ISO/TS 16949 Clause 7.6.3.1 - Internal Laboratory - Requirements

Mikey324

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#1
Hello again. I am stumped on another 3rd party audit finding. We were recently told that 7.6.3.1 applies to our new stamping operation (our company has no previous experience in this area). The only "testing" we will be doing is standard dimensional measurement using digital calipers, micrometers, height gage/dial indicator. I was not aware this could be considered an internal lab because this is an end of production line inspection. We have the equipment calibrated by 17025 companies, or calibration is traceable to 17025 standards. We have instructions and procedures for internal calibration in place. Is our auditor correct or is this leaning toward opinion based on the definition in 3.1.4?
 
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qusys

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#2
Re: TS 16949 Clause 7.6.3.1 - Internal Laboratory - Requirements

Hello again. I am stumped on another 3rd party audit finding. We were recently told that 7.6.3.1 applies to our new stamping operation (our company has no previous experience in this area). The only "testing" we will be doing is standard dimensional measurement using digital calipers, micrometers, height gage/dial indicator. I was not aware this could be considered an internal lab because this is an end of production line inspection. We have the equipment calibrated by 17025 companies, or calibration is traceable to 17025 standards. We have instructions and procedures for internal calibration in place. Is our auditor correct or is this leaning toward opinion based on the definition in 3.1.4?
Hi Mikey,

Could you please write the statement of the non conformance?
I did not understand the problem well.
Do you mean that a part of the production line was seen by the external auditor as an internal lab?
 
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Mikey324

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#3
Re: TS 16949 Clause 7.6.3.1 - Internal Laboratory - Requirements

Statement of NC is lab scope not defined. Very basic. We did not define a scope because we didn't know this section applied. The testing being done is only dim. checks recorded on an inspection sheet. This is done on the line, we do not have an actual lab that parts are taken into.
 

qusys

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#4
Re: TS 16949 Clause 7.6.3.1 - Internal Laboratory - Requirements

Statement of NC is lab scope not defined. Very basic. We did not define a scope because we didn't know this section applied. The testing being done is only dim. checks recorded on an inspection sheet. This is done on the line, we do not have an actual lab that parts are taken into.
I do not know. it results very strange to me.
Did you show your process flow to your external auditor? Did you show the PPAP that you should have signed off with your customer?
If what you say it is not a lab and it is included in the process flow you inserted in the PPAP signed by the customer, I would not see an issue.
Probably I may wrong and I do not have all available details , waiting for other experts' considerations and contribution on it.:bigwave:
 

Mikey324

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#5
Re: TS 16949 Clause 7.6.3.1 - Internal Laboratory - Requirements

I do not know. it results very strange to me.
Did you show your process flow to your external auditor? Did you show the PPAP that you should have signed off with your customer?
If what you say it is not a lab and it is included in the process flow you inserted in the PPAP signed by the customer, I would not see an issue.
Probably I may wrong and I do not have all available details , waiting for other experts' considerations and contribution on it.:bigwave:


It has not been approved by our customer (installation still under way), we are still working on the PPAP. As i said, very new process. We have multiple blanking PPAPs approved, no mention ever from the customer requireing a lab scope. Even for the future.
 

qusys

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#6
Re: TS 16949 Clause 7.6.3.1 - Internal Laboratory - Requirements

It has not been approved by our customer (installation still under way), we are still working on the PPAP. As i said, very new process. We have multiple blanking PPAPs approved, no mention ever from the customer requireing a lab scope. Even for the future.
Understood.

I know 3.1.4 definition of a lab in ISO TS.
If you had shown a process flow chart of your product realization ( from incoming to shipping, also requested to trigger FMEA and Control), you coud have avoided the ncn, if , as you say, this is an inline control and not lab in strict sense of the term.:bigwave:
 
D

ddonben

#7
If I am understanding your original statement that some of your gauges are calibrated internally, then the auditor is correct.
There must be a lab scope, procedures for the gauges you calibrate.
For the external labs, you need to have both a copy of their 17025 certificate and their lab scope.
 

Mikey324

Quite Involved in Discussions
#8
Re: TS 16949 Clause 7.6.3.1 - Internal Laboratory - Requirements

Understood.

I know 3.1.4 definition of a lab in ISO TS.
If you had shown a process flow chart of your product realization ( from incoming to shipping, also requested to trigger FMEA and Control), you coud have avoided the ncn, if , as you say, this is an inline control and not lab in strict sense of the term.:bigwave:
Process flow charts are not completed at this time because process design is still in process. This was explained.Process flow, minus this operation, was shown. My opinion is the same as yours, this is an online control used to verify product is within spec. If we were testing for function i might understand...
 

qusys

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#9
If I am understanding your original statement that some of your gauges are calibrated internally, then the auditor is correct.
There must be a lab scope, procedures for the gauges you calibrate.
For the external labs, you need to have both a copy of their 17025 certificate and their lab scope.
Reading again the original post, I did not catch if they calibrate tools internally...but probably I am wrong. If it is so, you are right as well as the external auditor.:bigwave:
 
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Golfman25

Trusted Information Resource
#10
The way you describe it, I think the auditor is correct (at least from my experience). However, why wouldn't your current "lab" scope cover it. I assume you already use the standard gages you listed to make dimensional checks. And your currently have calibration requirements, etc. If not, you simply need to add them to your current "lab" scope -- doesn't need to be real complicated. And don't get caught up in the word "lab" -- stampers "labs" are usually their shop floor. Good luck.
 
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