The person who discovered the test used to screen 30 million American men for prostate cancer, the prostate-specific-antigen or PSA test, says the test is a hugely expensive healthcare disaster. In the New York Times Op-ed piece  The Great Prostate Mistake Professor Richard J. Ablin  states

“I discovered P.S.A. in 1970. As Congress searches for ways to cut costs in our health care system, a significant savings could come from changing the way the antigen is used to screen for prostate cancer.”

Americans spend an enormous amount testing for prostate cancer. The annual bill for P.S.A. screening is at least $3 billion, with much of it paid for by Medicare and the Veterans Administration. Meanwhile, the test is hardly more effective than a coin toss. P.S.A. testing can’t detect prostate cancer and, more important, it can’t distinguish between the two types of prostate cancer — the one that will kill you and the one that won’t.Instead, the test simply reveals how much of the prostate antigen a man has in his blood. Infections, over-the-counter drugs like ibuprofen, and benign swelling of the prostate can all elevate a man’s P.S.A. levels, but none of these factors signals cancer. Men with low readings might still harbor dangerous cancers, while those with high readings might be completely healthy.

So why is it still used? According to Ablin it’s because drug companies continue peddling the tests and advocacy groups push “prostate cancer awareness” by encouraging men to get screened. Shamefully, the American Urological Association still recommends screening, while the National Cancer Institute is vague on the issue, stating that the evidence is unclear.

The bottom line?

“Testing should absolutely not be deployed to screen the entire population of men over the age of 50, the outcome pushed by those who stand to profit.”

This according to the man who discovered the test over four decades ago.

Personally, I think the logic used in Professor Palin’s op-ed piece should be used to assess the value of all recommendations used to test and medicate Americans into bankruptcy without improving health in the slightest.

Two researchers at the University of Arizona performed a study to determine why some Wikipedia articles rate high in terms of quality, while others score lower. Eller College of Management Professor Sudha Ram and Jun Liu, a graduate student, have found that entries on Wikipedia – the world’s largest open-access online encyclopedia – gain greater quality with contributions from people in many different roles. Sudha Ram, a UA’s Eller College of Management professor, co-authored the article with Jun Liu, a graduate student in the management information systems department (MIS). Their work in this area received a “Best Paper Award” at the Workshop on Information Technology and Systems held in conjunction with the International Conference on Information Systems, or ICIS.

Wikipedia has an internal quality rating system for entries, with featured articles at the top, followed by A, B, and C-level entries. Ram and Liu randomly collected 400 articles at each quality level and applied a data provenance model they developed in an earlier paper. “What was missing was an explanation for why some articles are of high quality and others are not,” Ram said. “We investigated the relationship between collaboration and data quality.”

To generate the best-quality entries, she says, people in many different roles must collaborate. Ram and Liu suggest that the results of this study should spark the design of software tools that can help improve quality. “A software tool could prompt contributors to justify their insertions by adding links,” she said, “and down the line, other software tools could encourage specific role setting and collaboration patterns to improve overall quality.”

Pyzdek Institute President and Lean Six Sigma Instructor

New online product added to existing online and live courses
Tucson, AZ March 1, 2010 – The Pyzdek Institute LLC has added Lean Six Sigma Black Belt training and certification to its portfolio of online and live courses on  Process Excellence topics. The new course is written and presented by Thomas Pyzdek, author of The Six Sigma Handbook and numerous other authoritative works. “We have been teaching Lean Six Sigma to clients in live classes for well over a decade, and we’ve been teaching Six Sigma for much longer than that,” Pyzdek said. “But the ongoing economic crisis is causing a substantial increase in customer demand for online training, which provides significant cost benefits. In response we are creating online versions of our most popular courses. Online Lean Six Sigma Black Belt training is the most recent result of this effort, and we are very excited about it.”

Online Lean Six Sigma Black Belt training consists of 69 modules covering the entire Lean Six Sigma Black Belt body of knowledge. Pyzdek stated “When I developed this training I did my best to fully integrate Lean and Six Sigma into a comprehensive approach to Process Excellence. When I teach the subject in my live seminars I emphasize that Lean and Six Sigma are complementary, and I tried to make sure that this message also came across in my online training. I believe that I succeeded.”

Among major providers of online Lean Six Sigma training, the Pyzdek Institute’s online training is the only one to utilize the popular Moodle Course Management System. Moodle allows the company to carefully monitor the progress of all students, including lesson modules viewed, resources downloaded, assignment submissions, quiz results, and so on. With Moodle, when a student says that they have successfully completed their training, they can provide documented evidence to prove it.

Moodle also lets corporate customers monitor their students as they move through training. Students can communicate with their instructors or with each other via Moodle forums, which students find are great for interacting with and learning from Master Black Belts and from each other. By using Moodle, The Pyzdek Institute can create separate “Groups” of students. Each group can be coached by its own Master Black Belt and when members of the group communicate with one another, their communications are private and can’t be seen by those who are not in the group. This allows corporate trainees to share their learning experiences with others internally, without worrying about compromising proprietary information. For example, Coventry Health Care is using The Pyzdek Institute to provide training to students in Florida and Arizona, coached by a Pyzdek Institute trained Master Black Belt employed by Coventry. Companies can even coordinate the training of employees anywhere in the world. Corporations can save substantially via group discounts.

The company’s training program is also unique in that it offers three levels of recognition, Bronze, Silver, and Gold. “We found that people have different training needs.” Said Pyzdek. “If a company will be testing and certifying their  own people, then Bronze recognition is right for them and save them money. Silver recognition adds certification testing, and Gold adds certification project presentation to a board of Master Black Belts.”

In addition, The Pyzdek Institute is the only major Lean Six Sigma training provider to offer payment plans. Every online course provides the option to pay for the training over a period of several months.

Media Contact:
Thomas Pyzdek (520) 204-1957
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Quality Digest reports that Toyota Motors Corporation (TMC) has announced the formation of a Special Committee on Global Quality. Toyota Motor Corporation president Akio Toyoda announced the formation of the committee at a press conference in Japan on February 17. According to Toyoda,

“I have been eager to keep management decision-making close to our customers. We need to be where we can hear directly from our customers. That will enable us to incorporate customer feedback swiftly in research and development and, as necessary, in hands-on measures in the marketplace, including product recalls.

“To further promote this effort, the Special Committee on Global Quality, which I will head and which will include people in the post of chief quality officer from various regions, is now being set up. In the same spirit, we have strengthened our framework for conveying customer input from each region directly to our company’s Quality Group and Product Development Group.”

In addition to the announcement, Mr. Toyoda summarized other activities relating to his company’s ongoing quality and safety issues. Read the complete announcement here.

TMC will appoint a person to the post of chief quality officer for each principal geographical region to make the company more alert to customer sentiment. Such officers will serve on the company’s newly established Special Committee for Global Quality. That committee, to be headed by TMC’s president, is for steering the company’s quality-improvement activities onto a new and higher plane. The Special Committee for Global Quality will hold its first meeting on March 30.

TMC will ask independent third-party experts to review the contents of that meeting.

In another initiative, TMC is strengthening its framework for conveying customer input from each region directly to its Quality Group and to its Product Development Group to translate that input more promptly into quality improvements in products. The initiative will get under way first in the United States, where TMC will expand its network of technical offices to fine-tune its information-gathering capabilities in an aim to be able to conduct on-site inspections within 24 hours of every reported incident of suspected product malfunction.

Toyota's Jim Lentz describes plans for fixing sudden unintended acceleration

The current activities are a response to issues with sudden unintended acceleration. Toyota’s Jim Lentz has described Toyota’s program for dealing with this problem. There is controversy regarding the effectiveness of Toyota’s actions to fix the problem. View the video here.

Unless you’ve been in a cave, you know that Toyota has been in the news lately for a problem involving “sudden unintended acceleration,” or SUA. This occurs when Toyotas apparently zoom off on their own, without the driver depressing the accelerator pedal. The official definition, according to the NTSB, is

“Sudden acceleration incidents” (SAI) are defined for the purpose of this report as unintended, unexpected, high-power accelerations from a stationary position or a very low initial speed accompanied by an apparent loss of braking effectiveness. In a typical scenario, the incident begins at the moment of shifting to “Drive” or “Reverse” from “Park”

The definition limitation “from a stationary position or a very low initial speed” has drawn criticism. Newer reports involve acceleration from highway speeds, with deadly results.

For facts-and-data people like us, there are a few questions that need to be asked:

1. Have SUA incidents been increasing in recent years?
2. Do Toyotas have a higher incidence than other vehicles? Does the Prius?
3. Has the cause of SAS ever been investigated by an objective researcher? If so, was a cause identified?

Let’s examine these one by one.

Trends

The data do appear to show a couple of spikes (see figure.) However, it is interesting that the spikes immediately follow news coverage of the problem. This is the second media feeding frenzy about this issue. The first was the Audi 5000, the target of a 1986 episode of “60 Minutes.” In other words, drivers have been complaining about sudden unintended acceleration events for a quarter of a century and continue to lodge these complaints with manufacturers and NHTSA.If the news reports were the result of covering the problem, rather than fanning the flames of public hysteria, one would expect the spikes to come before rather than after the reports. Another interesting fact is that a Google search on the term sudden unintended acceleration include a large number of legal firms in the search results. Could they be fanning the flames?

Are Toyotas The Worst of the Lot?

But does the focus of the news, the Toyota Prius, stand out as particularly dangerous? Not according to the web site AllAboutPrius. The site reports that an analysis of all complaints to the NTSB related to vehicle speed control for the 2004-2009 Toyota Prius revealed that it ranked only 18th in reported injuries. That’s roughly consistent with the number of Priuses sold as a proportion of overall new cars.

Root Cause

An investigation of the problem in the Audi 5000 in the mid-1980s by the NTSB concluded that the problem was driver error. Other NTSB investigations implicate floor mats. It is possible that SUA is related to the cruise control, a hypothesis that isn’t hard to test. Steve Wozniak, the cofounder of Apple, speculated that his Prius had the problem and speculated that software might be the issue. In short, the debate over the root cause of SUA is still unknown

Conclusion

Considering that it has been the object of intense interest for over 24 years, it seems unlikely that a consensus on the cause will be reached any time soon. There are many constituencies with an interest in prolonging the publicity around SUA. And there is no doubt that the public’s interest is intense. People have been killed and injured in accidents caused by SUA and millions of Toyota drivers (including me and my wife) are concerned about the safety of our vehicles. The news media is in the business of attracting an audience for their product, and this story does the trick. Product liability and personal injury lawyers stand to collect millions in fees and the longer the story is big news the greater the market for attorneys.

But one thing seems clear: the problem is not linked to the Toyota Production System, widely known as Lean. This has never been asserted by serious investigators or journalists, but it has been suggested by some who don’t especially care for Toyota. Lean is a methodology that assures that standard procedures are developed and followed to assure both efficiency and quality. It is almost certain that, once the cause is known, Lean will be part of the long-term solution by incorporating the revised design into the Toyota Production System.

PC World reports That AT&T’s wireless service has once again fared badly with its customers. This time with its business customers. AT&T has scored poorly in a wireless carrier satisfaction survey of small and medium businesses and large companies, mirroring an equally dismal performance among consumers last month. AT&T scored at or near the bottom of the major carriers in virtually every category, including voice service pricing, voice coverage, voice quality and customer service. Of the 11 categories surveyed, AT&T was last among the the major carriers in 9 categories.

AT&T Ranks Last for Customer Satisfaction

In a Consumer Reports survey of 50,000 wireless customers published last month AT&T scored dead last in most categories. That AT&T would bring up the rear “in high-profile markets like New York and San Francisco isn’t all that surprising,” Digital Daily said, adding “New Yorkers often carp about dropped AT&T calls, and complaints about lousy service in the Bay Area are legion… But to find that the carrier placed last in 17 other cities as well suggests that AT&T’s shortcomings are more widespread than the carrier would have us believe and not simply the product of a high concentration of iPhones in the country’s larger cities.”

In addition to its poor quality service, AT&T also had the most expensive average monthly bills for two-line plans, the survey found, as its wireless voice services clocked in at an average of $86 a month and its wireless voice plan with data averaged $134 per month. This double-whammy of low quality and high price is certainly something that will, sooner or later, be reflected in sales. Perhaps this is the reason behind AT&T’s recent announcement that it will ramp up capital spending on its wireless network by $1 billion next year. However, while this sounds good at first blush, it is less impressive when one realizes that it is an increase of less than 6% of AT&T’s capital budget.

Perhaps most disturbing is that apparently AT&T’s leadership wants to blame the customer for the poor satisfaction results. Ralph De la Vega, head of AT&T’s consumer services division, told investors that his company’s problems stem from users. “We’ve got to get them to understand what represents a megabyte of data. We’re improving all our systems to let consumers get real-time information on their data usage.” De la Vega predicts that charging for data is inevitable to protect AT&T’s network-and never mind how customers might respond to it. Perhaps this attitude is the reason why, according to Macworld magazine, Apple and AT&T could be headed for a split in 2010. If this occurs it will deprive AT&T of the one bright spot in it’s cell phone business, the wildly popular iPhone.

Tom Pyzdek is interviewed by Steven C. Wilson on Quality Conversations. Click to listen.

Steven C. Wilson interviews Tom Pyzdek

Kaiser Daily Global Health Policy Report reported that between 26 percent and 44 percent of artemisinin-based malaria drugs sold in Madagascar, Senegal and Uganda “failed quality testing” because of impurities or insufficient amounts of active ingredient, the Associated Press reports. The study, which was conducted by the nongovernmental U.S. Pharmacopeia program and received funding from USAID, adds to concerns about growing resistance to artemisinin, which is currently the most effective treatment for malaria.

Malaria, nearly eradicated by the early 1970s, began a resurgence after the US EPA banned DDT because, the EPA alleged, it caused bird’s eggshells to become too thin. Subsequent research casts doubt on this allegation. Nevertheless, other nations followed the USA’s lead and within a few years Malaria had once again reached epidemic proportions in many poor nations of the world, particularly in the tropics. The numbers are truly staggering. According to the CDC

• Forty-one percent of the world’s population live in areas where malaria is transmitted (e.g., parts of Africa, Asia, the Middle East, Central and South America, Hispaniola, and Oceania).
• Each year 350–500 million cases of malaria occur worldwide, and over one million people die, most of them young children in sub-Saharan Africa.
• In areas of Africa with high malaria transmission, an estimated 990,000 people died of malaria in 1995 – over 2700 deaths per day, or 2 deaths per minute.
• In 2002, malaria was the fourth cause of death in children in developing countries, after perinatal conditions (conditions occurring around the time of birth), lower respiratory infections (pneumonias), and diarrheal diseases. Malaria caused 10.7% of all children’s deaths in developing countries.
• In Malawi in 2001, malaria accounted for 22% of all hospital admissions, 26% of all outpatient visits, and 28% of all hospital deaths. Not all people go to hospitals when sick or having a baby, and many die at home. Thus the true numbers of death and disease caused by malaria are likely much higher.

Quality issues only exacerbate the problem of controlling this vicious, often fatal, illness. “The study is the first part of a 10-country examination of antimalarials in Africa by the U.S. and the World Health Organization. It follows evidence from the Thai-Cambodian border that artemisinin-based drugs there are taking longer to cure malaria patients, the first sign of drug resistance,” the news service writes.

“The experts subjected 200 samples of anti-malaria drugs to quality-control testing in a U.S. laboratory. They found 44% of the drugs from Senegal failed the testing, followed by 30% from Madagascar and 26% from Uganda. Patrick Lukulay, director of the U.S. government-funded Pharmacopeia programme, said it was a ‘disturbing trend,’” the BBC writes.

He said, “It is worrisome that almost all of the poor-quality data that was obtained was a result of inadequate amounts of active [ingredients] or the presence of impurities in the product”.

According to the AP, the “three-country report also found bad drugs in both the public and private health sectors, meaning governments – some buying medicines with donor funds – are not doing enough to keep poor-quality pills out. All of the drugs tested from the public sector in Uganda, however, passed the quality tests. But 40 percent of the artemisinin-based drugs in Senegal failed.” The study also notes that the same drug brands generally had similar results across all sectors, which could help governments that are trying to eliminate substandard drugs.

While the study is not the first to assess the quality of antimalarials in Africa, it is the most rigorous and complete, according to the AP, which notes that similar failure rates were found in previous work that did not focus specifically on artemisinin-based drugs. The WHO has examined malaria treatments in Cameroon, Ethiopia, Ghana, Kenya, Malawi, Nigeria and Tanzania, the AP reports, adding that while the results have not been made public, “Clive Ondari, who worked on the study for the WHO in Geneva, said failure rates in three of those countries were also significantly high. Ghana has already withdrawn more than 20 drugs from the market after receiving the initial results, Lukulay said”

I teach that by itself Lean is a way to redesign a value stream according to certain principles to improve flow in a value stream, thereby reducing cycle time and achieving a number of other benefits quickly. Six Sigma has two modes: project and operational. The project mode involves a framework such as DMAIC or DfSS. The operational mode employs Six Sigma principles (management by facts and data, statistical thinking, systematic identification of root causes of outcomes, etc.) to achieve stakeholder goals. Lean Six Sigma can be used to provide a framework for kaizen bursts, or to solve other problems preventing continuous flow in an organization or value stream.

Hmmm…Upon re-reading this it strikes me that it’s full of jargon. Let’s try putting it into layman’s terms.

Lean helps you make things with minimal waste and delay. Six Sigma helps you find out why things vary and how to reduce variation. Lean Six Sigma helps you solve challenging problems causing waste and delay.

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.