Identify Possible QC Procedures
Consider and include the following components in any QC procedure design:
- The QC materials to use (see "Identify Appropriate QC Materials").
- The number of control samples to analyze with each run.
- The distribution of the control samples within the run (for example, at the beginning, in the middle, at the end, or distributed throughout the run).
- The statistical process control (SPC) rules to apply to optimize the QC process while reducing false errors.
Consider the following when making decisions about how to apply these components to the QC procedure:
- The quality required for the testing procedure.
- The anticipated instability of the testing procedure (for example, the type, size and frequency of the errors).
- The practicality of the QC procedure working the laboratory.
The optional Westgard Advisor™ online module is an excellent tool for assisting in the design of QC procedures. While considering the selected quality specifications, Westgard Advisor™ online makes recommendations as to the SPC rules to apply and the number of control samples to run. See "Westgard Advisor™ online" for more information.