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

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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,

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