PharmTech.com Regulating Innovation, Quality, and Risk eBook January 2024 Pharmaceutical Technology
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25
Qualit
y
The RKI Cycle can also be applied as a detailed pro-
cess model to operationalize the RKI Cycle via deeper
assessment of QRM and KM practices and their inter-
dependency, resulting in the identification of gaps
a nd recom mended deploy ment act ions to bet ter
connect QRM and KM, and thus risk and knowledge.
Efforts by the authors are ongoing to develop detailed
RKI Cycle operationalization guidance. Several pre-
liminary recommendations include the following:
• Create a "knowledge map" for QRM (node 1 on RKI Cycle). A
k nowledge map is a KM practice used to un-
derstand the knowledge necessary for a given
activity, in this case, a quality risk assessment
(or risk review). An illustrative case study of a
knowledge map for the installation of an auto-
clave has been documented (20), for which the
industry participants provided overwhelmingly
positive feedback on the knowledge-mapping
experience, with 97% of the attendees agree-
ing that the knowledge mapping exercise helps
them think more expansively about knowledge
needed for QRM (inclusive of know-how, exper-
tise, and other tacit knowledge). The insights
from knowledge maps can be used as require-
ment s to i n for m K M prac t ices (or i mprove
current practices).
FIGURE 2. A summary of the Risk-Knowledge Infinity (RKI) Cycle. QRM is quality
risk management. KM is knowledge management.
