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| DMAIC dựa trên rủi ro× | Kiểm soát quá trình thống kê dựa trên rủi ro× | |
|---|---|---|
| Lĩnh vực | Thiết kế thí nghiệm | Thiết kế thí nghiệm |
| Họ | Process / pipeline | Process / pipeline |
| Năm ra đời≠ | 1990s–2000s | 1920s (SPC foundations); risk-based integration formalized in 2000s–2010s |
| Người khởi xướng≠ | Motorola (Six Sigma, 1986); risk integration formalized in quality engineering literature from the 1990s onward | Integrated from SPC (Shewhart, 1920s; Deming, 1950s) and risk analysis frameworks (FDA ICH Q10, ISO 31000) |
| Loại≠ | Process improvement methodology with embedded risk assessment | Hybrid quality-risk engineering method |
| Công trình gốc≠ | 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. DOI ↗ | Montgomery, D. C. (2020). Introduction to Statistical Quality Control (8th ed.). Wiley. ISBN: 978-1119399308 |
| Tên gọi khác | Risk-integrated DMAIC, DMAIC with risk analysis, Risk-aware Six Sigma, RB-DMAIC | Risk-based SPC, RBSPC, risk-prioritized SPC, risk-informed process monitoring |
| Liên quan | 6 | 6 |
| Tóm tắt≠ | 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. | 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. |
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