In more detail:
As stated in the document, subjectivity can directly impact the effectiveness of risk management activities and the decisions made. While subjectivity cannot be completely eliminated from quality risk management activities, it may be controlled with the proper use of quality risk management tools and maximising the use of relevant data and sources of knowledge.
An effective pharmaceutical quality system drives both supply chain robustness and sustainable GMP compliance. It also uses quality risk management and knowledge management to provide an early warning system. This includes
An understanding of formality in QRM can help to use resources more efficiently and can also support risk-based decision-making. This topic is addressed comprehensively, highlighting the fact that formality in quality risk management is not a binary concept (i.e. formal/informal), but includes varying degrees of formality. Those should be described within the quality system.
When formal QRM is applied, it should be complemented with structured decision-making. In general, higher levels of formality require higher levels of structure. Still, there can be varying degrees of structure with regard to approaches for risk-based decision-making.
The draft document is currently open for public consultation until 15 March 2022.
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