Configuration Management - AS9100 Rev B or C

M

Mbarr

My husband and I have a small machine shop. We've spent the last year training and getting ready for AS9100 certification and are lined up to undergo the third party audit in mid-October. Although we were trained on Rev C, we will be auditing to Rev B, which we've discussed with our trainer. Since Rev C covers Rev B, he said it would not be necessary to edit our QPM. The probably now lies, as I knew it would, in the area of configuration management. In Rev C, it is addressed in Section 7.3.1 and I believe a flow chart would be adequate to address the procedure. However, would it be more advisable to actually write a procedure, per Rev B? I'm down to the wire so the less procedure writing I need to do, the better - but on the other hand I don't need this to become a major. Advice please!

Elizabeth
 
J

Joy

My husband and I have a small machine shop. We've spent the last year training and getting ready for AS9100 certification and are lined up to undergo the third party audit in mid-October. Although we were trained on Rev C, we will be auditing to Rev B, which we've discussed with our trainer. Since Rev C covers Rev B, he said it would not be necessary to edit our QPM. The probably now lies, as I knew it would, in the area of configuration management. In Rev C, it is addressed in Section 7.3.1 and I believe a flow chart would be adequate to address the procedure. However, would it be more advisable to actually write a procedure, per Rev B? I'm down to the wire so the less procedure writing I need to do, the better - but on the other hand I don't need this to become a major. Advice please!

It is not in 7.3.1 but in 7.1.3. There is no specific need of a procedure. Without a documented procdure,you can have a system. For a machine shop like yours a strong system of product identification as per design specifications and changes may meet the requirements.
 
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M

Mbarr

Marc, thanks for your answer and also thank you for correcting my dyslexia... I've had my head buried in this stuff for days and I'm starting to see double, triple and eveything else! As far as CM, we certainly have very well-defined product tracking system (we don't do design and are excluding it from our QMS) and I think what you're saying is that we are covered by this.
 
K

KwalityWonk

I am a little confused by your situation. Are you auditing to Rev B or C? Rev B requires a documented process whereas Rev C does not. Rev C does however require that you "establish, implement and maintain" a process that includes as appropriate those elements listed in 7.1.3. A bigger question is whether you have taken an exclusion to the design requirements (7.3 ), as Configuration Management Processes are required to be much more in depth if it is your design, as opposed to just Maintaining configuration status as directed by Customer, Design or Regulatory authority. Preparing for Rev C without a documented procedure, and auditing to Rev B will lead to a Major finding. If auditing to Rev B, disregard Rev C requirements until you are ready to update. Unfortunately, they do not make it easy to design a QMS that will meet both, unless you just bite the bullet and document everything. Good Luck in your preparations and on your audit. Sounds like you are asking the right questions.
 
D

ddunn

I believe a flow chart would be adequate to address the procedure. However, would it be more advisable to actually write a procedure, per Rev B?

I'm a little confused here. A adequate flow chart is a documented procedure. I've often used flow charts for procedures with no problems during audits. They are quick, easy to understand and easy to use.
 
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M

Mbarr

Thank you both for the input.

1) we have claimed an exclusion from Design 7.3. 2) We are auditing to Rev B, but our manual has been designed for Rev C. Confusing, yes, I know. I did clarify with our trainer that this would be ok, HOWEVER Config Mgmt. seems to be the major sticking point. I don't want a major finding (also, thanks for letting me know that it would be!)

I thought, but was not sure, that a flowchart was, in fact, a documented procedure. I just completed designing one to spell out our config. mgmt. system. It just seemed to do a better job of it than trying to write a procedure. (At this point my brain is pretty fried)

I think I've got it covered now... fingers are crossed! Just in case, I will double check with our trainer.

Thanks again!
 
K

KwalityWonk

Indeed, a flowchart will be fine for Rev B. You also stated that your Quality Manual is designed for Rev C. While most of the elements are the same or at least similar, the clauses have been shuffled around, and requirements for Configuration Management, Risk Management, and Customer satifaction have changed significantly. And how are meeting the intent of 4.2.2b(BOLD) that has been removed from Rev C? I'M sure you have thought of all this, however it sounds like it would be difficult to do Clause by Clause Comparison of the Rev B Std and your Manual. While that is not a requirement, it sure makes it easy to ensure you have covered everything. Just make sure you have covered all the requirements for Rev B in your Manual, and have Fun!!
 
M

Mbarr

Kwalitywonk,

As I fill out the Stage One Readiness Review for our auditor, i'm doing a lot of cross-referencing. It is exactly as you say - a shuffling of clauses! I think that's why my brain is fried. The main thing is that we've covered it, documented it, can explain it, and mostly - we can walk the walk! I'm sure I'll be writing to this forum ALOT this month.

Elizabeth
 
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