Risk management

The desired state of reliable product quality and process control requires a deep understanding and mastering of the sources and relationships of process and product variability and associated risks. 

This requires the capability to determine what is Critical to Quality (CtQ) based on a multivariate quantitative risk assessment and process control and likely impacts on product quality.

Since current risk management tools (FMEA, CA, FTA, …) are limited in multivariate quantitative Quality Risk Management (QRM), there is a need for a novel, more capable risk management tool.

InSysteA's new innovative and practically proven risk management tool CARISMA (Causal Risk Management)
is based on CPPM Model applying Causal Product & Process Mapping (CPPM) methodology.

Consequently, CARISMA enables user to understand and determine risk propagation along the entire process under consideration of Quality by Design (QbD) Principles and Quality Systems Elements.

As a result, CARISMA allows you to perform:

  • Integrated leverage of the risk assessment results determined with standard tools
  • Risk assesment understanding probability and multidimensionality of risk propagation
  • Multivariate quantified determination of Critical to Quality process parameters and material attributes, as well as of accumulated risk of intermediates and drug product CQA’s (Critical Quality Attributes)
  • Investigational risk sensitivity analysis and diagnosis
  • Risk-based Quality by Design and Product Life cycle management

In consideration of the fact that CARISMA is based on the CPPM Model of the considered system, CARISMA represents
the first universally applicable multivariate and quantified risk management tool.

The application of the System Dynamics methodology make it possible to leverage CARISMA approach also for risk management of any other complex systems in the field of trading companies, public authorities, insurance companies and banking.

We offer you a demonstration and appropriate system analysis to determine a possible application of CARISMA in your company, please contact us.

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