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.

The following list outlines the required configuration in the order it must be performed:

1. Configure Checklists
2. Configure the Case Object Layout
3. Add the Start Checklist User Action to the Case Lifecycle
4. Replace the Start Checklist User Action
5. (Optional) Configure Case Lifecycle Entry Criteria to Consider Only Completed QC Checklists
6. Configure the Checklist Creation Rule Object Layout
7. Enable the Post-Closure QC Interval Setting
8. Update the Case Accepted Workflow
9. Grant Permissions

After completing the configuration on this page, see Configure QC Checklist Creation Rules for instructions on setting up sampling and rule criteria for Checklist generation.

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

Configure Checklists

To configure Checklists in your Vault:

1. Add the QC Checklists Picklist to the Checklist Type
2. Add User Actions to the Checklist Design Lifecycle
3. Create a Checklist Design
4. Change the Checklist Design State to Approved

Add the QC Checklists Picklist to the Checklist Type

To add the QC Checklists picklist value to all Checklist types:

1. Navigate to Business Admin > Picklists > Checklist Type (checklist_type__sys).
2. Under the Picklist Values section, select Create.
3. In the Create Picklist Value dialog, complete the following information: 
   • Picklist Value Label: Enter QC Checklists.
   • Insert Picklist Value to a Specific Position: Select No.
4. Repeat the above steps to create the following picklist values if they don’t already exist:
   • MR Checklist
   • FR Checklist
5. Select Save.

For more information, see Vault’s Configuring Checklists: Checklist Type (Picklist).

Add User Actions to the Checklist Design Lifecycle

Navigate to Admin > Configuration > Object Lifecycles > Checklist Design Lifecycle and add the following user actions and entry action on the following states of the Checklist Design Lifecycle:

State	Action Type	Conditions	Action Label
Draft	User action	Always > Change State to Approved	Change State to Approved
	User action	Always > Upload Design Configuration	Upload Design Configuration
Approved	User action	Always > Create New Version	Create New Version
	Entry action	Always > Make previous checklist design version superseded	N/A

Create a Checklist Design

You can create a Checklist Design using the Visual Checklist Designer for testing purposes and to ensure the basic Checklist functionality is correctly configured before using Checklists in your QC processes. 

Change the Checklist Design State to Approved

In the created QC Checklist, change the lifecycle state from Draft to Approved.

Configure the Case Object Layout

To update the Case object layout:

1. Navigate to Admin > Configuration > Objects > Case > Layouts > [Case Layout].
2. Insert the Case Checklist related object section with the following information:
   • Related Object: Case Checklist
   • Section Label: Case Checklists
   • Section Name: case_checklists
   • Creation Option: Prevent record creation
3. Select Done.
4. Select Save.

(Optional) 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 the Case Checklist Rule Assignment related object section with the following information:
   • Related Object: Case Checklist Rule Assignment
   • Section Label: Case Checklist Rule Assignments Checklists
   • Section Name: case_checklist_rule_assignments_checklists
   • Creation Option: Prevent record creation
3. Select Done.
4. Select Save.

(Optional) 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
   • Layout Name: qc_layout
4. Select Done.
5. In the QC layout, create the following pages:
   • QC
   • Activities
6. On the QC page in the Details section, ensure the following fields appear:
   • Report Type
   • Reporter Country
   • Organization
   • Event Country
   • Intake Format
   • Intake Method
7. Remove and add fields as needed.
8. Use the following table to add fields and insert sections to the QC and Activities pages:

Page	Section Type	Section Label	Section Name	Other Information	Fields/Columns
QC	Detail Form	Narrative	narrative	Section Layout: Detail Form - One Column	Narrative Preview Add other fields as needed.
	Timeline	Case Timeline	case_med_review_tl_section_control	N/A	Add as needed.
	Related Object > Case Checklist	Review Checklists	review_checklists	Creation Option: Prevent record creation	Add as needed.
Activities	Validation Results (Failures & Warnings)	Validations	case_validation_results_control	N/A	Add as needed.
	Related Object > User Task	Action Items	user_tasks	Creation Option: Create record in pop-up dialog Criteria VQL: object_type__vr.api_name__v CONTAINS ('case_task__v') Select Apply on Create	Add as needed.
	Related Documents > Case	Documents	documents	N/A	Add as needed.

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

Add the Start Checklist User Action to the Case Lifecycle

To test the functionality of the default QC Checklist, add the Start checklist user action to the QC state of the Case object lifecycle using the following information:

• Always > Start checklist
  • Checklist Type: QC Checklists
  • Action Label: Start checklist

Test the Start Checklist User Action

After configuring the Start checklist action, 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.

Replace the Start Checklist User Action

After testing the Start checklist user action to ensure a Checklist Design was successfully selected and a Checklist was successfully generated for the Case, you can remove the Start checklist user action and 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 Case locking is being used.
• A user action: Recommended if Case locking is not being used.
• An entry action: Recommended if the Case will be locked to a user before it enters the QC lifecycle state.

This action uses configured Checklist Creation Rules to generate a Checklist.

Remove the Start Checklist User Action

To remove the Start checklist user action from the Case object lifecycle, navigate to Admin > Configuration > Object Lifecycles > Case Lifecycle > QC state and select Edit next to the User Actions section.

(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.

(Optional) Configure Case Lifecycle Entry Criteria to Consider Only Completed QC Checklists

We recommend you configure 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 the following related object sections:
   • Checklist Creation Rule Criteria
     • Related Object: Checklist Creation Rule Criteria
     • Section Label: Checklist Creation Rule Criteria
     • Section Name: checklist_creation_rule_criteria
   • Case Checklist Rule Assignment
     • Related Object: Case Checklist Rule Assignment
     • Section Label: Case Checklists Created with this Rule
     • Section Name: case_checklists_created_with_this_rul
3. Select Save.

Enable the Post-Closure QC Interval Setting

To enable the Post-Closure QC Interval setting:

1. Navigate to Admin > Settings > Safety General Settings.
2. Select Edit.
3. In the Post-Closure Quality Control section, select a Post-Closure QC Interval 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: Run the first day of every month for the previous month.
4. Select Save.

When Vault generates QC Checklists for post-closure Cases, Vault generates a CSV log file and adds it as an attachment to the applicable Checklist Creation Rule.

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 workflow according to Configuring Checklist Workflows.
3. After configuring the workflow, select Make configuration active.

Grant Permissions

To allow users access to use this feature, configure: 

• Object permissions
• 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

(Optional) 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 and complete the following fields: 
   • Role: Select Viewer.
   • Users and Groups: Select a user or user group, for example, Case Processing.
     Repeat this step as applicable.
6. Select Save.

Next Steps

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:

1. Navigate to Admin > Settings > Safety General Settings.
2. In the Post-Closure Quality Control section, select Generate Post-Closure QC Checklists.

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.