Eralp DOGU, Northeastern University, Boston, MA, USA

Joint work with Sara Taheri and Olga Vitek

New extension of MSstats implements Statistical Process Control (SPC) tools to monitor LC-MS/MS process performance by tracking system suitability metrics such as peak area, retention time, full width at half maximum (FWHM) and full width at base (FWB). This toolset is essentially an introduction of simultaneous monitoring methods for metric-wise mean and dispersion and significantly improves the ability to detect special causes of variation earlier, therefore, reduces cost of control and cost of failure.

Our approach presents alternative methods of monitoring such as time weighted control charts to ensure that various types of process disturbances are detected effectively. Simultaneous control charts used in this framework can be classified into two groups: individual-moving range (ZmR) control charts and mean and dispersion cumulative sum (CUSUM) control charts. Experiment specific control limits are provided with the control charts to distinguish between random noise and systematic error. Case study results include comparisons for the widely used Levey-Jennings plots and reveal that our approach significantly increases the detection performance. The approach introduced here can be applied in a diverse range of QC metrics for system suitability analysis.