Batch Disposition Checks are a logical unit of work that needs to be completed before a usage decision is made for a Batch Disposition. Batch Disposition Checks group similar Batch Disposition Items together that support the decision, such as batch documents, test results, and Quality Events.
Check for Genealogy Batches
The Genealogy Batch Disposition Check monitors the Batch Disposition Items in a target batch’s genealogy for Quality Events, Documents, and Input Batch Dispositions. This allows users to discover and address any latent deviations in the manufacturing process, check Quality Events for any automatically dispositioned batches that may have been skipped, and check the status of any manually dispositioned batches.
Users can run the Genealogy check by selecting Full, By Exception, or No from the Include Genealogy picklist. When a Batch Disposition is created, Full Genealogy Check Batch Disposition Items are created for genealogy batches when the Include Genealogy value is Full; an error message is displayed if no Genealogy records are found. Vault displays the Batch Disposition Items in the Check section and includes the related record, material, batch, title, and state. Any changes to the batch genealogy need to be assessed for new or canceled Batch Disposition Check Items.
By Exception Genealogy Check
The By Exception Genealogy Batch Disposition Check ensures that Batch Disposition Items in a batch’s genealogy are not rechecked if the item already has been checked for a previously closed and approved Batch Disposition. While the standard Genealogy Batch Disposition Check allows users to address latent deviations and automatically dispositioned batches, the By Exception Genealogy check avoids rechecking any of these types of items that have already been checked and released. The By Exception Genealogy check also allows users to monitor Batch Dispositions that have been approved conditionally for use and check the last Batch Disposition at any level in the batch genealogy without creating Batch Disposition Items for all of the Batch Dispositions in the genealogy.
Users can run the By Exception Genealogy check by selecting By Exception from the Include Genealogy picklist.
Genealogy Check Configuration
Complete the following steps to configure the Genealogy Batch Disposition Check:
- Configure the Include Genealogy (
batch_disposition_check_requirement__v.include_genealogy__v) picklist field, and add the values of Full, By Exception, and No to the picklist. - Add the Include Genealogy field to the standard layout for all Batch Disposition Check types.
- Configure the Materials (
disposition_check_item__v.material__v) lookup field to display Batch Disposition Check Items in the Check section.
Change Control Check for Materials
The Change Control - Material Batch Disposition Check monitors approved and implemented Change Controls related to the batch’s materials. This ensures that all changes related to a batch’s materials and its batch genealogy are reviewed before users make a disposition decision for the batch.
This check creates Batch Disposition Check Items for all Change Controls in the Approved state type related to a batch’s material, including the materials in the batch genealogy when appropriate. The system evaluates the Implementation Date field on the Change Control to create items for changes that were implemented before the manufacturing date of a batch. A trigger on the Change Control - Material Batch Disposition Check updates open Batch Dispositions when records are created or updated. The standard Change Control Batch Disposition Check will continue to monitor Change Controls related to batches.
Change Control Check - Materials Configuration
To configure the Change Control - Material Batch Disposition Check, configure the Material (disposition_check_item__v.material) object relationship field to store the related material.
Change Control Implementation Date
During a Batch Disposition, users can review Change Controls implemented before the Batch Manufacturing Date to avoid reviewing changes that do not affect the batch. Users can record the Implementation Date of the change on the Change Control so that the Implementation Date can be evaluated against the Batch Manufacturing Date when Batch Disposition Check Items are created for Change Controls.
Activate the Implementation Date field (implementation_date__v) on Quality Events and Change Controls, and make it available for the Quality Event Change Control type.