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If you are in the drug, medical device, or dietary supplement industries and you do not follow Good Manufacturing Practices - GMPs, you can get in big trouble with FDA.  That’s a bad place to be because FDA can:

• Send you a Warning Letter, which will be placed on fda.gov for all to see,
• Seize your product,
• Fine you or,
• Indict you

However, there is something worse. 

Deming wrote his book, Out of Crisis, 40 years ago.  Why is it still so hard to convince managers that they must drive fear out of the workplace?  One problem is that managers, like all of us, are born into a culture of blame and most of them are never able to separate blame from accountability.  This is the story that I tell new managers to explain the difference:

What happens when your company gets a Warning Letter from FDA?  Let’s hope it never happens to you.  But we’re going to explore that possibility in this post.  Then we’ll discuss how you should respond to FDA by reviewing a recent Warning Letter that you can see at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/allay-pharmaceuticals-llc-609023-01272021

Recalling the Paperclips vignette allowed me to reflect upon a few other incidents from back in 1980, and the virtues of Japanese culture that enabled US and Japanese negotiators to artfully steer past an incident that might have seriously undermined sensitive negotiations.

Every day we hear a new cure-all for Covid-19.  Bleach, steroids, plasma, UV lights, Oleander; what’s next?  As we get into colder weather and people have to socialize indoors, Heating, Ventilation, and Air Conditioning creep into the conversation.  Let’s talk about what it will take to design an HVAC system that will actually do some good.