Table 21. Post-IQC impact assessment, end of run outside acceptable limits.
Recommended practice | Clear provisions: understandable for the staff responsible for applying them (adapted to the quality management system). Complete provisions: any type of method (quantitative/qualitative, automated/manual...), analyte (variable criticality), activity (continuous/discontinuous). Adaptable provisions: to all situations encountered. |
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Acceptable practice | No precise provisions, but correct practices and an impact study if necessary. |
Unacceptable practice | No provision and no impact study in case of non-compliance with the IQC. |
IQC – internal quality control. |