Is a lost calibrated tool an non-conformance for an audit?

#1
We use a contract auditor to do our internal audit since we are a very small shop. During this last audit, the auditor wanted to look at 3 calibrated tools. One of the tools (a caliper) could not be located. The auditor is saying that is a non-conformance because the tool register is now out of date. I have records showing that this tool was used less than 5 days earlier. That is leading us to have to establish a process to make sure no tool was lost at the end of each day. But what would happen if the tool was lost on the morning of the audit? Do I now have to place RFID trackers all the tools so I know where they are at all time?
 
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Jen Kirley

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#2
Welcome Dan!

I would be interested in just how this nonconformance is to be worded.

What is your process for ensuring that only calibrated/verified tools are used to inspect product or influence essential characteristics if a tool goes missing?

What does your process say about your register?

My point is, the standard is asking that calibrated/verified tools are used. If you have made a procedure that locks you into more, I would suggest looking into that. Disclaimer: I work to 9001, not AS9100. I may be missing a detail here.
 

Scanton

Wearer of many hats
#3
In the vast majority of the certification body audits I have been subjected to, the route taken is to identify a gauge at its point of use, records its type and serial number and trace it back through the calibration records to see if it is 1) in calibration and 2) traceable back to national standards.

If a measurement device is "in calibration" I couldn't give a monkeys chuff nut if it couldn't be located on demand at a specific moment in time, and I am unaware of anything in the ISO standards that says I should. (unless of course it is the only one of it's kind and vital to what is being produced, but in this case I am making the assumption it is one of many)

What happens if this calibrated item is a personally owned device, the device in question is in a personal locked cabinet and the person in question is on holiday or sick on the day of the audit? As far as I am aware, that is not an audit failure, how could it be. The device is in calibration and can't possibly be used so can't impact anything being produced anyway.

I would definitely challenge this and ask which clause or clauses of what standard this auditor thinks are not being met.
 

Ron Rompen

Trusted Information Resource
#5
Chiming in late here, but I also agree. I would like to see the wording of the nonconformance statement. Challenge the auditor to find a measurement device on the floor that is NOT currently calibrated (unless as was mentioned earlier, the device in question is something unique which is necessary to perform measurements of some unique nature).

Auditors (particularly contract auditors) seem to always be looking for SOMETHING they can write up, to justify the cost of their services. They will often use the most stringent interpretation of the standard, without actual consideration for what the standard is actually trying to say.
 

ScottK

Not out of the crisis
Leader
Super Moderator
#7
If the tool is one of several, I would not have done an NC.
If it is a unique tool that is needed to verify characteristics that nothing else can do, but product is being released anyway... I might consider it an NC if there is no deviation in place.
It also depends on what your procedures say so I can't really judge on if there is an NC or not with the info given. It's kind shady though.

I've had auditors that take the approach of pulling a few calibrated instruments from our log, and this is the primary danger of that technique - that a tool can't be located right away (might be locked in a person's tool box for example). I prefer when an auditor walks the floor and points out the tools he wants to see records for and I make that clear.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#8
As others have indicated, it's a bogus finding. "Show me the shall." There has to be a requirement for there to be a NC.

The standard's requirement to "maintain a register of the monitoring and measuring equipment" doesn't mean that the register can't be revised if one finds a tool has gone missing. As you say, if you audit it every day at the end of the day, it could go missing at 10 AM the next day and be audited as "missing" at 11 AM. Are you then to do hourly audits?

The good news is that it is an internal audit and you can say "you're wrong" and ignore the NC without further hassle.
 

Sidney Vianna

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#9
I have a slight different take on this one. It is a valid finding, but not necessarily a nonconformity. Small organization means (typically) not resource-rich, what translates to a potential lack of back up device to make measurements. So, what happens if the caliber is not found when a measurement needs to be made? Use a tape measure, instead? Since this is AS9100 related, which applies to aviation, space & defense applications, precise measurements tend to be more critical than "commercial products".

What happens when/if the tool is found? Since the chain of custody is lost, can we assure that the previous calibration is still valid? Or should the organization mandatorily have it re-calibrated, upon recovery?

Audits, internal or external, provide insight on the organization. Even if we all agree that this is not a valid nonconformity, we should not simply disregard the issue. The loss of an inspection, measuring & test device is SIGNIFICANT, even more for a small organization. And the reasons for the loss and the consequences should be evaluated.
 

dwperron

Trusted Information Resource
#10
Not really sure how it was determined that this is an AS9100D related issue, because there is no mention of AS9100D in the original post.
If it is an AS9100D audit, it could be a very picky finding:
"The organization shall maintain a register of the monitoring and measuring equipment. The register shall include
the equipment type, unique identification, location, and the calibration or verification method, frequency, and
acceptance criteria."
If it is not listed as lost in the register it could possibly be a finding. A stinky one, one that is almost impossible to avoid since you don't have a way of knowing when a tool gets misplaced, stolen, borrowed, etc., but a possible finding none the less.
 
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