Well, This should be interesting.
I’m an associate of a Sales Guy who sells Micro-Vu CMMs. Very recently, he managed to end his contract with a ‘distributor’ and now has a direct contract with the manufacturer.
It’s totally cool, but now that he’s a distributor, he has to not only sell the systems to customers, but install and calibrate them as well . . . that’s where I come in.
A year ago, one of his customers really, really, wanted their system ‘Validated’. Since I’d moonlighted for my friend and helped him develop some products that are related to Micro-Vu CMM’s, and I had more industry experience than I ever wanted . . . I figured out how to write a set of IQ/OQ/PQ protocols that confirmed that a Micro-Vu, as installed and calibrated, actually did what the ‘manufacturer’s specifications’ said it was supposed to do.
This resulted in a nice 1″ thick binder with professional looking tabs and some graphics on the front, and we now have about a dozen very happy customers who have a book to throw at an auditor when they ask if the ‘Automated Inspection System’ is validated. That ‘book’ is full of pages of requirements and statements that the requirements have been met, with initials and dates on each page. It also has the output of various ‘test runs’ that fill up sections of the binder. I am confident that I can support a customer during an audit.
I can point to a specification, then thumb through the book and show them evidence that the specification is ‘met’.
Of course, few of our customers (and their auditors) really understand that calibrating a test instrument, and validating a test method are two different things.
So we are careful to state that what we provide is an execution of a set of ‘Qualification Protocols’. To wit: and IQ, and OQ, and a PQ.
If they don’t realize that they might be expected to write a ‘report’ that says that there is a set of ‘approved’ protocols for an IQ/OQ/PQ, that said ‘approved’ protocols have been executed, and the results placed in the binder (with all pages numbered, and in sequence) . . . then, well, we might be called upon to perform a service at an astronomical hourly rate, to write such a document.
To be honest, I think it’s all kind of stupid.
So now we have to add ‘installation and calibration’ services, and get accreditation from a ‘body’ to the ISO 17025 standard. Just so we can put the accreditation body’s logo on our paperwork.
But this is going to really test the idea that ”ANY SIZE COMPANY” can establish a QMS, and obtain accreditation.
I mean, come on.
The Sales Guy is going to keep doing what he does, and his Associate, meaning me, is going to do everything else.
As I said at the beginning:
This is going to be interesting.