If calibration criteria fail during a run, what is the appropriate action?

If calibration criteria fail during a run, what is the appropriate action?

• A. Ignore and proceed with data.
• B. Quarantine the run and discard all data.
• C. Recalibrate the instrument and re-establish calibration curves.
• D. Switch to a different assay without recalibration.

Answer: (C)

Calibration ensures that the instrument’s response corresponds accurately to known concentrations, giving measurements that are traceable and trustworthy. When calibration criteria fail during a run, the measurements obtained up to that point cannot be relied upon, because the instrument may be giving biased or imprecise results. The correct action is to recalibrate the instrument and re-establish calibration curves. This involves preparing fresh calibration standards, running them, and verifying that the calibration curve meets all acceptance criteria for linearity, accuracy, and precision, with back-calculated concentrations within the defined limits. After achieving a satisfactory calibration, re-run the affected samples (or the entire batch), re-check quality control materials, and document the deviation and corrective steps taken. If the calibration continues to fail, escalate for instrument maintenance or method review. Other options fall short because ignoring the failed calibration allows invalid data to enter results; quarantining and discarding data is not the immediate or preferred fix when recalibration can restore validity; switching to a different assay without recalibration ignores the need to establish a proper calibration for that method.

Calibration ensures that the instrument’s response corresponds accurately to known concentrations, giving measurements that are traceable and trustworthy. When calibration criteria fail during a run, the measurements obtained up to that point cannot be relied upon, because the instrument may be giving biased or imprecise results.

The correct action is to recalibrate the instrument and re-establish calibration curves. This involves preparing fresh calibration standards, running them, and verifying that the calibration curve meets all acceptance criteria for linearity, accuracy, and precision, with back-calculated concentrations within the defined limits. After achieving a satisfactory calibration, re-run the affected samples (or the entire batch), re-check quality control materials, and document the deviation and corrective steps taken. If the calibration continues to fail, escalate for instrument maintenance or method review.

Other options fall short because ignoring the failed calibration allows invalid data to enter results; quarantining and discarding data is not the immediate or preferred fix when recalibration can restore validity; switching to a different assay without recalibration ignores the need to establish a proper calibration for that method.