The application of Quality Control charts is a widely used system to ensure that valid data continue being produced and valid products continue being received/manufactured.
The basic assumption is that when a test result falls within the Warning Limit, the system is under control, and the results of the batch can be accepted. A control result beyond the Warning Limit signals that something may be wrong or is likely to go wrong, while a control result beyond the Action Limit indicates that the system is statistically out of control and that the results must be rejected. The test must then be repeated after sorting out what went wrong and correcting the system.
Life Sciences Quality Control & Assurance can automatically compare test results against the specifications and allows calculating the trend and comparing test results against the trend limits, warning limits, and action limits.
Trend control is configured in the Test groups form (Life Sciences Quality Control & Assurance > Setup > Quality control > Test groups). Upon creation of a test group, the control chart capability can be activated for each test by enabling the Trend control parameter. Users must set up the rules for the calculation of the following corridors: trend, warning, and action. When generating a quality order, Life Sciences Quality Control & Assurance automatically calculates the values of the trend for the quality results according to the rules defined by the user in the test group.