‘Quality control’ and ‘quality assurance’ are terms whose meanings are often confused. Quality assurance relates to the overall measures taken by the laboratory to ensure and regulate quality, whereas quality control describes the individual measures which relate to the monitoring and control of analytical results.
We have seen that method validation quantifies a method’s performance capabilities and limitations. In routine use, specific controls need to be applied to the method to verify that it remains in control and is performing in the way expected. During the validation stage, the method was largely applied to samples of known content. Once the method is in routine use it is used for samples of unknown content. Suitable control can be applied by continuing to measure samples of known content, which may be secondary or working standard solutions, thus allowing the analyst to decide whether unexpected and unwanted changes are occurring in the method performance. In practice these known samples should be measured with every batch of samples as part of the quality control process.
Contents of the Guide
- Internal QC
- Using Control Charts
- External QC
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