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January 2018 | ISE Magazine 33 C Companies that are directly or indirectly regulated by the U.S. Food and Drug Ad- ministration (FDA) – includ- ing those that manufacture food, food packaging, medi- cal devices and drugs – are responsible for ensuring that their products are produced safely and consistently. The degree to which a company must meet these obligations depends on the in- tended or reasonably foreseeable use of the product. Ultimately, industry must ensure that its products are used in a manner that promotes consumer con- fidence, brand loyalty and, above all, protection of the public health. Although industry has demonstrated a high degree of competency in this re- gard, notable exceptions have occasion- ally tested consumer confidence and placed additional challenges on manu- facturers, converters, logistics providers and retail facilities to ensure that their products are manufactured, processed and handled with the highest degree of proficiency and diligence. Considering these responsibilities, FDA has wisely prescribed varying degrees of regulatory oversight depending on the risk profile of the product. In the context of food-contact ma- terials, however, the agency has imple- mented only a broad standard for ensur- ing that products are safe and suitable for their intended use. It is largely a company's responsibility, therefore, to ensure that a high degree of safety and quality is continuously met. To meet these obligations, companies often rely on fundamental principles of industrial engineering, including facility design, process control, operations management and auditing. FDA regulation of food-contact materials The Federal Food, Drug and Cosmetic Act defines a "food additive" as a sub- stance that is reasonably expected to become a component of food under the intended conditions of use. Food addi- tives are subject to an FDA premarket clearance. Therefore, substances used in the manufacture of food packaging that may become a component of food must be the subject of a food additive regula- tion, a food contact notification (FCN) or an applicable exemption. Substances that are not used in accordance with an applicable clearance or exemption result in food packaging that is adulterated (contains an added substance that may result in food that is injurious or oth- erwise unfit for consumption), per se, under the act. In addition to meeting compositional requirements, food-contact materi- als must be suitably pure for their in- tended use. Section 402(a) of the act, commonly referred to as the "general safety clause," prohibits the presence of substances that may result in food that is harmful to a person's health. In the ab- sence of specific guidance that industry should follow to meet this requirement, reliance on FDA's good manufacturing practice (GMP) regulations for food ad- ditives provides a helpful starting point. These requirements, which were re- cently revised by regulations adopted pursuant to the new Food Safety Mod- ernization Act (FSMA), state generally that "appropriate quality control opera- tions must be employed to ensure that food is suitable for human consumption and that food-packaging materials are safe and suitable." Good manufacturing practice concepts Although the agency has provided guid- ance to industry within the context of good manufacturing practice for cer- tain specific applications – most notably regarding the recent implementation of the Food Safety Modernization Act for food ingredients – FDA largely has remained silent about specific require- ments for food packaging. The agency's decision to rely upon industry's self-regulation of quality and safety (beyond the general adulteration standard) recognizes the careful balance industry maintains between employing appropriate quality control and safety procedures and efficiently manufactur- ing products. FDA expects that, inde- pendent of any economic considerations, industry will take the steps necessary to ensure that products meet a minimum standard of safety and quality. The gen- eral safety clause further requires that food-contact materials shall not give the food a physically discernable characteris- tic like an off-taste, odor or color. Good manufacturing practice is unique to each manufacturer and prod- uct. Several aspects of GMP are, how- ever, well-recognized principles of industrial engineering: Facility design and layout, process control, engineer- ing economics, supply chain logistics, operations management, data reporting and analysis and environmental health and safety. Each of these aspects spans the entire supply chain – from raw ma- terial acquisition through finished goods delivery to the customer. Between these first and final steps, GMP concepts in- fluence every aspect of the production process, including inventory control, material movement, manufacturing and quality inspection. Facility design and layout Before the first product reaches the con- sumer, and even before it is produced, careful consideration should be placed on facility design. Proper planning re- sults not only in opportunities for qual- ity control and safety improvements, but also in economic efficiencies and cost savings. With regard to food-contact materials, a properly designed facility is essential to promoting the purposeful addition of ingredients and materials at the right place and at the right time. Food packaging materials range from simple formulas to complex mixtures of chemicals, including resins, solvents and processing aids. Facility design represents a critical first step in mak- ing sure that the production process adds substances at appropriate points in suitable quantities and in proper ratios.