Dear All:
Im about to validate an automatic ampoule inspection machine. Right now I have all the data from the manual method, and Im about to inspect the Knapp set in the machine, you know, pass the knappten times and compare results.
But until that, to allow the start of the inspection proccess, quality control asks production to create a knapp set of 50 pieces (30 bad, 20 good) from that same lot that is going to get inspected, and then the set gets inspected ten times in each module of the machine (wich has 2 modules).
After validation is complete, I would see this starting proccess as a waste of time. Of course that you must prove that the validated parámeters are still stable, but im unsure of how many times you have to inspect a set and of how many pieces. Since it is just a verification, it should be less strict than a validation, but with enough data to back it.
On a previous job, the starting proccess was inspecting 10 bad ampoules 3 times and with the machine rejecting all of them. Is that enough? Do you have any info on that?.
Many thanks in advance.