Abstract
Mass production was part of the industrial revolution in 1870 and, with it, a huge step change in manufacturing processes. Its impact was ground breaking and became even more remarkable with automation in a business production environment. The chemical industry is one of the manufacturing sectors that has benefited from the technology of mass production achieved through automating the business process. In this era of industry 4.0 and with the associated advanced technologies of smart manufacturing, cloud computing, cyber physical systems and internet of things, mass production has been revolutionised but still faced issues such as quality control of the production process which was affected by supply chain management, customised production of commodity and specialty chemicals and huge demand from other chemical industry manufacturers. This chapter has reviewed the evolution of mass production during traditional manufacturing to the present day and carried out a risk assessment to quality of production in a mass production environment with a view to recommending adequate quality control of the production process. The chapter also included a case study for mass production of a pharmaceutical drug—Amoxicillin which was partly batch produced into dry powder and then mass produced using tableting and encapsulating machine, highlighting sources of contamination and inconsistency in tablet weight if adequate control measures were not put in place.
Highlights
Manufacturing is essential to a nation’s economic well-being and quality of life for citizens because it creates wealth which is distributed through high-value jobs
There are four industrial revolutions so far [2] including first industrial revolution associated with discovery of water and steam power engine in 1784, the second industrial revolution in 1870 which involved mass production using electrical energy, the third industrial revolution in 1970 which introduced the use of information technology systems for automation and the fourth industrial revolution describing the present day which embraces Internet of Things (IOT) and cyber physical systems (CPS)
As drug quality development progresses from the batch to continuous and smart manufacturing, quality assurance changes from quality by testing to quality by design and consolidating to quality by control based on standards and requirements
Summary
Manufacturing is essential to a nation’s economic well-being and quality of life for citizens because it creates wealth which is distributed through high-value jobs. The moving assembly lines enabled the development of mass production which provided low-cost products through large scale manufacturing. In the late 1980s, global competition and consumer demand for high product variety led to the development of mass customisation This was achieved by manufacturers designing the basic product architecture and possible options while customers selected the assembly combination of their choice. Another option is personalisation which designs/produces products which are personalised for individuals thereby achieving a high level of value differentiation for specific users. It will develop risk assessment that could guide process quality monitoring during mass production
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