AS9100C Implementation in a Complex Situation

CanadianQA

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#1
Hi there,

I'm new to this forum, but glad I stumbled upon it. I am the QA manager for a Transport Canada approved maintenance and manufacturing facility and am being tasked with implementing AS9100C. My company is one of a number of companies under a parent company. The problem is that both maintenance and manufacturing are in the same building, and share personnel and resources. We also have an engineering department which designs and develops our product, but does not give approval to to the design. My questions are these:

  • How do I get this project off the ground?
  • My company uses resources and processes That are not directly controlled by it, but by other companies under our parent company. How do identify what my core processes are, define and develop them when they are not under my control?
Thanks in advance for any advice. It seems there is a lot of QMS experience here.
 
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DannyK

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#2
Re: AS9100C Implemetnation in a Complex Situation

Hello,

I have helped several companies that have both Transport Canada approval and AS9100C.
The first step is to determine the scope of certification and decide what part of the business is included in AS9100C and what is not.
The next step is to determine the processes.
Afterwards you build your quality documentation ( manual & procedures).
 

CanadianQA

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#3
Re: AS9100C Implemetnation in a Complex Situation

Thanks DannyK.

As far as scope goes, we do design some of the products we produce and use customer drawings for some of the other items we produce. The approval of products we are authorized by TCCA to manufacture comes from TCCA themselves, where as the others we have no control over the design. Can an exclusion of 7.3 be justified in this case?

Also, we have enlisted a CB who has conducted a gap analysis. The auditor who came mentioned that inter company shared resources can be excluded from core processes. Is this really the case?
 
#4
Re: AS9100C Implemetnation in a Complex Situation

Thanks DannyK.

As far as scope goes, we do design some of the products we produce and use customer drawings for some of the other items we produce. The approval of products we are authorized by TCCA to manufacture comes from TCCA themselves, where as the others we have no control over the design. Can an exclusion of 7.3 be justified in this case?

Also, we have enlisted a CB who has conducted a gap analysis. The auditor who came mentioned that inter company shared resources can be excluded from core processes. Is this really the case?
If you have design control (change approval) for products in the scope of your QMS, then no exclusions are permitted. Also, your CB auditor is incorrect! Firstly, resources are under section 6 and can't be excluded and also, it doesn't matter who 'owns them', you still have to manage them including competencies, and so on! I'd be very afraid of any auditor who is making those kinds of statements - you will have problems later, no doubt!
 

CanadianQA

Involved In Discussions
#5
Re: AS9100C Implemetnation in a Complex Situation

Well, we only have design control of certain products, not all of them. How is it possible to claim to be design responsible for products when that applies to only 50% of the product rolling out the door?
 

Sidney Vianna

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Admin
#6
Re: AS9100C Implemetnation in a Complex Situation

Well, we only have design control of certain products, not all of them. How is it possible to claim to be design responsible for products when that applies to only 50% of the product rolling out the door?
The answer is a carefully crafted scope of the QMS and scope of certification. You certainly can not claim design exclusion if you are design responsible.

As for processes (you called it resources) performed by other organizations of the group, they are considered outsourced processes and must be controlled, as per 4.1 of the AS9100 standard. They can NOT be excluded from the QMS.
 
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