Assignment Task:
After discussing the calibration procedure with the tech who performed it, it was discovered that during the initial calibration, the instrument ran out of reagents and the calibration had to be reinitiated. Before restarting, the tech noticed that the calibrator was running low. They opened a new vial and restarted the calibration process. When checking the fridge to confirm the calibrator lot number, it was found that the tech opened a new vial from a different lot and the new lot information had not been updated in the instrument settings. The target value for the new lot was significantly lower than the previous lot of calibrator so it shifted all results to be falsely high.
QC is typically run after calibration and every 8 hours per SOP. When QC for the last 24 hours was reviewed, it was found that QC had failed multiple times each time it was run but it was repeated multiple times until it came into an acceptable range. No troubleshooting was performed at the time of QC.
Implement corrective/preventive action. Want Online Help?
Once the action plan is established, it should be implemented strictly according to the steps in the plan to correct the problem.
This step needs to be thoroughly documented and recorded, so that its effectiveness can be gauged. Ideally, this record should be stored centrally in a cloud-based system so it can be accessed in real-time by the necessary personnel.