What to think when a major manufacturer goes off the Quality track?

Wes Bucey

Prophet of Profit
As I browsed the news reports today, I came across this recent item relating to a major corporation being caught en flagrante delicto by FDA inspectors. Is this a harbinger of a trend? (Note this is the USA, not some third world country barely out of the Stone Age.)

THE QUESTION:
In YOUR opinion, is this an isolated corporation or are there many other bad eggs lurking which just haven't been caught? Got an underlying reason/justification for either opinion?
[FONT=Verdana, sans-serif]FDA reports slew of problems at Johnson & Johnson plant[/FONT]



[FONT=Verdana, sans-serif]By Lyndsey Layton[/FONT]

[FONT=Verdana, sans-serif]Washington Post Staff Writer
Thursday, July 22, 2010; 9:54 PM
[/FONT]
[FONT=Verdana, sans-serif]Federal officials who inspected a Johnson & Johnson manufacturing plant that makes Mylanta, Pepcid and other popular heartburn medicines unearthed quality control problems, chaotic recordkeeping and complaints by consumers that medicines were either ineffective or contained pills from different products in the same retail package. [/FONT]
[FONT=Verdana, sans-serif]The facility in Lancaster, Pa., is the third Johnson & Johnson plant to be flagged this year by the Food and Drug Administration for serious manufacturing defects -- an unusual number for a single company. [/FONT]
[FONT=Verdana, sans-serif]The FDA's latest report was released Wednesday, a day after Johnson & Johnson told investors it had received a subpoena from a grand jury in eastern Pennsylvania. The company is also the subject of a congressional probe into recalls this year of more than 100 million bottles of adult and children's Tylenol, Motrin, Benadryl, Zyrtec and other popular over-the-counter medicines. [/FONT]
[FONT=Verdana, sans-serif]The company has not recalled any products made in the Lancaster facility, which is a joint venture with Merck. [/FONT]
[FONT=Verdana, sans-serif]Spokesman Marc Boston said the joint venture "takes the issues raised by the agency seriously and is fully committed to addressing their concerns as rapidly as possible." [/FONT]
[FONT=Verdana, sans-serif]FDA officials who inspected the Lancaster facility from June 22 to July 9 documented 12 deficiencies, including the failure of the company to investigate why some consumers found maximum-strength tablets in regular-strength Pepcid bottles, or mint-flavored tablets in berry-flavor bottles. Experts say that kind of error suggests both a lapse in the manufacturing process as well as weak quality controls. [/FONT]
[FONT=Verdana, sans-serif]Inspectors described with frustration having to repeatedly ask for documents and waiting days to receive what should have been readily available, including things as basic as an organizational chart. [/FONT]
[FONT=Verdana, sans-serif]Federal inspectors found that the Lancaster plant could not ensure that drugs produced there were up to standard. "Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity," the inspectors wrote. [/FONT]
[FONT=Verdana, sans-serif]They also said the plant failed to follow its own written procedures for cleaning and maintaining equipment. [/FONT]
[FONT=Verdana, sans-serif]The FDA inspection took place about a month after a top Johnson & Johnson executive testified on Capitol Hill that the company was working feverishly to address all shortcomings and restore consumer confidence. [/FONT]
[FONT=Verdana, sans-serif]In January, the FDA identified problems at a Johnson & Johnson plant in Puerto Rico after the company recalled Tylenol, Motrin and Benadryl products made there. The company said a chemical leached from wooden pallets into the products, imparting a musty odor that later made some consumers ill with temporary gastrointestinal problems. [/FONT]
[FONT=Verdana, sans-serif]It became the first of four recalls of Johnson & Johnson products in the past year, including the April 30 recall of 136 million bottles of infant and children's Tylenol, Motrin, Benadryl and Zyrtec. Those products were recalled after FDA inspectors found widespread manufacturing problems at the Johnson & Johnson facility in Fort Washington, Pa., the only plant where they were being made. [/FONT]
[FONT=Verdana, sans-serif]The company has temporarily shuttered the Fort Washington plant while it fixes flaws there. In a call with investors Tuesday, Johnson & Johnson executives said that they don't expect to reopen that plant until mid-2011 and that the company is laying off 300 of the 400 workers based there. The shutdown is expected to cost Johnson & Johnson about $600 million in lost sales this year. The affected products will not be back on store shelves until next year. [/FONT]
Is this the same old story of the managers getting off scot free while the workers get hit in the paycheck?
 

Pancho

wikineer
Super Moderator
Wow! Talk about a failure of the qms. Wonder about their most recent internal or third party audits.

In YOUR opinion, is this an isolated corporation or are there many other bad eggs lurking which just haven't been caught? Got an underlying reason/justification for either opinion?
Is this the same old story of the managers getting off scot free while the workers get hit in the paycheck?

Sorry Wes, but these questions strike me as biased against corporations and managers. The whole system at J&J failed. Workers and managers are both at fault. And there is absolutely no reason to impute fault on other companies for what J&J may have done wrong, at least from the info in your clip.

Funny how workers do enjoy the credit for when things go right...
 
M

MIREGMGR

The J&J situation points directly to a gross mission-performance failure on the part of the COO, the VP Production Operations, and the VP Regulatory/Quality.

It's unfortunate that the local management and workers are caught up in this, but plenty of experience shows that a management/worker team that's been allowed to become ingrained with the wrong cultural values is very hard to turn around.

It's not entirely their fault, but the point here is to make good product, not to be nice to the employees. It's very hard to unlearn the "good enough" concept.

So, you have to clean house, literally and figuratively.

But it won't work if it doesn't go all the way to the top.
 
M

MIREGMGR

According to JnJ.com, Johnson & Johnson has, rather than a Mission Statement, a Credo:

Our Credo

We believe our first responsibility is to the doctors, nurses and patients,
to mothers and fathers and all others who use our products and services.
In meeting their needs everything we do must be of high quality.
We must constantly strive to reduce our costs
in order to maintain reasonable prices.
Customers' orders must be serviced promptly and accurately.
Our suppliers and distributors must have an opportunity
to make a fair profit.

We are responsible to our employees,
the men and women who work with us throughout the world.
Everyone must be considered as an individual.
We must respect their dignity and recognize their merit.
They must have a sense of security in their jobs.
Compensation must be fair and adequate,
and working conditions clean, orderly and safe.
We must be mindful of ways to help our employees fulfill
their family responsibilities.
Employees must feel free to make suggestions and complaints.
There must be equal opportunity for employment, development
and advancement for those qualified.
We must provide competent management,
and their actions must be just and ethical.

We are responsible to the communities in which we live and work
and to the world community as well.
We must be good citizens – support good works and charities
and bear our fair share of taxes.
We must encourage civic improvements and better health and education.
We must maintain in good order
the property we are privileged to use,
protecting the environment and natural resources.

Our final responsibility is to our stockholders.
Business must make a sound profit.
We must experiment with new ideas.
Research must be carried on, innovative programs developed
and mistakes paid for.
New equipment must be purchased, new facilities provided
and new products launched.
Reserves must be created to provide for adverse times.
When we operate according to these principles,
the stockholders should realize a fair return.
Those are fine words. Only problem is, obviously the people at the top haven't cared lately about all the responsibilities equally. Their focus seems to have been primarily on "reduce costs", "make a sound profit", and "stockholders".

Now we get to see whether their "moral compass" still points correctly.​
 
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