Risks in Lean Compliance

What is Risk?

Lean Biomanufacturing, Dr. Nigel J. Smart

As the famous T. S. Eliot once said, “Only those who will risk going too far can possibly find out how far one can go.” This is most certainly the case in the science and pharmaceutical industry. We are in an industry that requires researchers to take the knowledge that they skillfully have acquired and run with it. This knowledge will not be of any use bottled up in one’s brain, unheard by others. Knowledge and the ability to take risks is what truly gets people talking and from there brilliant ideas are drawn up.

Now, in the biopharmaceutical industry going lean is all about taking risks and understanding that risk. So what about the 80:20 rule you may ask? What’s all of the fuss about in regards to identifying risk in lean compliance? Let’s try and wrap our brains around this concept a bit.

“Risk is a balance of certainty and uncertainty, in addition to the probability of something occurring.” It’s vital to identify potential risks before embarking on any sort of endeavor, especially something that involves time and money for your research team. By ranking and understanding the probability of various occurrences, based on a specific action or step in your process, you will have an overall better grasp on what could potentially cause issues down the line.

If you’ve read SCG’s blog on waste removal, some of these concepts may not be unfamiliar to you. When identifying and understanding potential risks in lean biomanufacturing, one must follow these steps in order to be successful in your research: be proactive to assess probability and potential consequences, take action to reduce the probability of unfavorable consequences, use tools to try your best to predict likely problems and make sure to take predetermined measures/actions to minimize problems, should anything arise!

It’s simple, to the point, and you may be telling yourself, “Hey, I knew that all along!” It never hurts to dig a little deeper to understand what COULD go wrong. In the long run, your research will thank you, your team will thank you and you will be thanking yourself when you see profitable and successful results come through in the end. Don’t be afraid to take a scientific risk, as we need risk takers in order to lead the way to new possibilities. Just be sure to account for potential risks in order to be well equipped within your biopharmaceutical process.

For more information about understanding risks in lean compliance, reference Lean Biomanufacturing, by Dr. Nigel J. Smart.

 

 

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