The greatest life lesson occurred while in my High School Geometry class. During discussions of hyperbolic equations, the teacher turned around from the board to profound that, “Man is like a hyperbola, always striving to their asymptote.” It took me years and immersion into Buddhism to truly understand what he was conveying.
In hyperbolic geometry the lines of the curve never intersect with the axis (asymptote) as shown below:
Just as the Great Buddha stated; “The harder you search for something, the further away it gets”.
Focusing on a perfect outcome, just like a hyperbola can consume time and your sanity.
Let’s take a practical example when developing a new product or process. Ideally, you want to manage the outcome, but you also have timelines and resource constraints. Here is when risk management becomes a great tool for balancing your approach. Risk Management like a hyperbola assumes that there is no such thing as a zero risk. You can control risks, however, there are uncontrollable factors (human, manufacturing, tolerances) that prevent a risk-free product or process.
The organizational challenge is understanding the risk factors, then determining the effort(s) to reduce any catastrophic failures to minimize the outcome risks, whether patient safety, manufacturing validation or controls within your Quality System. As shown in the chart below, for each activity your organization performs, determine what are the risks you are willing to accept based on the amount of activities the group can expend.
Risk Management should be the first tool used when initiating any project, whether a new drug or device or implementing a new process; gaining acceptance on the risk tolerance when developing project plans. While we strive for zero risks, we must accept that an infinite amount of time will not lead to a zero-risk situation.
Does your organization integrate Risk Management into new product/process development cycle? Let Consult Wing help you understand that integrating the right tools will help you manage the Product Lifecycle and risk management for your organization. We strive to bring the right balance and tools to meet your needs.
If one has to jump a stream and knows how wide it is, they will not jump. If they don’t know how wide it is, they’ll jump and six times out of ten times make it. Risk Management helps you understand the width of your tasks and where/when to jump!!