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Author Topic: Help with differing interpretations in ISO 17025 and 21CFR820.72(b)(2)  (Read 9816 times)

Offline MyLocalDJ

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I need help with an interpretation of applying ISO17025 and 21CFR Part820.72(b)(2).
I will start by saying we are using external calibration labs for our calibration services.  When talking with a test tech in our company, I found out that some of our equipment that has been calibrated does not have a label that indicates the Calibration Due Date.  To me, this is a concern because the test operator using this piece of equipment has no ready way of knowing if the equipment that they are using is within the calibration acceptance date or not.
To further complicate this, I asked if the calibration certificate had the Calibration Due Date identified on it.  The answer was no.   As I reviewed the internal procedures, I learned that the calibration due date is 1 year from the date of calibration.  GreatÖ   As I looked at other equipment, I noticed that other calibration labs are including the Calibration Due Date on their certificates and equipment calibration labels.
From a past life in aerospace, my organization performed internal calibration services and we sent product outside for calibration also.  We typically did not want a calibration lab to put the Calibration Due Date on equipment that they were calibrating unless we provided that information to them.  The reason was the calibration lab had no way of knowing what our calibration interval was for the particular piece of equipment they were calibrating and often, they may be different.  I know most companies may have different calibration cycles for different pieces of equipment depending on the type of equipment and the risk introduced to the business or safety impact based on the potential of a calibration failure. Additionally, each company may decide to change the frequency even on one piece of equipment within a group of the same type of equipment based on that particular piece of equipment being used in a higher risk process or in the case of a piece of equipment having had a prior history of drift.  Because of this, the calibration supplier would likely not want to tell a company what the cycle should be.  So in my past life, when the calibrated equipment came back in house from the calibration lab, we entered it into our recall system and based on our procedures, assigned the Calibration Due Date and created an equipment label with the typical information including the Calibration Due Date.
In the company that I work for now (Medical Device Manufacturer), we send equipment out for calibration, receive it back and enter the information into a spreadsheet to track it.  We enter a Calibration Due Date into the spreadsheet based on our procedure that would indicate 1 yr from the date of calibration.  We do not create a new label so the equipment calibration lab label is the only calibration label on the equipment.
I was asked to contact the vendor to request that they start including the Calibration Due Date on their calibration label and the calibration certificate.  The vendor stated that they could not do this because of their accreditation to ISO 17025 and their internal procedures and that it was up to us as a customer and user of the equipment to establish our Calibration Due criteria.
My dilemma is that some calibration labs are doing this and one is not. Without an internal process to handle this, I donít see an easy way forward.  The interpretation of my organization is that ISO 17025 standard does not prevent the vendor from including this information and in fact to comply with this standard and 21CFR820.72(b)(2) the calibration lab must include this information or they are not in compliance.  My organization does not want to add or change process in house.
I donít want to bias this discussion any more than I probably already have but would like to hear from others on your interpretation with the standards that I mentioned and my organizations statement ďthat ISO 17025 standard does not prevent the vendor from including this information and in fact to comply with this standard and 21CFR820.72(b)(2) the calibration lab must include this information or they are not in compliance.Ē

Offline spanishfly25

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Stuck between the sword and the wall,  when a lab gets accredited they can't change the process because voids the accreditation, that may include changing procedures or labels, but 21CFR does required a due date on all paperwork including the sticker. Your vendor may not want to change procedures or labels, but thatís not acceptable to you, in that case change vendors
Also under 21 CFR you arenít allowed to use spread sheets for controlling data as easily can be tamper with and thatís why many companies are going with ProCal or Blue Mountain software especially made to meet 21 CFR requirements.
The one year interval is also a problem, since the user is the one that determines the cal interval, not the calibration company. Like you stated some instruments get used in a more critical area than others. Also if an instrument has a history of failing, you may want to shorten the cal interval.
In our case when we send an instrument for cal, we tell the vendor the cal interval
Now I may be wrong, but under ISO17025 for labels I think the minimum require fields are
ID#, performed by, date cal, and due date.
bottom line ask your vendor to include due dates and if they don't comply go to someone else. there are plenty of vendor willling to tap dance to your song.

Offline maccal

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ISO 17025, section 5.10.1.4,  no due date on the certs unless is agreed with the customer. I believe your vendor is obligated to add a due date if requested by the contract or purchase order.

Offline MyLocalDJ

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Thank you both!  My opinion is that we as a customer drive the calibration due date and must specify that to the calibration lab service supplier.  What also is important as maccal indicated is that there is a contract in place to specify the inclusion of the Calibration Due Date provision.  I suspect I will find that this is just a general PO provision and no real contract with any substance.  Your comments are in alignment with what I had provided as guidance.

Offline Hawaii596

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I'm probably not adding significantly, but it is correct that the customer drives the due date.  ISO17025 prevents the contracted lab from prescribing due dates, but as quoted above, the customer has every right to tell the contracted cal lab what due date the customer wants.  If the contracted lab will not provide it when prescribed by the customer (you), I believe they are out of compliance with ISO17025.  You might politely suggest to them that you may inform their accreditation body (ACLASS, A2LA, etc.).  I believe they are really supposed to provide you a due date if you contractually prescribe it to them.  I believe they may be a little confused about the requirements of ISO17025.  I believe they are just wrong in this.
"I often say that when you can measure what you are speaking about, and express it in numbers, you know something about it; but when you cannot measure it, when you cannot express it in numbers, your knowledge is of a meagre and unsatisfactory kind."
Lord Kelvin (1824-1907)
from lecture to the Institute of Civil Engineers, 3 May 1883

Offline spanishfly25

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hawaii I think the problem that mylocaldj is having, isn't so much with the actual due date, but that the contract cal lab's stickers and  certificates don't have a due date at all and the cal lab doesn't want to modified their stickers since they were accredited with the old sticker.

Offline RFCAL

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I agree with maccal-I know that Agilent and Fluke do not put due dates on stivkers or certs unless you specifically ask for it EVERY time you send something in for cal, but Tektronis does.
It is up to the customer to do due diligence.

Offline USMCPMEL

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I wonder what this person ever decided about this? We also do not include a due date on the paperwork for accredited calibrations as it is up to the customer to decide the interval. However if they request a specific interval then we do put the due dates on both the sticker and the paperwork. I know this is an OLD post but I ran across it and wanted to put in my 2 cents...

Offline RFCAL

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Now, you must request the due date be added to the sticker and cert. Most OEM's ( Keysight, Fluke, Tektronix ) leave the due date up to the customer. It it hard for the OEM's to figure out what cycle each customer is using. Anyway, cal cycles from OEM's are only recommended cycles. That's why they are left blank. And yes, that is a discrepancy for a 17025 audit.

Offline ck454ss

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This is how I solved that problem with a vendor.

State on the PO that a due date of X interval is required on the sticker.

If they fail to comply with the instructions on my PO a Corrective Action is issued.  Part of 17025 is reviewing the PO as that is the binding contract between customer and supplier.

If they refuse the instructions on the PO go find another vendor.
« Last Edit: 03-19-2015 -- 19:51:57 by ck454ss »

sdmetrol

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As an accrediting lab,  we can not recommend intervals but we can certainly follow the intervals prescribed by the client.

Offline griff61

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As an accrediting lab,  we can not recommend intervals but we can certainly follow the intervals prescribed by the client.

What would preclude you from making an interval recommendation to a client based on failure analysis?
Sarcasm - Just one more service I offer

Offline Hawaii596

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As the interval according to the ISO does belong to the customer, the only way to recommend an interval is based on some statistical method.  That would I think, leave the lab open to problems.  I wouldn't want to get into that territory in general.  However, perhaps as a consultant, a providing lab could offer the service of interval analysis for a customer.  But then there is the liability issue.  Once a providing lab makes an interval recommendation (other than an OEM interval or directly based on industry statistical practices), that implicitly is recommending to a defined statistical confidence level that their instrument is expected to remain in tolerance, and subject to audit by the customer's auditors.

That may be why the ISO has that policy, because each customer has varying confidence/risk level needs.   But I think the implied rule is the same.

However, the only requirement is intervals as agreed upon with the customer.  I occasionally do provide input to the customer when they request it (always remembering that the final decision on intervals is theirs).
"I often say that when you can measure what you are speaking about, and express it in numbers, you know something about it; but when you cannot measure it, when you cannot express it in numbers, your knowledge is of a meagre and unsatisfactory kind."
Lord Kelvin (1824-1907)
from lecture to the Institute of Civil Engineers, 3 May 1883

sdmetrol

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"What would preclude you from making an interval recommendation to a client based on failure analysis?"

If the client asked us to recommend the interval based on failure analysis, and they agreed with our recommendation, we would document that fact and follow through.  This can be tricky because agreement must be reached between the cal lab and client, and of course, all the facts (data) regarding the failure would have to be clear and available.  We would prefer that the client perform the failure analysis and then assign the interval.

I think the intent of the clause is to prevent cal labs from suggesting or requiring specific intervals for business purposes, therefore preventing the client from having the absolute say in the assigning of intervals.  On the other side, it protects the cal lab from liabilities from consequences of poorly assigned intervals.

« Last Edit: 03-21-2015 -- 00:48:41 by sdmetrol »

 

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