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

Any takers?

When you say 'lathing', are you referring to turning? i.e. turned parts made on a lathe.

If so, are we talking centre lathes, turret, capstan etc (you mentioned a manual process) or automatic lathes? If auto, what type of controls are used?

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


hiiiiiiiiii

the ISO 9001 says that the need for the process validation arises where the product can not be verified by susbsequent monitoring or measurement & the defects become apparent only when product is in use. So it is not mandatory but if u r ina TS org. setup qualification & process - re validation is mandatory for all the processes.

one more thing is that validating a machine on basis of rpm, feed cutting vel. ( manual process) is foolishness.