Lee Howard, Lee Heechan, Baik Jungmi, Kim Hyunjung, Kim Rachel
Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital.
Department of Transdisciplinary Studies, Graduate School of Convergence Science and Technology, Seoul National University.
Drug Des Devel Ther. 2017 Oct 19;11:3035-3043. doi: 10.2147/DDDT.S145310. eCollection 2017.
Failure mode and effects analysis (FMEA) is a risk management tool to proactively identify and assess the causes and effects of potential failures in a system, thereby preventing them from happening. The objective of this study was to evaluate effectiveness of FMEA applied to an academic clinical trial center in a tertiary care setting.
A multidisciplinary FMEA focus group at the Seoul National University Hospital Clinical Trials Center selected 6 core clinical trial processes, for which potential failure modes were identified and their risk priority number (RPN) was assessed. Remedial action plans for high-risk failure modes (RPN >160) were devised and a follow-up RPN scoring was conducted a year later.
A total of 114 failure modes were identified with an RPN score ranging 3-378, which was mainly driven by the severity score. Fourteen failure modes were of high risk, 11 of which were addressed by remedial actions. Rescoring showed a dramatic improvement attributed to reduction in the occurrence and detection scores by >3 and >2 points, respectively.
FMEA is a powerful tool to improve quality in clinical trials. The Seoul National University Hospital Clinical Trials Center is expanding its FMEA capability to other core clinical trial processes.
失效模式与效应分析（FMEA）是一种风险管理工具，用于主动识别和评估系统中潜在失效的原因及后果，从而防止其发生。本研究的目的是评估FMEA应用于三级医疗环境中的学术临床试验中心的有效性。
首尔国立大学医院临床试验中心的一个多学科FMEA焦点小组选择了6个核心临床试验流程，识别其潜在失效模式并评估风险优先数（RPN）。针对高风险失效模式（RPN>160）制定了补救行动计划，并在一年后进行了后续RPN评分。
共识别出114种失效模式，RPN评分范围为3-378，主要由严重度评分驱动。14种失效模式为高风险，其中11种通过补救行动得到解决。重新评分显示有显著改善，归因于发生度和探测度评分分别降低了3分以上和2分以上。
FMEA是提高临床试验质量的有力工具。首尔国立大学医院临床试验中心正在将其FMEA能力扩展到其他核心临床试验流程。
