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Improving Validation Through the Use of Confidence Statements Based on Attributes Acceptance Sampling | IVT

Because confidence statements are easily understood by non-technical audiences they can greatly enhance communications. For example, to state that the validation acceptance criteria were met is not as valuable and explanatory as this confidence statement: “Based on the completion of three independent test runs of ‘Process X’ with 100 representative units selected for inspection from each run, we can state with 99.9% confidence that Process X produces less than 2.3% defective units.”  With an understanding of the use of probabilities to justify confidence statements, one can use the...

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