Presented by: Pedro Ferreira,Head of Validation and Quality and Risk Management Services, ValGenesis®
ICH Q9(R1) introduced the need to manage and minimize subjectivity in risk management in order to enhance scientific sound risk based decision making. In this presentation, a practical approach to respond to this need is outlined in the context of a production process risk management. A set of digital state-of-the-art integrated tools is used to manage risk assessment activities. Once a risk baseline is defined, based on a existing set of tacit and explicit knowledge (if available), an iterative process of risk refinement is defined in which risks are re-calculated as new data and knowledge is available. Besides RPN revision, the integration with data allows the identification of new risks for a continuously improved control strategy.