Depends on what you’re talking about. There’s a lot of “PAT” stuff out there in pharmaceuticals that really doesn’t fit the overall bill.
If this is a PAT application where the sensors already exist, the tanks/blenders/lines are modified for them, and the methodology is validated against a standard assay, it might fit within the normal six sigma program.
If you’re looking at new technology/sensors, the lab’s not seen them before, there’s no in-house analytical expert on the technique, the equipment will have to be significantly modified, or a number of other issues, the overall project is way beyond a normal six sigma scope. Doesn’t mean you couldn’t break it up and look at the individual parts as several projects.
If you’re bumping into a regulatory issue, you’ll need QA, management, production, and Regulatory buy-in before you do much of anything. Good chance to try out those “soft” skills.
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