Challenge: I work as an engineer in the process development of a medical device for a manufacturing  company. The medical device was previously manufactured by another production plant, and the  manufacturing company I work for is being asked to manufacture the same device almost identical as  the one that already exists in the market.  After process development activities, the process is not giving  expected results, and there was a high scrap rate due to quality issues of the devices being built. Quality  issues are related mainly to one specific process step, the cutting step, it seems the designed tool to do  it was not working as intended and the yield of that step was unacceptably low. The cutting step uses a  cutting die where the pieces being built are pressed with a manually operated press, the pressure  applied to the piece against the die produces the sample to be cut in the desired form, however the  variability in pressure was producing pieces with irregular edges.

Selection: The tool I chose was learning launch, I executed small, quick, and cheap experiments to test  an idea to improve the cutting process. I chose it since I think it was applicable for the kind of challenge I  was being exposed, I needed to learn and improve through observation.

Application: I had an idea of a pneumatic cutting press to standardize the process, instead of manual  cutting press that was being used.  To start with my learning launch I built a cutting die that could be  used with a pneumatic press we already had in the facility, basically the sample would be placed in the  cutting die to be pressed against it, cutting the sample into the desired form. The idea was to have a  stable pressure of cutting and to produce acceptable samples each time. I involved 3 assemblers, which  would work as my “customers” since they will be the ones using the press and involved two engineers  more from different areas: one from manufacturing department and one from occupational health.  These engineers helped me mitigate my confirmation bias, as Heller mentioned.

I let assemblers and engineers to use the press meanwhile I started the observation phase. The samples  built with that press were subjected to the quality criteria test, unfortunately, samples failed the test.  The yield was improving but was not higher than 50%. This means I was getting disconfirming data. So,  the next step I took was to pivot: We improve the die by attaching some fasteners that were already  used in the device, this idea was given by one of the assemblers after noticing the key problem was the  piece moved when the pressure was going to be applied. After that improvement, we performed the  test again and got a 100% yield. I think the tool was applied effectively, since even though it did not  worked the first time, I learned from one of the stakeholders and the process was improved  tremendously thank to this.

Insight: The insight I got was from involving assemblers and learning from them. I realized the solution  did not had to be fancy looking or a big design breakthrough, it could be something as simple as using  materials you already have available. Specifically, I got to understand that executing these kinds of  experiments with different groups is key to understand the bigger picture of the problem, and of course  to came up with the best solution to it.

Approach: I would use the same tool again next time, the tool helped me to understand the key problem  in the process by observation of the applied experiments, and more importantly by the involvement of  different groups in the execution of those experiments. However, considering the useful insight I got  from the assemblers, next time, I would involve assemblers since the beginning of the process  development and use a tool like mind mapping to involve more stakeholders and their ideas.

