This is one of the biggest challenges of our companies. We focus on correcting the issues instead of preventing them.
I am not talking about obvious topics that you are for sure preventing. It’s more about issues that are appearing as the business starts to grow, as people start to be less dedicated or as managers think that all is under control because we have procedures in place.
On this article, I will propose you a methodology to help you look for potential issues that didn’t appear for now or issues that are still manageable. I’ll use some examples so you can really understand how to move forward with it.
Investment
The only roadblock for this kind of method is the fact that you need to invest to get to a point where you are on a preventing mode.
If you are currently suffering because you have a lot of fire to manage, how would you be able to use the technique to switch from correction to prevention?
So at the end think of your strategy because this can be critical for your business. This can reduce a lot of burdens as you will solve the problems before they happen.
But during the transition, there should be a mix situation between Correction and Prevention.
Podcast Episode
This article is also linked to a Podcast called Medical Device made Easy.
To check for the show notes of this episode here is the link.
Youtube Video
My Podcast episodes are also on Youtube if you want to see me talking.
Difference between Correction and Prevention
If you are ISO 13485 certified, you should have heard about Corrective Actions and Preventive Actions or CAPA?
This is a tool described in Chapter 8 of this standard.
If you want to know more about ISO 13485, you can check this article.
The CAPA system is here to solve issues or potential issues. There are 3 important terms to understand for that.
- Correction
- Corrective Actions
- Preventive Actions
If I summarise it, it looks like that.
- You discover a problem, you correct the immediate root cause (Correction).
- Then you identify an action to avoid this root cause to happen again (Corrective action).
- And finally, you identify if this can happen on other parts of your business and you put in place actions so this doesn’t appear (Preventive actions).
Imagine now that you use only the Preventive action part of your CAPA system.
Let’s say that today you have 95% of your CAPA system which is focused on Corrective Actions and 5% on Preventive Actions. I suppose you would find that normal?
Now if you put the effort to flip that even to 60% Preventive Actions and 40% Corrective Action this would be a great move.
Cost of a Corrective Action
If you have a Corrective Action, this means that the problem already happened. Not that maybe this can happen, but you are already in trouble.
In the case this problem impacts your products, you need to identify all the products that are affected.
Imagine now that the issue started 3 years earlier. If the risk for the product is too high, you’ll need to recall everything. But if your bounding is not accurate enough, you’ll maybe recall more than what is needed.
Plus, you have to stop your production and put in place an action to solve the issue. But your customers are waiting, so what to tell them? What to do?
In the end, this will cost you a lot of money.
I know, for the sake of this article the example looks exaggerated. But it’s not. During my career, we had to solve that kind of issues many times. We had to stop production and start to receive calls from our customers because they need this product. Difficult. Really hard.
- Customers are not confident on you anymore
- You have to pay for the recall and scrap your products
- You have to remanufacture new parts
- …
Oh my god, too much pressure. Are you on the same situation?
Gemba Walk
The method I will present you is inspired by “Gemba Walk”.
What means Gemba?
In Japanese, Gemba means a lot of thing like “The actual place” or the “Crime scene”. But for our topic, we will use the Business translation which is “The place where the value is created”.
So when you perform a Gemba Walk, you are walking where you are producing your products for example.
Process Knowledge
A Gemba Walk is an action to go to the place where the value is created to understand how the process is working.
Usually, some managers are leading their team or trying to solve problems without knowing the process at all.
The idea of Gemba is to go to the place where the process exists and understand how this works. Ask questions to get all the aspect of it.
This is also used to solve an issue. Instead of trying to solve a problem in a meeting room, one idea is to perform a Gemba Walk to have a better understanding of the issue. Collect information to really work on the root cause.
I hope this clarifies the word Gemba. And if you´ve never heard about this word before, now you know a Japanese word.
ODIAC method
The ODIAC method is derived from the Gemba Walk. It has the same roots which are to go to the place where the value is created.
The difference is that we are not trying to understand a process but to try to find a potential issue.
let me explain you. On the place where the value is created, we have certain procedures to follow. And maybe there are also some adverse events to some procedures.
So the objective is to try to identify potential issues before they become issues and to identify small problems before they become big problems.
Easy or not?
It seems easy but this is not. Because when someone identifies a potential issue, there are 2 attitudes:
- Management is following you because they understand that prevention is better than correction.
- Management is saying that this issue never happened before so why to invest in a solution for something rare?
And this can totally ruin your efforts. So it’s why this methodology needs a full agreement from management.
ODIAC
The acronyms ODIAC means:
- Observation
- Discovery
- Idea
- Action
- Confirmation
Let’s review each of these steps. But before that let me tell you what you need to execute it
Tools
To execute ODIAC you need:
- A form
- A Pen or a Tablet
- A good pair of shoes
The Form
The form should be prepared before. It’s a list of topics to check. This is completely up-to-you as this depends on your company. Maybe there are some specificities you want to check that is proper to your business.
One method you can use to create your form is the Ishikawa or the fishbone diagram.
For example to find a root cause for an issue the topics are divided on 6 M.
- Man
- Method
- Machine
- Measurement
- Material
- Mother Nature
But on our case, you already identify potential problems on each of those topics and then you write a question to ask to confirm that this issue doesn’t exist.
Example:
- Material – Mix-up: Is the material well identified?
- Man – Good Document practices: Is the signature on the work order legible?
You can start with a small list and make it bigger as you get more experience on ODIAC.
To help you I provide you with a template.
Participants
For the ODIAC method, you can decide to execute it alone, but I always recommend to do that with the person responsible for the area.
Why?
Because you need to have people adopting this tool. If only quality people are using it this will be stamped as a Quality Tool when this is something that should be used by anyone.
So you need to educate your employees by making them participate in this.
Organization
I can see you thinking: “My plant is big, so how to do that?”
As somebody said to me once: When you want to eat an elephant, eat it piece per piece.
This is exactly what you will do. Instead of organizing a BIG ODIAC session, you will divide your plant into many small areas. And you’ll create a calendar where you will plan your sessions and invite the right people.
Each of your session should not be more than 30 minutes of Gemba and 30 minutes of debriefing.
Let’s now review the different phases.
A gift for you
Download Free ODIAC Template
Observation
You are ready to start your first session. You are with your form that includes all the topics that you want to check. You are also with the responsible person of the area so he can also see if there are issues at his workspace.
So we are ready.
You will now check the first topic on your form and confirm that this is fine or not.
You note everything on the document as who you asked, or where you where exactly. This is only to get facts when you’ll arrive to the next steps.
Asking employees at the workplace is important. They are the one creating value so you need to confirm that they understand what they are doing and that there is no issue with their skill, competency…
Suddenly, you find one area where there is a potential issue. It’s not a problem now, but you imagine that this can become a problem. So we move now to the Discovery phase.
Discovery
You find a problem so you need to report that on the form.
To make the debriefing easier, I advise you to take pictures or to make videos. During the debriefing, you can maybe ask more people to come and this can help them understand the issue.
One thing that is important on this step is to not blame anyone. A problem can appear and you should not start to say to an employee that this is its fault. This can destroy the method.
You should take the information with you and wait for the debriefing to discuss the root cause.
If you start to blame people, they will not be collaborative the next time you come. Or they can hide information to you. Show them that you are here to support and not to punish.
The phase of Observation and Discovery go hand to hand because they are the one that you execute directly on the field. On the Gemba.
So after Discovery, you go back to Observation until you finish with the allocated time. And report all important information on the form.
In the end, you should now stop and go to a meeting room with the person that made the ODIAC with you. As mentioned previously, you can also invite other persons to help you.
Let’s move now to the next step.
Idea
You are now out of the Gemba. Oufff. How was it? Cool no???
Ok, but it’s not finished. Now as everything is fresh on your head, let’s move to the Idea phase.
As you may understand this phase is kind of a brainstorming session to first understand the root causes of the issues that you discovered and to identify potential actions to reduce or eliminate it.
5 Whys
As Simon Sinek says, you should “Start with Why”. This will explain to you why the “Why” is important.
See below the book and a TED talk from Simon Sinek.
Just use that to understand that the WHY is important but I will explain to you after the 5 Whys method which is different.
START WITH WHY shows that the leaders who’ve had the greatest influence in the world all think, act, and communicate the same way — and it’s the opposite of what everyone else does. Sinek calls this powerful idea The Golden Circle, and it provides a framework upon which organizations can be built, movements can be led, and people can be inspired. And it all starts with WHY.
Here is a video that explains in few minutes the “Start with Why” concept.
Subscribe to my Youtube Channel to get notified of my next videos
I hope you enjoyed it. Now let’s come back to the “Idea” phase.
So you have a problem and you need to find a solution to it. I recommend you to ask some SMEs to be part of this phase. As you may not know all the answer, it would be better to have people that can provide you with the right answer.
So instead of just making it theoretical, I will use a real example. During the Discovery phase, we find a problem which was a raw material mix-up on the raw material rack.
- Why was there a raw material mix-up?
- Because the person who fills the rack didn’t place it in the right place
- Why did this person not place it in the right place?
- Because the label on the raw material fall down so he didn’t know where to place it
- Why did the label fall down?
- Because this label is not sticking well on oily raw material
- Why are we using labels that are not sticking well on oily raw material?
- Because this is the method that was decided for all our raw material
- Why are we not using another method for different raw material?
- Because we never proposed another method to management
You are now arriving at the root cause. Your company never tried other methods to identify your raw material. So now you need to find the right method that goes with oily raw material.
Choices
You have 2 choices here:
- The SME knows the answer and can propose the right solution to eliminate the issue
- The SME needs to investigate the potential solutions.
The first choice is qualified for moving to the next step. This is an action that will eliminate the issue.
The second choice is not qualified for moving to the next step. We are still on the idea phase. So you need to ask the SME to come within a certain date to provide you with the action to implement.
List of Actions
You have now found a solution for each of the problems or potential problems that you identified.
You are now ready to move to the Action phase.
Action
Finally some action. Are you ready to kill those small monsters that can become big monsters if you do nothing?
During the previous phase, we identified the actions that should be implemented to reduce or eliminate the problem.
You should now:
- identify the right person to execute the action. So you should put a name (Only one, not many).
- Put the due date for this action
- Identify the status (40% done or 95% done). You should also monitor how long it stays on the same status.
You are now on the execution mode so it can take time. What is critical during this phase if to follow-up on the progress. This maybe means that you put in place a short meeting for people to come and explain the status of their actions.
But please, don’t just wait for the due date to ask why they are late or why this solution is not really solving the issue. You need to check before.
CAPA system (ISO 13485.2016)
One tool that is used is your CAPA system. This is a system that is on your quality system and can help you get credit on your actions.
If for example, the issue you discovered is a “Potential issue”, then you can open a Preventive Action. Imagine after many months using this tool and instead of having only corrective actions, you have a majority of preventive actions.
If I am an auditor and inspecting your company I would be surprised and the impression would be excellent.
“Instead of waiting for the problem to pop-up, they are preventing it.”
So your choice with the CAPA system, if well used, is a great tool for that.
Confirmation
Thanks for your patience. We are at the end. And you will now see the fruits of your work. But for that, you need to harvest them.
You have to go back to the field to check that the problem disappeared. During the confirmation phase, your work is to
- Confirm that the action was implemented
- And most importantly, to confirm that the problem is solved
Execution
To perform this you can plan a specific Gemba Walk to check that or you can use another ODIAC session and use a few minutes to confirm that the actions are finished and successful.
Adverse effect
Sometimes, we solve a problem but create a new one. During this step, you should also check if there is no adverse effect of what you implemented.
To verify that, you can first ask employees if they see that another problem is happening.
Second, you can make a 2 step confirmation.
- Immediate check that the action is done
- Wait a few weeks later and check if another problem didn’t appear.
As the ODIAC method is not a one time shot you will have opportunities to review if your solution was correct.
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Official or informal
At the start, I recommend you to make this method informal. This should be like a Pilot project to test for a few months.
When you will find the right balance in term of organization, planning, duration… then I would ask you to make it official.
You need to invest in this kind of program to always look for issues before they become big. More your employees are trained to it, better are the chance for you to receive a Return On Investment.
The issue is the fact that you cannot judge how much you saved as normally the problem should not happen. But maybe if you see fewer Non-Conformities or a change in term of the ratio Corrective Action vs Preventive Action, then you’ll consider this successful.
On this article I inform you how to create a procedure. I use the example of ISO 13485:2016 but this is not specific to it.
Important
One important thing is that, If you are missing the Confirmation step, all that you have done before can be for nothing. So please, always confirm that ODIAC Action is done before to closing that on your file.
If you miss it people will understand that anyway there is no check that the action is done. So they can be less focus on making things right.
So at the beginning of the implementation of the ODIAC method, you need to educate your employees so they are used to it. Don’t give up at the first roadblock. Just keep going but don’t underestimate the investment to implement this method.
Question for you?
I have a question for you and be honest.
QUESTION
ANSWER
Medical Device expert. Monir founded Easy Medical Device to help Medical Device companies to place compliant products on the market. He proposes his consulting services so don’t hesitate to contact him at info@easymedicaldevice.com or +41799036836
My objective is to share my knowledge and experience with the community of people working in the Medical Device field.
