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Solutions to Help Facilitate Your Failure Modes and Effects Analyses (FMEAs)

Patient Safety Quality Monthly, September 11, 2008

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The work that is done every day in our hospitals and healthcare facilities relies on the safety and efficiency of the methods and processes that we have developed. We cannot afford to wait until we have a serious process breakdown before we identify and fix potential risk areas in our processes. It is essential that we develop effective, proactive methods to evaluate and reduce risk before adverse events occur. Failure Modes and Effects Analysis (FMEA) is a proven tool that can help you assess and reduce risk in your processes. Unfortunately, many organizations find FMEAs cumbersome and difficult to finish. The Greeley Company helps by providing FMEA facilitation services, through which we work directly with your FMEA teams to make the FMEA process at your facility not only efficient but rewarding for the participants.

Selecting target processes for FMEAs
The selection of the processes to evaluate using FMEAs is an important decision. Unfortunately, sometimes the selection of target processes is driven more by regulatory or accreditation concerns than by a real understanding of where you can significantly reduce risk within your organization. We typically recommend that an organization perform "broader and shallower" FMEAs as risk scoping tools (similar to a whole-body scan). Then these broader FMEAs can be focused into "narrower and deeper" FMEAs on the highest risk areas.

FMEA team
The first step is to put together a team that includes the process owner, individuals who have knowledge of the process, and recipients affected by the outcome of the process. Employ rapid-cycle team methodology so that your FMEA projects do not drag on interminably.

Team work includes:

1. Preparation. The process owner prepares a preliminary process map prior to the first team meeting. This provides a solid starting point for the project.
2. First half-day meeting. The FMEA team kicks off its activities by holding an initial half-day meeting. At this meeting, the team reviews and edits the preliminary process map and works through the failure modes to ensure they are comprehensive and well-defined. Following this meeting, the project leader and facilitator transfer the failure modes into an FMEA spreadsheet, so that risk priority numbers (RPN) can be calculated for each failure mode.
3. Second half-day meeting. Ideally, the second FMEA meeting occurs the following day, to help sustain the momentum and thought process. Team participants might prefer to focus on the FMEA, complete it, and feel good about the success, rather than holding a series of shorter monthly meetings, during which much time is spent getting back up to speed on the project.
   
   At the second meeting, the team scores the severity, occurrence, and detectability for each of the failure modes. These three parameters are used to calculate the RPN for each failure mode. The FMEA spreadsheet is helpful in graphing and rolling up the RPNs to provide an effective understanding of the risks.
   
   Based on the risk scoring results, the team selects the highest-risk potential failures and specifies proposed corrective actions.
   
   The goal is to complete the FMEA by the end of the second meeting, resulting in the following deliverables:
   
   • A clearly defined overall process map
   • Failure modes diagrams for the process
   • A spreadsheet of all the failure modes scored for severity, occurrence, and detectability, with RPNs calculated and graphed
   • Selection of the highest-risk areas and initial specification of corrective actions for each high-risk area
   • An implementation plan
   • Measures to monitor success

Failure modes library
Although every facility implements its process in a different way, the underlying frameworks for the processes are similar. The Greeley Company has developed a substantial and growing library of potential failure modes and failure modes diagrams for many hospital processes. This library is a great resource to assist our clients in performing individual FMEAs and in planning long-term processes for proactive risk reduction and process improvement.

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