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38 Pharmaceutical Technology ® Regulating Innovation, Quality, and Risk eBook January 2024 PharmTech.com Qualit y reinvested (Figure 3) in their facility vs one whose short-sighted cost-cutting measures culminated in an unreliable manufacturing facility (Figure 4). The latter site incurred extremely high costs to remedi- ate, while the former site maintained high capability through moderate incremental investments. The full case study is available on the ICH website (83). Quality first, then efficiency In the 21st century, there has been much emphasis on cost reduction and "lean" manufacturing activities. When not well-conceived or overemphasized, it can adversely impact quality. As the concept of quality has evolved, there has been debate about whether the in- vestment required to produce consistent quality goods or services should be considered a "cost." Some people have even used the phrase "the cost of quality." But man- ufacturing is a cost, quality itself is not. Quality is an imperative. Any discussion of quality "costs" is probably better placed on the considerable repercussions to the business when factories produce poor quality products, or the "cost of poor quality" (84). The consistent produc- tion of acceptable quality products should be an intuitive baseline requirement for any manufacturing business. Inappropriate application of lean activities is an- other potential issue for any industry, including phar- maceuticals. Lean techniques are acceptable as long as they are applied appropriately and do not undermine quality assurance. When choices are made that re- duce assurance and create lower confidence in quality, there is a corresponding question of who bears that cost. Customer-focused manufacturing organizations are committed to quality and associated continual im- provements in operational reliability. Indeed, cost per unit can be reduced by investing in higher capability technology, which typically yields both better prod- ucts and higher throughput. Importantly, this serves both quality and lean objectives. However, in worst-case scenarios, unstable pro- cesses have been streamlined. Or, stable processes have become unstable when changes intended to "lea n out" a process removed impor ta nt cont rols (e.g., process step; in-process qua lit y check) t hat were incorrectly assumed to be "waste" or "non-crit- ical." Lean engineering, lean manufacturing, and operational excellence are popular initiatives (85), but problems have occurred when lower capability processes are targeted. An important learning has been that lean engineering should only be applied to stable processes, and when applied to those, the lean methods should not culminate in an operationa l change that could lower assurance of quality. Yearly Spend (After facility goes operational) OPEX + CAPEX Dollars _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Reinvestment over time using QRM as a business strategy FIGURE 3. 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)