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Setting up a Calibration Service with one employee - and getting certified in the process
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Jaysea
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28 October, 2015 - 1:49 AM
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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.

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Jaysea
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29 October, 2015 - 2:06 PM
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The experience has moved to the next step.

The 'Program Manager' of a consulting group that sets up an 'online QMS' system is probably tearing her hair out, dealing with someone like me who expects more from a 'QMS' system than just having a system that can pass an audit, for the sake of passing audits and helping get accreditation, so we can help our customers pass their audits.

We've paid our money, now they have to set up a QMS system for us.

They want us to color inside the lines, so they can quickly and efficiently create an online QMS, and then move on to the next phone call and their next customer.

I give the program manager a lot of credit.  I'm asking all kinds of questions that are 'outside' the lines of the service they provide for a fee.  She hasn't lost her cool yet, not that I want her to, that's not the objective.

We've paid thousands of dollars and signed up for an annual contract to do this, using their 'canned' software, which is really just a database, and possibly an online document storage area.

We'll see.

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Jaysea
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30 October, 2015 - 9:56 PM
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Temporarily ignoring what the QMS Cloud Software Supplier is doing (something about they've set up the survey module and I'm supposed to look at it) . . . 

I'm wandering around the 'standards' online bazaar and came across this link

I dug up this:

 Here's ISO9000 in a nutshell:

   1) Have a measurable process to develop things
   2) Make sure everyone involved understands and follows the measurable process
   3) Build things following the measurable process
   4) Measure your progress while you follow the process of building things
   5) Finish building things
   6) Evaluate how the things measure against what the process said they should be
   7) If there are issues then either fix the process or fix the thing or both
   8) Rinse & repeat

Nothing within that nutshell says anything about the size of the organization. Which is intentional because company size really has no bearing on whether or not it can meet ISO9000 requirements. Larger companies have an advantage because they have more resources and can potentially better afford the overhead of all that measuring, but small companies can do the same thing too.
So how can you follow ISO9000? Look at the summary steps above and go from there. The key elements are:

   1) Have a process
   2) Measure building progress based upon the process
   3) Fix the thing or the process when stuff is broke

I included this in an email to my partner (the Sales Guy) and included this thought:

'Things' can be a service, such as calibrating Micro-Vu CMMs.
 
Our Quality Policy can be as simple as: 
 
Be Efficient
 
 My plan is to take the output of the 'QMS Cloud Software Supplier', look at it through the lens of the Quality Policy,  and reduce it to the most efficient process for us.
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Christopher Paris
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14 November, 2015 - 8:54 AM
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Sorry for coming in late on this one, but it's a good read.

A few random observations:

  • Your quality policy cannot be "Be Efficient." That will fail an audit because ISO says you have to literally include the words "continual improvement" and (under 2015) something about "satisfying applicable requirements." They practically write the policy for you. I wrote an official Request for Interpretation to TC 176 on this, and they confirmed it. You have to include those words.
  • Getting advice on ISO 9001 on Reddit is ... um... unadvised. Especially guys that don't understand the difference between 9000 and 9001.
  • The Reddit post is folksy and populist, but it oversimplifies. If you do anything based on that post, you're doomed, and the anonymous "internet bro" that wrote it isn't going to pay you the money you lose from taking his advice.
  • Yes, ISO 9001 is for companies of any size. But there are minimum requirements, which require minimum expense. Most small companies simply can't afford it. That's because the TC 176 committee that writes ISO 9001 has few (if any) representatives of small companies advising it, so they write in grand requirements that result in certain costs. They don't care. 
  • ISO 17025 is much more complicated, and much more expensive. It is NOT designed for "any size company" because of the inherent and expensive requirements. Just calculating uncertainty can be a huge and costly job, requiring the hiring of a third party expert for a one-time exercise.

I think you've bought into the marketing of ISO a bit too much. And if things don't go well, saying "but ISO said it was for everyone" won't be much of a defense. 

This stuff costs money. The trick is to reduce those costs to as low as possible but still meet the requirements. And in your case, those requirements are really, really important. If you do a poor job in validating these measuring devices, a lot of bad product could be shoved into the marketplace with erroneous results, and that could have a real-world impact on someone. You need to get it right. If that's too much responsibility for a two-man shop, then they need to consider that. 

Otherwise, just keep plugging away and tackle each challenge as you can. But also temper your expectations.

Alternatively, you can just buy a Guber-cert. Heck, no one would probably even notice.

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