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Validation and accreditation questions

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Guest user Created:   Mar 21, 2022 Last commented:   Mar 22, 2022

Validation and accreditation questions

I don't know if you can help. We are looking for advice as we have two opposing trains of thought, both which can be valid when thought about. We want to accredit the analysis of Cu ores by acid digestion followed by ICP-OES analysis. There are samples with a Cu concentration of ~1% as well as samples with a Cu concentration of ~15%. The samples with the ‘low’ Cu concentration require crushing, whereas the samples with ‘high’ Cu concentrations samples do not. For sample digestion, the same acids will be used. However, after digestion, different dilutions are required to obtain the different Cu concentration ranges. Two Questions: 1)    must the process of sample size reduction for analysis be included in the validation process for accreditation? 2)    can you validate this as one method, even though different size reduction requirements and  dilutions are used prior to analysis?
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Tracey Evans Mar 22, 2022

You asked

1)    must the process of sample size reduction for analysis be included in the validation process for accreditation?

I understand it the sample size reduction is part of sample preparation, not sampling (from source), so yes that step must be included in your method validation. The sample preparation variability must be evaluated. 

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2)    can you validate this as one method, even though different size reduction requirements and dilutions are used prior to analysis?"

You can validate as one method if the same in-house or standard testing method is followed, and the dissolution and analytical part of the validation is common,

As an example. an accredited would be stated as Procedure for the dissolution of crushed ore, waste ore and concentrate (final product) with analysis by ICP-OES. For accreditation you must specify the Material or product tested, the Standard Specifications, Techniques / Equipment used, the Type of Tests / Properties Measured, and Range of Measurement (if applicable, for example your limit of detection is a restriction).

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