Turning Ideas into Products with CAQ.Net
When Thomas Quinger strides through his production facility in the German town of Flöha, near Chemnitz, he can look back at a proud history of over 25 years characterized by continuous growth and innovation. Founded by his father Joachim in 1990 as one-man business, the company today employs over 70 people. In a three-shift system they operate hybrid ARBURG Allrounder machines in order to manufacture injection moulded parts for a vast variety of industries.
Even though the company has its roots in the production of parts for the automotive sector, the medical technology sector is in recent times becoming increasingly important to Quinger GmbH. Today one third of the company’s products are already being manufactured for the medical technology sector. From a quality management perspective this means that Mr Quinger, so to speak, has the privilege of working in two of the most demanding sectors of the plastics industry. It was with the extremely high customer demands in mind that he initially set up a certified QM-system in the year 2000. In 2011, this system was taken to an all new level by the implementation of CAQ AG Factory Systems’ modular quality management solutions.
When the phone rings at Quinger GmbH in Flöha it is equally possible that the person on the other end of the line is a multinational tier 1 automotive supplier or represents the who’s who of medical technology. In both cases this means that Quinger GmbH must be able to provide quality-related information as fast as possible. Whether the automotive industry’s control plans with APQP, PPAP-initial sample reports and FMEAs or the medical technology sector’s ISO 14971 risk analyses, CAPA-processes or Ishikawa/5-Why root cause analyses: at Quinger GmbH all the relevant data is just a mouse-click away. In the past all this data was maintained on paper or MS-Excel. This meant that in the case of a customer enquiry, the required data needed to be tediously compiled by hand. Thanks to the QDrive.Net Central Quality Control module, the picture looks quite different nowadays. This interface allows Mr Quinger to select individual persons, customers, suppliers, articles, machines, or processes and receive precise, real-time feedback regarding the data of the selected entity from throughout the entire system.
Learning from One Another
There is an ongoing discussion regarding what quality management aspects the medical technology sector can learn from the automotive sector and vice versa. It appears that the AIAG and ISO/TS 16949 driven automotive sector and the FDA and ISO 13485 controlled medical technology sector may very well be able to supplement each other’s quality control toolsets in an ideal fashion. Being an expert in both these quality philosophies, Quinger GmbH already exhibits the manifestation of such an interface between the sectors. Thanks to CAQ.Net®, a whole host of best practices from the GxP, FDA, and ISO 13485 as well as the VDA, AIAG, or ISO/TS 16949 realms can be applied in the class 7 cleanrooms, multi-component injection moulding processes, and assembly of multi-component devices.
Comprehensive Assistance throughout the Production Process
“Turning Ideas into Products“ is the slogan of Quinger GmbH. The company provides everything from initial development and construction via CAD-design to material selection, prototype building, and surface treatment. Just as Quinger GmbH accompanies its customers right from the beginning, so too does the CAQ.Net® software. From risk analysis, initial sample inspection, incoming goods inspections and inspection planning to outgoing goods inspections and complaint management: CAQ.Net® facilitates monitoring and control of all quality assurance aspects. These production-accompanying tools are supplemented with management modules that allow the company to manage, monitor, and document all matters relevant to gauges, suppliers, audits, documents, and trainings. With CAQ.Net®, Quinger GmbH is in command of a holistic management system that ensures data transparency and creates a closed PDCA-cycle in the truest sense of continuous improvement.
The data transparency at Quinger GmbH however is not limited to the data from the CAQ-system, as the system is also directly connected to the ERP-software of the company. A standard interface exchanges all master and dynamic data between the two systems. If, for example, a new material shipment is registered in the ERP-system, the CAQ-system will automatically log on an incoming goods inspection and synchronize article master data. This direct communication between the systems further increases the process-efficiency of the company.
The Cycle of Continuous Improvement
As it extends all the way to the company’s communication with its customers and suppliers, the continuous improvement process at Quinger GmbH far exceeds the mere production process. The partner-like relationship between Quinger GmbH and CAQ AG is no exception to this. Just as Quinger GmbH profits from the comprehensive quality management solutions of CAQ AG, CAQ AG profits from the profound expert knowledge that is bundled at Quinger GmbH. The invaluable experience regarding quality-related aspects that Quinger GmbH gathers in its field of business allow the company to supply extensive input with regard to the functions of CAQ.Net®. Quinger GmbH can communicate its improvement ideas to CAQ AG via a variety of channels. After they have been evaluated and deemed suitable for the standard CAQ.Net® software, they are added to the functions of the software and made available for Quinger GmbH’s day-to-day quality management processes. Applying the continuous improvement process within this partner-like relationship means that both companies profit in the long run.
The Latest Product by Quinger
Together with Trokasure GmbH, a start-up medical technology company, Quinger GmbH was able to develop a patented and highly complex class IIa medical technology product and design all processes of the subsequent serial production. Quinger’s CAQ.Net® quality management system played a key role in the overall process. The product, known as “Trocar”, needed to be officially registered as medical product. This meant that the quality management processes of the companies had to be synchronized right from the beginning. Thanks to the sophisticated CAQ.Net® quality management tools at his disposal, Mr Quinger was able to assist Trokasure GmbH in all matters relevant to CE, ISO 9001, and EN ISO 13485 and successfully achieve said synchronization. All in all only 13 months elapsed from initial discussions between the two companies regarding a possible cooperation to the finished, serially produced product.