Compliance Management provides users with the ability to automatically create Quantitative Assessment records for substances of concern by determining if concentrations of restricted substances in the formula are within acceptable limits. Vault allows users to quickly determine whether a formula is compliant in specified local markets based on pre-defined mappings, allowing users to derisk product launches by assessing the right-to-sell in certain markets before initiating testing and commercialization.

You must complete all required steps in Configuring Quantitative Assessments before completing the steps in this article.

About Automatic Quantitative Assessments

Compliance Management Vaults include the Create Quantitative Assessments action on the Formulation object, which identifies any Substances in the related Formulation Concentrations that match the Substances in existing Regulatory Restrictions, including which of the substance’s concentrations exceeds the maximum allowable limit for the Formula’s intended use case. When users run the Create Quantitative Assessments action on a Formulation record, Vault suggests the applicable Quantitative Assessments for these substances of concern based on your pre-defined units of measure mappings, which allow you to define how Vault compares different units of measure. Users can then review the potential Quantitative Assessments and specify which records they want to create. When the action completes, Vault inactivates any existing Quantitative Assessments with the same Regulatory Restriction and Formulation Concentration values as the newly generated records.

For all Substances in the Formula’s related Formulation Concentrations, Vault suggests potential Quantitative Assessments for Substances with active Regulatory Restrictions that meet the following criteria:

  • The Amount field is populated.
  • The Restriction Type is “Max”.
  • The Unit maps to a corresponding value on the Formulation Concentration in either of the following ways:
    • The Unit value equals the Concentration Unit value of the Formulation Concentration.
    • An active Object Field Picklist Entry Mapping maps the Unit value to a custom unit of measure field on the Formulation Concentration.

If Vault finds multiple Regulatory Restrictions for the same Substance for different units of measure, the action only considers the most recently created Regulatory Restriction.

Configuration Overview

Configuring your Vault to use Quantitative Assessments involves the following steps:

  1. Configure object fields
  2. Map units of measure
  3. Configure the Create Quantitative Assessments action
  4. Configure user permissions

Configuring Object Fields

You must configure object fields on the Quantitative Assessment and Formulation Concentration objects to support the automatic creation of Quantitative Assessments.

Quantitative Assessment

Ensure that the Name field on the Quantitative Assessment object is system-managed.

Formulation Concentration

You must add the appropriate custom fields for units of measure to the Formulation Concentration object. These fields must be a Number type or Formula type that returns a numeric value. You can map these fields to the corresponding values in the Unit picklist.

Mapping Units of Measure

You can configure your Vault to compare different units of measure using Object Field Picklist Entry Mapping components to map the custom fields for units of measure on the Formulation Concentration object to the applicable values in the Unit picklist used in Regulatory Restriction records. Vault references these mappings when users run the Create Quantitative Assessments action and suggests potential Quantitative Assessments to create for all Substances for which applicable Regulatory Restrictions exist. For example, if your Formulation Concentrations specify Dioxane concentration in weight percentage (wt%) and your Regulatory Restrictions specify Dioxane units in parts per billion (ppb), you can map wt% to ppb so that Vault can easily compare a Formula’s Dioxane concentration to restrictions and identify which Quantitative Assessments to create for all applicable Regulated Categories.

To map concentration units of measure:

  1. Navigate to Admin > Configuration > Object Field Picklist Entry Mapping.
  2. Enter a unique Name for the mapping you are creating, such as wt_percent_ppb.
  3. For Object, select Formulation Concentration.
  4. For Field, enter the name of the custom field on the Formulation Concentration object you are mapping in “Field.[field_name__c]” format. For example, Field.wt_percent__c.
  5. Enter a unique Label for the mapping you are creating, such as “Wt Percent PPB”.
  6. For Picklist, select Unit.
  7. For Picklist Entry, enter the name of the Unit picklist value you are mapping to in “Picklistentry.[picklistentry_name__c]” format. For example, Picklistentry.ppb__c.
  8. Specify if the Object Field Picklist Entry Mapping is Active. If you select No, Vault ignores the inactive mapping.
  9. Click Save.

Object Field Picklist Entry Mappings must be unique. You cannot create multiple mappings for the same field and picklist entry combination.

Configuring the Create Quantitative Assessments Action

You must configure the Create Quantitative Assessments user action on the Formulation object to allow users to create Quantitative Assessments automatically. When users run the action on a Formula type of Formulation record, they can review a list of potential Quantitative Assessments for substances of concern on the Select the Quantitative Assessment records to create page before selecting which records to create.

About the Create Quantitative Assessments Action

Vault populates some fields on potential Quantitative Assessments depending on whether a value on a Formulation Concentration record is equal to the value on the applicable Regulatory Restriction record. If the values are equal, Vault uses the corresponding value. If the values are not equal and an active Object Field Picklist Entry Mapping component maps the unit values, Vault uses the mapped value.

Vault populates Quantitative Assessment fields as follows:

  • Formulation Concentration: Depending on value mapping:
    • Equal unit values: The Formulation Concentration record’s Total Concentration field value.
    • Mapped unit values: The Formulation Concentration record’s mapped field value.
  • Formula Unit: Depending on value mapping:
    • Equal values: The Formulation Concentration record’s Concentration Unit field value.
    • Mapped values: Formulation Concentration record’s mapped Unit picklist value.
  • Regulated Category: The Regulatory Restriction record’s Regulated Category field value.
  • Location: The Regulated Category record’s Location field value.
  • Intended Use: The Regulatory Restriction record’s Intended Use field value.
  • Restriction Amount: The Regulatory Restriction record’s Amount field value.
  • Restriction Unit: The Regulatory Restriction record’s Unit field value.
  • Converted Concentration: Depending on value mapping:
    • Equal unit values: The Formulation Concentration record’s Total Concentration field value.
    • Mapped unit values: The Formulation Concentration record’s mapped field value.
  • Assessment Status: Depending on concentration amounts:
    • If the Formulation Concentration is less than or equal to the Restriction Amount: Y
    • If the Formulation Concentration is more than the Restriction Amount: N

The Create Quantitative Assessments action will fail for the following reasons:

  • No mappings exist for the applicable units of measure and the corresponding record values are not equal.
  • You have configured a lifecycle on the Quantitative Assessment object.
  • Any applicable Regulated Restrictions have a Type that is not “Max”.
  • The relevant data on the applicable Formulation, Formulation Concentration, or Regulatory Restriction records change after a user runs the action and before the job completes.
  • Any Substance appears more than once in the Formulation.

How to Configure the Create Quantitative Assessments Action

To configure the Create Quantitative Assessments user action, assign the action to the Formulation object and do one (1) of the following:

  • Select the Available in All Lifecycle States checkbox to apply atomic action security defaults for the applicable lifecycle states.
  • Add the action as a user action to the applicable states of the Formulation object lifecycle.

Configuring User Permissions

You must ensure users have the appropriate read and create permissions to access the appropriate objects and object fields in addition to the permissions outlined below:

  • For the Formulation, Formulation Concentration, and Regulated Category objects: View permission.
  • For the Quantitative Assessment object: Create permission.
  • Pages: All Pages: Automate Quantitative Assessments Page.

You can complete all the steps in this article with the standard System Administrator or Vault Owner security profile. If your Vault uses custom security profiles, your profile must grant the following permissions:

Type Permission Controls
Security Profile Admin: Configuration: Objects: Create, Edit Ability to create and modify Vault objects and Object Field Picklist Entry Mapping components.
Security Profile Admin: Configuration: Picklists: Edit Ability to create and modify Vault objects.
Security Profile Admin: Security: Permission Sets: Edit Ability to view and use the Loader tab.
Security Profile Application: Vault Actions: API: Metadata API Ability to access the Object Field Picklist Entry Mapping page from the Application Configurations section of the Admin > Configurations page.