If you are setting up a surface treatment system to integrate into a mfg. process, and that system improves adhesion between plastic and an adhesive, what's a more appropriate requirement during IQ OQ PQ to establish as acceptance criteria that the system is working correctly?
a) the surface energy/cleanliness- either improved, changed, or met an expected value
b) a destructive test of the final product (after being treated, assembled, glued and cured)
The larger question in this specific example, is when you validate a specific system (equipment, station, etc.) do you book end its performance (option A) or do you expand into the larger process and tie the validation of your system into the overall outcome (option B)?
a) the surface energy/cleanliness- either improved, changed, or met an expected value
b) a destructive test of the final product (after being treated, assembled, glued and cured)
The larger question in this specific example, is when you validate a specific system (equipment, station, etc.) do you book end its performance (option A) or do you expand into the larger process and tie the validation of your system into the overall outcome (option B)?
