Norm Howe's blog

Why All This Paperwork?? 4 Seal Limbs

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. 

Why All This Paperwork?? 3 The Elixir of Death

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. 

Why All This Paperwork?? 2 They Called it “Smoked Sausage”

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. 

Industrialization provided employment for enormous numbers of workers who flooded into the cities by the millions.  As businesses learned how to use economies of scale, costs dropped dramatically. 

Why All This Paperwork?? 1 Before the Laws

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?" 

Setting the Framework for a Delegated Job

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.  

Whenever you assign a job, a dialogue must occur.  You have to explain to the employee what the boundary conditions are for this assignment.

Delegation for Dummies

frustrationYou 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.

When you delegate a task to others, you need to empower them. It’s required in any field.  It’s especially important in FDA regulated industries.

Mention the word empowerment in any plant and you’ll see everyone nodding in agreement.  It’s almost a paradigm that empowered employees mean a productive workplace.  But look deeper and you’ll see fear in their eyes. 

Conflict: Part 2. Don’t Solve the Problem, but Do Insist on a Solution

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.

The Art of Conflict Management

When you’re trying to achieve great things with groups of people, like Positive ComplianceTM that I described last time, you will have to deal with conflict:

Solomon, the legendary king of ancient Israel, set the gold standard for conflict resolution that managers have been trying to emulate ever since.  When two women each claimed to be the mother of the same baby, he ordered that the child be cut in two and then be divided between the two women. 

Transformation to A Strong Compliance Culture

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.  People

Hilton’s Big Secret to Business Success

shower curtainWhat do you do when you can’t get your department functioning at the level you need?  What do you do when little problems pop up randomly every day?  Could they have the same root cause that seems to manifest itself in a different way every time?  You don’t know.

If this sounds familiar, you’ll know how I felt a few years ago.  My department just wasn’t getting the job done; nothing dramatic, but it felt like the death of a thousand cuts. I tried every fashionable cure that the management gurus were spewing out.  Nothing worked.

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