Failure mode and effects analysis: A community practice perspective

Abstract

PurposeTo report our early experiences with failure mode and effects analysis (FMEA) in a community practice setting.MethodsThe FMEA facilitator received extensive training at the AAPM Summer School. Early efforts focused on department education and emphasized the need for process evaluation in the context of high profile radiation therapy accidents. A multidisciplinary team was assembled with representation from each of the major department disciplines. Stereotactic radiosurgery (SRS) was identified as the most appropriate treatment technique for the first FMEA evaluation, as it is largely self‐contained and has the potential to produce high impact failure modes. Process mapping was completed using breakout sessions, and then compiled into a simple electronic format. Weekly sessions were used to complete the FMEA evaluation. Risk priority number (RPN) values > 100 or severity scores of 9 or 10 were considered high risk. The overall time commitment was also tracked.ResultsThe final SRS process map contained 15 major process steps and 183 subprocess steps. Splitting the process map into individual assignments was a successful strategy for our group. The process map was designed to contain enough detail such that another radiation oncology team would be able to perform our procedures. Continuous facilitator involvement helped maintain consistent scoring during FMEA. Practice changes were made responding to the highest RPN scores, and new resulting RPN scores were below our high‐risk threshold. The estimated person‐hour equivalent for project completion was 258 hr.ConclusionsThis report provides important details on the initial steps we took to complete our first FMEA, providing guidance for community practices seeking to incorporate this process into their quality assurance (QA) program. Determining the feasibility of implementing complex QA processes into different practice settings will take on increasing significance as the field of radiation oncology transitions into the new TG‐100 QA paradigm.

Risk analysis of the Unity 1.5 T MR‐Linac adapt‐to‐position workflow

“…For detectability, 1 represented that the failure would be obvious and easily detected, while 5 would mean there is a great likelihood to go undetected 2 . To support the team in the scoring process which lasted several weeks, the team leaders held TG‐100 “office hours” where they were available virtually for 1 h each week to answer questions or provide clarification 3 …”

“…2 To support the team in the scoring process which lasted several weeks, the team leaders held TG-100 "office hours" where they were available virtually for 1 h each week to answer questions or provide clarification. 3 Once all the scores were returned to the team leaders, failures were sorted following recommendations of TG-100. Failures with the top 20% highest RPN scores based on both average and median scores and top 20% highest severity scores were isolated for analysis.…”

FMECA Application in Tomotherapy: Comparison between Classic and Fuzzy Methodologies

“…The methodology has also been identified by the American Association of Physicists in Medicine (AAPM) Task Group 100 as an effective tool in the risk analysis of modern cancer radiotherapy processes, receiving approval from many international scientific communities [1,[14][15][16][17].…”

The RABBIT risk-based approach to clinical implementation of new technology: SRS as a case study

“…Only two members of the MDT had prior SRS experience, so the other group members had to base their risk assessment on their experience of similar treatments (eg stereotactic body radiotherapy), reviewing the literature and visiting other centres already using the same equipment. There are several publications on the application of FMEA to SRS [4,[15][16][17][18][19] which are an excellent resource for groups preparing to implement this.…”