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26 Pharmaceutical Technology ® Regulating Innovation, Quality, and Risk eBook January 2024 PharmTech.com Qualit y • Recognize and manage the knowledge outputs from QRM (node 3 on RKI Cycle). In addition to the routine outputs of a quality risk assessment (e.g., results of risk ranking) is sufficient tacit knowledge captured to improve future risk assessment and review activ- ities, such as decisions and supporting rationale, alternatives considered, what was known at the time? Other knowledge outputs might include important experiential knowledge surfaced by subject-matter experts that should be codified for broader dissemination, gaps in control strat- egies, knowledge to inform supply chain, and other types of risks, gaps in knowledge where specific knowledge must be acquired, etc. Orga- nizations can take steps to define expectations for where and how this knowledge is managed, ideally for use in the future (e.g., risk review) or across similar risk assessments. • Inventory existing KM practices (nodes 4, 5, and 6 on RKI Cycle). Regardless of whether an organization has a for- mal KM program, understand what KM or "KM- like" practices exist in the categories of content management, search, expertise location, com- munities of practice, after action review/lessons learned, tacit knowledge transfer, and critical knowledge retention. These KM practices should be catalogued and made visible broadly across the organization. A more comprehensive (and complex) opportunity would be to perform a KM capability assessment (21) to understand an orga- nization's relative KM maturity and potential ac- tions to improve. • Conduct KM awareness training for QRM practitioners (nodes 1, 2, and 3 on RKI Cycle). Build KM competency for QRM practitioners via basic training that includes in- troductory KM concepts (e.g., definitions, princi- ples), mindsets and behaviors, and awareness of existing KM practices at an organization. In the opinion of the authors, the more awareness QRM practitioners have about KM and the opportunity for KM to support QRM, the greater the opportu- nity to recognize challenges and opportunities, and create a "pull" from QRM to improve KM—and from KM to improve QRM. • Develop and deploy simple KM practices (nodes 4, 5, and 6 on RKI Cycle). These practices should be based on known challenges and/or insights from QRM knowledge mapping (i.e., the first recommendation on this list). Such practices could be simple steps to pro- vide guidance on where content should be stored (and not stored) and create lists of subject matter experts and decisions or could be more involved, such as creating communities of practice or de- ploying search tools. The role of knowledge in enhancing realiza- tion of ICH Q9(R1). Considering the si x revision topics of ICH Q9(R1) and how each invokes a depen- dency on knowledge availabilit y and application (Table I), ICH Q9(R1) further reinforces this relation- ship between knowledge and risk. It is perhaps obvi- ous to say each of the six topics—subjectivity, product availability risks, formality, risk-based decision-mak- ing, risk review, and hazard identification—would each benefit by having the "maximum and collective knowledge of the organization available on demand," as is the intent of the RKI Cycle. The authors anticipate further evolution of KM prac- tices (and, therefore, improved knowledge access and availability) can benefit several of these targeted revi- sion topics. For example: • Subjectivity. Consider the use of a "hazard library" (or "risk bank") to identify common hazards for a given risk scenario. Such lists could reduce sub- jectivity by minimizing variability across dif- ferent teams of experts in identifying common hazards. Furthermore, other KM processes such as lessons learned could funnel new hazards into such standardized lists. • Hazard identification. In addition to such a "hazard library," processes such as directed recognition (22), aim to reduce "unknown-unknowns." Many of the processes, such as those described in the referenced article, focused on reducing unwel- come surprises (e.g., checklists and interviews) and are, in fact, KM-like processes to surface, con- nect, and transfer tacit knowledge. • Risk-based decision-making. Research into risk-based decision-making in the pharmaceutical industry has identified 21 characteristics of risk-based de- cision-making in high-reliability organizations (e.g., aerospace, nuclear) (23). Many of these char- acteristics—eight in total—have a dependency on KM practices, including concepts of data and knowledge sources, data and knowledge avail- ability, and taxonomy. • Risk review. In addition to the recommendations above involving knowledge capture from QRA to inform future risk review, consider the use of "risk registers" as a KM tool to monitor and track actions identified during risk assessments. Knowledge as the currency of managing risk Knowledge is a fundamental enabler to pharmaceuti- cal quality. QRM should strive to apply the collective knowledge of the organization to recognize and un- derstand risk and, in turn, to inform risk-based deci- sions that can have direct impact to patient safety and product availability. Said differently, knowledge is the currency of managing risk. Investing in the practice of knowledge management can provide an intentional, standard, and repeatable "how" for knowledge to be more effectively managed.