A
Adam S
Let me start this by clarifying that I am no lathing engineer; I have very limited technical knowledge of lathing as a process.
I'm looking for any input into how members would approach process validation of such a manual process? Does every tool change or set-up adjustment change the process sufficiently to cancel any (other than IQ) validation work previously performed? It's not practical to expect a qualification of every set-up change, is it? Or could the basic checks that the setters perform after adjusting the lathe be defined as a qualification (a stripped down OQ)? Or is lathing a process that cannot be validated beyond IQ, requiring the output undergo verification in place of validation?
I'm not sure which path to pursue
I'm looking for any input into how members would approach process validation of such a manual process? Does every tool change or set-up adjustment change the process sufficiently to cancel any (other than IQ) validation work previously performed? It's not practical to expect a qualification of every set-up change, is it? Or could the basic checks that the setters perform after adjusting the lathe be defined as a qualification (a stripped down OQ)? Or is lathing a process that cannot be validated beyond IQ, requiring the output undergo verification in place of validation?
I'm not sure which path to pursue