AS9100 and 21CFR145 Systems in the Same Company

A

AndreaG

#1
Hi Everyone,

I am hoping that someone can help me with a situation I am in.

I was brought into a company to implement AS9100C. The company is already 145 cerified. All the company does is paint aircraft. The company also works under part 21.

There are processes that are applicable to AS9100 that are already controlled under part 145 (nonconforming material, receiving, shelf life control, painting forms and process documentation).

The forms that are being used to show compliance to 21CFR145 are the same forms I need to show compliance to AS9100.

Is there anything wrong with utilizing the same form numbers for both systems but segregating them by color?

I dont want to have to run 2 systems and 2 sets of forms if the only difference is a repair station number.

I guess my other question is do I need to maintain 2 separate sets of instructions (except the 6 mandated procedures) for 145 and AS9100? Everything that overlaps is exactly the same.

Any help or suggestions would be appreciated.

Thanks,

Andrea
 
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R

Reg Morrison

#2
Is there anything wrong with utilizing the same form numbers for both systems but segregating them by color?

I dont want to have to run 2 systems and 2 sets of forms if the only difference is a repair station number.
Hi Andrea, the right approach is to understand that your organization has ONE (and only one) Quality Management System. CFR 145 (and 21) are Regulations. AS9100C is a (voluntary) standard. AS9100 does refer to regulatory requirements in several places. So, AS9100 reminds us that we MUST comply with the law(s).

So, there should be no conflict to develop a SINGLE QMS that addresses customer requirements and regulatory requirements as part of your operation.

You asked a great question, but gone are the days of suppliers having multiple quality manuals, one for each customer/program.

What you really shoot for is a cohererent, business-friendly quality system that satisfies all customer and FAA requirements. That's the goal.

Good luck!
 
A

AndreaG

#3
So if I understand your post correctly everything that the repair station does I can use as objective evidence of fulfilling a requirement under AS9100?

Example would be a training matrix that shows training requirements for receiving inspection, shelf life control, control of nonconforming product, determining paint defects, FOD and subsequent tests or OJT that show training and competency.

Thanks,

Andrea
 
R

Reg Morrison

#4
So if I understand your post correctly everything that the repair station does I can use as objective evidence of fulfilling a requirement under AS9100?
Unequivocally, YES. One thing you need to keep in mind is that, while (FAA) certificated repair stations might be certified to AS9100, the most applicable standard would be AS9110, which is very similar to AS9100, but developed to address the needs of repair stations.

So, AS9110B could be a much better fit for you, instead of AS9100C. Be advised, however, that, if you are going to seek certification, there are fewer AS9110 approved registrars and auditors. So, that might impact your certification quest.
 
A

AndreaG

#5
We went through AS9100 or AS9110 and the decision was made to go AS9100.

When I signed us with our registrar I specifically went the route of getting us assigned an auditor that is certified in both AS specs and also familiar with FAA requirements.

My feeling was that if we had someone in here not familiar with FAA requirements and AS requirements we would be potentially setting ourselves up for additional non value added work.

Thanks again for your help.

Andrea:thanks:
 

John Broomfield

Leader
Super Moderator
#6
Andrea,

There was a time when people referred the system standards as systems. And when people operated a separate set of documents for each system/standard.

Now most of us recognize that the organization working with its customers, employees and suppliers is the system.

And as Reg says, the organization has one management system to ensure the requirements are known and fulfilled. These organizational management systems are process-based and one process may cover several clauses in the regulations and system standard.

We also know that only parts of the management system are documented. Indeed, the most important parts of management systems, care and respect, usually remain undocumented.

Seek to understand the system, capture the management system that actually runs your organization and make sure it conforms to AS91XX (I agree with Reg that AS9110 is best for repair stations) and the CFRs.

By going with the grain and working closely with your colleagues as process owners, you'll keep everyone on board with developing, using and improving their management system (not your's!) to meet requirements wherever those requirements come from.

John
 
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