השוואת שיטות

	ניתוח יכולת תהליך מבוסס-סיכון	ניתוח מצבי כשל והשפעותיהם (FMEA)
תחום	תכנון ניסויים	תכנון ניסויים
משפחה	Process / pipeline	Process / pipeline
שנת המקור	1990s–2000s (formal integration with risk analysis)	1949 (military); widespread industrial adoption 1970s–1980s
הוגה השיטה	Evolved from classical capability indices (Juran, Kane) integrated with risk frameworks (FMEA, ISO 9001)	U.S. Military / NASA (formalized by MIL-P-1629, 1949)
סוג	Quantitative quality engineering method	Proactive risk analysis technique
מקור מכונן	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
כינויים	RBPCA, risk-adjusted capability analysis, capability-risk integration, risk-informed SPC	FMEA, Failure Modes and Effects Analysis, FMECA, Failure Mode Effects and Criticality Analysis
קשורות	4	6
תקציר	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.	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.