Differing interpretations in ISO 17025 and 21CFR820.72(b)(2)

M

MyLocalDJ

[FONT=&quot]I need help with an interpretation of applying ISO17025 and 21CFR Part820.72(b)(2).[/FONT]

[FONT=&quot]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.[/FONT]

[FONT=&quot]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. Great… 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.[/FONT]

[FONT=&quot]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.[/FONT]

[FONT=&quot]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.[/FONT]

[FONT=&quot]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.[/FONT]

[FONT=&quot]My dilemma is that some calibration labs are doing this and one is not. Without an internal process to handle this, I don’t 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.[/FONT]

[FONT=&quot]I don’t 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 “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.”[/FONT]
 

mdurivage

Quite Involved in Discussions
What they may referring to is the fact that the calibration interval must be supplied by your company, as they are not allowed to make the determination on their own. The calibration houses that I have used in the past have all had the date due on the stickers and certificates.
 
G

Gmzita

Under ISO 17025 Sec. 5.10.4.4: A calibration certificate (or calibration label) shall not contain any recommendation on the calibration interval except where this has been agreed with the customer. This requirement may be superseded by legal regulations.

In our ISO 17025 System - we ask customers to list the calibration interval on their Purchase Orders or document it during discussions for scheduling the calibration service. If no guidance is given to the onsite technician, he is required to ask and document who/what he was told in his report. In my opinion - this is simply an issue of misunderstanding and an opportunity for the Calibration Lab to improve its services by improving its procedures.

However, you might have to guide them a little on this issue.
 
M

MyLocalDJ

Gmzita, thank you. I think you must have already read a number of my internal communications. That is exactly the approach that I was taking - going for the revision of the PO to include this requirement and information.
 
M

MyLocalDJ

Here are the basis that I was operating under... you already quoted the 17025 element.

Regulatory basis:
ISO 17025:2005, 5.10.4.4 states: A calibration certificate (or calibration label) shall not contain any recommendation on the calibration interval except where this has been agreed with the customer. This requirement may be superseded by legal regulations.

Additionally,
21CFR820.72(b)(2) Calibration records. The equipment identification, calibration dates, the individual performing each calibration, and the next calibration date shall be documented. These records shall be displayed on or near each piece of equipment or shall be readily available to the personnel using such equipment and to the individuals responsible for calibrating the equipment.

Although 820.72(b)(2) does not state how the next calibration date shall be documented, it does require it to be documented. So technically, this could be documented by the user organization within their calibration system or provided through the documentation from the calibration lab service provider.

To further research this issue, I referenced the standard, UL Calibration Requirements: Equipment Used for UL/C-UL/ULC Mark Follow-Up Services. Although this standard is not directly relevant as a requirement for equipment used in the manufacture of Medical Devices, it does provide further interpretation of the ISO 17025 standards. This standard recommended “…providers of calibration services be accredited under ISO/IEC 17025.” This standard further stated “All IMTE being calibrated – as well as measurement standards used for calibrations – shall include evidence of calibration status, e.g., a label or other marking indicating the next calibration due date.” Additionally, the example of the Calibration Certificate contained within the UL standard included a “Recommended Due” date but did not use the terms “Calibration Due” or “Calibration Expiration.”
 
G

Gmzita

Your bases are definitely covered. :applause:
You just need to advise the outside Calibration lab/s of your requirements and that under ISO 17025 Sec. 5.10.4.4 - they are required to fulfill your request and include the expiration date on the calibration sticker in order for you to fulfill your FDA requirements for calibration status and documentation.

The best way to do this ... is always in the issued Purchase Order. But again - you may need to do a little "hand-holding" the first time out to make sure the Calibration Lab understands. (Also - don't forget to actually issue the Purchase Order! We have had instances here where the Purchase Order is "phoned in" and we never actually see the hard copy until the request for corrected Stickers/Certificates is received. Live and Learn!)

Good Luck!
 
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