TS16949 Design Exclusion when Design is done in a different Facility

M

mohamedhrr

#1
Dear Experts,

I need some suggestions.

We are into Automotive Engine parts manufacturing, Our Main Plant is in Japan which is TS certified and carries out the design and manufacturing of products.

Recently has opened a unit in India to fulfill requirements of Indian market.
The scope of this unit is manufacturing and sales of products.

whereas the Main Plant is still responsible for Design and development.

Since we are (new plant) going for TS certification.

Kindly suggest, how to go about it, can design be excluded.
Or the main plant will also be audited during our audit for certification.
:thanx:
 
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John Broomfield

Staff member
Super Moderator
#2
Re: TS16949 design Exclusion

mohamed,

You've mentioned only design and development of automotive products.

ISO/TS 16949 also requires use of clause 7.3 for the design and development of the process(es) for manufacturing automotive products.

I therefore doubt an exclusion of clause 7.3 would be feasible.

John
 
M

mohamedhrr

#3
Re: TS16949 design Exclusion

Both Product and Process design is carried out by the main plant. we are only into manufacturing and sales.
do still the design can,t be excluded.
 

John Broomfield

Staff member
Super Moderator
#4
Re: TS16949 design Exclusion

Mohamed,

Perhaps, if you can show that the production processes and work environment in India are exactly as specified by Japan.

This includes any changes from Japan to India and from India to Japan.

It also raises the question of Japan gathering data from the India production processes and work environment to monitor conformity to the design.

How does Japan exactly replicate its production processes and work environment in India?

John
 
M

mohamedhrr

#5
Re: TS16949 design Exclusion

Is it Enough if we Maintain the Engineering Documents related to Products and Processes received from Japan.
Can We consider them as a supplier or we have to consider them as a supporting department.
Will the CB audit them too.
 

John Broomfield

Staff member
Super Moderator
#6
Re: TS16949 design Exclusion

Mohamed,

Your India company's management system should share the same CB as Japan's. Or at least should share equivalent if not the same accreditations.

It might be better to extend the whole Japan management system to India so India is part of the Japan certification. This recognizes that the whole system influences the quality of its products.

As I've implied above, just keeping the product and process information from Japan in India will be insufficient.

John
 
M

mohamedhrr

#7
Re: TS16949 design Exclusion

I hope you mean, that Japan unit should include Indian Plant as their supporting unit in their Quality management system with same certification.
 

harry

Super Moderator
#9
Re: TS16949 design Exclusion

My views are as follows:

1. Unless you can prove that you are not design responsible such as being a contract manufacturer, then it is possible for you to get away with product design.

2. With regards to design of processes in your plant, whether it is carried out by people from your main plant or third parties, it is actually an outsourced arrangements and you are still responsible. Therefore I don't think you can get away from this area.

Best to check with your existing or potential CB.
 

Englishman Abroad

Involved In Discussions
#10
Re: TS16949 design Exclusion

Mohamed,

In ISO TS section 1.2, the only exclusion permitted is product design and product development.

Hence for the Indian plant you would be expected to show process design & process development, although some part of this may be done in Japan.

The Japanese plant is a "Supporting function" providing a product design service to the Indian plant. You already stated that the Japanese plant is ISO TS certified, so that should not be an issue.

It is easier but not mandatory to have the same CB for the Japanese and Indian plants. It is also easier but not mandatory to have the same QMS.

In order to have the Japanese plant recognised as a supporting function by the CB for the Indian plant, you will need to supply the Indian CB with the certificate, and all audit reports and NC data for the Japanese plant.

As Harry says - contact your CB to discuss the supporting function interface.

During the audit of the Indian plant, the auditor will want to investigate the interfaces between the Japanese and Indian plants; How is manufacturing feasibility performed, FMEAs performed, Production and Customer issues feedback to Product design etc.

I suggest that for your first certification you also discuss with your CB the possibility of a pre evaluation (mock audit) by your CB before the real audit. (You will have to pay for the pre evaluation).

Good luck for your certification
 
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