How to address an audit of another facility that is not ISO/TS 16949 ?

rvanelli

Involved In Discussions
#1
My company makes an electronic component for Ford in China. It is then shipped to the US to be inspected/reflashed as necessary and then shipped to Ford. The China facility is going through TS certification but the US facility is just ISO 9001. As part of the China certification the registar plans to visit the US facility as well to audit.

Is this typical? If the US facility is not part of the TS registration what could the scope of this audit be?

Thanks in advance for any guidance.
 
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Kales Veggie

People: The Vital Few
#2
Re: Question about TS external audit

Yes, this is typical. That facility has to be part of your registration. TS does not give you a choice to decide.

You have to document in your QMS what they do in that facility.
 

rvanelli

Involved In Discussions
#3
Re: Question about TS external audit

Interesting. I am not up to speed on the TS requirements. Is there a section in the TS standard that mentions this as a requirement? I am at the US facility and TS is not our focus but we certainly want to be prepared.

Thanks again.
 

Jim Wynne

Staff member
Admin
#4
Re: Question about TS external audit

I think your best course of action would be to contact the CB and find out (a) what their rationale is and (b) the scope of the audit as it pertains to your facility.
 

qusys

Trusted Information Resource
#5
My company makes an electronic component for Ford in China. It is then shipped to the US to be inspected/reflashed as necessary and then shipped to Ford. The China facility is going through TS certification but the US facility is just ISO 9001. As part of the China certification the registar plans to visit the US facility as well to audit.

Is this typical? If the US facility is not part of the TS registration what could the scope of this audit be?

Thanks in advance for any guidance.
From my understanding based upon what you wrote, it is correct that CB will audit it. I think these operations ( inspection/reflashing) and shipping to Ford should be part of mfg process flow. They should have and P-FMEA and Control plan as well. ISO TS should be appplied also to your US SIte as a part of supply chain. Check with CB if US site could be considered as "remote function" as well.
Please, let us updated with further development.
 

rvanelli

Involved In Discussions
#6
Excellent information as usual. Thanks guys.

We have not been contacted by the certifying body as of yet just by our manufacturing facility in China. I have requested a scope and audit plan but from the responses here I need to also look at what they list and their process and interactions as well as their FMEA and Control Plans and the develop a course of action. The audit is for the end of July and we just found out last week of the requirement.
 
M

Murphys Law

#7
If this is small part of process for that site, you may be able to get a waiver from Ford acknowledging that that operation is just ISO9001.
 
M

Murphys Law

#9
If you only service 1 auto customer (1 off )and they waive it, I don't see why the registrar could say anything. If you have other auto customers, then it gets a harder argument as this is now a mainstream business model.
 

qusys

Trusted Information Resource
#10
Excellent information as usual. Thanks guys.

We have not been contacted by the certifying body as of yet just by our manufacturing facility in China. I have requested a scope and audit plan but from the responses here I need to also look at what they list and their process and interactions as well as their FMEA and Control Plans and the develop a course of action. The audit is for the end of July and we just found out last week of the requirement.
It could be a tricky question. Please, specify better what US Site does for inspection and reflashing if they are value added operation.
In any case , I think that there is the question of shipping process because yiu said US ship finished good to Ford. My question is: who owns this shipping process? Who controls it? US Site or China Site?
Probably there are some missing step that your organization has not considered in the mfg process flow, because it is intending from incoming ( raw materials used for you product realization) to shippin ( finished good to the customer) through production. I am afraid that your organization did not consider the last portion , where it is also requested FMEA, COntrol Plan and control on the process. Look at par. 1 Scope of ISO TS in part related to ISO TS , out of the box.
Probably support functions you said were not correctly addressed in the relationships of QMS processes of the China mfg site.
Please let us know :bigwave:
 
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