Quick Tip: 3 benefits of risk-based thinking
Risk-based thinking helps you to make optimal, explainable and defensible decisions while practicing a least-burdensome approach to regulatory compliance
It is fashionable to invoke the phrase risk-based thinking, especially when it comes to making decisions that have implications for regulatory compliance.
But what does it mean and how do you build the capability to make risk-based decisions in your organization?
Risk-based thinking is really a process of decision making, which involves a careful consideration of risks in the context of benefits, or costs. It is easier said than done, because it does involve a considerable amount of judgment.
However, risk-based thinking delivers significant benefits to your organization if it is done right. It helps you to identify and select the most optimal solution under a given set of circumstances. You are able to explain and defend your decisions, especially when they are being reviewed in a regulatory context. Finally, you can gain significant efficiencies in your Quality System by taking a least-burdensome approach to regulatory compliance.
It is important to develop a formal and structured process that involves a cross-functional team with sufficient expertise and experience relevant to the context of each situation. Although it is best to gather all relevant scientific, technical and real-world information, it may not always be practical to do so. Sometimes, the level of uncertainty is too high or a decision is needed quickly under significant time pressure.
It takes time and resources to build an organizational capability in risk-based thinking. But it delivers a high return on your investment in the long run.
