posted 27 August 1998 03:51 PM               

Painting as a 'special process'
You can check thickness with newer 'tools' but it used to be you would have to take a slice through to the base metal.
Let's say the paint is supposed to last 30 years before fadingand you have an accellerated life test to verify that it does last 30 years before fading. From that aspect the process could be called 'special' as ther is not way to verify it without scarificing the test part.

Welds used to be 'special processes' but with x-ray and such you can now see inside of welds making it not so much a special process as it used to be.

Some bomb fuse assembly is 'special process' because once the thing is assembled you 'assume' nothing shifted or anything - and you can't see inside. You have to verify the 'lot' by setting a few off. Air bag modules are the same type of 'you gotta destroy a few to verify the lot' situations.

posted 27 August 1998 07:11 PM               

Yes, I am confused.

We were "handed" a bunch of Procedures right before our audit last December. We managed to achieve certification in spite of the procedures because the auditor took into account we hadn't had them long and we obviously knew what we were doing as far as production and quality. A group of us are now in the process of trying to rewrite the procedures to fit what we actually do. You can expect a lot of dumb questions from me over the next few weeks.

posted 27 August 1998 10:39 PM               

As far as the insert, the 'verification' is the next process step its self (you say "It would be obvious before a end user customer got it if the insert were'nt right because the next step of assembly would be impossible." Your company has made a conscious decision to not inspect at the step. Probably for good reason, such as a lot failure rate.

Breakdown:

--> Where the results of processes cannot be fully verified by
--> subsequent inspection and testing of the product and where,

Key word in bold.

--> for example, processing deficiencies may become apparent only
--> after the product is in use,

Are your returns showing any failure of the paint or the inserts? The question becomes, how far do you go. Always look first at your Requirements (both internal and customer), but consider known failure modes and their failure rates (when known).

--> the processes shall be carried
--> out by qualified operators and/or shall require continuous

Key words in bold. So - you only have to have one method.

But again, as I said earlier, I would consider (as always) both internal and customer requirements (not to mention some common sense).

--> monitoring and control of process parameters to ensure that
--> the specified requirements are met.
-->
--> The requirements

What are your requirements - both internal and customer?

--> for any qualification of process operations,
--> including associated equipment and personnel (see 4.18),
--> shall be specified.

You addressed this in your training/certification program. Right? With regard to requirements, right?

Did you over do it? Probably a little bit.