Wide Spectra of Quality Control Part 1 pdf

WIDE 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 All chapters are Open Access articles distributed under the Creative Commons Non Commercial Share Alike Attribution 3.0 license, which permits to copy, distribute, transmit, and adapt the work in any medium, so long as the original work is properly cited. After this work has been published by InTech, authors have the right to republish it, in whole or part, in any publication of which they are the author, and to make other personal use of the work. Any republication, referencing or personal use of the work must explicitly identify the original source. Statements and opinions expressed in the chapters are these of the individual contributors and not necessarily those of the editors or publisher. No responsibility is accepted for the accuracy of information contained in the published articles. The publisher assumes no responsibility for any damage or injury to persons or property arising out of the use of any materials, instructions, methods or ideas contained in the book. 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 orders@intechweb.org 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 Dapčevi ć 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 . WIDE SPECTRA OF QUALITY CONTROL Edited by Isin Akyar Wide Spectra of Quality Control Edited by Isin Akyar Published by InTech Janeza Trdine 9, 510 00. orders@intechweb.org 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. Adediran Chapter 10 Need for Quality Assurance Program of Donor Screening Tests 17 7 Young Joo Cha Chapter 11 Quality Control in Pharmaceuticals: Residual Solvents Testing and Analysis 18 3 Changqin