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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