Change-Point Analysis
DR. WAYNE A. TAYLORTaylor Enterprises, Inc., Libertyville, IL 60048Change-point analysis is a powerful new tool for determining whether a change has taken place. It is capable of detecting subtle...
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Describing Compounder Accuracy
Suppose the accuracy of a compounder was described as ±5% or ±10%. What does this mean to you? In many ways, this description is lacking. First, what percentage of dispenses would you expect to be...
View ArticleAdjusted Control Limits for P Charts
Abstract: P charts are used for count data following the Binomial distribution. However, the P chart has symmetrical control limits when the Binomial distribution is nonsymmetrical. As a result, the...
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Normalized Individuals (IN) Control Chart
Abstract: The only commonly used control chart that cannot be normalized is the Individuals (I) chart. A procedure called a Normalized Individuals (IN) chart is provided for normalizing data...
View ArticleAdjusted Control Limits for U Charts
Abstract: U charts are used for count data following the Poisson distribution. However, the U chart has symmetrical control limits when the Poisson distribution is nonsymmetrical. As a result, the...
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STAT-04: Statistical Techniques for Design Verification
This is part of a series of articles covering the procedures in the book Statistical Procedures for the Medical Device Industry.PurposeDesign verification studies are confirmatory studies to ensure...
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STAT-12: Verification/Validation Sampling Plans for Proportion Nonconforming
This is part of a series of articles covering the procedures in the book Statistical Procedures for the Medical Device Industry. Purpose This procedure provides tables and instructions for selecting...
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STAT-16: Statistical Techniques for Equivalence Testing
This is part of a series of articles covering the procedures in the book Statistical Procedures for the Medical Device Industry.PurposeThis procedure provides statistical techniques for demonstrating...
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STAT-18: Statistical Techniques for Normality Testing and Transformations
This is part of a series of articles covering the procedures in the book Statistical Procedures for the Medical Device Industry.PurposeTo provide guidance on normality testing to ensure the assumption...
View ArticleAcceptance Sampling Standards
Updated October 1, 2018Note: Most of the standards below are specific to manufacturing applications. A small number are also applicable to validation. Those are specifically marked. Military...
View ArticleTrimmed Estimators for the Average and Standard Deviation
Abstract: The Distribution Analyzer software package identifies points that are potential outliers by reporting all values more than 4.5 standard deviations from the average. It uses robust estimators...
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