The first aim of the study was to create a general template for analyzing potential failures in external beam radiotherapy, EBRT, using the process failure mode and effects analysis (PFMEA). The second aim was to modify the action priority (AP), a novel prioritization method originally introduced by the Automotive Industry Action Group (AIAG), to work with different severity, occurrence, and detection rating systems used in radiation oncology. The AIAG PFMEA approach was employed in combination with an extensive literature survey to develop the EBRT-PFMEA template. Subsets of high-risk failure modes found through the literature survey were added to the template where applicable. Our modified AP for radiation oncology (RO AP) was defined using a weighted sum of severity, occurrence, and detectability. Then, Monte Carlo simulations were conducted to compare the original AIAG AP, the RO AP, and the risk priority number (RPN). The results of the simulations were used to determine the number of additional corrective actions per failure mode and to parametrize the RO AP to our department’s rating system. An EBRT-PFMEA template comprising 75 high-risk failure modes could be compiled. The AIAG AP required 1.7 additional corrective actions per failure mode, while the RO AP ranged from 1.3 to 3.5, and the RPN required 3.6. The RO AP could be parametrized so that it suited our rating system and evaluated severity, occurrence, and detection ratings equally to the AIAG AP. An adjustable EBRT-PFMEA template is provided which can be used as a practical starting point for creating institution-specific templates. Moreover, the RO AP introduces transparent action levels that can be adapted to any rating system.

中文翻译：

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外照射放射治疗的过程失效模式和影响分析：引入基于文献的模板和新颖的行动优先级

该研究的首要目标是使用过程失效模式和影响分析 (PFMEA) 创建一个通用模板，用于分析外照射放射治疗 (EBRT) 中的潜在失效。第二个目标是修改行动优先级 (AP)，这是一种最初由汽车工业行动小组 (AIAG) 引入的新颖的优先级方法，以与放射肿瘤学中使用的不同严重程度、发生和检测评级系统配合使用。AIAG PFMEA 方法与广泛的文献调查相结合，开发了 EBRT-PFMEA 模板。通过文献调查发现的高风险故障模式子集已添加到适用的模板中。我们修改后的放射肿瘤学 AP (RO AP) 是使用严重性、发生率和可检测性的加权总和来定义的。然后，进行蒙特卡洛模拟，比较原始AIAG AP、RO AP和风险优先级数（RPN）。模拟结果用于确定每种故障模式的额外纠正措施数量，并根据我们部门的评级系统对 RO AP 进行参数化。可以编译包含 75 种高风险故障模式的 EBRT-PFMEA 模板。AIAG AP 对于每种故障模式需要 1.7 个额外的纠正措施，而 RO AP 的范围为 1.3 到 3.5，RPN 需要 3.6。RO AP 可以进行参数化，以便它适合我们的评级系统，并与 AIAG AP 同等地评估严重性、发生率和检测评级。提供了可调整的 EBRT-PFMEA 模板，可用作创建机构特定模板的实用起点。此外，RO AP 引入了透明的行动级别，可以适应任何评级系统。