Project Haselmeier s.r.o.

In the world of business, unexpected challenges and obstacles can arise that require quick and effective solutions. This is even if you try to plan properly and in advance. Our company recently faced a situation where one of our key interim managers (with a healthcare focus) became ill, and we had to rely on our team’s skills and flexibility. This case study focuses on how we were able to manage a difficult situation and ensure a successful project completion.

Situation

Our long-term client had an urgent need to qualify a new production tool, but ran into capacity issues due to turnover. So we agreed on a solution involving one of our interim managers.

Originally, one of our colleagues was supposed to take on this role, but unfortunately he suddenly fell ill and it was clear that he would not be able to complete the project. It was a difficult situation and we had to quickly find a solution that would lead to customer satisfaction. There are not many people in the Czech Republic who are familiar with medical materials and their production.

Solution

When our colleague Martin Kratochvil (a sales manager known for his ability to find solutions where others give up) found out, he immediately took up the cause and started looking for a suitable replacement. After careful consideration of the situation, we decided to deploy Aleš, the owner of our company.

Aleš has extensive experience with the validation process especially in the field of engineering. At the same time, he is an internal auditor for the 13485 standard, i.e. healthcare, so it was an obvious choice. Having him on the project meant that the client could start to quickly and effectively use the increased validation capacity in the form of our boss.

Goal and result

The aim of the project was to commission (document) and verify the functionality of the laser station for marking plastic parts. And this within a rather ambitious deadline of 2023-10-31. According to GMP :-). 

An important aspect of the project’s success was working with colleagues from the client’s company who are true experts in their respective fields. Their professionalism, commitment and knowledge played a major role in achieving the common goal.

The main outcome of the project was the validation and qualification of the laser, and was achieved through collective effort and teamwork.

As Aleš says: “I was definitely not the smartest in the room. I was just hands, head and thanks to a great team, an extra opinion. I just sat down at the table, went through about a million training sessions and then twenty more. Went over the points with my colleagues who walked me through the race, pointed out the various obstacles, and got to work. I read a lot, familiarized myself with the features, software and hardware of the machine, dove into the internal guidelines (in great detail) and started creating documents for:

• validation plan,
• installation qualification,
• operational/functional qualification,
• performance qualification,
• The PaD-FMEA and risk analysis were conducted in a team setting where I was able to learn about various requirements from the medical standards and was able to confront them head-on with requirements or areas of other standards. Which was interesting.”

The PaD-FMEA and risk analysis were conducted in a team setting where I was able to learn about various requirements from the medical standards and was able to confront them head-on with requirements or areas of other standards. Which was interesting.”

This study reminds us of the importance of being flexible and prepared for seemingly unpredictable events. Our company was able to manage this challenge thanks to the collaboration and capabilities of the teams involved. Not only here in the CZ office, but also on the side in DE.

Aleš enjoyed the project and the cooperation and with a newfound appetite he plunges into another adventure, this time again in the “pureCZ” automotive industry.

We would like to thank Haselmeier s.r.o. and Mr. Tisot and Mr. Pena for their repeated trust and we look forward that this cooperation will not be our last.