AS9100 Design Contract Issue - Contractor without AS9100 Quality System

[GMC-Guardian]

Hi There,

I'm new with AS9100 standard, actually I was a design engineer and just started to ramp up to take care of the QA program within our company, a small company around 20 employees.

We have a plan to set up the AS9100 QA program in our company. At the same time, we are going to work with a HW design company for a new product.

My question is as following.

As we step forward to have QA program, AS9100 for example, in place, how can we deal with a contractor who does not have AS9100 program setting up in their company?



Thanks in advance!

 

[alspread]

There is no requirement for your supplier to be certified to the same standard that you are (i.e. AS9100).

AS9100 does require that your purchasing processes/systems comply with the requirements of section 7.4 Purchasing.

You may elect to require your suppliers to be AS9100, if you so desire. Probably not a good idea for your organization, but I really don't know. It may make supplier management slightly easier to take care, but it may severly impact your supplier base.

Section 7.4.1 covers the controls you are required to have for your outside suppliers.
The basic steps are:
A. You must maintain a list (with some minimum requirements).
B. You must purchase only from suppliers on the list (barring some special circumstances that you may define).
C. You have to have a method to get suppliers on to the list.
D. You have to have a method to get suppliers off the list.
E. And you have to periodically evaluate the suppliers on the list.

I'm leaving out some of the detail requirements, but, basically, those are the steps.

Good luck

 

[Sidney Vianna]

At the same time, we are going to work with a HW design company for a new product.

It seems that you are outsourcing the design process for the new product. According to AS9100C, outsourcing must be controlled. In principle, ALL of the AS9100C requirements associated with product design must be flown down to the supplier and you must have means of ensuring they are being complied with.

 

[GMC-Guardian]

...
There is no requirement for your supplier to be certified to the same standard that you are (i.e. AS9100).

AS9100 does require that your purchasing processes/systems comply with the requirements of section 7.4 Purchasing.

Section 7.4.1 covers the controls you are required to have for your outside suppliers.
...

First, thank you for the information. This leads me to study and try to understand the AS9100 more deeply.

For my understanding what you were saying is that no matter the contractor has or not has the AS9100 certificate, we, as the final product provider, have to ensure the specified requirement as mentioned in the Section 7.4.

As a Hardware Design contract is not a simple purchasing processes, we are involved in the entire Design Processes. How does Section 7.3 apply to this case as well? Please advise.

Thanks.

 

[GMC-Guardian]

It seems that you are outsourcing the design process for the new product. According to AS9100C, outsourcing must be controlled. In principle, ALL of the AS9100C requirements associated with product design must be flown down to the supplier and you must have means of ensuring they are being complied with.

So, this points to section
4.2.3 Control of Documents
4.2.4 Control of Records
7.3 Design and Development
7.4 Purchasing

Any thing else?

Thanks!

 

[Sidney Vianna]

Any thing else?

Look at the Guidance Document for Outsourced Process. Even though it was developed for ISO 9001, the principles also apply for AS9100.

 

[GMC-Guardian]

...

Even though it was developed for ISO 9001, the principles also apply for AS9100.

It is what it is!

 

[alspread]

I would also recommend the Supply Chain Management Handbook (SCMH) offered by the International Aerospace Quality Group (IAQG) on their website http://www.iaqg.sae.org/iaqg/. Look under publications. This handbook offers a lot of guidance on several areas of the standard.

You mention design. Are you responsible for the design of the product or the design of the process to produce the product to someone else's design?

 

[GMC-Guardian]

I would also recommend the Supply Chain Management Handbook (SCMH) offered by the International Aerospace Quality Group (IAQG) on their website

Look under publications. This handbook offers a lot of guidance on several areas of the standard.

You mention design. Are you responsible for the design of the product or the design of the process to produce the product to someone else's design?

I would like to say thank you first and then will take time to study to learn. It will pop up tones of questions for sure. As a new student in the area I will do my home works and hope you can correct them.

We are responsible for the design of the product as well as the process to produce the product in accordance with the customer requirements. Our contractor will work with us to realize the hardware and possibly to give us recommendation for the production realization. At current step the contractor will work with us to select the parts for the architecture and the mechanical design such as enclosure, input key. The software is designed by us.

Not only that, the most interesting I've found this morning is that we, as a start up company, are really stand on the shoulders of giants as well as dwarfs.

Considering the quotation from Jeremy Bentham regarding Push-pin vs. Poetry, i.e. reference to The Rationale of Reward, published in 1830, I would like to say:

Prejudice apart, the control process of giant is of equal quality with that of dwarf.

:truce: