方法对比

	基于风险的全因子设计	失效模式与影响分析 (FMEA)
领域	实验设计	实验设计
方法族	Process / pipeline	Process / pipeline
起源年份	2000s (formal integration with risk frameworks circa 2005–2009)	1949 (military); widespread industrial adoption 1970s–1980s
提出者	Developed at the intersection of classical factorial experimentation (Fisher, 1935) and formal risk analysis frameworks (ICH Q8/Q9, 2005–2009)	U.S. Military / NASA (formalized by MIL-P-1629, 1949)
类型	Structured experimental design with risk-informed factor prioritization	Proactive risk analysis technique
开创性文献	Montgomery, D. C. (2017). Design and Analysis of Experiments (9th ed.). Wiley. ISBN: 978-1119113478	Stamatis, D. H. (2003). Failure Mode and Effect Analysis: FMEA from Theory to Execution (2nd ed.). ASQ Quality Press. ISBN: 978-0873895989
别名	risk-informed full factorial design, RB-FFD, risk-prioritized factorial experiment, risk-based FFD	FMEA, Failure Modes and Effects Analysis, FMECA, Failure Mode Effects and Criticality Analysis
相关	3	6
摘要	Risk-based full factorial design integrates formal risk analysis — typically Failure Mode and Effects Analysis (FMEA) or a comparable risk-ranking tool — with a full factorial experiment to ensure that factors posing the greatest quality or safety risk receive exhaustive experimental coverage. All combinations of selected factor levels are run, but the selection of which factors to include and the range of their levels is explicitly guided by prior risk scores rather than purely by engineering intuition or resource availability.	Failure Mode and Effects Analysis (FMEA) is a structured, proactive risk management technique used to identify potential failure modes in a system, process, or product design, evaluate their consequences, and prioritize corrective actions before failures occur. Originally developed for the U.S. military in 1949 and later adopted by NASA, automotive, and manufacturing industries, FMEA is now a cornerstone quality-engineering tool embedded in standards such as AIAG-VDA and ISO 9001-aligned processes.