We suspect that one of our batch is impacted by a drying problem in the production line. We would like to verify if the residual humidity of this batch is similar to others batches (not significantly higher than their humidity level). I am thinking about 2 options:
- The first option is to use the actual control chart established by historical batches for continuous process validation. We will conclude that our batch is not impacted if the its value falls within the control limits. In that case, only 5 units will be measured for the batch (each point of the actual CC is the average value of 5 random units of a batch).
- The second option is to build a new control chart from this batch by using 30 random units for example. Based on the control limits of this chart, I can check if the Out-of-spec risk is low or not.