Statistical process control for the FDA-regulated industry / Manuel E. Pena-Rodriguez.

Format:

Book

Author/Creator:

Pena-Rodriguez, Manuel E., author.

Language:

English

Subjects (All):

Process control--Statistical methods.

Process control.

Manufacturing processes--United States--Quality control.

Manufacturing processes.

Physical Description:

1 online resource (205 p.)

Edition:

1st ed.

Place of Publication:

Milwaukee, Wisconsin : ASQ Quality Press, 2013.

Language Note:

English

Summary:

The focus of this book is to understand and apply the different SPC tools in a company regulated by the Food and Drug Administration (FDA): those that manufacture pharmaceutical products, biologics, medical devices, food, cosmetics, and so on. The book is not intended to provide an intensive course in statistics; instead, it is intended to provide a how-to guide about the application of the diverse array of statistical tools available to analyze and improve the processes in an organization regulated by FDA.This book is aimed at engineers, scientists, analysts, technicians, managers, supervisors, and all other professionals responsible to measure and improve the quality of their processes. Although the examples and case studies presented throughout the book are based on situations found in an organization regulated by FDA, the book can also be used to understand the application of those tools in any type of industry.Readers will obtain a better understanding of some of the statistical tools available to control their processes and be encouraged to study, with a greater level of detail, each of the statistical tools presented throughout the book. The content of this book is the result of the author's almost 20 years of experience in the application of statistics in various industries, and his combined educational background of engineering and law that he has used to provide consulting services to dozens of FDA-regulated organizations.

Contents:

Intro

Title Page

CIP Data

Dedication

Table of Contents

List of Figures and Tables

Preface

Chapter 1: Regulatory Importance of Statistical Process Control

1.1 Overview

1.2 Process Control within the Code of Federal Regulations

1.2.1 Current Good Manufacturing Practices (21 CFR 211)

1.2.2 Quality System Regulation (21 CFR 820)

1.3 Process Control within the FDA Guidances

1.3.1 Quality System Approach to Pharmaceutical cGMP Regulations

1.3.2 Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production

1.3.3 Process Validation: General Principles and Practices

1.4 Process Control within International Guidances and Standards

1.4.1 ICH Q10

1.4.2 ISO 13485:2003 Standard

1.5 Summary

Chapter 2: SPC and the Life Sciences Regulated Industry

2.1 Overview

2.2 Recent Observations About Misuse of Statistical Process Control

2.3 SPC and CAPA

2.4 Summary

Chapter 3: Process Variation

3.1 Overview

3.2 The Causes of Variation

3.3 Summary

Chapter 4: Basic Principles of Statistics

4.1 Overview

4.2 Types of Data

4.3 Sampling

4.4 Describing the Sample

4.5 The Normal Distribution

4.6 Summary

Chapter 5: Graphical Tools

5.1 Overview

5.2 Histogram

5.3 Box Plot

5.4 Dot Plot

5.5 Pareto Diagram

5.6 Scatter Plot

5.7 Run Chart

5.8 Normality Test

5.9 The Importance of Assessing Normality

5.10 Summary

Chapter 6: Measurement Systems Analysis

6.1 Overview

6.2 Metrics

6.3 Performing a Gage R&amp

R

6.4 Summary

Chapter 7: Process Capability

7.1 Overview

7.2 Process Capability and Process Performance Indices

7.3 How to Interpret the Process Capability and Process Performance Indices

7.4 Process Capability Analysis for Nonnormal Data

7.5 Performing a Process Capability Analysis

7.6 Summary.

Chapter 8: Hypothesis Testing

8.1 Overview

8.2 Comparing Means

8.2.1 One-Sample t-Test

8.2.2 Two-Sample t-Test

8.2.3 One-Way ANOVA Test

8.2.4 Two-Way ANOVA Test

8.3 Comparing Medians

8.3.1 One-Sample Sign Test

8.3.2 Two-Sample Mann-Whitney Test

8.3.3 Kruskal-Wallis Test

8.4 Comparing Variances

8.4.1 F-Test

8.4.2 Bartlett Test

8.4.3 Levene Test

8.5 Summary

Chapter 9: Regression Analysis

9.1 Overview

9.2 Least Squares Method

9.3 Regression Metrics

9.4 Residuals Analysis

9.5 Simple Linear Regression

9.6 Multiple Linear Regression

9.7 Summary

Chapter 10: Design of Experiments

10.1 Overview

10.2 Design of Experiments Terminology

10.3 Full Factorial Experiments

10.4 Fractional Factorial Experiments

10.5 Blocking

10.6 Repetition and Replication

10.7 Experimental Strategy

10.8 Design of Experiments Example: Two Levels, Two Factors

10.9 Summary

Chapter 11: Control Charts

11.1 Overview

11.2 The Rational Subgroup

11.3 Nonrandom Patterns

11.4 Variables Control Charts and Attributes Control Charts

11.5 Variables Control Charts

11.5.1 Individuals and Moving Range Chart

11.5.2 X-bar and R Chart

11.5.3 X-bar and s Chart

11.6 Attributes Control Charts

11.6.1 p-Chart

11.6.2 np-Chart

11.6.3 c-Chart

11.6.4 u-Chart

11.7 Summary

Chaper 12: Final Thoughts

12.1 Overview

12.2 Order of Tools

12.3 Continuous Process Monitoring versus Once-a-Year Analysis and Reporting

12.4 Proactive or Reactive?

12.5 Next Steps

Appendix A: Variable and Attribute Data Applications

Appendix B: Applications for Various Graphical and Statistical Tools

Appendix C: Basic Statistics for an Annual Product Review (APR) Report

Appendix D: Most Commonly Used Hypothesis Tests

Endnotes

Index.

Notes:

Includes index.

Description based on print version record.

ISBN:

9781953079800

1953079806

9781953079794

1953079792

9781628701074

1628701072

OCLC:

891397296