Title

Monitor and investigate failure of internal controls and improve accordingly

Why

In the previous activity internal quality controls were formulated for each procedure and the SOP for Internal Quality Control was written. The purpose of internal quality controls is to control the quality of each single step of each procedure performed in the laboratory. However, to assure the quality of each procedure the internal quality controls need to be monitored. When deviations and quality control failures are detected, the laboratory needs to act quickly to prevent that faulty examination results are reported.

What

Create a system to ensure continuous monitoring of internal quality control results. The objective of this system is to detect quality control failures and deviations from trends in an early stage to prevent reporting of flawed results. If necessary, make use of graphs and statistical analyses.


When deviations from the trend/internal quality control failures are detected actions need to be undertaken to solve these deviations/failures as soon as possible. It should never happen that examination results are reported in case of quality control failure.

How & who

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 Recording, Reporting 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, reviews 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, decrease 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.

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This activity belongs to the QSE Assessment

 

ISO15189:2007: 4.2.2
ISO15189:2012: 5.6.2.3
ISO15190:2003: