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