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Statistical Procedures for the Medical Device Industry

List of Statistical Procedures Covered

Dr. Wayne A. Taylor

Below is a list of all the statistical techniques covered by the book of procedures.  For each procedure step-by-step instructions are provided.  For about half the procedures spreadsheets are provided.  Extensive tables are provided for selecting sampling plans.  Otherwise, instructions are provided for executing the procedure in Minitab, Distribution Analyzer, Change-Point Analyzer, Sampling Plan Analyzer and VarTran software packages.

 

Area/Statistical Technique

Where to Find

Confidence Intervals - 1 Group

 

Upper Confidence Limit for Percent Conforming - Attribute Data

STAT-12, Appendix D

Upper Confidence Limit for Percent Conforming - Variables Data

STAT-12, Appendix E

Upper Confidence Limit for Rate of Nonconformities

STAT-13, Appendix D

Confidence Limits for the Average

STAT-14, Appendix A

Upper Confidence Limit for Standard Deviations

STAT-15, Appendix I

Upper Confidence Limit for Relative Standard Deviations>

STAT-15, Appendix J

Confidence Intervals – 2 Groups

 

Confidence Limits for the Difference between Two Averages

STAT-16, Appendix A

Confidence Limits for the Difference between Two Averages - Paired Data

STAT-16, Appendix C

Confidence Limits for the Ratio of Two Standard Deviations

STAT-16, Appendix D

Equivalence Tests

 

Equivalence Test for the Average

STAT-14, Appendix B

Equivalence Test for Two Averages

STAT-16, Appendix B

Equivalence Test for Two Averages - Paired Data

STAT-16, Appendix D

Equivalence Test for Two Standard Deviations

STAT-16, Appendix F

General Techniques

 

Regression Analysis - Correlation Study for Substitute Measurement Methods

STAT-08, Appendix I

Analysis of Variance (ANOVA)

STAT-18, Appendix E

Kruskal-Wallis Test

STAT-18, Appendix F

Capability Study

STAT-11, Appendix F

Screening Experiment - Design of Experiment

STAT-11, Appendix D

Response Surface Study - Design of Experiments

STAT-11, Appendix E

Normality Test

 

General Normality Tests (Anderson-Darling, Shapiro-Wilk and Skewness-Kurtosis All)

STAT-18, Appendix A

Skewness-Kurtosis Specific Normality Test

STAT-18, Appendix C

Sampling Plans (Also see Equivalence Tests)

 

Attribute Single and Double Sampling Plans for Proportion Nonconforming

STAT-07, Appendix A

STAT-09, Appendix A

STAT-12, Appendix A

Variables Single and Double Sampling Plans for Proportion Nonconforming

STAT-09, Appendix A

STAT-12, Appendix B

Narrow Limit Gauging Single and Double Sampling Plans for Proportion Nonconforming

STAT-09, Appendix A

Single and Double Sampling Plans for Rate of Nonconformities

STAT-07, Appendix B

STAT-13, Appendix A

Single and Double Sampling Plans for Standard Deviations

STAT-15, Appendix A

Single and Double Sampling Plans for Relative Standard Deviations

STAT-15, Appendix B

Product Life Sampling Plans - Parametric with Specified Test Time

STAT-17, Appendix A

Product Life Sampling Plans - Censored Failure Time Plans

STAT-17, Appendix B

Specification Setting

 

Tolerance Analysis

STAT-11, Appendix A

Tolerance Sensitivity Analysis

STAT-11, Appendix B

Robust Design using Tolerance Analysis

STAT-11, Appendix C

Test Method Validations

 

Gauge R&R Study

STAT-08, Appendix B

Gauge Reproducibility Study (Variance Components Analysis)

STAT-08, Appendix C

Trending Tools

 

Pareto Chart

STAT-10, Appendix A

  or Average-Standard Deviation Control Chart

STAT-10, Appendix B

Normalized IN Chart for Individual Values

STAT-10, Appendix C

Box-Cox I Chart

STAT-10, Appendix D

U Chart for Counts with Independent Events

STAT-10, Appendix E

P Chart for Pass/Fail Proportions with Independent Events

STAT-10, Appendix F

Laney U’ Chart for Counts with Dependent Events

STAT-10, Appendix G

Laney P’ Chart for Pass/Fail Proportions with Dependent Events

STAT-10, Appendix H

Change-Point Analysis

STAT-10, Appendix I


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Last modified: September 08, 2017