Author Archives: Chris Vallee
After Mark Paradies presented a talk on root cause analysis at the 2016 PDA/FDA Joint Regulatory Conference, a question was asked,
“How can we use TapRooT® Root Cause Analysis specifically to help solve “biological” driven problems that occur during biopharmaceutical product processing?”
The group had many general questions during his talk titled, “Identification of True Root Cause – and Impact to the Quality System,” and liked the points that he made. The question above however made me wonder why some industries or some industry-specific issues appear more complex than others when it comes to problem solving.
We use Safeguard Analysis to help identify the factor hazard/safeguards/target during our TapRooT® Root Cause Analysis. We look for errors of loss of control in these factors to find if these changes impacted the big problem that we are investigating. We also look for these changes formally by using a Change Analysis Table, taught in our 5-Day Courses. The linked Safeguard Analysis article above walks you through a near miss incident with a fast moving train and people. Once you identify your Hazards, your Targets, and any Safeguards we ask simple questions such as:
– was there an error that allowed a Hazard that shouldn’t have been there, or was larger than it should have been;
– was there an error that allowed a Safeguard to be missing;
– was there an error that allowed a Safeguard to fail;
– was there an error that allowed the Target to get too close to a Hazard; or
– was there an error that allowed the Incident to become worse after it occurred.
So here is the complexity question, what makes a near miss with a train incident different or a biopharmaceutical product processing near miss more complex to investigate than a train incident? Can we use the same root cause process for both types of problems?
Let’s walk through how we can turn the complex into the simple.
Simplifying the Issue:
In safety investigations, either the target got hurt or almost hurt. If the target got hurt, how badly?
In biopharmaceutical investigations, either it is a True Batch Failure, a False Batch Failure, a Safety Compromised or a Non-Standard Efficacy issue.
The similarity between seeming complex productions verses a train incident? Either a hazard got to the Batch (target) knowingly or unknowingly and was the loss of control caught in time?
The other questions would be….
1. How easy would it be to document the process of transactions that occurred during the Batch Process?
2. How easy would it be to identify the hazards of say…moisture, catalyst issues, enzyme or bacteria controls for the Batch Process? Simply, did they get the recipe right?
3. Finally, once identified, can the SME’s identify the error opportunities listed above?
If you are in the Biopharmaceutical Industry whether from the GCP or GMP side, give us a call or just sign up for a course and apply it.
Words that I hate to hear when asked to help with an investigation: “I am surprised this incident did not happen earlier!” Rarely have I seen an incident where there is not a history of the same problems occurring. Think of it like a math equation:
X + Y (A) = The Incident
A company’s issues are just waiting for the right math equation to occur at the right time. What are some of the common factors that populate the equation above?
- Audit Findings (risk or compliance)
- Near Misses (or some cases, Near Hits)
- OSHA Non-Recordable(s)
- Defects (caught before the defect reached the customer)
- Project Delays
- Procurement Issues
- Behavior Based Safety Entries
This list of variables is infinite and dependent on the industry and service or product that your company provides. Should you be required to perform a full root cause analysis on each and every write-up or issue listed above to prevent an Incident? Not, necessarily.
Instead, I recommend that you start looking at what would be a risk to employees, customers, environment, product/service or future company success if you combined any of your issues in the same timeline or process of transactions (in TapRooT® our timeline is called a SnapCharT®). For example, take the 3 issues listed below that have a higher potential of incident occurrence when combined in the right equation.
Issue 1: Audit finding for outdated procedures found in a laboratory for testing blood samples.
Issue 2: Behavior Based Safety Write-up entered for cracked and faded face shields
Issue 3: Older Blood Analyzer has open equipment work orders for service issues.
Combining the 3 items above could cause a contaminated blood sample, exposure of contaminated blood to the lab worker or a failed test sample to the patient.
If the cautions about your future combination of known issues are not heeded then please do not acted surprised after the future Incident occurs.
Want to learn about causal factors? It’s not too late to sign up for our Advanced Causal Factor Development Course, August 1-2, 2016, San Antonio, Texas.
I must be crazy, I teach TapRooT® Root Cause Analysis and say it’s not about the root causes? Yes, it is true. Root Cause Analysis is really about fixing, prevention and improved ability to recover from a problem.
Yes, an objective root cause process is a must, for hints read the 7 Secrets of Root Cause Analysis. However the reason behind the need for and the end intent of the root cause analysis is just as important. Lets start with a new idea for many doing root cause analyses today, “improved ability to recover from a problem.”
Sometimes the first action to correct a problem on the spot was like pouring water on an oil fire. Didn’t cause the fire but sure did not help the situation, and in some cases it really made the problem. Many problem solvers just look for the root causes that caused a problem and not what also made it worse.
Here are just a few examples of actions or lack of actions that made the initial problem grow larger in extent if not worse at the end of the day:
- Flint River Lead Exposure Delayed Response
- Firestone Tire Delayed Recall
- 1947 Explosion Caused by Incorrect Response to Initial Fire
- A case closer to this article writer’s life when the wrong medicine was given for heart failure of loved one: Root Cause Analysis Tip: Patient’s heart stopped twice in the Emergency Room… what was missed?
So why do I say “improved ability to recover from a problem” is a new concept for many doing root cause analyses today? Simple, many start and stay with “why did the problem occur.” Read more on how to improve the use of the more simple “why” tools if you have to use them: A Look at 3 Popular Quick Idea Based Root Cause Analysis Techniques: 5-Whys, Fishbone Diagrams and Brainstorming.
The easiest way to improve the ability to respond to a problem is to map out a timeline for actions that occurred before the problem occurred, and the immediate responses to control or correct the problem. If the response made things worse, then perform a root cause analysis on that problem as well.
The last topic is prevention. The intent of a root cause analysis is not just to find the one “rootiest cause” or even a multitude of root causes. The intent is to find the problems and root causes that caused the problem and the problems that failed to catch/stop the problem AND THEN Eliminate or Mitigate those root causes so that future problems can be prevented or at the minimum, have the probability of the problems occurrence reduced.
- Who is mandating the time of root cause analysis completion?
- What does finished really mean in relation to this set deadline?
- Are there stopping and rest points to reach while you race towards the finish line?
- Does racing to the finish line ensure a good root cause analysis with effective corrective actions or does it just mean you won’t be yelled out for missing the deadline mandate instead?
Who is mandating the time of root cause analysis completion?
Is the deadline an internal company or an external client/agency requirement? If it is an external requirement, you really need to evaluate questions 2 and 3 to ensure that you are utilizing your time and resources optimally during the root cause analysis process. If the deadline mandate is an internal company rule, stop and evaluate the timeline requirement for the following criteria:
A. Do you separate Triage Response to the Incident from the actual Root Cause Analysis Investigation of the Incident?
If you stabilize the incident environment first, this will allow you more time to effectively manage your investigation. The risk to further injury and damage is reduced.
B. Do you check that your prescribed corrective actions are not driving what information you collect and analyze during the Root Cause Analysis?
Often investigators drive what they think happened and how they want to fix the problems. This can reduce the time to complete the investigation but like the Hare in the race, you never made it to the true Root Cause Analysis Finish Line.
What does finished really mean in relation to this set deadline?
Are there stopping and rest points to reach while you race towards the finish line?
These two questions can help you define the timeline for investigation completion for your own company’s internal rule; however, it is also mandatory that you understand the client’s/agency’s definitions for the criteria listed above.
For example, a contract company was required to have an incident which occurred on a client’s property investigated analyzed and corrected within 30 days from the incident’s occurrence. There was also a review process where the client would review the incident and reject it for additional clarifications or changes.
The contract company sent the finished investigation with completed correction actions on day 30. The client was frustrated because there was no time per their set deadline to send back the incident for changes. Problem is that the contract company met the mandate as written, no rules were broken.
Investigated, analyzed and corrected are great stopping points to send in information for review. The other question to ask is whether the investigation is finished once the corrective actions are created, implemented or reviewed?
The client in the above example changed their process to have turn in points for review for each phase of the Root Cause Analysis Investigation to ensure that the full 30-day completion date was met with quality investigations and effective corrective actions being completed.
Does racing to the finish line ensure a good root cause analysis with effective corrective actions or does it just mean you won’t be yelled out for missing the deadline mandate?
Now we get to the race itself: 1 hour, 1 day, 1 week, 1 month. Can a good root cause analysis get completed with good corrective actions within each of the times above? Yes, but it depends.
- How complex is the incident?
- How recent was the incident?
- Does your company have a process to collect evidence and written statements immediately, no matter what the degree or level of incident? (Information is often lost because of a delay to define and incident had a major incident.)
- Are your trained TapRooT® Root Cause Investigators available when needed and onsite? (Note that anyone at any level of the company can be trained to perform a Root Cause Analysis)
If your company follows all the key points listed, you are on the way to reaching the finish line to ensure a good root cause analysis with effective corrective actions and not it just meeting the deadline mandate. As far as the Turtle and the Hare? I’ll assign the Hare to triage and stabilize the environment and then assign my Turtle to investigate in an effective pace.
Learn more about conducting quality investigations with effective corrective actions at the 2016 Global TapRooT® Summit, August 3-5 in San Antonio, Texas.
“Easier than making a mistake” … now that is good Human Engineering!
While listening to a radio commercial recently, I heard the announcer say, “Easier than making a mistake!” As a TapRooT® Root Cause Instructor with a quality and human engineering (Human Factors) background, all that I could think about is mistake-proofing, Poka-yoke.
The concept was formalized, and the term adopted, by Shigeo Shingo as part of the Toyota Production System. It was originally described as baka-yoke, but as this means “fool-proofing” (or “idiot-proofing”) the name was changed to the milder poka-yoke. (From Wikipdia)
Now, I did not learn about Dr. Shigeo Shingo during my Human Factors study, even though a large part of training dealt 100% with design and usability from products, to controls and to user graphic user interfaces. On the flip side, Human Factors and Usability was rarely discussed during my Lean Six Sigma certification either, even though Poka-yoke was covered.
Why are two major interactive topics such as Human Factors and Poka-yoke kept in isolation, very dependent on where and what you study? Simple, shared best practices and industry secrets are not always the norm.
Where can you learn about both topics? In San Antonio, Texas during our TapRooT® Summit Week August 1-5.
In the pre-summit 2-Day TapRooT® Quality Process Improvement Facilitator Course, we cover the error of making weak preventative or corrective action items that are not based on the actual root causes found and not optimizing and understanding mistake-proofing that will impact your success in continuous process improvements.
For those that need a deeper understanding of why mistake-proofing should be considered, you should look into signing up for the 2-Day Understanding and Stopping Human Error Course.
If it is written down, it must be followed. This means it must be correct… right?
Lack of compliance discussion triggers that I see often are:
- Defective products or services
- Audit findings
- Rework and scrap
So the next questions that I often ask when compliance is “apparent” are:
- Do these defects happen when standard, policies and administrative controls are in place and followed?
- What were the root causes for the audit findings?
- What were the root causes for the rework and scrap?
In a purely compliance driven company, I often here these answers:
- It was a complacency issue
- The employees were transferred…. Sometimes right out the door
- Employee was retrained and the other employees were reminded on why it is important to do the job as required.
So is compliance in itself a bad thing? No, but compliance to poor processes just means poor output always.
Should employees be able to question current standards, policies and administrative controls? Yes, at the proper time and in the right manner. Please note that in cases of emergencies and process work stop requests, that the time is mostly likely now.
What are some options to removing the blinders of pure compliance?
GOAL (Go Out And Look)
- Evaluate your training and make sure it matches the workers’ and the task’s needs at hand. Many compliance issues start with forcing policies downward with out GOAL from the bottom up.
- Don’t just check off the audit checklist fro compliance’s sake, GOAL
- Immerse yourself with people that share your belief to Do the Right thing, not just the written thing.
- Learn how to evaluate your own process without the pure Compliance Glasses on.
If you see yourself acting on the suggestions above, this would be a perfect Compliance Awareness Trigger to join us out our 2016 TapRooT® Summit week August 1-5 in San Antonio, Texas.
“The actor, Harrison Ford, was struck by a hydraulic metal door on the Pinewood set of the Millennium Falcon in June 2014.”
“The Health And Safety Executive has brought four criminal charges against Foodles Production (UK) Ltd – a subsidiary of Disney.”
“Foodles Production said it was “disappointed” by the HSE’s decision.”
Read more here
“You get what you ask for,” ever hear that phrase? Well, it is a good lead into root cause tip #1.
#1 Know why you are doing the root cause analysis but DON’T let the reason drive the root cause process and findings itself.
The quality of a root cause analysis report, or in many cases the amount of information contained in the report, is driven by the requirement for the root cause analysis itself.
- Government Agency Requirement
- Regulatory Finding Requirement
- Internal Company CEO/CFO Requirement
- Internal Company Policy Requirement
- Supervision Request but no policy requirement
Which one of the requirements above most likely requires a more extensive root cause analysis report, written in a very specific way? Most of us, by experience, would focus on items A-C. Besides the extensive amount of time it takes to produce the regulatory report, how could the report requirement become a driver for poor root cause analysis?
- Report writing drives the actual evidence collection.
- Terminology required in the report forces people to prioritize one problem over another, and in some cases ignore important information because it does not have a place in the report.
- Information is not included or addressed because the report is going to an outside organization.
If A-C root cause analysis requirements could lead to biased or incomplete root cause analyses because of the extensive regulatory requirements, then D-E should be better right? Well, not so fast.
- Less oversight of the root cause analysis report (if there is one) could result in less validated evidence or a list of corrective actions with limited support to substantiate them.
- There is often a higher variability of how the root cause analysis is performed depending on who is performing it and where they are performing it.
So how do you counter the problems of standardization verses non-standardization issues in root cause analysis? The easiest method is to use a guided investigation process and not drive the process itself. Once the root cause analysis is complete, then and only then focus on writing the report.
Below is a list of 7 points with a link to read more if needed that can help reduce bias and variability. 7 Secrets of Root Cause Analysis
- Your root cause analysis is only as good as the info you collect.
- Your knowledge (or lack of it) can get in the way of a good root cause analysis.
- You have to understand what happened before you can understand why it happened.
- Interviews are NOT about asking questions.
- You can’t solve all human performance problems with discipline, training, and procedures.
- Often, people can’t see effective corrective actions even if they can find the root causes.
- All investigations do NOT need to be created equal (but some investigation steps can’t be skipped).
This is just plain project management advice. If the team and process owner of the issue being analyzed believe that you as the root cause facilitator own the root cause analysis, guess what… You Do! It’s your evidence, your root causes, your corrective actions and your accountability of success or failure. It is easier to pass the buck so to be speak and can also hamper the support that the facilitator needs to ensure an effective investigation.
In most cases the root cause analysis facilitator is just that, the facilitator of information. Keep it that way and establish ownership up front.
#3 As a team, define what finished means for the root cause analysis and if there is a turnover of the root cause analysis, ensure that ownership is maintained by the appropriate people.
Often the root cause analysis facilitators in my courses tell me that once the analysis portion is done at their company, the report is handed off to their supervision to make the actual corrective actions. Not optimal in itself, and should include a validation step handled by the root cause facilitator to ensure that the corrective actions match up to the original findings. The point, however, is that whatever “finished “ is, and wherever a true handoff of information must occur, it needs to be established up front along with the ownership discussed in tip #2.
In TapRooT® Root Cause Analysis, the following would be great investigation steps to focus on with your team and peers when discussing what finished means, hear more about these steps here.
- After Creating Summer SnapCharT® – Is the SnapCharT® thorough enough or do we need more interviews & data?
- After Defining Causal Factors – Are they at the right end of the cause-and-effect chain? Was a Safeguards Analysis conducted? Were all the failed safeguards identified as causal factors?
- After RCA and Generic Cause Analysis – Did they use their tools (Root Cause Tree®, Root Cause Tree® Dictionary, etc.)? Did they find good root causes? Did they find generic causes? Did they have evidence for each root cause?
- After Developing Corrective Actions – Use corrective action helper to determine effectiveness of corrective actions.
These 3 root cause tips were designed to reduce the barriers to good quality root cause analysis. Comment below if you have additional tips that you would like to pay forward.
Can You Use One Root Cause Analysis Tool for Quality, Safety, Production, IT, Cost, and Maintenance Issues?Posted: December 2nd, 2015 in Root Cause Analysis Tips
The disagreement of which root cause analysis tools are used by who actually starts with the creation of internal company functional silos. Companies that run smoothly almost transparently as one unit realize that Quality, Safety, Production, IT, Cost, and Maintenance Departments impact each other, either positively or negatively, and should use similar tools during root cause analysis to enhance root cause analysis communication between departments. Unfortunately, this unison is not often common. Let’s break it down a little.
IT (Information Technology) – often focuses on rapid root cause diagnosis and analysis.
Quality – tends to focus on the 8 Basic Quality Tools and Lean Activities with different variations in the sequence of root cause analysis.
Safety – focuses on root cause analysis tied to hazard and risk to reduce Health, Safety and Environment Issues.
Production – is probably the closest tied to quality and cost reduction issues, whereas safety is more often viewed as cost aversion. The problem solving tools utilized here are often tied to the Quality and Cost root cause analysis tools to ensure production is met and the company makes money.
Maintenance – is focused on operational efficiencies and cost to run and maintain the equipment. Often tied to Quality and Production root cause analysis tools but more tied to equipment specifics.
Cost – everybody needs to know where the money goes and if we have enough to keep the business alive. Financial knower’s in the company get tasked by many of the departments listed above, some departments more than others. Their root cause analysis tools are more tied to transactional processes.
Now that the different company functions listed above are established, what often happens next is that the department leaders search for root cause analysis tools created just for their types of problems and the silo walls between departments get even bigger. Why? Simple, the specific function tools often only look for issues and causes tied to their specific issues. So what’s wrong with that you ask?
Input – Process – Output across your Company’s Work Processes
What each functional department changes or produces impacts another department either upstream or downstream from that department. Root cause analysis tools that are too functionally specific tend to not explore or encourage multi-department discussions during root cause analysis. If the tools don’t talk your language, they do not apply to you or in some cases, the company does not think you need to be trained in the other tools.
Case in point, as a lean six sigma black belt in a previous company, I spent my last year in manufacturing mentoring our safety department in quality tools. No one from safety had ever attended our quality training that we taught internally, even though we taught classes every month. Operations and Maintenance employees attended the training because they were more tied to the return on investment company costs.
Break the silo department barriers, look for a root cause analysis process that can tie Quality, Safety, Production, IT, Cost, and Maintenance Department issues together to help solve problems as one.
For over 28 years, System Improvements has prided itself in having a standard root cause analysis process called TapRooT®. No matter what the problem being analyzed they all start with Defining the Worst Consequence that Occurred, Identifying What Happened and How It Happened and then Why. We also teach and include Corrective Actions that are global industry best practices.
Don’t fret, because we don’t recommend that you throw away your other data collection and analysis tools, instead we recommend that you use the TapRooT® Root Cause Analysis Method as the standard communication and investigation tool for the root cause process to enhance and consolidate current programs for one company vision. After all, everything has a timeline of events or a sequence of transactions, start your problem solving with a proven root cause analysis process that starts there first and then helps guide employees through multiple types of problems to help you understand Human Performance
All Root Cause Analyses started have an initial goal…
Reduce, Mitigate or Eliminate a Problem!
As TapRooT® trained root cause analysis investigators soon learn, there is usually more than one Causal Factor that caused the Incident being investigated, and each Causal Factor has more than one Root Cause. If this sounds foreign to you as an investigator, check out our TapRooT® Root Cause method here. So if problems do not occur in isolation, why should the investigator work in isolation? Thus, the topic of today, “Peer Feedback to Improve Root Cause Analysis.”
Previously we discussed real–time peer review during the investigation TapRooT® Process and reviewing a completed TapRooT® looking for the “Good, Bad and the Ugly” with a spreadsheet audit included.
Root Cause Analysis Video Tip: Conduct Real-Time Peer Reviews
The Good, The Bad & The Ugly
So what’s next? Are peers created equal? What value can a peer add? What value does the peer get from giving feedback about a root cause analysis? Let’s see….
Peers are not created equal! This is a good thing. Below is a short list of peers to get feedback on your root cause analysis progression and the value that they add.
1. Coach/Mentor: This is a person who is competent and formally trained in the root cause process that you are using. They are not teaching you the process but guiding you through your use of it after you were formally trained. They have been in the trenches and dealt with the big investigations, These process champions can easily get you back on the right track and show unique techniques.
Too many companies get large numbers of employees trained in a process and then let them run free without future guidance or root cause analysis feedback. This is why our TapRooT® Instructors are available for process questions after training is complete. This is also why we encourage key company employees to attend our 5-Day TapRooT® Advanced Root Cause Analysis Team Leader Training to help mentor those that have taken our 2-Day TapRooT® Incident Investigation and Root Cause Analysis Course.
2. Equal: This is the person who has attended the same root cause analysis training that you have and has the same level of competence. They may also have the same industry technical experiences that you have.
The value of the feedback from this person is to keep each other grounded in the process you are using and to help validate that the evidence received is substantiated. It is very easy sometimes to start pushing any root cause process into one’s biased direction once the energy gets flowing. The trained TapRooT® investigator and peer will remind you to slow down and let the TapRooT® process guide you to the root causes.
3. Novice: There are two types of novices to get feedback from, one that is not trained in the TapRooT® process and one that is not familiar with the investigation or process being investigated.
There is a natural tendency that the more you know about the process you are investigating, the less that you put down on paper. After all, everyone knows how that thing works or what happened. Why do I need to write it down? Simple… “What does not get written down does not get investigated!” As the novice asks you more questions to understand the root cause analysis that you are performing, the more you explain and the more you write down.
4. Formal Auditor: The formal auditor usually audits the root cause analyses after they are completed and the corrective actions have been implemented. There is less communication and engagement between you and the auditor, which is very different than the first peers listed above.
The value of this feedback is that it is designed to look for consistency and standardization across multiple root cause analyses. The auditor may find investigations that need to be recalibrated but may also find new and better ways of doing an investigation based on other’s unique techniques. We also encourage auditors to have taken our 2-Day Advanced Trending Techniques Course, to help look for trends.
The final plus for this feedback activity…..
“Everyone learns something and recalibrates their Root Cause Analysis Techniques and we all help meet the goal of Reduce, Mitigate or Eliminate a Problem!”
A Look at 3 Popular Quick Idea Based Root Cause Analysis Techniques: 5-Whys, Fishbone Diagrams and BrainstormingPosted: August 26th, 2015 in Root Cause Analysis Tips
Today’s root cause tip will walk through a few popular quick-idea based root cause analysis techniques used by many.
Do a quick search using Google or Yahoo search engines for “Root Cause Analysis Training” and these techniques often pop up in your internet browser: 5-Whys, Fishbone (Ishikawa) Diagrams, Brainstorming and of course, TapRooT® Root Cause Analysis. Now type in “free” or “quick root cause analysis templates” and you will not find TapRooT®. Is that good or bad? Of course my dad always taught me that what is earned and worked for was always more satisfying and led to a stronger sense of accomplishment. The end product also lasted longer.
Why would a person search for root cause analysis training on the Internet? If I were to brainstorm the whys as defined in dictionary.reference.com:
– a sudden impulse, idea, etc.
– a fit of mental confusion or excitement.
-1890-95; brain + storm; originally a severe mental disturbance
Then I might suggest the following “whys”:
- The person was bored.
- A student was doing research.
- A training department was assigned to find and schedule quick low cost training techniques that can be taught online.
- You were assigned to find good root cause training to solve problems.
Now those weren’t too many suggestions on my part. But there is hope, because brainstorming is best served in groups. As defined in wikeipedia.org:
Brainstorming is a group creativity technique by which efforts are made to find a conclusion for a specific problem by gathering a list of ideas spontaneously contributed by its members.
But we have to establish a few rules per wikipedia.org:
- Focus on quantity…. The more the merrier.
- Withhold criticism…. No why is a bad why and you might shut down the quantity given by others that were made fun of.
- Welcome unusual ideas
- Combine and improve ideas… we can build off other peoples’ whys for a really good why to solve a problem.
Okay with our new rules and group in place, we came up with more whys to why someone was searching for root cause analysis on the internet:
- The person was bored.
- A student was doing research.
- A training department was assigned to find schedule quick low cost training techniques that can be taught online.
- You were assigned to find good root cause training to solve problems.
- The current root cause techniques are not working very well.
- You are planning a party and this would be a great team game. (This one was my favorite suggestion)
Fishbone (Ishikawa) Diagrams
Brainstorming not quite good enough in our quest to solve why people are searching for root cause analysis on the internet you think? Let’s do a guided search for whys with our group using a Fishbone (Ishikawa) Diagram.
- Agree on a problem statement as a group. Ours is “why are people searching for root cause analysis on the internet?”
- The problem statement is placed at the head of the fish as seen in the diagram above.
- Now Brainstorm the major categories of the cause of the problem and list them underneath each category. For our fishbone from wikipedia.org, we are going use Methods, Machines, Material and Measurements.
a. Methods: How the process is performed and the specific requirements for doing it, such as policies, procedures, rules, regulations and laws
b. Machines: Any equipment, computers, tools, etc. required to accomplish the job
c. Materials: Raw materials, parts, pens, paper, etc. used to produce the final product
d. Measurements: Data generated from the process that are used to evaluate its quality
Caution, there are many categories to chose from which may lead the group into different directions each time they use one. We could have also used the categories as listed in wikipedia.org:
The 7 P’s
The 5 S’s
Here is our refined fishbone. I have to admit, it does look a little better than the brainstorming list above. Did not take that much time at all.
- As each idea is given, the facilitator writes it as a branch from the appropriate category.
- Again ask “why does this happen?” about each cause.
- Write sub-causes branching off the causes. Continue to ask “Why?” and generate deeper levels of causes. Layers of branches indicate causal relationships.
Item number 4 gets into looking for causal relationships within our suggested causes which leads into our 5 whys discussion next.
Let’s take one of the “causes” listed above and get to a good root cause with our group to understand why people are searching for root cause analysis on the internet?
Here are the simple instructions for performing a 5 Whys as listed in wikipedia.org:
5 Whys is an iterative question-asking technique used to explore the cause-and-effect relationships underlying a particular problem. The primary goal of the technique is to determine the root cause of a defect or problem by repeating the question “Why?” Each question forms the basis of the next question.
- Why are people searching for root cause analysis on the internet?
Answer: Because there is no database to search in on their computer and the boss wants training answers now.
- Why is there no database on the computer to search from?
Answer: Because these are computers produced in 1995 and a knowledge database cannot be installed.
- Why do we not have new computers that can have databases installed?
Answer the company is short money.
- Why is there no money left to purchase computers?
Answer: Because we have lost money on repeat incidents.
- Why do we have repeat incidents?
Answer: Because we do not have a good, effective, cost reducing Root Cause Analysis Process. I have a great solution for this problem….. look here for future courses in TapRooT® Root Cause Analysis.
Okay, I agree this was a very high level and superficial exploration of the 3 Popular Quick Idea Based Root Cause Analysis Techniques: 5-Whys, Fishbone Diagrams and Brainstorming.
However, the steps that we explored are valid steps and flow of the actual processes. The ending results from superficial creation of whys are very true and have been the cause for repeat problem occurrences.
If you are going to use these process, as they are often still required for everyday issue resolution for some and for others are actually considered their only root cause tools, then head off some of the issues with a couple of these best practice suggestions.
- Never start with Brainstorming. This is a great tool for suggesting corrective actions tied to actual root causes, but should not be used for evidence collection and figuring out why something happened.
What to do instead? Go Out And Look (GOAL). Never armchair troubleshoot from a conference table surrounded by people.
- Only use a Fishbone (Ishikawa) Diagram if:
a. You have collected evidence
b. You standardized and defined your fishbone cause categories
c. You have the right experts in the room
d. Cause or Corrective action ideas do not drive the actual what and why questions.
- Only use 5 Whys for trying to identify the actions or inactions that allowed an issue to occur and not the actual root causes. Why?
a. There is a tendency to look for only one cause when using the process; even if you ask 5 Whys for each action or inaction found on the Fishbone (Ishikawa) Diagram, there is still a tendency to look for only one cause in each section. I have never just had one cause for any problem that I have investigated.
b. It is not how many questions one asks but what one asks.
c. When used to collect evidence or understand evidence, there is a tendency for “group think” to occur that drives which direction the evidence and causation linkage goes. Look up the Space Shuttle issue tied to the o-ring failure for a group think example that was detrimental to life.
d. There is nothing to push the investigations outside what they know as a whole and what may be missing from the investigation. In that case, always bring in different knowledgeable and people new to the problem for constant checks and rechecks. Also look for outside industry best practices and knowledge to help get better investigations completed.
So in closing…..
- If it looks too easy and requires less work, you get what you put in it.
- If there is a large amount of guessing, you are also guessing at the corrective action.
- If the right expert is not in the room when using the tools explored, nobody will know what to ask or to verify.
- If the people using the process are the only thing driving the evidence collection, bias has a stronger natural tendency to take over.
I look forward to your examples of using these processes and also comments on some of the traps you did or did not avoid while using these 3 tools.
When it comes to effective root cause analysis and problem solving, are you jumping to the “ultimate why” or the “ultimate fix” without truly knowing the “ultimate what” behind the problem?
It is not how many questions you ask or even how many solutions that you throw at a problem; instead, it is how you define the scope of your problem that needs to be solved, what you learn when you find out what happened during the problem’s occurrence, what you ask based on what you learn and how you fix what you find out.
The sequence of what happened, why “the what” happened and then fixing what you find for good problem solving sounds simple, right? Then why do so many people not follow this critical sequence of problem solving? A personal experience comes to mind from a recent investigation failure that I observed. Note that you should always start with defining what the problem is that needs to be analyzed before you start a root cause analysis.
The problem scope of the investigation failure mentioned above was to understand why there was a repeat of an incident after a team had completed their incident investigation and implemented their created corrective actions.
What are the probable costs of not analyzing an incident?
1. Hazards to people, equipment, processes or a customer not identified and therefore will not be removed, isolated or mitigated.
2. The next associated incident has a worst outcome:
a. A loss of life, injury or other harm to people
b. Damage to the environment
c. Equipment run to unplanned failure
d. Loss of a process or production system
e. A loss of client from repeat defects and failures
f. Government or other independent Agency involvement
3. A backlog of incidents and rework of incidents that includes a backlog of corrective actions.
Below are some of the facts that I collected for the repeat incident failure that I observed:
1. The investigation team had a natural tendency to take shortcuts by using experienced-based guessing to reduce investigation time.
If you already “know” the whys of a problem or you know the solution that you want to implement, then you do not need to verify what happened.
This team’s shortcuts then became “longcuts” due to guessing and expert driven tunnel vision that led them into erroneously based evidence collection and why selections. This error ended in wasted time and poor corrective actions that did not lesson or mitigate the problems that caused the original incident.
2. Poor problem solving skills for many of the team were taught previously in “well meaning” problem solving training… 5-Why’s, Ishikawa Diagrams and Brainstorming Solutions.
Items one and two above support each other and are easily adapted by expertise driven problem solvers. Just call these factors above co-enablers. These methods tend to feel good because they support your own experiences and they are quick and easy tools to learn and use. These tools assume that all right experts are sitting in the room, all the right people went out to look at the problem and no guesses or assumptions were made. Not the case on most situations during problem solving.
A good root cause analysis process does not replace the need for a company’s process experts, workers or managers. It instead should pull good information from these people in an unbiased and effective manner. It should also ensure good corrective actions are developed, implemented, verified and validated.
The problems identified above encouraged the company’s problem solvers to deviate from an effective problem solving sequence of what, why and then fix during root cause analysis, which caused this team’s incident to repeat.
So what happens when investigators follow the “Ask Why First” method instead of trying to learn what happened first?
1. The investigators tend to pull from their own experiences first and quickly try to fit their experiences to the problem being analyzed. This is the first stage of failure called guessing. Never assume what happened is the same as to what really occurred during a problem. Also, if you never experienced the problem before, you will have no experience to fit the problem to.
2. Investigators often throw multiple “possible” root cause options at a previously “known” problem. The more causes the merrier, right?
Actually no. For every cause you throw at a problem not based on facts of the incident, you now have to take time to collect information, causing you to waste time. Often you choose which cause is the most important to you before you know the facts and then ignore collecting any other “unimportant” information.
3. Depending on the previous problem solving training received, investigators often drive the evidence collection with linear brainstorming why questions (5 Whys style).
You increase the probability of delaying, if not actually ignoring, viable evidence. This process also tends to let you drive to find just one “real root cause”. This problem is a critical error. After all, even a fire, like any other problem that you may investigate, has more than one ingredient and cause. This can also produce “tunnel vision” designed to find the “most important” or “rootiest root cause”.
Let’s look at the “Fix the Problem First” method. Many well-meaning problem solving methods state that solving the problem is more important than finding all the whys or what’s of the problem that needs to be resolved. Management doesn’t care how you fix the problem as long as you solve it, right? What could go wrong if we just try to brainstorm a solution first and by-pass the whole finding a cause thing?
1. The focus of the investigation tends to be for the investigators to quickly put things back to normal, to stabilize the environment for damage control. This is not problem solving in reality, it is actually called triage. Triage is where you quickly assess the issue, make a best solution guess and then put that guess into action. Reduction of time to solution is vital in triage.
There is a need for triage with immediate actions, however this should not be practiced during good problem solving because it becomes a “Broke-Fix” mentality as opposed to understanding the problem to improve preventing the problem from occurring again.
2. If you have a fix in mind, you have an agenda. This agenda looks for supporting evidence to validate the selected fix and also tends to filter out other important issues.
The level of your organization chart that is driving the solution during this process can also set the stage for what is acceptable for the investigators at that site to discuss and address at the employee level. This often restricts getting all the facts and restricts what is allowed to be changed.
So how does starting with “What happened first” during problem solving prevent the issues listed above?
1. Identifying what happened before the problem that needs to be resolved occurred and what happened after it occurred, with proper detail and supporting evidence, reduces the case for assumption led decisions.
2. Writing down what happened, increases the ability to identify more clearly the conflicting statements from interviews and gaps in a process being investigated.
3. Writing down what happened, allows you to identify what worked right. This helps validate good processes and demonstrates that you’re using a root cause analysis process that looks for the good, the bad and the missing best practices. This is good for morale and increases the probability for effective and sustaining corrective actions.
4. You now have good documentation to help you find out why the problem that needs to be resolved occurred and why the fix is justified. This documentation can reduce the amount of corrective actions rejected by managers and regulators.
5. You are now using a good root cause process to not only figure out why the problem occurred but what also why actions or inactions failed to mitigate the problem or made it worse.
6. At the end of the day your initial gut feeling of what happened, why it happened and how to fix it is either substantiated or rejected based on facts and not emotions.
The sequence of What, Why and then Fix… There is No Other Sequence for good Root Cause Analysis.
For extra credit after reading this TapRooT blog article, let me know what movie the ultimate answer “42” came from and what the question really was for the answer.
You can also join me to learn more about effective TapRooT® Root Cause Analysis by attending one of my classes. We can talk about the movie over coffee or a soda and make a SnapCharT® for why the world was going get destroyed for a new galactic highway.
The 22-year-old man died in hospital after the accident at a plant in Baunatal, 100km north of Frankfurt. He was working as part of a team of contractors installing the robot when it grabbed him, according to the German car manufacturer. Volkswagen’s Heiko Hillwig said it seemed that human error was to blame.
A worker grabs the wrong thing and often gets asked, “what were you thinking?” A robot picks up the wrong thing and we start looking for root causes.
Read the article below to learn more about the fatality and ask why would we not always look for root causes once we identify the actions that occurred?
“Doctor… how do you know that the medicine you prescribed him fixed the problem,” the peer asked. “The patient did not come back,” said the doctor.
No matter what the industry and or if the root causes found for an issue was accurate, the medicine can be worse than the bite. Some companies have a formal Management of Change Process or a Design of Experiment Method that they use when adding new actions. On the other extreme, some use the Trial and Error Method… with a little bit of… this is good enough and they will tell us if it doesn’t work.
You can use the formal methods listed above or it can be as simple for some risks to just review with the right people present before implementation of an action occurs. We teach to review for unintended consequences during the creation of and after the implementation of corrective or preventative actions in our 7 Step TapRooT® Root Cause Analysis Process. This task comes with four basic rules first:
1. Remove the risk/hazard or persons from the risk/hazard first if possible. After all, one does not need to train somebody to work safer or provide better tools for the task, if the task and hazard is removed completely. (We teach Safeguard Analysis to help with this step)
2. Have the right people involved throughout the creation of, implementation of and during the review of the corrective or preventative action. Identify any person who has impact on the action, owns the action or will be impacted by the change, to include process experts. (Hint, it is okay to use outside sources too.)
3. Never forget or lose sight of why you are implementing a corrective or preventative action. In our analysis process you must identify the action or inaction (behavior of a person, equipment or process) and each behaviors’ root causes. It is these root causes that must be fixed or mitigated for, in order for the behaviors to go away or me changed. Focus is key here!
4. Plan an immediate observation to the change once it is implemented and a long term audit to ensure the change sustained.
Simple… yes? Maybe? Feel free to post your examples and thoughts.
We can all remember some type of major product recall that affected us in the past (tires, brakes, medicine….) or recalls that may be impacting us today (air bags). These recalls all have a major theme, a company made something and somebody got hurt or worse. This is a theme of “them verses those” perception.
Now stop and ask, when is the last time quality and safety was discussed as one topic in your current company’s operations?
You received a defective tool or product….
- You issued a defective tool or product….
- A customer complained….
- A customer was hurt….
Each of the occurrences above often triggers an owner for each type of problem:
- The supplier…
- The vendor…
- The contractor…
- The manufacturer….
- The end user….
Now stop and ask, who would investigate each type of problem? What tools would each group use to investigate? What are their expertise and experiences in investigation, evidence collection, root cause analysis, corrective action development or corrective action implementation?
This is where we create our own internal silo’s for problem solving; each problem often has it’s own department as listed in the company’s organizational chart:
- Customer Service (Quality)
- Manufacturing (Quality or Engineering)
- Supplier Management (Supply or Quality)
- EHS (Safety)
- Risk (Quality)
- Compliance (?)
The investigations then take the shape of the tools and experiences of those departments training and experiences.
Does anyone besides me see a problem or an opportunity here?
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
Airplane loses power during take off at a Kansas Airport and plane strikes building. Pilot of the King Air Aircraft that crashed and 3 people working in a flight simulator inside that building are dead. Read more here at KAKE News in Wichita, KS.
I post this because of the debates and blame that are going to ensue. Was it just one thing, the plane crashing, that caused this issue to occur? Was it the location of all the flight buildings in the vicinity of an airport. Was this just a “freak accident”. So much more to learn… I hope they get it right so it does not happen again.
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
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
We just saw a loss of life in the local Tennessee area following a flat tire while still on the roadway. The driver with the flat tire stopped in or near a high traffic lane, got out of the vehicle and was killed when cars hit the stopped car. Unfortunately, this type of fatality or near miss to a fatality happens too frequently in all parts of the world.
If you drive, know someone that drives or knows someone that will soon be getting a license to drive, please heed the following…..
Do not stop in the travel lanes for any reason (lost or confused about directions, vehicle breakdown, or letting out a passenger). Keep moving until you can safely pull your vehicle off the roadway. (reference the Tennessee Driver’s Manual)
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 doughnut 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
By Chris Vallee
I was an aircraft mechanic in USAF when this incident occurred. The aftermath of the F-15 Crash and Pilot Fatality continued with an Airman’s suicide was loss to many.
While, I knew the basics, I just recently found a follow up report and wanted to share it. The information is taken directly from the article as is without my paraphrase. Here is the website.
An Air Force review board has partly cleared the name of an F-15 mechanic who committed suicide in 1996 rather than face a court-martial for a fatal repair error.
Evidence showed that TSgt. XXXXXX did not perform the botched control rod maintenance at issue, although he did check the work and found nothing wrong.
In addition, several previous incidents in which other mechanics made the same mistakes should have alerted the Air Force to a potential problem, according to the board.
“We did not think XXXX was totally free of all responsibility,” said Lee Baseman, chairman of the correction board. “But it was our view that he was unduly carrying the burden for a series of missteps that went back at least 10 years.”
In May 1995, XXXX and TSgt. YYYYYY were carrying out maintenance on an F-15C based at Spangdahlem AB, Germany, when YYYYY accidentally crossed flight control rods while reinstalling them. XXXX did not catch the miscue, which made the airplane impossible to control in the air. It subsequently crashed, killing Maj. Donald G. Lowry Jr. (Great GUY!!)
Air Force authorities charged XXXX and YYYYY with dereliction of duty and negligent homicide. XXXXX shot himself in October 1996 during a break in court proceedings. Commanding officers then accepted YYYYY request for administrative separation, on grounds that the interests of the service would be best served by bringing the tragic case to a swift conclusion.
Similar crossed-rod cases occurred at least twice before the Spangdahlem crash, noted the review board-once in 1986 and again in 1991. But in both instances the problem was caught before takeoff.
In its conclusions, the board stated, “After the Black Hawk shootdown [in 1994], the demand for accountability for this accident may have been pursued with such zeal as to leave fairness and equity behind. The fatal crash was a tragedy waiting to happen, yet the decedent was singled out to pay for an accident that could have been prevented anywhere along the ‘chain of events’ had any of the numerous individuals involved made different decisions.
“Most disturbing was the way the Air Force leadership allowed this case to be handled. The Air Force’s representatives resisted the inclusion of potentially exculpatory evidence from the review and report and managed to have a good deal of it excluded from consideration in the pending trial.”
Following the death of Lowry, the Air Force took steps to prevent such a mix-up from happening again. The control rods are now color-coded to ensure proper installation, and the maintenance technical manual warns against the mistake. All flight control systems must now be checked any time the control rods undergo maintenance. ” “
Ref: Journal of the Air Force Association, June 1998 Vol. 81, No.5, Peter Grier
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.