Systematic quality management (QM) enables companies in the manufacturing industry to maintain the quality of their production at a consistently high level and to identify scope for further improvements. QM systems based on DIN EN 9001 have now become the standard. The standard, which was formulated in 1987 and last revised in 2015, requires consistent thinking in terms of processes and the precise definition of all quality-relevant internal procedures. For example, it is important to define in detail which legal regulations or market-related requirements must be met when manufacturing a particular product. Such and similar specifications are summarized in a QM manual, which from then on serves as the basis for the standardization, monitoring and documentation of all internal sub-processes. Whether the specifications have actually been implemented is determined in special audits for QM certification in accordance with DIN EN 9001, which take place once a year. This procedure includes a comparison of the manual and documentation, individual interviews and spot checks in all standard-relevant processes, for example on the production line.

Successfully passing this audit and receiving or confirming certification is particularly important for suppliers, who have little chance of having their products accepted without DIN EN 9001 quality certification. For medium-sized industrial companies in particular, however, it is a considerable challenge to continuously ensure that all processes conform to the standard and to provide seamless proof of this. While the fully automated processes of large-scale industry can be adapted to standards and fully documented with relative ease, the processes of medium-sized industrial companies are heavily dependent on human work and concentration with their well-known fluctuations. One example of this is the series production of electronic assemblies: Individual work steps are usually carried out manually and are accompanied by several measuring and testing processes, some of which are voluntary and some of which are required by law. However, the high level of attention required to carry out and document the manual steps and measurements is becoming increasingly difficult to achieve under the immense time pressure of modern work processes.

Supported process control

The 'EIM' software guides the worker through the individual steps of the workpiece inspection.

© Elabo

Data management software such as 'EIM' from Elabo provides relief here. With its help, the production of electronic assemblies can be controlled while at the same time fully complying with the documentation requirements of DIN EN ISO 9001. The starting point of the solution is the work of the research and development department. All design and measurement parameters, all assembly instructions, circuit diagrams and test plans defined or created there are entered into a central SQL database. Based on this data pool, EIM then controls all processes by extracting the relevant data records for material procurement and warehousing, production and quality assurance as well as service and maintenance and making them available at the individual workstations.

In this way, it is possible, among other things, to implement process-controlling functionalities that support the standard-compliant implementation and documentation of internal processes. For example, incorrect parameterization is virtually eliminated, as all measuring and testing instruments are automatically parameterized via EIM in accordance with the R&D specifications.

It is also possible to automatically import a detailed representation of the production steps to be carried out on the workstation PC, in which the technician can document the execution of each step via an input log. The software is also able to prevent the employee from omitting or incompletely carrying out individual work, testing and documentation steps. For example, a measurement process can be blocked by default if certain assembly instructions have not been followed or their implementation has not been properly recorded. It is also possible to prevent the next assembly step from being carried out if an intermediate measurement has been missed. For example, the power supply to a soldering station can be interrupted or access to the next slide of an assembly instruction can be prevented.

Advantages for technicians and auditors

This comprehensive support for all work and test steps makes it easier for the technician to carry out and record the relevant steps correctly and thus comply with the respective quality specifications. This sustainably improves their working conditions. Documentation as such is also simplified: the laborious, still mostly paper-based record-keeping is no longer necessary, as all measurement and test results as well as the process-compliant execution of all assembly steps can be recorded automatically.

At the same time, data records are created in the background, so to speak, which are also useful for the work of the R&D departments: Error statistics generated during production can point out weaknesses in the design plan and provide valuable suggestions for future development work. The optimized design data in turn flows directly into the manufacturing and quality assurance processes and modified measurement and test parameters are automatically transferred to the respective instruments.

By using 'EIM', the DIN-EN-ISO-9001 requirement to identify and exploit optimization potential is ultimately also implemented. The long-term archiving of obsolete data records, which 'EIM' implements when new design data is entered, is also part of this context. This archiving automatically implements the legal requirement to store design and test plans for the long term in order to ensure that older products can be repaired and maintained professionally at any time.

The benefits of DIN-EN-ISO-9001-compliant process management and documentation, made possible by data management software, ultimately benefit more than just the companies themselves. Such systems also make the work of the certification body's auditors easier. On the one hand, process documentation is easier to trace if it is available in the form of data records instead of in the form of heavy QM file folders. Secondly, subsequent manipulation or additions to the records are ruled out, so that the authenticity of all documents is guaranteed. These advantages of automatically generated process documentation make it conceivable that the existence of such documentation will be rated as a significant plus point in future DIN EN ISO 9001 audits.

Author:
Horst Maywald is an authorized signatory and head of the workplace systems division at Elabo.