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| Projekt pełnoczynnikowy oparty na ryzyku× | Analiza rodzajów i skutków możliwych błędów (FMEA)× | |
|---|---|---|
| Dziedzina | Planowanie eksperymentów | Planowanie eksperymentów |
| Rodzina | Process / pipeline | Process / pipeline |
| Rok powstania≠ | 2000s (formal integration with risk frameworks circa 2005–2009) | 1949 (military); widespread industrial adoption 1970s–1980s |
| Twórca≠ | Developed at the intersection of classical factorial experimentation (Fisher, 1935) and formal risk analysis frameworks (ICH Q8/Q9, 2005–2009) | U.S. Military / NASA (formalized by MIL-P-1629, 1949) |
| Typ≠ | Structured experimental design with risk-informed factor prioritization | Proactive risk analysis technique |
| Źródło pierwotne≠ | Montgomery, D. C. (2017). Design and Analysis of Experiments (9th ed.). Wiley. ISBN: 978-1119113478 | Stamatis, D. H. (2003). Failure Mode and Effect Analysis: FMEA from Theory to Execution (2nd ed.). ASQ Quality Press. ISBN: 978-0873895989 |
| Inne nazwy | risk-informed full factorial design, RB-FFD, risk-prioritized factorial experiment, risk-based FFD | FMEA, Failure Modes and Effects Analysis, FMECA, Failure Mode Effects and Criticality Analysis |
| Pokrewne≠ | 3 | 6 |
| Podsumowanie≠ | Risk-based full factorial design integrates formal risk analysis — typically Failure Mode and Effects Analysis (FMEA) or a comparable risk-ranking tool — with a full factorial experiment to ensure that factors posing the greatest quality or safety risk receive exhaustive experimental coverage. All combinations of selected factor levels are run, but the selection of which factors to include and the range of their levels is explicitly guided by prior risk scores rather than purely by engineering intuition or resource availability. | 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. |
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