New Process - What's an auditor looking for?

S

SteelWoman

#1
We have an audit coming up in which I hope to have a new machine added to the scope of our certification to QS. I queried our registrar some time ago to try and make sure I had all my ducks neatly lined up - see what they would be looking at, exactly, but never got a response. This is a "first" for me, having never been through an audit where I've added a new process. Can some of you seasoned auditor folks chime in on what you'd be wanting to see? Just want another set of eyes, make sure I'm 150% BEFORE the auditor arrives.

Thanks for ANY help you can offer.
 
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R

Randy Stewart

#2
New Equipment

Depends on what the purpose is, but here's some items to consider:
Does it change a PPAP, PSW, etc. If so follow the SREA etc.
If its for new product line I would look at the Team Feasibility Review.
Was a Life Cycle Cost Analysis done (doesn't have to be)
Has it been added to the preventive maintenance schedule (4.9.g.1) based on MTBF and MTTR.
If there is TE-9000 involved was R&M applied?

Also look at 4.9.1 through 4.9.5. I sure there may be some more areas affected so look at the SPC and APQP books.
Hope this gives you a place to start.
 
#3
I received a minor for something similar to this situation.
We re-arranged a process by re-locating machines wiyhin the existing area.
The para referenced by the minor was 4.2.6 "The supplier shall use a multi-disciplinary approach for developing facilities, processes and equipment plans in conjunction with the advanced quality planning process.
Noncompliance: - No evidence of multi-disciplinary approach,
- No evidence of quality palnning.
 
S

SteelWoman

#4
update

Just to update "ya'll," we came through this part of the audit with flying colors. Audit was quite thorough, looking at Statistical process controls, capability studies, training records, process control, inspection and testing, calibration records, packaging, claims, etc. But we passed with no non-conformances and got this new process added to our cert! :)
 
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