If calibration curve acceptance criteria are not met, what is the next step?

• A. Proceed with the current data and report results.
• B. Discontinue testing for the batch.
• C. Recalibrate the instrument and re-establish calibration curves.
• D. Replace all samples with fresh aliquots.

Answer: (C)

Calibration curves link instrument response to known concentrations and must meet predefined acceptance criteria to ensure accuracy and reliability. If those criteria aren’t met, the data from the current run can’t be trusted, so you don’t rely on them. The next step is to recalibrate the instrument and re-establish the calibration curves, using fresh standards and validated procedures, and often re-check system suitability and run quality control samples to confirm the method again meets criteria. This process addresses potential drift, instability, or degradation that caused the failure, ensuring the relationship between signal and concentration is accurate once more. Only after a successful recalibration and confirmation of acceptance criteria should you re-analyze samples from the batch. Replacing samples or proceeding with unverified data wouldn’t fix the calibration issue.