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Quality & Risk Management: Beware of Black Swans!

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Rick Cooley
Rick Cooley  
1/23/2014 9:11:28 AM
User Rank Change Agent (Brown Belt)
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Black Swan Detection
Brian, it is ironic that I just posted a comment wrt continuous learning/improvement on your post about criticality. I think it also applies here. We should be encouraged; not discouraged to make process changes as new knoweldge becomes available on "Black Swans" or potential "Black Swans" rather than just plucking them and saying I didn't see a Black Swan did you? LOL

I agree we have to do a much better job of identifying where potential "Black Swans" can enter our process and many of these that I've learned about through the years should have been fairly obvious from the start. For example, if you perform a blend operation, dispense into a tote bin, then move that tote bin across a floor that has seams in it that impart vibration to the tote bin as it moves across the floor, why would you not expect the once uniform mixture to demix? Or a process is developed using a moisture sensitive raw material at a site where humidity doesn't fluctuate widely then the process is transferred to Puerto Rico why would you not recognize this as a potential problem? Sometimes you deserve to be bitten on the butt by the "Black Swan".

 

Mudassir
Mudassir  
1/15/2014 12:16:43 AM
User Rank Dealmaker (Master)
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Proactive Approach
The proactive approach is very important to minimize the risk of any incidence in future. The most of companies manage properly the Risk Management department in which experts are make standards to minimize the risk of surprise incidence and try to control the loss of productivity. This is informative post and give us insight picture for risk managment.

Vimal
Vimal  
9/15/2013 12:09:49 PM
User Rank Dealmaker (Master)
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Risk management
Thanks Brian for the excellent post. "Never underestimate complexity "should be the key principle of Risk management. I think based on this principle and a risk management framework many of the issues may be effectively tackled

ALM at Global B2B
ALM at Global B2B  
8/13/2013 7:08:43 PM
User Rank Cultural Capitalist (Black Belt)
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reports of improved processing in finance publications?
See http://www.dailyfinance.com/2013/08/12/1-hidden-pharmaceutical-technology-for-your-portfo/

 

If you pay attention to the finance press reporting on pharma this story is quite unusual in referencing new methods that bear on production metrics...

This may be a good sign ..

as they say-- "follow the money"

Brian Carlin
Brian Carlin  
7/31/2013 8:50:01 AM
User Rank Blogger
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Re: Predetermining Unknowns
All models are wrong, some are useful!

Continuous evolution of knowledge throughout the product lifecycle will identify what is significant, but until we holistically increase our raw material, process, and product understanding the unknowns will continue to confound quality. We should plan accordingly.

Ben
Ben  
7/26/2013 11:04:28 AM
User Rank Blogger
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Re: Predetermining Unknowns
I think this is a great question and what it boils down to is dropping out factors from our models that are insignificant.  This is the Principle of Parsimony.  Of course giving a nod to Einstein's other quote to make our models "as simple as possible, but no simpler."  Better predictive power comes out of streamlined models where we remove insignificant factors, rather than running them with all hundred (or more) factors left in to "more closely model nature."

 

Brian Carlin
Brian Carlin  
7/25/2013 5:41:54 PM
User Rank Blogger
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Re: Predetermining Unknowns
Kerstin,

Regrettably the tendency of the Pharmaceutical industry to simplify reality is a fertile breeding ground for black swans (not a cause for chuckles). Until we address the complexity of our raw materials and the complexity of the finished products we will continue to operate at a 2-3sigma level of manufacturing efficiency.

We must extract order out of complexity, not simplify. To quote Albert Einstein:-

Occurrences in this domain are beyond the reach of exact prediction because of the variety of factors in operation, not because of any lack of order in nature.

mdmconsult
mdmconsult  
7/24/2013 7:46:42 AM
User Rank Survivor (White Belt)
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Re: Black swans - reducing variability great challenge !
Being proactive is good. It is important to detect early risk by monitoring areas provide status updates, automation and more. Monitor different data sources through automation tools.

Kerstin Carson
Kerstin Carson  
7/23/2013 12:25:10 PM
User Rank Cultural Capitalist (Black Belt)
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Predetermining Unknowns
This article made me chuckle a bit because of the rarity of black swans in nature versus the common occurrence of quality assurance and risk management issues.

Brian, while pharmaceutical systems are complex, is there a way to identify which part(s) of the system can be simplified...even if only a little bit?

For example, you mention the very real issue of unknowns in pharmaceutical systems. However, with the history that the pharma industry has under its belt, is there any way to use such a legacy to avoid certain unknowns? Or is such a question difficult to answer due to continued issues with proper documentation during design, manufacturing, and testing?

 

Brian Carlin
Brian Carlin  
3/29/2013 1:16:09 PM
User Rank Blogger
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Re: New regulations and black swans
No

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