Calibration Verification/Linearity System
Trouble Shooting Guide

AUDIT® MicroControls™ recommends the following checklist if your initial calibration verification fails for any specific analyte or analytes:

1. Quality Control Material

  • Are there patterns among controls (e.g. all are below the mean, all are above the mean)?
  • Are there any noticeable trends or shift over time?
  • How is the accuracy and precision?

2. Acceptable Range

  • Re-examine your laboratory’s determination of the acceptable range for calibration
    verification material.
  • What is your laboratory’s current range around the expected target value for that specific analyte
    in question?

3. Reagent Changes

  • Have there been any changes to your reagent?
  • New lot of reagent?
  • Different manufacturer?
  • New formulation of current reagent (check package insert)?

4. Instrument Maintenance Logs

  • Review daily, weekly, monthly, quarterly, semi-annual and annual logs for any deviations or changes.

5. Environmental

  • Has the instrument been moved recently?
  • Any changes to the environment of the instrument and its surroundings?

6. Servicing

  • Has the instrument been serviced recently?
  • Any software or hardware upgrades or changes?

7. Operation

  • Are there new instrument operators?
  • Any recent modification to the technique in how the assay is run?

8. Comparative Method

  • Is there another nearby laboratory that can also run the calibration verification material to compare results?
  • If all the above has been performed, and there are still problems, re-calibrate the instrument.
  • If the instrument still does not perform within laboratory control limits, call the instrument
    manufacturer for further troubleshooting.


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