Norm Howe's blog

The big boss from Germany was in town to kick the tires and spread the corporate gospel.  I had recently been bumped up to production manager at our little pharmaceutical plant in the Midwest and I busied myself with paperwork while he was talking to the plant manager.

We had been meeting our production targets and the quality was good, so I had hope that this was just a routine visit.  Eventually the grey eminence of Dr. Blickensdorf heaved-to outside my door.  He was not happy.

Q.  How are botulism, salmonella, petroleum, and black widow spider venom alike?

A.  They are all natural and they’re all toxic.

BTW, the image on the right is a natural product extraction plant.

US-FDA has announced a plan to phase out synthetic food dyes…and we’re all supposed to feel safer.  Assuming that a product is benign, much less, healthy just because it’s natural is beyond stupid.  The purpose of this post is to show you why, and to outline what should be done instead.

In our consulting work we have helped out many companies.  They span the gamut of knowledge of FDA regulations and general business experience.  Most of them are struggling with the regulations (Go figure.  That’s why they call us.)  So, if you’re struggling with regulatory compliance, you’re in a very large club.  Don’t feel bad.

There are, however, companies who are not struggling.  Not many, but we’ve seen enough of them to recognize a pattern.  These companies are rolling on a virtuous cycle of quality. 

This post is primarily targeted at Quality Managers, but it could equally apply to any kind of leader.  LEADERSHIP, rather than MANAGEMENTSHIP, is more important for Quality Managers than most others. 

Although Quality Managers may perch atop a substantial orgchart, in many organizations they have a miniscule (or no) staff.  They have to make their decisions count through influence and persuasion. 

So, in general, ITS MORE IMPORTANT FOR QUALITY MANAGERS TO LEAD THAN OTHER MANAGERS.

I taught a course on Quality Systems at the University of Michigan, Ann Arbor.  Because I’m lazy I decided that I’d ask my friends to come in and guest lecture.  That didn’t work to well, probably because most of my friends just like to drink beer and watch football.  So I ran out of guest lecturers in a hurry.

My backup plan was a moonshot.  I called up the Detroit office of FDA and asked if they had anyone who would like to give a seminar at UoM.  Amazingly they did.  And who should show up but the Director of the Office of Compliance.