A field report

For INOVAMED GmbH, a quality management system certified according to ISO EN DIN 9001:2008 and ISO 13485- 2012-11 Medical Devices has been standard for years. The QM system serves for the constant compliance with high quality, customer satisfaction, cost reduction, waste reduction, and finally for the successive improvement and competitiveness of a company.

Suboptimal QM system

For a long time, the documentation of quality-relevant documents at INOVAMED was mapped with Word, Excel and PDF files in a directory structure according to the Donabedian quality model. The individual documents were coded as A 3.1.1.7.0, dressing boxes.docx. If this model perhaps does show clearly structured document designations, the two QM officers Yvonne Krämer and Jörg Sevenich could not shake off the feeling that they had so far relied on a QM administration that was too abstract.

"Many of our employees did not find their way through the file jungle of process descriptions, work instructions, checklists and other work aids, and there were many queries to the QM officers. A typical scenario. Because the administration and maintenance effort of the Q-documents grew from day to day into infinity. So much so that the management pulled the emergency brake and put the previous Q-document management completely to the test," explains the QM representative Jörg Sevenich.

In order to transform the QM system into a living system that supports the employees, a ruthless analysis was carried out. What are the most common problems, what are the requirements that the stakeholders expect from an optimal system? As usual in a process, some difficulties had to be solved first:

• high administrative effort of the Q-documents, especially for the control of documents and records - updating service by paper is costly
• Searching for documents with the desired content is time consuming
• Stress before the audit
• Suggestions for improvement are implemented only slowly
• The work almost always remains with the QMB
• Employees have no recognizable advantage of the QM system

Parallel to the identification of the difficulties, however, the requirements were defined which a living and beneficial QM system should fulfil among the employees and the management.

Conclusion: "After the analysis, it quickly became clear to us that a user-friendly QM system with a simple search function and access at every workplace, as well as simple administration, were the main criteria," says Sevenich. Above all, a QM promotes fast information processes, whereby documents, work instructions, checklists should not be disregarded.

There is an unmanageable number of providers for such systems on the market, which are often priced for larger companies. For smaller companies, the investment in the software, implementation and update costs is often out of proportion to the benefits.

A database with Microsoft Access

So INOVAMED came up with the idea of programming its own database with Microsoft Access, but without any knowledge of databases and Access. Therefore, the managing director Tibbeke Neumann turned to team babel AG in Herzogenrath, a consulting firm for QM and efficiency in the company. In a lengthy discussion, it quickly became clear that the effort for an in-house development would be much too high, because no know-how was available in the company.

WikiWiki - the solution

As an alternative, "WikiBabel" was brought into play, which team babel had previously successfully introduced to companies as a QM platform.

A wiki is an easy-to-use online platform for the exchange of information and documents. All you need is a browser to write and edit contributions or to upload entire files to the wiki. The name Wiki comes from the Hawaiian language and means "fast". The fast buses there are called WikiWiki, whereby the doubling in Hawaiian stands for the increase "very fast".

The basic idea of the wiki is collaborative work on texts, supplemented by photos or other media if necessary.

The basic idea of the wiki is collaborative work on texts, supplemented by photos or other media if necessary. The fact that each participant can easily contribute via the browser enables a collaborative collection of knowledge. Everyone can store their knowledge in the wiki and add other knowledge. By adding keywords and categorizations, a structure is built up that makes researching the "preserved" knowledge easy. Probably the best known and largest example is the free online encyclopedia Wikipedia.

For a QM system WikiBabel brings many advantages:

1. Wiki-Babel provides the perfect platform to quickly search, find and collaborate.
2. Wiki-Babel offers a high degree of user-friendliness because pages are easy to create and link, structures are easy to design, and the amount of training required is low.
3. Wiki-Babel offers many extensions, designs and interfaces.
4. Wiki-Babel offers a sophisticated version management (all changes are logged) and rights management.

In cooperation with team babel, Wiki-Babel was then also installed at INOVAMED on the company's own server. The free Dokuwiki system is used, which is promoted and supported by the Berlin-based Cosmocode as an open source project.

"In a two-day workshop, together with team babel, we defined the structure of the wiki interface for a first department. In addition, the access page (the portal) was designed. In the following two weeks, we then set about creating the other sections in the new QM Wiki, which is called "Ino-Wiki". Finally, we presented the wiki to the approximately 66 employees at the two sites in Aachen and Augsburg," Jörg Sevenich continues.

The new QM Wiki structure

In order to promote the idea of the continuous improvement process, each division has also been given special Ino-Wiki pages that can be used by employees for improvement suggestions, ideas, activities. In addition, a so-called postit function has been introduced. Each employee can post tips, advice and generally useful thoughts on the company wiki, which can be accessed by any other employee.

"A few months after the introduction, the first interim conclusion I can draw is that Ino-Wiki has been very well received by all employees - interestingly, even by the older users who are not so PC-savvy. Everyone has the current documents at their workstation and changes made by the responsible supervisors and approved by the QMBs are immediately available," says Jörg Sevenich, taking stock of the situation.

Founded in 1989, INOVAMED has distinguished itself as a provider of logistics services for medical practices and clinics, as well as small businesses.

About INOVAMED GmbH

INOVAMED GmbH was founded in 1989 and is a provider of logistics services for medical practices, clinics and medical facilities. The company operates a nationwide network with more than 120 employees, 300 external warehouses and many regional specialist shops for high customer accessibility.

INOVAMED GmbH is certified according to ISO EN DIN 9001:2008 and ISO 13485-2012-11 Medical Devices. The QM system is a guarantee for consistently high quality, customer satisfaction, cost reduction, avoidance of waste, continuous improvement and competitiveness.