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Archive for the ‘Quality’ Category

Root Cause Analysis Tip: Interesting Article in Quality Digest About Verifying the Effectiveness of a Corrective Action

Tuesday, June 23rd, 2009

Part of a root cause analysis is the development of an effective corrective action.

But how do you know if a corrective action was effective? Here’s an good article from Quality Digest that gives you some ideas…

http://www.qualitydigest.com/inside/fda-compliance-article/verifying-effectiveness-corrective-action.html

Job Opening: Uxbridge, UK - Elan Defense - Material Quality Coordinator - Needs Root Cause Analysis Skills

Saturday, May 16th, 2009

See:

http://www.thecareerengineer.com/Material-Quality-Coordinator-5399439.html?src=ILC-LatestHomePageJobs&attr=any

Trouble Trending in the Nuclear Industry

Thursday, May 7th, 2009

200905031631.jpg

I recently read 11 nuclear plant trend reports. Not one had a mathematically valid way to trend. (One did come close.)

These 11 nuclear industry trend reports are not unusual … They are typical of trend reports from various industries.

This makes one ask: “Why do so many companies have trouble trending?”

Let’s look at specific problems in the 11 reports.

First, many “trend” reports showed no trends. Three of the eleven reports didn’t even have a single graph. They were just discussions of incidents and audits in a particular quarter with discussions of “trends” with no data.

Most of the reports that had graphs used simple bar and line graphs. Bar graphs with no timeline don’t really show “trends.” They are best used to look for the Pareto Principle and help to identify the biggest problems to attack first.

One report tried to use a mathematically based approach. They used a c-Chart with limits based on 3 times the square root of the mean of the data. But c-Charts require independent data with a constant area of opportunity – which is unlikely for incident data.

The most common error made in trending reports (and by management) is looking at the number of problems in one quarter and comparing them to the next quarter. If the number of problems goes down – that’s a good trend. If the number of problems goes up – that’s a bad trend. They tend to use straight-line approximations to “project the future” (as in the example below).

200905031635.jpg

What’s wrong with this approach? Management starts reacting to noise rather than signals.

Some might say that there’s nothing wrong with trying to “fix things when they aren’t broke.” But they are wrong.

They don’t understand the cost of reacting to non-problems.

They don’t understand how employees get tired of the new improvement flavor of the week.

They haven’t thought about the negative cycle of blame, cover-up, and surprise that is all too common when major accidents occur.

What should people do? Where can they find out about the best practices in trending? First, they can read Chapter 5 of TapRooT® - Changing the Way the World Solves Problems. The new TapRooT® Book explains the problems with trending and the ways to implement best practices in performance measures and trending.200905031637.jpg

Would you like to go beyond reading? Then you should plan to attend this year’s Advanced Trending Techniques Course on October 5-6 in Nashville, Tennessee (just before the Summit).

What will you learn? First, you will learn why trending is needed and the basics of trending (including the proper way to apply Pareto Charts).

Second, you will learn the math behind Process Behavior Charts (the only chart you need to view trends over time). This math only requires addition, subtraction, multiplication, & division (no different¬ial equations).

Third, You will also learn special ways to use the charts to trend infrequently occurring accident data.

Finally, you will learn how to use your own trend data including how to improve the data and how to present it to management. Get more information about the course by clicking on the “Courses” button above.

200905031640.jpg

Root Cause Analysis Tip: Patient’s heart stopped twice in the Emergency Room… what was missed?

Wednesday, March 25th, 2009

200903201634

A patient suffering from pregnancy induced high blood pressure walks into an Acute Care Clinic 5 Day’s after giving birth with the following symptoms (1):

* Fatigue and weakness
* Rapid heartbeat
* Shortness of breath (dyspnea) when you exert yourself or when you lie down
* Reduced ability to exercise
* Persistent cough or wheezing with white or pink blood-tinged phlegm
* Swelling (edema) in your legs, ankles and feet
* Lack of appetite and nausea
* Difficulty concentrating or decreased alertness

The patient is sent home after a lung x-ray and with medicine to slow her heart rate down. Six hours later she is admitted to the Emergency Room by ambulance with the following symptoms (1):

* Fatigue and weakness
* Irregular heartbeat
* Shortness of breath (dyspnea)
* Persistent cough or wheezing with white or pink blood-tinged phlegm
* Swelling (edema) in your legs, ankles and feet
* Lack of appetite and nausea
* Difficulty concentrating or decreased alertness

The patient is dropped off at the front desk to answer questions because she is able to sit up and speak. Finally the patient is paralyzed in order to be examined and the staff realize that she is having Congestive Heart Failure.

Two heart stops later, admission to the ICU and after fiver years, my wife, Babette, is doing okay… still gets tired but she did not need a new heart nor did she receive brain damage from lack of oxygen.

So what does this have to do with Root Cause Analysis and what I teach today…..

There must have been something “Different” with this patient… There must have been a recent “Change” in how to diagnose Congestive Heart Failure….

We have talked about performing a Change Analysis before on this site and we teach this in our 5-Day TapRooT® Advanced Root Cause Analysis Team Leader and Equifactor® Equipment Troubleshooting & Root Cause Failure Analysis courses…. but what if you do not find a recent Change or Difference, how could you have prevented this from happening?

While the initial thought may have been these were abnormal symptoms (A Difference)…. the symptoms listed above are pulled directly from a well known medical clinic (1). Staff are trained to look for these issues and no Change was made recently in their processes.

So could you have proactively prevented my wife’s missed diagnosis and the findings listed below?

“Multivariable analysis showed that patients who presented to the emergency department with acute cardiac ischemia were more likely not to be hospitalized if they were women less than 55 years old.”(2) So is AGE enough of a a patient difference to understand what went wrong on January 5th, 2004?

The only major difference between an audit finding and investigation finding is timing and the severity of the outcome! In all our TaprRooT® training courses proactive auditing is covered…. but what is the difference between a great audit and just watching someone work to see what policies and procedures they broke?

Go Out and Look (GOAL) and perform a robust audit. Knowing what you know now, what would you look for when auditing an examination of a patient in an Acute Clinic or the Emergency Room? Where would you start? What would you look for?

What critical Near Cause Categories could occur during this process in the timeline from Acute care clinic > ambulance > ER front desk ER > ICU (just to mention a few)…

Misunderstood Verbal Communication?

Turnover Needs Improvement?

No Communication or Not Timely?

Within each of these TapRooT® Near Cause Categories are Root Causes. So what would a Good Near Cause Category and Root Cause Best Practice look like…. the opposite of our definitions. By looking for these best practices during an Audit, you will find problems in you current unchanged process before it is too late.

So while performing an audit what is better and why… a surprise no notice audit or and a scheduled audit with plenty of notice…… I would love to see guests to the weblog and our TapRooT® students answer the above question.

After all The only major difference between an audit finding and investigation finding is timing and the severity of the outcome! Why wait! Join us and other leaders in the industry in an upcoming TapRooT® training course to learn more about effective proactive auditing.
(more…)

The Cost of Poor Quality

Friday, February 13th, 2009

Just yesterday, I blogged about the continuing saga of the Georgia Peanut plant - yesterday the issue was whether management could potentially be prosecuted.  Today, the company filed for Bankruptcy…..how long will it be before they go under for good?

http://news.yahoo.com/s/ap/20090213/ap_on_bi_ge/salmonella_outbreak_bankruptcy

The cost of poor quality can vary, but it can even put a company out of business.  TapRooT® can help you avoid these problems.  Right now, the press and fear mongers are trying to convince everyone that there is no money for anything.  I say this is the perfect time to raise the bar and differentiate your business from the shortsighted competition.  Simply put, investing in quality is investing in the customer - if you think you cannot afford to, I say you cannot afford not to.  Just my opinion.

See you at a TapRooT® course in the near future - together, let’s improve the business community, one firm at a time. 

Which Expert is Missing from your Problem Solving Brainstorming Session?

Tuesday, February 10th, 2009

200902091632

Brainstorming is often successfully used to develop new ideas, increase employee moral and unfortunately… even to attempt to find Root Causes for problems. Lets start with the basics. Who should be sitting at the brainstorming table? When should brainstorming be used and more importantly when should it NOT be used? If you solve problems what can you use that has been successful?

So let’s start with roll call… say present if here:

Human Engineering Expert?

Procedure Expert?

Quality Control Expert?

Communication Expert?

Management Systems Expert?

Work Direction Expert?

Training Expert?

What… someone is missing? Who? Why would this matter you may ask? Let’s take a missing Training Expert. When is the last time a new training idea was suggested, developed and THEN handed off to the Training department to run with? Have you seen new training ideas getting stopped in their tracks because no one understood the process… after your brainstorming team invested all that time? After all, time is money. Why do we at System Improvements, Inc. think these are the right experts? Just take a look at our TapRooT® success stories and their companies’ return on investment and reduction of incidents.

One caution from experience, once you get the experts in the room you must also have a facilitator present to help the team keep the same perspective and reference. Try this if you don’t think so: ask everyone in a team to close their eyes and point North… which way do we go? TapRooT® has a way to solve arguments and to keep people on track, use our Root Cause Dictionary & Laminated Root Cause Tree. These tools will standardize your points of reference in your problem solving session.

When should brainstorming be used… Now that seems like it might be a tough question to answer, but it’s not. Use it when you first need to develop possible venture ideas, develop new ways to work a process or to communicate what others may have successfully done. Sometimes brainstorming can be used to develop corrective actions on GOOD problem Root Causes. System Improvements, Inc. has also developed a Corrective Action Helper® to use with our SMARTER technique. This guide includes best practice examples from multiple industries and includes references to allow you to dig even deeper.

When should brainstorming NOT be used… DO NOT use it to solve problems or to find Root Causes for problems. Why not you may ask? Brainstorming requires you to ASSUME that you know why a problem existed. Think about it, how many brainstorming sessions have you been in where you were called in as group for a company crisis… did it go a little like this:

“We are here today to solve the XYZ crisis. Write down your ideas on yellow stickies as to what the problem could be. We will affinitize these ideas and vote as a group on what the problem is and put a team on it to fix it.”

Whoa… how can you solve a problem when you don’t have the facts nor do you know the sequence of events of the problem you are attempting to solve? It CAN NOT be done from behind a table and you must GO OUT AND LOOK (GOAL)? If you are using brainstorming and other similar tools to solve your major issues and the problems continue to repeat or even get worse, then it is time to CHANGE. Look at our TapRooT® success stories and then talk to us at System Improvements, Inc. to see when the next Public class starts.

Security Incident with Computers for Houston Municipal Courts

Monday, February 9th, 2009

Is this an incident?

Houston’s Municipal Court are shut down for three days while crews scramble to eliminate a virus that infected hundreds of city computers.

The work, being performed by a contractor, will cost about $25,000.

Should they do a root cause analysis of this computer security breach?

To watch a news report on the virus incident, see the video below…

And what about a “quality of service” incident to those who showed up for court, only to be turned away?

Seems there is lots that could be learned by applying advanced root cause analysis.

Same Old Story - Didn’t Learn Before Major “Accident”

Monday, February 9th, 2009

The Houston Chronicle headline reads:

Trouble signs were ignored at peanut plant

Isn’t this always the case?

Can you ever remember a major accident that didn’t have precursors that could have been learned from?

Now, what can you learn from this about your facility?

Or will you follow in the footsteps of the Peanut Corporation of America?

Pca

Surgery Checklist Reduces Surgery Deaths

Thursday, January 15th, 2009

Eight hospitals reduced the number of deaths from surgery by more than 40% by using a simple 19-step pre-surgery checklist.

http://www.medicalnewstoday.com/articles/135487.php

The report in the New England Journal of Medicine says that if all hospitals adopted the checklist, they could save tens of thousands of lives and $20 billion ANNUALLY. 

This same article appeared in the January 15 edition of USA TODAY.  This article goes on to state that:

- Surgeons are good at making sure they do most of the things most of the time, but not very good at doing all of the things all of the time.
- An operation’s success depends far more on teamwork and communications skills than on an individual surgeon’s skill.
- The checklist takes about 2 minutes to complete.
- It is modeled on checklists used on the aviation industry.
- The checklist has nothing to do with high tech solutions, instead focusing on basic safety measures.

It is almost frustrating to read an article like this.  TapRooT® has been teaching these exact principles for 20 years, and now the World Health Organization funds a study that repeats exactly what our TapRooT® investigators would find if they had conducted their own investigation.  In fact, after reading the article, I’d swear the author had just attended a TapRooT® course.  You can scan through this article and attach the TapRooT® root causes directly to his individual statements.

Luckily, I’m more of an optimist.  This study proves that we can make a difference and save lives right now.  Even the most basic TapRooT® investigations have the opportunity to fnd and correct these types of relatively simple mistakes.  All we have to do is DO IT!

New England Journal of Medicine article:
http://content.nejm.org/cgi/content/full/NEJMsa0810119

Checklist (including video of proper use):
http://www.who.int/patientsafety/safesurgery/en/index.html

Is it safer to fly or to go to the hospital?

Tuesday, January 13th, 2009

US carriers have gone 2 years without a passenger fatality. Here is the story:

http://www.cnn.com/2009/TRAVEL/01/12/us.air.safety/index.html

As someone who worked for airlines for 27 years (the last 10 in safety and compliance) before joining System Improvements, I can attest to the professionalism of all the employees, from mechanics to pilots to operational folks and beyond.  Safety is ingrained in the culture of this industry; after all, the smallest problem can be devastating.  Congratulations to all the airline employees, suppliers, manufacturers, and air traffic controllers for getting it right over and over, day after day.

On the other side of the coin, medical mistakes have been blamed for thousands of deaths per year in the US.  The same best practices for human performance used by the airlines and countless other industries can be used to reduce this alarming problem. 

The Joint Commission http://www.jointcommission.org/AboutUs/ is working to address these issues, but the data clearly shows there is a long way to go. In the meantime, at least you can feel good about getting on an airplane, as long as you don’t eat the food!

Healthcare Professionals - take a stand and fight against these preventable errors!  Attend a TapRooT® course in 2009 - here is the schedule:

http://www.taproot.com/courses.php
 

Story tries to link the economy to safety performance….what do you think?

Monday, January 12th, 2009

Here is the story:

http://www.dailyadvance.com/news/state/as-economy-sinks-nc-workplace-deaths-rise-363528.html

Excerpts:

“Workplace deaths in North Carolina rose in 2008 after three years of
declines, and officials worry that the nation’s sagging economy is
partly to blame.”

“Labor observers worry that companies could be cutting corners on
safety, making their workplaces more dangerous. Labor Department
spokeswoman Dolores Quesenberry said training and safety measures are
often among the first things cut from budgets.”

I don’t know if the rise in deaths in this state is tied to the economy or not; however, I have seen and heard about safety measures being cut during trying times.  As safety professionals, it is our job to stand up for the employees and to rise up against the bean-counters (unless they cut us first of course!)

Don’t get caught in this trap!  Today’s economy requires that a business runs smoothly; cutting back on things like safety, environment, and quality is not the answer.  Take a stand - attend a TapRooT® course in 2009, be proactive, solve problems, and SAVE the company money.  Show management how your efforts contribute to the bottom-line.  Here is the schedule:

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

New Year’s Resolutions

Friday, January 2nd, 2009

Happy New Year everyone!

So that’s it - 2008 is in the history books and we are ready to start a new chapter.  Of course the first thing people always think about is resolutions, and this usually involves some type of bad habit!  For me, it is a diet (how original)! 

Besides those personal resolutions, what about our business lives?  Should we make a resolution for work as well?  I say yes, and here is a good example:

“My resolution for 2009 is to improve organizational performance (reduce fatalities, injuries, medical mistakes, production problems, equipment downtime, environmental spills, customer complaints, cost overruns, property damage, etc. etc.)”

That’s a great resolution, but how does one get there?  Why not start with a TapRooT® course in early 2009? 

See the schedule: http://www.taproot.com/courses.php

Oil spill report & Equipment problems

Wednesday, December 17th, 2008

When equipment fails, the equipment itself becomes a convenient target to affix blame; however, a good investigation will many times find that human performance problems led to the failure.  TapRooT® (and the Equifactor® module) will help you pinpoint these problems; why not enroll you and your staff in a course for 2009?  See the schedule for a three day course (or a 1 day Equifactor® if you have already had the two day or five day TapRooT® course) at http://www.taproot.com/courses.php?d=3 

Oil spill report:

http://www.gomr.mms.gov/PDFs/2008/2008-056.pdf

Excerpt:

“The investigation found that the lease operator had not performed the required annual cathodic protection (CP) inspection nor submitted the results of the inspection to the MMS and had allowed the CP of the pipeline to fall below standards of both MMS and National Association of Corrosion Engineers (NACE).  The failure to maintain adequate CP led directly to the pipeline corrosion, which caused the pipeline holes, and resulted in the pollution event.”  

53 rescued as ski tower collapses

Wednesday, December 17th, 2008

Hmm…..preventative maintenance and inspections? 

Not a good PR situation for someone hosting the Olympics.  Nevertheless, I’m glad there were no serious injuries.

     

      

AOL News
Last Updated: Wednesday, 17 December 2008, 06:50 GMT

More than 50 people were rescued from about 30 gondolas after a tower supporting the lift cables partially collapsed at Canada’s Whistler ski resort.

Police said there were no serious injuries at the resort in British Columbia, which is to host the alpine events of the 2010 winter Olympic games.

A resort statement said structural failure appeared to have caused the collapse.

Skier Graeme Bell said he was in a car that hit the ground, breaking the windows and allowing occupants to scramble out. Mr Bell said one man had a bloody head.

Another gondola hit a bus shelter, while two more were left dangling.

A crane was brought in to support the leaning tower and fire crews worked quickly to evacuate three cars that were the most in danger.

It took more than three hours to evacuate the 53 people stranded in about 30 gondolas.

Thirteen people were sent to the Whistler Health Care Centre, but all were released by late last night, health officials said.

The resort said in a press release that the gondola section where the incident took place is approximately 30ft above the ground.

“We are very thankful that no one was seriously injured in this incident,” the release said.

Here is a video of the rescue:

http://www.cnn.com/2008/WORLD/americas/12/16/canada.gondola.accident/index.html#cnnSTCVideo

Grey’s Anatomy not the whole story…………

Tuesday, December 16th, 2008

Interesting article - training, fatigue, and hand-offs are all discussed:

http://well.blogs.nytimes.com/2008/12/02/panel-calls-for-changes-in-doctor-training/#more-344

Healthcare professionals; how about a 2 or 5 day TapRooT® course for the New Year?  See course schedules at http://www.taproot.com/courses.php

 

USS San Antonio Repairs Complete - Heads Back Out to Sea

Saturday, November 29th, 2008

 Images 215*153 Uss San Antonio1126.Art Gfi2Vhjs.1 Uss San Antonio.13545208

If you read our previous article about equipment problems on the USS San Antonio, you may be interested that the repairs have been completed and the ship is headed back out to sea.

The repair team spent 25 days making repairs to poor welds and poorly supported piping that caused leaks in the engine lubrication system.

According to an Express-News article in MySanAntonio.com, Navy spokesperson Pat Dolan said:

The failures can be attributed to inadequate piping support, poor welding, material selection and insufficient quality assurance. They ended up putting in additional pipe support, going in and taking out in some cases whole sections of pipes and joints. I can’t tell you the blow-by-blow, what they did or repairs. I can tell you that’s in general what they did.

She also said the the Navy team that made the repairs was “… just returning from Bahrain so we don’t have the root-cause analysis complete yet.

I’ll translate this from Navy terminology … They haven’t decided who to blame yet.

Interesting Blog Post About Boeing 787 Problems …

Thursday, November 13th, 2008

Was the approach to finding the root causes of the Boeing 787 fastener problems adequate?

Read this blog entry that questions the results:

http://www.themanufacturer.com/uk/content/8718/Workforce_Training_is_Not_a_Quality_Management_System

Navy Times Reports Equipment Problem Aboard USS San Antonio

Wednesday, November 12th, 2008

Here I am in San Antonio reading about the USS San Antonio which has been laid up in Bahrain because major lube oil leaks.

 Xml News 2008 11 Navy Sanantonio 111008 Nt Lpd17Leak

What was I teaching today? The Equifactor® (equipment troubleshooting) piece of the TapRooT® System. What a coincidence.

A pdf of pictures of the problems is attached below.

Usssanantonio
(click to open)

A Navy spokesperson said:

… engineers are conducting a root cause analysis and making repairs to welds … some that require replacing whole sections of pipe.

The problems were documented in October and are cause for concern. The spokesperson said:

Any time lube oil is leaking, we take that very seriously,” she said. “If you have leaking oil, that could cause a fire.

Another quote from the story:

The extended layover in Bahrain is just the latest in a string of performance problems with the first-in-class ship that was delivered late and at $1.8 billion, $1 billion higher than planned. A July 2005 inspection report made clear the first ship of the LPD 17 class would have perpetual problems.

Inspectors found “poor construction and craftsmanship … throughout the ship,” and officials singled out problems with wiring. “Poor initial cable-pulling practice led to what is now a snarled, over-packed, poorly assembled and virtually uncorrectable electrical/electronic cable plant,” the report said.

For the complete Navy Times story, see:

http://www.navytimes.com/news/2008/11/navy_sanantonio_111008/

I wonder if they got a warranty?

Does the Lemon Law apply?

Blog Posting on How To React To A Mistake

Wednesday, November 12th, 2008

The blog posting on another site starts out with …

I was thrashed by my boss way back in 2001 for a minor mistake I did working on a project based on a very new technology. I literally had tears in my eyes after I was shouted upon, knowing that I had worked on the module for 18 hours at a stretch without taking a single break, learning the technology and getting job done. My mistake was minor, but the one my boss committed was major. He lost my respect.  Shouting was his way of reinforcing the belief that he was in charge. I moved on!

Another interesting case happened with one of my friends Alan who was a tech lead with a multi-national company. He had accidentally replaced the production database with an incorrect version leading to overall application failure. Alan knew that he would get a beating and probably may lose his job. While he was still preparing himself mentally for the eventuality, his manager approached him. He entered with a smile on his face and said “I know this is serious, but I am also sure you would do whatever it takes to correct this. Let us put our best and get this back on track”. Alan and his team worked overnight to correct it next morning and client really appreciated this in form of an encouraging email. A few days after this incident, the manager called Alan in the canteen to share a cup of coffee. It was then that the manager inquired about the root cause of such a mistake. The manager informed Alan that such mistakes should not have happened and that he needs to be careful in future.

Being more careful IS NOT a good corrective action. But I like the ideas in the rest of the article. To read the whole post, see:

http://qualsys.wordpress.com/2008/11/10/to-err-is-human-treating-people-when-they-make-mistakes/

What is the SPAC and is this Good Enforcement?

Tuesday, November 11th, 2008

 Nfs Nursinglink Attachment Images 0007 8809 Shutterstock 697993 Crop380W

Read this article about a recent nursing home incident and post-incident discipline:

http://www.nursinglink.com/news/articles/6093-nurse-pays-for-her-good-deed

Now think about this:

1. Was a complete root cause analysis performed?

2. Was discipline an appropriate corrective action?

3. Did performance improve as a result of using discipline as a corrective actions?

Leave your comments by clicking on the comment link below.

Thanks

Mark

Child Has Wrong Kidney Removed - Press Releases, News, Investigation - But They Didn’t Find Root Causes!

Friday, October 24th, 2008

I started reading about this sentinel event in the Irish Times:

http://www.irishtimes.com/newspaper/breaking/2008/1023/breaking47.htm

Then I visited the press release at the hospital’s web site:

http://www.olchc.ie/MediaRoom/

Next, the independent sentinel event report:

http://www.olchc.ie/MediaRoom/FileUpload,2132,en.pdf

And the policy for Correct Site Surgery:

http://www.olchc.ie/MediaRoom/FileUpload,2133,en.pdf

All very interesting.

Here are the root causes as listed in the report:

1. Delays in filing hard copy x-ray reports in the medical records, and lack of reference to an electronic
copy.
2. Patients are regularly admitted outside normal working hours.
3. Radiology is not normally sent to the ward or to theatre.
4. Formal consent is generally taken by surgeons who are not competent to perform the procedure.
5. The person taking consent for a procedure will not normally review imaging.
6. SpR hours and workload, and concomitant lack of planning for cross-cover.
7. The hospital has no site marking policy, or common practice.
8. The operation and planning of the parallel theatre list.
I think the report’s “root causes” were actually Causal Factors in TapRooT® terminology and that the independent report didn’t get to root causes or generic causes. I’m not sure if these are all the Causal Factors because I didn’t see enough information in the report to create a good SnapCharT®.

Instead of finding root causes, the independent investigation team jumped from Causal Factors to corrective action recommendations. These recommendations are based on the investigation team’s knowledge and biases. They may work … They may not.

Because the team didn’t completed a real, advanced root cause analysis and because the odds of a reoccurrence are so low, we may never be able to tell if the team’s recommendations will solve all the problems that caused this tragic sentinel event.

One last comment … Perhaps the most amazing fact is that they think they found root causes when they really did not. And these are the experts brought in for that purpose…

Job Opening: GE - Houston, TX - Process Quality Engineer with Root Cause Analysis Skills

Tuesday, August 26th, 2008

See:

http://www.gecareers.com/GECAREERS/GECControllerServlet?actionid=90001&checkFlag=&Theme=us&Job=832609

Error in London Tube “Oyster Card” System To Be Analyzed To Find Root Causes

Wednesday, July 30th, 2008

A spokesperson for TransSys said: “Steps are being taken to ensure that this does not happen again and we will undertake a full root cause analysis.”

For more information see:

http://www.hastingsobserver.co.uk/latest-london-news/Oyster-card-tube-glitch-resolved.4326652.jp

Root cause analysis is being applied to more and more kinds of problems. Do your problem solvers need advanced root cause analysis training? See:

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

TapRooT® User Best Practices - Jack Frost - Proactive Root Cause Analysis of Audits

Tuesday, July 15th, 2008

About 100 TapRooT® Users broke into tables of about 10 people and discussed their best practices. Each table selected a representative to share the table’s pick for its best Best Practice.

Below is a .wmv video of a Jack Frost (of Hess in the UK) presenting an idea about using root cause analysis proactively to improve audits.

Jackfrost
(.wmv format)

What I learned at the 2008 Summit

Monday, July 14th, 2008

Dscn0088 2

I was so busy at the 2008 Summit that I really didn’t have a chance to take a break from Sunrise to Sunset.

That’s why I didn’t provide minute to minute reporting on what I was learning at the Summit - I just didn’t have a chance to write.

I did take some notes and I thought that readers might be interested in what I learned. Therefore, I will share my “A-Ha’s” here for everyone to read.

1. I learned from Darby Allen that 5-10% of all profits are consumed by the costs of accidents and incidents. The costs include hidden costs. For example:

  • Fines
  • Legal
  • Investigation
  • Productivity Loss
  • Retraining
  • Lost Production/Missed Orders
  • Sullied Reputation
  • Hidden Equipment Damage

2. I learned from Dave Prewitt that senior management needs a single source (a single database) that has all failure data and costs in it. This includes audit findings. That senior management can then use the data to build an organization that is resistant to disaster because they proactively ensure that systems are safe.

3. I learned from Lt. Col. Hayles that big organization naturally tend to cover up senior management failings and look for scape goats when big things go wrong. That this is a natural part of “protecting the mission of the organization”.

4. I received lots of good ideas about TapRooT® and the TapRooT® Software from the TapRooT® Advisory Board Meeting.

5. I really enjoyed the great people at the Summit and had a wonderful time at the Reception/Birthday Party where I got a chance to catch up with two old friends - David Busch and Kevin O’Connor.

6. I learned from Carolyn Griffith that the UK Rail Accident Investigation Board spends 7 months training one of their new investigators. Also, that a “no blame” policy is a major part of their investigations.

7. I heard many user best practices at several best practice sharing sessions including the TapRooT® User Best Practices Session run by Linda Unger and Michele Lindsay. I’ll try to do a separate write up of these later.

8. I learned from Chris Vallee (Six Sigma Black Belt and TapRooT® Instructor) that SnapCharT®s and Swim Lanes can be combined into a powerful Lean/Six Sigma tool.

9. That even though I had studied the accident at Three Mile Island extensively, I could learn much more by listening to an operator who was at the panel (Ed Frederick).

10. I learned from Marcia Wieder that dreams and visions are similar and that fear is the biggest roadblock to achieving your dreams (vision).

11. That I need to practice if I am going to play golf!

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I also learned so things in general about the Summit that others should know about…

1. That there were many outstanding sessions that people told me about (and that I wanted to attend) but that I couldn’t go to. Therefore, bring several people from your facility to cover all the applicable sessions that you want to learn from.

2. That you should come early and stay late. This helps you learn more.

Start by attending one of the many pre-Summit courses.

Next, come down early in the morning and have a leisurely breakfast while networking with other participants.

Don’t plan to leave early. Plan to stay over Friday night and leave Saturday morning.

3. That people love to share best practices. We had 10 Best Practice sharing sessions at the 2008 Summit that were focussed on allowing participants to share their knowledge with others. These were some of the highest rated sessions of the Summit because the calibre of the attendees at the Summit is so exceptional.

4. That people love to be inspired. Speakers that inspire are always highly rated. Heinz Bloch, Marcia Wieder, Nikki Stone, and Beverly Chiodo inspired their audience and helped people leave the Summit energized to make a difference when they returned to work.

5. That even with a crowd that is as enlightened at people at the TapRooT® Summit, it is hard not to blame people for mistakes. This became apparent after Lt Col Hayles talk. Some of the people I spoke to just could get by his mistake when he pulled the trigger in a friendly fire incident. They could see how he was set up for the accident by factors beyond his control. And that to prevent future friendly fire accidents, you must go beyond “being more careful next time.”

6. That a hot room for one is a cold room for another. Temperature is an individual preference.

Here are some things I already knew, but were reinforced by the Summit:

1. We have great clients that are industry leaders. I’m always impressed by the discussions we have and how willing participants are to share their best practices.

2. I have a great staff that knows what they are doing, plans well, and handles unexpected changes with panache (style, grace, and a flair for excellence).

3. That even the best in any industry can learn from others. Even the best companies can improve.

4. That even companies with the most to learn, have best practices that others can learn from.

5. That some of the most eye opening lessons come from outside your industry (if you can translate from their terminology to yours).

6. That having a good time and learning are not mutually exclusive activities.

7. That TapRooT® really is an exceptional root cause analysis tool that is changing the way the world solves problems.

8. That EVERY facility and company that uses TapRooT® should have someone at the Summit. We guarantee that what you learn will produce a return on investment at least 10 X the cost of your attendance or you get your money back. So start planning to attend in 2009!

Bloomberg Financial Reports Chinese Shipyard Crane Accident Could Cause Business Losses/Gains in Shipbuilding Industry

Tuesday, June 3rd, 2008

What happens if an accident causes you to not be able to meet production commitments? Your customers go elsewhere. At least that’s what a Bloomberg Financial story implies. See:

http://www.bloomberg.com/apps/news?pid=20601080&sid=aHkVUrWJmA0M&refer=asia

Would you call losing a customer an incident?

Tuesday, May 13th, 2008

Why do I ask this you may wonder? In today’s world “keyword’s” help internet users find what they need…. sometimes. However, many times “keyword” searches limit your field of opportunities, regardless of what the meaning or purpose of the word may represent. So continuing down this train of thought, would you consider losing a customer an incident?

Oxford’s definition of Incident:

An event or occurrence : several amusing incidents.
• a violent event, such as a fracas or assault : one person was stabbed in the incident.
• a hostile clash between forces of rival countries.
• ( incident of) a case or instance of something happening : a single incident of rudeness does not support a finding of contemptuous conduct.
• the occurrence of dangerous or exciting things : the winter passed without incident.
• a distinct piece of action in a play or a poem.

The TapRooT® definition of Incident:
• The reason the investigation is being conducted and defines the investigation scope
• The incident usually the most serious event that took place

So would losing a customer be a “serious event”? What if you had a customer complaint and still have a chance to keep from losing the customer? I don’t know about you, but I want to keep my customers. By defining the possible loss of a customer as a significant incident what should your next step be? Think TapRooT®, a root cause analysis system and training that helps solve problems both reactively and proactively. The next step is to find out where to learn about TapRooT®:

1. TapRooT® Summit
If you want to learn how others in numerous industries have applied TapRooT® to resolve customer and product issues in oil refining, oil drilling, bio and medical manufacturing, medical care, aviation (service and manufacturing), nuclear regulatory agencies, engineering companies, chemical manufacturing, governmental agencies…. and numerous others, the TapRooT® Summit in June may be your answer. Click on Summit on www.taproot.com to select a topic track that fits your business needs.

2. TapRooT® Public Courses

Meet other industries in a our public courses as you learn the way to perform a solid TapRooT® investigation for any type of incident. Click on Courses on www.taproot.com for a location near you.

3. TapRooT® Onsite Courses

Let us come to your company and train your employees, supervisors, and managers in house. Call us at 865.539.2139 for quotes.

Job Opening: Bothell, Washington - Senior Quality Engineer with Root Cause Analysis Experience

Monday, May 12th, 2008

See:

http://jobs.nwsource.com/careers/jobsearch/detail/jobId/9166543/viewType/rss?rssref=stbiz

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

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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.

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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