The best software for quality and risk management.For 80 years, the Belgian family business Kela has specialised in producing and distributing human and veterinary medicines. Today the company has branches in several countries, employs some 330 people, and its largest markets are in Europe, Asia and Africa.
Stefan Langers is the business process manager at Kela. As Kela grew, efficiency, consistency and overview became more and more critical for the company. A few years ago, Stefan, therefore, started a project to describe and optimise all business processes within Kela.
“3 years ago, we started looking for a document management system in which we could make the descriptions of our processes available to all employees,” says Stefan. “We came across Infoland through the grapevine. We were particularly interested in combining Zenya DOC with the Zenya FLOW reporting system.”
Kela uses Zenya DOC to manage SOPs (work instructions for people on the shop floor), safety instruction cards and safety data sheets, among other things. “The biggest advantage of Zenya DOC is that all approvals are done electronically. In the past, this was done manually and was sometimes very time-consuming.”
Meanwhile, a large part of all processes within Kela were already described. So now it is mainly a matter of optimising and partly automating those processes with Zenya FLOW.
“From GMP, legislation within the pharmaceutical industry, all deviations within a certain process must be reported,” Stefan explains. “We use Zenya FLOW for this. Is a certain process done in a different way than described? Then it is easy to report it. It then reaches our quality unit, which assesses the deviation and its impact.”
Stefan and his colleagues have already set up many different flows. “To request changes for devices and products, to submit a request to destroy materials, for the start of new employees, for work permits, … We build all our flows ourselves and can add functions, fields and so on as we like.”
The biggest advantage of Zenya DOC is that all approvals are now done electronically and no longer manually. That saves us much time.”
In addition to Zenya DOC and Zenya FLOW, the company also uses Zenya CHECK to draw up internal questionnaires. These questionnaires are used during Gemba walks.
“A Gemba walk is a safety walk within a certain department,” says Stefan. “During the walk, the management team checks various items, such as PPE, fire safety, cleanliness, etc., using a questionnaire. Afterwards, we put the results in Zenya CHECK so that a report can be made. This way, all questionnaires and results are centralised, and it is clear throughout Kela where improvements can be made.”
Recently, the company also started using iQualify, a tool for e-learning. “We are still considering how we want to use iQualify exactly, but we are already using it to provide internal training. We compose the training ourselves and add a test at the end. Employees can choose for themselves when they go through the information and take the test.”
“The advantage is that with iQualify, we can intervene quickly if we notice that there are problems with a certain process. We then compile a training course around this ourselves and have the employees follow it.”
Stefan explains that it was not always easy to get everyone physically together in the past at the same time. However, with iQualify, this is no longer necessary. “Everyone has half an hour now and then to follow a short training. Moreover, iQualify offers a handy dashboard on which we can see how many people already followed a specific training and what their results were.”
We especially like the flexibility of Zenya. Does one of our employees have a remark about a flow? No problem: there is a good chance that we can deal with it ourselves.”
Stefan and his team create all flows themselves but always consider the people who need to use them. “Feedback from people is easy to adjust. But we would not be the pharmaceutical sector if we did not make things a little more complicated”, Stefan laughs. So the company also takes care of the validation of all flows itself.
“This validation is a requirement from the legislation. Just as with new appliances, new processes must also be validated, and we must also document this validation.”
User requirement specifications are first drawn up for each new process and change, describing exactly what the flow must do (e.g. describe a deviation, implement a change, etc.). Then, the flow is tested, everything is documented, and various parties must give approval. Is everything in order? Then the flow can be used within the production environment.
“Setting up flows goes very smoothly,” says Stefan. “And if we do encounter problems or have questions, we can contact the Infoland helpdesk, which always provides a quick answer.
Stefan also likes to visit the Infoland community. “I regularly check to see whether there are any users with the same questions as us. If Stefan sees interesting topics in the community, he or one of his colleagues can easily start building a particular flow.
He sees this as the software’s greatest strength. “Does someone have an idea or a remark? Then they just have to say it. There is a good chance that we can then get to work on it ourselves.”
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