis, su dosificación y adecuación y la monitorización y seguimiento intra e interdiálisis. La hemodiálisis es una de las formas de tratamiento renal sustitutivo, por lo que menciona la necesidad de la inclusión en lista de espera para trasplante y la relación con las unidades de diálisis peritoneal. La calidad de vida del paciente en hemodiálisis comprende la necesidad de relacionarse y viajar por lo que se revisa y estandariza la atención de los pacientes transeúntes. La gestión de calidad es una herramienta necesaria actualmente para lograr la mejora continua de cualquier procedimiento como la hemodiálisis. Esta Guía pretende ser una ayuda para el buen funcionamiento de las Unidades de Diálisis, para los responsables de las mismas, así como para los gestores sanitarios.
Institutional quality and patient safety programs: An overview for the healthcare epidemiologist
2021, Infection Control and Hospital Epidemiology
The IDEAL framework for surgical robotics: development, comparative evaluation and long-term monitoring
2024, Nature Medicine

View all citing articles on Scopus

View full text

A Practical Guide to Failure Mode and Effects Analysis in Health Care: Making the Most of the Team and Its Meetings

Article-at-a-Glance

Background

The Multidisciplinary Team

Scheduling

Conclusions

Section snippets

Clinically Active Health Care Staff

How Many Team-Meeting Hours Are Required to Undertake FMEA?

Conclusions

Jt Comm J Qual Patient Saf

Jt Comm J Qual Patient Saf

Jt Comm J Qual Patient Saf

Jt Comm J Qual Patient Saf

Jt Comm J Qual Patient Saf

Jt Comm J Qual Patient Saf

Design of a safer approach to intravenous drug infusions: Failure mode effects analysis

Qual Saf Health Care

Using healthcare failure mode and effect analysis tool to review the process of ordering and administering potassium chloride and potassium phosphate

Healthc Q

Using ISMP Canada’s framework for failure mode and effects analysis: A tale of two FMEAs

Healthcare Q

Health care failure mode and effect analysis: A useful proactive risk analysis in a paediatric oncology ward

Qual Saf Health Care

Identification of priorities for medication safety in neonatal intensive care

Drug Saf

Safe chemotherapy administration: Using failure mode and effects analysis in computerized prescriber order entry

Am J Health Syst Pharm