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ISO 9001 audit, non conformance about measuring tool

Discussion in 'ISO 9001:2008 - Quality Management Systems' started by event, May 19, 2016.

  1. event

    event New Member

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    Hello,
    was on Elsmar's some time ago, quiet disappointment to see that its gone. Nice though to have a backup here :)

    Maybe You could help me with this problem:
    We recently had an ISO 9001 audit at our camshaft and the auditor found one non conformance: We use several manual measuring tools at SPC stations (simple OK/NOK tests), and one tool was found to be out of tolerance at the yearly calibration.
    The auditor still asks us how we can be sure that the parts we produced since the last measuring tool calibration were all ok (since we don't now when it was damaged enough to be out of tolerance).

    Since we do weekly 100% measurements on our CMMs as double check it would have been detected earlier if NOK parts were being produced, also no customer complaints about this specific feature ever. Still the auditor is not satisfied.

    Sounds like he wants to see some process if a situation like this ever happens again, or a different way to check the measurement tools. But You can't cut the intervalls down indefinetly, there will always be some time frame where You will be unsure what happened if You find out one measurement tool is out of tolerance.

    Any idea how to solve this (sounds liks a riddle to me actually)?
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Well you have in some ways created a problem for yourself which, until it's changed will feed the auditor's question. If you are doing 100% cmm checks, the previous gauging doesn't really need calibration, maybe a simple verification will be adequate. Sometimes, in an effective calibration/control system there's a situation which can be used to define if the amount of out of tolerance is significant. This helps in a number of ways, not least of which is the auditor not worrying about being simply "out of tolerance", but by HOW MUCH? That might assuage their lack of confidence too.

    Of course, it could be the audit is just like a dog with a bone and the best thing is to suggest to the CB that they don't come back...your choice.
     
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  3. BradM

    BradM Moderator Staff Member

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    I agree with Andy.

    I guess I'm interested in what perspective the auditor was not satisfied.

    Was this documented and included/reference with the out of tolerance instrument?

    You have instrument X and you choose to send it off to be calibrated. You have documented that an out of tolerance for instrument X has no impact due to 100% inspection. I wouldn't see why that would be an issue.
     
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  4. Qualmx

    Qualmx Well-Known Member

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    Event
    Elsmar is back,wonderful both sites, full or interesting information
     
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  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Did the auditor ask to see how much OOT it was, compared to the product tolerance? If not, they don't understand the subject!
     
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  6. MarkMeer

    MarkMeer Well-Known Member

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    I don't understand what the auditor's issue is. Am I correct that this was the sequence of events:

    1. You calibrate on a yearly schedule
    2. At the yearly calibration the tool was found to be out of tolerance
    3. You did an impact assessment, and concluded that there is no concern of affect on items produced in the year because of 100% weekly CMM checks, and the fact that no customers have complained of any issues.
    (4. (presumably) the tool was taken out of service until it can be returned to conformity)

    If all of the above was documented, I don't see the problem.

    It appears that this whole process is functioning fine, and this incident only demonstrates that the tolerance deviation was not significant.
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Except it's usual to adjust the recall to catch it before it wears again - unless it was a damage issues, in which case some form of awareness session with operators might be needed.

    However, the point is well made - the 100% checks would have detected something - so my guess is the auditor doesn't understand what calibration/control is about.
     
  8. MCW8888

    MCW8888 Well-Known Member

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    1. OK: Calibration was done according to schedule.
    2. "Tool was found to be out of tolerance". What is the tolerance? Since you are doing 100% weekly CMM checks, recommend changing your calibration schedule to a weekly calibration verification using a reference material that has an established specification.
    Hope this helps.
     
  9. event

    event New Member

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    I think the main problem is that we don't have any documents about the risk assessment. The colleague exchanged the measurement tool (only 2µm out of tolerance which is 20µm) but didn't document any risk assessment (as far as I know also didn't even check the parts since the last 100% CMM measurement). We will install a process that a risk evaluation has to be done and be documented if there is ever any measurement tool out of tolerance again. I will keep You updated, thanks for the replies so far!
     
  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    There's no need for a "risk assessment", as such. Just create a form which is a "Significance of OOT" record (or if you have a database make a note and fill that in, file it with the gauge certs etc and move on.
     
  11. David Graham

    David Graham Member

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    We use a IM&T Determination Worksheet to document OOT conditions. This ties in with our Maintenance Software being able to track all calibrated tools to a job card. This software tracks the tools unique ID, its PN and SN and it calibration cycle, and the tools entire calibration history. If a tool is out of calibration, it cannot be selected in the technical record as a useable tool. Now this does not stop JQ Public from using the tool which would be another problem in and of its own, but it does allow for positive recall. Now positive recall in my world, which is Avionics repair on the CF18, means we must be able to tell at all times, instantly, where an OOT calibrated tool was used (this is an airworthiness requirement) since its last calibration.

    Now we use the IM&T determination sheet, once the Calibration facility has noted an OOT, it covers all the tool ID stuff, last calibration date, we record the OOT results from the Calibration center. This is then compared to the tolerance specifications of the item in question. If our test specifications are tighter than those the tool calibration specs a determination is made, if the test specifications are wider than the tool calibration specs than a determination is made. We also list all items this tool was used on since last known calibration, and we take all that data, hold a technical review board to make a 'recall' determination. If a recall is required, that decision is recorded as well as all items by PN and or SN that require, revalidation. If no recall is required, we document our reasoning and close the sheet, this sheet is scanned into the tools record and becomes a part of the tools history. I have uploaded a sanitized copy of our sheet.

    I actually understand what you auditor is after, but he/she are not articulating it well. And yes, a risk assessment of some type is required, I know this will rub people the wrong way, but in my world of Avionics and Aircraft safety, calibration is a pillar of maintenance. In our maintenance software, if no OOT was reported during a calibration, we are required by the airworthiness regulator to state that, if an OOT was noted, we must state that as well and the actions we took.

    Hope this is helpful, if not, I apologize.
     

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  12. Andy Nichols

    Andy Nichols Moderator Staff Member

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    And I'm guessing here, but there's likely a FAR which requires that (but this is the ISO 9001 forum, where yes, an organization might have to be aware of such a regulation, but generally they don't apply in the vanilla 9K world)
     
  13. senior

    senior Member

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    I agree with Andy.
    CB auditors must look for evidence before issuing NCs.
    In this case gauge use is to measure attribute data and no evidence OOT of gauge exceed spec limit.
     
  14. Ganesh Sundaresan

    Ganesh Sundaresan Active Member

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    What do you mean by "weekly 100% measurement on our CMMs" ?
    Perhaps your Auditor was looking for a system to comply with the following ISO 9001 requirement;

    the organization shall assess and record the validity of the previous measuring results when the
    equipment is found not to conform to requirements. The organization shall take appropriate action on the
    equipment and any product affected.
     
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  15. tony s

    tony s Well-Known Member

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    Ganesh is right. In the event you found out that your IMTE is OOT after calibration, what will you do to the equipment? and to the affected product?
     

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