An Interview with José Fuentes – Part 3: Sustainability and Future Plans

In the final section, José discusses sustainability considerations for the clean room and the team’s commitment to continuous improvement. He also shares insights into the size of the quality team in Mexico and their approach to lean manufacturing standards. Finally, José reflects on his role and the challenges ahead in ensuring the project’s success.

Viola Frey

Let’s talk about sustainability. Are there any new requirements you must meet to fulfill any sustainability issues, or is there anything you can do to be more sustainable with the new clean room?

José Fuentes

In terms of sustainability, maintaining the clean room’s ISO A classification after qualification is important.

This means that once we have the qualification, we must maintain the right conditions to avoid anything out-of-specification in those particular areas, such as temperature, particles, or contamination.

In this sense, the situation of the cleanroom at the beginning is that there is nothing in it. We have no equipment or operations, so we only need to enter the cleanroom once we receive all the machines and production lines. We received some of the machines in mid-January, and that’s when we had to make the appropriate preparations to avoid contamination when we started moving all the production equipment into the cleanroom. A second qualification or re-qualification will be required once we have all the equipment in the cleanroom.

Viola Frey

And when will that be – at the end of 2024?

José Fuentes

Yes, by the end of this year, or, let’s say, Q4/2024, we expect to have all the equipment inside the clean room and to achieve the re-qualification.

The re-qualification aims to demonstrate that the clean room meets the requirements according to the ISO standard of classification A with all the equipment inside the clean room.

Viola Frey

Will you be responsible for quality when the machines arrive and production starts?

José Fuentes

That’s exactly right. From a quality perspective, we are involved even when we are not producing. But it is necessary to maintain the conditions of the clean room in terms of good manufacturing practices or GMP standards.

Viola Frey

What is the size of your quality team in Mexico?

José Fuentes

At the moment, we have six people on the quality team:

Besides myself as the Quality Assurance Manager, we have four Quality Technicians and one Quality Engineer on the team, who also came with me to Switzerland for training. We are also considering hiring two additional Technicians and one Quality Assurance Engineer for the project. This will be not only for the project but also for the regular production once we have the product in production, and certainly for the rest of the products we make.

Viola Frey

When planning the clean room, did you consider applying Six Sigma and lean manufacturing standards, as these are our usual standards?

José Fuentes

Yes, since this project involves transferring technology from Switzerland to Mexico, we have the great advantage of the experience that the Swiss team has gained over the last month. So, from a planning perspective, we have a design of the warehouse’s layout, including the clean room and the auxiliary areas that will provide services to it. For example, the raw material feed, which will be located next to the clean room, is included in this layout.

This will be very efficient for the process. The intention is to have a lean process from the beginning and avoid any significant improvements needed before the process’s release. Later, once we start producing the new components, continuous improvement will be in place. Our starting point will begin with the baseline from the Swiss production line.

Viola Frey

What do you see as the biggest challenge in this project?

José Fuentes

Well, the biggest challenge from a quality perspective is that at the end of the project, before we start regular production, we can show that the Saltillo site can produce quality parts based on customer requirements.

Viola Frey

That’s the beauty of this project, right? To serve the European market from Switzerland and the North American market from Mexico. So this clean room is dedicated to one customer, but with the remaining capacity at the Saltillo site, we have room to expand, and more customers could benefit from this: Swiss quality – made in Mexico.

José Fuentes

That’s true! The whole team in Mexico is committed to this project and loves being a part of it. They all want to show how well we can execute, so we look forward to finishing the project and getting into regular production. I am very proud of this team.

Viola Frey

Thank you very much for the interview, José.

Read the second installment of this interview series here.