Adaptation of standards from outside the industry

Dhe Erfurt-based company Qundis GmbH voluntarily follows the strict norms and standards of the automotive industry when it comes to quality management. The impetus for this was given when a major customer audited Qundis according to automotive standards and new requirements for release procedures such as initial sample procedures/PPAP arose.

To meet the new requirements, development, production and SCM processes had to be reviewed and in some cases adapted. In collaboration with several specialist departments and under the direction of an internal QM process manager, the overall processes were reviewed and adapted, and the corresponding standard documents were updated.

Automotive industry served as a model
Standards and methods were adapted from the ISO/TS 16949 standard and applied by Qundis to specific situations. In a pilot phase, typical automotive methods were initially tested for suitability for use at Qundis in a new product development and production transfer in parallel with the traditional procedure. Not everything could be adopted 1:1 and some methods, such as FMEA, were clearly too complex - but many basic approaches were certainly applicable. The method and its results were presented to the project team and the deeper analyses, improved risk detection and earlier elimination of errors convinced everyone involved. Although this was a lot of additional work in the pilot phase, it has since become a fixed and valued standard in Qundis QM. The methods and procedures are continually adapted and further developed depending on the situation.

In the meantime, the adapted automotive methods have become a fixed standard in quality management and are reflected in an internal company guideline, which was newly created at Qundis and contains basic requirements for products and their quality.

Tests during production to increase product reliability
In practice, quality management is implemented in automated test procedures throughout production for individual components in the various assemblies. In automated production in particular, testing is carried out after each step in order to detect errors at an early stage and not just at the end of production when the end product has been created. The Qundis production planning and control system (PPS) provides the employees at the individual stations with all the necessary materials, aids, work instructions and test steps electronically on monitors. Production control plans were used to determine in advance which measuring equipment is to be used, which test steps are to be carried out and which tolerance and intervention limits apply to the individual production stations. As soon as a device does not function faultlessly and the test result "Fail" is displayed, the assembly cannot be processed any further and is rejected. The defined intervention limits make it possible to react to deviations at an early stage. The data collected in this way is automatically collected, evaluated and made available via a database system. They are the basis for the monthly evaluation of the quality situation.

With adapted product and process FMEAs, Qundis evaluates possible weak points in the product and production process as well as their probability of occurrence, probability of detection and significance for the customer at an early stage. In this way, possible improvements can be derived and problems ruled out in advance of mass production. In product audits accompanying production, QM employees completely disassemble individual devices in regular random samples to check their components, the software and production quality. Using predefined audit checklists, the employees can see whether all components have been processed correctly and completely and whether the product functions properly, whether it has been packaged correctly and whether all accompanying documents are complete.

Isolated solutions are a thing of the past
Further quality management tools in the production and marketing phase are the complaints database and the QM ticket management system. Qundis has relaunched these and standardized them in databases. This results in a higher quality of defect analysis and evaluation. In the databases, Qundis documents comprehensive investigations into the reasons for failures and defines corrective measures across all areas. In addition to the production evaluations via the PPS, they form a further basis for the monthly quality reporting and thus function as an early warning system in the event of frequent errors. This closes the circle of the quality-oriented overall view.

The starting point for this was the dissatisfaction of the employees with various small and mostly departmental isolated solutions and a lack of a consistent process, as a result of which problem solving sometimes did not run optimally. Under the direction of the QM process manager, the wishes of the departments were recorded and weak points identified. The necessary preliminary work of the upstream departments resulted from the requirements of the recipients and so first target processes and requirements could be defined. Based on the process draft, further improvement potentials and possible solutions were discussed and gradually released and established in the organization. It was important to have representatives from all areas at one table from the very beginning and to involve them in a joint solution. It was also helpful that the department heads were involved and that employees from day-to-day business were able to provide and discuss practical input in these workshops. With the support of external IT service providers, it was possible to map the new processes using suitable database solutions and also to train them immediately. With the help of the databases, fast and efficient reporting options were also created, which all areas can access at any time, so that all employees have the same and current level of knowledge. The processing of complaints could thus be accelerated significantly. In the meantime, complaint evaluations are also regularly included in FMEAs in order to be able to eliminate known weaknesses.

Tried and tested in practice - expansion of the reference to automotive QM standards planned
The newly established quality management of Qundis, which is based on the standards of the automotive industry, is having an effect. The sustainability of the products was strengthened and the early detection of defects improved. The complaint rate has been halved in two years and warranty periods have been extended. Although the automated process monitoring and the transmission of key figures during production resulted in additional costs during the introduction phase, the result during operation is higher efficiency, lower complaint costs and improved environmental friendliness. Quality reporting with corresponding control key figures in the incoming goods, production and complaints areas has been strengthened. By involving employees in the quality assurance methods, acceptance of the measures among the workforce increased. It became clear that the implementation of methods always requires comprehensive training of employees.

In addition to positive findings, the challenges for quality management are also evident, such as the fluctuating quality of supplier parts. Particularly difficult are international procurement, a change of supplier and the implementation of supplier qualification. Another touchstone is ensuring high product reliability with an increasingly complex product portfolio. Qundis ensures this, for example, through incoming goods inspections, component-specific inspection plans, supplier audits and close cooperation with external specialist laboratories. In addition, there are further challenges for quality management due to ever shorter product development cycles as well as agile development in order to be able to react even faster to customer wishes. The increasing importance of software and the increasingly complex product portfolio with all its interfaces must also be mastered.

For this very reason, the alignment with automotive standards is to be further expanded. An even stronger process orientation is planned for the future. Although quality tests have already been implemented in the prototype phase, Qundis is planning to use them even more intensively: All qualification tests such as endurance tests, leak tests, transport and storage tests, mechanical dynamic tests and others are to be carried out in an early prototype phase, i.e. well before the pilot series, in order to obtain qualitative findings even earlier.