Book:LIMS Selection Guide for Manufacturing Quality Control/Introduction to manufacturing laboratories/Safety and quality in manufacturing industries

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1.3 Safety and quality in manufacturing industries

The previous section highlighted a variety of laboratory testing activities that goes on across the three broad manufacturing-based roles, including safety and QC testing. Additionally, mention was made of standards and regulations affecting manufacturers and their QC methods (more on that in the second chapter). This focus on safety and quality in manufacturing certainly doesn't occur in a vacuum; after all, history has shown that today's focus on safety and quality are often byproducts of yesterday's people and animals injured or killed due to inadequate manufacturing processes, insufficient research, sheer incompetency, or willful neglect or malice.^[1]^[2]^[3]^[4] However, the relationships among consumers, manufacturers, and regulators haven't always been easy. In his 1988 work Consumer Safety Regulation: Putting a Price on Life and Limb, Peter Asch had the following to say about these relationships^[2]:

The anti-market position of most consumer safety advocates is necessarily severe. Consumers are believed to desire additional safety, and manufacturers to know how to produce it; yet the two groups, interacting in the marketplace, do not get the job done. Precisely why this failure occurs is seldom explained by advocates of expanded regulation.

This is not to claim that exponents of a larger government role are necessarily wrong, or that a compelling rationale for such public expansion cannot be invoked. Rather, the case has not usually been made. The success of consumer protection advocates is, therefore, all the more remarkable.

Take the food and beverage industry, for instance. According to 2011 estimates by the CDC, "48 million people get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases each year in the United States."^[5] Whether contamination occurs in the natural growing environment of the produce farm or mechanical confines of a processed food manufacturer, these numbers point to a need for continuing to develop and modify policies and regulations that better prevent foodborne illness and encourage speedy response to such illnesses in the farm-to-fork process chain.^[6]

The drivers for this safety and quality are most obvious when viewed from the governmental level. In the U.S., several government bodies play a roll in testing and monitoring food safety and quality. For example, the USDA estimated in 2017 that some "7,500 food safety inspection personnel go to work in more than 6,000 regulated food facilities and 122 ports of entry," and "[a]nother 2,000 food safety professionals go to work in three public health laboratories, 10 district offices, and our headquarters office. These employees run test results, dispatch outbreak investigators, and unpack data to reveal telling trends and inform proactive, prevention-based policies that will lead to safer food and fewer illnesses."^[7] In another example, the CDC and its FoodNet surveillance program conducts "active surveillance; surveys of laboratories, physicians, and the general population; and population-based epidemiologic studies" for roughly 15 percent of the U.S. population.^[8] Additionally, entities like the USDA and the FDA are significant forces behind the development of regulations that affect how and when other entities—governmental and non-governmental—conduct their food and beverage testing and production activities.

In the same way, other manufacturing industries' motivations and actions towards quality and safety are driven by standards and regulations (as well as a desire to remain competitive, relevant, and profitable). From pharmaceuticals and cosmetics to gasoline and paints, manufacturers who wish to maintain a level of success in their industry will put additional focus on the safety and quality of their products, and as we learned above, that task usually falls into the domain of the manufacturing lab, be it in the manufacturing plant proper or outside the organization. That said, safety and quality labs exist not just because of regulatory controls, but also because of private incentives towards maintaining reputation and a standard of quality in the industry. Talking specifically of food safety but applicable to other industrues, Virginia Tech's John Bovay emphasized this in an August 2022 research paper^[9]:

Producers and sellers often implement private or collective standards for food safety as an investment in their own reputations. Producers who have invested in such standards can benefit from additional regulations that improve safety because these regulations can further bolster the reputation of the industry and also raise costs for rival firms. Thus, food-safety regulations may have effects on competition and certainly can have differential welfare effects.

That is all to say that reputation, standards, and regulation are interlinked in producer efforts towards safer, higher-quality products. Supporting those efforts is, in turn, quality, standardized laboratory testing that meets or exceeds the needs of the producer, as well as the overall industry. Furthering those laboratory efforts of gauging the quality of manufactured products are information management systems, which unify analytical data, help better report it, and ensure the accuracy and timeliness of that reported data. However, before we can examine the information management and informatics solutions that assist manufacturing-related laboratories in their efforts, we first need to discuss the standards and regulations affecting manufacturers and the laboratories they depend on.