How Do I Start With Risk-Based Thinking?





The clearly articulated focus of Risk-Based Thinking in ISO 9001:2015 has some people scratching their heads. What exactly does this mean? Where is the checklist? Where do I start?

So the question arises, How do I start with risk-based thinking?


The reality is you already use risk-based thinking.

You just may not have clearly articulated that thinking. Most likely everyone reading this article has been involved with a CAPA(Corrective And Preventive Action). You received a customer complaint or hadCAPA.jpg a product or service fail to meet specifications. You began asking questions to find out the root cause of the problem and put measures in place to correct it and prevent it from happening. So how is this different than risk-based thinking?


CAPA's are typically a reactive approach to a problem.


Risk-Based thinking is more than putting root cause.jpgthe cart before the horse. You start thinking about the process holistically. Do we really need a cart? Is a horse the best conveyance? How long will the wheels on the cart last? What will happen if the wheels fall off? What if the horse throws a shoe? How do these events affect customer satisfaction? What can we do to make sure the customer will be satisfied or better yet delighted with our product or service? Who assumes the risk? Internal? External?

You may have heard the term Poka-Yoke. The phrase is credited to Shigeo Shingo in the early 1960s. Simply put, you error-proof the process. I enjoy learning visually and that is why I think I really like this approach. Start with a flowchart of the process. Find the sources of mistakes or errors.

The end goal is simple:

  • Eliminate the error(s).
  • Substitute the sources of errors with better methods.
  • Use the KISS method-  make it easier to not make an error than making an error.

So how does this help you to start with risk-based thinking?

customer loyalty.jpg

Make a process flow map of the entire customer cycle from beginning to end AND then loop it back to capture the customer lifetime value. Segment every interaction/process from the customer satisfaction perspective and look at every possible source that can lead to customer dissatisfaction(risk). Once these sources have been clearly articulated then determine the next steps to manage those risks.

This is a simplistic overview of risk-based thinking and we will be continuing this series of articles with specific risk-based thinking ideas and tools.


 Ask Us A Question

Phil Wiseman

Phil Wiseman

Phil Wiseman is Chief Marketing Officer at Alliance Calibration. He earned a B.S. in Chemical Physics from Centre College. Phil is an ASQ Certified Quality Auditor and ASQ Certified Manager of Quality/Organizational Excellence.

Related Posts

Where is calibration mentioned in ISO 9001:2015?


The release of ISO 9001:2015 has many companies re-evaluating how they do business. Why? While...


Throw it out, it's cheaper than having it calibrated



Throw it out, its cheaper than having it calibrated…

Or is it?

Time and time again, I’ve heard...


The 7 Wastes in Calibration & Measurement


The seven wastes of lean is not a new concept to most reading this blog.  For a detailed look at...