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24 Pharmaceutical Technology ® Regulating Innovation, Quality, and Risk eBook January 2024 PharmTech.com Qualit y Furthermore, when asked about the potential benefits of improved QRM–KM integration, a variety of import- ant benefits associated with better connectivity between risk and knowledge were identified, including: • Better risk-based decisions where decisions are in- formed by risk and knowledge • More data/knowledge-driven risk assessments • Increased ability to leverage off of prior knowledge • Improved control strategies that better reflect risk and knowledge • Improved PQS effectiveness, better supporting de- cision making, validation, change management, outsourcing, etc. • Improved protection and value for patients through reduced risk of defects, drug shortages, etc. Notably, these anticipated benefits ref lect the role of knowledge as a commodity—or currency—in de- livering improved risk assessments, control strategies, decision making, and quality outcomes. These 2021 results depicted in Figure 1 coupled with anticipated benefits identified by survey responses clearly suggest that QRM and KM were not well-con- nected, nor as connected as they should be, and that im- portant benefits are possible if QRM and KM are better integrated in the future. The authors are hopeful that this connection between risk and knowledge will be more prevalent with the adoption of ICH Q9(R1) which clearly recognizes the role knowledge plays in quality risk management and risk-based decision-making. A framework to connect risk and knowledge. As one potential means to address this need to connect risk and knowledge, a framework was developed by the authors in partnership with Kevin O'Donnell, PhD, market compliance manager, Health Products Regula- tory Authority. This framework, the RKI Cycle (19), was proposed based on the previously referenced literature review of pharmaceutical regulatory guidance, input from industry and regulatory agency experts, practices in other industries (e.g., aerospace), and fundamental principles of knowledge management (e.g., enabling knowledge to "flow"). Figure 2 provides a summary of key RKI Cycle features, including: • The RK I Cycle, high lighting t he relationship between risk and knowledge, and underlying key concepts reinforced throughout regulatory guidance. • The RKI Cycle as applied to ICH Q10, with pro- posed guiding principles to connect QRM and KM as a means to operationalize the integration of risk and knowledge. • The RKI Cycle over the product lifecycle, illus- trating that knowledge increases over time, pro- viding the opportunity to apply this to increase understanding, decrease uncertainty, and, ulti- mately, reduce risk. Given this summary of the RKI Cycle and supporting concepts and principles, the following sections will explore its application and contribution to ICH Q9(R1). Practical application of the RKI Cycle framework. The authors propose the RKI Cycle can be applied in dif ferent ways to help address the disconnect be- tween risk and knowledge. In the simplest manner, the RKI Cycle can readily be applied as a conceptual model for organizations to ref lect on whether risk and knowledge are intentionally connected via a connectivit y between an organization's QRM and KM practices. The six guiding principles (Figure 2b) provide "target conditions" throughout the cycle, which can be qualitatively assessed for alignment of an organization's practices. FIGURE 1. Exploring the integration of quality risk management (QRM) and knowledge management (KM). FIGURES COURTESY OF THE AUTHORS.