Application of Failure Modes and Effects Analysis for Patient-Specific Quality Assurance
LIU Yaxin1,2, SHEN Jiuling3, YUAN Qingqing4, LI Guangjun1, BAI Sen1,2
1. Department of Radiotherapy, West China Hospital, Sichuan University, Chengdu Sichuan 610041, China; 2. College of Physics,
Sichuan University, Chengdu Sichuan 610041, China; 3. Department of Radiation Chemotherapy, Zhongnan Hospital of Wuhan
University, Wuhan Hubei 430072, China; 4. Department of Radiotherapy, Shenzhen Center, Cancer Hospital Chinese Academy of
Medical Sciences, Shenzhen Guangdong 518116, China
Abstract:Objective To determine potential failure modes (FMs) with high-risk during patient-specific quality assurance (PSQA)
by using failure mode and effects analysis (FMEA), to improve current quality management program based on the AAPM TG-100
report. Methods A risk ranking team was formed to determine the workflow and every FM of PSQA, and constructed the process
map. The team evaluated occurrence (O), severity (S) and detectability (D) of every FM, and the product of O, S and D was risk
priority number (RPN). The failure modes with 20% highest RPN were defined as high-risk FMs for furthermore analyzed.
Results The PSQA process consisted of 8 major steps and 28 sub-steps. 61 FMs were listed and 12 of them were defined as highrisk
FMs to be made improvement strategies. Conclusion The application of FMEA for PSQA workflow can effectively enhance the
accuracy and validity of PSQA results. It can ultimately improve the safety of radiotherapy.
刘亚昕1,2,沈九零3,袁青青4,李光俊1,柏森1,2. 失效模式与效应分析在治疗前特定患者的计划剂量验证流程中的应用研究[J]. 中国医疗设备, 2022, 37(3): 34-37.
LIU Yaxin1,2, SHEN Jiuling3, YUAN Qingqing4, LI Guangjun1, BAI Sen1,2. Application of Failure Modes and Effects Analysis for Patient-Specific Quality Assurance. China Medical Devices, 2022, 37(3): 34-37.