In the third in his series of articles on internal quality control, Stephen MacDonald continues his overview of process design with a look at defining process stability, setting target values, and how they should be used.
In the previous article in this series (December 2018 issue, page 27) we discussed the desirable properties of internal quality control (IQC) material; now we move on to how it should be used. There are two aspects to consider: first, quantifying the innate instability of the process to define expected performance; and second, we must be able to detect when the process deviates from what we expect. We shall discuss defining the process stability and setting target values in this, the third article of the series, with monitoring of performance following in Article 4.
Quality control material validation
Control material is assessed by manufacturers across numerous techniques, analysers, operators and lot numbers of reagents to validate utility. For assays where no commercially available IQC exists, and assays are controlled using in-house material, this validation must be performed locally. The same standards expected of manufacturer control materials apply and were discussed in Article 2. Upon validation, we are provided with an expected range of results that should be able to be reproduced in all local laboratories. These are termed the manufacturers’ ranges and are the starting point for our implementation.
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