Laboratory Scope - Submitted a new PPAP for approval and the SQA rejected it

J

jkittle

#1
Help,

I always love when I get a new SQA from my customer! We recently submitted a new PPAP for approval and the SQA rejected it because he said we did not submit a lab scope (no phone call just rejection, nice).

I have to admit I'm confused, we are not A2LA or ISO 17025 certified and the only thing we do in our lab/QA inspection area is measurements and minor calibrations on hand tools with NIST traceable gage blocks/pins etc.

So what in the world do I need to submit? I asked what he was looking for and he said "our lab scope". Technically we are not a lab even though we refer to our inspection room as our QA Lab.

Anyone have any ideas?
 
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Jim Wynne

Staff member
Admin
#2
Re: Lab Scope

Help,

I always love when I get a new SQA from my customer! We recently submitted a new PPAP for approval and the SQA rejected it because he said we did not submit a lab scope (no phone call just rejection, nice).

I have to admit I'm confused, we are not A2LA or ISO 17025 certified and the only thing we do in our lab/QA inspection area is measurements and minor calibrations on hand tools with NIST traceable gage blocks/pins etc.

So what in the world do I need to submit? I asked what he was looking for and he said "our lab scope". Technically we are not a lab even though we refer to our inspection room as our QA Lab.

Anyone have any ideas?
The AIAG PPAP manual, 4th Edition, page 10 (2..2.12 Qualified Laboratory Documentation) says, in part:
Inspection and testing for PPAP shall be performed by a qualified laboratory as defined by customer requirements (e.g., an accredited laboratory). The qualified laboratory (internal or external to the organization) shall have a laboratory scope and documentation showing that the laboratory is qualified for the type of measurements or tests conducted.
Emphasis in the original.

Does your customer have a documented requirement for PPAP testing/inspection to be performed by a "qualified laboratory"? If so, then you're obliged to meet the requirements. If not, then you need to ask your SQA to refer you to the source of the requirement he's trying to hold you to.
 
T

Teri - 2011

#3
Re: Lab Scope

You didn't say if you were TS 16949, but it also requires you to have a lab scope. 7.6.3.1
 
J

jkittle

#4
Re: Lab Scope

We are TS registered. They do not require us to be a certified lab.

I'm just don't know what he wants when he says lab scope.
 
R

ralphsulser

#6
Re: Lab Scope

Please read TS169449 section 3.1.4 and 3.1.5.

We developed these because we have in house calibration, and off line physical testing. Not hard to do, you don't need to be certified to any other standard. This has been discussed here in the 'Cove" in the last few days
 
T

Teri - 2011

#7
Re: Lab Scope

7.6.3.1
An organization's internal lab. facility shall have a defined scope that includes its capability to perform the required inspection, test or calibration services.

Now, most of our customers do not require that we submit the lab scope, but if your customer wants it as part of their requirement, and your TS certified, you should have one, to meet the above requirement.
 
Q

qualityboi

#8
Re: Lab Scope

What concerns me more is Ralph's comment. Does an internal lab that does testing (reliability) and calibration need to have ISO17025 if the customer requirements state "the supplier shall follow or align to the AIAG blue book requirements"?
 

Jim Wynne

Staff member
Admin
#9
Re: Lab Scope

What concerns me more is Ralph's comment. Does an internal lab that does testing (reliability) and calibration need to have ISO17025 if the customer requirements state "the supplier shall follow or align to the AIAG blue book requirements"?
Does your customer actually say "...AIAG blue book requirements"? Like I said earlier, the PPAP "blue book" says that "Inspection and testing for PPAP shall be performed by a qualified laboratory as defined by customer requirements..." (Emphasis added). If the customer requirements don't define requirements for laboratory qualification, then there are no requirements as far as PPAP is concerned.
 
R

ralphsulser

#10
Re: Lab Scope

What concerns me more is Ralph's comment. Does an internal lab that does testing (reliability) and calibration need to have ISO17025 if the customer requirements state "the supplier shall follow or align to the AIAG blue book requirements"?

I don't recall anything in the AIAG blue books that requires your internal lab to conform to ISO17025. When I first went thru QS9000 and the blue books, the registrar stated that we needed an interrnal lab scope because we did off line testing. Currently our physical test lab for the heat treat dept. is required to conform to Ford WHTX, and the new CQI-9.
 
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