6.4.8 Calibration Labels

Hello,

We are in the process of our recertification audit for ISO 17025 - the auditor has brought up calibration labels per section 6.4.8 All equipment requiring calibration or which has a defined period of validity shall be labelled, coded or otherwise identified to allow the user of the equipment to readily identify the status of the calibration or period of validity.

Our process is that each gage is identified with an ID number then the technician can look up that gage for the calibration status via our intranet system where we store the data of recent tests and when the next one is due (IQS database).

The audit is informing us that we should have a physical label on each gage. Our work environment is oily and we have found that labels just slide off and do not stay on...which is why we have an engraved ID number.

We have interpreted the standard as it is labeled and you can easily look up the status therefore it falls under the otherwise identified part of the standard.

Does anyone have any experience with this part of the standard or advice on how they have handled meeting this requirement?

Thanks!
-Carlee

 

Hello Andy,

Thanks for the quick response! I am glad that we were not being unreasonable pushing back on the auditor. I believe we were able to showcase our process and prove that we are meeting this requirement. The auditor was trying to convince us that we would need to label that storage area with the status, which just felt silly when we have this easily accessible database that already has to be updated when you complete the calibration.

Thanks!!
-Carlee

 

Your approach is most acceptable (my professional experiences have placed me in similar situations as you describe). As @Andy Nichols and @Miner indicated, my counsel is you have the auditor define/show how your method is inconsistent with the requirement (he/she can not, because your described process clearly meets the requirement). If unsuccessful, appeal the result.



Hope this helps.
Be well.

 

Well done.

 

Just make sure everyone who uses the gages knows how to look up the status. That is where you might get pinched -- if someone is unsure.

 

Hi Carlee, risk-based thinking is that how often do technicians check the calib. status via Intranet before using the equipment? and how likely do they use expired gage? In my lab, they omit this step sometimes, even when the expiration date is clearly on the physical label. So, it really depends on how advanced your lab/incl. personnel is. And the auditor might have good reasons to note it an NC. Work environment is oily? do the technicians use gloves? do they have to take their gloves off before working with computer/keyboard? etc.

 

Hi Andy, What would you do with the test result if your technician discovered post-testing that he inadvertently utilized expired equipment? In my situation, given the substantial risk involved, I've chosen to prominently document the expiration date on the equipment label to prevent such oversights.

 

Yes. But it's essential to consider that your test results might become inaccurate. Moreover, there's a concern about the potential impact if these results have already been shared with clients or incorporated into their records. Naturally, it falls on everyone to minimize risks, with the management holding the ultimate responsibility. In the case of Carlee's laboratory, the auditor has recommended the implementation of physical labels on each piece of equipment. However, if this isn't feasible due to the presence of an oily environment, it might not be a non-conformance (NC), but rather an opportunity for improvement (OFI). In similar situations, some technicians may opt for a more traditional approach, where they jot down the IDs and expiration dates of frequently used equipment on a piece of paper that they keep in their pockets for convenience and time-saving. How can the management assist them? Is this approach considered old-fashioned?