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PharmTech.com Regulating Innovation, Quality, and Risk eBook January 2024 Pharmaceutical Technology ® 39 Qualit y In short, efforts to reduce costs have sometimes been short-sighted and shifted the risk from the producer to the consumer by eliminating necessary operational safeguards that prevented defects from being shipped from a facility. Less capable facilities and equipment, reduced quality control measures, or diminished qual- ity assurance have led to poor quality outcomes. Davis and Atkison reported on a sur vey of busi- nesses that found "firms sometimes confuse opera- tional speed (moving quickly) with strategic speed (reducing the time it takes to deliver value). The two concepts are quite different. Simply increasing the pace of production, for example … often leads to de- creased value over time, in the form of lower quality products and services" (86). Firms that increased op- erating profits realized, in part, that they needed to "defy the laws of business physics" by "slowing down to speed up." By slowing down to be strategic in their operating investments, they could "ref lect and learn," which included the "ability to explore new technolo- gies" to deliver better products and cost gains. While it may seem intuitive that such attention to quality will lead to improvements that address c ustomer expec t at ions, bu i ld bra nd con f idence, increase efficiency, launch products on time. and otherwise enhance ROI, it is not always recognized. Models sufficiently robust to show these benefits are not in routine use. Evaluating the relationship between manufacturing robustness and business outcomes If we assume delivery of a product of good quality to each customer is the minimum standard, then the ques- tion shifts to how quality can be better assured through improved systems and manufacturing capabilities. The industries that understand that many busi- ness efficiencies accrue from manufacturing excel- lence have widely accepted continual manufactur- ing improvement as a business imperative to remain competitive and deliver customer satisfaction. They upgrade their manufacturing technology routinely. In these cases, it has been considered integral to the long-term business strategy for ongoing improvements to be made and to use contemporary technology. This is consistent with Deming's chain reaction model of business value. Similarly, Taguchi found that both business and society is served by a company that makes robust products using highly capable pro- cesses (87). And Crosby showed that quality pays for itself (Crosby), or "quality is free." In industries that continually improve, the right combination of internal and external forces are in FIGURE 4. A graph that shows the substantial long-term financial benefits of consistently reinvesting in facilities, including preventing quality risks via timely upgrades in facility/equipment design. This demonstrates the financial value of ongoing lifecycle risk review and risk reduction, which supports sound change management. (Figure courtesy of International Council for Harmonisation) Years (After facility goes operational) OPEX + CAPEX Dollars _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Shift by Company to CAPEX and OPEX Reduction Remediation Spend Post- Remediation Spend _ _ _ _ _ _ _ _ _ _ _ _ _ _ _