Only error-free is really safe

The Bassersdorf-based high-tech medical manufacturer Dyconex is committed to products of exceptional quality. For 40 years, the company has been developing and producing PCBs (Printed Circuit Boards) for pacemakers, aerospace and other industries that demand the highest standards.

In other words, Dyconex products are manufactured ultra-precisely, with the finest structures and in a cleanroom environment. Every nuance of all processes must function perfectly. How does Dyconex AG ensure the process quality that is indispensable for this without getting lost in the details?

306,000 Links

Daniel Brändle, Head of Process Quality at Dyconex, starts by giving us figures: 1,728 documents are currently managed, controlled, planned and updated; 177 employees are assigned clearly defined functions and thus know and master all their tasks in the individual processes. Each individual linked to all the documents in the process flows would theoretically result in around 306,000 links for one goal: freedom from errors.

Absolutely everything that is taught in the medical field must be proven in writing and on a regular basis. And because of the high safety requirements, Dyconex keeps a "skills matrix" for each employee. It shows on which machines he is trained and on which he is not. It is absolutely impossible for a team member to stand in for a colleague who has dropped out if he or she has not been trained accordingly.

A case for IQSoft

Humans alone can only handle this with a great deal of effort. That is why Dyconex has been using the IQSoft quality management software from IQS AG in Zofingen for twelve years. The program has a modular structure. Users only purchase licenses for those modules they really want to use.

Daniel Brändle, who has only known IQSoft since joining the company two years ago, is highly satisfied with this solution: "I appreciate the clear methodology and systematics. It gives us security during audits by the authorities and especially with auditors that our customers send to us. There we always want to pass with flying colours. EDUC2, IQSoft's training management module, simplifies everything greatly."

Daniel Brändle fans out the topic of training for us. Linking all relevant documents with each other and with the employees in their assigned functions in the respective processes results in 6850 relevant connections that have to be kept track of constantly. The balance as of the end of June 2013: All training courses, open and completed, are logged completely in IQSoft and maintenance, for example due to document revisions, is automated.

The fact that Dyconex also monitors all operating equipment and equipment tests with IQSoft and ensures all necessary quality steps is only mentioned in passing here. Repairs and maintenance are also comprehensively managed with the electronic assistant.

Nobody wants to go back

Once you have worked with a good electronic quality management program, you usually don't want to do without it. This is also the case for Daniel Brändle. When we ask him how he would approach document management, audits, training, operating and test equipment management and the visual design of process flows without an electronic tool, he agrees with every quality manager we have interviewed in recent years: "That would be a problem. We would lose track of everything and immediately have outdated data. No, I'm not giving it away anymore."

Distributed roles

Daniel Brändle shares responsibility in a focused way: "Anchoring is important. That's why I'd rather have more supervisors than fewer." Accordingly, the administration of training with EDUC2 lies with the department heads. Five to six people have access to the modules for gauge management and operational maintenance data. A further 15 use IQSoft to look after all other quality issues, right down to the dress code in the production rooms.

Conclusion

Should you ever need a pacemaker or travel to the stars, there is a good chance that high-tech components from Dyconex will protect your life - thanks to the globally recognized product quality of the Bassersdorf-based company, for which process manager Daniel Brändle and his electronic manager IQSoft are jointly responsible.