validation and compliance services for FDA regulated industries
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My friend Charles Adams Kelly contributes this story from his time at Ford. It's a perfect illustration of how culture and habits dictate the success of organizations:
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.
You know instinctively you have a problem. Everyone else in your department realizes there’s an issue. But with all the competing priorities coming from all directions in the company, nobody knows whether THIS is the problem that we need to elevate to priority one.
Yesterday I watched another black life lost in a grisly video. The police arrested an un-armed black man for a minor offense. The police knew that they were being watched. They had to know that their actions were being filmed. Yet they did it anyway. Why?
In 
My colleague’s call created both pride and stress at the same moment. Pride because he had asked me to take an assignment, but also stress because I was to work with him closely for the next few weeks and to coach him in his new role as a quality manager.
How do we know what Quality means in our business? As quality consultants for the pharmaceutical and medical device industries, that’s a question we hear frequently. Maybe not in so many words; but many times the question boils down to that.
Managing people is like fishing, especially in a regulated environment. A lot of ideas that should work, just don’t. Like, for instance, telling people what to do. You’d think that if you’re the boss, the employees would do what you tell them to do, right? At least most of the time…Validation & Compliance Institute
Ann Arbor, MI
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