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Assessment of Process FMEA Methods Used for Radiotherapy Applications

Industry: Healthcare

Keywords: FMEA; Medical; Services

Level: Advanced


Medical physics is a healthcare field that focuses on the application of foundational physics in the areas of radiology, radiation oncology, nuclear medicine, and radiation safety. With the continual advancements of equipment and techniques for radiation therapy planning and delivery across multiple modalities, quality assurance has become an increasingly complex task for the medical physicist. The published guidelines in the report of Task Group 100 of the American Association of Physicists in Medicine (AAPM) are considered the “gold standard” for radiation therapy risk analysis.

As the report of Task Group 100 was published in June 2016, the FMEA guidance was similar to AIAG’s 4th edition methodologies. Although the newer AIAG & VDA methodology was published in 2019, analogous updated guidance has not been released and accepted in radiation therapy. The purpose of this project was to analyze the potential benefits of updating the methods by which quality management is conducted for risk analysis in radiation therapy. Sample process failure mode and effects analyses (FMEAs) were created for IMRT radiotherapy using the guidance recommended in the report of Task Group100 as well as the newer AIAG & VDA methodologies.

The process FMEAs were then compared to identify the similarities and differences between the results of following each method and to evaluate potential benefits of implementing updated quality management methods. This presentation will provide examples where the need for improvement was immediately recognized and will demonstrate how the risk analyses in FMEAs modeled after the AIAG & VDA methods provide a more comprehensive risk profile.

While this presentation is directly related to healthcare protocols, the steps followed and the lessons learned while translating this system from an automotive-based approach to the medical application will be shown to be applicable for any service-based process.


Timothy Christopher Brown

Junior Consultant, Brown & Associates Quality Consulting, Inc., Atlanta, GA, USA

Timothy Brown is a 2023 graduate of the Georgia Institute of Technology’s Nuclear & Radiological Engineering department and has a Master of Science degree in Medical Physics. He is a junior consultant for Brown & Associates Quality Consulting and holds credentials as an auditor for ISO 13485 Medical Device Management Systems through Exemplar Global.

His graduate project centered around analyzing the potential benefits of updating methods for risk analysis in radiation therapy, including the use of the AIAG & VDA methodology for FMEAs. Hands-on experience in radiotherapy was gained through the Winship Cancer Institute of Emory University Hospital – Midtown. His undergraduate research included development work on a targeted delivery mechanism for chemotherapy medications used in cancer treatment.

Mr. Brown has consulted on the development of FMEAs for medical treatment applications, using updated FMEA guidance from the AIAG & VDA guidelines, including integration of Monitoring and System Response (MSR) evaluations into medical treatment protocol FMEAs. He has supported the development and delivery of training courses and materials for a variety of Quality Management topics. Mr. Brown is an avid hunter and outdoorsman. He has trained as a power lifter, introducing colleagues to the sport who have since set state records.

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