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What is Quality for me? - Easy Medical Device website

When I started to look at how I wanted to answer the question “What is Quality?”, I made some search on what is said on the internet and I find a lot of websites showing you how to start to create a procedure or which ISO you should use or which software would really suit to your business.

I definitely said to myself that I should bring something else to people wanting to know what is quality. And as a Quality professional, I challenged myself to find an unconventional answer. So here is my contribution to this big puzzle.

This post will not be providing any specific technique to learn but more some behavior to have.

What is Quality for Monir El Azzouzi?

For me, Quality is a Philosophy and not a tool. It should be part of you as a professional and not only as a toolbox where some are using a hammer to put a screw on a wall.

All the companies I did work for did say the same things. Quality cost too much.

I need to hire inspectors to inspect the finished products. I need to hire engineers to solve issues. I need to hire professionals to manage my complaints. It’s costing more and more.

I should maybe agree but I am not. To save money on the quality budget, companies should increase education and awareness of their employees.

They should teach them why it’s important to offer the right product to the right people at the right time and the right price.

If your employees care they will understand but the Top Management should follow you. Without that, it will not work.

How are perceived our Quality Departments?

Since I am working in the Quality area, I see employees putting all the pressure related to identified problems in their Quality Department.

“If there is a problem, call Quality. They are paid to solve it”.

Oh my god. No!!!

As long as your company does have this mindset you will fail and pay more for your quality activities.

Instead, we should put ourselves on our customers’ shoes and ask “Would I give this product to a member of my family”.

If you really love your family and say “Yes” then you can sleep well and watch yourself in the mirror.

If “No” then it’s your right to stop everything. If your company is really caring about their customer they will understand.

Recall or not recall? this is the question

I had once a hard decision to make. I started to receive a complaint on an implant my company was selling. Nothing alarming as it’s an issue that occurs before the product is implanted. It’s during the functional test. So we replace it and we can go.

After 2 weeks I received more complaints from hospitals on the same product and the same issue. This was not normal. One hospital said that during the surgery all the implants they were trying failed. So the surgeon finds his way to complete the surgery but it was a hard moment for them.

We had to investigate immediately on this problem. But the first action from our side was to issue a “Stop Shipment”. Means that no more of those products are going to hospitals until we understand the issue. Our official communication to our customers was that “We are on Back-order”.

What do you think about this situation? Really hard No!

My CEO was a commercial guy and his main interest was to sell and sell more. So telling him that I stopped the delivery of one of his best selling implant was not something he really liked. But as soon as I talked about compliance, the risk to patients, reputation to your company then he started to listen a bit more.

While we were doing the investigation with the Product Development department, we identified that there was a lot of mistakes in the drawings of this product. It was launched many years ago so we normally have a lot of experience with it but apparently, it was not the best design ever.

Conclusion: The design was mainly the reason for the issues in the field.

After knowing the root cause, I had to convince my CEO that we need to start a voluntary recall. My second worst moment with my boss. But to put all the chance on my side, I didn’t go alone. I called for a meeting with all the management. Exposed all the problems. Define all the risks.

At the same moment, the Surgeon that developed the implant with us and was also a user of it complained that he had no more products available on stock and that it’s not possible to buy more. “What’s going on? I have postponed surgery because of that.”

Selling more or protecting our patients

After our meeting, the CEO was convinced that he had to accept the recall of the product.

It was a big loss of revenue but he understood that it would have also been a big issue on the market. If all the implants we were providing fail before being implanted, this would be a bad advertisement for us.

The bad news was that the correction of the design problem would take more than 1 year with resubmission of the dossier to the authorities…

So between Quality and Profitability, my company decided. And I was proud of it as I really did it like I was thinking this product will be implanted on my son’s body.

Sandwich effect

I am convinced that by inspiring our employees, we can succeed. What is blocking us sometime is our procedures, policies, documentation. They can be really difficult to handle.


Because I imagine that at the beginning, there was a version 1 of this procedure. This one should have been not so detailed and opened the door to non-identified issues. Or maybe too open to people’s creativity.

On the other side, version 1 can also have been created by someone who did put too many details on it. And I already saw some procedure where there was so much detail that it was impossible to carry out.

Usually, after version 1, we find some issues and start a revision of it. We create more checkpoint or constraints out of that issue.

Finally version change after version change, the procedure looks like a Sandwich with more and more layers.

I call it the “Sandwich effect”.

Each time a new problem arrives or a new person own a procedure, they create something new on it. A simple extra sentence which maybe will create more work for everyone. Or remove one sentence because everyone is complaining.

When you are looking at a procedure it should be globally and not only for that piece of problem you have.

More inspection

Once we had a new process for a new product. We created a procedure for manufacturing and inspection of it.

After a few months, we observed a Non-Conformity during production and the outcome of it was to include more control.

At the end of the process, we find another issue. So we asked to put again more control.

When I realized that there was too much inspection, I asked why do we have all those controls in place.

People were mentioning to me all the issues they did saw and to mitigate those issues they needed to check more and more. The purpose of this was to be sure that there are no wrong products that go on the field.

So I suppose that employees were doing something wrong if at each step we have to inspect what they normally should do right the first time.

Conclusion, we are not confident about our processes.

The coffee cup syndrome

So imagine now that you are walking in the street. Behind trash, you see an empty plastic coffee cup lying on the floor. You pass just by and say to yourself,

“I could have taken it and put it on the trash but it’s not my job. And I am sure there are employees that are paid for that. If everyone is doing it then those people would have no job. So it’s a service I am doing for them to not pick it and put it on the trash”

I know it’s a bit exaggerated but I am sure that you recognize yourself on it. For sure, I am not blaming you.

But this Coffee Cup syndrome is what you see on companies that have too much inspection steps. People at the beginning of the chain are doing their job but make a mistake. The next person who did find the issues says to himself:

“Ok, I think there is a mistake here. This will be identified at the final inspection normally so I can let it go. If I alert my manager, I’ll have to fill some documentation and it’s nearly the end of my day. So I will let it go”

Ok, I think you understand the concept of letting an issue go because someone else will find it. But this will increase your costs. The next operations until the final inspections will be executed which will cost money for the company. So you are paying for something that you should normally scrap. This is not quality.

To illustrate the Cup of Coffee syndrome, I want you to have a look at this video. This is an experiment made in Lille (France). Imagine from my example that the person passing by are your employees.

So, if every people passing by were helping we will save time and energy. Keep that in mind when you identify an issue and say that this will be corrected by someone else.

Does quality cost more every year?

Quality Cost more and more - Easy Medical Device

What I described to you before is the disease of our industry. As we put more controls, more people on the loop some of our employees feel not responsible anymore. They try to give the hot potato to someone else and this is non-quality. So non-quality is costing money.

It’s why the Quality Manager is always asking for more resource. Because he has no other short-term solution than to increase inspection workforce. And Engineering Department has no other solution than to increase Control points and sample size.

But as mentioned this is a short-term solution. If you have it as your last solution then you fail. You should use this short-term solution while you start a long-term one. Otherwise Yes Quality will cost you more.

Long term solution

As mentioned at the beginning of this article for me Quality is a philosophy and not a robotic automatic system. You need all those tools to make your life easier. But if you don’t know how to use them or if you use them only to cross a checkbox on your procedure without an added value it will also not work.

A philosophy. It’s funny talking about philosophy as I hated this discipline at school. I really didn’t understand it or maybe because my teachers were not able to help me understand it.

This is also what happens to our companies when we talk about quality.

My dream company

Imagine a company where there is no Quality Department or maybe just one person that is in charge of Quality.

When we are manufacturing a part, everyone is so dedicated to it that there is no need for tons of inspectors to verify the work as the person who made it did really take care.

The procedures are created on the philosophy of “Write what I do and do what I write”. So no fancy idea of things we should execute but we are not able to do in reality.

Each people I hire is really dedicated to satisfying our customers. And want to help any other department that struggles to make it happen.

On all the walls of the company, the Vision and Mission are written so you always know why you are doing what you are doing.

Last technologies are implemented to give to our customers the best service and best quality possible.

I know it’s only a dream it’s why I put a rainbow on my first image.

On our companies, Logistic people ask quality to remove some steps on the procedures to accelerate the delivery of urgent parts without looking at why this process was built like that.

Product development is asking “why I should verify if the method I am using to measure my parts is correct. This method is used since ages?” or “Why you need to inspect 100% a feature that is Critical to Quality?”

I really want to introduce a Quality Seed on each people’s mind so this grows slowly but will offer the benefits later. Quality Culture is not built on a short-term but more on a long-term.

What should every company do?

If I was asked, I would say that communication is where I should invest the most to change the Quality Culture over time.

Do every employee know the Quality Policy or the Vision and Mission of your company. This information should be on your website, your walls, a training of the employees should be done every year to remind them. You should also test this by asking your employees if you think we are complying with all this. Perception is really important.

Repeat it

If you say it only once, this will not work on the long-term. Your employees should hear it and see it applied by the top management. If top management says that they should do this or that, and employees see that they are doing something different, it will not work.

The only moment that you will notice if your company changed their company culture is in difficult situations (or opportunities for improvements).

If you have a problem with one of your product, you will see:

  • If logistics is pushing to hide it because they have some timeline to respect.
  • Maybe Product Development is trying to push the product to go to production even if the problem is not solved. All the bad aspects of your companies are seen when there is an unexpected situation to solve.
  • or Production department is not escalating the issue because for them it’s nothing and it’s too much paper to create.

Regulation to follow

The other aspects of Quality are when it is linked to a regulation. When we have to respect a law, we should not ask why but respect it. If this law makes no sense then you should try to change it but not put it aside because it doesn’t fit your expectations.

One thing that I experimented that you should know.

When we asked other departments of the company to be involved during audits, we really noticed some changes. When there is a question related to maintenance. it’s the maintenance SME (Subject Matter Expert) who is answering the auditor. When it’s about logistics, production,… it’s the same.

We involve SMEs of different departments as they are the expert who should know the answer to the question.

One of the reasons other departments push everything on the quality department is because for them we are the one that is in front of audits.

So they don’t feel responsible if there is an issue.

But, with this method, when we have a problem with production, the Production expert should answer the auditor questions. It helps to increase awareness.

Why is this helpful?

Because next time there is a problem in production and I got challenged, I ask them “Would you be comfortable to explain that to an Auditor?”. As he already experimented it, it’s easier for him to answer.


Quality is a philosophy that everyone should embrace.

If you want to decrease the cost of quality, each employee should have a piece of it on all what they are doing. Without this, you will always pay more for quality and be less competitive.

All the other companies that are following that advice will in 3-4 years be able to cut their cost and propose less expensive products to their customers. Or at least not increase cost.

If you recognize yourself on this or if you have another opinion, please let me know.

What is Quality? Definition and Behavior Guide [Medical Device]
Article Name
What is Quality? Definition and Behavior Guide [Medical Device]
As an expert on Quality in the Medical Device Industry, I wanted to answer myself this question without talking about ISO standards or Quality System Software.
Publisher Name
Easy Medical Device
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Categories: Quality

Monir El Azzouzi

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 or +41799036836 My objective is to share my knowledge and experience with the community of people working in the Medical Device field.

UK Representative from January 1st, 2021

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