ISO 9001:2015 - Record requirements for out of calibration tool

embedded

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#1
We are preparing for our annual surveillance audit, and in reviewing prior CARs(so I can ensure we are prepared to show effectiveness) I came across a CAR I'm not sure why we were written up for. Kind of late as it's said and done, but just for my understanding... We had a tool that the calibration house reported as out of calibration, so we took it out of service but we had no records of who decided what and took what actions so we were written up. Specifically - ISO 7.1.5 requires that "The organization shall determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary.". To make sure we're in compliance today, I read ISO section 7.1.5 as well as our internal procedures and I don't see where it specifically says records must be maintained. Am I misunderstanding or missing something?
 
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Ninja

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#4
Nope. It isn't even a requirement that you do it ever...at all...

Though it may well be a customer requirement...
 

Sidney Vianna

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#6
A rule I live by is if you didn't document it then it didn't happen
Without trying to derail the thread, but that rule is not smart. You got off the bed this morning, didn't you? Is there a record of such feat anywhere? I doubt it.

Recording of activities has to be selective, because record creation, maintenance, storage, etc...costs money, time, effort. That's the reason why the determination of what records need to exist is also supposed to be risk-based. Irrelevant records need not to created. The one, subject of this thread creation is, typically, a critical one, because it might indicate that nonconforming products might have been allowed in the market place, which can have significant consumer and user safety implications.

But, to say: if it is not recorded, it did not happen is simply nonsensical. Not every business is in the nuclear business supply chain. Mind set has be adjusted to context.
 

dubrizo

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#7
Without trying to derail the thread, but that rule is not smart. You got off the bed this morning, didn't you? Is there a record of such feat anywhere? I doubt it.

Recording of activities has to be selective, because record creation, maintenance, storage, etc...costs money, time, effort. That's the reason why the determination of what records need to exist is also supposed to be risk-based. Irrelevant records need not to created. The one, subject of this thread creation is, typically, a critical one, because it might indicate that nonconforming products might have been allowed in the market place, which can have significant consumer and user safety implications.

But, to say: if it is not recorded, it did not happen is simply nonsensical. Not every business is in the nuclear business supply chain. Mind set has be adjusted to context.
Fair enough - It does depend on industry and common sense application... Do I record getting a coffee when I arrive at work, no. Do I record a gauge R&R study, absolutely
 

Ninja

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#8
Putting it back to the OP...which has nothing about GRR in it...

An out of calibration gage which may or may not have "passed" material that should have "failed"...records certainly seem in order for what, when and what you did about it both to correct the gage and retroactively for the lots "passed" by that gage when it's performance was in question...
 

embedded

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#9
Thanks guys. I like how pragmatic the people on this forum are, or said another way how you keep the perspective of quality as well as what makes good business sense.

In our specific business, we sell relatively low cost products and if we were to go overboard we wouldn't be making money. In regards to the finding we were written up for, it was a torque screwdriver. It is used for consistency and doesn't impact the quality of the product. To clarify a bit more if screws were falling out of products customers wouldn't be happy, but it's not a situation where if the screw isn't tightened to x inch / lbs the product won't work. I don't see anywhere where it says a record is required, so was this a valid CAR - where is the requirement that we violated?
 

Sidney Vianna

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#10
In our specific business, we sell relatively low cost products and if we were to go overboard we wouldn't be making money. In regards to the finding we were written up for, it was a torque screwdriver. It is used for consistency and doesn't impact the quality of the product. To clarify a bit more if screws were falling out of products customers wouldn't be happy, but it's not a situation where if the screw isn't tightened to x inch / lbs the product won't work. I don't see anywhere where it says a record is required, so was this a valid CAR - where is the requirement that we violated?
If the torque is irrelevant, why do you have a torque-adjustable screwdriver? Why not a simple power screwdriver? Any auditor who sees a torque-adjustable power tool will become inquisitive. Even more confusing, if it is not critical and costs are paid attention to, why send it to an outside lab for calibration? You see? The context of the situation you are describing does not add up to a conclusion that "it can not affect quality". If that is the case, a simple, non-adjustable powertool will give you consistent results. Until then, as an auditor, I would also be looking for EVIDENCE (if you don't see a need for a record) that the out of tolerance condition was evaluated BY SOME with the necessary knowledge/authority to make a proper determination of any potential action.
 
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