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 Batch Genealogy
Admins can configure Batch Disposition Check Requirements to use Include Genealogy, which ensures that Vault monitors the Quality Events, Documents, and Batch Dispositions related to any batch used to make a dispositioned batch. 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.
Check By Exception Genealogy
The By Exception Genealogy 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 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 Include 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.
Include Genealogy Source Data
Using Include Genealogy when you perform a Batch Disposition Check requires using the batch’s as-built or as-designed bill of materials (BOM), with the as-designed BOM being used when the as-built BOM is not available. The as-built BOM is managed using Related Batch records, and the as-designed BOM is managed using Related Material records. Using the as-designed BOM is valuable when you are monitoring Change Controls that are related to Materials, without requiring the Full Batch Genealogy. Using Include Genealogy By Exception is not supported when you are using the as-designed BOM. When you use the as-built BOM, set the Relationship Type field on the Related Material record to BOM.
When you execute the Generate Material Genealogy action on Material records, Vault also automatically creates Material Genealogy records, which establishes a relationship between the Material record and all of the materials used to make it. Any time a Related Material is updated, the Material Genealogy record is updated as well.
Material Genealogy Configuration
Admins can configure the Generate Material Genealogy action on the Material (material__v) object lifecycle.
Batch Disposition Check Status
To help improve reporting on Batch Dispositions and Batch Disposition Checks, the following boolean fields are available:
- Item State Roll-up: This field is set True when all items on a Batch Disposition Check are Closed.
- Check Decision Roll-up: This field is set to True when all check decisions on a Batch Disposition are Compliant.
- Check State Roll-up: This field is set to True when all Batch Decision Checks on a Batch Disposition are Complete.
These fields provide visibility to the Batch Disposition Check status when users run a Batch Disposition Report or review the Batch Disposition Checks in the Batch Disposition list view.
Change Control Check
The Change Control Check monitors approved and implemented Change Controls related to a batch or its material for an impacted organization. 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.
By default, 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. To configure which states should be monitored instead of the default, select the state types in the Change Control Check Requirement Change Control State field. If impacted organizations are selected on the Change Control, Vault monitors the impacted organization only if the batch was manufactured by the organization. If no impacted organizations are associated with the Change Control, Vault then monitors batches manufactured at any organization. A trigger on the Change Control 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.