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위험 기반 통계적 공정 관리×공정능력 분석 (Cp, Cpk)×
분야실험설계통계학
계열Process / pipelineProcess / pipeline
기원 연도1920s (SPC foundations); risk-based integration formalized in 2000s–2010s1986
창시자Integrated from SPC (Shewhart, 1920s; Deming, 1950s) and risk analysis frameworks (FDA ICH Q10, ISO 31000)Victor Kane
유형Hybrid quality-risk engineering methodQuantitative process evaluation index
원전Montgomery, D. C. (2020). Introduction to Statistical Quality Control (8th ed.). Wiley. ISBN: 978-1119399308Kane, V. E. (1986). Process capability indices. Journal of Quality Technology, 18(1), 41–52. DOI ↗
별칭Risk-based SPC, RBSPC, risk-prioritized SPC, risk-informed process monitoringProcess Capability Indices, Capability Study, Süreç Yeterlilik Analizi, Process Performance Analysis
관련62
요약Risk-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.Process Capability Analysis quantifies how well a manufacturing or business process produces output within specified tolerance limits. Introduced formally by Victor Kane in 1986, it summarises process spread and centering into dimensionless indices — most notably Cp and Cpk — allowing engineers and quality managers to judge whether a stable process is inherently capable of meeting customer or design specifications consistently.
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