Plastic Injection Moulder - Design exemption from AS9100

[fraktion]

Hello all.

I'm the QM for a plastic injection moulder. We've had our certification for 14 years now. For all of these 14 years, we've had an exemption from the design clause. We manufacture tooling for some customers that then produces parts to a drawing the customer has designed. Hence being exempt.

Recently, we had an audit where a fresh faced youngster, with all of 3 AS9100 audits under his belt, got into a heated discussion with my MD as in his eyes, we should have the design clause within our scope. the thinking behind this was due to the fact we design / manufacture the tooling to make the customers parts, we are technically designing a product. The product being the tool.

My question is. Is he right? 14 years of multiple audits from the same company and customer audits, nobody has suggested we should have design as part of our scope. The MD does not want design as part of our scope. Do we have to have design as part of our scope?

Thank you for your help

 

[RCW]

Re: Design exemption from AS9100

You say "We manufacture tooling...". Do you perform this process using documents or drawings provided by your customer?

If the answer is yes, then you are correct. Design shouldn't be in your scope.

If you are developing the drawings and documentation to fabricate this tooling, I would say you would fall under the design scope.

 

[fraktion]

Re: Design exemption from AS9100

The correct answer is no. More often than not, it is completely down to us to make the tool that produces a part that is designed by the customer. We choose where to put hot runner systems, feed points etc. We create the tool that makes the part the customer wants.

The boss is adamant that we merely 'manufacture tooling' and as we had no part to play in the design of the finished resulting product, by that reasoning design doesn't apply to us.

Like I said, 14 years without the design clause. Now we're being told we need it. The MD is dragging his heels as he "doesn't want any more bureaucracy"...

Is it compulsory?

 

[Michael_M]

Re: Design exemption from AS9100

Is the design of the tooling a requirement to your manufacturing? Could the making of the tooling be classified as a 'core process'?

 

[fraktion]

Re: Design exemption from AS9100

I don't know what you mean by a requirement to our manufacturing?

Our Tooling process is indeed one of our core processes...

 

[fraktion]

Re: Design exemption from AS9100

I can see both sides.

On one side, the MD is saying "we manufacture the tooling that makes a finished part that the customer has designed"

On the other side, the auditor is saying "You design the tool, therefore you must have design in your scope"

Is it simply a case of knowing exactly what the customer has ordered and what do they expect from us? If they ask us to create a tool for them to make a part they designed, place an order for the tool but no parts, then we have technically designed the tool.

If they place an order for a tool with an accompanying production run for 50,000 parts from that tool, then still from what I see, we've designed a tool that makes a part the customer has designed.

So does AS9100 design clause apply purely to 'finished product' whether that product is a plastic widget or the tool that makes the plastic widget?

 

[RCW]

Re: Design exemption from AS9100

Here is my frame of reference when I gave you my opinion:

Disregard what your tooling will eventually be used for. In this case it is to manufacture the "end use" component. The tooling could just as well be fabricated and used by sitting on somebody's desk as a paperweight.

From what I am reading, what you are contracted with your customer to provide is the tooling. Is that tooling being fabricated to drawings or other documents supplied to you by your customer or some other outside source? The answer sounds like - "no". It sounds more like your are designing the tooling to your customer's specifications.

Again, this is my opinion and I would be interested as to what other Covers say here.

As far as the 14 year history of this never being identified, I too am finding tightened examination by outside auditing sources. This could be good or bad depending on what side of the fence you are on.

 

[Irvingstark]

We went round and round with our registrar with this issue as well. We don't control customer drawings. These drawings are what we are going to produce end product. The drawings for tooling are a means to accomplish the process of producing the part, not for designing the end product. It is then appropriate to exclude the design element of ISO.

It speaks to a basic misunderstanding of manufacturing process to some registrars.

 

[fraktion]

We went round and round with our registrar with this issue as well. We don't control customer drawings. These drawings are what we are going to produce end product. The drawings for tooling are a means to accomplish the process of producing the part, not for designing the end product. It is then appropriate to exclude the design element of ISO.

It speaks to a basic misunderstanding of manufacturing process to some registrars.

This is where the confusion lies.

The auditor is seeing the end product as the tooling created. So if a customer just orders some tooling, does that not in itself mean that the 'end product' is actually the tooling? Therefore, we have designed the 'end product' (the tool)?

Even though said tool goes on to make the actual product...

 

[Golfman25]

It speaks to a basic misunderstanding of manufacturing process to some registrars.

And that's a problem.

Short answer is no. IMO, the intent is to address product design. Tooling falls outside the scope. Good luck.