Process / pipelineEngineering methods

Risk-Based Full Factorial Design — Risk-Informed Experimental Planning

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.

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Sources

  1. Montgomery, D. C. (2017). Design and Analysis of Experiments (9th ed.). Wiley. ISBN: 978-1119113478
  2. International Council for Harmonisation. (2009). ICH Q8(R2): Pharmaceutical Development — Quality by Design and Risk-Based Experimental Approaches. ICH Secretariat. link

Related methods

ScholarGateRisk-based full factorial design (Risk-Based Full Factorial Design of Experiments). Retrieved 2026-06-04 from https://scholargate.app/en/experimental-design/risk-based-full-factorial-design