I’m not sure of your question. IQ, OQ PQ is done to validate a process not parts as they are manufactured.
IQ, OQ, PQ are independent of manufacturing volume or even in some instances the type of process. Have I misunderstood your question?
IQ, OQ, PQ are independent of manufacturing volume or even in some instances the type of process. Have I misunderstood your question?
For machine tool such as lathe etc, you can perform process capability studies wherein by statistical methods you can assess if the machine tool and its combination of the tool, material and the method (including the person) is capable of giving outputs within the required tolerances. You will still continue to measure the output part once it has been taken off the lathe.
You will appreciate that process validation is more meaningful in situations where the resulting output cannot be verified by subsequent monitoring or measurement, due to which deficiencies become apparent when the product is in use.
You will appreciate that process validation is more meaningful in situations where the resulting output cannot be verified by subsequent monitoring or measurement, due to which deficiencies become apparent when the product is in use.
Typically: The process of individually hand-crafting parts is not subject to validation because it relies on 100% inspection of manufactured parts (and thus does not require validation).
There will almost certainly be elements of an IQ that would provide value to the shop, and if you want to implement meaningful control plans, you will tend to move away from hand-crafting towards a process that lends itself to process validation.
There will almost certainly be elements of an IQ that would provide value to the shop, and if you want to implement meaningful control plans, you will tend to move away from hand-crafting towards a process that lends itself to process validation.