Laboratory Manager:

1. The internal quality controls results are recorded in the laboratory register. Each time a Result Report is reviewed the correctness of internal quality controls must be checked (this should be made a standard activity in the procedure on authorization of reports; if necessary, adapt the SOP on Reporting, Recording and Archiving of Results to include this step and make sure the staff members authorized to review Result Reports before release are informed).
2. In addition to checking whether internal quality control results were correct before authorizing Result Reports, the internal quality control data must also be monitored to identify possible trends and deviations over time. Assign one staff member to perform weekly, or more often, review of internal quality control results to see if they remain stable (including, if necessary, the use of graphs and statistical analyses). Deviation of quality control results over the long term could indicate deterioration of reagents, deterioration of staff competency, etc.
3. When deviations/quality control failures are detected action must be undertaken according the procedure in the SOP for Internal Quality Control to solve the deviations/quality control failures.
4. If necessary, perform an analysis to find the cause underlying the failure or the deviation from the trend, and formulate preventive and corrective actions.