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Method validation/verification

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Guest user Created:   Oct 07, 2022 Last commented:   Oct 07, 2022

Method validation/verification

Yes, we are in the process of implementing ISO17025 and have almost completed creating our quality management system. I am struggling with method validation/verification for my analyses. One is semi-quantitative while primarily identification (NIOSH 9002) and I am unsure how to verify the method since I can’t order standards and I have previous PT samples I can use but they don’t cover the entire scope and since the method is partially identification I can’t re-use them as blinds. The other method is random by nature so again I can’t order standards. I just want to ensure that the verification that I perform is robust enough.

 

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Tracey Evans Oct 07, 2022

It is through method verification of a standard method the laboratory proves with objective evidence that they can perform the method and achieve the expected performance

How this can be achieved depends on the method technique. For example for microscopic examinations, if you are the only technician (hance know the makeup of retained sample) get an independent person to issue the samples to you blind. If you don’t have samples across the range, try and identify another laboratory that does have samples, to do a bilateral study with. I can’t comment specifically on the method you describe as “random”. I suggest you engage with your accreditation body to see if they can assess it as part of their scope. If it is a method that involves certain activities, for example weighing or a complex calculation determination, then do what you can by breaking the method up into these activities and verify the activities you can. For example competency to weigh accurately using certified calibration weights and by validating complex calculations for determination of a parameter.

 

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Oct 07, 2022

Oct 07, 2022

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