An assessment of pipette calibration stability using statistical process control charts
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Routine pipette calibration is an essential part of any quality assurance and quality control program in the forensic sciences and beyond. Pipette calibration standards in a forensic laboratory are typically set to the limits outlined by the document ISO8655, published by the International Organization for Standardization for the general scientific community. Alternative methods exist that may be capable of monitoring pipette stability across time in a forensic setting. Statistical process control charts, or Shewhart charts, are one such form of process control, which is being investigated for its potential application to pipette calibration monitoring for forensic DNA laboratories. Indeed, the application of process control lines for monitoring the calibration of volumetric equipment is not without precedent.1 To investigate the applicability of process control charts for monitoring pipette stability, a series of X ̅ and S charts, a type of Shewhart chart, have been produced from eight years of collected calibration data. A total of 71 pipettes of the following sizes were examined: 1-10 µL, 1-10 µL multi-channel, 10-100 µL, 100-1000 µL, 1-3 µL, 30-300 µL, 5-50 µL, 5-50 µL multi-channel, and 500-5000 µL pipettes. The ISO8655 calibration recommended volume limits of these pipettes have been added to the charts for the purposes of comparison. With these charts, it is possible to assess pipette performance over time in comparison to the ISO8655 calibration standards and to the control limits imposed by the Shewhart charts. The completed charts suggest that the methodology proposed by Shewhart shows promise as a supplement to ISO8655 recommendations for monitoring pipette stability across time. To corroborate the value of using Shewhart charts to monitor pipette performance, a serial dilution study in conjunction with a series of simulations with dynamic modeling software was performed. This dilution study investigated whether the systematic biases shown by the Shewhart charts could be measured in a laboratory setting. The simulations investigated multiple hypothetical pipetting scenarios concerning various levels of systematic bias. The simulations consistently corroborated the value of Shewhart charts to enforce better compliance between a pipette’s nominal and actual volume delivery, while the serial dilution study offered partial evidence of systematic pipetting bias.