MICHAEL SCHAEFER
Quality Engineering
Quality Engineers
Although Quality Engineers are present in many companies today, it is often unclear what Quality Engineering really means. The attached material may give a closer insight into daily live of the quality engineers.
Statistical sampling plans, tools and acceptance criteria
As a freelancer I am used to provide statistical analyses and rationales to evaluate the outcome of process validations, design verification or routine manufacturing. Introducing statistical sampling plans as per ISO 16269-6, ISO 2859-1 or ISO 3951-1 is part of my portfolio including discussion of non-normally distributed data. The tools I am using include Minitab and Wayne Taylor’s sampling plans analyzer.
Acceptance criteria for process capability indexes generated from statistical tolerance intervals as per ISO 16269-6
This document intends to evaluate, if acceptance criteria for process capability indexes could be generated from statistical tolerance intervals calculated as per ISO 16269-6. It is not intending to question or challenge the approaches as such.
Acceptance criteria for Gauge R&R studies
I recently added the statistical paper to intending to evaluate, if acceptance criteria for Gauge R&R studies could be generated from statistical tolerance intervals calculated as per ISO 16269-6. Any feedback would be appreciated!
Anforderungen an Klebeprozesse
Klebeprozesse sind allgegenwärtig in der Medizintechnik. Schade eigentlich, dass nicht alle über die detaillierten Anforderungen an diese Prozesse nachdenken. Dabei könnte die branchenunabhängige „Klebenorm“ DIN 2304-1:2016 helfen. Diese Norm, abgeleitet aus der DVS 3310 Richtlinie, gibt zahlreiche Hintergründe und Anforderungen an Klebeprozesse. Mehr Informationen finden Sie im Dokument.
Test Method Development
It is often forgotten to invest time and resources into test methods although this is essential to understand manufacturing processes. The results we observe in experiments and validations, are first of all the results measured with the test method. Only if we have an accurate test, we will be able to read the results of the process under consideration. Test method development and test method validation should get a much higher priority in our medical device industry. A common tool is Gauge R&R studies. A simple control chart may do as well.
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