Hello all...

Let me start by saying that although I am mostly a lurker here, these forums have been INVALUABLE.

My question may seem silly to some, but I honestly struggle with this one and can't find an answer. I have used 'search' but nothing I can find addresses this little detail.

AS9100, Revision B. Clause 7.5.2, a) (sub note) states:
- qualification and approval of special processes prior to use

Does this mean on every single setup, or just that the process itself must be approved before it is used, and not after? This question again seems simple on the surface, but it is the difference between us contracting a 3rd party testing lab to analyze our samples periodically, and us purchasing and setting up the equipment/personnel required to test these samples every single time we use the process.

I welcome any and all comments and advice. Thank you all in advance for your time.

- SRG

I typically think of it prior to original use, but in some cases it might also require approval prior to each use.

Hello all...

Let me start by saying that although I am mostly a lurker here, these forums have been INVALUABLE.

My question may seem silly to some, but I honestly struggle with this one and can't find an answer. I have used 'search' but nothing I can find addresses this little detail.

AS9100, Revision B. Clause 7.5.2, a) (sub note) states:
- qualification and approval of special processes prior to use

Does this mean on every single setup, or just that the process itself must be approved before it is used, and not after? This question again seems simple on the surface, but it is the difference between us contracting a 3rd party testing lab to analyze our samples periodically, and us purchasing and setting up the equipment/personnel required to test these samples every single time we use the process.

I welcome any and all comments and advice. Thank you all in advance for your time.

- SRG


I am not a AS9100 expert, but in my former ISO 9001:1994 Aerospace days this was approach in the following.

As a Customer each Supplier's special process was qualified through the use of either in house of third party testing of samples according to a qualification plan and specification requirements. So many samples per lot of parts (chemical processing). Once the Supplier was qualified, we based the acceptance of each subsequent lot on the Certificate of Compliance. However, in addition we made certain that we had the necessary test equipment to sample inspect the special processes for verification. An alternative would be to send samples to a third party for verification.

I believe that you have to be able to verify what the Supplier is selling you by reasonable means to ensure conformity to your customers requirements.

As a supplier performing Special Processes for a Customer, IMHO you have to be able to verify the special process that you are selling to the customer from each batch or lot of parts that are processed. Dependence on a Certificate of Compliance puts you at risk with the customer, something only you can determine is acceptable.:tg:

Thanks for the great responses. I suppose I should go into a little bit more detail. (Excuse my possible improper use of "verify", it could be "validate" in this case)

We are setting up a spot welding process, to no specific specification or requirement. The only requirement is that the strength meets the tables in a MIL spec.

The current plan is to verify the process itself through "periodic" 3rd party tests (not every batch but perhaps every 6 months or whatever), and simply control the process each time. There will be test specimen available from each batch, but they will not be tested for each batch.

If that isn't acceptable then we have to purchase and setup all of the necessary equipment and training to test these samples in house for every batch. The reasoning behind this is, if we setup the job, and then send out a test piece, by the time we get the test piece back we would have to set up the job again. If it was truly verifying the process at this point it would be invalid, because a time span of days or even a week could have passed between the test specimen and the production lot.

Financially the first option is superior. Cost is not the only factor here though. I am thinking that training each operator to the procedure, controlling the process every time (and of course recording that control) combined with the original process verification, and subsequent re-verification whenever any part of the process has changed (and possibly periodicly), would satisfy this requirement. I am concerned however, that if my auditor interpretes this the other way it could lead to a major NC.

Any thoughts?

Yep!

Consider documenting a qualification plan where you test say 10 consecutive lots. Then step to every second lot, then step to every fourth lot, then step to every sixth Lot, then step to every eighth lot, then step to every tenth lot or some variation of the above.

Once you have qualified the process then move on to some standard sampling after either so many lots, shifts, or time.

Good luck!:)

Now that is an idea. Should this sampling plan be "statistically valid", but based on production lots. Say for every 20 lots we test 8 or so? Or would what your saying be acceptable in saying that we have proven over time the process does not change results in a way that would lead us to believe anything was trending in the wrong direction?

I would prefer to do as you suggested, and include some kind of catch clause that if 1 specimen is bad, it starts over. I will adjust the numbers to make sense for us in our situation, of course.

Thanks for the awesome idea.

Now that is an idea. Should this sampling plan be "statistically valid", but based on production lots. Say for every 20 lots we test 8 or so? Or would what your saying be acceptable in saying that we have proven over time the process does not change results in a way that would lead us to believe anything was trending in the wrong direction?

I would prefer to do as you suggested, and include some kind of catch clause that if 1 specimen is bad, it starts over. I will adjust the numbers to make sense for us in our situation, of course.

Thanks for the awesome idea.

Well only think you should make the qualification quantity sufficient to ensure that you have a robust process since you will not have a way to test the parts yourself. (Think Risk and the Quality Level that is acceptable to you) In thinking ahead, the only time you will have to defend what you have done is if there is a failure or someone questions how you qualified the process. The other view of course if how to ensure that your set up is robust from lot lot? I came from both welding and chemical process control arenas and usually the customer had requirements as far as the qualification plan and afterwards there were routine weekly and Monthly test monitoring of the processes some destructive and some non destructive.


One other risky point is what is your action if the test coupon fails, are you setting up a methodology to inform and or recall the parts from the customer?