Process failure mode and effects analysis for external beam radiotherapy: Introducing a literature-based template and a novel action priority

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.