Prepared for Medical Audits Anytime: Quality Data Management with ZEISS PiWeb

In the center of a large, sunny room is an operating table among a half dozen medical-technical devices. Along the wall hang endoscopes, hand instruments and other assorted equipment that are used for operations. In the back, a large video screen is showing an operation in progress. A sign warns that the area around the operating table is off-limits to unauthorized persons, but that’s misleading: no one is being operated on here. Normally, this room is meant to give visitors to Olympus Surgical Technologies Europe in Hamburg a behind-the-scenes look at the company’s product portfolio. But there are no visitors due to the extra caution connected with the Covid-19 pandemic. Instead of welcoming clients and other interested persons, today employees of this medical technology company are waiting in line during their break to get vaccinated in a side room of the showroom. It’s an offer emplyees are thankful for, and eagerly take up too.

Covid-19 has once again made society aware of the relevance of modern medicine — and highlighted the progress that has been made since the last global pandemic, the Spanish flu in the early 20th century.

The medical innovations that have taken place since then are in no way inferior to those in automobile manufacturing, aviation and IT. Things we take for granted today would have seemed like magic to people back in 1918. That said, medical progress has gone hand in hand with rapidly increasing regulatory requirements for medical technology companies. This has created significant challenges for manufacturers in this industry, from the product development stage all the way to final quality assurance, as companies have to ensure not only high quality, adherence to the standards for their products, and reliable processes in production and testing. They also need to be able to trace everything, with no gaps in-between. To avoid mountains of paper and the accumulation of information on an endless number of drives, Olympus Surgical Technologies Europe relies on the ZEISS PiWeb solution to manage the quality data in its Quality Laboratory. The laboratory uses the ZEISS database to save all inspection plans and measurement data associated with production development, and to create analyses and reports. The result has been a massive increase in data and process reliability, significant cost and time savings, and new possibilities to document things. It has turned audits from being a nerve-wracking experience to child’s play.

As a high-tech specialist within the Olympus Corporation, Olympus Surgical Technologies Europe is the development and manufacturing center for rigid endoscopy, bipolar high-frequency surgery and reprocessing. With a total workforce of 2,600 employees at nine locations in EMEA and its headquarters in Hamburg, the company stands for exceptional performance in medical diagnostics and therapy, and offers a full range of the most modern endoscopic applications, from single products to procedure-oriented systems solutions. Hamburg is the manufacturing site for essential medical products such as rigid endoscopes, video endoscopes, surgical instruments, ENT (ear, nose, throat) instruments and much more. Hamburg is also where Research & Development and the Quality Laboratory are located. The Quality Laboratory is the central competence center for dimensional metrology and mechanical tests at Olympus Surgical Technologies Europe. Each year, this department performs around 6,000 inspections on behalf of R&D, Operations and Quality Assurance as part of the product development and product approval, and for supplier development & qualification.

As Olympus Surgical Technologies Europe had already been using several ZEISS devices, including coordinate measurement systems (CMS), and ZEISS software for many years, the company quickly focused on ZEISS PiWeb. ZEISS presented this software solution for reporting and statistics during the 2018 Control trade fair, and that’s where Jens Biedebach and his team were introduced to ZEISS PiWeb for the first time. They were immediately excited. “At the time, we were looking for a database that could connect all devices, no matter from which manufacturer, including handheld measuring devices, and which we could use to document our inspection plans, measurement results and calibrations, and also run statistical analyses. All that is possible with ZEISS PiWeb. The search for alternative solutions was unsuccessful: “Naturally, we inquired about such a solution with other companies to see if they had something similar,” explains Biedebach, “but they told us that what ZEISS PiWeb offers, they hadn’t even started to develop. That made the decision easy for us.” An important issue during the implementation was connecting all the measurement machines. “A big advantage of ZEISS PiWeb for us is that CMSs from ZEISS work together natively. That’s important because we do a lot of measurements with very tight tolerances,” explains Merle Stiller, Quality Specialist at Olympus Surgical Technologies Europe, who was responsible for the implementation of ZEISS PiWeb. “There’s hardly any other database that harmonizes so well.” Another important consideration was the ability to connect to the measurement equipment of third-party manufacturers, including the different handheld measurement devices that are used for interfaces. As a result of this connectivity, Olympus Surgical Technologies Europe was able to integrate its software systems in ZEISS PiWeb. The Quality Laboratory for product-lifecycle management uses Siemens NX with an add-in from a company named neoapps in order to identify features and tolerances. All this could be transferred to ZEISS PiWeb, as well as the approved technical drawings. Information about the testing equipment also has to be provided for every inspection, so the database for inspection equipment, which is in SAP, was implemented in ZEISS PiWeb as well through an API. The protocols, including all digital signatures, are filed in the PLM system ProLIMA and automatically exported to ZEISS PiWeb.

This complete digital workflow with ZEISS PiWeb has been in place at Olympus Surgical Technologies Europe since December 2020. And the results are impressive. “All raw data, calculated data, inspection plans and measurement values are saved in one place, we create the protocols centrally and can compare the values fast and easily, for example the batches from suppliers,” says Jens Biedebach. “This has led to a massive boost in efficiency compared to our previous situation when our data was saved in many different places and could only be analyzed manually.” ZEISS PiWeb has also become a big asset for planning inspections thanks to the ability to achieve extensive standardization. “We now have the possibility to save a clear inspection plan for every single item and therefore to standardize our process,” says Jens Biedebach. “We can also attach instructions to any inspection plan about the inspection method, or the correct group of inspection equipment to use. Features of the same parts can therefore be researched – all of this makes it so much easier for the inspectors to achieve a consistently high level, which is ultimately reflected in a higher quality of the measurement data.”

Last but not least, ZEISS PiWeb provides peace of mind for the audits that happen several times a year, for example audits on how the inspection equipment is calibrated. As Jens Biedebach explains, “In the past, we had to find and gather all the relevant documents from paper file folders or from different directories. Today, everything can be easily researched in one validated database. That gives you a totally different feeling when you go into an audit week.” The connectivity of ZEISS PiWeb offers significant advantages in ful-filling the ever-stricter requirements during these audits. “Previously, you could just show the auditors the protocols; today, everything is much more in-depth. For example, the auditors want to see detailed data about the inspection equipment, etc.,” says Jens Biedebach. “It’s important to be able to keep up with this develop-ment, and with ZEISS PiWeb we have found the optimal way to do that.”

Merle Stiller is pleased that the introduction of ZEISS PiWeb, for which she was mainly responsible, is more or less complete. Even better: in the summer of 2020, the team won a global award from the Japanese Olympus Corporation, beating out all other large change projects that were in the competition. Merle Stiller is entirely satisfied with today’s result: “It‘s fun to work with the software and it’s just great to see what it’s doing for us.” The cooperation with ZEISS was positive throughout the project. “There was also a terrific communication, our wishes were taken into account, and our requirements taken seriously. And whenever something was implemented by ZEISS, they always followed up right away to ask if everything was working OK. This kind of dedication also contributed to our close partnership.” Jens Biedebach agrees: “We were impressed with how ZEISS always had an open ear for us and was always prepared to develop a solution specifically for us. ZEISS is a partner that on the one hand knows its customers and their requirements and on the other hand is always prepared to learn new things together with its customers – that’s a perfect mix and leads to an excellent relationship where you feel really comfortable.” That’s the reason why Olympus Surgical Technologies Europe is expanding the ZEISS PiWeb project. The company has decided on an enterprise license in order to be able to connect more business areas and more geographic locations to ZEISS PiWeb in the future. The data sources of external suppliers and service providers will be able to be integrated too. Furthermore, a global manufacturing execution system (MES) is planned in the future for Olympus as a whole. ZEISS PiWeb will be the central place for data collection and data analysis for this new MES. “Anyone who has experienced the added value of our end-to-end digital system can’t get enough of it,” states Jens Biedebach. “Thanks to ZEISS PiWeb, we have laid a valuable foundation for our future and we will benefit from it for a long time.”