Should Purchased Software for both SPC and Gage R&R be documented in the QMS?

D

dbulak

#1
I am using a purchased software program for both SPC and GR&R. Where should and how should they be documented in the QMS? Would they be considered documents of external origin? Right now I have them listed as a "supplier" we purchase from. Some one says this is not good enough and we have to be more specific. Please comment and as always thanks for taking the time to answer!
 
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SteelMaiden

Super Moderator
Super Moderator
#2
Re: Where does it go?

I am using a purchased software program for both SPC and GR&R. Where should and how should they be documented in the QMS? Would they be considered documents of external origin? Right now I have them listed as a "supplier" we purchase from. Some one says this is not good enough and we have to be more specific. Please comment and as always thanks for taking the time to answer!

You could document the existence of these programs anyplace where you talk about doing SPC or GR&R. If you don't have specific procedures or work instructions, you could mention their use in your quality manual (or not, you don't have to say what software you are using) One thing you do need to do is to make sure that you've defined your record retention....
 

qusys

Trusted Information Resource
#3
Re: Where does it go?

I am using a purchased software program for both SPC and GR&R. Where should and how should they be documented in the QMS? Would they be considered documents of external origin? Right now I have them listed as a "supplier" we purchase from. Some one says this is not good enough and we have to be more specific. Please comment and as always thanks for taking the time to answer!
ISO TS does not mention any requirements concerning with what you said.
The key fact is to assure the data integrity as well as the processes themselves. AIAG blue books are the references for SPC and MSA.
The algorithms that are used in those program should be aligned to what the blue books say.
Another thing could be related to training and competences, because the personnel that use these software have to be trained and know how to use the data coming from the calculation for their own analysis.
 
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