EffiValidation 3.0 is a compliance-ready ISO 17025 and GxP laboratory software.

Control Chart

A chart on which observations are plotted as ordinates in the order in which they are obtained and on which control lines are constructed to indicate whether the population from which the observations are being drawn is remaining the same. Control charts are used especially in industrial quality control.

ISO 17025:2005, chapter 5.9.1 states:
The laboratory shall have quality control procedures for monitoring the validity of tests and calibrations undertaken. The resulting data shall be recorded in such a way that trends are detectable and, where practicable, statistical techniques shall be applied to the reviewing of the results. This monitoring shall be planned and reviewed and may include, but not be limited to, the following:

  1. regular use of certified reference materials and/or internal quality control using secondary reference materials;
  2. participation in interlaboratory comparison or proficiency-testing programmes;
  3. replicate tests or calibrations using the same or different methods;
  4. retesting or recalibration of retained items;
  5. correlation of results for different characteristics of an item.

EffiValidation 3.0: Example of a Control Chart – example from the ISO 8258 standard

Control charts.jpg