Calibration Dates - Exact day or end of month?

#1
Hi everyone - great to be back.

We recently went through an internal equipment audit, and our auditor did not like the fact that we perform all of our calibrations before the end of the month. We do not use exact dates. The problem the auditor brought up was that we did not have verbiage in our DOP that says it's okay to exceed the calibration date by ~30 days.

For example, if we calibrate on 5/1/2016, with an interval of 6 months, the next due date for us would be November 2016; however, if we calibrate it on 11/30/2016, it would be ~30 days after we first calibrated the instrument. We've been doing this for 30 years, and it never came up until now in an internal audit.

The auditor wants us to place some verbiage in our DOP that says it's okay to exceed the calibration date. I'm not really sure what kind of verbiage I need to state. We do perform a bi-annual review of all of our calibration intervals, where we make increases or decreases. We've been doing this for 10+ years. We also have a system in place that any instrument with 3 out of tolerances in a row goes to a CAPA for investigation. We review this each month.

Anyone have recommendations on the verbiage? I've done some searches on the net, and one stated:
But realistically, due dates are put there for the convenience of auditors. If you have been performing periodic surveillance of your equipment with formal or even informal spot checks, you know very well if it is functioning within your requirements. Calibration intervals should be assigned by valid statistical methods and the increased risk of using an item a few days past its due date is extremely low if you have done your job and assigned a realistic interval.
 
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#2
Re: Calibration Dates - exact or end of month?

I call on several companies that define their specified calibration intervals as sometime withing a given month and it works just fine.

You get to not only choose what the interval is, you get to define it as well. If it is not well defined, your auditor is helping you by pointing that out. It is often defined in a calibration procedure if you choose to have one.
 
D

DRAMMAN

#3
ISO9001 is not specific at all on this topic. It is very common for organizations to simply require calibrations to be completed in a month. It is also very common for organizations to identify a specific date with a grace period such as 30 days. From an audit perspective it depends on what you put in your policy/procedure. Then the auditor will evaluate if it makes sense. For example, stating that you allow a 1 year grace period will probably get you a nonconformance.

My company has a grace period statement saying simply that we have 30 days from the calibration date to get it completed. We pretty much did it to give us some wiggle room should an auditor find a stray gage. We recently switched to just stating a monthly due date.

But you mention this was an internal audit so your company or corporate function can make any requirement they want.
 
T

Ted Schmitt

#5
I personally don´t see a "big deal"... a simple alteration of your procedure to include "calibration may occur up till 30 days after the expiration of the 6 month calibration period". I think as long as you can trace back any calibration equipment that you might find out of calibration... you should have no problem.
 
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BradM

Staff member
Admin
#7
The task of the calibration program is to be effective in providing confidence and mitigating risks. Barring specific industry requirements, the intervals should be determined based on risk assessment. This would include usage, criticality, previous performance, etc. This may mean I calibrate something every week+\- a few hours, or every two years plus or minus a month.

To the point of your audit/ auditor, I'm not sure where the auditor is coming from when they state "exceed the calibration date". I think the auditor may feel that all calibration fall to a "day"; and that is not accurate. it's like getting your car inspected, to an extent. Your inspection is due.. 05/2016. You can get it done any time during that month. It's just expired after the 06/01/2016 day. :)

That said, the intervals, and their possible adjustments, need to be defined in a procedure. In general, I would recommend that the longer the interval, the more flexibility you should have. +\- 30 days for a six month calibration is reasonable, IMO. Once that is defined, I would think the auditor should be satisfied.
 

Ninja

Looking for Reality
Trusted Information Resource
#8
This is the type of non-substantive "finding" that makes people crazy. Been there. We do it simply by using months, not specific dates. Just put something in your procedures that allows the grace period and move on.
I agree, to a point. It is a self-imposed non-conformance ... not really a big deal...but a NC all the same. Tough call between finding and OFI...to me it would depend on the reaction of the company during the audit.
"It's fine the way it is" might make me write a finding.
"Thanks for catching that, we'll update the document" might make it an OFI.

Verbiage to add could simply be "Calibration dates refer to the month in which the date falls, not the specific date (even if a specific date is given). Recalibration within 30dys of the calibration due date is acceptable."

Stick the verbiage in your procedure and move on to something more important...
 

Candi1024

Quite Involved in Discussions
#9
I personally don´t see a "big deal"... a simple "calibration may occur up till 30 days after the expiration of the 6 month calibration period". I think as long as you can trace back any calibration equipment that you might find out of calibration... you should have no problem.
This sounds good to me.

We had a finding for it as well, and are to be adding it into our procedure. It was 6 months ago, and we have an internal requirement that all findings, even for internal audits are to be addressed by the CAPA team. A CAPA was written, but not assigned to the maintenance department yet, therefore the change has yet to be made.

We are a really efficient company.:sarcasm:
 

Golfman25

Trusted Information Resource
#10
I agree, to a point. It is a self-imposed non-conformance ... not really a big deal...but a NC all the same. Tough call between finding and OFI...to me it would depend on the reaction of the company during the audit.
"It's fine the way it is" might make me write a finding.
"Thanks for catching that, we'll update the document" might make it an OFI.

Verbiage to add could simply be "Calibration dates refer to the month in which the date falls, not the specific date (even if a specific date is given). Recalibration within 30dys of the calibration due date is acceptable."

Stick the verbiage in your procedure and move on to something more important...
Here's the problem. If "wordsmithing" makes the issue go away, then how substantive could it be and what's the point. Once it becomes busy work, the credibility of your system starts to diminish in the eyes of the users.
 
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