方法对比

	基于风险的实验设计	故障树分析 (FTA)
领域	实验设计	可靠性
方法族	Process / pipeline	Process / pipeline
起源年份	2000s–2010s (formalized in pharmaceutical and process engineering contexts)	1981
提出者	Emerged from ICH Q8/Q9/Q10 pharmaceutical guidelines; formalized in engineering by integration of FMEA/FTA with classical DoE	Vesely et al. (US NRC Fault Tree Handbook)
类型	Experimental design method with risk-based factor prioritization	Deductive top-down failure analysis
开创性文献	Myers, R. H., Montgomery, D. C., & Anderson-Cook, C. M. (2016). Response Surface Methodology: Process and Product Optimization Using Designed Experiments (4th ed.). Wiley. ISBN: 978-1118916018	Vesely, W. E., Goldberg, F. F., Roberts, N. H., & Haasl, D. F. (1981). Fault Tree Handbook (NUREG-0492). U.S. Nuclear Regulatory Commission.
别名	Risk-based DoE, risk-informed experimental design, risk-prioritized DoE, RB-DoE	FTA, Fault Tree Method, Top-Down Reliability Analysis, Hata Ağacı Analizi
相关	4	3
摘要	Risk-based design of experiments (RB-DoE) integrates formal risk assessment — typically using tools such as FMEA or fault tree analysis — with classical experimental design to prioritize which process or product factors are most critical to investigate. Rather than treating all candidate factors equally, this approach ranks factors by their risk priority number or likelihood of affecting quality, safety, or reliability, then allocates experimental runs preferentially to high-risk factors. It is widely used in pharmaceutical development, chemical process engineering, and manufacturing quality management.	Fault Tree Analysis (FTA) is a top-down, deductive reliability method that begins with an undesired top-level failure event and systematically traces backward through chains of contributing causes using Boolean logic gates (AND, OR). First formalized by Watson at Bell Telephone Laboratories in 1961 and later standardized by Vesely, Goldberg, Roberts, and Haasl in the landmark 1981 NRC Fault Tree Handbook, FTA has become a cornerstone of quantitative risk assessment in nuclear, aerospace, and industrial safety engineering.