Late calibration (Calibration Past Due Date) - What do I do now?

T

Ted Schmitt

#11
Re: What do I do now?

Right! I also had a shadowgraph (optical comparator) that never went out of calibration in ten years.

Can we agree the N/C is minor unless the instrument was out of calibration? In ether case, the true test of character is in the Corrective Action deployed and implemented and the evaluation to assure the C/A is working!
Yes agreed... :agree1:
 
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#12
Re: Late calibration - What do I do now?

Hmm...

I don't agree, I don't see this as a question of whether the instrument is or was in tolerance, or whether the calibration frequency is appropriate, or opening the question of adjusting frequencies.

I see this as a human error which needs to be accounted for in the calibration process so that the organization can consistently meet the planned recall and calibration dates it assigns to its instruments.
I 100% agree with this, yes it maybe a minor NC now but if it happens again? I also believe that it is lax to just flick it off as a minor incident not in need of investigation. What happens if you leave the organisation, the New guy will probably forget aswell! It is a simple process and one that would not much time to fix. So you should fix it and be done with it, no matter how minor the EFFECTS of your actions, it is the ROOT CAUSE that matters.

It makes me think of FMEA, the severity of the effect might be rated 1, and your occurence and detection ratings are both 10, then you get an RPN of 100. BUT what if next time the error happens the severity of the effect is much greater (non-conformance at the customer!) then your RPN begins to increase. Fix it now!
 

BradM

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#13
Re: What do I do now?

Can we agree the N/C is minor unless the instrument was out of calibration? In ether case, the true test of character is in the Corrective Action deployed and implemented and the evaluation to assure the C/A is working!
I think I agree :)

It's only a corrective action if your system tells you it's a corrective action, or you want it to be a corrective action.

No system is perfect, you will forget things from time to time. However....if issuing a corrective action will facilitate process improvement where you have a better that catches gauges, then do so.

As an aside.. I would implement some type of system where it notifies you of instruments due for calibration. I would have a spreadsheet that you check every other week; Access report once a week.

So, don't drop back into the same system that allowed the oversight in the first place, but I would also not make it a five-alarm blaze.
 
P

Phil Fields

#14
Re: Late calibration - What do I do now?

As part of our calibration system process we measure On Time Calibration. This is from the time taken out of service (collected for cal, compared to Due Date). We look for trends, and known reasons of why we are not on schedule.
There have been times when we OK'd a piece of equipment to go one month past due to equipment availability and production (with confidence that we have not seen past issues). We have done this knowing that if the unit was out of cal we would need to take appropriate corrective action to any possible out of spec material.
I see no reason to issue a Corrective Action for the equipment being past due by one month, unless it is a continual issue.

Phil
 

gpainter

Quite Involved in Discussions
#15
Re: Late calibration - What do I do now?

I would say "why was the system not followed"? If it is human error, how can we mistake proof it? Most of the auditors that I have dealt with have been lax on calibration possibly because they may have limited knowledge. At past lives we had an issue with calibration and believe me it is important. One of the indicators that I use for issue of CA is "If this is not correct, what is the likelyhood of sending nonconforming product/parts?".
 
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P

Pazuzu - 2009

#16
Re: Late calibration - What do I do now?

You send it for calibration, update the calibration calendar (assuming you have one) to reflect the new cycle, and informally set some flagging system up as a reminder. A formal NC...not required. But some sort of action must take place.

If the device is often used (daily, weekly) leave a note inside the case that reminds you when the next calibration date is. If it is not used that frequently then the chances of it being out of calibration are diminished (most things dont de-calibrate by sitting there). Set up a reminder on your computer...as long as there's something to remind you. The last thing you need is your external auditor finding out that you continually send it late without any sort of correction.
 
K

Ken K

#17
Re: Late calibration - What do I do now?

Interesting opinions so far.

IMHO, write yourself a non-conformance. You obviously missed a due date, for whatever reason, so now's a good chance to see how your corrective action procedure works.

Has it happened before? Will it again? If you try and correct the mistake without documenting it, why bother with a quality system?
 
P

potdar

#19
Re: Late calibration - What do I do now?

It doesn't matter much, I think.
I agree. Whether you write a CA or not does not matter. What matters is what you do about this human error.

Human errors are not system breakdowns. System breakdowns count as Non-Conformances. What needs to be ensured is that the human errors do not increase in quantity / frequency to degenerate into system breakdowns. The system should be robust enough to ensure that.

There are many ways of designing a robust calibration recall system. Many have been discussed. You are the best person to design one to suit your setup.

Confirm the robustness. Take any actions necessary if the device was found to be out of calibration - record them and the delay. Please note that a device may be out of calibration even if calibrated on schedule. With this, you would have met the requirements whether with or without a CA.
 
A

amanbhai

#20
Re: What do I do now?

Let's be realistic here. My experience is many instruments are still in calibration when sent to the shop or lab for the required recalibration - the whole point is to set up the schedule so the equipment does NOT go out of calibration triggering the backtracking described.

This is an opportunity to revisit your calibration schedules and adjust accordingly. Do not look at it as a major nonconformance unless the equipment WAS out of calibration and triggered the backtracking and then the nonconformance should address the matter of ALL calibration schedules and the process to assure the schedule is followed.
Correct! but we are late by almost six months. We know that the equipment calibration due date was over but sure enough that the equipment is giving us the accurate readings since we regularly participate in the round robin (PT program) as one of the requirement of ISO/ IEc 17025:2005.
CAR has been raised by the auditor, I don't know how to close this CAR specially when auditor ask me to check all the tests data of last six months. etc etc etc:confused:
 
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