Abstract
We present a summary of the historical evolution of quality control measures which is the focus of this chapter in order to help contextualize current practices in different fields of study. The chapter describes the important events and efforts of past pioneers to establish quality control measures in various industries and organizations. Quality has always been a need from the beginning of civilization to sustain and survive livelihood. The concept of quality assurance was initiated in medieval times in the form of guilds. Since that period, quality assurance has passed through phases of quality control, such as statistical quality control, quality assurance, and total quality management. All these efforts were later synthesized in the form of guidelines and rules for different organizations and practices and eventually evolved as GMP (Good Manufacturing Practices), GCP (Good Clinical Practices), and GLP (Good Laboratory Practices). These rules and measures have been evolving following the complex needs of organizations and technological changes. Various regulating authorities have been entrusted with ensuring that these guidelines are systematically followed in the area of specialization they are required. This chapter provides an outline of how quality tools were established in various organizations and industries over time. This chapter also provides a preface for all other chapters discussed in the book. The whole cycle of quality and the procedures and training involved in introducing and maintaining quality have been described in these chapters.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Greenhill S. The changing patterns of work satisfaction. Can Med Assoc J. 1958 Feb 15;78(4):266.
Rosser G. Crafts, guilds and the negotiation of work in the medieval town. Past Present. 1997 Feb;1(154):3–1.
Young HH. A brief history of quality assurance and peer review. Prof Psychol. 1982 Feb;13(1):9.
Berwick DM. Controlling variation in health care: a consultation from Walter Shewhart. Med Care. 1991 Dec;1:1212–25.
Marsh P. The new industrial revolution: consumers, globalisation and the end of mass production. New Haven: Yale University Press; 2012 Jul 17.
Knegt R. Labour constitutions and market logics: a socio-historical approach. Soc Leg Stud. 2018 Aug;27(4):512–28.
Cesaretti R, Lobo J, Bettencourt LM, Ortman SG, Smith ME. Population-area relationship for medieval European cities. PLoS One. 2016 Oct 5;11(10):e0162678.
Epstein SA. Wage labor and guilds in medieval Europe. Chapel Hill: UNC Press Books; 1991.
Ogilvie S. The economics of guilds. J Econ Perspect. 2014 Nov;28(4):169–92.
Humphreys GH. Guild medicine. Ann Surg. 1950 Oct;132(4):844.
Tulchinsky TH, Varavikova EA. A history of public health. In: The New Public Health, vol. 1. New York: Elsevier; 2014.
Brooks FW. William de Wrotham and the Office of Keeper of the King’s Ports and Galleys. English Hist Rev. 1925 Oct 1;40(160):570–9.
Brooks DH. Physicians and the pressures of industrialisation. Am J Public Health. 1975 Feb;65(2):182–3.
Uddin N, Hossain F. Evolution of modern management through taylorism: an adjustment of scientific management comprising behavioral science. Proc Comput Sci. 2015 Jan 1;62:578–84.
Taylor FW, Taylor FW. The father of scientific management. FB Coley Edited. 1923;2
Hamid SR, Isa S, Chew BC, Altun A. Quality management evolution from the past to present: challenges for tomorrow. Organizacija. 2019 Aug 1;52(3):157–86.
Copley FB, Taylor FW. Father of scientific management. New York: Harper and Brothers; 1923.
Chambers JW, Carosso VP. The tyranny of change: America in the progressive era, 1900-1917. New York: St. Martin’s Press; 1980.
Shewhart WA, Deming WE. Statistical method from the viewpoint of quality control. North Chelmsford: Courier Corporation; 1986.
Best M, Neuhauser D. Walter A Shewhart, 1924, and the Hawthorne factory. Qual Saf Health Care. 2006 Apr 1;15(2):142–3.
Walter BD, Shewhart A. Economic control of quality of manufactured product (1931). In: Landmark writings in Western mathematics 1640-1940. New York: Elsevier; 2005 Jan 1. p. 926–35.
Franco BC, Celano G, Castagliola P, Costa AF. Economic design of Shewhart control charts for monitoring autocorrelated data with skip sampling strategies. Int J Prod Econ. 2014 May 1;151:121–30.
American Society for Quality (ASQ). Quality Assurance and Quality Control [Internet]. https://asq.org/quality-resources/quality-assurance-vs-control. Accessed 1 Dec 2020
Human SW, Chakraborti S, Smit CF. Shewhart-type control charts for variation in phase I data analysis. Comput Stat Data Anal. 2010 Apr 1;54(4):863–74.
Celano G, Castagliola P, Chakraborti S. Joint Shewhart control charts for location and scale monitoring in finite horizon processes. Comput Ind Eng. 2016 Nov 1;101:427–39.
Deming WE. Out of the crisis. Cambridge, MA: MIT Press; 2018 Oct 16.
Johnson BE. In the library: deming management at work. Strategic Finance. 1992 Feb 1;73(8):14.
Tsutsui WM. W. Edwards Deming and the origins of quality control in Japan. J Jpn Stud. 1996 July 1;22(2):295–325.
Gryna FM, Juran JM. Quality planning and analysis: from product development through use. New York: McGraw-Hill; 2001.
Peterson R, Barker M. Company wide quality control in Japan: implications for Western management practices. Policy Org Soc. 1992 June 1;4(1):83–91.
Kiran DR. Total quality management: key concepts and case studies. Oxford: Butterworth-Heinemann; 2016 Oct 28.
9000Store. ISO 9000 series of Quality Standards [Internet]. Available from https://the9000store.com/what-are-iso-9000-standards/. Accessed 1 Dec 2020
Kent R. Quality management in plastics processing. New York: Elsevier; 2016 Nov. p. 30.
American Society for Quality (ASQ). What is the ISO9000 Standards series [Internet]. https://asq.org/quality-resources/iso-9000. Accessed 1 Dec 2020.
9000Store. ISO 9001:2008 Requirements in plain English [Internet]. https://the9000store.com/iso-9000-tips-iso-9001-requirements/. Accessed 1 Dec 2020.
Jasiulewicz-Kaczmarek M. ISO 9000: 2015 quality management principles as the framework for a maintenance management system. Zeszyty Naukowe Politechniki Poznańskiej. Organizacja i Zarządzanie. 2016(69):49–65.
Schneider K. Faking it: the case against industrial bio-test laboratories. Amicus J. 1983;1983:14–26.
Shukla J. Good Manufacturing Practice (GMP): an overview.
U.S. Food and Drug Administration. Good Manufacturing Practices for the 21st century for food processing (2004 study) section 1: Current Food Good Manufacturing Practices[Internet]. 2004; Updated27 Dec 2017. https://www.fda.gov/food/current-good-manufacturing-practices-cgmps-food-and-dietary-supplements/good-manufacturing-practices-21st-century-food-processing-2004-study-section-1-current-food-good. Accessed 1 Dec 2020.
Jain SK, Jain RK. Evolution of GMP in pharmaceutical industry. Res J Pharm Technol. 2017;10(2):601–6.
Immel BK. A brief history of the GMPs for pharmaceuticals. Pharm Technol. 2001 Jul;25(7):44–53.
Vijayananthan A, Nawawi O. The importance of good clinical practice guidelines and its role in clinical trials. Biomed Imaging Interven J. 2008 Jan;4(1):e5.
Williams JR. The Declaration of Helsinki and public health. Bull World Health Organ. 2008;86:650–2.
Carlson RV, Boyd KM, Webb DJ. The revision of the Declaration of Helsinki: past, present and future. Br J Clin Pharmacol. 2004 Jun;57(6):695–713.
Malik AY, Foster C. The revised Declaration of Helsinki: cosmetic or real change? J R Soc Med. 2016 May;109(5):184–9.
Garrafa V, Lorenzo C. Moral imperialism and multi-centric clinical trials in peripheral countries. Cad Saude Publica. 2008 Oct;24(10):2219–26.
World Health Organization. Handbook: good laboratory practice (GLP): quality practices for regulated non-clinical research and development. World Health Organization; 2010 Feb 2.
Shukla S, Shankar R, Singh SP. Food safety regulatory model in India. Food Control. 2014 Mar 1;37:401–13.
Sitaraman R. Incorporating good laboratory practices in academic research laboratories: prospects and perspectives. In: Proceedings of the National Conference on “GLP and ISO/IEC-17025 - Emphasis on Regulatory Affairs and Application in Academic Research”. Chennai: IIBAT. p. 83.
Marshall E. The murky world of toxicity testing. Science. 1983;220:1130–2.
United States Environmental Protection Agency. Quality assurance guidance document-model quality assurance project plan for the PM ambient air. 2001;2.
Baldeshwiler AM. History of FDA good laboratory practices. Qual Assur J. 2003 Sep;7(3):157–61.
Smith RJ. Creative penmanship in animal testing prompts FDA controls. Science. 1977;198:1227–9.
Kendall G, Bai R, Błazewicz J, De Causmaecker P, Gendreau M, John R, Li J, McCollum B, Pesch E, Qu R, Sabar N. Good laboratory practice for optimisation research. J Oper Res Soc. 2016 Apr 1;67(4):676–89.
Becker RA, Janus ER, White RD, Kruszewski FH, Brackett RE. Good laboratory practices and safety assessments. Environ Health Perspect. 2009 Nov;117(11):A482–3.
Salzman J. Decentralized administrative law in the Organization for Economic Cooperation and Development. Law Contemp Prob. 2004;68:189.
Wollin KM, Harston S, Lilienblum W. Quality assurance in toxicology. Regul Toxicol. 2020;2020:1–9.
Rasmussen K, Rauscher H, Kearns P, González M, Sintes JR. Developing OECD test guidelines for regulatory testing of nanomaterials to ensure mutual acceptance of test data. Regul Toxicol Pharmacol. 2019 Jun 1;104:74–83.
Nischal PM. Parliamentary committee report on the functioning of Medical Council of India. Natl Med J India. 2016 May 1;29(3):185.
Kochanek SA. The transformation of interest politics in India. Pac Aff. 1995 Dec;1:529–50.
Khan F, Khan H. Quality management in the healthcare industry. Decision. 2004 July 1;31(2):0304.
Hajare P. Quality Council of India [Internet]. 18 Aug 2020. https://pscnotes.in/quality-council-of-india/. Accessed 1 Dec 2020.
Verma S, Gray SJ. The creation of the Institute of Chartered Accountants of India: the first steps in the development of an indigenous accounting profession post-independence. Acc Historians J. 2006 Dec;33(2):131–56.
Teck-Heang LE, Ali AM. The evolution of auditing: an analysis of the historical development. J Mod Account Audit. 2008 Dec 1;4(12):1.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2021 The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd.
About this chapter
Cite this chapter
Khosla, R., Srivastava, V. (2021). Historical Overview of Quality Assurance in Biological Research. In: Anand, A. (eds) Quality Assurance Implementation in Research Labs. Springer, Singapore. https://doi.org/10.1007/978-981-16-3074-3_1
Download citation
DOI: https://doi.org/10.1007/978-981-16-3074-3_1
Published:
Publisher Name: Springer, Singapore
Print ISBN: 978-981-16-3073-6
Online ISBN: 978-981-16-3074-3
eBook Packages: MedicineMedicine (R0)