One military family’s holiday experience

October 28, 2010

One of my colleagues posted the following in a forum that we both participate in (names omitted to preserve his privacy):

I’m upstairs working.

I hear my 3 year old granddaughter crying downstairs. She is sobbing.

After a few minutes, I go downstairs.

My granddaughter is crying.
My Daughter-in-law is crying.
My wife is crying.

I ask what is going on. Nobody can speak.

My granddaughter tells me she wants to go in a bag.

I finally get out of my wife that they were packaging up fudge to send to our son who is in the Navy, deployed in Japan. My granddaughter didn’t understand why they could not put her in a bag so she could go see her Daddy.

I am so proud of my two sons who are in the service. I’m proud that we are a “military family.” However, right now, my heart hurts for a little girl who doesn’t know what pride is. She just wants to see her Daddy.

 

Dave Gardner, Gardner & Associates Consulting http://www.gardnerandassoc.com


GlaxoSmithKline enters Business Execution Hall of Shame

October 27, 2010

GlaxoSmithKline (GSK) has committed a string of business execution failures—some of the most outrageous failures that I could ever have imagined in the pharmaceutical industry.  The bottom line: GSK has agreed to pay a fine of $750 million for producing and selling “adulterated and improperly made drugs.”

What is GSK admitting happened at its now-closed manufacturing plant in Cidra, Puerto Rico?  The plant:

o         Produced medications that were mislabeled

o         Produced defective medications—too weak or too strong

o         Mixed dosages of the same drugs in the same packaging, e.g., 10 mg and 30 mg tablets

o         Produced drugs contaminated with micro-organisms

According to 26OCT10 MSNBC.com article “Drug maker to pay $750 million for defective meds,” “A big factor in the lawsuit was the role of a former quality assurance manager for GSK who became a whistleblower after she was fired.”  Her job was to monitor products produced and speak up about non-conformity to standards. This woman spoke up and it cost her her job.

Pharmaceutical products are produced under GMP—good manufacturing practice–standards.  What does this mean?

Rigorous testing and quality control practices must be continuously applied for every lot of drugs produced.  This is to ensure consistency in the drug formulation, quality, etc.  Documentation must be maintained proving that the testing was performed by a specific employee, the date and time of the testing, the serial number of test equipment used, the last calibration date and next calibration date of each piece of equipment used, the test results, etc.  All of the test information is captured.  It is not permissible to modify any information in the test process—any changes must be crossed out (not erased) and signed and dated by a supervisor and the person performing the test.

For example, if you manufacture a product called “aspirin,” there are rigorous tests that must be conducted to prove the product is indeed aspirin and meets the FDA requirements for what an aspirin is.  This would include things such as confirming that an aspirin tablet contains all right ingredients in the correct proportions but will also dissolve within a certain period of time enabling the drug substance “aspirin” to be absorbed into the human body through the digestive system.

What conclusion can we reach? GSK knew about the problems and chose to look the other way. GSK did not do the right thing even when it had the chance.

This fine was not the result of an isolated incident.  This was an out of control plant, a plant that has since been closed.

The pharmaceutical and biotech industries attract competent, brilliant, compassionate, and caring people—people with a great deal of integrity.  I’m sure those in the industry find what happened at the Cidra GSK manufacturing plant to be as abhorrent as I do.

GSK has a moral, ethical and fiduciary obligation to produce drugs that conform to industry GMP standards.  For this horrific business execution failure, Gardner & Associates Consulting enters GlaxoSmithKline in the Business Execution Hall of Shame.

Dave Gardner, Gardner & Associates Consulting http://www.gardnerandassoc.com

© 2010 Gardner & Associates Consulting


Dave Gardner’s “Thank God It’s Monday” 25OCT10

October 25, 2010

“Thank God It’s Monday” is to help companies thrive!

This week’s focus: leadership

A leader tells people what they need to hear, not necessarily what they want to hear.

Do you want people saying “nice idea” or “our company isn’t where we need to be on this—we need to take action now!”

The path of least resistance is to “go with the flow.” This is seldom the best path.

Companies that thrive welcome a different, stronger, more compelling perspective.

Thought for the week:

“It is the nature of man to rise to greatness if greatness is expected of him.” —John Steinbeck


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Dave Gardner, Gardner & Associates Consulting http://www.gardnerandassoc.com

© 2010 Gardner & Associates Consulting  All Rights Reserved

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Dave Gardner’s “Thank God It’s Monday” 18OCT10

October 18, 2010

“Thank God It’s Monday” is to help companies thrive!

This week’s focus: innovation

When a company wants to talk to me about what they do, I really do not want them to be a solution in search of a problem. I want a company to understand my business challenges (or my client’s business challenges), not merely talk about their technological capability.

I do not want them to make me think too much or too hard.  I need to be able to “get it” very quickly, or I lose interest very quickly.  Prospective customers are not much different.

Companies that thrive bring simplicity, not complexity, to their customer’s world.

[Note: Read the entire article at The Business Forum Journal.]

Thought for the week:

“If there is one line that could sum up all the varied and curious lessons I’ve learned in business, it’s this: scale doesn’t matter—people do.” –Sir Richard Branson, Business Stripped Bare
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Dave Gardner, Gardner & Associates Consulting http://www.gardnerandassoc.com

© 2010 Gardner & Associates Consulting  All Rights Reserved

Note:  To receive an email version of “Thank God It’s Monday” to start your week, please subscribe here.  I would very much appreciate your suggesting to others that they subscribe.

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Dave Gardner’s “Thank God It’s Monday” 11OCT10

October 11, 2010

“Thank God It’s Monday” is to help companies thrive!

This week’s focus: business execution

The plight of 33 Chilean miners trapped beneath 2200 feet of rock has captivated the world’s attention since early August.  The “Plan B” drilling operation succeeded in reaching the trapped men in just the past few days—nearly 2 months earlier than originally predicted.  The “Plan A” and “Plan C” drilling veered off course and were abandoned.

When failure is not an option, we must applaud the Chileans for employing multiple, parallel approaches to rescue these men. I am grateful for the extraordinary efforts of everyone involved in this rescue.  With great anticipation, I await the safe return of all 33 men to the surface in the next few days.
 

Recently, my “Thought for the Week” was:

“When obstacles arise, change your direction to reach your goal, not the decision to get there.” -Zig Ziglar

The Chileans personify this thought.

Thought for the week:

“If you’re tightening your belt, it means your belt is already too loose or you have too much weight to begin with. Why not take a strategic look at your operation instead of a reactive one caused by external elements?” – Dr. Alan Weiss, Summit Consulting
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Dave Gardner, Gardner & Associates Consulting http://www.gardnerandassoc.com

© 2010 Gardner & Associates Consulting  All Rights Reserved

Note:  To receive an email version of “Thank God It’s Monday” to start your week, please subscribe here.  I would very much appreciate your suggesting to others that they subscribe.

Privacy Statement:  Our subscriber lists are never rented, sold, or loaned to any other parties for any reason.


Dave Gardner’s “Thank God It’s Monday” 04OCT10

October 4, 2010

“Thank God It’s Monday” is to help companies thrive!

This week’s focus: business execution

Sign on Interstate Highway 80 near Elko, Nevada:

Be alert today

Be alive tomorrow

This warning works for business as well as driving. Constant vigilance will help your business thrive.

Thought for the week:

“Action to be effective must be directed to clearly conceived ends”
-Jawaharlal Nehru
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Dave Gardner, Gardner & Associates Consulting http://www.gardnerandassoc.com

© 2010 Gardner & Associates Consulting  All Rights Reserved

Note:  To receive an email version of “Thank God It’s Monday” to start your week, please subscribe here.  I would very much appreciate your suggesting to others that they subscribe.

Privacy Statement:  Our subscriber lists are never rented, sold, or loaned to any other parties for any reason.