Enable QC Checklist Generation

With the 24R1 release, Vault supports quality control (QC) checklist generation for open Cases and closed Cases. These Checklists assist users with performing QC tasks.

24R3 Update: QC Checklist Updates

With the 24R3 release, you can add the Execute Checklist Rules action as a workflow step or user action. See the following sections to configure your Vault for the updated feature:

• (24R3) Add the Execute Checklist Rules Workflow Step
• (24R3) Add the Execute Checklist Rules User Action

Overview

Complete the following procedures to enable QC checklists in your Vault:

1. Configure the Case object layout
2. Set up checklists
3. Optional: Configure Case lifecycle entry criteria
4. Configure the Checklist Creation Rule object layout
5. Define the application settings
6. Update the Case Accepted workflow
7. Grant permissions
8. Configure Checklist Creation Rules
9. Optional: Manually test QC checklists

Configure the Case Object Layout

To update the Case object layout:

1. Navigate to Admin > Configuration > Objects > Case > Layouts > [Case Layout].
2. Insert a related object section for the Case Checklist object.
3. Select Done.
4. Select Save.

Configure the Case Object Layout for Post-Closure Checklists

If enabling post-closure Checklists, follow the steps below to update the Case object layout:

1. Navigate to Admin > Configuration > Objects > Case > Layouts > [Case Layout].
2. Insert a related object section for the Case Checklist Rule Assignment object. We recommend labeling this section Case Checklist Rule Assignments.
3. Select Done.
4. Select Save.

Create the QC Layout on the Case Object

If you have reached the maximum number of sections on the Case layout, create a new QC layout on the Case object:

1. Navigate to Admin > Configuration > Objects > Case > Layouts.
2. Select Create.
3. In the Add Layout dialog, complete the following information:
   • Object Type: Case
   • Layout Label: QC
4. Select Done.
5. In the QC layout, create the following pages:
   • QC
   • Activities
6. Ensure the Details section includes the following fields:
   • Report Type
   • Reporter Country
   • Organization
   • Event Country
   • Intake Format
   • Intake Method
7. Insert sections and add fields to the QC and Activities pages:

Page	Section Type	Section Label	Parameters
QC	Detail Form	Narrative	Include the Narrative Preview field
	Timeline	Case Timeline	N/A
	Related Object > Case Checklist	Review Checklists	Creation Option: Prevent record creation
Activities	Validation Results (Failures & Warnings)	Validations	N/A
	Related Object > User Task	Action Items	Creation Option: Create record in pop-up dialog Criteria VQL: object_type__vr.api_name__v CONTAINS ('case_task__v') Select Apply on Create
	Related Documents > Case	Documents	N/A

After creating the QC layout, create an applicable layout profile and assign users to the profile as needed.

Set up Checklists

You must configure and design checklists in your Vault. When setting up checklists, ensure you complete the following:

1. Create the following values for the Checklist Type picklist:
   • QC Checklist
   • MR Checklist
   • FR Checklist
2. Configure actions for the Checklist Design lifecycle:
   • Add the following user actions to the Draft state:
     • Change State to Approved
     • Upload Design Configuration
   • Add the Create New Version user actions to the Approved state.
   • Add the Make previous checklist design version superseded entry action to the Approved state.
3. Create a Checklist Design for testing purposes and to ensure the basic Checklist functionality is correctly configured before using Checklists in your QC processes.
   • For Checklist Type, select QC Checklist.
   • Ensure the checklist includes at least one section, one question, and one answer.
4. Move the Checklist Design to the Approved state.
5. Configure the Start Checklist user action on the QC state of the Case lifecycle.
   • Create a QC Checklist using the Start checklist user action on a Case in QC state to ensure a Checklist can be generated. You should see a generated Checklist in the Checklists section of the Case.
6. After ensuring the action generates a checklist, remove the Start checklist user action from the Case lifecycle.
7. Add the Execute Checklist Rules action as one of the following:
   • A workflow step (recommended when the Case workflow is initiated using the workflow user action and if your Vault uses Case locking).
   • A user action (recommended if your Vault does not use Case locking).
   • An entry action (recommended if your Vault locks Cases before they enter the QC lifecycle state).

(24R3) Add the Execute Checklist Rules Workflow Step

To configure the Execute Checklist Rules workflow step for the desired Case workflow:

1. Navigate to Admin > Configuration > Workflows > [Workflow].
2. In the Workflow Steps section, select Create.
3. On the Create Step page Details section, enter the following:
   • Label: Enter a label for this workflow step.
   • Type: Select System Action.
   • Next Steps: Select a workflow step to follow the newly created step.
4. Under the System Action Options section, select Execute Checklist Rules.
5. Select Save.

(24R3) Add the Execute Checklist Rules User Action

To configure the Execute Checklist Rules user action, assign the action to the Case object and add the action as a user action to the QC state.

Add the Execute Checklist Rules Entry Action

To ensure Vault generates a QC Checklist for a Case upon entering the QC lifecycle state, add the Execute Checklist Rules entry action to the QC state of the Case object lifecycle.

Configure Case Lifecycle Entry Criteria

We recommend configuring entry criteria on the Case lifecycle to prevent the Case from moving forward if the QC Checklist is not complete:

1. Navigate to Admin > Configuration > Object Lifecycles > Case Lifecycle > [State].
2. Add the following entry criteria:
   • Always > State of Related record > Checklists > All records equal > Completed
     • Select the Conditions On Related Records checkbox.
       • Object Type > includes > Case Checklist
3. Select Save.

Configure the Checklist Creation Rule Object Layout

To configure the Checklist Creation Rule object layout:

1. Navigate to Admin > Configuration > Objects > Checklist Creation Rule > Layouts > Checklist Creation Rule Detail Page Layout.
2. Insert related object sections for the Checklist Creation Rule Criteria and Case Checklist Rule Assignment objects.
3. Select Save.

Define Application Settings

Enable the Post-Closure QC Interval Safety general setting to define the interval at which Vault should identify closed Cases for post-closure QC Checklist generation:

• Daily: Runs every day for the previous day.
• Weekly: Runs every Monday for the previous week.
• Monthly: Runs the first day of every month for the previous month.

Update the Case Accepted Workflow

To update the Case Accepted workflow, which will be used to complete QC Checklists:

1. Navigate to Admin > Configuration > Workflows > Case Accepted.
2. Configure the accepted workflow.
3. Activate the workflow configuration.

Grant Permissions

To allow users access to use this feature, configure: 

• Object permissions
• Optional: Sharing rules

Object Permissions

Ensure your permission sets are updated to grant the appropriate level of access for users to objects and object types according to your organization’s process. Manage object permissions from Admin > Users & Groups > Permission Sets > [Permission Set] > Objects > [Object].

The following table summarizes the objects and object types to use this feature and the recommended level of access for your permission sets:

Objects	Object Types	Permissions
Case Checklist	Base Case Checklist	Read
	Case Checklist	Read Create Edit
Case Response	Base Case Response	Read
	Date Response	Read Edit
	Multiple Choice Response	Read Edit
	Number Response	Read Edit
	Text Response	Read Edit

Sharing Rules

You can configure custom sharing rules to provide certain users or user groups Read access to Case Checklists:

1. Navigate to Admin > Configuration > Objects > Case Checklist > Sharing Rules.
2. Select Create.
3. On the New Sharing Rule page, enter a name for the rule in the Label field, for example, Viewer Access.
4. Select Save.
5. In the Roles section, select Add
6. For Role, select Viewer.
7. Select the applicable Users and Groups.
8. Select Save.

Create QC Checklist Creation Rules

After completing the configuration on this page, you must configure QC Checklist Creation Rules, which are based on Checklist Creation Rule Criteria and sampling. Vault uses these Checklist rules to generate a Checklist Design specific to each Case. We recommend testing your configuration by creating a sample Checklist Creation Rule and then running this rule for in-process then post-closure Cases. You can also create more Checklist Designs for different use cases. For example, in-process clinical Cases, in-process spontaneous Cases, post-closure clinical Cases, post-closure spontaneous Cases, and Product-specific Cases.

Manually Test Post-Closure QC Checklists

Vault generates post-closure QC Checklists at the interval defined by the Post-Closure QC Interval setting. However, for intervals set to Weekly and Monthly, you can manually generate post-closure QC Checklists for testing purposes without the need to wait until the end of the configured interval. For a Case to be eligible, they must first be closed to ensure Vault sets the Process Completion Date. Manual interval testing requires the Process Completion Date values to be from the previous day(s) relative to the UTC.

To manually generate post-closure QC Checklists for testing purposes, select the Generate Post-Closure QC Checklists button on the Safety General Settings page. Vault displays a message to notify you the job has begun and sends you a notification when the job completes. If you trigger the action multiple times, Vault consecutively runs each job in a queue.