Configuring Material Verification Checklists (HSE, QMS)

QualityOne Vaults provide audit-specific checklist functionality to allow users to create their own material verification checklists. These checklists allow users to perform internal and supplier verification for foreign-supplied material to help control hazards using a checklist’s functionalities. Users can collect internal and supplier responses for all the hazards that need to be controlled for material compliance with industry requirements such as FSMA (Food Safety Modernization Act).

You must configure this functionality before users can start working with material verification checklists in their audits. For more information about configuring and designing general checklist functionality, see Configuring Checklists and Designing Checklists.

Note: This feature is currently available only to Early Adopters. Contact your Veeva Representative for more details.

Material Verification Checklist Objects

QualityOne uses the following core objects and object types to support Material Verification Checklist:

Material (material__v): This object represents material code such as raw material and finished material.
Hazard (hazard__v): This object represents the library of hazards.
Material Verification (material_verification__v): This object represents materials that require hazard control verification.
- Verification by Material (verification_by_material__v): This Material Verification object type represents the verification of a single material.
- Verification by Material Category (verification_by_material_category__v): This Material Verification object type represents the verification of a category and sub-category of a material.
Material-Hazards (material_hazards__v): This object represents the join between Material and Hazard.
Material Category-Hazards (material_category_hazards__v): This object represents the join of a Material Category picklist and Hazard.
MV Response-Hazard (mv_response_hazard__v): This object represents the join between MV Response and Hazard.
MV Response-Action Item (mv_response_action_item__v): This object represents the join between MV Response and Action Item.
Action Item (action_item__qdm): This object represents action items.
Material Verification-Material (material_verification_material__v): This object represents the materials in the specified material category and sub-category verified by the material verification.

Configuration Overview

Enable Checklists in your Vault
Configure the Material Verification checklist workflow
Configure your Material Verification checklist design
Configure user permissions for Material Verification

Note: Depending on your Vault’s creation date and which features are currently enabled and configured, some of the steps described in this article may be unavailable or already complete in your Vault.

Enabling Checklists

You can configure your Vault to allow you to submit data in a checklist format. To enable this feature, navigate to Admin > Settings > General Settings and click Edit. In the Checklist section, select the Enable Checklists checkbox and click Save.

Once enabled, you can create a Checklist Type for the Material Verification object. See Configuring Checklists for more details.

Important: Once enabled, you cannot disable Enable Checklists.

Configuring the Material Verification Checklist Workflow

By default, the MV Accepted and MV Pending Acceptance object workflows are active and do not contain steps. If your organization plans to use workflows to initiate checklists, we recommend you use these because they have specialized system actions that are not available with other workflows:

Set Respondent, which sets the Respondent field.
Ensure Completeness, which verifies that all sections of the checklist are completed.

To configure the MV Accepted and MV Pending Acceptance object workflows, see Configuring Checklist Workflows for more details. Replace the Accepted workflow with the MV Accepted workflow and Pending Acceptance workflow with the MV Pending Acceptance workflow for the purposes of the Material Verification Checklist configuration.

Note: The best practice for workflow configuration depends on whether you use the entry action option or the user action option of the Start checklist object action.

Configuring the Material Verification Checklist Design

Once you have enabled Checklists and configured the workflow, you can configure and design your material verification checklist to allow users to submit data in a question and answer format. You can build checklist designs by creating records for the various Material Verification Checklist objects within your Checklist Design, or you can use the Visual Checklist Designer to design and manage your checklist from a single page. For help designing your checklists, see Designing Checklists.

To configure a Material Verification Checklist Design, see Configuring Checklists for more details. Complete the steps listed in the Configuration Overview and ensure that you also do the following at the appropriate step in the process flow:

During Section Design creation, ensure the Name values for checklist sections match the Hazard Classification picklist values. See Adding Hazards to Material Verification Checklists for more details.
During Material Verification Lifecycle configuration, ensure you configure the Start checklist action. See Configuring Start Checklist Object Action for more details.

Adding Hazards to Material Verification Checklists

When designing your checklist, you must ensure users are able to add Hazard records to their responses so that users can identify the hazards to control for a material in their checklist response.

To add hazards to a material verification checklist:

Add values to the Hazard Classification picklist. We recommend the following values:
- Biological Hazards
- Chemical Hazards
- Physical Hazards
- Allergens
Ensure the section names in your configured checklist designs match the picklist values you add to the Hazard Classification picklist. This enables checklist respondents to add Hazard records with a Hazard Classification value that matches the section name to their responses in that section. Vault populates additional Hazards for checklist respondents to add to their responses from Material-Hazard records, or from Material Category-Hazard records when Material-Hazard is not specified.

Configuring Start Checklist Object Action

The Material Verification lifecycle contains the Start checklist action. Start checklist triggers Vault to instantiate a checklist for the Material Verification object and send the checklist to the respondent. Add this action as a record action on the Material Verification object. Do not select Available in All Lifecycle States and click Save.

You must configure this action as an entry action or a user action on a Material Verification lifecycle state needed to initiate the material verification checklist. Ensure that you configure the checklist using only the user action approach or only the entry action, but not both. See Configuring Checklists for more details.

If you configure the Start checklist action as a user action, ensure you configure the MV Accepted workflow. If you configure the Start checklist action as an entry action, ensure you configure the MV Pending Acceptance workflow. See Configuring the Material Verification Checklist Workflow for more details.

Configuring Material Verification by Material Category

You can give users the ability to instantiate one (1) checklist for multiple materials in the same material category and sub-category, specified as a field value on the Material object record.

To do this, you must first do the following to configure Material Verification object types:

Ensure the Verification By Material and Verification By Material Category object types are set to Active.
Ensure the Material and Supplier fields are assigned to the Verification by Material object type.
Ensure the Material Category, Material Sub-category, and Supplier fields are assigned to the Verification by Material Category object type.

You must also populate the Material Category and Material Sub-Category picklists with the appropriate values, which will be available for users to select in the Material Category and Material Sub-category fields of Material Verification records.

To use the Verification by Material Category feature, you must also populate the Material Category-Hazard object records, which store the hazards associated with each material category and sub-category. When populated, the list of Material Category-Hazard records will display as a list of hazards for each category and sub-category of materials.

Limitations

The following limitations affect material verification checklists:

You cannot add Hazards to ad hoc questions in a checklist.
If a Hazard Classification is inactive, the related Hazards cannot be added to a question response.
Depending on configuration, you can add a maximum of 15 Hazards per question response with eight (8) Hazards as the default limit. For additional help on this configuration, contact your Veeva Representative for more details.

Configuring User Permissions

You must ensure users have a security profile with the appropriate Read, View, Edit, and Create permissions to access the appropriate objects and object fields:

For the Audit object: Read permission
For the Material object: Read permission
For the Hazard object: Read permission
For the Material Verification object: Read permission.
For the MV Response-Hazard object: Create and Delete permission.

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: Object Lifecycles: Edit	Ability to modify object lifecycles.
Security Profile	Admin: Configuration: Objects: Create, Edit	Ability to create and modify Vault objects.
Security Profile	Admin: Security: Permission Sets: Read, Create, Edit, Delete	Ability to make changes to permission sets for users.
Security Profile	Admin: Settings: General Information: Edit	Ability to modify settings in the Vault General Settings page.