QS9000 Section 4.4.2.1 indicates a number of skills that the design facility should be qualified in(GD&T, QFD, DFM, DFA, VE, DOE, FMEA, FEA, Solid modeling, simulation, CAD, CAE, Reliability, MTTR, MTBF, FTA, LCC, environment characterisation. What consistitues "qualification", and does anyone know of testing organizations that provide tests to prove adequacy or qualification in those areas.

thanks

Paul

My (limited) experience with the "qualification" of most of these items for the auditor was showing training attendence and effective use. My company is not design responsible, where DFM and DFA come in, but for some of the others - Finite Element Analysis, COmputer Aided Engineering, etc., the folks doing this should have a training record at least, but I think even better is to show how some of those items were implemented and how successfully they were used. We had a person with a BA in Math doing our FEA and Boundary Element Analysis. She had worked with other engineers and the folks writing the beta software. She never actually took a test, but could tweak a circuit to its max. I personally took 3 courses in GD&T, and design most of the hard gages. I never took a test, but my gage design would stand scrutiny. Most of the training for these items does not include a "test" in the end. We took the offensive with our auditors and showed them a couple of these, they haven't asked since.

I think proper analysis, by trained people, and proper implementation is what they will be looking at. More worldly auditors may be better resources in this...

They don't put any 'threshholds' in. Your company decides whar is appropriate to address the 'qualification' issue. It may just be experience or may include formal training. The key here is they don't for example, require FMEA training per se, but it does look good. I learned FMEAs some years ago at GM but I never took a test nor do I have a certificate. If pressed, I would present my 'course' on FMEAs.

Originally posted by Marc Smith:

....but I never took a test nor do I have a certificate.I mis-spoke. I did take a Stat-A-Matrix course and have that certificate.