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.
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.
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…
Whether doing it by hand or in our TapRooT® Software, what can go into the Rectangles that we call Events (Who did whats or what did whats that occurred during the timeline that you are investigating)?
Actions by the Operator, Mechanic, Manager, Vendor, Supplier, Contractor, Technician, Customer Service Rep, Engineer, Designer, Nurse, Doctor … as you can see the list is unlimited but understanding the who (we use job titles only) helps us to see if the who was setup for success prior or during the action he/she performed.
Caution ( … this may not be what you expected or have been doing)
Equipment Actions: Relay opened when energized, Butterfly valve stuck shut, I.V. bag port become blocked with debris, fuel gravity fed into container through piping …
Hint: If working with equipment, pull up the equipment and system functional diagram up immediately to help you map out the Events.
Chemical Process Actions: Catalysts heated up, hot mix heated up …
Transactional Process: Purchased order received by customer service, SAP sent late warning to warranty …
Hint: Yes, you can follow a piece a paper, hazardous material shipment.. that is handed off from person to person just like you would a person.
Hopefully, this should open up your investigation options even more! By the way, I even mapped out the actions of a horse and a monkey which was analayzed under Human Engineering.
For any successful process improvement implementation, Senior Leadership support and actual presence is necessary. Aurobindo Pharma’s Leadership presence in the early stages of the course and the questions that they asked their students directly is a clear indication that this first team of investigators have full support and expectations set.
Second requirement for success is to have cross utilization during investigations and learning between departments. From the lab, materials, shipping to QA, there was complete and thorough team building.
Finally, the Senior Leadership set expectations and future growth opportunities to include future training and possible multi-user intranet based software licensing. Based on building successes and return on investment.
It was a pleasure to teach and work with this group personally in Hyderabad, India.
If you have to perform Root Cause Analysis for regulatory, equipment and safety issues in India, but are not able to set up an onsite course like the Leaders of Aurobindo Pharma did, I suggest you go to your leadership and get commitment to attend the upcoming Mumbai 2-Day course in February. Seats fill up fast and getting funds authorized may take time so do not delay if you are ready to go World Class with your peers.
Go here to register for the 2-day http://www.taproot.com/courses.php?d=1709&l=1
See the public courses and root cause articles for India:
Pharmaceutical Company Receives FDA Letter for Bad Manufacturing Practices Including Inadequate Root Cause AnalysisSeptember 15th, 2011 by Mark Paradies
See the story at:
India Information Technology (IT) and TapRooT® Software Developers all in one room? If close to India, Here is Your Invite!August 24th, 2011 by Chris Vallee
When you need TapRooT® Root Cause Analysis Software implementation advice or have other technical IT needs, who do you call? Easy… our clients call 1.865.539.2139 and ask for Steve, Zach or Dan. When the IT experts here or at your place of business need help, what do they do for help? Simple, they map out the issue using TapRooT®’s SnapCharT® first and then find out where the equipment or human performance difficulty issue needs to be addressed.
Why tell you all this today you may ask? Because Dan Verlinde, Director of Information Technology & Software Development, and several U.S based and India based software developers will be attending our 5-Day TapRooT® Advanced Root Cause Analysis Team Leader Training in New Delhi this September.
New Delhi, India Sep 5 – Sep 9 Register
If you are the IT TapRooT® Software Lead based in or Near New Delhi, sign up for the September course before it is too late.
If today was Wednesday … what measurements (metrics) could be used to describe it:
1. There are 52 Wednesdays in the Calendar Year of 2012.
2. There were 53 Wednesdays in the Calendar Year of 1873.
3. Wednesdays make up 14% of the Days of a Calendar Year.
4. There are 9 letters in the word Wednesday: 2 e’s, 1 w, 2 d’s, 1 s, 1 n, 1 a and 1 y to be exact.
5. There are two syllables in the word Wednesday.
The point of my number parade? Simple, we can measure anything … but does it provide value or predictability? Are the numbers representative of what one is truly trying to measure?
In the Changing the Way the World Solves Problems book provided to all our TapRooT® students, there is a section titled A Guide to Improving the Use of TapRooT®. The tip today from this guide focuses on Topic 1: Measurements. With the first question being, has your company agreed on a reliable measurement system?
Why a measurement system and not standalone metrics that represent individual problems in individual departments? The answer is because no one person or one department works in true isolation. Measurements of money savings, defect reductions, tool repair or tool selection reported by one department may actually cause an increase of those measurements in another department. So no actual money saved for the company!
Developing a Reliable Measurement System starts with the developing and defining the fundamental components and rules for your company. I caution against generic one-fits all Systems developed outside of your company.
Measurement: An observable (observed either by human or equipment) behavior (behavior of equipment, people or process) that can be measured quantitatively or qualitatively.
Rules for Measurements:
- Only used to measure for what it was intended to measure. Nothing worse than using someone else’s numbers for your own needs just to find out it does not measure what you thought it did.
- Collected and Documented using the same method with the same types of tools (equipment, forms). Not sure of the consistency of your measurement collection process? Perform a Measurement System Analysis (MSA) on it.
Types Measurements (Just to mention a few):
- Human Resources
- Financial (Fringe or Burdened)
- Maintainability and Reliability
- Direct or Indirect Labor/Costs
Purpose for Measurements:
- Predictive Indicator- Can tell you what could happen before it happens. Note: No predictor is 100% correct but many are very reliable.
- Lagging Indicator- Too late! Good or bad news, it already happened but it is a necessary to know. Note that some Lagging indicators can be a leading indicator for another lagging indicator. For example, an increase in near misses can be a predictor of a severe incident if not corrected.
Measurement System: A system allows good measurements to produce good indicators. Of course it also allows junk in junk out, even with the best system in place. So to help define what a measurement system is or could be, answer these questions:
- Based on the measurements input, can you see the company “big picture” and can you then break down these indicators to their lowest input level?
- Are reports and graphs pulled from one central location to prevent duplication?
- Are measurements pulled from the same set of numbers to increase consistent trending?
- Is the system audited for consistency and accuracy?
Seems like a lot to make sure you know where your company is going and where it has been doesn’t it? Did I also tell you that you should also be able to translate all measurement indicators into company production and operation dollars? As the our book says, “dollars are the language and measuring stick of management.”
If this post gets you to think … “Why does this make so much sense and why did I not think of this before with the same perspective”?
If the answer is yes, then I have some options for you that appear once a year in a public setting this February:
Chris Vallee joined System Improvements in 2007 and is a Senior Associate, TapRooT® Instructor, and Investigation Facilitator.
Root Cause Analysis Tip: You Know How to Perform a TapRooT® RCA but Where Do You Target Your Resources?June 29th, 2011 by Chris Vallee
Let’s be honest, all companies want a good Return on Investment (ROI) on any investment. This is exactly why Mark Paradies and Linda Unger provide a section in our TapRooT®, Changing the Way the World Solves Problems book titled A Guide to Improving the Use of TapRooT®. The tip today focuses on Topic 2: Target Selection.
If you have set up good metrics to measure (Read these for more ideas on metrics: (Tip 1, Tip 2), you can start by looking for your Top Drivers in a Pareto Chart. The idea is that if 80% of your issues are caused by or correlated to 20% of a sampled set of categories, then start there first for more ROI. Review the Chart below and then read the cautions below:
1. “Never Ever Ever” define a category as “Miscellaneous” or “Other”! I promise you that it will always be in the Top Three every time.
2. When it comes to the y-Axis on the Chart, do not just use Cost as a measurement, also use Risk and Frequency. One near miss may not have cost any money but it could have killed someone. If you look at Cost or Frequency only, this would not show up as a Top Driver.
Another Quick Way to decide where to Target your resources is to use a Plot Map. Read more here as to how this map reduced illnesses from the water supply in certain areas.
Finally you may want to measure how accurate and precise your improvements have been. In earlier trending articles (1, 3) we introduced the Process Behavior Chart. Below is one more example of how to measure Risk Reduction using a scatter and bulls-eye chart.
1. The Center (Bulls-Eye) of the chart represents that the risk targeted has been eliminated.
2. Each subsequent ring of the target indicates risk mitigation at lower levels (the outside rings do show risk mitigation but not as strong as the inner rings).
3. The red dots indicate the actual risk level mitigated for each RCA performed with corrective actions implemented and verified for effectiveness (sounds like SMARTER technique from class don’t it?).
Looking at charts above, which two Charts would you be happy with and why?
To find out where to receive hands on training for the next TapRooT® Trending Course look here: http://www.taproot.com/courses.php#c7