A lot of options. Zero error tolerance.

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Mariana Kaesemann
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PROCEED magazine 
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Digital reorganisation of interim audits and final inspections

Bad Ems, Germany - When it comes to life or death, mistakes are simply not allowed to happen. When manufacturing medical ventilators for hospitals and clinics or for domestic use, Löwenstein Medical therefore pursues a zero-tolerance strategy vis-à-vis all possible human errors. With the help of SCIIL AG, the intermediate and final inspections scheduled to be conducted during the production process were reorganised in just 6 months, and leave no room for misunderstandings despite the previously unwieldy number of device variants.
Löwenstein Medical is a manufacturer and distributor of top-quality medical products focusing on neonatology, anaesthesia and intensive care medicine, as well as sleep and respiratory medicine and oxygen therapy. A profound service commitment, practised customer proximity, and enormous innovative strength in the development of new technologies, are the decisive factors that have made Löwenstein Medical a market leader in many areas of medical technology. The employees of the Bad Ems-based company work every day with great motivation and expertise and fully dedicated to the health and quality of life of patients.

A lot of options. Zero error tolerance.

The greatest possible flexibility with the equipment variants, and the numerous individualisation options that can be adapted to accommodate the intended application, is a real blessing for the customer – in this case the patient – and can make even a serious illness a little more bearable. However, the production line, in particular the quality inspection, is often faced with the difficult challenge of working flawlessly, yet efficiently with a large number of variants.

Until recently, Löwenstein Medical used inspection plans in the form of general paper forms that had to be filled in by hand by the inspecting employees, who had to decide which inspections were relevant for the respective device variant and options on the basis of instructions and their own experience. Despite regular and (time-) intensive training, this system provided for a certain probability of error due to the existing scope for interpretation.

The new system should guarantee clearly defined, traceable and documented controls during the production, as well as full final controls before delivery. It was also necessary to develop a system to steer the regular warranty inspections.
After analysing the previously used documents and a closer examination of the production and maintenance workflow, a precise specification was drawn up in collaboration with the customer. In particular, the idea of using a variant coding for the inspection plans solved several problems in one fell swoop. In particular, it was now possible to configure device specific checklists and specifications. Before it was implemented, the ergonomics of the application were tested by employees during a pilot project, and were spontaneously perceived as being an „alleviation for the day-to-day work“.

THE ATTAINED BENEFITS BECAME VISIBLE DIRECTLY AFTER THE NEW SOLUTION WAS PUT INTO USE

Check lists are now created automatically according to the product variant and specification, and are completed in full by the testing staff, thus eliminating incomplete or incorrect tests. In contrast to the previously manually maintained product check lists (the servicing personnel had to be notified individually), the servicing schedules and associated check lists are now created automatically together with a reminder function. And whereas all the check lists used to be stacked at Löwenstein Medical in a paper filing system, and laboriously retrieved as required, traceability is now possible in just a few seconds by means of a simple database search.
SOFTWARE MADE
SOFTWARE

Despite Löwenstein Medical‘s extremely individual requirements, SCIIL‘s experts were able to draw on an entire series of existing software modules for designing the new process configuration, and in doing so assembled an enormously powerful overall package in a very short time and with persuasive cost calculations.
Alongside the „Inspection Plan“ (IP) module for the inspection planning of measurements, attributive inspections and check lists, and the TRACE module for tracing serial numbers or batches with a full production background, the extremely extensive „Statistical Process Control (SPC) / „End of Line“ (EOL) module was also integrated. It enables test planning with variable, attributive and visual characteristics test results and instructions, as well as the incorporation of various measuring devices and instruments. PC terminals or user devices with touch screens can be used to enter the test data. Furthermore, the SPC also enables process events and notification services to be automatically controlled, and last but not least, offers comprehensive statistical evaluations and process analyses.
Alongside implementing the modules, various customer- specific adaptations obviously had to be made as well. Interfaces to the customer‘s proprietary test equipment were developed to enable automatic data transfers. A further interface to the planning system was also created for automatically generating the device serial numbers with corresponding equipment variants and additional options. The automated creation of device-specific test plans and the automatic controlling of regular test schedules during the warranty period (including the generation of measures for service personnel) were also rethought and redesigned. And last but not least, SCIIL implemented an offline function that allows test results to be recorded during the servicing work even at sites with poor or non-existent data connections. This means that the relevant inspection data can now be loaded onto a handheld user device in advance by the service employee. Once a connection has been successfully established, an automatic synchronisation with the server takes place.

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Contact

Mariana Kaesemann
COO

+49 (0) 2631 999 88-0

Download

SCIIL Image-Magazin "PROCEED"
(PDF 2,3 MB)
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