Search the Elsmar Cove!
**Search ALL of Elsmar.com** with DuckDuckGo including content not in the forum - Search results with No ads.

Implementing an AS9100 Aerospace Quality System

K

Kiartys

#41
Re: Implementing an AS9100 Quality System

Hi Houste,
Thanks for your reply. Yes you are correct. Its not AS9100 but my interpretation thats proving troublesome. At the end I will probably find that I can reduce the content or number of procedures. Its just getting to the end.
 

John Broomfield

Staff member
Super Moderator
#42
Re: Implementing an AS9100 Quality System

I am currently backed into a corner, or run into a dead end, or any other overused metaphor out there.

I am trying to combine and implement the AS9100C requirements into my current quality system, which address ISO9001:2008, ISO13485, 21CFR820, and a few additional customer quality requirements.

When I initially setup my ISO9001 system, I had the 'help' of a consultant. Looking out at the information available regarding ISO9001, there is a TON of information and books. When I added the ISO13485 to my system, the amount of available information was greatly reduced, but the ISO14969 spec really helped to explain what was meant in ISO13485.

Now I am at AS9100C's doorstep, and I am hardly finding any information. By that I mean 1) books - nothing available and the two I have for the Rev B spec were basically worthless even by Rev B standards. 2) Magazine articles - Yes, they go over the Rev C highlights but not in any detail to understand what the AS9100C spec truly requires. 3) It looks like there are no industry guideline specs similar to ISO14969 for medical devices. I've seen references to ISO10006 and ISO10007 but they all seemed directed to developing major operations or towards large companies.

I've tried to do a Gap Analysis but I can't analyze that which I don't understand. I've done a lot of searching here at the Cove, which has helped some, but I still have a lot of questions to go with a lot of confusion. I do want to understand what the requirements are versus buying pre-packaged procedures. (I've already been down that road before.) There seems to be more complexity with AS9100 requirements than there was with ISO13485. By that, I mean the additional AS9100 requirements above and beyond ISO9001.

I've been told to implement AS9100 by upper management (most of us have heard that one before) and I've also been told no funds are available for a consultant.

Am I just whining? Maybe but I guess I am looking for words of wisdom or a finger pointing me in a direction somewhere.
RCW,

You can develop your process-based management system to conform to other standards very easily if you continue to think process.

Take a look at the additional requirements and they either require additional controls to existing processes or new processes to be included within your management system.

Then, in consultation with the relevant process owner, agree how best to add the additional controls. You may find it is already being done. If the control is new then the process owner can bring the process team up to speed on the new control and agree with them how best to institutionalize the change. This may require update of the procedure, instruction, checklist, form or database.

New processes from the new standard need to be analyzed (if the process exists) or designed (if it does not) and documented with the process owner advising on what other processes are affected by this change to your management system.

If the process is brand new to your management system then you will have designed it but it is not yet a reality. For this your organization needs to make competent the team running the new process complete with a process objective so everyone knows whether it is effective or not.

In short, reduce all of the differences to new processes, controls and documentation and bring these changes into your management system using your process for managing changes to your management system.

Best wishes,

John
 
K

kunal_nigam

#43
Hi All,

My organization is only a IT serive provider and we use standard CAD/CAM/CAE tools to perform the model. We have few external consultants who are hired to provide technical expertise. Nothing else is purchased. As such they are hired based upon their domain knowledge. What do I perform a risk management while selecting a supplier. We are findind it difficult to explain to the auditor.

Any suggestions are welcomed

Regards,

Kunal
 

John Broomfield

Staff member
Super Moderator
#44
Kunal,

Simply show the auditor the criteria your organization used to select its consultants with due regard for:

A. Past performance with similar assignments
B. Ability to help make your organization more successful
C. Value and availability

Your purchase order or subcontract and monitoring of their performance will have been adjusted to address any particular concerns. So show your auditor evidence of these normal management measures too.

As you can see, the evidence may not be neatly packaged with a risk management label.

John
 
Top Bottom