This article in the Houston Chronicle about and FDA audit and problems left unsolved at Blue Bell Ice Cream should convince people that thorough root cause analysis and implementation of effective corrective actions is needed to prevent business disasters.
Find out how TapRoot® can help you solve problems by reading this link:
I read an article in the Houston Chronicle about failed corrective actions at Blue Bell® Ice Cream.
It made me wonder:
“Did Blue Bell perform an adequate root cause analysis?”
Sometimes people jump tp conclusions and implement inadequate corrective actions because they don’t address the root causes of the problem.
Its hard to tell without more information, but better root cause analysis sure couldn’t have hurt.
Find out how TapRooT® Root Cause Analysis can help find and fix the root causes of problems by reading about TapRooT®’s history at:
Tune in to this week’s TapRooT® Instructor Root Cause Analysis Tip with Chris Vallee. He shares a great process quality tip and news about his upcoming Process Quality & Corrective Action Track at the 2015 Global TapRooT® Summit, June 3-5, 2015 in Las Vegas, Nevada!
Was this tip helpful?
Check out more short videos in our series:
Equifactor® – Are You Using it to Prevent Equipment Failures? (Click here to view tip.)
Be Proactive with Dave Janney (Click here to view tip.)
Conduct Real-Time Peer Reviews with Mark Paradies (Click here to view tip.)
What Makes a World-Class Root Cause Analysis System with Ken Reed (Click here to view tip.)
Caution: Watching this Video can and will make you laugh…… then you realize you might be laughing at…
… your own actions.
… your understanding of other peoples actions.
… your past corrective or preventative actions.
Whether your role or passion is in safety, operations, quality, or finance…. “quality is about people and not product.” Interestingly enough, many people have not heard Dr. Deming’s concepts or listened to Dr. Deming talk. Yet his thoughts may help you understand the difference between people not doing their best and the best the process and management will all to be produced.
To learn more about quality process thoughts and how TapRooT® can integrate with your frontline activities to sustain company performance excellence, join a panel of Best Practice Presenters in our TapRooT® Summit Track 2015 this June in Las Vegas. A Summit Week that reminds you that learning and people are your most vital variables to success and safety.
To learn more about our Summit Track please go to this link. https://www.taproot.com/taproot-summit
If you have trouble getting access to the video, you can also use this link http://youtu.be/mCkTy-RUNbw
Many people know how successful TapRooT® is at stopping safety incidents. But I had a potential TapRooT® User call me to ask:
“Can TapRooT® be used to solve quality issues?”
I was surprised by the question. Of course, the answer is YES!
We’ve had people using TapRooT® to solve quality problems ever since we invented it. In our first consulting job back in 1989, we used TapRooT® to solve engineering and construction quality issues.
Why didn’t this potential TapRooT® User know that TapRooT® could be applied to quality issues?
The only answer was … We had not told him!
Quality issues, just like safety issues, are mainly caused by human errors. And TapRooT® is excellent at helping people find the correctable root causes of human errors.
Why does TapRooT® work on all kinds of problems (including ones that cause quality issues)? Because TapRooT® doesn’t care what the outcome of an error is. TapRooT® is looking for the correctable cause (or causes) of the error.
For example, an operator working in a factory may open the wrong breaker and stop the wrong piece of equipment. When he makes this mistake, he doesn’t know if the outcome will be a safety incident, a maintenance headache, an operations problem, or a quality issue. He wan’t planning on making the mistake and he certainly wasn’t deciding what kind of outcome his mistake would result in. And fixing the reason for his mistake will stop the problem no matter what outcome occurred after the error.
That’s why the examples in our standard 2-Day and 5-Day TapRooT® Courses apply not only to safety, but also to quality, maintenance, operations, and even hospital patient safety issues.
So if you are wondering if TapRooT® would work for the type of issues that your company faces, the answer is YES!
OSHA General Duty Clause Citations: 2009-2012: Food Industry Related Activities
Doing a quick search of the OSHA Database for Food Industry related citations, it appears that Dust & Fumes along with Burns are the top driving hazard potentials.
Each citation fell under OSH Act of 1970 Section 5(a)(1): The employer did not furnish employment and a place of employment which were free from recognized hazards that were causing or likely to cause death or serious physical harm to employees in that employees were exposed……
Each company had to correct the potential hazard and respond using an Abatement Letter that includes words such as:
The hazard referenced in Inspection Number [insert 9-digit #]
for violation identified as:
Citation [insert #] and item [insert #] was corrected on [insert
Okay so you have a regulatory finding and listed above is one of the OSHA processes to correct it, sounds easy right? Not so fast…..
….are the findings correct?
….if a correct finding, are you correcting the finding or fixing the problems that allowed the issue?
….is the finding a generic/systemic issue?
As many of our TapRooT® Client’s have learned, if you want a finding to go away, you must perform a proper root cause analysis first. They use tools such as:
o SnapCharT®: a simple, visual technique for collecting and organizing information quickly and efficiently.
o Root Cause Tree®: an easy-to-use resource to determine root causes of problems.
o Corrective Action Helper®: helps people develop corrective actions by seeing outside the box.
First you must define the Incident or Scope of the analysis. Critical in analysis of a finding is that the scope of your investigation is not that you received a finding. The scope of the investigation should be that you have a potential uncontrolled hazard or access to a potential hazard.
In thinking this way, this should also trigger the need to perform a Safeguard Analysis during the evidence collection and during the corrective action development. Here are a few blog articles that discuss this tool we teach in our TapRooT® Courses.
Monday Accident & Lesson NOT Learned: Why Do We Use the Weakest Corrective Actions From the Hierarchy of Safeguards?http://www.taproot.com/archives/28919#comments
Root Cause Analysis Tip: Analyze Things That Go Right … The After-Action Review
If you have not been taking OSHA Finding to the right level of action, you may want to benchmark your current action plan and root cause analysis process, see below:
BENCHMARKING ROOT CAUSE ANALYSIS
Look over recent FDA Warning Letters (http://www.fda.gov/iceci/enforcementactions/WarningLetters/default.htm) to medical device manufacturers, and you will see that about a third of them are issued because of failures of CAPA (Corrective and Preventive Action programs).
The FDA expects medical device manufacturers and drug makers to find the root causes of quality issues, effectively fix them, and monitor them to make sure that the fixes worked.
A key part of a CAPA program is effective root cause analysis. Without effective root cause analysis, problems tend to repeat – and the FDA definitely doesn’t like repeat problems.
What makes effective root cause analysis? That’s a question we’ve been dedicated to answering for over 25 years. We designed the TapRooT® System to include tools to help guide investigators to the root causes of human performance and equipment reliability issues and find effective corrective actions to stop repeat problems from occurring.
Want to see how TapRooT® can help your company find and fix the root causes of quality issues? Then I would recommend attending one of our public 5-Day TapRooT® Advanced Root Cause Analysis Team Leader Courses. See the upcoming public course schedule by CLICKING HERE.
Don’t be afraid that the TapRooT® System won’t work at your company. Our training is guaranteed:
Attend this course, go back to work, and use what you have learned
to analyze accidents, incidents, near-misses, equipment failures, operating issues, or quality problems.
If you don’t find root causes that you previously would have overlooked and if you and your management
don’t agree that the corrective actions that you recommend are much more effective,
just return your course materials/software and we will refund the entire course fee.
It’s that simple. We know TapRooT® will work for you because we’ve seen it work at so many companies in so many industries including pharmaceutical and medical device manufacturers. See success stories from multiple industries at:
But don’t wait. You can’t afford a major finding adverse to quality and a warning letter. And you don’t want to have the course you want to attend fill up before your register (seats are limited in each class). Register today and start applying TapRooT® to improve performance and avoid quality incidents.
Watch two children explain their morning routine using a process flow chart and a control chart.
If you do not have a knowledgeable kindergartner hanging around to help you, I would recommend attending the following this April during our TapRooT® Summit Week:
Advanced Trending Techniques
TapRooT® Quality/Six Sigma/Lean Advanced Root Cause Analysis Training http://www.taproot.com/taproot-summit/pre-summit-courses#TapRooTSixSigma
Process Quality and Corrective Action Programs
Material found in a doughnut, see the initial indications from the KAKE media article below. A child is in a hospital bed at an Army Hospital after he took a bite of a glazed cake doughnut from a large retailer bakery. His mother says that the child said the doughnut tasted crunchy and then he chipped a tooth. “There were pieces of black metal, some of them looked like rings, like washers off of a little screw, some of them were black metal fragments, like real sharp pieces,” says the mother. The mother says that the child complained he had abdominal pains after swallowing the objects from the doughnut. Read the article here. The retailer spokesperson said the company’s food safety team is looking into the incident, reaching out to the doughnut supplier and trying to figure out what happened. Now what? Is this a safety or quality issue or both? If you were the retailer what would you do? Would you quarantine the doughnutt and ask for access to the material found in the stomach? Would you be allowed? If you were the doughnut supplier what would you do? Would you look for similar batches and quarantine them? Would you inspect the batches or turn them over to the supply? Would you be allowed? If you were the doughnut manufacturer what would you do? Would you inspect the equipment used for this batch? Would you look for facility work order reports already completed or reported? For all 3 parties, would you work together as one team to resolve the issue? What if you could not find any evidence on your side of missing parts? Everything just discussed would be part of the analysis/investigation planning stage. The first step of our TapRooT® 7 step investigation process. To learn more about what you would do following a problem, here are a few articles to learn more about are process and courses available. What is Root Cause Analysis? Root Cause Analysis Tip: Why Did The Robot Stop? (Comparing 5-Why Results with TapRooT® Root Cause Analysis Results) Our public course schedule
I know, it is too early for Friday’s Joke of the Day, but I could not help it. I saw this posted recently and had to share.
As you are laughing, look into your tool cabinet and tell me that you do not have these 2 items in it.
Now if you want to know how to troubleshoot equipment the right way to find the right what’s and why’s and want an Individual TapRooT® Software License (comes with the course), then join us at one of our Equifactor® courses.
Here is the current schedule: http://www.taproot.com/store/3-Day-Courses/
I’ll bring my WD-40 and Duct Tape for the classroom equipment.
What are the risks of setting a circuit breaker without knowing why it opened?
I just saw this local news article about a father teaching his daughter about the circuit breaker panel in their house after a ceiling fan stopped working. End result….. House on fire. Read more here.
With eighteen years in aviation and having worked on the C-141 Aircraft, this incident brought to mind the wrong pump replaced and reseting the circuit breaker during testing explosion. Read more here.
There are additional ways to gain equipment troubleshooting experience without starting a fire. The easiest way is to attend one of our upcoming Equifactor® Course coming up in your local area. See the schedule here: http://www.taproot.com/store/3-Day-Courses/
With community protests after losing school aged loved ones, the Indian Government is closing in on suspected causes to include suspects. But is this a sign of Systemic Food Quality Control or as TapRooT® calls them “Generic Causes”? Will the nature of the investigations detour looking for Generic Causes by looking for blame instead?
Read below and ask, how would this be investigated or analyzed if it were in your hometown? What would be the response of the lunch cafeterias and Food on Wheels programs for the elderly and sick?
In a months time…..
23 students in the southwestern coastal state of Goa were treated at a hospital after they got sick at lunch
23 students died and 25 people were hospitalized from food poisoning after a school lunch in northern India’s Bihar state
Schoolchildren falling sick after drinking contaminated water from hand pumps continued for the third consecutive day on Saturday with at least 35 more students taken ill in different parts of Bihar.
Arrests made in two of incidents with possible cause being insecticide poisoning; the water pump incident possibly criminal intent and the Bahir lunch room incident due to possible negligence. The Goa incident not so clear in details yet.
Due to fear, large lunch producers temporarily shut down their lunch kitchens resulting in children not getting their mandated free lunches during school.
See more at this link:
Whether in the medical device, pharmaceutical or the food manufacturing industry, a company usually has had many violation corrective action chances before they get a consent decree of permanent injunction. At this point a third party reviews current deviations and often identifies a weak or non-existent root cause analysis program.
Now don’t get me wrong, this is often when our TapRooT® Root Cause Process gets recommended as a possible option and we gain a new client. However, I would prefer working with an FDA regulated company to develop effective corrective actions before they get in trouble. Or at least when they get their first FDA Finding.
Often FDA findings are found by an external audit. To remain independent, the auditor turns over the findings through proper protocol and the company involved must provide proof that the causes were found and that the corrective action is effective. So if this protocol is followed, how did we get to a permanent injunction? Can the repeat findings be purely an Enforcement Needs Improvement Root Cause for policies not followed?
I suggest Enforcement needs improvement is not the only problem. To find out what your company might be missing in your RCA process. Find a course close to you and send one of your key quality or safety problem facilitators. Here is our upcoming courses link: http://www.taproot.com/store/Courses/
To get you thinking about possible gaps in your root cause analysis program, view this presentation given at our 2012 TapRooT® Summit. http://www.taproot.com/content/wp-content/uploads/2012/02/RileyandGorman.pdf
Then check out the quality track in the upcoming 2014 Summit in April. http://www.taproot.com/products-services/summit
Why Do People Have Problems Finding Root Causes? Read this Article – Under Scrutiny – from Quality Progress…February 25th, 2013 by Mark Paradies
Do you have problems finding the root causes of quality problems, safety incidents, or mechanical failures? It could be becuse of the root cause analysis tools you have chosen to use. Some tools have inherent weaknesses that are “built in.”
The article attached below (as first appeared in Quality Progress, the flagship magazine of the quality professional society ASQ), explains why some techniques commonly recommended for root cause analysis (like 5 Whys) will cause problems when applied by people in the field.
(click the link above to download the article)
Once you finished reading about the limitations of 5-Whys and Cause-and-Effect, sign up to learn about the advanced root cause analysis system that was intelligently designed to avoid those problems … TapRooT®.
Healthcare Scandal in UK – Calls for Major Improvements in Patient Safety and Criminal Prosecution of “Wrongdoers”February 24th, 2013 by Mark Paradies
Here’s a link to one of many stories about the “scandal” at UK hospitals in the Midlands:
The story says that “…up to 1,200 patients are believed to have died between January 2005 and March 2009 as a result of poor care at Stafford hospital.”
Here’s a link to the Executive Summary of the report referred to in the article:
Here’s a page where you can download the entire report:
The reports are extensive and I haven’t yet been able to wade through them (many volumes and 290 recommendations).
Here’s a press conference by the Chair of the Inquiry, Robert Francis QC:
The problems reported certainly do seem shocking. The problems are obviously systemic (generic) and seem to be related to the organization. The call for culture change seems obvious, but how to change the culture will be difficult. The problem for patients is the lack of choice (there is only one NHS) so that patients can’t “vote with their feet” when the standards of care become substandard.
The popular press and political outcry is calling for increased regulation and criminal prosecution of those who violate the rules. This seems close to the standard blame game and may succeed temporarily until the increased scrutiny eventually succumbs to complacency. This seems common in organizations with a monopoly on a certain service or product.
It seems to me that competition from hospitals trying to win additional patients would be the ultimate culture change recommendation. However, it is unlikely that this approach could be taken since the UK has had a single national service for so long.
Being in the UK when the story was receiving so much press, I was constantly being asked about how one would find the root causes of patient safety relayed problems. Of course, I described how healthcare organizations in the US use TapRooT® to investigate sentinel events. In the US, patient safety is becoming a competitive advantage – a way that hospitals may compete for patients.
What does your hospital do to ensure the highest standards of patient safety? Does your root cause analysis find and fix the root causes of patient safety problems? Does your management require advanced root cause analysis and insist on the implementation of effective corrective actions to sentinel events? Can you show the improvement in patient safety through the use of advanced trending tools?
Those interested in improving patient safety should consider attending the Improving Healthcare Quality and Patient Safety Track at the 2013 Global TapRooT® Summit in Gatlinburg, TN, on March 20-22. For more Summit information see:
And for the track’s detailed schedule, see:
and click on the button on the left for the track specific schedule.
For those in the UK, changes as great as those described will be difficult and take tremendous effort. I wish you luck but advise you that thorough advanced root cause analysis and effort will be required on a continuing basis if progress is to be made.
Based on client’s request, we have scheduled our ONLY Public India 5-Day TapRooT® Advanced Root Cause Analysis Team Leader Training for April 22 – April 26.
For those not familiar with the course, it includes the TapRooT® single user software (unless attendee’s company has a network software license), TapRoot® book, Corrective Action Helper®, Root Cause Dictionary & Laminated Root Cause Tree, Course Workbook.
Course Fee which includes a software individual license for each student is only $2,395 USD. Here is the registration link: Register
Please register 30 days prior to the course if you need a quote first to send to your billing department. Anything within 30 days or less must be paid for during registration. All course seats must be paid for prior to the course to hold the seat and attend the course.
We look forward to seeing our repeat clients and new clients in our only 5-Day public India course for 2013.
Take 2 minutes from your afternoon to learn from TapRooT® Instructor/ Six Sigma expert Chris Vallee. He’ll highlight what you’ll learn when you attend the Improving Quality & Corrective Action Programs track at the 2013 Global TapRooT® Summit.
Are you interested in attending our Summit? Register today!
Visit our 2013 Global TapRooT® Summit page for more information.
A recent article about a drug manufacturer quality problem said:
“Root cause analysis isn’t new, but it is one of the most often misunderstood quality processes drugmakers must master. In fact, inadequate root cause analysis is one of the FDA’s most common findings during an inspection.”
It then says they can send you a booklet to learn how to perform root cause analysis.
A booklet? You must be kidding. For something as important to pharmaceutical quality, would you depend a booklet?
Why not check out the techniques used by industry leaders around the world – TapRooT®.
For public course information see:
Or drop us a note to set up a course at your site.
In our 5-Day TapRooT® Advanced Root Cause Analysis Team Leader Training Course and in our TapRooT® book, TapRooT® Changing the Way the World Solves Problems, we introduce the Critical Human Action Profile (CHAP) tool to help collect more information to analyze any type of problem at the process task level. I like to call this looking at a problem at the 1 foot level as opposed to many investigations that analyze their problems at the 100,000 mile view only.
The tip here, however, is “why wait for a problem to use CHAP?”
Identify, Evaluate and Improve before it is too late!
Using a very over simplified list of procedure steps on How to Remove a Fuel Pump, found on the internet, I would like to show you how to use CHAP proactively to improve Safety and Quality during a task.
WARNING: The steps listed in the demonstration example below on removing a fuel pump shall not be used. They are incomplete and not necessarily accurate.
Where to start? First off you already perform JHA, AHA, JSA, Observations…. So Going Out and Looking (GOAL) should not be new or require a lot more additional resources. The difference is that you will be utilizing your resources more efficiently.
1. Start by identifying a task performed by employees that are critical to:
a. Customer/client satisfaction
b. Product Quality
c. Project Timeliness
d. Employee Safety
e. Customer Safety
f. Environmental Exposure
2. Once the task is identified, list the steps to be performed like listed in the image below.
Note: Do not forget to use the Basic Cause Category Procedure in our TapRooT® Root Cause Tree to look for missing best practices as well when listing the steps.
3. Identify each step of the task that is critical to the items listed in step 1 criteria of this article.
Which steps listed above for the fuel pump removal do you think would be listed as critical?
4. For each critical step in the task perform a CHAP Profile.
Note: For each of the items listed below, do not forget to include the Best Practices listed under the Human Engineering Basic Cause Category in our TapRooT® Root Cause Tree.
As an ex-aircraft mechanic and a “sometimes gotta work on my own car” mechanic, I have in the past borrowed or made some of the tools pictured below. The questions remain:
Bad Access by Design?
Or a little bit of them all?
Finally, ever have one of your modified tools bite you back? Share your stories in the comment section.
Job Opening: USA – Alcoa – Quality Technician – Needs Root Cause Analysis and Corrective Action Development SkillsJanuary 17th, 2012 by Mark Paradies
Job Opening: Houston, TX – Champion Technologies – Global QHSSE Quality Specialist II – Needs TapRooT® Root Cause Analysis SkillsJanuary 13th, 2012 by Mark Paradies
Karen Migliaccio has done a tremendous job setting up this first TapRooT® Summit Quality Track. From cross industry representatives to demonstrating field successes all the way up to company process changes, you will find this Summit Week Track interesting and applicable.
TapRooT®; Implementation Success Stories:
Successful Implementation of TapRooT® at Steris (Kevin McManus)
High Quality TapRooT® Implementation (Dennis Osmer)
Using the Baldrige Criteria to Achieve Performance Improvement (Kevin McManus)
Root Cause Analysis of Quality Problems:
Challenges in Biotech Quality Root Cause Analysis (Michael Gorman)
Root Cause Analysis of Incidents Occurring in the Pharmaceutical
Industry (Debbie Riley)
CAPA in Quality: The Strong and the Weak (Karen Migliaccio)
Quality Initiatives That Lead To Continuous Improvement Efforts (Bryan
Using a Quality Plan to Drive Improvement (Zena Kaufman)
The 7 Secrets of Incident Investigation & Root Cause Analysis (Mark Paradies)
Designing Your Continuous Improvement Program (Kevin McManus)
How Pfizer Achieves Operational Excellence (Gerry Migliaccio)
Planning Your Improvements
To read more about each session see:
Then select the Quality and Corrective Action Programs Track.
But there’s more!
Before the Summit we have a special nTapRooT® Root Cause Analysis Course focused on finding the root causes of quality issues.
When you attend both the pre-Summit course and the Summit, you save $200 off the course fee.
Just click on the link below for more information…