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The five stages of FMEA implementation
By Patrice Spath, RHIT
Brown-Spath & Associates
Forest Grove, OR
Health care organizations have been improving processes for years. Recently, however, the Joint Commission on Accreditation of Healthcare Organizations mandated that organizations use a proactive risk assessment technique — failure mode and effect analysis (FMEA) — to improve the safety of patient care activities. Unfortunately, many organizations are failing to fully realize the benefits of the FMEA process. This proactive risk assessment technique can be a powerful process improvement tool, yet often it is perceived as something that must be done to meet an accreditation requirement. FMEAs can and should be a key element in a health care organization’s performance improvement strategy. Understanding the differences between those organizations that use and do not use FMEAs correctly can help you become one of those who experience the immense patient safety improvement benefits that FMEAs can bring.
Organizations normally can be categorized in one of five implementation stages. Organizations that achieve measurable patient safety benefits operate in stages four or five. Unfortunately, many health care organizations still are in stages one through three, with most in stage one.
• Stage one. Typically, the organization in stage one uses FMEAs because it has to meet a requirement imposed by an external oversight group or accreditation body. Physicians and/or staff members conduct the FMEA right before the deadline for completion. Often, the wrong people perform the FMEA. The quality management department ends up analyzing the process and/or authoring the required documents rather than making the FMEA team members responsible for completing each step.
Management does not understand the value of an FMEA, and there may be a lot of confusion and disagreement on how to complete each step and fill out the FMEA form. Debate occurs when team members attempt to prioritize the potential failures in the process. Because accurate feedback systems often don’t exist to base the priority ratings on, people make uneducated and sometimes inaccurate guesses about the probability and effect of failures. The team uses these best guesses to assign a criticality score to each potential failure. If too many high-priority failures requiring actions are identified, the team may adjust the ratings to bring the score below the action trigger level. Obviously, this can disrupt the entire FMEA process and make it meaningless.
At stage one, the organization fulfills its FMEA requirement but the value of each FMEA is greatly diminished. Many potential patient safety problems remain unsolved. The individuals performing the FMEAs believe they are doing them correctly because the organization’s leaders are accepting them. Eventually, people begin to see the FMEA process not as a valuable patient safety improvement tool but just as something that has to be done to meet requirements.
• Stage two. Management ensures that the individuals who will perform and use the FMEA data are trained in the proper technique. They realize that the people performing the FMEAs must be experts in the process. Rather than being confused by the FMEA terminology, people realize they have used proactive risk-assessment techniques before but never called it FMEA. Although people have proactively improved processes before, they have not done it in a rigorous way using a systematic FMEA methodology. Thus, the full benefits of process improvement activities were not achieved.
In stage two, everyone involved gains an understanding of what high-priority failures are and why it is important to find and prevent them. Management also realizes that it doesn’t have systems in place that will give the team the data needed to accurately determine the failure probability and effect ratings. Using the limited objective data they have, the FMEA team members know they will have to use their knowledge of the process to arrive at the ratings. Due to the lack of an objective basis, the team members don’t waste a lot of time arguing about the criticality ratings of potential process failures.
People who are involved in FMEAs come to believe in the power of this technique for improving the safety of patient care processes. Unfortunately, these same people may doubt whether management will provide the time and resources necessary to complete a comprehensive FMEA and successfully implement action plans.
• Stage three. The organization begins to use FMEAs correctly for targeted high-risk patient care processes. Early on, there is excitement that the FMEAs will result in significant safety improvement, but as people begin the undertaking, worry starts to set in as the team uncovers and documents the complexity of the process being analyzed.
Everyone knew the complexity existed but had never seen it documented before. FMEA projects grow from the two to three short team meetings that used to be normal to longer sessions involving more people. The organization must overcome its fear of the increased length and complexity of a comprehensive proactive risk assessment if FMEAs are to be successful. FMEA risk-assessment projects should be a key element in the health care organization’s quality planning process; they must be planned for and adequately funded and staffed.
As more FMEAs are completed, many problems will be uncovered that must be solved if the organization is to make patient care as safe as it can be. There may not be enough resources to solve all of these problems and still meet the project completion deadlines. Knowing this, people begin to proclaim that FMEAs take too much time without enough return on the investment. They begin to wonder if all of the hard work was a waste of time. What good is it to know what is wrong with a process and not be able to correct it? Life was a lot easier when all the problems were not documented. If organizations don’t overcome this obstacle, they may slip back into stage one.
• Stage four. Management realizes the length of an FMEA project cannot be predetermined. The complexity of the process being analyzed determines the length. Management makes it clear to those involved in the FMEA that all of the problems uncovered in the project can’t be solved at once. Management will have to make objective decisions as to what to work on now and what must be delayed. Once the initial FMEA is done, management creates a long-term plan to improve the process further. This plan is shared with everyone involved in the initial FMEA so they understand that management is not ignoring important concerns.
• Stage five. The organization has implemented several proactive risk-assessment projects and action plans to answer the majority of high-priority failures identified in the FMEAs. Systems now exist to provide data to more accurately set failure criticality ratings. Due to the accuracy of the new criticality ratings, people are able to predict process failures better and implement focused corrective actions. Now actions required for improvement can be prioritized better.
Before significant process changes are made, the FMEAs are reviewed. If a process change must be made, staff review the FMEA to determine the impact the change will have on safety. When an undesirable patient care event occurs, the appropriate physicians and/or staff members consult the FMEAs. If the FMEA inadequately addressed the failure, changes are made to ensure that all possible steps have been taken to prevent a similar problem in the future. The organization uses the FMEAs as internal training tools because they contain important knowledge about the safety of high-risk patient care processes.
The FMEA process can be a powerful tool for improving patient safety when properly used. As with any tool, before it can be used well, it must be understood. Organizations that want to gain full benefit from FMEAs must confront and overcome the common barriers summarized in the box below. Otherwise, undesirable consequences will occur. Once organizations fully understand and commit to the FMEA process, people will be pleasantly surprised with the patient safety improvements that result.