TS 16949 External Lab for Raw Material Certs for PPAPs

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gjkoenig

#1
We are a metal stamping company and are new to TS16949, recently passing our Stage 2, having upgraded from ISO 9001:2008. We have 5 minor NCs from the Stage 2, but one is giving me a lot of trouble. A finding was made during a review of an automotive customer's PPAP that the raw metal material cert we received from material bought from an ISO 9001 supplier was not supplemented with outside testing from a TS or ISO 17025 certified lab. We are in the process of finding a certified lab that can do both chemical and mechanical analysis of the raw metal in order to close the corrective action for this NC. Some labs do chemical but not material analysis (tensile, conductivity, hardness, roughness) vice versa.

Am I correct in assuming that all data on the ISO supplier's cert has to be 3rd party verified/tested by the certified TS or ISO 17025 lab?

My main question is, do we have to have all subsequent shipments of production material tested or is the TS requirement satisfied for material bought in the pre-production stage of a PPAP only? This answer is critical as the cost of using a non-TS/ISO 17025 supplier will be prohibitive considering the added cost of 3rd party testing. Using a TS supplier is not always an option given the limited supplier base of certain materials and pricing considerations.
 
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Golfman25

Trusted Information Resource
#2
IMHO it is a nit pick and shows a complete misunderstanding by the ISO committee of how the steel markets work.

Find out where the cert. data came from. It will either be from the mill or your distributor will have its own internal data. 90% of the time we see actual mill certs. You really aren't using an external/ commercial/ independent laboratory as indicated in 7.6.3.2. You are really using the internal laboratory of the mills. They are pretty good at what they do.
 
S

Sean Kelley

#3
I agree with Golfman and work for a steel mill. This has never been an issue with using our internal lab as long as the stell mill is also TS certified or at least ISO 9001.
 

Jim Wynne

Leader
Admin
#4
We are a metal stamping company and are new to TS16949, recently passing our Stage 2, having upgraded from ISO 9001:2008. We have 5 minor NCs from the Stage 2, but one is giving me a lot of trouble. A finding was made during a review of an automotive customer's PPAP that the raw metal material cert we received from material bought from an ISO 9001 supplier was not supplemented with outside testing from a TS or ISO 17025 certified lab. We are in the process of finding a certified lab that can do both chemical and mechanical analysis of the raw metal in order to close the corrective action for this NC. Some labs do chemical but not material analysis (tensile, conductivity, hardness, roughness) vice versa.

Am I correct in assuming that all data on the ISO supplier's cert has to be 3rd party verified/tested by the certified TS or ISO 17025 lab?

My main question is, do we have to have all subsequent shipments of production material tested or is the TS requirement satisfied for material bought in the pre-production stage of a PPAP only? This answer is critical as the cost of using a non-TS/ISO 17025 supplier will be prohibitive considering the added cost of 3rd party testing. Using a TS supplier is not always an option given the limited supplier base of certain materials and pricing considerations.
I would challenge this. 7.6.3.2 of ISO/TS 16949 says, in part:

External/commercial/independent laboratory facilities used for inspection, test or calibration services by the organization shall have a defined laboratory scope that includes the capability to perform the required inspection, test or calibration, and either
⎯ there shall be evidence that the external laboratory is acceptable to the customer, or
⎯ the laboratory shall be accredited to ISO/IEC 17025 or national
equivalent.

Note the bolded bit. The requirement applies to external labs used directly by the organization, not to labs used by the organization's suppliers. Almost all raw material (metal) test data emanates from the mill, and the mills use their own internal labs.
 

WCHorn

Rubber, Too Glamorous?
Trusted Information Resource
#5
I agree with Jim; 7.6.3.2 cannot be used as a basis for the nonconformance. However, you didn't cite the nonconformance for us.

If the auditor was reviewing a PPAP submission, then he may have a basis for the nonconformance if he cited 2.2.12 of the PPAP manual. It cites that "inspection and testing for PPAP shall be performed by a qualified laboratory as defined by customer requirements (e.g., an accredited laboratory)." If your customer requires a TS or ISO 17025 laboratory, then I believe the finding is valid.
 

Jim Wynne

Leader
Admin
#6
I agree with Jim; 7.6.3.2 cannot be used as a basis for the nonconformance. However, you didn't cite the nonconformance for us.

If the auditor was reviewing a PPAP submission, then he may have a basis for the nonconformance if he cited 2.2.12 of the PPAP manual. It cites that "inspection and testing for PPAP shall be performed by a qualified laboratory as defined by customer requirements (e.g., an accredited laboratory)." If your customer requires a TS or ISO 17025 laboratory, then I believe the finding is valid.
The requirement you cite is pretty much universally interpreted to apply to performance testing, not material testing. If that requirement applied to all PPAP material test reports, the vast majority that have ever been submitted would be nonconforming.
 
G

gjkoenig

#7
The NC came from a PPAP audit review, where the auditor stated AIAG PPAP requirements require a TS or ISO 17025 certified lab perform testing of our raw material. Our supplier is only ISO 9001, therefore, their certificate of conformance is not adequate. The only other way out is if our customer agrees to not have the material tested, which is not an option.

The auditor told me that unless directed otherwise by the customer, a general PPAP request by the customer defaults to the AIAG requirements.

My question is whether this is only a requirement for PPAP sumbittal which is above and beyond that of the general TS requirement that suppliers be at least ISO 9001 certified.

I can't see why an auditor would expect all future production material to be lab tested under TS/ISO 17025. In this case, I just wanted to seek other opinions on the matter. I appreciate the responses that have been given.
 

Jim Wynne

Leader
Admin
#8
The NC came from a PPAP audit review, where the auditor stated AIAG PPAP requirements require a TS or ISO 17025 certified lab perform testing of our raw material. Our supplier is only ISO 9001, therefore, their certificate of conformance is not adequate. The only other way out is if our customer agrees to not have the material tested, which is not an option.

The auditor told me that unless directed otherwise by the customer, a general PPAP request by the customer defaults to the AIAG requirements.

My question is whether this is only a requirement for PPAP sumbittal which is above and beyond that of the general TS requirement that suppliers be at least ISO 9001 certified.

I can't see why an auditor would expect all future production material to be lab tested under TS/ISO 17025. In this case, I just wanted to seek other opinions on the matter. I appreciate the responses that have been given.
Can you give us the full NC statement from the auditor, including reference to the requirement that was allegedly not fulfilled?
 
G

gjkoenig

#9
The Audit NC is as follows:

ISO/TS Clause: 7.3.6.3

Statement of nonconformity: The product approval process is not conducted as required by customers.

CSR or TS Requirement: The organization shall conform to a product and manufacturing process approval procedure recognized by the customer.

Objective Evidence: Laboratory documentation was not included in the PPAP submittal for P/N XXXX


The requirement in 7.3.6.3 is implying the approved procedure by the customer is the AIAG PPAP requirement. The auditor pointed out that for the Level 3 PPAP were submitted, we were supposed to have provided for #12 in Table 4.2 - Qualified Laboratory Documentation. We only had the CofC from the ISO 9001 supplier. The auditor pointed out that only a TS supplier or ISO 17025 lab is considered a "qualified lab".

It seems odd that TS says its OK for a supplier to be ISO 9001, but a PPAP requires TS or ISO 17025 testing.
 

Jim Wynne

Leader
Admin
#10
The Audit NC is as follows:

ISO/TS Clause: 7.3.6.3

Statement of nonconformity: The product approval process is not conducted as required by customers.

CSR or TS Requirement: The organization shall conform to a product and manufacturing process approval procedure recognized by the customer.

Objective Evidence: Laboratory documentation was not included in the PPAP submittal for P/N XXXX


The requirement in 7.3.6.3 is implying the approved procedure by the customer is the AIAG PPAP requirement. The auditor pointed out that for the Level 3 PPAP were submitted, we were supposed to have provided for #12 in Table 4.2 - Qualified Laboratory Documentation. We only had the CofC from the ISO 9001 supplier. The auditor pointed out that only a TS supplier or ISO 17025 lab is considered a "qualified lab".

It seems odd that TS says its OK for a supplier to be ISO 9001, but a PPAP requires TS or ISO 17025 testing.
I would definitely challenge the NC. If you have an approved PPAP that does not include the lab documentation the auditor was looking for, that's direct evidence that the statement "The product approval process is not conducted as required by customers." is wrong. There are many instances where elements are not applicable to a given PPAP, even when the submission level is 3.
 
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