השוואת שיטות

	Six Sigma DMAIC מבוסס סיכונים	ניתוח מצבי כשל והשפעותיהם (FMEA)
תחום	תכנון ניסויים	תכנון ניסויים
משפחה	Process / pipeline	Process / pipeline
שנת המקור	1990s–2000s	1949 (military); widespread industrial adoption 1970s–1980s
הוגה השיטה	Motorola (Six Sigma, 1986); risk integration formalized in quality engineering literature from the 1990s onward	U.S. Military / NASA (formalized by MIL-P-1629, 1949)
סוג	Process improvement methodology with embedded risk assessment	Proactive risk analysis technique
מקור מכונן	De Mast, J., & Lokkerbol, J. (2012). An analysis of the Six Sigma DMAIC method from the perspective of problem solving. International Journal of Production Economics, 139(2), 604–614.	Stamatis, D. H. (2003). Failure Mode and Effect Analysis: FMEA from Theory to Execution (2nd ed.). ASQ Quality Press. ISBN: 978-0873895989
כינויים	Risk-integrated DMAIC, DMAIC with risk analysis, Risk-aware Six Sigma, RB-DMAIC	FMEA, Failure Modes and Effects Analysis, FMECA, Failure Mode Effects and Criticality Analysis
קשורות	6	6
תקציר	Risk-based Six Sigma DMAIC embeds structured risk assessment — typically failure mode and effects analysis (FMEA), risk priority numbers (RPN), or probabilistic risk tools — at each stage of the standard DMAIC cycle. The goal is not only to reduce defects and variation but to prioritize improvement actions by their risk consequence, ensuring that critical failure modes are addressed before less impactful ones. It is widely applied in manufacturing, healthcare, aerospace, and process industries where both quality and safety are at stake.	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.