Process Monitoring and Improvement Handbook

Manuel E. Peña-Rodríguez

Description

The concept of process monitoring and improvement applies to any type of industry: automotive, textiles, food, pharmaceuticals, biologics, medical devices, electronics, aerospace, banking, educational institutions, service providers, and so on. The focus of this book is to identify and apply different process monitoring and improvement tools in any organization.
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. Many times, these professionals do not have a formal education on the use of these tools but learn about them throughout the different improvement projects in which they are involved in their work environment. This book is intended to fill the gap between the lack of formal education in the tools and the need to implement those tools in an improvement project. The book can also be used as a refresher course for those professionals who did learn about these tools as part of their educational background.

Sujets

• Business
• Qualité, hygiène, sécurité, environnement
• Techniques
• Automatisation et Contrôle
• Contrôle des processus
• Automatisation
• Automate
• Six Sigma
• Engineering
• Technology
• Seis Sigma
• Sciences et techniques
• Quality Control

Informations

• Publié par: ASQ Quality Press
• Date de parution: 27 août 2018
• Nombre de lectures: 0
• EAN13: 9781953079077
• Langue: English
• Poids de l'ouvrage: 5 Mo

Extrait

Pr o ce s s
Monitoring and
Improvement
Handbook
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00_H1549_FrontMatter_i-xx.indd 1 7/27/18 2:09 PMAlso available from ASQ Quality Press:
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The Certified Pharm a ceut ic al GMP Professional Handbook, Second Edition
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and Auditing
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Improvement, and Data Analy sis
Lance B. Coleman
To request a complimentary cal toag of ASQ Quality Press publications,
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00_H1549_FrontMatter_i-xx.indd 2 7/27/18 2:09 PMProcess
Monitoring and
Improvement
Handbook
Second Edition
M a n ue l E . P e ñ a - R o d r í g ue z
ASQ Quality Press
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Milwaukee, Wisconsin —0
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00_H1549_FrontMatter_i-xx.indd 3 7/27/18 2:09 PMAmerican Society for Quality, Quality Press, Milwaukee 53203
© 2019 by ASQ. Printed in 2018
All rights reserved.
Printed in the United States of A im caer
23 22 21 20 19 18 5 4 3 2 1
Library of Congress Cataloging-i n-P ublication Data
Names: Pena- Rodriguez, Manuel E., author.
Title: Pro cess monitoring and improvement handbook / Manuel E. PeR noad-riguez.
Description: Second edition. | Milwaukee, Wisconsin : ASQ Quality Press, [2018] |
Includes bibliographical references and index.
Identifiers: LCCN 2018029361 | ISBN 9780873899741 (hardcover : acid f-ree paper)
Subjects: LCSH: Proc ess control— Handbooks, manuals, e tc. | Quality control —
Handbooks, manuals, e tc.
Classification: LCC TS156.8 .P447 2018 | DDC 660/.2815—d c23
L C r e c o r d a v a i l a b l e a t h t t p s :l /c/ c n . l o c . g o v / 2 0 1 8 0 2 93 6 1
No part of this book may be reproduced in any form or by any means, electronic,
mechanical, photocopying, recording, or otw heisre, without the prior written permission
of the publisher.
Director, Quality Press and Programs: Ray Zielke
Managing Editor: Paul Daniel O’Mara
Sr. Creative Ser vices Specialist: Randy L. Benson
ASQ Mission: The American Society for Quality advances individual, o nrgaizational,
and community excellence worldwide through learning, quality improvement, and
knowledge exchange.
Attention Bookstores, Wholesalers, Schools, and Corporations: ASQ Quality Press
books, video, audio, and software are available at quantity discounts with bulk
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contact ASQ Quality Press at 800-248-1946, or write to ASQ Quality Press,
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To place o rders or to request a fre e copy of the ASQ Quality Press Publications Ca lotga,
v i s i t o u r w e b s i t e a t h t t p w: / w/ w . a s q . o r g / q u a l i t y - p r e s s.
Printed on acidf r-ee paper
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00_H1549_FrontMatter_i-xx.indd 4 7/27/18 2:09 PMTo my beloved wife Marisol and my daughter Stacey Marie. Thanks for
always being by my side, inspiring me in everyt hing I do.
Also, to my best friend José (Pepe) Rodríguez- Pérez. Thanks for
all your support and for letting me travel around the world spreading
our passion for quality.
Fi nally, to all the readers of the first edition who shared with me
their wonderful comments. I hope this second edition also fulfills
your expectations.
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00_H1549_FrontMatter_i-xx.indd 6 7/27/18 2:09 PM Table of Contents
List of Figures and T ables ................................. xi
Preface ................................................ xvii
Chapter 1 Importance of Pro cess Monitoring
and Improvement 1
1.1 Pro cess Monitoring and Improvement within the
ISO Standards .................................... 1
1.2 Pro cess Monitoring and Improvement within the Code
of Federal Regulation..............................s 2
1.2.1 Current Good Manufacturing Practices
(21 CFR 211) ................................. 3
1.2.2 Quality System Regulation (21 CFR 820 .........)3
1.3 Summary ........................................ 4
Notes..............................................4
Chapter 2 Diff er ent Approaches for Proc ess Monitoring
and When to Use Them 7
2.1 Overview7
2.2 Representative Sample ............................s 7
2.3 Sampling versus Statistical Pr coess Contro ............l8
2.4 Recommended Approaches at Va orus Si tages........... 11
2.4.1 Incoming Inspection ......................... 11
2.4.2 In-P rocess Inspection ........................ 11
2.4.3 Final Inspectio .............................n 12
2.5 Other Sampling Approaches for Incoming Inspecti.....on 14
2.6 Summary ....................................... 17
Notes.............................................. 18
C h a p t e r 3 P r o c e s s V a r ia t i o n 19
—-13.1 Overview........................................ 19
—03.2 The C auses of Variation ............................ 20
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viii Table of Contents
3.3 Summary ........................................ 22
Note............................................... 23
Chapter 4 Basic Princi ples of Statistics 25
4.1 Overview 25
4.2 Types of Data .................................... 26
4.3 Samples Collection and Sample Size Calculatio ........n 26
4.4 Describing the Sample ............................. 30
4.5 The Normal Distributio ...........................n 31
4.6 Summary ........................................ 34
Chapter 5 Graphical Tools 37
5.1 Overview 37
5.2 Histogram....................................... 37
5.3 Box Plot......................................... 38
5.4 Dot Plot 41
5.5 Pareto Diagram................................... 41
5.6 Scatter Plo ......................................t 45
5.7 Run Chart 45
5.8 Normality Tes ...................................t 53
5.9 The Importance of Assessing Normali ...............ty 55
5.10 Summary ....................................... 56
Note............................................... 56
C h a p t e r 6 M e a su r e m en t S y s t em s A n a l y s i s 57
6.1 Overview........................................ 57
6.2 Metrics ......................................... 58
6.3 Performing a Gage R&R ........................... 58
6.4 Summary ....................................... 62
C h a p t e r 7 P r o c e s s C a p a b i l i t y 63
7.1 Overview 63
7.2 Pro cess Capability and Proc ess Perf orm ance Indice s..... 64
7.3 How to Interpret the P c reoss Capability and
P ro c e s s P e f r o r m a n c e I n d i c e.........................s 67
7.4 Pro cess Capability Analy sis for Nonnormal Dat ........a 68
7.5 Performing a Pro cess Capability Analys is .............. 72
7.6 Summary ........................................ 76
Chapter 8 Hypothesis Testing 79
8.1 Overview 79
8.2 Comparing Means ................................ 82
8 . 2 . 1 O ne S- a mp l e t - Te s t ........................... 82
-1— 8 .2 .2 T w o - S a m p l e t - Te s t 83
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8.2.3 One-W ay ANOVA Test ....................... 85
8.2.4 Two- Way ANOVA Test 88
8.3 Comparing Medians............................... 91
8.3.1 One-S ample Sign Test ........................ 91
8.3.2 Two- S ample Mann- Whitney Tes ...............t 93
8.3.3 Kruskal- Wallis Test .......................... 93
8.4 Comparing Variances.............................. 97
8.4.1 F - Te s t ..................................... 97
8.4.2 Bartlett Te ................................st 99
8.4.3 Levene Test 102
8.5 Summary ....................................... 103
C h a p t e r 9 R e g r e s s i o n A n a l y s i s 105
9.1 Overview........................................ 105
9.2 Least Squares Metho..............................d 106
9.3 Regression Metrics 106
9.4 Residuals Analysi s ................................ 108
9.5 S imple Linear Regression........................... 110
9.6 Multiple Linear Regressio..........................n 112
9.7 Summary 115
Chapter 10 Design of Experiments 117
10.1 Overview....................................... 117
10.2 Design of Experiments Terminolog .................y 118
10.3 Full Factorial Experiment.........................s 119
10.4 Fractional Factorial Experimen ....................ts 120
10.5 Blocking ....................................... 122
10.6 Repetition and Replicati .........................on 123
10.7 Experimental Strateg.............................y 127
10.8 Design of Experiments Example: Two Levels,
Tw o F a c t o r s ...................................... 128
10.9 Summary ....................................... 131
Chapter 11 Control Charts 133
11.1 Overview 1