השוואת שיטות

	בקרת תהליך סטטיסטית מבוססת סיכונים	ניתוח יכולת תהליך (Cp, Cpk)
תחום	תכנון ניסויים	סטטיסטיקה
משפחה	Process / pipeline	Process / pipeline
שנת המקור	1920s (SPC foundations); risk-based integration formalized in 2000s–2010s	1986
הוגה השיטה	Integrated from SPC (Shewhart, 1920s; Deming, 1950s) and risk analysis frameworks (FDA ICH Q10, ISO 31000)	Victor Kane
סוג	Hybrid quality-risk engineering method	Quantitative process evaluation index
מקור מכונן	Montgomery, D. C. (2020). Introduction to Statistical Quality Control (8th ed.). Wiley. ISBN: 978-1119399308	Kane, V. E. (1986). Process capability indices. Journal of Quality Technology, 18(1), 41–52.
כינויים	Risk-based SPC, RBSPC, risk-prioritized SPC, risk-informed process monitoring	Process Capability Indices, Capability Study, Süreç Yeterlilik Analizi, Process Performance Analysis
קשורות	6	2
תקציר	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.	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.