When a quality order is associated with a test group having trend control parameters defined, Life Sciences Quality Control & Assurance automatically compares the test results against the specifications (warning limits and action limits) and allows to calculate the trend.
Upon quality order generation, the values of the corridors are automatically calculated according to the trend control parameters.
Whenever entering a test result, the status of the trend for the entered result is displayed in the Quality order line results form. The trend legend is as follows:
Trend | When |
|---|---|
Within trend limits | |
Out of trend limits but still within warning limits | |
Out of warning limits but still within action limits | |
Out-of-action limits | |
Trend control not active / Not enough historical data |
Starting from Life Sciences release 2026-Q1, this functionality is integrated with Microsoft’s Quick result entry form, allowing users to view the outcome of the trend control from the updated interface.
Example
The trend control parameter is enabled in the test group, and the following values are defined:
Sample size: 6
Trend sigma: 0.5
Warning sigma: 1
Action sigma: 2
The trend control cannot be calculated until there is enough historical data to evaluate the trend, warning, and action corridors. In this case, at least six completed quality orders (i.e., with results inserted and validated) must be available for the same item, same test group, same site, and different batch.
The following results have been entered for the test “Impurities” for the six available quality orders:
12 (not enough historical data to calculate the trend)
120 (not enough historical data to calculate the trend)
100 (not enough historical data to calculate the trend)
112 (not enough historical data to calculate the trend)
98 (not enough historical data to calculate the trend)
100 (enough historical data to calculate the trend)
For the sixth quality order, the following trend control data are calculated:
Trend min: 103.179
Trend max: 113.488
Warning min: 98.045
Warning max: 118.642
Action min: 87.716
Action max: 128.95
The trend color for the sixth result “100” will be blue (i.e., out of trend limits but still within warning limits).