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Do you spend too much time writing CAPAs and nonconformance reports? Do your operators take too many shortcuts? Do batch sheet errors take up your whole day?
Last time we heard about the invention of Elixer Sulfanilamide, or the Elixir of Death, as it was called in the newspapers. Science and business had created a powerful drug that has saved countless lives. But along with the enormous good that had come from the invention of antibiotics there were some unanticipated consequences. 
Our story moves forward in time and across the Atlantic to the battlefields of the First World War. On the Eastern Front a young German Army medic tried to keep wounded soldiers alive in the filth of trench warfare. Try as he might, it was a losing battle. Even if he could sew the broken bodies back together, they would die from infection. 
Last time I talked about the days before there were any laws regulating foods and drugs; a time when “Let the Buyer Beware” was the law of the land. But as science advanced and America industrialized, that law was no longer sufficient. 
When you're the one who has to lead a quality compliance effort, sometimes it's best to start with a current headline and then ask, "How did this happen? Aren't there supposed to be laws protecting us from poisons in the products we buy?" 
Last time I talked about the value of delegating the whole job to employees; a piece of work that they will recognize to have intrinsic value. Now I want to discuss the importance of communicating the scope of the job to the employee. 
You can find any number of treatises on delegation in management textbooks. Here’s a more nuts-and-bolts approach that allows you to get started right away.
Well, let’s say that you’ve bought into the idea that you shouldn’t solve your employees’ problems for them. That doesn’t, however, mean that you should remove yourself from the conflict resolution process entirely. In fact, the opposite is true. The difference is in the manner in which you intervene.
When you’re trying to achieve great things with groups of people, like 
1Anybody leading an organization in a new direction has a tough job. Our company, Validation & Compliance Institute (VCI), was tasked with helping a site of several hundred employees to dramatically improve compliance with FDA regulations. This was an especially difficult project, considering that, like most biotech organizations, the company leaders were technical managers. PeopleValidation & Compliance Institute
Ann Arbor, MI
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