Can anyone tell me the proper process for a make to order job on a lot tracked part?
Do you have to make the lot once you start the customer shipment or are you supposed to do it somewhere before that?
Our process is typically: run the job (the operators mark operation as complete), and then create the pack and ship from job. At that point it asks for a lot, do you create it there?
As a contract manufacturer (Job Shop), medical devices make up the majority of our make to order jobs. Due to the regulations regarding traceability, Lot numbers are an important part of the process. We have all of our customer parts and materials for these jobs set up in the Part Master as Lot Tracked.
When material is received into Epicor the lot number is entered. It is then issued to the job by lot.
Upon completion of the Jobs we then enter the Lot Number of the finished part when shipping. This Lot Number varies by customer (sometimes defined on their PO, a combination of PO/Line #, etc…).
We have been through dozens of audits (including FDA) and this has been sufficient to meet the Traceability requirements.
Sounds like you are already doing it the same. So I think you should be good to go. Hope this helps.
Having come from the MD world myself, we had the same issue with serial numbers. That process is a little different if you ever have to do a make to order job. There you have to assign the serial numbers on the job so the serial numbers will be available to ship. It was nice when you utilize masking, it became part of the process to create the job, assign the serial numbers, and then print the traveler which had the serial numbers on it. That way the assembly team would know what they were working with before starting.