ISO/TS 16949 certificability - Design Center - No Production

[anilo]

I posted one year ago about ISO/TS.
Now we are going to start the certification iter.
But...
We are a design center.
Our outsourcer, that assemblies our Electronic Control Unit, has got just us like the only one automotive customer.
So, It can't be wholy certificate.

Our outosourcer's CEO had an Idea to semplify the procedure: to certify ISO/TS just the ICT and EOL area (Test Area), avoiding the entires SMT lines!!
At the Incoming of the Test Area we should receive 2 parts, the semiassemblied board, and the mechanical cover.

In your opinion, is this a right way to move?
I don't like it very much, even because the IPC has 2 standard to check the quality of electronic lines, that are IPC 7912 and 9261.

But Our certification Body said us that it is feasible!
It sounds to me so strange... it seems to me to be such an "italianata" to avoid a relevant part of job...

P.S: forgive my english..

 

[howste]

When auditing to TS 16949 the CB auditor can only audit those processes, documents, and records that result in OEM automotive applications. Anything that doesn't end up in automotive is not audited (excluded from the audit).

However, if you (or your contract manfacturer) are doing manufacturing, you can't skip these processes! It would defeat the whole point of the certification.

 

[Howard Atkins]

If I understand correctly you are a design center that does not produce.
You have a supplier/outsource who produces.

If this is correct as I understand it you cannot be TS as you do not produce.
The supplier/outsource can be TS for the actions that refer to the part for the auto application

Our outosourcer's CEO had an Idea to semplify the procedure: to certify ISO/TS just the ICT and EOL area (Test Area), avoiding the entires SMT lines!!
At the Incoming of the Test Area we should receive 2 parts, the semiassemblied board, and the mechanical cover.

Is the incoming at your plant and then you assemble?
If you assemble then you can be TS on the assembly and the flow is normal, incoming goods etc.. If the supplier/outsource is assembling and he does the SMT as well he can not omit this.

 

[anilo]

Thank you Howard.
We do NOT produce.
Our Outsourcer wouldl be ISO/TS, and we should appear in the certificate as "Support centre"- see point 1.1.
My question is: considering that our outsourcer assemblies the entire PWA, starting from buying some components we decide they can buy, incoming inspection, storing, SMT, Reflow, AOI, Wave soldering, Touch- up, ICT, EOL, Final checking, Shipping.
We produce a very low volume of automotive parts (10000 in a year), so the outsourcer doesn't want to certify the entire line, because this should be too expensive 'cause we are their only automotive client.
So the CEO had an idea: we certify ISO/TS just the Test Phase (ICT+EOL), excluding incoming, storing, SMT, reflow, wave and Touch- up.
At the incoming of this "test zone" we should consider the board, that comes from Touch- up after PTH, as if it was a product we buy semiassemblied yet, as if it comes form another Plant (instead everything happens in the same Plant).
At the incoming of this "test zone" we should arrange an hard incoming inspection, but just on the Board ant the cover, the only parts still to check e to assembly.

I thought this was an extreme interpretation of the ISO/TS.
But our Certification Body said to us it is ok!!!
So I Design and produce an Electronic Cotrol Unit, and I exclude the entire manufacturing, and consider a board with 700 components, actives and passives, connectors as if it was a "part" just like a metal cover!
Is it possible to do?
Is it correct?
And, doing so, should we have a real added value by ISO/TS, or should it be just a "formal certification" for our Clients??
Thanks again.

 

[Howard Atkins]

anilo,

Has any one actually asked for ISO/TS as if they haven't you do not need to do this.
Why do you call the supplier (manufacturer) outsource?
As I understand it he is a supplier of a part which you sell as the designer and owner of the production file.
You are not a support center as you are a different company.
In general the scope of ISO/TS is only for the parts that are manufactured for the automotive so if the company does SMT for 100 parts and only one is for the automotive then the SMT for that one part is in the standard, that means that for that one part there must be a control plan, FMEA etc and not for all the others. The audit for the ISO/TS only will audit that one part.
This audit can also count for the ISO9001 audit.

I still do not understand

So the CEO had an idea: we certify ISO/TS just the Test Phase (ICT+EOL), excluding incoming, storing, SMT, reflow, wave and Touch- up.
At the incoming of this "test zone" we should consider the board, that comes from Touch- up after PTH, as if it was a product we buy semiassemblied yet, as if it comes form another Plant (instead everything happens in the same Plant).
At the incoming of this "test zone" we should arrange an hard incoming inspection, but just on the Board ant the cover, the only parts still to check e to assembly.

Who is this, the assembler or you?

If it is you then this is your production, if it is the supplier then I agree it has taken all the meaning of the standard away.

The standard is for companies and the important thing is to define how many companies there are and what they do, then the certificates go to the companies as according to their actions.

As I understand
Company A- design and marketing
Company B production and supply of finished part to company A

Company A ISO9001:2000 Scope- Design and marketing of ..........
Company B ISO/TS16949 Scope - Production of ..... for the automotive industry (only the actual part)

Does this make sense?

I have opened a more general discussion on this issue here
http://elsmar.com/Forums/showthread.php?p=103638

 

[anilo]

Sorry Howard, I try to better explain.

Company A: Design center, EOL and ICT designer, Owner of the product, Tier1 Supplier.
Company B: Just produces what A wants in the way A decides. B is responsible only to planning production after A ordered the ECU, to Set- up and mainteinance the machine, Human resources (A is responsible to instruct B employees upon its test machine, too).

A is the seller to Automotive Clients.
B is Invisible, in the sense that tomorrow, if A wants, the product can be assemblied by another company, C for example.

So, Automotive Clients are asking to A to be TS2.
But A can't be TS2 stand alone, because A does NOT produce anything!
The production Plant, today, is B, but tomorrow could be C, or D.
A decides where assembly its products.

Here begins the problem.
A is only 2% of B Turn over.
A is the only B automotive Client.
B could assembly the entire A products in a week!
Of course, B cannot do this, because A receives a planning by its customers.
So, SMT lines are used just for a minum time of the day to realize A products.
B CEO said: I don't want to certify the entire line because it's too expensive.
Just do this: we could consider that B is "virtually" divided in 2 parts: a part that assemblies, according to ISO9001: 2000, and produces a Board (incoming, storing, SMT, Reflow, AOI, etc..).
The second part is TS2, and it considers just the ICT+EOL of A products.
So we have a virtual division of B; there would be an "inside sell" about the ISO9001 zone to the TS2 zone.
When TS2 zone receives the board, here start an incoming to the board and to the metal cover, before accepting the goods.
(Please note: all of this happens in the same plant at B location).

Our Body said we can do a "corporate" certification to TS2.
B Should be the TS2 owner, and A would appear in the certicate as a "remote design center", even if A and B are 2 different organizations.

A, at the moment, is ISO9001, and is responsible about the production.
That is: if A clients expertise a production problem (e.g.: tombstoning), A is guilty for the problem caused to the Clients.
A and NOT B.
After this, A will ask to B what happened during the production etc..
Here is because I call B "outsourcer".
Because A is, for the Client, responsible even for the production, doesn't matter if B, C or D is the one that phisically realize the products.

So: exluding the SMT line is correct?
Our Body said Yes.
And I can't understand how, producing an electronic control unit, I can exclude the entire SMT process, storing, incoming at the B "ISO9001" zone, purchasing etc.. and include only the Test zone to the TS2 certification.

Hope this is clear.
Thanks again.

 

[Boing]

Hmm might not be right on this....

But thought that you have to have a manufacturing site to be able to qualify for TS accreditation ?

If the company does this virtual segregation as described wouldn't they be acting as services to the manufacturing half and therefore still not qualify for accreditation.

Also regarding the comments that the product could be made at either C or D wouldn't that mean complete PPAP resubmission as manufacturing location etc has changed ?

 

[anilo]

Thank you Boing.

I Thought ICT+EOL was a manufacturing phase.
I never thought it as a service...

We are ISO9001, at the moment, so we shouldn't need to submit a PPAP.
However, that was just an example: change from B to C is not so easy, it's enough thinking to all the training we should performe to C employees!

We do a PPAP only if our client ask for it.

 

[vanputten]

Hello

Just because you outsource the product realization portion of the quality management system, doesn't mean you are not responsible for the outsourced process. This is true for any outsourced process.

You can and should be able to be audited to TS 16949. Company A is still responsible for the inputs, outputs, and monitoring of the outsourced process at company B. The "manufacturing", as everyone has identified, doesn't have to inside your facitlity. Company A is reponsible for the Product Relaization and Company A appears to be a Teir 1 supplier selling automotive product to an automotive customer.

Initially this may seem strange but think about it interms of a system and think less about it in tangible terms (manufacturing is in our building or somewhere lese.)

It may help to review the ISO Guidance on Outsourcing located at:

http://isotc.iso.org/livelink/livel...c=ll&objId=1069636&objAction=browse&sort=name

Cut and paste the link into your internet browser. Check out the guidance document.

Regards, Dirk

 

[Howard Atkins]

Hello

Just because you outsource the product realization portion of the quality management system, doesn't mean you are not responsible for the outsourced process. This is true for any outsourced process.

You can and should be able to be audited to TS 16949. Company A is still responsible for the inputs, outputs, and monitoring of the outsourced process at company B. The "manufacturing", as everyone has identified, doesn't have to inside your facitlity. Company A is reponsible for the Product Relaization and Company A appears to be a Teir 1 supplier selling automotive product to an automotive customer.

Initially this may seem strange but think about it interms of a system and think less about it in tangible terms (manufacturing is in our building or somewhere lese.)

It may help to review the ISO Guidance on Outsourcing located at:

http://isotc.iso.org/livelink/livel...c=ll&objId=1069636&objAction=browse&sort=name

Cut and paste the link into your internet browser. Check out the guidance document.

Regards, Dirk

Please also relate to the discussion here
http://elsmar.com/Forums/showthread.php?p=103638 as this issue in my opinion is not so clear in general

anilo,
You customer should know that you do not do the manufacturing as if he wants to visit, audit etc he will get a surprise if he does not know from the start.

A, at the moment, is ISO9001, and is responsible about the production.
That is: if A clients expertise a production problem (e.g.: tomb stoning), A is guilty for the problem caused to the Clients.
A and NOT B.
After this, A will ask to B what happened during the production etc..
Here is because I call B "outsourcer".
Because A is, for the Client, responsible even for the production, doesn't matter if B, C or D is the one that phisically realize the products.

If the problem was not tomb stoning but a faulty diode then it is obvious that you are responsible to your customer but it is the supplier of the diode who needs to perform corrective actions, the same for a production problem such as tomb stoning , the supplier has the same responsibility if it is a component or workmanship.