Partial Shipping of Lots - Shipping of product prior to the lot being completed

[TNHunter]

I question has arisen in our organization about shipping of product prior to the lot being completed.

We recently started producing lots in excess of 30,000 pieces. Upper management has done this to reduce the number of work orders on the shop floor. The customer may want 3000 of these parts prior to the 30,000 being completed, so 3000 pieces are pushed through and shipped even though it may be 2 -3 weeks before the work order is completed.

Would the customer have to grant a concession to accept product given the above?

How would traceability be effected by this? How much traceability is required, Not defined in ISO? Can we define how much traceability is required or should the customer define it?

I have used break off travelers previously to allow for this with traceability back to the original work order, effectively making this a sublot.

Any thoughts would be appreciated.

[LSS Master]

It seems to me that there are several issues involved.
First and most importantly, what information/requirements regarding this issue does the contract (PO, order, etc.) from the customer contain? If there are requirements regarding shipping of partial orders and traceability, they must be followed/satisfied.

In the absence of contract requirements, ISO requires that the producer maintain traceability throughout the production process, including delivery to the customer ("delivery" should be defined in the contract requirements). The method used is up to the producer to define.

From a Lean manufacturing perspective, fewer work orders through the shop may result in higher inventories. Has anyone performed a cost/benefit analysis to determine which path produces the higher savings?

I hope you find this to be of use!

[Golfman25]

Everyday fact of life where I come from. And you certainly don't want to hold a shipment waiting for additional parts to work their way through.

Walk thru your system and make sure you are covering each step for the partial shipments. For example, if you have a final inspection, make sure you apply it to the partial shipment as well as the balance. Apply your traceability requirements to the partial shipment as well as to the balance. Exactly what you do and how you keep records will be dependent upon your system requirements. Good luck.

[gholland]

What does your Quality Manual say? That's the first question you would be asked. If you don't have a process for partial lots established then you're not following your procedures and you're exposed to audit findings. If I were forced I would document in your traceability system that you didn't follow your procedures intentionally, rationalize why it's ok, and start a Corrective Action to establish a procedure.

Otherwise Golfman25 has it. If I were asked to do this and change my company's QM procedure I would require a subset of in-process and lot acceptance testing be performed based on lot size. I would also establish traceability to make sure if there was an issue found later in the large lot that you have some way of tracking this smaller lot so you can recall it.

Good luck

[TurtleD]

Hi. A company that I used to work for got "dinged" in an ISO audit for partial shipments so we opted to reference partials in multiple procedures (as applicable) ... this is an excerpt from the Device History Record procedure:
Release prior to completed work ticket
In the event product from a work ticket must be shipped to customer prior to completion of work ticket, the following process is to be used:
Finished product must be inspected by Manufacturing and Quality (or their designee)
Product’s container is stamped “QC” or “Approved”
Work Ticket is stamped with: Partial Release Approved (or equivalent) and signed/dated by Manufacturing & Quality or their designee
Lot Tracking log is filled in with necessary ship to information (may include customer’s PO number or HM’s invoice number)
Remainder of work ticket’s product is completed following 4.6 – 4.9