Norm Howe's blog

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

Posted on Oct 6th, 2013 by Norm Howe

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.

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. 

Leading a Cluster of Equals 4: Other Powerful Uses of Personality Types

Posted on Aug 31st, 2013 by Norm Howe

You can use your newfound expertise in personality types to better understand how to deal with other aspects of employee behavior.  Need to get a decision out of that quiet lady by the copiers?  If you’ve done your homework on personality types, you will recognize that that her reluctance does not come from obstructionism. 

Rather, she is an analyzer.  She has to absorb and analyze every piece of information before she makes a decision.  She needs time and a lot of information before she comes to a conclusion.  If she requests more data right when you think that the cluster should have reached a decision, it’s not because she’s trying to thwart your plan. 

Leading a Cluster of Equals 3: Recognition

Posted on Aug 25th, 2013 by Norm Howe

medalsHand in hand with Achievement goes Recognition for that achievement.  There’s a right way and a wrong way to recognize good performance.  The problem is that it’s different for every individual.  This is another situation for you to use your analytical skills to learn how to do it right.

There are many systems on the market that can help you to understand how your fellow workers think, True Colors, Myers-Briggs, DiSC, to name a few.  They each have different strengths and I don’t want to recommend one over the other.  The critical similarity among all of them is that they all measure differences in personalities.

Leading a Cluster of Equals 2: Understanding Motivation

Posted on Aug 18th, 2013 by Norm Howe

Continued from Part 1.

Before we get into the specifics of how to motivate your team members, let’s talk about the subject of motivation itself.  Here is an opportunity for you to use your analytical skills to apply general research to your specific situation.

Frederick Herzberg was a professor in the School of Business at the University of Utah who developed the Dual Structure theory of motivation.  Herzberg defined motivation in a special way.  His research demonstrated that a true motivator is a factor that comes from an internal motor within the employee.  That motor runs under its own power.  The proverbial Kick-In-The-Pants (KITP) can influence employee behavior but it is not a motivator because it requires an external influence and its effect is short term. 

Leading a Cluster of Equals, When You’re NOT a Born Leader. Part 1

Posted on Jul 31st, 2013 by Norm Howe

This is how it starts.  Your boss just assigned a project to you.  It’s too big and too complicated for you to do alone.  So your boss has given you a list of people to help you.  “Great,” you think.  “I’ve been asking for a project like this for a long time.  It’s bigger than anything I’ve ever done, and it’s important for the department to get it done quickly.” 

There’s only one problem.  None of these people report to you.  You can’t order them to do anything.  Most of them don’t work in your department.  Many don’t even work in your company. 

Look at your “team”: 

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