Dossier de preuve de méthode

Risk-based full factorial design

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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Risk-Based Full Factorial Design of Experiments

Dossier de méthode taxonomique · process-pipeline / experimental-design

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

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Méthodes apparentées

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Taxonomic bucketDesign of experimentsmachine-suggested · Relational suggestion, not evidence.Taxonomic bucketFailure Mode and Effects Analysismachine-suggested · Relational suggestion, not evidence.Taxonomic bucketRobust Full Factorial Designmachine-suggested · Relational suggestion, not evidence.