Batch Disposition Checks are logical units of work that need to be completed before a usage decision can be 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
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 review all Quality Events associated with the batches used to create a batch, setting Include Genealogy? to By Exception avoids rechecking any of these types of items that have already been checked and released. The By Exception Genealogy check surfaces only latent Deviations or Quality Events associated with batches that were automatically dispositioned and not checked.
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.
Release Exception Decisions
When Include Genealogy? is set to By Exception, users can select Release Exception Decisions. When a disposition decision matches the Release Exception Decision, Vault does not create a related Batch Disposition Item, preventing users from needing to review items that were previously reviewed and accepted.
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.
Bill of Materials Check
You can check a batch’s as-built genealogy against its as-designed BOM to ensure that they match. This ensures that manufacturers produce a product to specification, such as ensuring that the correct and latest artwork, labels, packaging, and instructions are included. If you add a Bill of Materials check to a Batch Disposition Plan, the system creates Batch Disposition Items for any discrepancies between the batch genealogy and the BOM, such as a Material missing from either, in the Batch Disposition. A trigger on the Related Material record and the Batch Genealogy record will create and close the Batch Disposition Items when the discrepancies are discovered or resolved due to BOM changes.
Bill of Materials Check Configuration
To configure the Bills of Materials check, add the Bill of Materials Check (bill_of_materials_check__v) object type to the Batch Disposition Check Requirement and Batch Disposition Check objects.
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.
Deviation, Complaint, & Lab Investigation Checks
The Deviation, Complaint, and Lab Investigation checks monitor all Deviations, Complaints, or Lab Investigations in all states related directly to the individual batch or, when the Include Genealogy field value is Full, all batches in the genealogy. The By Exception option is useful for these check types if you only want to surface records that were not reviewed in a prior Disposition.
Disposition Check
The Disposition check monitors the state of related Batch Dispositions to ensure compliance before a batch can move forward. The check includes batches that were consumed to create this batch, as well as the disposition status of related target batches that rely on this batch’s status before they can be released.
Document Check
The Document check monitors certificates, batch records, and other documents that need to be reviewed and completed.
Manual Check
You can select the Regular and Market Specific Check Behavior options to create either general or market specific checks for market-ship decisions.
Qualification Check
Materials used to make a Finished Product are often qualified for use in specific finished material products for specific markets. The Qualification check ensures that only qualified suppliers and manufacturers are used when creating a batch by surfacing Qualification records at the specified lifecycle state, or when they are not found.
You can select the following Check Behavior options on Qualification checks:
- Regular: Ensures that Approved Suppliers were used during batch creation. Choose this option when Approved Suppliers are driven internally and can be used in the creation of any product.
- Finished Material: Ensures that Approved Suppliers were used and approved for a Finished Material. Choose this option when approvals are product or Finished Material specific.
- Market: Ensures that Approved Suppliers were used and Approved for a specific market. Choose this option when approvals are market specific.
- Finished Material & Market: Ensures that Approved Suppliers were used for a Finished Material and Market. Choose this option when approvals are both Finished Material and market specific.
Qualification Check - Configuration
To configure the Qualification check, add the Qualified Markets and Qualified Finished Materials sections to the Supplier Qualifications page layout.
Regulatory Check
The Regulatory check monitors market approvals for Change Controls affecting materials and products used to make a finished product batch for market-ship decisions.
You can select the following Check Behavior options on Regulatory checks:
- Market Specific: Vault creates Disposition Items when the market ship decision matches a market on the Change Control’s Regulatory Activity Item. Choose this option to evaluate impacted markets for Materials on a Change Control.
- Finished Material: Vault creates Disposition Items when the batch includes a Finished Material. Choose this option to evaluate impacted finished materials.
- Finished Material & Market Specific: The default setting, which evaluates approvals for impacted markets on impacted finished materials.
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.
Batch Disposition Check Settings
The table below summarizes the available settings for each type of Check.
| Check Type | Monitored State | Check Behavior | Item Behavior | Include Genealogy & Release Exception Decision | Allow Add Document |
|---|---|---|---|---|---|
| Bill of Materials | X | N/A** | |||
| Change Control | X | X | X | ||
| Deviation, Lab Investigation, Complaint | X | X | |||
| Disposition | X* | Regular, Market Specific | X | X | |
| Document | Regular, Market Specific | X | X | X | |
| Manual | Regular, Market Specific | X | |||
| Qualification | X | Regular, Market Specific, Finished Material | X | X | |
| Regulatory | X | Market Specific, Finished Material | X | X |
* No Record Found only
** Vault always includes Full Genealogy
Monitored State
This setting allows Admins to configure Check Requirements to monitor specific lifecycle states of the related object. If users select No Record Found, Vault creates a Disposition Item when no record is found in the specified monitored states. Since Disposition Checks monitor all states by default, No Record Found is the only option available.
Check Behavior
This setting controls the behavior of Check Requirements when included in market-ship decisions:
- Regular: Vault creates a general, non-market specific Check.
- Market Specific: Vault creates market specific Checks that monitor related records for those markets.
- Finished Material: Vault creates a general check to evaluate finished materials on the related record.
- Finished Material & Market Specific: Vault creates market specific Checks that monitor approvals for markets on finished materials.
Item Behavior
This setting controls whether users can manually close Disposition Items in Checks:
- Automatic Only: Default behavior
- Automatic & Manual: Allows users to close items manually
Include Genealogy & Release Exception Decision
This setting controls whether a Check can evaluate a batch’s genealogy and, if so, how:
- No: Surfaces records related to the target batch (default behavior)
- Full: Surfaces records related to any batch used to make the target batch
- By Exception: Surfaces records related to any batch used to make the target batch that were not evaluated and accepted in a prior disposition in the target batches genealogy
- Release Exception Decision: Sets the acceptable Disposition Decision for By Exception evaluation. Decisions selected here are considered Acceptable. This setting does not surface records Disposition Items.
- Full - Material: Surfaces records related to any material used to make the target batch. This is useful when evaluating Changes or Qualifications where the batch genealogy is unavailable. Users cannot filter on batch manufacturing sites when they select this option.
Allow Add Document
This Document Check setting controls whether users can add documents manually.