13/14 December 2023
Risk- and knowledge management were introduced mainly by the ICH guidelines (ICH Q8 onwards). In the meantime, it is becoming more and more appreciated and implemented through other guidances like the EU-GMP Guidelines. The forthcoming ICH Q12 will provide an operational view of how risk- and knowledge management can work together over the lifecycle of a product.
The different elements required for the implementation of Quality Risk Management (QRM) outlined in ICH Q9 - risk identification, analysis, evaluation and control - require tools and practices that are linked to good knowledge management. The initial stages, dealing with risk identification and analysis, should effectively capture knowledge, map processes, and allow the definition of an ontology of objects (unit operations) with specific attributes (inputs and outputs). That should be followed by establishing the causality between those inputs (process parameters) and outputs (quality attributes), from which the whole criticality analysis exercise will develop.
When FMEA is not enough
The workflow above will provide a science-based foundation for the risk-management exercise. The target of completing an FMEA (Failure Mode and Effects Analysis) is in practice very difficult and extremely time-consuming to achieve if the initial 'knowledge-based' steps are skipped. Many questions need to be taken into account:
The following figure summarizes the different tools that are available in practice for each stage, showing that some are more adequate than others for each stage. In our experience of risk-management facilitation, different tools will be required, and the use of mapping and brainstorming tools ensures team alignment, empathy across multiple functions and an effective knowledge-sharing and harvest right from the beginning, all needed for a successful QRM project.
Figure 1 - Multiple tools exist to perform each of the tasks involved in risk-management. (graphic by Prof Dr José C. Menezes, CEO 4Tune Engineering)
The use Lifecycle Management (LCM)
After an end-to-end risk-assessment is completed (i.e., risks are identified, understood, quantified, ranked and a control strategy is proposed), a lifecycle management plan should be put in place to manage unacceptable risks, evaluating the control strategy performance, detecting improvement opportunities and managing additional risks originated from new events (e.g., post approval changes). Such a plan will be used to aggregate all actions, findings and experience to manage product and process knowledge over the lifecycle.
Using QRM within a LCM framework, is a very effective way to ensure consistency at all levels where modern pharma operations are concerned: quality-culture and operational excellence: in the end a characteristic of class-A 'learning-organizations'.
(Prof. Dr. José C. Menezes. CEO 4Tune Engineering and Associate Professor, University of Lisbon for Bioengineering)