Case Study
Bild eines Laborarbeiters in der Elektobranche

Quality in production

Expanding horizons: Raising awareness about quality

The highest expectations for quality are part of everyday life in the pharma and life sciences industry. One medical technology manufacturer wanted to reduce its error rate on a production line for electric specialty pumps by a factor of ten through improved quality management. Together with ROI, the company identified the right approach and increased quality in a way that is scalable to other product lines.

Challenge

A medical technology company had to reduce the number of errors on the production line for one of its top products by a factor of ten. Strict market regulations limit the means at their disposal.

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ROI’s solution

A precise analysis revealed the key sources of error. In workshops, ROI also created the foundation for a new work culture that increases the team’s sense of responsibility for improving quality.

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Lessons learned

Discussing the work culture in terms of specific actions at all levels of hierarchy. Motivating employees to find and take advantage of opportunities to improve. Not just focusing responsibility for quality in one area, but rather distributing it across many hands.

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Success model of ROI

In this project, transparency was the key to change. The focus was on the flow of material and information on the assembly line and on new insights by employees into their own practices concerning quality and errors.

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Strict certification requirements ensure the safety of patients in the field of medical technology. From dental drills to nuclear magnetic resonance imaging machines, every product goes through a long cycle of internal and independent testing. Only then – and after a declaration of conformity is issued – is the product given a CE mark in Europe or approved for sale in the US by the Food and Drug Administration (FDA). These regulations require, among other things, extremely precise quality controls in production to make sure that faulty devices are never used on patients. But once a product is given a CE mark and becomes FDA-certified, the selection and arrangement of components, cables, or miniature screws cannot be modified in the production process as easily as with other industries – any change, however small, must first go through another time-consuming testing and approval process by officials for the entire product. 

Quality control with high standards

Under these conditions, quality management in the production of medical technology has to accomplish a great deal because many errors cannot be eliminated simply through design changes. In this particular case, a European manufacturer of electric specialty pumps already had an extensive quality testing process in place for the production lines of its top product. But the company was not satisfied with just shipping flawless devices to its customers. Management knew that streamlining assembly lines for efficiency and effectiveness is only one side of the coin. The other side is constantly making small improvements in quality control processes to increase overall quality while saving time and money. But the art is to identify these areas and quickly implement them in everyday production. 

Uncovering sources of error 

The project team, made up of ROI consultants and project managers from R&D, production, and quality assessment, tackled this very task. The COO of the company gave the team a clear objective: reduce the number of errors in the pump assembly process by a factor of ten. The plan was to do this first in a production line with nine assembly stations and then later adapt it to two other lines.

Assembly errors are inevitable

In the first step, the project team identified the sources of errors and the primary groups of errors in the pre-assembly and assembly phases for the specialty pumps. It turned out, for instance, that misconnected cables and hoses created an extremely high error rate. Employees on the line have to plug in about 70 cables for each pump – 70 very thin, minimally labeled cables of the same color. So assembly errors are inevitable. 

Poka-yoke is not an option

But to eliminate these sources of error, for the reasons mentioned above, it was necessary to rule out options and principles like poka-yoke that modify the design or structure of the product. It is simply more expensive to put new and improved model generations through the strict approval process again and get them ready for market than it is to correct product errors internally during the production process itself. 

First pass yield rate reveals weaknesses 

In the case involving specialty pump assembly, the company therefore tolerated a first pass yield rate of 80 percent during quality assessment. In other words, out of 100 devices, 80 passed the final quality check without any problem, while 20 had to be repaired. This is a serious problem when the volume of devices produced each year runs into the thousands. Especially since it is not just the quality control and repair of “rejects” that cost time and money, but also error reporting and unquantified losses caused by undocumented reworking.

Ways of increasing quality

Once the company in tandem with ROI had clearly identified the most important error sources during the analysis phase, the project team turned its attention to three areas of improvement: tools, quality gates, and a new work culture.

Measures to prevent errors

A detailed analysis of the most common errors showed where to quickly avoid simple mistakes in the assembly and preassembly phases. Asking a couple questions was key: How is the material provided? What is the assembly process? Based on their answers, the project team took action. For instance, reconfiguring assembly devices and instructions and quickly eliminating sources of error using other tools, templates, or accessories for the work stages.

Introducing quality gates

Despite extensive testing of finished devices during the final quality control phase at the end of the assembly line, approximately 20 percent of the pumps had errors that were detected during subsequent continuous operation. As a result, the project team installed quality gates at all assembly stations to check the assembly output of the upstream station. Errors were therefore discovered before any further assembly work was done on the device. When the person causing the error can fix it immediately, this not only raises consciousness about quality but it also increases the ability to visualize all the mistakes occurring at each assembly station: What classic errors occurred? Were there more or less of them? Did we meet the error goal? What were the most common errors?

Noticeably changing the work culture

In this way the factory team was able to quickly determine the right improvements almost immediately during the first few days of this project phase. But an even bigger benefit from this process came from another area. Previously, the team was only able to see routine “individual” errors, but not the actual source of systematic errors. So it was necessary to change the work culture to clearly identify these kinds of errors instead of sugarcoating them with excuses. After all, if you take on the truly important problems head on, you improve quality much faster.

Raising awareness about quality

During change management workshops, ROI therefore showed the team how to raise awareness about its own workflow. At the management level, for instance, this took place in the context of a higher-level change initiative: What kinds of goals should we set? What (very specifically) is preventing us from doing that? What are the specific actions needed to achieve a change in the work culture? How does each member of the management team specifically contribute to this mission?

ROI conducted this same workshop with all other staff members. Some employees experienced a similar “aha moment.” Despite making obvious mistakes, they had simply stopped improving in some areas and had passed on responsibility for quality to the quality assessment phase at the end of the line. During the project they saw how looking out for and identifying mistakes improves not only the quality assurance process but also simplifies their own work. This realization was a critical turning point – now it is just a matter of ensuring that employees maintain their sense of quality and motivation for achieving this going forward.