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Eastek Earns ISO-13485 Certification at Lake Zurich Headquarters

Diversity Matters

Leveraging experiences, cultures, and generations, we showed how diversity may be our greatest strength.

Eastek diversity matters

A medical device customer came to us wanting final assembly done in our Lake Zurich, Illinois facility. Unfortunately, upon conducting a joint audit, we determined the facility wasn’t ready yet. We needed to find a solution–one that would require the knowledge, best practices and experience that have differentiated our company for the past 25 years.

Very often, exceeding customer expectations isn’t what’s easiest, most profitable, fastest, or most comfortable. Still, we try to do what is best or what is right for our customers. It’s part of our culture at Eastek, and we believe it has healthy, long-term benefits. When our engineers and project managers stretch their creative muscles, it makes us a stronger company. And we’ve found that doing the right thing, consistently, is why our customers choose us, stay with us, and refer us to others.

At Eastek International, we love the products we make. And in turn, our customers love what we make possible for them. With each new program, we’re challenging ourselves and leveraging our global experience in order to provide the best possible single source solution for our customers.

Manufactured products can be indistinguishable from one another once they enter the marketplace. Best case scenario, they look alike and function the way they should. Where Eastek stands out from other contract manufacturers is at the ground level, where our people and their creativity make the difference.

People like Barb Parsons and Juanita Martinez are integral to the Eastek story. Last summer, the aforementioned medical device customer contacted Parsons with a well-documented, high risk project that could revolutionize its industry.

Both sides wanted manufacturing done in Lake Zurich. However, the customer wanted its manufacturing done in a facility that has already done assemblies and already had the ISO-13485 infrastructure (which includes Device History Records (DHRs) and Device Master Records (DMRs)). Parsons knew the Lake Zurich site wasn’t ready. And a joint internal audit confirmed that. But, she also knew that Eastek’s smaller facility in Menomonee Falls, Wisconsin (called “EACT”) was already ISO-13485-certified. In fact, she lived nearby and worked with Martinez for many years before Eastek president Joe Rocco acquired the shop in 2013.

Located just outside Milwaukee, Martinez, Parsons and EACT had built a strong and proud reputation for over two decades. The acquisition by Eastek represented a decidedly larger scope. Eastek’s 1,000 employees are spread around the world–in Illinois, in Wisconsin, and in Dongguan, China. Rocco’s long-term vision was that of a unified brand communicating, working creatively, and serving customers with one voice. At the time, however, EACT had not yet worked in great depth with the other two sites.

Tribal knowledge regarding ISO-13485 existed throughout the company. But, the challenge in the summer of 2017 was to pull it all together under the guidance of mentors with useful experience, while figuring out some way to get the customer’s project moving in the right direction.

Eventually, the creative engines began to churn.

It was Parsons who initially suggested transferring manufacturing to EACT, which while limited in space, had the desirable capabilities. But she wasn’t sure how to make it happen. All the required parts were being shipped to Lake Zurich. Also, the project required a sophisticated six-foot long test fixture. When originally quoted from an external source, it called for a four to six-week lead time.

Then, for the second time, an answer surfaced in our own backyard. Former Eastek VP of Operations for Asia, Jeffrey Li, suggested enlisting our Dongguan facility to build the necessary testing rack and send it to EACT to be assembled. The workaround would reduce lead time by a month and save the customer unnecessary costs.

Li was already helping Lake Zurich pursue its ISO-13485 certification, and saw the opportunity to lean into our vertical integration strengths. Taking existing best practices from Dongguan, Lake Zurich and EACT, we produced a solution which the customer approved, ultimately intending for long-term production to continue in Lake Zurich once the site was certified.

As the mentor of the team, Li used his wealth of experience to open and cement alliances overseas. He also took the drawings, and the parts, and assembled everything himself. This allowed the rest of the team to produce work instructions and other relevant best practice documents.

The engineering team in Lake Zurich worked cohesively with the team at EACT and masterfully put the production line together. All along, 28-year old quality engineer Ulises Perez was learning to paint the picture with help from project lead Tarik Galesik, and EACT colleagues Sandra Coman and Andy Bailey.

Eastek diversity is a strength for contract manufacturing customers

Across borders, languages, ages and genders, nearly 20 Eastek employees leveraged decades of global experience to a single product need. The collaboration became a symphony of moving parts and complementary backgrounds, spanning generations, cultures, and time zones.

Li’s creative test fixture solution not only reduced lead time, but also resulted in lower costs for the customer. In addition, keeping the test fixture design and build in-house allowed Eastek to monitor and quickly address any issues that would have arisen.

Perez helped set up the manufacturing floor at Lake Zurich and assisted the engineering team in creating the necessary DHRs. He was also part of the quality assurance team that managed the internal timeline, noting what was necessary to become ISO-13485. The team spent the fall working on procedures necessary to accomplish their goal, such as design transfer, the DHRs, DMRs, and final acceptance.

When the customer’s internal auditors finished their second evaluation on October 12th, they acknowledged the huge difference from where Eastek was just four months earlier. They expressed a high level of confidence in our ability to make their product for them.

What was responsible for closing that gap so quickly?

“We’ve made a number of improvements to our quality management systems over a three-year period that have allowed us to show our strengths and partner with customers to meet these requirements,” Martinez said. “I’m proud of the folks in Lake Zurich for their achievements.”

Martinez acknowledged room for improvement, but also highlighted the sort of communication that has become a hallmark for Eastek, which foreshadows more collaboration to come.

“Putting together the infrastructure for this customer required us to work as a team and lean into our intracompany relationship,” she said. “The big win for us is in the synergy expressed by three different sites on two continents coming together to complement and expand on each other’s capabilities.

“That’s also a win for customers,” Martinez added. “The experience forced everyone here to be better for other projects they’re going to work on together in the future. It showed that we have some really creative people and opportunities to collaborate in-house.”

This was a multi-generational win for Eastek. Across locations, age groups, genders, backgrounds, and departments, everyone had an instrument to play. Even for customers that aren’t involved in medical devices, this shows how Eastek is able to make a type of product that was a little bit outside our box, and how we could evolve our core competencies to offer even more.

“Some might do the bare minimum. We try to do what is best or what is right,” Rocco said. “That takes a more serious investment of time, energy, creativity and sometimes cost. The end result is better for the customer and ultimately better for Eastek, too.”

“It’s so rewarding when you take your knowledge and best competencies from around the world, as well as your lessons learned and come together as one company,” Martinez said. “The project required a key component from each one of the sites, so there was a sense of real pride here from the people involved as well as everyone in the company seeing their success.”

Indeed, it was a team effort, and perhaps a tipping point moving forward.

“When you’re in the moment, it’s hard to look at it the way we do now,” Perez said. “It’s really amazing what we accomplished. The transition wasn’t necessarily smooth, but those bumps along the way will help moving forward. Those lessons learned will help all three sites work better next time we have a project that involves them all.”

When customers regularly visit the Lake Zurich corporate headquarters, they understandably want to see what Eastek does. The facility has the square footage and the domestic presence many American companies demand from manufacturers. Now, as the company continues to expand its footprint in medical device manufacturing, Eastek expects the Lake Zurich facility to have ISO-13485 certification by May, 2018.

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