Feedback on our rephrasing proposal regarding the manufacture according to QM system
In our October newsletter we had mentioned the topic of the manufacture of lithium cells and batteries according to quality management program and also a reformulation proposal ...
...
or deletion of references, with which the responsibility
for compliance lies 100% with the manufacturer.
We received the following very clear description from Sebastian Roehler of VARTA Microbattery GmbH describing this
process and also an absolutely plausible explanation why using the word "Quality Management System" would make
more sense.
Here is the email with his explanations, which we are allowed to provide to you:
Von: "Roehler, Sebastian"
Betreff: AW: Newsletter Nr. 6-222
Datum: 20. Oktober 2022 um 16:10:08 MESZ
An: Eva Glimsche
Hello Eva,
Thanks for your feedback! You are welcome to publish it and name me. I have polished the wording for it a bit more:
The term "quality assurance" is no longer appropriate. Quality cannot be "assured". For a product to meet its quality
requirements, the quality requirements must be implemented in all phases of product development. The approach of
quality assurance was to check in downstream phases whether a product meets the requirements. However, this only
works to a limited extent. An example from the world of batteries: if a defect is built into a cell due to a poor production
environment, it cannot be detected by a quality inspection at the end of the manufacturing process. However, this
defect can later lead to a safety-critical failure of the cell. Such defects can be avoided by a quality management
system that keeps an eye on all risks and takes appropriate measures to mitigate them.
I therefore recommend that the term "quality management" be retained. What always irritates me is the "program" in
"quality management program". I have not encountered this term anywhere outside of the hazardous materials
regulations. In my opinion, it should be "quality management system". The international standard ISO 9001 describes
how such a QMS can be developed. Manufacturers who operate a system according to ISO 9001 would then not
have to additionally confirm that their "quality management system" is also a "quality management program".
