The document describes a process for sterilizing medical devices using outside processing. Products are loaded onto pallets which are then batched into loads and sent for sterilization. A quality plan tracks each pallet and load. A purchase order is created for the entire load which is pro-rated across individual products. Upon receipt, products enter a hold area until sterilization certification allows their release.

1. Sterilization processing using Oracle Outside Processing
High level characteristics
The process of 'Sterilization' is often used in the Medical Device Industry and consists of a specialized
outside service that is performed on a load basis. A product is optional in the same state before and after
sterilization, however the commercial characteristics are very different, including regulated transactions
that can be done with these products. The manufacturing process is typically completed, but the
product cannot be sold in this state. The lead-time to perform the sterilization process is often 5 days or
longer and is significant in planning and ATP-calculations.
Many workarounds are used, including:
• a different lot 'state' (disadvantage is there is no lead-time connected to a 'state')
• different item numbers (disadvantage is the effort to transform the non-sterile into a sterile item
number while under lot traceability)
• same item in a different non-reservable sub-inventory (disadvantage again is the lack of lead-
time)
• outside processing (disadvantage is the extra transactions necessary due to the batching logic as
well as traceability to the load in case of recalls)
The developed process, is an extension of the outside processing alternative, with added features to
control the pallets and the loads using quality plans.
During the final assembly, the discrete jobs are loaded onto a pallet and registered as such. Once the
pallet is complete, the paperwork for the pallet is printed. The pallets are batched into a load and
transacted while loading. The load will go out on one purchase order at a price of the complete load.
The individual discrete jobs are charged by prorating the purchase order price across the purchase order
lines. Once received, the product goes into a hold area until the sterilization certificates indicate it is
allowed to release the product for further transactions.
The total solution consists of:
• Outside Processing Move transactions resulting in Quality Plan entry (Pallet Plan)
• Printing of Pallet reports (multiple jobs on one pallet)
• Transaction of pallets to create a sterile load (Load Plan)
• Printing of Load reports
• Creation of the purchase order for the load
• Receipt/Inspection/Delivery of the purchase order (standard process)
• Standard PO-Invoice matching process
• Sterile Load Put-Away report to support warehouse delivery transaction
• Reconciliation reports
• Status reports
• Status inquiries from various standard forms to show the sterile load status (sent, received,
released by quality)
Note that this process can also be applied to other batch oriented manufacturing that are considered an
outside service, like heat treatment, radiation or testing.

2. Process Steps
Mandatory Collection Plan is added to the OSP Department containing the Sterilization resources.
Quality plan requires the following entries:
• Pallet Number (selected for existing pallets or the next number is generated)
• Barcode from the product (box contents, expiration and lot number barcode)
• Number of boxes placed on pallet
• Pallet complete indicator (default value is 'No')

3. All additional field are defaulted or loaded from the discrete job:
The Sterile Pallet Quality Plan collects all data related to the pallet and will be updated through
concurrent requests after each process step. A separate inquiry folder is created to show the pallet status
fields for information.

4. Completion of the pallet will print the pallet sheet and pallet placer.

5. The pallets that are loaded into the load can be scanned using Mobile Supply Chain or through the
standard Quality Entry form. Additional features are added to include 'Dunnage' to fill a load. Once the
pallet is scanned, a label will be printed with the load number.

6. The Purchase Order can now be prepared in the Purchase Order Autocreate form:
The Purchase Order is created using the Sourcing Rules and Approved Supplier List features. It will
default the current supplier and generate the purchase order. The Load Price is derived from the Item
Organization attributes and pro-rated over all lines on the purchase order.
Additional charges for testing will be added in Accounts Payables during invoice matching. If known
ahead of time, these charges can be manually added to the Purchase Order.

7. The standard Purchase Order approvals will be used to create and print the purchase order (if needed).
The status of the Sterile Pallet can be monitored through an inquiry:
This inquiry can be made available from many places within the standard applications through a zoom
capability. An example is from the Item Workbench (Custom Inquiry Form), using 'Tools'.
The receiving process is the same as regular receiving, but can be tailored to add features as necessary.
These features can include quality requirements and receiving reports.