Informational Is Past due calibration a non-conformance if tagged "Do Not Use"?

[greif]

We have a piece of equipment that was due for calibration last month. Being very busy and not needing a piece of equipment in the near future, we have tagged it as "do not use". We calibrate most of our equipment internally, so it is not a matter of sending it out.

Is this practice a non-conformance under either 9001:2015 or 17025:2017?

 

[Pjservan]

I don't see why this will be a nonconformance as long as you are able to prove that the item was under control and not used. In an extreme case maybe you want to include it as part of your policy.

 

[hogheavenfarm]

Just remove it from your "active" list, tag it, quarantine it if possible. Thats pretty much what I do. We have much equipment that is only used once in a great while, I tag these as OOS (Out of Service) and CBU (calibrate before use) and go from there. If possible I remove them from the floor where someone could "use them anyway" just to avoid issues.

 

[Marc]

We have a piece of equipment that was due for calibration last month.

If there is a question, it is going to be when was it taken out of use and were there 'acceptance' measurements being made with it prior to it being found out-of-calibration, and if so what about those measurements made prior.

quarantine it if possible.

Yup - Lock it up.

 

[Eredhel]

Marc makes a good point. Quarantining takes care of it of course, I have a bit of a pile of old measuring instruments myself . But its effect on product conformity before catching it, if there was one, is probably what you need to figure out.

 

[K Roeder]

Just remove it from your "active" list, tag it, quarantine it if possible. Thats pretty much what I do. We have much equipment that is only used once in a great while, I tag these as OOS (Out of Service) and CBU (calibrate before use) and go from there. If possible I remove them from the floor where someone could "use them anyway" just to avoid issues.

This is similar to our process when the determination is made not to calibrate an item--we physically remove it from circulation, mark it as 'Inactive' in our tracking database, and tag them with "Calibrate Before Use" labels. If the item is physically too large to be removed from the area, or if it is mounted in a certain place (as with several pieces of production equipment,) we follow the same protocol for marking it as inactive and labeling it with "Calibrate Before Use" notices, but we also send out an e-mail to all employees.

If you haven't already, you may want to ensure your procedure includes information regarding your company's practices when something goes out of calibration.

 

[Marc]

its effect on product conformity before catching it, if there was one, is probably what you need to figure out.

Precisely. I've been through it in client audits going back years. And when I was doing audits I went right there when auditing calibration - Not out of meanness or for a 'got you' for a finding, but to see if they had addressed potential issues prior to pulling it out of use as well as their procedure (or 'policy') for taking measurement equipment out of service.

If you haven't already, you may want to ensure your procedure includes information regarding your company's practices when something goes out of calibration.

Another excellent point.

 

[greif]

Nice assortment of things to think about- Thanks!

 

[dwperron]

Another consideration, when you are taking the tool out of service it should be calibrated / verified.

What happens if it was actually out of tolerance when you took it out of service?
That means you could have been doing acceptance measurements with an OOT tool, and you might never know this if you never get around to calibrating it, or you retire it.

Remember, calibration is a backwards looking event - it tells you how your tool was, not how it will be.

 

[Marc]

Old Man rant follows...

Nice assortment of things to think about- Thanks!

The point of Elsmar for years has been this. Ultimately the point is: When an auditor comes in, are you really ready to explain things to your auditor. By reading threads like this, a person can 'get ideas' and think of things that they might not have. I saw a person promote the phrase "Dominate Your Auditor" in the relatively recent past. Here we do not see it as an adversarial confrontation. We here believe that an audit should be agreeable, and if not pleasant it should be professional and impersonal.

In the 1980's, we passed about cartoons like this one attached in Post 1 here: The Gang Audit

When at clients I tried my best to explain to every employee that auditors are not:

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This is what you want in your company:

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Be ready to know the answers to potential auditor questions. To do this the company only needs to ensure employees know their jobs, their qualifications to do their jobs. In reading this thread, I labeled it Informational. Out of use instruments is an important point in a calibration system. It's a line an auditor can easily ask about that many company calibration systems do not specifically, with detail, address.