Blogs

The Symptoms Make the Diagnosis Inevitable

Posted on Sep 18th, 2024 by Norm Howe

US-FDA just hammered Greco Gas, Inc.  The Warning Letter told Greco they must (among many other requirements) provide:

“A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity.”

Why Are Workers So Afraid When Unemployment Is So Low??

Posted on Aug 28th, 2024 by Norm Howe

The US unemployment rate is 4.3%, a historically low number.  The inflation rate has dropped to 2.9%; about average for the past ten years.  Why, then are workers so fearful? The answer, of course, is that they have good reason to be fearful.

Last year the tech sector cut more than 170,000 jobs.  But that’s just the tip of the iceberg.  17 million American workers were fired in 2022. 

The New York Federal Reserve Survey of Consumer Expectations tells us the impact that these layoffs have on how workers feel:

Chevron Deference Struck Down

Posted on Jul 22nd, 2024 by Norm Howe

In 1984 the Supreme Court ruled that courts should defer to a Federal agency’s opinion when a law is ambiguous.  That decision was known as the “Chevron Deference”. The effect of that  decision was to give regulatory agencies (who are staffed with technical experts) deference in courts, when they were challenged on how the law should be enforced.

Even the Experts Still Don’t Get It

Posted on Jul 17th, 2024 by Norm Howe

Ever wonder why product quality and customer service seem to be going downhill these days?  The answer is employee fear.  Here’s a little incident that tells you why:

A business resource website for quality experts recently required its members to update their profiles.  I dutifully updated mine and then pushed a button to make it visible to the public.  Then I got out of the site, re-entered, and searched for my profile.

NOTHING.  No sign of my profile.

What if FDA Gets Cut?

Posted on Jul 3rd, 2024 by Norm Howe

Like every organization, public or private, the Food & Drug Administration has a budget.  That budget changes from year to year depending on Congress and the Executive Branch.  If that budget gets cut, what does it mean for ordinary citizens?

Let’s first look at the big picture and then drill down.  Here’s a list of the types of products FDA regulates:

  • Food, human & animal
  • Drugs, prescription & OTC
  • Infant formula
  • Medical Devices
  • Dietary Supplements
  • Radiation-Emitting Products
  • Tobacco Products
  • Cosmetics
  • Vaccines, Blood, and Biologics

Your mission statement finds you

Posted on May 7th, 2024 by Norm Howe

When was the last time you saw somebody take the company mission statement down off the wall and say, “According to THIS, we ought to be doing THAT”?

Never, I’ll bet.  Most likely nobody has ever heard of the company mission statement.  If they knew about it and could even find it, it would have so much dust on it that it would be unreadable.

The Heinrich Safety Pyramid and Quality

Posted on Apr 29th, 2024 by Norm Howe

The Heinrich Safety Pyramid has been used in personnel safety management for near a century.  Based on research done by Herbert Heinrich in the 1930s, it stated that the number of injuries in a workplace increases as the severity of the recorded injury goes down.  In later versions by Frank Bird in the 1960s the ratios were modified to:

1 death:

10 serious accidents

30 minor accidents

600 near misses

Unsafe acts

Boeing’s New Bonus Plan is all PR, we hope

Posted on Mar 13th, 2024 by Norm Howe

Until now 75% of Boeing’s bonus score was based on financial metrics…and we wondered why their planes crashed and burned.  Now, their Commercial Airplane division has elevated safety and quality metrics to 60% of their annual incentive score.

What are we, the flying public, to make of this change?  We don’t have any details, but for a start, how about, “It’s about #$^g time!”

Speaking as a quality professional, now comes the hard part for Boeing.  Again, no details, but the term ‘annual’ does not bode well.  How many safety/quality improvements are started and completed within a year?  Especially with complex products like passenger jets?!  Anyone who’s been around for more than six months knows the answer.

GEMBA Walks are Stoopid

Posted on Feb 4th, 2024 by Norm Howe

Everybody’s got a GEMBA recipe for sale.  They want you to believe that if you follow their formula [just click on this link and send money] you can become a charismatic leader.

In fact, GEMBA walks only get between you and your followers.

I hasten to add, GEMBA Walks – stoopid – should not be confused with ordinary Management by Walking Around (MBWA) which is essential.

Measurement is Even Harder than You Think

Posted on Jan 17th, 2024 by Norm Howe

When we take a drug or a dietary supplement, we often ask ourselves whether the active ingredient is actually there.  And is it there in the amount listed on the label?

We hope that the manufacturer tested the product.  If it’s a drug, the answer is almost assuredly yes.  If it’s a dietary supplement, well…

But even if it did get tested, there are lots of things that can go wrong.  We’re not going to get into the technical details of analytical method validation here.  We’re going to zoom out and ask about the purpose of measurement.  What are we trying to accomplish with our measurement?

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