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Archive for the ‘Quality’ Category

Audits Identify Serious Readiness Problems in US Navy Fleet - What are the Root Causes of These Maintenance and Safety Issues?

Thursday, May 8th, 2008

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(link to pictures with major findings highlighted)

If you attend a TapRooT® class you will hear the instructor promote proactive improvement including proactive use of root cause analysis tools. The instructors will show you how to find and fix the root causes of problems before a major accident occurs.

It seems that the Navy has a chance to act proactively. A recent audit (called an INSURV Inspection) turned up a litany of serious operational and safety problems on two Navy surface ships. Now the question is … Will the Navy find and fix the root causes or just fix the symptoms?

A fresh coat of paint and a haircut (tried and true Navy solutions) won’t solve these problems. Cracked gun barrels, degraded engines, and inoperable radars are signs of improper or inadequate maintenance. And poor maintenance is only an indicator of where the bigger problems lie.

My guess is that these ships and their crews have been run hard and underfunded. It would be interesting to see data that may shed light on my guess.

Support for the troops shouldn’t be just a political slogan. The real measure of support is funding to maintain equipment and to train those who go in harms way. Politics shouldn’t get in the way of the proper tools that our brave sailors, airmen, and solders need to fight a difficult war.

Spring 2008 ASQ Automotive Excellence Magazine

Sunday, May 4th, 2008

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In February I had the opportunity to teach a portion of the science behind The TapRooT® System to the ASQ Automotive chapter in Detroit. The presentation went well and the research that supported my presentation was recently published in the ASQ Automotive Excellence Magazine. For more information about the article and ASQ, click on this link: ASQ Automotive Excellence Spring Magazine. There are also over 40 references listed in the article that helped me give a robust representation of root cause analysis research that you can look up.

Another Insurer Says They Won’t Pay for Medical Mistakes…

Thursday, April 17th, 2008

A press release from Cigna:

As part of its ongoing focus on improving health care quality, CIGNA HealthCare is taking steps to stop reimbursing hospitals for so-called “never events” and avoidable hospital conditions, which are errors in patient care that can and should be prevented. CIGNA’s new policy is consistent with and based on the policy of the Centers for Medicare and Medicaid Services (CMS), and both policies will become effective on Oct. 1, 2008.

“CIGNA is committed to improving quality for our members throughout the health care system,” said Jeff Kang, MD, chief medical officer for CIGNA HealthCare. “Our policy on never events and avoidable hospital conditions is designed to put patient safety first and to encourage hospitals to improve quality every day, one patient at a time.”

“We commend CIGNA for its commitment to patient safety and quality improvement,” said Helen Darling, president of the National Business Group on Health. “Hospitals, health care professionals and health plans must all work together to ensure that ‘never events’ never happen, avoidable conditions are always avoided, and every patient receives quality treatment in a safe and caring environment.”

As defined in CIGNA’s policy, “never events” are surgical procedures that are performed on the wrong side, wrong site, wrong body part or wrong person. They earned that name because they should never happen in medical practice. For example, surgery erroneously performed on the right knee instead of the left knee, or the erroneous removal of a gall bladder instead of an appendix, are considered to be never events.

CIGNA will not reimburse for never events because they are not “medically necessary.” Surgery performed on the wrong side, wrong site, wrong body part or wrong person is not considered medically necessary to diagnose or treat an illness, injury or disease, and is therefore not reimbursable.

(more…)

Is a Safeguard Based on “Modern Rules” as Good as a Natural Safeguard (Distance)

Sunday, April 13th, 2008

A debate taking place in the agricultural community and on Capital Hill is really about the strength of Safeguards.

A story in the Houston Chronicle explains the debate.

The government is considering moving the Plum Island Animal Disease Center from an Island off the coast of New York, to a facility on the mainland of the United States.

Previous unintentional releases of live foot-and-mouth disease have been contained to the island because of the distance from the mainland.

The government argues that the release happened long ago (1978) and that modern safety rules, policies, and procedures make it safe to move the facility to one of these potential locations:

San Antonio, TX
Manhattan, KS
Athens, GA
Butner, NC
Flora, MS

House Energy and Commerce Committee is considering the administration’s plans to move the facility. The new site could be selected later this year, and the lab would open by 2014.

The System Administrator Misinterpreted the Root Cause

Thursday, April 10th, 2008

The FBI concluded that the crash of Senator Joe Lieberman’s web site WAS NOT a dirty trick from the opposing camp (Ned Lamont).

According to the FBI the data logging indicates a simple overload of the site combined with a misconfiguration of the server by the administrator. The FBI concludes that:

“The system administrator misinterpreted the root cause…”

For the complete story see The New York Times article:

http://cityroom.blogs.nytimes.com/2008/04/09/fbi-lieberman-2006-crashed-its-own-site/

Baggage Meltdown to Cost British Airways $32 Million

Friday, April 4th, 2008

Today, The Wall Street Journal reported that the baggage mess at Heathrow Airpo’s Terminal 5 will cost British Airways $32 Million Dollars. These costs are the result of cancelled flights (lost revenue), the cost of forwarding bags, and the cost of putting up stranded passengers at hotels. The costs do not include the damage to the airline’s reputation.

What does this mean to people performing root cause analysis?

If testing, audits, and proactive root cause analysis had been used prior to the opening of this terminal, these costs could have been avoided.

Also, the industry (or at least British Airways) didn’t learn from the root causes of the fiasco at the new Denver airport (not so many years ago). If the root causes of that failure were analyzed and shared, lessons could have been learned that might have prevented this “baggage meltdown.”

 

Follow-Up on Wrong Kidney Removal Article

Wednesday, April 2nd, 2008

 File Thumbview Approve 2564442 2 Istockphoto 2564442 Caduceus Medical Symbol Chrome

I previously wrote a blog entry about the wrong kidney being removed from a cancer patient.

Yesterday, I read an AP article with the following quotes:

Twenty-four wrong-site surgeries were reported to the Minnesota Department of Health between October 2006 and October 2007. Two were at Methodist, but Carlson said they were relatively minor compared with last week’s error: a needle biopsy on the wrong lung, and a diagnostic exam of the wrong bronchial tube.

Kathleen Harder, a University of Minnesota researcher, said medical errors of this magnitude are rare but do happen.

“Medical errors” certainly are NOT rare. The question is: “How rare are high consequence medical errors?

The answer is: “No one knows.

Why?

Because their is no national law that requires the reporting of high consequence medical errors to a central reporting agency.

Thus all statistics are a guess.

On top of that, to avoid liability errors may disguised as normal deaths. I read a sad story about a family being told that “every possible had been done” to save the life of their grandmother. They chose not to have an autopsy performed. Later, they found out that she had been administered large doses of blood thinner that may have contributed to, or caused, a fatal hemorrhage in her brain. The death would have been a natural death in the statistics. It would have gone unreported. Yet, the family now believes it was a covered up medical error that was detected by a nurse (a family member) reviewing the medical records.

I’m not a person that favors large government regulatory initiatives. And I’ve seen many government programs go astray. But unless the healthcare industry can come together to establish effective reporting and improvement programs, a large government lead regulatory initiative will surely be the eventual result.

If you are interested in efforts to reduce medical errors, you should participate in the TapRooT® Summit in Las Vegas on June 25-27. There is a Best Practice Track dedicated to medical error reduction. And you can network with experts inside the medical field and from a large variety of other industries. The cross industry networking may be the only hope for accelerated improvement in the healthcare industry. After all, as Sam Levenson quipped:

You must learn from the mistakes of others. You can’t possibly live long enough to make them all yourself.

If you are in the medical industry leading an improvement effort, don’t miss this once a year chance to learn from others.

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Baggage Handling Root Cause Analysis?

Tuesday, April 1st, 2008

An article in the Daily Express described the trouble at Heathrow as a “Baggage Meltdown.”

The results of thousands of “lost” bags are called a “Luggage Mountain.”

They have had to fly jumbo jets loaded with just bags across the ocean to try to unite travelers with their luggage.

And news outlets say the problem could get WORSE!

The cost of this “incident” is more than just the immediate costs to the airlines and travelers. Some say it has caused damage to the whole British reputation.

Picture 49

What is the “cause?” Everyone has an opinion. Most are looking for someone to blame.

But instead of looking for someone to blame, they should try advanced root cause analysis.

TapRooT® has been applied by many major airlines. Alaska Airlines even used it to analyze delayed flights and improve on-time departure statistics.

Perhaps British Air should try TapRooT® to stop the baggage meltdown and improve customer service?

And next time they should use root cause analysis as a PROACTIVE tool to improve performance BEFORE they open a new terminal and thus avoid a major quality of service incident.

Who said you need to replace your existing Six Sigma or Lean Program?

Monday, March 31st, 2008

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Coming to System Improvements, Inc. as a Six Sigma Black Belt with ” the good, the bad, and the ugly” of Six Sigma company implementations, I often get asked how does the TapRooT® root cause analysis system tie in with the above pictured improvement systems and tools? During recent WebEx’s and conference calls, System Improvements, Inc. clients are often concerned about the cost of replacing their current highly invested Six Sigma Programs with TapRooT®. Peculiar thing is that companies questioned the same thing about Kaizen, Lean, and Six Sigma implementations as discussed in an article by Terence T. Burton. For those with existing Six Sigma Programs you can rest; TapRooT® does not replace the above mentioned processes but instead compliments the gaps in root cause analysis (Define and Analyze) and corrective actions (Implementation) to ensure robust proactive and reactive solutions to multiple system problems. For more about six sigma and lean practices integration with TapRooT® sign up for the TapRooT® Summit.

Below are some hard learned lessons, I picked up along the way that should be useful to current process improvement practitioners.

1. There should be no improvement “system” distinction between lean, six sigma, or any other improvement tool or process. People argue needlessly for days. Think about the old schools of psychology, you were either for nurture or nature, or crazy like Freud. Now schools teach that people are effected in the womb by the environment (nurture) and the cells develop (nature) like good soup. Needs to be the right temp and right conditions at the right time and don’t shake the pot. When we are born we are predispositioned to behave certain ways… all the music lessons in the world will not give you a good ear for music. Then it is up to the environment to guide the person. Point is that you must integrate the tools in a process that suppliment or compliment weakness and strengths. See an example of combining a six sigma tool and TapRooT®.

2. “Experts” who implement lean without truly understanding the integrated supply chain, the business needs, and the market will work improvement projects that sub-optimize other projects. A bad thing.

3. Perceived easiness of certain root cause tools in company experts’ hands… i.e. engineers, mechanics, operators, QA…, are actually limiting the analysis. As experts we developed rules-of-thumb and already “know” what the problem is. Funny thing, our children must be ignorant because all they want to do is ask a lot of why and what questions. It is not until we become adults that we know everything. Link to root cause research

4. YOU (the project black belt) must personally convince the boss to change to make the boss commit to a project; if you can’t too bad….Wrong! Influencing without authority means find the person the boss listens to and convince that person the project is the right thing to do…. there are a number of ways to “plant the seeds” of change.

5. Toyota experts developed excellent tools to improve their company… wrong. They went out and looked, understood their process, and then developed tools to represent their improvement needs. The problem with this is that we go out and buy fancy tools, put garbage data in from a company process that we do not not fully understand and then blame six sigma for its failure. You must understand the process used to improve, understand the process you are trying to change, and use tools to complement these processes.

6. Another major problem of six sigma is keeping safety, hr, and training as the outsiders who don’t see the “hidden factory”. Why… because of the initial low Return of Investment. When has your six sigma program observed the core competencies (skills and tasks) needed to perform their job and do it successfully? Does annual training still cover key skill needs?

Hope this helps and I see you in Las Vegas at the TapRooT® Summit.
Link to root cause research

Otis Elevator Recognized as Leader in Service Quality in China

Wednesday, March 26th, 2008

The China Association for Quality Promotion (CAQP) has recognized Otis Elevator Company as a leading service provider in China for its consistent national service model, standardized processes and best-in-class response time. Otis is a unit of United Technologies Corp and a Licensed TapRooT® User.

Otis was the only elevator company to receive the distinction and one of only 15 companies selected out of the 2,339 evaluated.

Otis Elevator Company is the world’s largest manufacturer and maintainer of people-moving products including elevators, escalators and moving walkways. With headquarters in Farmington, Connecticut, Otis employs 63,000 people, offers products and services in more than 200 countries and territories and maintains 1.6 million elevators and escalators worldwide. United Technologies Corp., based in Hartford, Connecticut, is a diversified company providing high technology products and services to the building and aerospace industries. United Technologies is a Licensed TapRooT® User worldwide.

For more info, see:

http://www.forbes.com/prnewswire/feeds/prnewswire/2008/03/26/prnewswire200803260700PR_NEWS_USPR_____NEW009.html

More News on Southwest Maintenance Issues - Some Flight Temporary Grounded Due To Maintenance Records

Thursday, March 13th, 2008

See:

http://www.chron.com/disp/story.mpl/business/5615204.html

Report on an Amazing Hospital Audit

Thursday, March 13th, 2008

It’s rare to see an audit or evaluation be this blunt. See:

http://www.smokymountainnews.com/issues/03_08/03_12_08/fr_hrmc_power.html

Could this audit be performed by an internal auditor?

Would it be possible to conduct an audit like this if the Hospital Administrator was still there? (He quit before the audit was conducted.)

Could the Board be more independent and should have they found the problems and forced the Administrator to Change (or fired him) before it came to the point of losing Medicare certification?

What do you think?

Another View of Accident - NASA Style Fireworks

Wednesday, March 12th, 2008

Southwest Faces $10.2 Million Fine - But Were Root Causes Found and Fixed?

Friday, March 7th, 2008

There was an interesting article in the Houston Chronicle. It discusses a maintenance problem (overdue inspections) on Southwest jets.

The FAA is proposing $10,2 million in fines. The article says:

The FAA alleged that between June 18, 2006, and March 14, 2007, Southwest operated more than 59,000 flights without complying with a 2004 order requiring repetitive inspections of fuselage areas to detect fatigue cracking.

Further, the FAA charged that the airline flew nearly 1,500 more flights using the same planes in March 2007, even after it determined that it had not done the necessary inspections.

“The FAA is taking action against Southwest Airlines for a failing to follow the rules that are designed to protect passengers and crew,” Nicholas Sabatini, the FAA’s associate administrator for aviation safety, said in a prepared statement.

The fine is the largest levied against an air carrier, FAA spokeswoman Laura Brown said.

The missed inspections were discovered by Southwest and self-reported to the FAA. The missed inspections were then performed in the month of March 2007. Cracks were found and corrected in 6 or the 46 jets that were inspected.

What were the root causes of the missed inspections and have they been corrected?

Fines do little good if the problems root causes aren’t effectively addressed.

My hope is that both the FAA and Southwest thought of this. Why didn’t the reporter dig deeper to find this out and include it in the story?

Reporting on the politics of a fine is one thing, but assuring passengers of their safety by verifying that an effective root cause analysis was performed is quite another.

Proactive Improvement, Operational Excellence, and Lean/Six Sigma

Wednesday, February 27th, 2008

If you are interested in Operational Excellence, Lean, Six Sigma, or proactive improvement, you should attend the TapRooT® Summit. The Summit has a Best Practices Track focused on these topics. What’s in the track? Here are the speakers and topics:

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Pursuing Process Excellence - What It Takes to be One of the Best - Kevin McManus, President, Great Systems!

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Using TapRooT® to Improve Lean/Six Sigma - Chris Vallee, Six Sigma Black Belt, System Improvements

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Culture Shift Secrets - Changing Systems to Shift Cultures Towards High Performance - Kevin McManus, President, Great Systems!

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Measuring Performance - The Latest Research on Performance Measures - Dr. Joel Haight, Penn State University

Hal Head

Dealing with Obstacles that Make Change Difficult - Hal Curry, Consultant, Hal Curry & Associates

Managing the Risks Associated with Change
- Malcolm Gresham, Principal Consultant, Practical Solutions Group, Australia, & Jim Whiting, Managing Director, Risk @ Workplaces Pty. Ltd. Australia

Applying Performance Measures in Industry & Healthcare - Dr. Joel Haight, Penn State University

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TapRooT® User Best Practices - Linda Unger, VP, System Improvements, & Michele Lindsay, Principal Consultant, P2, Canada

Character Driven Success
- Dr. Beverly Chiodo, Texas State University

Changing Behavior by Praising the 49 Character Traits - Dr. Beverly Chiodo, Texas State University

Planning Your Improvements

In addition to these Best Practice Sessions, there are great Keynote Speakers. For the complete list see:

http://www.taproot.com/keynote_speakers.html

The Summit will be June 25-27 in Las Vegas.

To register for the Summit, or for more information, see:

http://www.taproot.com/summit.php

FDA Checks Wrong Plant - Maybe They Need to Apply Advanced Root Cause Analysis?

Tuesday, February 19th, 2008

Two different plants. Two similar names. Oops! Wrong plant!

If you’ve been following the FDA investigation of allergic reactions to Baxter’s heparin blood thinner, you know that a Chinese manufacturer is supplying a key ingredient. The supplier that produces the ingredient was not previously inspected by the FDA because the FDA went to the wrong plant. It seems there are two plants with similar names in the agency’s database.

Joseph Famulare, Deputy Director of the Compliance Department at the FDA’s Center for Drug Evaluation and Research said that the wrong factory had a history of positive inspections and wasn’t re-inspected. This month, they discovered their error. Famulare says that as far as the FDA knows, this is an isolated error. FDA inspectors will travel to China this week to check the right plant.

The FDA has notified Doctors to stop using Baxter’s heparin because of 350 reports of adverse reactions (including deaths) this year.

For more information see the Associated Press story at:

http://www.chron.com/disp/story.mpl/world/5550954.html

Adverse Drug Reactions Lead to Root Cause Analysis

Saturday, February 16th, 2008

The approach discussed in the article (link below) seems similar to Change Analysis. What are the differences in lots of the drug that lead to adverse patient reactions?

To read about this problem see:

http://www.nj.com/business/index.ssf/2008/02/heparin_probe_finds_us_tie_to.html

NRC & Operator Integrity - Could This Happen to You? - And What is the Root Cause?

Wednesday, February 6th, 2008

Article about an actual event written by Mark Sharp:

What Was I Thinking?

“… former senior reactor operator who mistakenly entered incorrect information into a plant computer during a maintenance operation on Nov. 8, 2006, and subsequently attempted to cover up the mistake by falsifying the record…” NRC news release, October 22, 2007

After 25 years of working in the nuclear power industry in both operations and operations training, you would think that I would have had a handle on operator fundamentals. Self-checking, placekeeping/logging, and error reduction techniques were a part of my every day activities. One of these fundamentals, the trustworthiness and honesty of the employees, became a stumbling block for me one night in the early hours of the morning. Before I can talk about that, I need to give you some background information, including some aspects of human performance/operator fundamentals that need to be reviewed and that could be applied to all nuclear plants.

The multi-unit site I was working at requires a few manual inputs into the plant computer(s) for maintaining the secondary calorimetric up to date. One of these inputs is to account for the Steam Generator Blowdown flowrate from each steam generator. Every time you change the flowpath, and thereby the flowrate, you have to update the computer with the Engineering supplied flowrate constant. This maintains the secondary calorimetric indicated power equal with actual power level. Optimum plant power levels can then be maintained without exceeding limits.

So, what happened that night shift back in November 2006? Following maintenance, our crew was tasked with restoring piping associated with the Steam Generator Blowdown heat exchanger. This would require realigning the blowdown flowpath. Following the required alignment, I made an error in pulling the Steam Generator blowdown constant number off of the operator aid (multiple column/multiple rowed 3” x 4” card) taped to the side of the computer screen and inputting this wrong number into the computers. I also logged this same incorrect number into the constant change log book. The person performing the independent verification (IV) of the action failed to identify my mistake.

(more…)

FDA Cites Bad Root Cause Analysis & Corrective Action in Warning Letter

Monday, February 4th, 2008

FDA News Reports: Stryker Recalls Hip Implants After WarningFor more information see:http://fdanews.com/newsletter/article?issueId=11268&articleId=103627

Australian Chicken Factory Evacuated after an Ammonia Leak

Wednesday, January 9th, 2008

An Edinburgh, Australia chicken factory was evacuated after an Ammonia leak. 20 people were affected by the fumes.

The food processing industry is a great place to put TapRooT® to work finding the causes of all sorts of events including industrial safety issues, food safety issues, and equipment reliability problems.

In this case, there was a combination of equipment reliability and industrial safety issues.

For more information about learning about TapRooT® in Australia, see these two web sites:

Practical Solutions Group

Capability Resources

Monda Accident & Lessons Learned: Bad Welds - Wrong Filler Used, Corrective Action … More Training!

Monday, December 24th, 2007

The Navy Times reported that that several submarines and nuclear powered aircraft carriers could have substandard welds.

The corrective action? According to the article, a change in a policy and more training.

Are these strong corrective actions or weak ones? How will shipyard management know if the policy change is being followed?

What can you learn from this quality incident?

Missed Opportunities to Stop Contamination Cause Bankruptcy at Topps Meat

Wednesday, October 24th, 2007

 Images 2007 10 23 Business 23Meat.1-650

Recent outbreaks of E coli contamination in the US food supply has caused the press to start reporting on food safety. However, the increased press reports don’t seem to be enough to get the attention of all executives at companies supplying food to the US market.

A New York Times article with the headline:

Many Red Flags Preceded a Recall of Hamburger

points out the danger food processors face if they ignore warning signs.

What can happen? When management misses the warning signs and fails to fix the root causes of minor problems, then major accidents, product recalls, and operating difficulties are just around the corner. According to the information in the article, failure to act on smaller problems caused a major outbreak of food-borne illness, a major recall of their product (ground beef patties), and bankruptcy of the company (owned by the private equity firm Strategic Investments & Holdings since 2003). If only management at Topps had understood the use of advanced root cause analysis to analyze and solve problems, they could have prevented this E coli outbreak and saved the company from bankruptcy.

What does this have to do with your company? Try asking these questions and see what answers you get:

What would a major recall cost your company? Could your company survive?

Does your management know how to use advanced root cause analysis to spot problems and improve performance?

Does your company spot problems when they are small and use what they can learn from a thorough root cause analysis to prevent major problems?

Would your management like to learn how to keep major accidents from happening by applying known best practices?

For more information about training your management, call System Improvements at 865-539-2139 or click here and drop us a note.

But don’t wait too long and let disaster strike your company.

CNN/AP Report on Debate Over Increased Food Processing Regulations to Improve Food Safety

Thursday, September 13th, 2007

To read the story see:

http://www.cnn.com/2007/HEALTH/09/12/salad.safety.ap/index.html

Do Aviation Manufacturers Need Improved Root Cause Analysis?

Thursday, September 6th, 2007

James Wallace of the Seattle Post-Intelligencer reported that Boeing is having trouble meeting the production schedule for the 787 Dreamliner and will compress the testing schedule to a previously never accomplished time frame. If they miss this condensed schedule, they won’t meet their May 2008 delivery schedule and will owe the purchasers financial compensation (penalties).

An additional story with comments from an AP reporter mentioned that troubles at competitor Airbus has caused billions of losses due to “wiring problems.”

Billions lost and critical path delays … Sounds like an opportunity to apply advanced root cause analysis!

Job Opening: GE Needs Quality Engineer with Root Cause Analysis Skills

Wednesday, August 29th, 2007

See:

http://www.bayt.com/job/job.adp?xid=551446

Job Opening in Ontario - Project Engineer with Root Cause Analysis Skills to Analyze Quality Issues

Wednesday, July 25th, 2007

For more information see:

http://www.eluta.ca/search?ptitle=Project+Engineer&position=ae4f2a5eed5d4fb7d3184569838dc944&imo=1

Monday Accident and Lessons Learned: FDA Warning Letter Cites Inadequate Root Cause Analysis

Monday, July 23rd, 2007

What can inadequate root cause analysis get you? A warning letter from the US FDA and a big headache.

Recent press reports detail the headaches of Srtyker Ireland, LTD and their troubles with the FDA. For more information see these links:

http://www.reuters.com/article/health-SP/idUSN1926664420070619

http://www.fdanews.com/newsletter/article?issueId=10468&articleId=96073

http://www.fda.gov/foi/warning_letters/s6387c.htm

http://www.ryortho.com/NEWSSHORTS/volume3/issue20/06-22-07-NS-FDA.htm

How big a problem is failure to perform adequate root cause analysis in industries regulated by the FDA? A quick search of the FDA’s reading room warning letter database yielded 26 letters in the past 12 months. That’s not an exhaustive study, but it is an indicator. Many medical device manufacturers and drug companies need to do a better job finding and fixing root causes.

Lesson Learned? Think ahead! Get an advanced root cause analysis program in place before the regulator arrives with a letter. Then make advanced root cause analysis a key part of your performance improvement and operational excellence program.

For more information about advanced root causes analysis courses around the world, see:

http://www.taproot.com/courses.php

Root Cause Analysis Lessons Learned?

Tuesday, July 10th, 2007

The Associated Press published the following:

Zheng Xiaoyu’s execution was confirmed by state television and the official Xinhua News Agency.

“The few corrupt officials of the (State Food and Drug Administration) are the shame of the whole system and their scandals have revealed some very serious problems,” SFDA spokeswoman Yan Jiangying said at a news conference held to highlight efforts to improve China’s track record on food and drug safety.

“We should seriously reflect and learn lessons from these cases. We should step up our efforts to ensure food and drug safety, which is what we are doing now and what we will do in the future,” Yan said about Zheng and a separate case involving Cao Wenzhuang, the administration’s former pharmaceutical registration department director.

Is this an effective corrective action to the root causes of a problem?

To read the entire article, click here.

A Wrong Site Surgery or a near-Miss Occurs Every Other Day in Pennsylvania, Reports the Patient Safety Authority

Wednesday, June 27th, 2007

To read the article, click on the headline below:

Patient Safety Authority Releases Wrong-Site Surgery Data

US Government May Stop Paying Hospitals Extra for Common Medical Errors

Thursday, May 24th, 2007

It’s an interesting concept … The hospital makes an error - like a caretaker contaminating a needle and causing a bloodstream infection - and the government then pays the hospital more to cure the disease they created.

This process seems to reward the hospital with additional payments for making errors. It certainly doesn’t reward a hospital that spends more to stop medical errors.

An article in the May 22 edition of the Indy Star indicates that Medicare is rethinking this payment policy and may stop paying for the following conditions acquired after admissions:

1. Catheter-associated urinary tract infections.
2. Bed sores.
3. Objects left in after surgery.
4. Air embolism, or bubbles, in bloodstream from injection.
5. Patients given incompatible blood type.
6. Bloodstream staph infection.
7. Ventilator-associated pneumonia.
8. Vascular-catheter-associated infection.
9. Clostridium difficile-associated disease (gastrointestinal infections).
10. Drug-resistant staph infection.
11. Surgical site infections.
12. Wrong surgery.
13. Falls.

With Medicare being such a large payer of claims, this would certainly give hospitals a much bigger reason to improve - their profitability!

And as a taxpayer I can’t see why they have waited this long.

For the complete article, see:

http://www.indystar.com/apps/pbcs.dll/article?AID=2007705220351

Six Sigma - Lean for Healthcare

Monday, May 7th, 2007

Six Sigma methodology focus is implementation of a measured-based strategy that focuses on process improvement and variation reduction through the application of Six Sigma improvement project. But any process improvement in healthcare demands knowledge of how its systems affect patient care. Harry Wetz and David Davis presented “Six Sigma/Lean Healthcare” at the Summit. To view their papers, see the icon below:

Six Sigma Quality

Six Sigma-2

Kaizen Event Summary - Medication Administration

Wetz.Harry

Meeting FDA Expectations for Corrective Action Programs

Friday, May 4th, 2007

In your company, is retraining the employee the frequent answer to Corrective and Preventive Actions (CAPA)? Are CAPAs often viewed as an afterthought to conducting Root Cause Analysis (RCA)?

Summit attendees learned what the FDA expects from the Biological Pharmaceutical (Bio Pharma) industry in the area of CAPAs. In Lisa Smith’s Summit presentation, an example of an adequate CAPA versus a robust CAPA was discussed and the benefits of each was compared.

Attendees learned about:

FDA requirements

Criteria for effective CAPAs

The difference between adequate versus robust CAPAs

The concept of mistake-proofed CAPAs

The importance of using cross-functional improvement teams to solve nagging problems systemically

The importance of assessing the post-implementation effectiveness of CAPAs

Click the link below to download a copy of Lisa’s presentation.

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Teruyuki Minoura (Toyota Exec) Talks About Problems with 5-Whys

Wednesday, March 14th, 2007

The following is quoted from a Toyota web site.

A Toyota Exec is talking about the Toyota Production System.

The article says:

- - - Start of quote - - -

When an error occurs, the first thing that needs to be done is fix the error. Minoura recalls that Ohno used to order them to ask the question “Why?” five times over because “that way you’ll find the root cause, and if you get rid of that it’ll never happen again.” However, Minoura emphasizes that on-the-spot observation rather than deduction is the only correct way to answer a “Why?” question. “I’m always struck that the five-why method doesn’t seem to be working as well as it should be because there’s been a lack of practical training. The reason is that they end up falling back on deduction. Yes, deduction. So when I ask them ‘Why?’ they reel off five causes as quick as a flash by deduction. Then I ask them five whys again for each of the causes they came up with. The result is that they start falling back on deduction again, and so many causes come back that you end up totally confused as to which of them is important.”


“Through real training,” Minoura says, “you’ll be able to discover dozens of problems and also get to their root causes. You’ll be able to make dozens of improvements. If you incorporate all the accumulated knowledge of root causes that you’ve got from always asking ‘Why? Why? Why? …’ into your equipment, you’re going to have something that no one else can come close to. I don’t think it’s got anything to do with nationality; it all has to do with whether or not you’ve received the proper training. I feel though that the tendency to give that kind of training and education forms the basis of Toyota’s approach to monozukuri.”

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Most people that talk to me about 5-Why’s, Cause-and-Effect, or Fault Trees stress the need for deductive reasoning to find root causes. Yet here is someone who worked under Ohno (the 5-Whys expert) who says that deduction is BAD - only direct observation is good.

I like the idea of direct observation. But I think people need more guidance than just asking “Why” 5 times to be able to solve difficult problems. Perhaps 5-Whys works for simple problem. But how do you know if a problem is simple before you solve it?

Maybe 5-Why’s would work for a dedicated master problem solver like Ohno. But it is difficult - or perhaps impossible - to train everyone needed to his level of skill.

That’s why in the TapRooT® System for Root Cause Analysis, we’ve built in an expert system to help people find the root causes of human performance and equipment problems. This helps everyone - from the novice problem solver to the expert - perform better root cause analysis.

And we teach people to use direct observation - the facts - to find root causes using a root cause analysis tool called the Root Cause Tree®.

And we’ve built this whole system into a patented Root Cause Analysis Software - the TapRooT® Software.

What is required to reap the benefits of the investment that we have made in developing TapRooT® into a world class problem solving system? Training for your people.

You will need to train your expert problem solvers in our 5-Day TapRooT® Advanced Root Cause Analysis Team Leader Course.The software is included in the course fee for this course.

You will need to train your everyday problem solvers in our 2-Day TapRooT® Incident Investigation and Root Cause Analysis Course.

And your maintenance and equipment problem solvers need the 3-Day TapRooT®/Equifactor® Equipment Troubleshooting and Root Cause Analysis Course.

What kind of benefits can you achieve after this investment? See the Success Stories on the About TapRooT® page.

Would you like to learn about TapRooT® and hear first hand about what TapRooT® users are doing? Then plan to attend the 2-Day TapRooT® Course prior to the TapRooT® Summit and the TapRooT® Summit.

Your investment in improvement is safe because we guarantee all of these events!

Course Guarantee (last paragraph)

Summit Guarantee (bottom right of page)

Company Reports That Peanut Butter Recall to Cost $50 - $60 MILLION

Wednesday, February 28th, 2007

Have you noticed the empty shelves where Peter Pan and Great Value peanut butter used to be?

It has been recalled.

Another expensive food quality problem.

Kevin McManus, a TapRooT® Instructor and food safety expert, wrote an article titled:

Are You Hungry for TapRooT®

That is available at his web site: http://www.greatsystems.com

It seems that many food processors could used advanced root cause analysis to investigate recall problems. It would be even better if they were applying TapRooT® PROACTIVELY to find and fix the causes of the food safety/quality issues before they become recalls.

Note that one of the Saturday session at the TapRooT® Summit is a session for Pharmaceuticals Manufacturers and Food Processors to discuss quality improvement and improving manufacturing performance. If a Food Processor wanted to jump ahead in the performance improvement race, they could go to San Antonio and:

1. Attend the 2-Day TapRooT® Incident Investigation and Root Cause Analysis Course on April 23-24.

2. Attend the TapRooT® Summit on April 25-28. I think that one of these tracks would probably be the most applicable:

- Corrective Action Program Best Practices
- Lean, Process, & Quality Improvement Best Practices
- Proactive Improvement Best Practices

and then on Saturday attend the Pharmaceuticals Manufacturers and Food Processors Benchmarking session.

I don’t think you could find a better six days to get new ideas and best practices that one could use to prevent food safety issues. Why? Because these won’t be the same old industry sessions. They will be cross-industry best practices from around the world.

I hope to see quite a few food processing companies take advantage of this timely opportunity.

For more on the peanut butter recall see a Business Week/AP article at:

http://www.businessweek.com/ap/financialnews/D8NDRL380.htm

How Much Does a Quality Incident Cost?

Tuesday, February 27th, 2007

VW is recalling 790,000 vehicles that could have improperly installed break lights. Now that’s a quality incident.

If it costs just $30 per vehicle for the recall, the the cost will be about $24 million dollars.

How much proactive root cause analysis and corrective actions could you buy with $24 million?

Instead of waiting for problems to solve with reactive analysis, proactive analysis prevents problems.

For more on proactive root cause analysis, watch for the new TapRooT® Book to be released this Summer. Or attend a 5-Day TapRooT® Advanced Root Cause Analysis Team Leader Course.

For more about the recall, see:

http://www.cnn.com/2007/HEALTH/02/26/volkswagen.recall.ap/index.html

Customer Complaints? You Need Advanced Root Cause Analysis

Tuesday, December 12th, 2006

What do you do when you receive a customer complaint?

They are obviously (or are they?) a quality problem.

And they can get you bad press. (See the example at this link: http://hosted.ap.org/dynamic/stories/C/CT_SIKORSKY_COMPLAINTS_CTOL-?SITE=CTDAN&SECTION=NORTHEAST&TEMPLATE=)

Major customer complaints deserve a complete root cause analysis.

For advanced root cause analysis training that can help you dig into and solve quality problems that may cause customer complaints, see:

http://www.taproot.com/courses.php