QA/QC Approaches: An Instrument Manufacturer's Perspective

Oral Presentation

Prepared by C. Russo, N. Klinkhammer, G. Klinkhammer
ZAPS Technologies Inc., 4314 SW Research Way, Corvallis, OR, 97333, United States

Contact Information:; 541-207-1122


A major challenge facing online monitors and their use in compliance monitoring is defining where to draw the line between Quality Assurance (control of process; QA) and Quality Control (control of product; QC). This definitional challenge is amplified for the case of online monitors because the quantity of data generated and the rate at which it is generated are both very high, and the data being produced is often presented in a finalized form. The full benefit derived from the continuous nature of online monitors is only achieved when the data they produce are able to be used in real-time to help optimize process control, an aspect that precludes the need for continuous offline post-processing. In addition, the increasingly large data sets produced as online monitor networks grow become less manageable if they require large amounts of post processing. In order to fully benefit from the advances offered by online monitors, QA/QC procedures that govern their use should focus on maximizing the continuous nature of the data sets they produce while minimizing the need for post processing corrective action.

Here we present several real-world examples of automated approaches that can be used to evaluate the quality of continuous data as it is being generated. Real-time evaluation of continuous data can be used to identify, flag, or alert when data aberrations occur, simplifying data quality review. Building on these examples, we then demonstrate how automated tasks or calibrations can be used to generate complementary data sets designed to report diagnostic indicators of an instrument’s overall performance and maintenance records. Lastly, we present a few possibilities of how the different approaches discussed can be combined to create easily interpreted summaries for use in a QA/QC compliance audit.