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40 Pharmaceutical Technology ® Regulating Innovation, Quality, and Risk eBook January 2024 PharmTech.com Qualit y play to induce vigilant attention to manufacturing capability and timely continual improvements. In some companies, internal and external forces are insufficient to cause the organization to consistently adopt manufacturing and quality (including quality system) advancements (88,89). Industries that focus on avoiding the cost of poor quality (COPQ) and optimize operations as a continu- ing long-term imperative are the ones most likely to fortify their business dependability. Because the pharmaceutical industry is generally considered slow to implement technological improve- ments, it would be especially beneficial if enhanced efforts were made to demonstrate the business ben- efits of quality. Past foundational research on cost/ benefit of improving manufacturing reliability The need to demonstrate business value has been frequently highlighted in literature as an import- ant driver for adopting improvements in the areas of manufacturing, quality, and supply. While there are many case studies, comprehensive ROI models that integrate long-term benefits and the COPQ are not always widely adopted by certain industries. In their review paper on "cost of quality" (CoQ) mod- els, Schiffauerova and Thomson noted that a "CoQ analysis links improvement actions with associated costs and customer expectations, and this is seen as the coupling of reduced costs and increased ben- efits" (90). However, they added that "Companies rarely have a realistic idea of how much profit they are losing through poor quality … Even though qual- ity is now widely acknowledged as a key competitive weapon, it seems that there is a lack of quality vision and commitment among top management." There are nonetheless a substantia l number of success stories, and many models exist in non-phar- maceutical contexts that are useful to explore. Some examples are summarized in Table II. These industr y learnings and transformations were of ten d r iven by orga n izat iona l habit s t hat demonstrated the value of quality. Notably, Tatikonda and Tatikonda observed that ROI estimates are pivotal in the decision whether to conduct quality improvement projects, and to choose between options (102). In the pharmaceutical realm, the literature is most ly anecdota l or genera lized without extensive definition of parameters to fully support investing in manufacturing infrastructure and related quality systems. Even so, the experience from other industries provides promising indications that quality improvement is well worth the initial investment. Long-term efficiency and predictabil- ity gains should be a major part of a comprehensive ROI calculation in tandem with better quantif ying TABLE II. Examples of industries with models that analyze costs/ benefits of improving reliability. Industry Comments Agricultural A four-layer model demonstrates business value of investing in enhanced technology for mass production using a soybean oil production method and for food traceability (91). (There are additional similar quality-business synergy investment examples in the food Industry) (92) Automobile A model for comparing manual process vs. robotics outcomes considers quality, performance, and availability (93). Healthcare Data demonstrates better patient safety outcomes are attained through improved patient care practices, which leads to improved financial performance (94). Electronics, semi- conductor Includes quality-business framework for improved quality, reduced defects, increased customer satisfaction, increased market share, and profitability (95). Hotel Researchers created a model that measures the quality of hotel design (e.g., layout, HVAC, quality of interior materials, lighting, space, security, style, location), and showed consequent higher customer satisfaction and loyalty that leads to repeat customers (96). Aviation One model demonstrates the value of reliable production by describing the benefits of avoiding costly corrective actions from unreliable equipment and maintenance errors (97). Also see Ref. 98. Multiple industries— integrating online digital technology (includes smart manufacturing and industry 4.0 concepts) Model includes factors that would promote production of a maximally profitable "zero defect" quality product for consumers. It includes considerations such as modern technology, continuous quality control during each unit operation, and predictive maintenance (99). Multiple industries— knowledge management Papers show relationship of knowledge management (including both tacit and explicit knowledge) from perspectives of: "Customer centricity" (100) and profitability. Addresses creating value for the customer and business ("competitive edge") by understanding cost drivers and the value chain. For example, "executional cost drivers include work force involvement (commitment to improvement), total quality management (Kaizen and zero defects approaches), capacity utilization, plant layout, product configuration, and linkages with customers and suppliers" (101).