A Modified Failure Mode and Effects Analysis for Linear Accelerator Quality Assurance

Purpose: Failure mode and effects analysis (FMEA) is a proactive method for evaluating failure modes and the consequences of those failures. In radiation therapy, a risk-based approach such as this can be used to inform and drive the quality assurance (QA) program, help prioritize QA, evaluate the i...

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Main Authors: Nicole Jessop, DClinSci, Jamie Fairfoul, MSc
Format: Article
Language:English
Published: Elsevier 2025-09-01
Series:Advances in Radiation Oncology
Online Access:http://www.sciencedirect.com/science/article/pii/S2452109425001149
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author Nicole Jessop, DClinSci
Jamie Fairfoul, MSc
author_facet Nicole Jessop, DClinSci
Jamie Fairfoul, MSc
author_sort Nicole Jessop, DClinSci
collection DOAJ
description Purpose: Failure mode and effects analysis (FMEA) is a proactive method for evaluating failure modes and the consequences of those failures. In radiation therapy, a risk-based approach such as this can be used to inform and drive the quality assurance (QA) program, help prioritize QA, evaluate the impact of any changes to the QA process, and raise awareness of the potential failure modes. A classical FMEA can result in identical risk priority number (RPN) values for different combinations of occurrence, severity, and detectability. This assumes that these 3 values hold the same significance. In radiation therapy, high-severity failure modes can lead to severe clinical consequences and so should be prioritized. Methods and Materials: A classical FMEA was carried out for the Varian TrueBeam linear accelerator QA at Peterborough City Hospital. This highlighted the issue of high-severity failure modes appearing relatively low in the FMEA table because of low overall RPN values. Therefore, a modified FMEA using a new clinical severity factor (S2) with hybrid RPN values was proposed and performed. Results: None of the failure modes resulted in very high RPN values. Some failure modes with high severities, such as gating system beam hold, breathing trace display, and backup timer operation, had relatively low overall RPN scores. The new modified FMEA minimized this effect by moving these failure modes up the FMEA table. For the modified FMEA, the higher scoring failure modes all relate to machine parameters associated with beam delivery and are important for techniques used for most patients. Therefore, the modified FMEA proposed gave clinically relevant results. Conclusions: A new modified FMEA is proposed for linear accelerator QA in radiation therapy. This method is recommended to prevent high-severity failure modes from appearing low in the FMEA table and thus being given a low overall priority.
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spelling doaj-art-470e0cb83eef42e7be5b4f155731c0de2025-08-20T02:56:39ZengElsevierAdvances in Radiation Oncology2452-10942025-09-0110910182710.1016/j.adro.2025.101827A Modified Failure Mode and Effects Analysis for Linear Accelerator Quality AssuranceNicole Jessop, DClinSci0Jamie Fairfoul, MSc1Corresponding author: Nicole Jessop, DClinSci; Radiotherapy Department, North-West Anglia NHS Foundation trust, Peterborough, UKRadiotherapy Department, North-West Anglia NHS Foundation trust, Peterborough, UKPurpose: Failure mode and effects analysis (FMEA) is a proactive method for evaluating failure modes and the consequences of those failures. In radiation therapy, a risk-based approach such as this can be used to inform and drive the quality assurance (QA) program, help prioritize QA, evaluate the impact of any changes to the QA process, and raise awareness of the potential failure modes. A classical FMEA can result in identical risk priority number (RPN) values for different combinations of occurrence, severity, and detectability. This assumes that these 3 values hold the same significance. In radiation therapy, high-severity failure modes can lead to severe clinical consequences and so should be prioritized. Methods and Materials: A classical FMEA was carried out for the Varian TrueBeam linear accelerator QA at Peterborough City Hospital. This highlighted the issue of high-severity failure modes appearing relatively low in the FMEA table because of low overall RPN values. Therefore, a modified FMEA using a new clinical severity factor (S2) with hybrid RPN values was proposed and performed. Results: None of the failure modes resulted in very high RPN values. Some failure modes with high severities, such as gating system beam hold, breathing trace display, and backup timer operation, had relatively low overall RPN scores. The new modified FMEA minimized this effect by moving these failure modes up the FMEA table. For the modified FMEA, the higher scoring failure modes all relate to machine parameters associated with beam delivery and are important for techniques used for most patients. Therefore, the modified FMEA proposed gave clinically relevant results. Conclusions: A new modified FMEA is proposed for linear accelerator QA in radiation therapy. This method is recommended to prevent high-severity failure modes from appearing low in the FMEA table and thus being given a low overall priority.http://www.sciencedirect.com/science/article/pii/S2452109425001149
spellingShingle Nicole Jessop, DClinSci
Jamie Fairfoul, MSc
A Modified Failure Mode and Effects Analysis for Linear Accelerator Quality Assurance
Advances in Radiation Oncology
title A Modified Failure Mode and Effects Analysis for Linear Accelerator Quality Assurance
title_full A Modified Failure Mode and Effects Analysis for Linear Accelerator Quality Assurance
title_fullStr A Modified Failure Mode and Effects Analysis for Linear Accelerator Quality Assurance
title_full_unstemmed A Modified Failure Mode and Effects Analysis for Linear Accelerator Quality Assurance
title_short A Modified Failure Mode and Effects Analysis for Linear Accelerator Quality Assurance
title_sort modified failure mode and effects analysis for linear accelerator quality assurance
url http://www.sciencedirect.com/science/article/pii/S2452109425001149
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