ISO/IEC 17025 Nonconformance Series: Equipment Maintenance and Calibration Requirements
By on December 20, 2019
In the first episode of our webinar series on ISO/IEC 17025:2017 on common nonconformances, Tim Osborne, vice president of A2LA WorkPlace Training, reveals that 1,278 (38%) of the nonconformances that have been found by A2LA assessors deal with section 6.4 or the standard: equipment maintenance and calibration requirements. Considering the broad scope of the standard as a whole, this is a very significant observation.
Tim addresses individual sub-sections of the standard, revealing where common nonconformities are found. We also share how you can mitigate your risk for nonconformities in these areas by automating your processes using Qualtrax workflows. You can view the first webinar in its entirety here.
Why is equipment management so critical?
Equipment maintenance and calibration requirements are the base of the pyramid that ultimately culminates with the results you provide to your customers. If these items are not appropriately managed and tracked, you cannot be sure that your results are valid.
What you really need to be asking is: does what we do affect the results we’re providing to our customer, either internally or externally? The standard (6.4.1) says that you have to have equipment that provides correct performance in the laboratory activities. The bottom line in 17025, according to Tim, is that you have competent people, that you’re providing results impartially and, equally as important, that you have consistent results.
A competent person will be able to articulate or derive what the impact of equipment maintenance and calibration requirements might be – positively or negatively – and make the necessary adjustments to the system to improve or correct it.
Here is a real-world example related by Tim:
I visited a calibration lab that performed a lot of precision electrical calibration work. The shop wasn’t “OCD clean,” but it was organized and there was a lot of equipment stacked one on top of the other. When I looked at the back of the instruments, where the cooling fan intake was, the pre-filters were clogged. Now, mind you, this is a maintenance item that the manufacturer highlights because a hot instrument gives false readings. So I asked the technician to determine if the instrument temperature was an issue, how it was a part of the electronic device and if the temperature was out of tolerance. Sure enough, when he looked at the information that was logged on the electronic device it was out of tolerance. So he was making bad measurements and, had I not brought that up, it could have caused failures for our customers: either it was failing and is now passing or it was passing and should be failing. The moral of the story is that we need to make sure that we understand how the maintenance impacts the measurement accuracy and the measurement uncertainty of the measurements we are making.
Tim focuses on equipment as defined as defined by section 6.4.1, corrections to the measurement management system, how ISO/IEC 17025:2017 plays a role in that and how the calibration program assists in this and the top five nonconformances within section 6.4 of the standard. You will also learn how Qualtrax can help manage your equipment maintenance schedules and requirements, as well as your calibration records. This can take a lot of the stress and pain of keeping track of a manual schedule off of your shoulders and allow you to continue to focus on the day-to-day tasks and duties assigned to your role.
The bottom line is this: equipment management affects your ability to satisfy your customers. You should focus on making sure your equipment and assets are being utilized to their full potential and you’re getting the most out of them that you possibly can. Look closely at your measurement results. Look at the uncertainties and accuracy. If you’ve got errors and correction factors, make sure they’re used and updated appropriately.
These things affect your ability to make decisions based on risk and rules. Managing your equipment tells your technicians – your internal customers – that they are making good measurements. This gives them confidence and helps them feel that they can go out and make measurements and not feel like they’re compromising their customers. Then, ultimately, you’ve got great customer confidence in your product.
Are you confident in your compliance? Would you like to learn more about how Qualtrax can help your organization manage your equipment maintenance and calibration requirements? Contact us and we will be happy to help you assess your needs and share how our workflow tool can streamline your approach.
Be sure to subscribe to our email list for notifications on future webinars, including the next in this series on top nonconformities and how to address them!
Categories: Calibration, Testing Labs
