Until recently, preventive action was one of the most important standard quality management 
principles; an understanding that with the right tools and information, a problem in quality management can be resolved through action before the problem arises or in the early stages of the problem. Over time, however, this approach was found to have several serious flaws in oversight. As an example of one issue, monitoring systems and standards to ensure that potential problems are identified early enough were found to have less than stellar success rates.
The movement towards Risk-Based Thinking has come about, to be specific, because of the change in the 2015 edition of ISO 9001 norms, which replaced the previous concept of “preventive action” with Risk-Based Thinking.However, this has left many companies in a difficult position: they find the risk-based approach alluring, but hard to completely adopt due to trouble understanding and adopting it in Quality Management. In essence, risk-based thinking is a risk-management-based approach that requires companies to have a proactive approach in quality management towards the risk of various actions, instead of having it as a simple part of their quality management. What this means, in essence, is that companies that are dealing with their manufacturing processes by keeping constant track of their systems, and first determining all the variables that increase or decrease risk of all outcomes. After this, they meddle with these variables until they find the balance that provides the maximum probability of the best outcomes.
As is clear, this is much easier said than done. The risk-based thinking approach requires a diligent, objective, result-oriented approach. For a thorough review of the processes and systems involved in implementing this risk-based approach, the following steps are recommended:
- Evaluation:
A clear, cohesive view of the entire process and identifying the correct parameters that impact quality are essential as the first step of setting up of a risk-based thinking approach. Understanding the chain – from the inputs and the manner in which they are sourced all the way to the final product or service delivery – is integral to conduct a risk based thinking evaluation.
- Outcome Determination:
Armed with a thorough understanding of the processes of your company, you need to list every conceivable outcome that might arise in a particular situation. Be bold.
- Observation Points:
Understanding the variables and the outcomes, you need to evaluate how the changes in variables that lead to the different outcomes should be observed. Setting up monitoring mechanisms or systems that would make your process dynamic and reactive to changes is amongst the most important aspects of a risk-based thinking approach.
Once you have followed these steps, determining your risk and how to deal with it becomes easier. However, the most complex and most rewarding aspect of risk- based thinking is arranging these variables to mitigate the risk of situations with the potential for negative outcomes, and this requires a level of expertise and enterprise that only experts have.The best manner to gain this information is to attend manufacturing conferences by our expert speakers.
