Table Of ContentWIDE SPECTRA OF
QUALITY CONTROL
Edited by Isin Akyar
Wide Spectra of Quality Control
Edited by Isin Akyar
Published by InTech
Janeza Trdine 9, 51000 Rijeka, Croatia
Copyright © 2011 InTech
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Publishing Process Manager Niksa Mandic
Technical Editor Teodora Smiljanic
Cover Designer Jan Hyrat
Image Copyright Norph, 2011. Used under license from Shutterstock.com
First published September, 2011
Printed in Croatia
A free online edition of this book is available at www.intechopen.com
Additional hard copies can be obtained from [email protected]
Wide Spectra of Quality Control, Edited by Isin Akyar
p. cm.
ISBN 978-953-307-683-6
Contents
Preface IX
Part 1 General Quality Control 1
Chapter 1 Analytical Method Validation 3
Pedro Lopez Garcia, Ernesto Buffoni,
Fabio Pereira Gomes and Jose Luis Vilchez Quero
Chapter 2 General Introduction to
Design of Experiments (DOE) 21
Ahmed Badr Eldin
Part 2 Quality Control in Laboratory 27
Chapter 3 Good Clinical Laboratory Practice (GCLP) for
Molecular Based Tests Used in Diagnostic Laboratories 29
Raquel V. Viana and Carole L. Wallis
Chapter 4 Quality of the Trace Element Analysis:
Sample Preparation Steps 53
Maja Welna, Anna Szymczycha-Madeja and Pawel Pohl
Chapter 5 Aspects of Quality and Project Management
in Analyses of Large Scale Sequencing Data 71
von Reumont Björn M, Meid Sandra and Misof Bernhard
Chapter 6 Gene Markers Representing Stem
Cells and Cancer Cells for Quality Control 91
Shihori Tanabe
Chapter 7 Study of Degradation Products and Degradation
Pathways of ECD and Its Drug Product, ECD Kit 105
Kung-Tien Liu, Yu-Yung Lin,
Yi-Chih Hsia, Jian-Hua Zhao, Chang-Yung Su,
Shang-Yu Shen, Lee-Chung Men and Lie-Hang Shen
VI Contents
Chapter 8 Analog and Digital Systems of
Imaging in Roentgenodiagnostics 133
Dominika Oborska-Kumaszynska
Chapter 9 Quality Assessment of Solid Pharmaceuticals and
Intravenous Fluid Manufacturing in Sub-Saharan Africa 155
Adedibu C. Tella, Musa O. Salawu, Lyabo M. Phillips,
Ojeyemi M. Olabemiwo and George O. Adediran
Chapter 10 Need for Quality Assurance
Program of Donor Screening Tests 177
Young Joo Cha
Chapter 11 Quality Control in Pharmaceuticals:
Residual Solvents Testing and Analysis 183
Changqin Hu and Ying Liu
Chapter 12 The Application of the Potentiometric Stripping Analysis
to Determine Traces of M(II) Metals (Cu, Zn, Pb and Cd)
in Bioinorganic and Similar Materials 211
Biljana Kaličanin and Ružica Nikolić
Chapter 13 Near Infra Red Spectroscopy 237
Ahmed Badr Eldin
Part 3 Quality Control in Clinics 249
Chapter 14 Quality Control in Hospital Bone Banking 251
Eline Zwitser and Barend van Royen
Chapter 15 Future Applications of Electronic-Nose
Technologies in Healthcare and Biomedicine 267
Alphus Dan Wilson
Chapter 16 Quality Assurance and Quality Control of Equipment in
Diagnostic Radiology Practice-The Ghanaian Experience 291
Stephen Inkoom, Cyril Schandorf,
Geoffrey Emi-Reynolds and John Justice Fletcher
Chapter 17 Pressure-Sensitive Adhesives for Medical Applications 309
Zbigniew Czech and Agnieszka Kowalczyk
Part 4 Quality Control in Food Sector 333
Chapter 18 The Role of Empirical Rheology in Flour Quality Control 335
Tamara Dapčević Hadnađev, Milica Pojić,
Miroslav Hadnađev and Aleksandra Torbica
Contents VII
Chapter 19 Sensory Analysis in Quality Control:
The Gin as an Example 361
Montserrat Riu Aumatell
Chapter 20 Spectral Imaging as a Tool in Food Research
and Quality Monitoring of Food Production 373
Stina Frosch, Bjørn Skovlund Dissing,
Jens Adler-Nissen and Michael Engelbrecht Nielsen
Part 5 Quality Control in Environment 385
Chapter 21 Mass Rearing and Quality Control Parameters for
Tephritid Fruit Flies of Economic Importance in Africa 387
Sunday Ekesi and Samira A. Mohamed
Chapter 22 Quality Control of Baculoviral Bioinsecticide Production 411
Solange Ana Belén Miele,
Mariano Nicolás Belaich and Pablo Daniel Ghiringhelli
Part 6 Quality Control in Engineering 429
Chapter 23 Quality Control and Characterization
of Scintillating Crystals for High
Energy Physics and Medical Applications 431
Danile Rinaldi, Michel Lebeau,
Nicola Paone, Lorenzo Scalise and Paolo Pietroni
Chapter 24 Effect of Last Generation
Additives on the Concrete Durability 475
Ana M. Carvajal, M. Soledad Gómez,
Pablo Maturana and Raul Molina
Chapter 25 A Convenient and Inexpensive Quality Control Method
for Examining the Accuracy of Conjugate Cam Profiles 485
Wen-Tung Chang and Long-Iong Wu
Chapter 26 Material Characterization and Failure
Analysis for Microelectronics Assembly Processes 509
Chien-Yi Huang, Ming-Shu Li,
Shan-Yu Huang, Cheng-I Chang and Min-Hui Huang
Preface
Quality control is a standard which certainly has become a style of living. With the
improvement of technology every day, we meet new and complicated devices and
methods in different fields. In order not to be back on the wrong horse we should
really be on the ball, this means we should be aware of what is happening and able to
react to the situation quickly and cleverly. In order to get rid of errors and mistakes
there should be well organized procedures. Total quality philosophy is the acceptance
that the necessities of a program or a project will be fully met based on set up quality
policies and procedures. Total Quality Management (TQM) is an attitude that
institutions use to ameliorate their internal procedures and increase customer
satisfaction. When it is correctly put into action, this style of management can lead to
lowered costs correlated to corrective or preventative maintenance, better complete
performance, and an increased number of happy and faithful customers.
Nevertheless, TQM is not something that happens in a day. While there are a number
of software solutions that will assist institutions immediately by putting a quality
management system into action, there are some fundemental philosophies that the
company must implement throughout every department of the company and at every
level of management. Whatever other resources we use, we should accept the critical
principles of Total Quality Management as a basis for all our activities. Quality can
and must be managed. Various institutions have gotten stuck in a repetitive cycle of
chaos and customer accusations. They admit that their operations are simply too large
to efficiently control the level of quality. The first step in the TQM process, then, is to
become aware that there is a problem and that it can be controlled.
In fact, the real problems are the processes, not the people. If our process is riddled
with problems, it won’t matter how many times we hire new employees or how many
training sessions we put them through. We should fix the process and then train our
people on these new procedures. We should not treat symptoms but rather look for
the cure. If we just stuck on the basic problems in the process, we will never be able to
fully reach our capacity. We should seek the source to fix the problem. Every
employee is authoritative for quality. Everyone in the institution, from the workers on
the line to the upper management, must appreciate that they have a particular role in
guaranteeing high levels of quality in their products and services. Everyone has a
customer to delight, and they must all accelerate and take responsibility for them.
X Preface
Quality must be measurable. You can not manage something that you do not know
and measure. A quality management system is seldom productive when we cannot
quantify the results. We need to see how the process is started and if it is having the
wanted effect. This will help us set our goals for the future and guarantee that every
department is working towards the same result. Quality improvements must be
continuous. Total Quality Management is not something that can be done once and
then forgotten. It’s not a management “phase” that will end after a problem has been
fixed. TQM is a long-term investment, and it is designed to help us find long-term
success. Quality control refers to the measures that must be included during each
assay run to verify that the test is working properly. Quality Assurance is defined as
the overall program that ensures that the final results reported by the laboratory are
correct. The aim of quality control is simply to guarantee that the results generated by
the test are correct. However, quality assurance is concerned with much more: that the
right test is carried out on the right specimen, and that the right result and right
interpretation is delivered to the right person at the right time. Quality control
explains the directed use of testing to measure the achievement of a specified
standard. Quality control is the process, procedures and authority used to accept or
reject all components, drug product containers, closures, in-process materials,
packaging material, labeling and drug products and the authority to review
production records to assure that no errors have occurred, that they have been fully
investigated. The quality and reliability of test data rely on the state and condition of
the test system which is used in its production.
“Trust is Good, Control is Better” says an old proverb. The quality which is supposed
to be achieved is not a concept which can be controlled by easy, numerical or other
means, but it is the control over the intrinsic quality of a test facility and its studies.
The aim of this book is to share useful and practical knowledge about quality control
in several fields with the people who want to improve their knowledge.
Dr Isin Akyar
Acibadem University, School of Medicine,
Department of Medical Microbiology, Istanbul,
Turkey
