Preface

Quality control (QC) is the most important component of any hospital or laboratory project. Clinical laboratory science has undergone a vast change in the last 25 years. Although a good design with properly prepared drawings and specifications is essential for a quality end product, the QC and quality assurance (QA) efforts are also essential to assure that the construction complies with the drawings and specifications. Various different reports on medical/laboratory fallacy/misconception have raised the visibility for the necessity to aug‐ ment patient safety and quality resourcefulness. Prominence has relocated from simply di‐ agnosing and treating disease to identifying and controlling disease, risk factors and maintaining health. The purpose of establishing laboratory quality standards is to ensure the accuracy of test results; to increase the confidence of patients, clinicians and communities in the value of laboratory testing; and to elucidate in patient management. Quality standards are an integral part of the quality system. They are designed to help laboratories meet regu‐ latory requirements, including local health regulations, and monitor laboratory functions, thereby ensuring laboratory safety and consistency of performance. The purpose of this book is to provide procedures, guidance, references, checklists and worksheets to help in the quality control (Internal Quality Control and External Quality Assurance), quality manage‐ ment and QA and to help in performing periodic quality assurance inspection. The book stresses prominence on three facets: (1) components such as cases and controls, defined and well-managed processes, and integrity and performance aspects, (2) competence and (3) quality of laboratory reports. Each administrative and technical procedure in the laboratory must be subject to a quality monitoring process developed with the help of relevant labora‐ tory staff. Each process must be documented using a step-by-step approach. Heads of labo‐ ratories are responsible for ensuring that each document is understood, and all processes are fully implemented by laboratory staff. Advances in technology have totally changed the way we practise diagnosis and treatment. Now, the testing techniques have moved from test tubes, beakers and large, automated analysers to microanalytic systems ("lab on a chip") that allow reduced sample size, fewer reagents and smaller instruments. Nowadays, pa‐ tients can even carry small-sized instruments with them that can help them in finding out various parameters. The continuation, prolongation and preservation of a quality manage‐ ment system are crucial to a laboratory for providing the correct test results every time. All these, however, require rigid quality control. Establishing and maintaining laboratory quali‐ ty standards are essential. They are important for several reasons, including ensuring the quality and traceability of patients' results, supporting clinical and public health decisionmaking, procuring equipment, using standard techniques and reagents, sharing documenta‐ tion, training programmes, quality assurance, meeting requirements for reimbursement for national insurance schemes, and complying with national or international accreditation and licencing systems. A well-staffed and well-financed organization centre is critical for estab‐

lishing and running a successful quality assurance programme, that supports participants. Hence, I sincerely hope that this book will enable all aspects of medical science and the pa‐ tients to improve their everyday life.

This work would not have been possible without the support of IntechOpen. I am especially indebted to Ms. Romina Rovan, Publishing Process Manager, who has been supportive of my book and who worked actively to provide me with all facilities. I am grateful to all of those with whom I have had the pleasure to work during this project. Each of the authors of the different chapters has provided me extensive professional help and obliged me on this scientific venture wherever possible. I would especially like to thank the authors of the vari‐ ous chapters of the book:

Ayed Dera, Irfan Ahmad, Aguilar Quesada Rocio , Matthew R. Pincus,Husniza Hussain, Rusidah Selamat, Santana Monique Freire, Agustin G. Asuero, Antonio Gustavo González, María Ángeles Herrador, Julia Martín, Amir Momeni-Boroujeni, Verónica Valdivieso-Gó‐ mez and Luiz Carlos de Lima Ferreira.

Nobody has been more important to me in the pursuit of this project than the members of my family. I would like to thank my parents, Late Taufiquz Zaman and Late Jaiba Zaman, whose love and guidance are with me in whatever I pursue. Most importantly, I wish to thank my loving and supportive wife, Mrs. Jarin Tanwir Hussain, who is my ultimate role model, and my two wonderful children, Naushad Muntasir Zaman and Umar Sarwar Za‐ man, who provided me with unending inspiration during the project.

> **Dr. Gaffar Sarwar Zaman** King Khalid University, KSA

**Chapter 1**

**Provisional chapter**

**Introductory Chapter: History and Scope of Quality**

**Introductory Chapter: History and Scope of Quality** 

Laboratory quality control encompasses the integral and essential monitoring of investigative analytics to find out investigative and interfering flaws, miscalculations and blunders that appear or materialize during the analytical procedures and conclusively avert the erroneous reporting of results to the patient. Quality control is usually used to monitor the accomplishment of a test, and, to find the accuracy. Levey and Jennings were the pioneers of using statistics for the standardization and calibration of analytical procedures. The substances used for quality control are known as quality control (QC) materials. They are usually aliquoted in a stable form. Nowadays, most laboratories purchase the QC material from reputed companies instead of making them. The QC material is usually in a powdered form and can be stored for more than a year. The concept of statistical quality control decreased to a great extent the cost

Walter Andrew Shewhart (March 18, 1891–March 11, 1967) was an American engineer, statistician and physicist, also called "the Father of Modern Quality Control," and he is also credited as the founder of the "Shewhart cycle" [1] (**Figure 1**). Walter Shewhart was instrumental in the introduction and development of "Process Control" in the year 1924. Prevention of the manufacture of defective products was the main aim of this method. For

> © 2016 The Author(s). Licensee InTech. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

© 2018 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use,

distribution, and reproduction in any medium, provided the original work is properly cited.

DOI: 10.5772/intechopen.74593

**Control in Laboratories**

**Control in Laboratories**

http://dx.doi.org/10.5772/intechopen.74593

Additional information is available at the end of the chapter

of quality control by the help of the method of sampling.

**2. Historical perspective of quality control in laboratories**

Gaffar Sarwar ZamanAdditional information is available at the end of the chapter

Gaffar Sarwar Zaman

**1. Introduction**

#### **Introductory Chapter: History and Scope of Quality Control in Laboratories Introductory Chapter: History and Scope of Quality Control in Laboratories**

DOI: 10.5772/intechopen.74593

Gaffar Sarwar Zaman Gaffar Sarwar Zaman

lishing and running a successful quality assurance programme, that supports participants. Hence, I sincerely hope that this book will enable all aspects of medical science and the pa‐

This work would not have been possible without the support of IntechOpen. I am especially indebted to Ms. Romina Rovan, Publishing Process Manager, who has been supportive of my book and who worked actively to provide me with all facilities. I am grateful to all of those with whom I have had the pleasure to work during this project. Each of the authors of the different chapters has provided me extensive professional help and obliged me on this scientific venture wherever possible. I would especially like to thank the authors of the vari‐

Ayed Dera, Irfan Ahmad, Aguilar Quesada Rocio , Matthew R. Pincus,Husniza Hussain, Rusidah Selamat, Santana Monique Freire, Agustin G. Asuero, Antonio Gustavo González, María Ángeles Herrador, Julia Martín, Amir Momeni-Boroujeni, Verónica Valdivieso-Gó‐

Nobody has been more important to me in the pursuit of this project than the members of my family. I would like to thank my parents, Late Taufiquz Zaman and Late Jaiba Zaman, whose love and guidance are with me in whatever I pursue. Most importantly, I wish to thank my loving and supportive wife, Mrs. Jarin Tanwir Hussain, who is my ultimate role model, and my two wonderful children, Naushad Muntasir Zaman and Umar Sarwar Za‐

> **Dr. Gaffar Sarwar Zaman** King Khalid University, KSA

man, who provided me with unending inspiration during the project.

tients to improve their everyday life.

mez and Luiz Carlos de Lima Ferreira.

ous chapters of the book:

VIII Preface

Additional information is available at the end of the chapter Additional information is available at the end of the chapter

http://dx.doi.org/10.5772/intechopen.74593
