ISO9000 and AS9100

[QC Guy]

Our company has been AS9100 certified for a decade. We made it much harder than necessary in the beginning. As an example, the QC guy before me, required that gage pins be sent out for calibration. The first question I asked, was "How can you put a serial number on a .061 gage pin?" So you send the gage pin to a calibration lab, and immediately lose traceability if there are TWO gage pins of the same size! I became aware from the drawings I was inspecting to, that .001 was the tightest tolerance needed for our core product stream. I purchased a new set of gage blocks, gave them a 3 year calibration window, and verified my micrometer to .0001. I did not even tag them "Measure before use." I said that in the procedure. We do not need Deltronic pins for the parts we make, so we do not need to be that finicky. This would not work for everyone, but the takeaway is...how do you fail a test you write the questions for? Don't put anything in your procedure that you don't already do. One auditor said "You must have Computer Software to manage your calibration assets." I asked him to show me in the standard where it is required. We keep ours on a spreadsheet, and that is perfectly sufficient for what we do. Say what you already do, and do what you say, and any Quality Management System will be pretty easy to manage. Syteline is an excellent ERP program that makes it easy to include quality actions, it is expensive though. By the way, I got about 20 people to tell me the "Required Temperature" for a "QC Lab." I contacted an Engineer at NIST and asked. He said "What does it say in YOUR quality manual?" If you need to get certified, remember that the external auditor is your contractor. Have your own Quality System, and defend it. Be careful of consultants. Like the previous poster said, there is a lot of BS out there. I will answer any question asked of me....with one caveat. What we do does work well for us. You may have statutory, or regulatory requirements we do not have.

 

[???]

I like the idea of "calibrate before use" sticker. If you're working with +/- .001 this should be totally acceptable and even half that tolerance.

My process is to have the masters pictured calibrated annually and we should be able to self calibrate from those to satisfy traceability.

We calibrate some tools daily or multiple times a day and others sit in a drawer for months or years before they get used. Swapping stickers every time is annoying but I guess a necessary evil?

Also, what does a "lab" do to a Mitutoyo digi mic to calibrate it? Don't they just measure a set of pins? I mean even with a digital there is certain amount of 'feel' when measuring.

I have to say, aside from accounting/taxes this is probably my least favorite part of this business.

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I worked as a toolmaker at a pharmaceuticals company, our personal micrometers were checked at multiple positions and then the anvils were checked with optical flats by the certified company lab. Eventually they just loaned us all Tesa digital micrometers that they checked on a annual basis.