Part d states: "perform first off/last off part validation, as applicable; where appropriate, first-off-part should be retained for comparison with the last-off-parts; where appropriate, last-off-parts should be retained for comparison with first-off-parts in subsequent runs
My question: how do we define applicable and appropriate in this clause? For example: we may run a job today that we don't run again for a year. Or, we may run a job today and all of the perishable tooling (and therefore the set-up) will be used up and require a new set of tools for the next run. Is it OK to take the stance that our variable job schedule and reliance on perishable tooling make it inappropriate to compare the last-off-piece to the subsequent first-off piece? How are other companies handling keeping and tracking these last-off pieces if they have long periods of time between jobs?
The criteria for appropriateness is whether is reasonable and whether it will provide some value to the quality control of the product. In the case you've stated, in my opinion, it wont be appropriate so you don't have to perform first off/last off part validation.
The second criteria is the customer requirement. If the customer requires it, you have to do it, whether it is reasonable or not.