Archive for the ‘News’ Category

Massive Johnson & Johnson Recall

Sunday, January 31st, 2010
Tylenol Recall

Johnson & Johnson says pallets to blame

NEW YORK (CNNMoney.com) – More than a week after a big recall of tainted Tylenol and other non-prescription drugs, a battle has erupted between drugmaker Johnson & Johnson and makers of a shipping component the company blames for the problem.

An undisclosed number of containers of Tylenol, Motrin and other over-the-counter drugs were recalled earlier this month after consumers complained of feeling sick from an “unusual” odor.

Johnson & Johnson officials are now saying that the problem was caused by the wooden pallets used to ship the products. Pallet manufacturers take exception to this. National Wooden Pallet and Container Association (NWPCA) president Bruce Scholnick points out that there are 1.2 billion pallets used each day in the USA and that industry experts have no knowledge of pallets ever being responsible for release of either of the two chemicals that Johnson & Johnson blame for the problem.

“We also insist that you provide technical and scientific theory as to how this chemical could spread from a tertiary packaging component to a primary packaging component through various layers of cardboard and plastic packaging surrounding the primary product,” said Scholnick.

Regardless, it is obvious that the incident is causing image problems for the company. The Christian Science monitor reports that, unlike the proactive approach taken by the company in its voluntary 1982 recall of tainted Tylenol, Johnson & Johnson dragged its feet in the current episode. According to a FDA spokesman, McNeil Consumer Healthcare, the business unit responsible for the products, didn’t respond to the problem quickly. “While McNeil has cooperated with FDA in recent weeks, their initial response was unsatisfactory,” says Christopher Kelly, an FDA press officer. “We repeatedly pressed them.”

Slow to respond. Quick to point fingers at others. A root cause that sounds a bit far-fetched and which is, according to NWPCA spokespersons, “factually unsupported.” This doesn’t sound like the same company that we all came to know and admire in 1982. I hope subsequent actions by Johnson & Johnson prove me wrong.

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Carbon Cycle Feedback Effect Adjusted Downward

Friday, January 29th, 2010

In a letter published in the journal Nature (Nature 463, 527-530 (28 January 2010)) entitled “Ensemble reconstruction constraints on the global carbon cycle sensitivity to climate” the authors discuss the processes controlling the carbon flux and carbon storage of the atmosphere, ocean and terrestrial biosphere. These processes are likely to provide a positive feedback leading to amplified anthropogenic (i.e., human caused) warming. But the magnitude of the climate sensitivity of the global carbon cycle and thus of its positive feedback strength, is under debate, giving rise to large uncertainties in global warming projections. The paper describes a study designed to quantitatively estimate the feedback parameter, γ, based on pre-industrial CO2 estimates based on “proxies” such as ice cores.

The authors conclusion:

“We find that γ is about twice as likely to fall in the lowermost than in the uppermost quartile of their range. Our results are incompatibly lower (P < 0.05) than recent pre-industrial empirical estimates of ~40 p.p.m.v. CO2 per °C, and correspondingly suggest ~80% less potential amplification of ongoing global warming.” (italics added.)

In short, the cabon cycle feedback effect is weaker than formerly thought by climate researchers. This will require a revision of the simulation models used to forecast climate change and will, in all likelihood, lower the projected impact of human activity on the climate. An amplification reduction in the 80% range could result in dramatically lower projected impact.

All models are wrong, some models are useful. Corollary: apply models with care and always temper their interpretation with sound judgment.

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Toyota Experiencing Quality problems

Wednesday, January 27th, 2010
Toyoto Logo

Will Toyota's Image Suffer Permanent Damage?

One Wall Street Journal headline shouts Toyota Sales Halt Raises Quality Questions and a WSJ blogger opines that this incident could be a crippling blow to Toyota’s mystique. Certainly this episode is one of the darkest in Toyota’s history. The scope of the shutdown is staggering and includes suspending sales of eight of its most popular models in the U.S. due to potential accelerator problems. The extraordinary step follows a recall last week of 2.3 million vehicles in the U.S. and an earlier recall of 4.2 million vehicles — both due to similar issues. Clearly, it is hard times for Toyota, which has lost more than $7.1 billion in the past two years. In addition to the immediate financial impact there is a concern that Toyota’s reputation for quality will suffer long-term damage.

It is well known that a reputation for quality allows companies to charge premium prices. High quality also leads to lower costs and greater efficiency, both of which are negatively impacted by quality problems. In addition, a reputation for quality means lower advertising and marketing costs and free word of mouth promotion. In terms of customer loyalty, Toyota was No. 1 last year in the U.S., according to R. L. Polk & Co. It remains to be seen where Toyota will come in this year. It’s doubtful that they will remain on top.

This being said, I am unwilling to write Toyota off as dead. Their action demonstrates a commitment to quality that is sharp contrast to other automobile manufacturers, who often fight prolonged legal battles before agreeing to recalls. And keep in mind that Toyota’s production shut down is voluntary and unprecedented. It shows that Toyota leadership is willing to sacrifice short-term profitability (and even to take huge short-term losses,) to defend the integrity of their brand. It just may be that the current crisis will be viewed in retrospect as yet another boost to Toyota’s reputation. Only time will tell.

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Quality in Education a Concern in India

Monday, January 25th, 2010

Public and private universities have largely failed to implement the aims and objectives of higher education, the University Grants Commission (UGC) has observed. The problem may be due to the fact that the term “quality” hasn’t been defined for education. In the quality profession a thing hasn’t been operationally defined unless it includes an objective method of measuring it. The UGC, and The Daily Star article, presume that everyone understands the meaning of “quality education” as they discuss the failure to achieve it. However, those of us working in quality in business have learned that unless an operational definition has been developed, different people have different ideas of what a term such as quality education means. After reading and re-reading the Star article, I must admit that I don’t have a clue as to what the UGC is using as their operating definition. The authors talk about the distribution of the universities and a “concern over the standard of eduction in both public and private universities.

After failing to define just what quality is, and how it hasn’t been achieved, the UGC goes on to identify the root causes. “The reasons for the failure include influence of partisan politics on student bodies, session jam, lack of transparency and accountability in the activities of teachers and students, uncontrolled consultancy and part time jobs of teachers, it said.” They also offer a variety of solutions, such as “Practical steps should be taken on an emergency basis to build a national consensus taking opinion of all political parties. Students and teachers’ politics aimed at protecting their collective interests can be encouraged.”

The poor quality of education has been a political issue since at least the time I became an adult, which was a very long time ago. If analysis such as that in the UGC report is the best we can do it will be an issue for some time to come. I suggest that concerned individuals would do well to take a lesson from the community of quality professionals and define precisely what is meant by the term “quality education.” This will then become what they are solving for, the Y, the response variable, the metric which tells them if they are making progress. Until this step is taken we will continue to see the kind of rambling, pointless analysis

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Terrorist List Errors Cause Problems for Many

Monday, January 18th, 2010
Despite TSA Assurances, their watchlist has its problems

Despite TSA Assurances, their watchlist has its problems

We’ve all heard about the terrorist with high explosives in his pants who got through airport security despite being on the TSA’s watchlist. If the null hypothesis is that the passenger is not a terrorist (innocent until proven guilty,) then this is a case of failing to reject the null hypothesis when it is actually false, a Type II error. As you might suspect,  the other type of error occurs as well, non-terrorists are subjected to additional security. The situation is summarized in the table.

H0: Passenger is not a Terrorist
HA: Passenger is a Terrorist
Passenger is Not a Terrorist (H0 correct) Passenger is a Terrorist (HA correct)
Passenger is Passed Through Security Correct Type II Error
Passenger is Frisked at Security Type I Error Correc

More than one list is involved here. One is the well-known “no fly list,” which includes about 2,500 names, 90 percent of which are not US Citizens. The other is the Transportation Security Administration’s (TSA) “automatic selectee” list — its list of about 13,500 names of people who are not permitted to board an aircraft without being given the once-over by the agency’s machines and uniformed, latex-gloved personnel — is based on people’s names, not on physical factors like age. One such automatic selectee, 8-year old Cub Scout Mickey Hicks, has been on the list, apparently, since birth.  For the Hicks family, which travels a lot, this is something of a hassle.

Statistical risk is unavoidable. Whenever decisions are made there is a chance that the wrong decision will be made. The questions involved are extremely difficult, and extremely important. In this case the question is about the tradeoff between liberty and safety. However, according to the NY Times,

For every person on the lists, hundreds of others may get caught up simply because they share the same name; a quick scan through a national phone directory unearthed 1,600 Michael Hickses. Over the past three years, 81,793 frustrated travelers have formally asked that they be struck from the watch list through the Department of Homeland Security; more than 25,000 of their cases are still pending. Others have taken more drastic measures.

It is one thing to err on the side of safety when adding names to a secret list, but there is room for debate about the correct error rate. Hundreds to one seems a bit excessive, to me anyway.

The problem is exacerbated by the extreme difficulties encountered in getting one’s name off of the automatic selectee list. Thousands of people who aren’t terrorists cannot prevent the list from misidentifying them, causing them delays and embarrassment when trying to board commercial aircraft. In a free country it is incumbent on the authorities to make every effort to correct their errors once they have become known.

Another issue is that the TSA’s list is also used for purposes other than airport security. Sen. Frank Lautenberg (D-N.J.), encouraged by New York City mayor Michael Bloomberg, wants to prohibit anyone on the FBI’s terrorist watchlist from possessing a firearm. Yet, the list and its criteria are secret, and Lautenberg’s bill would criminalize the exercise of a constitutionally protected right while denying a person the opportunity to clear himself of accusations in a fair and open hearing before a court of law. Besides that, one can argue that the tolerable error rates for the purpose of airport security would be different.

Also, it makes me very nervous to hear about lists of citizens being kept by governments. These are not people who have been accused of any crime. They are not being sought to be brought in for questioning or for trial. There are no warrants out for these people. History tells us that such lists will inevitably be misused by those in power, often to terrible ends.

The TSA’s process for doing this is obviously broken and in need of quick and drastic improvement. Six Sigma can help the TSA do this. One can only hope that they take advantage of it soon. Our safety and liberty depends on it.

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Lean Financial Services

Friday, January 8th, 2010

The Wharton School and Boston Consulting Group (BCG) have released a special report investigating the reasons why the financial services sector is lagging in their adoption of lean tools and practices. The study finds that the attitudes are changing, albeit slowly. Apparently lower costs, fewer errors, improved efficiency and reduced cycle times appeal to bankers. Who knew?

Lean’s manufacturing origins are probably part of the problem. Non-manufacturing organizations have a difficult time making the mental adjustment between manufacturing and services terminology. I recall many years ago teaching a class where I presented a control chart of a manufacturing process. The data showed the diameters of truss rods. This was a public seminar and I had a mix of students from manufacturing, health care, insurance, services and other industries. These students were truly baffled as to how they could make this work with their businesses. Sensing the reason, I though I’d try something. I wrote the first few rows of the data table that was used for the control chart, but I didn’t put a title on the table. Then I went around the room one-by-one and asked the students some questions about their businesses. For the health care student I wrote the title on the table as “Infections per 100 Surgeries.” For the insurance student “Claims Processed per Worker per Hour.” For the service department student “Service Calls Requiring a Follow Up Visit.” As I addressed each student’s particular application, I could visibly see the light come on.

This exercise caused me to be somewhat disappointed in analysis presented by the Wharton/BCG report’s authors. Deepak Goyal, a partner in BCG’s New York office, commented “Finance is just a different kind of factory. It is a processing factory, and there’s a lot of waste.”  Another comment was “Becoming lean involves eliminating the “seven deadly sins” of waste in a process — overproduction, waiting, poor transportation/logistics, over-processing, sub-optimal inventory control, rework, and unneeded movement.” Yeah, sure. But I doubt that people in the financial sector know precisely what these guys are talking about. I suspect that a few specific financial sector examples of each type of waste would go a long way towards improving understanding. I mean, is it supposed to be obvious that sub-optimal inventory control is a problem at a bank?

Still, the report is a wealth of valuable information for those seeking to expand the reach of Lean to non-traditional areas. Those of us who are professionals in this area can glean a lot of useful guidance from the report, because we already understand Lean and Lean Six Sigma. We can add a great deal of value by translating the report into terms that our clients and employers understand so they can see exactly how these important process excellence philosophies and technologies can be applied to the processes in the financial sector.

Then, perhaps, the lines at the teller window and the waiting times for loan approvals won’t be quite so long!

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iSixSigma Names Project and Program Finalists

Thursday, December 24th, 2009

iSixSigma.com has announced the finalists for the most successful lean six sigma start up program, most successful re0energized lean six sigma program and the largest-breakthrough improvement projects. “The iSixSigma Live! Awards recognize programs and projects that have demonstrated outstanding accomplishment,” said Jessica Harper, editor in chief of iSixSigma. “All entries demonstrated admirable efforts in applying Lean Six Sigma at their organizations. There were some, however, that stood out among the rest in their achievement of breakthrough results.”

Such awards are a source of information for firms seeking benchmark partners, case studies they can learn from, or just plain old inspiration. The lists include technology companies, hospitals, government and military candidates, proving that Lean Six Sigma’s reach is far and wide. Candidates for Largest-Breakthrough Improvement Project included organizations in four industries: customer Service, manufacturing, supply chain, and transactional. Areas addressed by the finalists were cycle-time, defects and error rates, process improvement, parts avaiability, advisor licensing, lead time, call abandonment and handle time, and efficiency.

I was most impressed with the variety, both in the industries represented and the projects. I’m often asked if “Six Sigma” or “Lean” will work in {name the industry or process}, my answer is “If you are working with a process, then you can improve with Lean, Six Sigma, or a combination of the two.” The iSixSigma awards confirm it.

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Why Healthcare Quality Stinks

Monday, November 30th, 2009
Tom Pyzdek

Tom Pyzdek

Let’s be honest, America’s healthcare non-system has its problems. Let’s not quibble over whether or not it is better than socialized systems. For one thing, the demand side is already socialized. Nearly 90% of the cost of healthcare is paid for by third parties, either the insurance company or a government program like Medicare or Medicaid. When a person doesn’t have to bear the cost of the product or service they receive, whatever the system is, it isn’t Capitalism. The supply side however, is pretty much free, at least in the sense that the patient has free access to whatever services and medications their primary care physicians prescribe. The physician doesn’t pay for it; the patient doesn’t pay for it. How about a CT Scan for that pain you’ve had for the past couple of days? Why not? You’re not paying for it!

Exactly what to call this arrangement escapes me. I think there’s plenty of ammo here for a lively political debate where both sides can point fingers at the failings of the other side. There’s plenty of blame to go around. However, it’s not my purpose to examine the whole healthcare issue in this single column. Instead, I’d like to discuss the impact of the current ridiculous situation on the field I’ve spent a lifetime in: quality.

Once upon a time I was working with hospitals trying to improve quality. I assume that we can all agree that this is a worthwhile effort. After all, there is little argument that there is room for improvement. The 1999 report “To Err is Human” by the Institute of Medicine estimated that medical mistakes kill about a jumbo-jet full of people each and every day, and subsequent studies by other groups have shown this to be a low estimate. Anyway, I was lucky enough to work with groups of dedicated healthcare professionals who were able to make significant improvements in areas such as reduced infections, reduction of unnecessary c-sections, faster response times, etc.. The result was a reduction in the average length of stay, fewer readmissions, and other improvements that patients and their families were happy about. One of the most enthusiastic of those working on quality improvement was a young man who I will call Rob. Rob had a great deal of experience in all aspects of hospital administration and soon found himself appointed as administrator of a 500 bed medical center. All of us who had worked with Rob were delighted and we looked forward to an expansion of the quality improvement work Rob had championed when he was in middle-management.

For a while, that’s exactly what we got. Rob’s leadership support began making big dents in chronic problems that were costly in terms of unnecessary patient suffering as well as in waste due to preventable problems. Thanks to Rob I was able to attend meetings with the hospital board of directors, where Rob arranged to have quality improvement teams present their remarkable results to apparently enthusiastic board members.

Soon, however, the atmosphere at these meetings began to change. The chairman of the board, also the president of the bank which held most of the hospital’s debt, pointed out to Rob that the reduced patient-days, lower number of c-sections, reduced readmissions, etc. were cutting into the hospital’s revenue stream. He pointed out the obvious: private and government insurance company money was available to pay for treating a medical mistake, there was no way to know if many c-sections were necessary or not, a readmission paid the same as a first admission. In short, quality improvement was costing the hospital money.

Rob wasn’t blind to the implications. If he couldn’t get revenues up, he would be replaced. Furthermore, in addition to the pressure from the board, physicians were also grumbling about the impact of improved quality on their incomes. Quality was nice to talk about, but when it came to actually giving up the added income, well, that was another story. Rob had a simple choice: follow his conscience and lose his job, or return to business as usual. Soon the quality improvement activities were reduced to a few token people. Gradually, the improvements came undone. Rob eventually lost his job anyway, but the message was clear enough that his successors had no difficulty figuring it out.

In typical buyer/seller situations the problems would be resolved by competition. If one manufacturer’s television set isn’t as good as another the word will spread and people will vote with their dollars for the better value. However, try finding out about the problems at your local hospitals. Or about your physician’s performance relative to others in your area. I’ve tried. And while I’ve discovered some sources of information, the data seems skimpy to me and, shall we say, sanitized. I don’t see the kind of honest customer commentary I see in places like Amazon.com. I suspect there are forces at work making the world work this way.

To summarize: based on personal experience I can tell you that the quality tools that work with other industries work just as well in healthcare. This is no surprise, really. Healthcare has processes, and our tools help people rapidly improve processes. Quality healthcare can be as easily judged by healthcare consumers as by consumers of other services, and our tools help people rapidly improve quality. We can help remove waste from healthcare value streams as surely as we can from any other value streams.

But the missing element is the incentive to improve forced upon other industries by competition and easy access to information. In other industries, customers decide where to spend their own money and have to live with the costs and consequences of their decisions. They have access to frank and open assessments of others about their experiences with a particular supplier and the products and services they provide. They are free to move to a new supplier easily if they decide it is in their best interest to do so. None of these things hold true in healthcare. If we truly want to improve healthcare, in the sense of that we get higher quality service at a lower cost, then we need to address the root causes of the problem. Look at the proposed solutions to the healthcare crisis through this lens and ask yourself if they are treating the underlying disease or making it even worse.

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SAS software billionaire John Sall on Six Sigma

Thursday, October 8th, 2009

SAS software billionaire Sall on Six Sigma and the economic recovery: Big Brain Week continues – Burns on Business.

You would expect John Sall of SAS Institute to embrace the statistical approach. But he goes beyond merely giving a nod to the quality movement and Six Sigma. “The quality movement really changed the world…because of the appreciation for using data and measurement to show cost savings and revenue enhancements.” Said Sall. “Before Six Sigma, you were proving you were watching things rather than figuring out what you should do.”

In other words, you went from focusing on results to understanding what drove those results. This is, I believe, a critical distinction that is lost on most business schools. Business schools must teach aspiring managers all about command-and-control systems, guided by “results.” In my opinion you can’t figure out what needs to be done merely by watching results. Results tell you nothing about causes. They are effects. They are the Y in a transfer function that links them to causes and a process. The process is the set of actions that links the inputs and causes to the results. Business schools and accounting systems can not teach a business leader about these relationships.

Sall doesn’t promote Six Sigma. In fact, he seems to dismiss it. “As a brand, Six Sigma is not as strong. It overpromised. The brand will fade.” No doubt. Brands always fade, eventually. Still, as a brand Six Sigma has outlasted nearly all other contenders. SPC, TQM, Reengineering and many more have come and gone while Six Sigma remains. But it’s not about the staying power of the Six Sigma brand. John Sall sees it as analyzing data and experimentation. I believe that it’s about something deeper than this. It’s about understanding cause-and-effect. Statistical analysis helps with this, as does experimentation. But there’s another ingredient that isn’t emphasized nearly as much as it needs to be: thinking.

Thinking is a process of integrating new facts with all existing knowledge. It is a profoundly individual activity. Business schools act as if a leader can effectively lead by using command-driven management to direct activities and using results as feedback. This approach leads to superstitious learning and management actions that are based on trial-and-error . This approach is largely responsible for the failure of many formerly great enterprises.

Ultimately, management is not about Six Sigma, quality, analyzing data, or experimentation. It’s about knowing how to create and deliver consistent, long-term value for all stakeholders. These other things are tools to help managers figure out how to do this well.

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10 Reasons Why Six Sigma is Fading

Wednesday, October 7th, 2009
  1. It isn’t. Six Sigma is still going strong. Under new names. As part of the way things are normally done.
  2. Charlatans and hacks.
  3. Baggage from previous failures. As leaders move from places where it was poorly done. BSS leader’s “DPMOs!” comment.
  4. Saturation of the base. Most manufacturing organizations of any size are already doing it. Other areas are more resistant.
  5. Cost cutting. In the economic downturn programs of this type are easiest to cut.
  6. Mobility of management. One of Deming’s deadly diseases. Owner- and Board-driven PE seems to last longer.
  7. Victory has been declared. Many businesses, especially in America and Europe, only did it to deal with some crisis.
  8. Displaced by Lean. Lean can get you a fast, big improvement using simple tools. Why bother with the complexity of Lean Six Sigma or Six Sigma?
  9. Not the latest-and-greatest thing. Many organizations did Six Sigma because it was the big thing at the moment. Six Sigma has been around for a while. The glamor is no longer there compare to other fads.
  10. Death by accounting. Six Sigma and ABC or RCA don’t mix well. These are still the dominant accounting systems used by business. Until they go away, leaders who improve using Six Sigma will continue to suffer as the accounting systems mistakenly report poor performance. Until an item made for sale is valued differently than an item made for inventory, Six Sigma is doomed.

The only acceptable reason is one that I don’t think is true: A better way to achieve process excellence has been discovered. If there is a better approach to achieving operational excellence, I don’t know what it might be. If you have any ideas, please let me know. I’m all for copying a good thing when I see it!

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What is Six Sigma?

By Thomas Pyzdek, Author of The Six Sigma Handbook

For Motorola, the originator of Six Sigma, the answer to the question "Why Six Sigma?" was simple: survival. Motorola came to Six Sigma because it was being consistently beaten in the competitive marketplace by foreign firms that were able to produce higher quality products at a lower cost. When a Japanese firm took over a Motorola factory that manufactured Quasar television sets in the United States in the 1970s, they promptly set about making drastic changes in the way the factory operated. Under Japanese management, the factory was soon producing TV sets with 1/20th the number of defects they had produced under Motorola management. They did this using the same workforce, technology, and designs, making it clear that the problem was Motorola's management. Eventually, even Motorola's own executives had to admit "our quality stinks." Read More...