Outsourcing part of Design & Dev Process- Still requiring D&D ver & val-7.3.5, 7.3.6?

O

onin111

Hi,
We are the outsourced engineering services facility. Our Lead Design unit(same company) in another country is directly interfacing with OEM. So basically they identify the engineering changes, draw a mark-up of changes in the powerpoint, send us the CAD files & powerpoint, and simply change the CAD drawings on that data. Our output is the updated CAD files. The Lead Unit checks our output, does all the Verification & Validation processes (7.3.5, 7.3.6).

Now we are for conformance to TS16949, and the auditor keeps on looking for the D&D verification & validation process, but i keep on saying that it is done by the Lead Unit. She said that we should identify it in the scope of QMS, but excluding such clauses would contradict 1.2.

Our setup has really been a headache for CBs. Our previous CB already understood our setup. With the new CB, we have to orient them again.

So my question, how can we state in our quality manual that we are only catering some of the D&D processes in a way that we are not excluding them, unlike stating it under 1.2 ("The only permitted exclusions for this Technical Specification relate to 7.3 where the organization is
not responsible for product design and development."

Thanks!
 

Stijloor

Leader
Super Moderator
Re: Outsourcing part of Design & Dev Process- Still requiring D&D ver & val-7.3.5, 7.

Hi,
We are the outsourced engineering services facility. Our Lead Design unit(same company) in another country is directly interfacing with OEM. So basically they identify the engineering changes, draw a mark-up of changes in the powerpoint, send us the CAD files & powerpoint, and simply change the CAD drawings on that data. Our output is the updated CAD files. The Lead Unit checks our output, does all the Verification & Validation processes (7.3.5, 7.3.6).

Now we are for conformance to TS16949, and the auditor keeps on looking for the D&D verification & validation process, but i keep on saying that it is done by the Lead Unit. She said that we should identify it in the scope of QMS, but excluding such clauses would contradict 1.2.

Our setup has really been a headache for CBs. Our previous CB already understood our setup. With the new CB, we have to orient them again.

So my question, how can we state in our quality manual that we are only catering some of the D&D processes in a way that we are not excluding them, unlike stating it under 1.2 ("The only permitted exclusions for this Technical Specification relate to 7.3 where the organization is
not responsible for product design and development."

Thanks!

Comments/suggestions anyone?

Thanks!

Stijloor.
 

howste

Thaumaturge
Trusted Information Resource
Re: Outsourcing part of Design & Dev Process- Still requiring D&D ver & val-7.3.5, 7.

Hi,
We are the outsourced engineering services facility. Our Lead Design unit(same company) in another country is directly interfacing with OEM. So basically they identify the engineering changes, draw a mark-up of changes in the powerpoint, send us the CAD files & powerpoint, and simply change the CAD drawings on that data. Our output is the updated CAD files. The Lead Unit checks our output, does all the Verification & Validation processes (7.3.5, 7.3.6).

Now we are for conformance to TS16949, and the auditor keeps on looking for the D&D verification & validation process, but i keep on saying that it is done by the Lead Unit. She said that we should identify it in the scope of QMS, but excluding such clauses would contradict 1.2.

Our setup has really been a headache for CBs. Our previous CB already understood our setup. With the new CB, we have to orient them again.

So my question, how can we state in our quality manual that we are only catering some of the D&D processes in a way that we are not excluding them, unlike stating it under 1.2 ("The only permitted exclusions for this Technical Specification relate to 7.3 where the organization is
not responsible for product design and development."

Thanks!

Are you doing product manufacturing? Only manufacturing sites can have a TS 16949 certificate. The other locations can only be included as support locations on the manufacturing site certificate.

If you aren't doing manufacturing at your location, then your facility should only be audited for the functions you're doing to support the manufacturing site. If you are doing manufacturing, then the Lead Design Unit should be listed on your certificate as a support location, and audited accordingly.
 

qusys

Trusted Information Resource
Re: Outsourcing part of Design & Dev Process- Still requiring D&D ver & val-7.3.5, 7.

Are you doing product manufacturing? Only manufacturing sites can have a TS 16949 certificate. The other locations can only be included as support locations on the manufacturing site certificate.

If you aren't doing manufacturing at your location, then your facility should only be audited for the functions you're doing to support the manufacturing site. If you are doing manufacturing, then the Lead Design Unit should be listed on your certificate as a support location, and audited accordingly.

From what the Covers said in his post, it appears that they are ISO TS certified... He should provide more details :confused:
I agree with what you wrote in the post. They do not seem to be a mgf site but he talks about their quality manual too.
 
O

onin111

Re: Outsourcing part of Design & Dev Process- Still requiring D&D ver & val-7.3.5, 7.

From what the Covers said in his post, it appears that they are ISO TS certified... He should provide more details :confused:
I agree with what you wrote in the post. They do not seem to be a mgf site but he talks about their quality manual too.
Thank you for the replies.

We are not certified, we are TS conformance/compliance only since we are not manufacturing, only design, and to make it a bit complicated, part only of the design process, and in another location.

The way it is setup here is that, our facility has our own conformance audit (independent from manufacturing plant audit) so that when the other plants we are supporting are audited, we show them our conformance audit report. We are supporting multiple engineering and manufacturing plants.

Yes, we have our own supplementary quality manual covering our own processes. And the auditor suggested that we define there that our processes are engineering services only, not the entire design process.
 

howste

Thaumaturge
Trusted Information Resource
Re: Outsourcing part of Design & Dev Process- Still requiring D&D ver & val-7.3.5, 7.

Thank you for the replies.

We are not certified, we are TS conformance/compliance only since we are not manufacturing, only design, and to make it a bit complicated, part only of the design process, and in another location.

The way it is setup here is that, our facility has our own conformance audit (independent from manufacturing plant audit) so that when the other plants we are supporting are audited, we show them our conformance audit report. We are supporting multiple engineering and manufacturing plants.

Yes, we have our own supplementary quality manual covering our own processes. And the auditor suggested that we define there that our processes are engineering services only, not the entire design process.
I've never heard of a "conformance audit report" for a support location from an IATF recognized Certification Body (CB). This raises some more questions.

Is your "conformance audit" done by the same CB as the manufacturing sites? If so, they should certainly recognize the interactions between the locations because they are auditing them all.

If the CB is different than some of the manufacturing sites, here are the rules:
TS 16949 Rules said:
...a certification body may accept the audit by another certification body of the remote supporting locations subject to the following conditions:
1 ) the audit was conducted to ISO/TS 16949:2002 by an IATF recognized certification body,
2) the audit covered the complete product scope of those functions, consistent with the process based audit approach,
3) the client provides prior to the audit to the certification body a copy of the audit plan, audit report, all findings, all corrective actions, and all verification actions by the other certification body. This information shall be in the language agreed between the client and the other certification body,
4) the information confirms during the stage 1 readiness review that all the interfaces between the remote supporting location and the site were adequately audited by the other certification body,
5) verification of the client's corrective actions is conducted by the certification body that audited the remote supporting location. Copies of all onsite verification activities reports shall be provided by the client to the certification body.
 
O

onin111

Re: Outsourcing part of Design & Dev Process- Still requiring D&D ver & val-7.3.5, 7.

I've never heard of a "conformance audit report" for a support location from an IATF recognized Certification Body (CB). This raises some more questions.

Is your "conformance audit" done by the same CB as the manufacturing sites? If so, they should certainly recognize the interactions between the locations because they are auditing them all.

If the CB is different than some of the manufacturing sites, here are the rules:

Sorry, the proper term of what I meant is Letter of Conformance.

We could not attain same CB with manufacturing/engineering sites because we have a lot of sites to support with their own discretion of which CBs to do the audit them.

After we get the letter of conformance, we give it to the sites we support so they can list us as their support sites in their respective TS certificates.
 
Top Bottom