- Jochen König
A few years ago I was struck by a quote from Christina Graffner of the Swedish Medical Products Agency pinpointing the essence of a risk-based approach for assuring the quality of medicines. Risk management, she said, “is about doing things consciously”. Specifically, she had coined this sentence in a fairly narrow context of the then nascent “Quality by design” initiative of the ICH[i]. However, I have not found an application area of risk management for which this statement did not hold true. Risk management evaluates the uncertainties about achieving a goal and addresses them in a forward-looking way. In practice things tend to be even more complicated as organizations usually deal with multiple, sometimes competing goals like product quality, production efficiency and various internal and external compliance requirements at the same time. Process oriented risk management supports you in identifying, assessing, mitigating the different risks related to your business processes in a meaningful context and showing dependencies.
The need for a risk-based approach, rather than simple black-and-white rules usually increases dramatically with the complexity of a process or product and the number of possible interactions. The exact outcome and cost of molding polyethylene bottles is much more predictable than that of a multi-step biotechnological production. Similarly, assuring compliant customer communication during sales is easier when operated through an internet portal than for the complex interactions between pharmaceutical companies’ marketing and sales, doctors, payers and patients.
A thorough and demonstrable understanding about the underlying processes, their variability and how this may impact their outcome is the basis for conscious, differentiated decisions when simplistic black-and-white rules would strangle successful business operations. Another pillar of process-oriented risk management is the ability to define meaningful indicators for monitoring processes as they run and actually use the measurements for active process control.
