Norm Howe's blog

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.

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.

A New Paradigm to Lower the Risk of Vendor Qualification. 2nd Half.

Last time I posed the problem that every company struggles to solve, insuring quality raw materials and components.  Even intensive on-site audits cannot always find major vendor problems.

To get to the solution we have to answer this question, why don't vendors always comply with the regulations.  My answer, based on years of auditing and operations management, is that by far the most common reason is lack of knowledge of the regulations through-out the organization. 

A New Paradigm to Lower the Risk of Vendor Qualification.

When FDA inspected a Heparin supplier, Shanghai No. 1 Biochemical & Pharmaceutical Co. Ltd., they thought they were seeing the real plant.  It turned out that it was only a show facility.  The real plant was a shadow plant located somewhere else. 

The US-FDA Warning Letter later stated, “The inspection revealed that the facility was not manufacturing, and did not appear to have ever manufactured, Heparin Sodium USP (or heparin sodium) for the U.S. market."

Why Most Compliance Remediation Projects Struggle on Forever

Are you a heavyweight project manager?  I’m not asking if you’re a heavy project manager.  Let me explain what a heavyweight project manager is and why it’s important.

If you are leading a compliance upgrade project, most of the people whom you rely upon to make the project successful probably don’t report to you.  You don’t write their performance reviews.  You didn’t hire them.  You can’t fire them.  You are not a heavyweight project manager.

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