方法对比

	基于风险的统计过程控制	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	1920s (SPC foundations); risk-based integration formalized in 2000s–2010s	1949 (military); widespread industrial adoption 1970s–1980s
提出者	Integrated from SPC (Shewhart, 1920s; Deming, 1950s) and risk analysis frameworks (FDA ICH Q10, ISO 31000)	U.S. Military / NASA (formalized by MIL-P-1629, 1949)
类型	Hybrid quality-risk engineering method	Proactive risk analysis technique
开创性文献	Montgomery, D. C. (2020). Introduction to Statistical Quality Control (8th ed.). Wiley. ISBN: 978-1119399308	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-based SPC, RBSPC, risk-prioritized SPC, risk-informed process monitoring	FMEA, Failure Modes and Effects Analysis, FMECA, Failure Mode Effects and Criticality Analysis
相关	6	6
摘要	Risk-based statistical process control (Risk-based SPC) is an engineering quality method that integrates formal risk analysis — typically FMEA or a risk matrix — with statistical process monitoring to focus control chart resources on the process parameters that pose the greatest risk to product quality or system safety. Rather than applying control charts uniformly across all variables, risk-based SPC directs tighter monitoring toward high-risk, high-impact process characteristics identified through structured hazard prioritization.	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.