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基于风险的过程能力分析×统计过程控制×
领域实验设计实验设计
方法族Process / pipelineProcess / pipeline
起源年份1990s–2000s (formal integration with risk analysis)1924–1931
提出者Evolved from classical capability indices (Juran, Kane) integrated with risk frameworks (FMEA, ISO 9001)Walter A. Shewhart
类型Quantitative quality engineering methodProcess monitoring and quality control method
开创性文献Montgomery, D. C. (2020). Introduction to Statistical Quality Control (8th ed.). Wiley. ISBN: 978-1119399308Shewhart, W. A. (1931). Economic Control of Quality of Manufactured Product. Van Nostrand. ISBN: 978-0873890762
别名RBPCA, risk-adjusted capability analysis, capability-risk integration, risk-informed SPCSPC, statistical quality control, process control charting, Shewhart control
相关46
摘要Risk-based Process Capability Analysis (RBPCA) combines classical process capability indices (Cp, Cpk, Pp, Ppk) with structured risk assessment tools — such as FMEA risk priority numbers — to prioritise improvement actions not merely by how capable a process is, but by the potential harm its failures can cause. The approach is widely used in automotive, aerospace, medical device, and pharmaceutical manufacturing to align quality engineering decisions with risk management requirements.Statistical Process Control (SPC) is a data-driven quality method that uses statistical techniques — primarily control charts — to monitor a manufacturing or service process over time. By distinguishing natural process variation (common cause) from unusual, actionable variation (special cause), SPC enables practitioners to maintain processes in a stable, predictable state and to detect problems early, before defective output reaches customers.
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ScholarGate方法对比: Risk-based Process Capability Analysis · Statistical Process Control. 于 2026-06-15 检索自 https://scholargate.app/zh/compare