A Look at the Evolution of Quality throughout History

Quality in preindustrial societies

Throughout human history, the concept of quality has been ever-evolving. Hunter-gatherers employed primitive quality techniques to identify which food was safe to consume. When they organized themselves as families, the tasks were divided between members in an efficient manner with excellent co-ordination. People then organized themselves in villages and divided their works which resulted in certain specialized skills and trades, such as farming and fishing. People in these trades were knowledgeable about their tools and processes. They would take their goods to the marketplace and make face-to-face sales with customers. The customers would use their senses to judge the quality. Caveat emptor (“let the buyer beware”) was the basis of trade. This made sense as the buyer and seller usually resided in the same village and the buyer could assess the quality of the items before purchase. If the quality of the product was poor, the producer’s reputation and livelihood was at risk.

The role of Guilds (trade unions) in regulating quality

The growth of commerce and transportation in ancient times introduced merchants into the supply chain, leading to a situation where the producer and end customer did not directly interact. The assurance about the quality of the product was provided through written quality specifications and quality warranties. This ensured that the seller was aware about the product that he was buying. In order to ensure that products met these specifications, measuring devices were developed during these periods to improve accuracy and precision. The movement of artisans who made these products to new places resulted in competition which had a negative impact on their livelihoods. Additionally, the production of subpar goods by these artisans spoiled the reputation of other artisans. To address these issues, trade unions known as guilds were formed to regulate the quality of goods produced by artisans and grant monopoly for the practice of trade in a specific region. The guilds only allowed artisans to practice if they were able to produce high-quality work. They regularly inspected the products, and applied their “mark” to finished products for traceability. Artisans who produced poor quality goods were at risk of having their membership cancelled.

Government regulation of quality

The Code of Hammurabi, dating back to 2000 B.C., prescribed the death penalty for builders whose buildings collapsed and killed the owner during their stated lifespan.

The guilds discouraged efforts to improve quality because they saw it as unfair competition that threatened the equality and livelihood of their members. It controlled the internal competition but not the external competition. External competition was controlled through import restrictions and protection of trade secrets. The guilds were successful during the Middle Ages but declined during the Industrial Revolution. Apart from the guilds, the Governments were involved in regulating quality due to its impact on the safety of its citizens and its economy. In order to protect consumers and reduce ambiguity, governments have standardized measurement tools and affixed quality seals or marks on products that have been cleared by inspectors. These seals or marks help identify the producer, provide traceability through batch numbers, provide product information, and serve as a guarantee of quality. During these periods, inspection was primarily used to assess quality.

The Industrial Revolution and its impact on quality

The Industrial Revolution in Europe during the 18th century marked a significant shift in the way quality was viewed, as it replaced artisans with power-driven machines.  Special tools and the division of labor were utilized to reduce the cycle time of manufacturing activities. The division of labor also created a situation where the internal customer, rather than the end customer, received the product, leading to a shift in the focus of quality from customer satisfaction to meeting specifications. The importance of specifications, uniform measurement, and standardization also grew during this time due to the need for interchangeable parts in products.

Continuous quality improvement through process and product development

The Industrial Revolution also laid the foundation for continuous quality improvement through process and product development. Manufacturing processes were redesigned to increase efficiency, and research laboratories were established to develop new products. However, it wasn’t until the Japanese quality revolution in the 1970s that significant progress was made in reducing chronic waste.

Quality in the 21st Century

American manager F.W. Taylor introduced a system of scientific management with the goal of improving production and productivity. In Taylor’s system, planning and execution were separated, with planning handled by engineers and execution carried out by the workforce. While this approach increased productivity, it had a negative impact on quality due to the lack of emphasis on human relations. In an effort to improve quality, inspection was moved from the production department to a new department, which was eventually transformed into a quality assurance department.

Quality assurance versus quality control

Quality assurance is similar to quality control, but the main difference is their purpose. Quality control is primarily concerned with the personnel responsible for conducting and regulating operations, while the primary purpose of quality assurance is to provide information and assurance about the state of quality to those who are not directly involved in operations.

The rise of consumerism and its impact on quality

In villages, quality assurance was traditionally carried out through inspection and testing. In the crafts system, quality assurance was achieved through the training and evaluation of apprentices. Guilds established process and product standards and conducted audits to ensure compliance. During the 20th century, customers began requiring suppliers to follow quality control systems in order to remain their suppliers. However, since each customer had their own view of what constituted a quality system, this created problems for suppliers. Eventually, national standardization bodies and the International Organization for Standardization (ISO) standardized quality control systems, leading to the widespread acceptance of the ISO 9000 series. This also led to the replacement of audits by various customers with audits and certifications to the ISO series. The adoption of quality systems and the provision of data demonstrating compliance also shifted the responsibility for quality assurance from the customer (caveat emptor) to the supplier. For example, NATO’s Allied Quality Assurance Publications (AQAP) reduced the need for multiple audits for the procurement of defense equipment. The power of customers also forced reluctant suppliers to adopt these quality systems.

The future of quality in the 21st century

During the 20th century, there was a need to reduce customer dissatisfaction, as warranties and customer service were not sufficient to address it. The defects should be avoided from occurring. Increased consumer awareness has led governments to implement regulations that prevent defective products from reaching customers. These regulations are preventive in nature, aiming to prevent defects from occurring rather than addressing them after the fact. The establishment of foreign subsidiaries by multinational companies in order to avoid trade barriers also intensified competition on quality. It forced the local manufacturers to have quality at the center stage of everything (e.g. the Japanese quality revolution after World War II). While the 20th century was characterized by a focus on productivity, the quality revolution and increased consumer awareness are likely to make the 21st century the century of quality.

Published by Venkatesh

Venkatesh is a pharmacist and an alumni of Madras Medical College who is exploring his interests in Good Manufacturing practices. This blog is dedicated to the pharmaceutical regulations in India. It mostly contains the topics related to pharmaceutical technology, Good Manufacturing Practices and other legal aspects.

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