September 2013

A New Paradigm to Lower the Risk of Vendor Qualification.

Posted on Sep 29th, 2013 by Norm Howe

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

Posted on Sep 21st, 2013 by Norm Howe

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.

Five Ways to Accelerate Root Cause Investigations. Part 2

Posted on Sep 15th, 2013 by Norm Howe

In this final installment (Part 1) I'll cover a surprising element of investigations that you don't hear much about.  Yet this is the element that produces most of the facts that you need to get at the truth.

  1. Drive out fear.  W. Edwards Deming, the famous quality guru, insisted that managers must drive out fear.  But in training seminars many managers would ask, "Why should employees fear me?  I'm a nice guy, and besides, I'm just doing my job."  Deming would respond that fear arises from the structure of the employee – manager relationship.

Five Ways to Accelerate Root Cause Investigations

Posted on Sep 8th, 2013 by Norm Howe

Finding the root cause for errors and preventing them from happening again is always good business.  Your quality improves every time you prevent an error.  Costs go down.  And in some industries, like pharmaceuticals or medical devices, it's more than good business.  It's the law. 

Why then do we managers do such a poor job of investigating errors?  Let's examine a typical case.