TS 16949 Certification Questions

[amaan]

Dear all,

I have newly joined a company going for TS:16949 certification in India.
My job responsibility is documentation for TS:16949 certification.
we are into manufacturing and sales of auto parts in India.
Scope of certification is Manufacturing and sales.
we do not carry out design and development of product.
Design & development is carried out by our main plant in Thailand, which is already TS:16949 certified unit.
All the product and process design documents we get from our head office.
I have got our main plants quality manual for reference.

My questions:
1.In what way we can go for the certification (can we exclude design).
2.can we use the duplicate of same manual, since the product & procedures are same.
3.The manual has 26 procedures (including 7 mandatory). Can we have only 6 mandatory procedures or should we follow all of those.
( e.g control procedure for purchasing, control procedure for production, control procedure for equipment maintenance etc.)


Kindly help with suggestions.
AMAAN

 

[Jen Kirley]

Welcome to the Cove!

7.3 (Design) is the only element permitted to be excluded in TS 16949. So yes, you can exclude it. However, you will be expected to exhibit revision control of these designs.

Are you intending to use your corporation's quality manual? I wonder then if your organization might elect to pursue a certificate that lists you as a remote site? Otherwise, I see no reason why you cannot use the same manual as Thailand site if it accurately represents your operations.

Only 6 documented procedures are explicitly required by ISO 9001, which is the basis of TS 16949; however, I believe you can expect your auditor to pressure you to show how you ensure the process(es) (set of activities based on responsibilities and controlled inputs) can be executed in a controlled and consistent manner without established procedures.

You will be expected to establish a control plan for the products you manufacture. The control plan will be expected to be unique to the product if its treatments are not the same as the other products.

I hope this helps!

 

[Chennaiite]

There is a similar discussion here; TS16949 Exclusions - Design & Development is carried out by our parent company

....
Only 6 documented procedures are explicitly required by ISO 9001, which is the basis of TS 16949; ...

It is 7 infact for ISO/TS, including the one of 'Training'.

 

[dmp06]

Exclusion can be taken for product design. You state that you are not process design responsible? You will have to provide evidence that your site does not design or change design of process. TS requires 7 documented procedures, although you can use one document for two required procedures (ie. CAPA).

"You will be expected to establish a control plan for the products you manufacture. The control plan will be expected to be unique to the product if its treatments are not the same as the other products." Your organization is responsible to meet the APQP requirements including DFMEA, PFMEA, Control Plans, PFCs, and all customer-specific requirements. Don't get all focused specifically on the Control Plan until you have ensured you have defined all customer-specific and other requirements for your product and all design and process potential/actual failures.

Too many auditors today are focusing on the control plan as a method to determine process and system effectiveness without determining if the control plan is accurate/correct and complete.

You may want to take a TS 16949 Internal Auditor course or equivalent before you embark on this journey. Competence is a requirement.

 

[amaan]

Thanks for the suggestions.

we consulted our CB.
CB says that " Since Our parent company is responsible for design & development, so we cannot exclude design".
We have to go with the scope of Design & Development Inclusion.
But during our Audit we have to submit the audit reports of our Parent company which does design & development for us.

Is this the correct procedure.

 

[Englishman Abroad]

Amaan,

Yes, IMO your CB is correct.

The Product Design and Dev is performed by your parent company, which in ISO speak is a supporting location to your audit scope. Product Design is in the scope, but just performed at a different location.

Your CB will want to see the ISO TS certificates and reports for the parent company that perform the design and interface with your plant.

This is normal, eventually these certificates and reports will be referred to on page 2 of your certificate.

During your audit, your auditor will probably focus on the interfaces between you and the product design function. (Feasibility, DFMEA, etc).

 

[qusys]

Thanks for the suggestions.

we consulted our CB.
CB says that " Since Our parent company is responsible for design & development, so we cannot exclude design".
We have to go with the scope of Design & Development Inclusion.
But during our Audit we have to submit the audit reports of our Parent company which does design & development for us.

Is this the correct procedure.

Dear Amaan, you can exclude design & development for your mfg site only for the "product" but not for the "process". Take into account this one otherwise there is the risk of failing.