Litware Medical: Subcontracted Sterilization, Quality Holds, and Recall Traceability
Litware Medical assembles sterile procedure kits and subcontracts gamma sterilization to one vendor. Components are shipped to the vendor, sterilized, and returned as serialized finished kits. Quality requires incoming inspection on every returned lot, and batch disposition status must be 'Unavailable' until the quality order is closed. Last month a lot was released to sales before the quality result, and a recall showed that blocked kits could still be reserved. The subcontracting BOM lists the vendor's sterilization service as a normal component, and the route has no vendor operation. Serial numbers are recorded only at shipment, not at receipt from the vendor. Litware also wants vendors to see purchase order status and confirm delivery dates, and needs traceability from sterilized kit back to the vendor lot and component serials.
1. How should subcontracting be configured for sterilization, including BOM and route, so that component issues and the vendor service are tracked?
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Model sterilization as a subcontract operation, not as a normal material. Create a resource of type Vendor with the vendor's calendar and lead time, and assign it to the sterilization route operation. Add a service item for the sterilization service so the production order can generate a purchase order for the vendor. In the BOM, keep Litware-supplied components as normal lines; add any material supplied by the vendor, such as a sterile bag, as a line of type Vendor so it is not issued from Litware inventory. Set the production order's subcontracting parameter so the purchase order is created and the components are shipped to the vendor. The current setup fails because a normal component line implies Litware owns and issues the service, which cannot be inventoried or costed correctly, and the missing vendor operation means no external capacity or purchase commitment. Test with one lot and trace the vendor purchase order, component shipment, and returned kit.
2. Which quality and batch disposition settings ensure returned kits cannot be reserved or shipped before approval?
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Create a quality association that applies to the returned kits by item and vendor, with the quality order generated on receipt. Create a batch disposition master with a status such as Unavailable or Quarantine, and set that status to block reservations and inventory issue transactions. Assign the disposition as the default on the item or on the receipt, so returned lots start blocked. Close the quality order only after inspection, then change the batch disposition to the released status. The recall happened because a status label alone does not block transactions; the blocking flags on the disposition must be enabled, and users must not be able to override them. Also check that the inventory status is not left as Available and that sales order reservation respects the disposition. Test by trying to reserve a blocked lot; the system should reject it.
3. What must change so serial numbers are captured at vendor receipt and visible for recall, and how should vendor confirmation be enabled?
Read the worked answer
Activate serial tracking in the tracking dimension group on the finished kit and register serial numbers at receipt of the subcontract purchase order, not only at shipment. That creates the genealogy link from the returned sterilized kit to the vendor lot and to the component serials issued to the vendor. Configure vendor collaboration so the vendor can view purchase order status and confirm delivery dates; set up the vendor collaboration user roles and the purchase order confirmation workflow. Use the vendor's confirmation to update the expected return date, and keep the quality order linked to the receipt. The reasoning is that recall traceability depends on capturing identity at the point of receipt; later capture leaves a gap. Test a mock recall by selecting a finished kit serial and tracing back through the subcontract purchase order to the vendor lot and component serials.