Interpreting "Design" and development - AS9100B Section 7.3

D

Dubh12000

#1
Hello All,

Hopefully you can help me give a definitive statement on this to a client of ours. Part of what we are helping them with at the moment is guiding them through AS9100B, and forward to NADCAP.

Our client is a job shop for conventional and non-conventional machining processes. Part of what they do would include modifying machines to carry out bespoke machining operations, and they would design and produce a large percentage of the tooling and fixturing associated with these operations. Because they have a CAD station they seem to think the standard applies directly to this inhouse function........whereas I would opinion that the "design" mentioned in section 7.3 of the standard relates to design input on the customer product, and that the validation of the fixture design is part and parcel of the FAIR at the process development stage.

What do you guys think? ( Did I miss something in the Standard on this?)
 
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A

Angelika

#2
Dubh12000 said:
Hello All,

Hopefully you can help me give a definitive statement on this to a client of ours. Part of what we are helping them with at the moment is guiding them through AS9100B, and forward to NADCAP.

Our client is a job shop for conventional and non-conventional machining processes. Part of what they do would include modifying machines to carry out bespoke machining operations, and they would design and produce a large percentage of the tooling and fixturing associated with these operations. Because they have a CAD station they seem to think the standard applies directly to this inhouse function........whereas I would opinion that the "design" mentioned in section 7.3 of the standard relates to design input on the customer product, and that the validation of the fixture design is part and parcel of the FAIR at the process development stage.

What do you guys think? ( Did I miss something in the Standard on this?)

Hi Dubh 12000,

Could you explain who is the design holder? Is it your client himself or does your client's customer supply the approved design data and your client produces parts i.a.w. these data including all the necessary operations?

Angelika
 
D

Dubh12000

#3
Angelika said:
Hi Dubh 12000,

Could you explain who is the design holder? Is it your client himself or does your client's customer supply the approved design data and your client produces parts i.a.w. these data including all the necessary operations?

Angelika
Guten Morgen Angelika,

Our client's customer supplies the approved design specifications that our client manufactures against.

Our client would be the design holder of the associated fixturing required to manufacture to those specs.
 
A

Angelika

#4
Dubh12000 said:
Guten Morgen Angelika,

Our client's customer supplies the approved design specifications that our client manufactures against.

Our client would be the design holder of the associated fixturing required to manufacture to those specs.
Guten Morgen, Dubh12000!

Where from this beautiful country do you come from?

Now to your question: In my opinion we are talking of two different processes.

Process 1 is the production of parts i.a.w. customer's design including F.A.I. for new products etc.
Your client receives approved design data from your customer which are the basis for production. Your client makes sure that the produced parts/components are in conformance with the approved design data and confirms this by issuing a CofC or an EASA Form One. This process has not directly to do with 7.3, except that, in case of your client issuing a "Form One", there must be a PO/DO-agreement between the two parties (EASA Part 21A.133).

Process 2 is the design of associated fixturing by your client. Since your client is the design holder of the fixturing, he has to fulfill 7.3 of EN/AS 9100, let's say the complete design process, including verification and validiation of the designed product.

Hope I could help you. Regards from the cold and snowy South of Germany!

Angelika
 
D

Dubh12000

#5
Angelika said:
Guten Morgen, Dubh12000!

Where from this beautiful country do you come from?

Now to your question: In my opinion we are talking of two different processes.

Process 1 is the production of parts i.a.w. customer's design including F.A.I. for new products etc.
Your client receives approved design data from your customer which are the basis for production. Your client makes sure that the produced parts/components are in conformance with the approved design data and confirms this by issuing a CofC or an EASA Form One. This process has not directly to do with 7.3, except that, in case of your client issuing a "Form One", there must be a PO/DO-agreement between the two parties (EASA Part 21A.133).

Process 2 is the design of associated fixturing by your client. Since your client is the design holder of the fixturing, he has to fulfill 7.3 of EN/AS 9100, let's say the complete design process, including verification and validiation of the designed product.

Hope I could help you. Regards from the cold and snowy South of Germany!

Angelika
Thanks for that Angelika, and regards from a suprisingly dry and sunny Cork!

Funny you should mention EASA Part 21, this came up on another subject recently with regard to Aeroengine repair qualification. I know nothing about it, can you recommend and introductory reading on the subject.

(P.S. I worked for years north of Zurich.........I miss the snow.......)
 
A

Angelika

#6
Dubh12000 said:
Thanks for that Angelika, and regards from a suprisingly dry and sunny Cork!

Funny you should mention EASA Part 21, this came up on another subject recently with regard to Aeroengine repair qualification. I know nothing about it, can you recommend and introductory reading on the subject.

(P.S. I worked for years north of Zurich.........I miss the snow.......)

:topic: Welcome, Dubh12000! A couple of years ago we spent a week in an old Irish farmhouse in Cork - wonderful!

You can get any information you need on EASA Part 21 from the EASA website which is www.easa.eu.int.
 
H

Hoeyster

#7
Angelika said:
Guten Morgen, Dubh12000!

Where from this beautiful country do you come from?

Now to your question: In my opinion we are talking of two different processes.

Process 1 is the production of parts i.a.w. customer's design including F.A.I. for new products etc.
Your client receives approved design data from your customer which are the basis for production. Your client makes sure that the produced parts/components are in conformance with the approved design data and confirms this by issuing a CofC or an EASA Form One. This process has not directly to do with 7.3, except that, in case of your client issuing a "Form One", there must be a PO/DO-agreement between the two parties (EASA Part 21A.133).

Process 2 is the design of associated fixturing by your client. Since your client is the design holder of the fixturing, he has to fulfill 7.3 of EN/AS 9100, let's say the complete design process, including verification and validiation of the designed product.

Hope I could help you. Regards from the cold and snowy South of Germany!

Angelika
Hi all, I am in the process of trying to decipher Design & Development also, actually I'm trying to exclude this portion of the standard.
First of all, what is i.a.w.? Never saw that acronym before, and I've never heard of EASA.
Secondly my company is of the same belief that because they design fixturing and have a CAD system that they fall under Design & Development.
Our customer is the design holder for product. They send us a customer print and we produce product conforming to it. The fixturing is designed around the customer design.
The CAD system would fall under Configuration Management wouldn't it?
 
A

Angelika

#10
Hoeyster said:
Hi all, I am in the process of trying to decipher Design & Development also, actually I'm trying to exclude this portion of the standard.
First of all, what is i.a.w.? Never saw that acronym before, and I've never heard of EASA.
Secondly my company is of the same belief that because they design fixturing and have a CAD system that they fall under Design & Development.
Our customer is the design holder for product. They send us a customer print and we produce product conforming to it. The fixturing is designed around the customer design.
The CAD system would fall under Configuration Management wouldn't it?

Just for your explanation regarding EASA. EASA is the European Aviation Safety Agency, the European equivalent to the FAA in the USA. There are similar regulations as for example Part 145 for maintenance, Part 21 for design and production and so on. Since both Dubh12000 and me are European, I referenced to EASA regulations.

In my opinion, your situation is about the same as described by Dubh12000.

Your customer supplies you with specifications and you do the design work. Even if your customer validates the design, you are involved in design and you cannot exclude 7.3 from the standard.

If you only produced parts according to your customers design, this would be part of production and 7.3 would not apply.

Configuration management starts in the very early design phase and accompagnies the product throughout its whole life cyle. Following that, configuration management is part of your CAD activities.

There have been several very good threads in this forum about configuration management that might be helpful for you as well (I remember a very good one from Paula that helped me a lot to understand that all).
 
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