New process capability analysis required when changing a product on the same line?

[Tomas Valenta]

Hello, hereby I would like to ask you if there is any norm supporting or requesting validation act - new process capability required when we are introducing a different product to same production line which is already approved and released. Same machines to be used but different product characteristics are on new product. My experienced is telling me that YES it is mandatory but is this supported on any norm? VDA,AIAG,IATF,ISO9001?
With kind regards
Tomas

 

[Bev D]

I can’t tell you if it is required, but it is certainly a good thing. (And I would interpret ISO to ‘require’ this. Not a Cpk calculation but certainly some validation that the product will meet specifications). New characteristics and new product should be validated even if on an established process line…I‘m always amazed that some people will only do the right thing if it’s required by some standard or law…

 

[Tomas Valenta]

I can’t tell you if it is required, but it is certainly a good thing. (And I would interpret ISO to ‘require’ this. Not a Cpk calculation but certainly some validation that the product will meet specifications). New characteristics and new product should be validated even if on an established process line…I‘m always amazed that some people will only do the right thing if it’s required by some standard or law…

Thank you for your response. Absolutely agree with you. Just trying to defend my quality statement and requirement to my colleagues by particular requirement. And of course it should be our own aim to ensure process is validated and safe. Regards. Tomas

 

[Golfman25]

I can’t tell you if it is required, but it is certainly a good thing. (And I would interpret ISO to ‘require’ this. Not a Cpk calculation but certainly some validation that the product will meet specifications). New characteristics and new product should be validated even if on an established process line…I‘m always amazed that some people will only do the right thing if it’s required by some standard or law…

I think the confusion lies in the term "validation." OP originally asked about a process capability which to me conjures up images of x bar R and CPK math. Might be overkill when a simple first article inspection might do.

 

[Bev D]

Uhn. I would want to know what the ‘process’ is, what the product is and what are the new characteristics…

 

[Tomas Valenta]

Uhn. I would want to know what the ‘process’ is, what the product is and what are the new characteristics…

Hello, Hi - machines are already validated - process validation - process capability studies in the past - are the same and no major changes done with them. Situation is that machinesX,Y,Z were used for product A and machines X,Y,Z to be used for product B which has different product characteristics - completely different drawing requirements. Regards. Tomas

 

[optomist1]

Hi Tomas,
my three Euros here...from experience at an OEM and several Tier 1 suppliers...purely from the prior experience, including process/product "issues" resulting from "seemingly small, meaningless changes", for all parties concerned it is best to "prove, validate.." the change, whether process capability, other other measure(s) requested by the customer. The automotive field is scattered with "similar" situations were minor changes, revisions resulted in unforeseen outcomes... Some OEMs, have a FR or Forever Requirement....terminology may vary...generally, this addresses any change no matter how minor, not normally addressed by a CN or Change Request/Notice...this places the customer in the loop and frequently their rep. SQ will request test(s), other criteria...to satisfy them...hope this helps