Abstract
Purpose: To develop and implement a failure mode and effect analysis (FMEA) on routine monthly Quality Assurance (QA) tests (physical tests part) of linear accelerator. Methods: A systematic failure mode and effect analysis method was performed for monthly QA procedures. A detailed process tree of monthly QA was created and potential failure modes were defined. Each failure mode may have many influencing factors. For each factor, a risk probability number (RPN) was calculated from the product of probability of occurrence (O), the severity of effect (S), and detectability of the failure (D). The RPN scores are in a range of 1 to 1000, with higher scores indicating stronger correlation to a given influencing factor of a failure mode. Five medical physicists in our institution were responsible to discuss and to define the O, S, D values. Results: 15 possible failure modes were identified and all RPN scores of all influencing factors of these 15 failue modes were from 8 to 150, and the checklist of FMEA in monthly QA was drawn. The system showed consistent and accurate response to erroneous conditions. Conclusion: The influencing factors of RPN greater than 50 were considered as highly-correlated factors of a certain out-oftolerance monthly QA test. FMEA is a fast and flexible tool to develop an implement a quality management (QM) frame work of monthly QA, which improved the QA efficiency of our QA team. The FMEA work may incorporate more quantification and monitoring fuctions in future.
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