Mortara Instrument and Document Management Excellence Part 1

This is part 1 of our 2-part blog series featuring Milwaukee-based manufacturer, Mortara Instrument. At SyteLineCon 2016 we saw how Mortara Instrument was faced with the challenge of too much paper in their business processes. Too much paper can not only drive up the cost of doing business, but it can also slow down the performance of your workers and harm the environment by needlessly depleting natural resources. John Duren, Senior Vice President of Mortara Instrument presented at the conference how their organization facilitated rapid growth plans by eliminating the paper that was slowing down their business.

This presentation was part of the Better Your Best Contest at SyteLineCon 2016, where we asked participants to tell us how The Lake Companies’s products have helped them realize improvements in their manufacturing businesses. John Duren was kind enough to share his story with other manufacturing industry professionals who attended the conference, and we’re here to give you a recap of his presentation with the hope that you and your company will benefit too.

Mortara Instrument is a rapidly growing manufacturer of medical diagnostic cardiology equipment. The company was started in 1982 by David W. Mortara, PhD, in Milwaukee, Wisconsin with the guiding philosophy of “design to a need, keep it simple, and make it economically accessible.” Lives depend on the pacemakers and products produced by Mortara Instrument, which leaves no room for error. Since Mortara Instrument makes products that can be the difference between life and death, the company’s manufacturing processes are highly regulated by the FDA and other global organizations.

This led to a challenge for Mortara: how could they stay in compliance with the many regulations, while still maintaining their business?

Some of the compliance requirements they have to follow include:

  • Traceability for each instrument: what went into it, where did it go, what customer has it, and what service was performed on it?
  • Documentation during the manufacturing process: what work was done, who was the operator, and was there a specific part number that went into a component?
  • And most importantly, documentation requiring that everything has to be perfect.

The Paper Problem

Mortara Instrument has experienced great growth since its founding in 1982, and has plans to continue doing so. Beyond the Milwaukee, Wisconsin headquarters, Mortara has additional offices in Australia, Italy, Germany, the Netherlands, and the United Kingdom, and has plans to add additional facilities and to double its size in 5 years. However, with that many locations and plans to continue growing the business, Mortara faced the challenge of managing all the paper that came with their business processes.

As John Duren stated at SyteLineCon 2016, “To give you an idea of the paper processes that were taking over Mortara, we would print out over 100,000 pages of paper per year for this process. That’s twelve pallets of bankers storage boxes. If we double in size that would be 200,000 pages per year.” That is significant time and maintenance dedicated to paper documentation processes.

“The biggest concern is those records have to stay around forever,” Duren said. “We have to keep them 20 years beyond the expected life of the device. Our devices last anywhere from 7-10 years, so effectively we are keeping the records forever.”
John Duren

There were two major challenges with Mortara’s paper-based compliance system. The first was concerning the normal job packet that everyone was used to seeing in SyteLine.

“We’d print the packet, our serial number labels, and we’d take all the information off the line,” Duren said. “The operators would work on a device and when they were done and finalized all the job paperwork, we’d take that paperwork and scan it so that it would be retrievable in the system. And then we’d put it in a bankers box and file it away.”
John Duren

In addition, when you manufacture a medical device, you have to create something called a Device History Record. This document basically tells anyone everything that has ever happened with the device: what components went into it, who the operators were, the serial number, and much more.

Duren went on to say, “So we were maintaining two pathways. That form had to be printed on a completely separate system where we’d record job information. We had manual signatures and approvals on that. QA would have to review every one of those before we could ship a unit. And finally we’d have to scan it and file it away for future years. Again, a very onerous process. Part of what we review is that nobody missed a signature. There’s huge opportunities for errors here, and we decided that there had to be a better way.”

Duren said that as Mortara continued to grow, they considered several options:

  1. The first was to not do anything. They could continue to grow, add more employees and standards, and thus more copiers.
  2. The second option was to find a better way to scan the documents to make the process easier.
  3. The third option, which they ended up moving forward with, was to figure out how they could fundamentally change the process and eliminate the paper and all of the manual operations that went along with it.

To accomplish this, Mortara contacted The Lake Companies.

Duren said, “So what we did was sit down with The Lake Companies. We said, ‘Come on in and look at our process.’ Steve Smiley was a key component of this and he said, ‘Well here’s what you’re doing wrong.’”

To be continued…

Stay tuned for the second part of this 2-part blog series where we’ll see the solution Mortara Instrument implemented with the help of The Lake Companies to take control of their paper-based processes and how they achieved significant cost savings.