Department of Radiation Oncology, MD Anderson Cancer Center at Cooper, Camden, New Jersey, USA.
J Appl Clin Med Phys. 2024 Aug;25(8):e14391. doi: 10.1002/acm2.14391. Epub 2024 Jul 10.
In failure modes and effects analysis (FMEA), the components of the risk priority number (RPN) for a failure mode (FM) are often chosen by consensus. We describe an empirical method for estimating the occurrence (O) and detectability (D) components of a RPN. The method requires for a given FM that its associated quality control measure be performed twice as is the case when a FM is checked for in an initial physics check and again during a weekly physics check. If instances of the FM caught by these checks are recorded, O and D can be computed. Incorporation of the remaining RPN component, Severity, is discussed. This method can be used as part of quality management design ahead of an anticipated FMEA or afterwards to validate consensus values.
在失效模式和影响分析(FMEA)中,失效模式(FM)的风险优先数(RPN)的组成部分通常通过共识来选择。我们描述了一种用于估计 RPN 的发生(O)和可检测性(D)分量的经验方法。该方法要求对于给定的 FM,其相关的质量控制措施执行两次,就像在初始物理检查中检查 FM 并在每周物理检查中再次检查一样。如果记录下这些检查中捕捉到的 FM 实例,则可以计算 O 和 D。讨论了包含剩余 RPN 分量(严重程度)的问题。此方法可用于在预期 FMEA 之前或之后进行质量管理设计的一部分,以验证共识值。