CAQ-Software at Wild & Küpfer: Quality Excellence for Medical Technology
Wild & Küpfer is an internationally operating company that specializes in the production of injection-moulding parts and subassemblies. It was founded in Switzerland in 1979 and today has over 170 employees. Eighty-five injection-moulding machines at Wild & Küpfer produce high-tech plastic parts for a vast variety of industries. Even though the supplied industries such as building, sensor, electronics, automotive, or telecommunications technology all have particular requirements regarding the manufacturing process, one industry is particularly demanding: medical technology. In order to meet the strict regulatory prerequisites of the FDA and ISO 13485, Wild & Küpfer lays its trust in the software solutions of CAQ AG.
For production, Wild & Küpfer relies on a high-tech infrastructure that combines elements such as fully automated 3- and 5-axis HSC milling in toolmaking with single- and multi-component technology and class ISO 7 cleanroom on a total production area of over 30,000 m². During production, robot- and cycle-controlled component assembly, laser marking, tampon printing, hot stamping, ultrasonic and laser welding round off Wild & Küpfer’s comprehensive production capabilities.
With such a highly networked and continuously digitized production, quality assurance is of course not neglected either: the most modern measuring microscopes, optical and tactile measuring machines, computer tomography (CT), material testing with DSC, tensile and compression tests, colour and surface measurements as well as moisture content measurements form the quality assurance arsenal of the company.
"Wild & Küpfer stands for highest quality and reliability. Our continuously digitized systems, controlled and monitored by our highly trained specialists, make our work safer, faster, and more economical." COO, T. Wild Jun.
A Focus on Quality Management
All areas of the company work strictly in accordance with ISO 9001 and ISO 13485. Thus, the quality management at Wild & Küpfer is also subject to the highest demands. As the existing QM software was getting on in years and neither support nor further development was possible, the company set out in 2015 to find a new supplier in order to also use high-quality solutions in terms of software. Wild & Küpfer first drew up a detailed specification sheet against which a large number of potential applicants had to measure themselves.
Committed to Quality
The specification sheet contained both basic technical requirements for the software solution to be used as well as detailed requirements, which were oriented to the respective areas of application. The software solution would need to have a modular structure, be validatable, and connectable to the ARBURG "ALS" host computer system. In addition, it had to meet the ISO 9001, ISO 13485 (2016) and ISO 14001 standards and, in particular, the FDA requirements regarding authorization concept, audit trail, and corresponding approval processes. The prospective manufacturer of the software solution had to also be an established provider with a verifiable number of successfully implemented projects at comparable medical technology companies in Switzerland or Germany and always able to provide prompt support.
The Selection Process
The demanding specification sheet with its basic requirements already meant that the air became thin for many manufacturers of software solutions. The detailed specifications for the individual software modules, the desired module mix, and the high expectations regarding the integration of third-party systems such as the ERP system and the MES from ARBURG ultimately meant that only CAQ AG with its modular CAQ.Net® software solution remained as a suitable supplier. The implementation of CAQ.Net® began immediately in August 2015 with the quality assurance solutions for gauge management, initial sample inspection, complaint management, and preventive maintenance. To this the solutions for document management and training management as well as the web solutions and the audit trail were added. The lattermost is necessary for compliance with the requirements of ISO 13485 and FDA, as it ensures data integrity and aspects of records management.
Central Quality Control
With the introduction of the module for inspection planning, quality inspection, SPC and LIMS in 2018, CAQ.Net® was expanded to a true quality center at Wild & Küpfer. Thanks to its integrated CAQ solution, the company now has a powerful, multilingual solution for software-aided quality management, the main advantages of which, according to Daniel Soldini, Head of Quality Management at Wild & Küpfer, are among other things that:
- All modules are fully networked and configurable
- Third party systems (ERP) are integrated
- Seamless change control and traceability is facilitated
- External access via web applications is possible
- Automatic notifications in case of deviations are made
- ARBURG-ALS data can be statistically evaluated
- All measuring hardware is directly connected
- List evaluations are created and sent automatically
- A generally very high degree of automation is possible
- The requirements of the ISO 9001, ISO 13485, 21 CFR 820, 21 CFR Part 11 standards are met
The future viability of the system was also a key decision factor in the selection of the system. In addition to regular adaptations to technical developments in the area of IT infrastructure, CAQ AG also ensures that relevant changes to standards, particularly in the area of medical technology, are always promptly implemented in the software.
The Human Factor
Technology alone does not make the difference. The consistent use of high-tech infrastructure and superior CAQ software solutions are only part of Wild & Küpfer’s recipe for success, because the far more important part is found in the interdisciplinary cooperation of various teams of specialists. At Wild & Küpfer, aspects such as experience, professional skills and scientific thinking come together in consulting, development, design, toolmaking, series injection moulding and assembly, which in their entirety make the trend-setting production of technical and medical plastic parts possible. It is precisely in this sense that the two companies Wild & Küpfer and CAQ AG fit together wonderfully, because their partnership-based cooperation means that both can always learn from each other and thus always create top-quality technical products in their respective fields.