Enable QC Checklist Generation

Learn how to configure your Vault to support quality control (QC) checklist generation.

About the Feature

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

For more information, see Generate a QC Checklist.

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. Set the Post-Closure QC Interval Setting

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

This section outlines the procedures for configuring 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. Set Up Questions and Answers in the Checklist Design
5. Change the Checklist Design State to Approved

Add the QC Checklists Picklist to the Checklist Type

Follow the steps below to add the QC Checklists picklist value to all checklist types:

1. Go to Business Admin > Picklists > Checklist Type (checklist_type__sys).
2. Select Edit.
3. Under the Picklist Values section, in the field for new values enter “QC Checklists” and select the Plus icon.
4. Save the page.

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

Add User Actions to the Checklist Design Lifecycle

Follow the steps below to add the following user actions to the Checklist Design lifecycle:

• Change State to Approved
• Upload Design Configuration
• Change State to Draft

1. Go to Admin > Configuration > Object Lifecycles > Checklist Design Lifecycle.
2. In the Draft state, add the following two (2) user actions:
   • Always > Change State to > Approved
     • Action Label: Change State to Approved
   • Always > Upload Design Configuration
     • Action Label: Upload Design Configuration
3. Save the page.
4. In the Approved state, add the following user action:
   • Always > Create New Version
     • Action Label: Create New Version
5. Save the page.
6. Go back to the Approved state and add the following entry action:
   • Always > Make previous checklist design version superseded
7. Save the page.

Create a Checklist Design

Create a Default QC Checklist design for testing purposes and to ensure the basic checklist functionality is set up correctly.

Follow the steps below to create the Default QC Checklist checklist design:

1. Go to Business Admin > Objects > Checklist Designs.
2. Select Create.
3. Complete the following information:
   • Checklist Name: Default QC Checklist
   • Checklist Type: QC Checklists
4. Save the page.
5. To go to the object detail page view, select the View Record Detail Page () icon.
6. In the All Actions menu, select Configure Layout.
7. Hover over the area where you want to insert a new section and then select the Plus icon > Insert Section > Related Object.
8. Insert the following related object sections and leave the default section labels and names:
   • Dependency Design
   • Question Design
   • Response
   • Section Design
9. Save the page.

Set Up Questions and Answers in the Checklist Design

Follow the steps below to configure questions and answers for your new checklist design:

1. In the Default QC Checklist design, select the View Record Detail Page icon.
2. Expand the Section Designs section and select Create.
3. In the Create Section Design window, select Question Section and then Continue.
   You cannot create a question without a section design.
4. Complete the following information and then save the page.
   • Name: Enter a name for the question section.
   • Order: Enter “1”. This field sets the order in which the system searches Checklist Designs.
5. Go back to the Default QC Checklist design and expand the Questions section.
6. Create as many questions as needed for this default checklist design. For help configuring questions and answers, see Vault’s Checklist Question & Answer Setup.
7. For each created question, select Configure Layout from the All Actions menu to insert the Available Answer Design related object section.
   This section allows the system to easily capture the answers to each question in the checklist design.
8. Hover over the area between the Details and Workflow Timeline section and then select the Plus icon > Insert Section > Related Object.
9. Complete the following information and then select Done:
   • Related Object: Available Answer Design
   • Section Label: Available Answer Designs
   • Section Name: available_answer_designs
10. Save the page.
11. In the Checklist Design Question records, expand the Available Answer Designs and select Create.
12. Complete the following information and then save the page:
    • Answer Text: Enter an answer to the checklist design question.
    • Order: Enter the number of the question to which this answer corresponds. For example, “1”.

To create dependency questions (follow-up questions that depend on the answer of an original question), see Vault’s Using the Visual Checklist Designer. To create dependencies from the object detail page view, see Vault’s Designing Checklists.

Change the Checklist Design State to Approved

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

Configure the Case Object Layout

Follow the steps below to insert the Case Checklist related object section to the Case object layout:

1. Go to Admin > Configuration > Objects > Case > Layouts > Case Page Layout.
2. Hover over the area you want to insert the Case Checklist related object section and select the Plus icon > Insert Section > Related Object.
3. Complete the following information:
   • Related Object: Case Checklist
   • Section Label: Case Checklists
   • Section Name: case_checklists
   • Creation Option: Prevent record creation
4. Select Done.
5. Save the page.

(Optional) Configure the Case Object Layout for Post-Closure Checklists

If enabling Post-Closure Checklists, follow the steps below to insert the Case Checklist Rule Assignment related object section to the Case object layout:

1. Go to Admin > Configuration > Objects > Case > Layouts > Case Page Layout.
2. Hover over the area you want to insert the Case Checklist Rule Assignment related object section and select the Plus icon > Insert Section > Related Object.
3. Complete 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
4. Select Done.
5. Save the page.

(Optional) Create the QC Action Layout on the Case Object

If you have reached the maximum number of sections on the Case Page Layout, create a new QC layout using action layouts:

1. Go to Admin > Configuration > Objects > Case > Layouts.
2. Select Create.
3. In the Add Layout window, complete the following information:
   • Object Type: Case
   • Layout Label: QC
   • Layout Name: qc_layout
4. Select Done.
5. In the QC layout, create two (2) pages.
6. Name the first page “QC” and the second page “Activities”.
7. In the QC page Details section, ensure the following fields appear:
   • Report Type
   • Reporter Country
   • Organization
   • Event Country
   • Intake Format
   • Intake Method
8. Remove and add fields as needed.
9. Use the table below 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 action layout, create an applicable layout profile and assign users to the profile as needed.

Add the Start Checklist User Action to the Case Lifecycle

Add the Start checklist user action to the Case lifecycle so that you can test the functionality of the Default QC Checklist.

Follow the steps below to add the Start checklist user action to the Case lifecycle:

1. Go to Admin > Configuration > Object Lifecycles > Case Lifecycle.
2. Go to the QC state.
3. Add the following user action:
   • Always > Start checklist
     • Checklist Type: QC Checklists
     • Action Label: Start checklist
4. Save the page.

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.

(Optional) 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 an entry action, workflow step, or another user action.

This action uses configured Checklist Creation Rules to generate a checklist. You can configure the action using one (1) or more of the methods below.

Add the Execute Checklist Rules Entry Action

Configure the Execute Checklist Rules entry action so that a QC checklist is automatically generated for a Case upon entering the QC lifecycle state:

1. Go to Admin > Configuration > Object Lifecycles > Case Lifecycle.
2. Go to the QC state.
3. Add the following entry action:
   • Always > Execute Checklist Rules
4. Save the page.
5. Go back to the QC state.
6. Beside the User Actions section, select the Edit icon.
7. Remove the Start checklist action and select Save.

(24R3) Add the Execute Checklist Rules Workflow Step

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

Configure the Execute Checklist Rules user action for Cases in QC state:

1. Navigate to Admin > Configuration > Objects > Case > Actions.
2. Select Create.
3. In the Create Action window, select Execute Checklist Rules.
4. Select Continue.
5. On the Create Action page, select Save.
6. Navigate to Configuration > Object Lifecycles > Case Lifecycle.
7. In the States section, select QC.
8. Beside the User Actions section, select the Edit icon.
9. Remove the Start checklist action.
10. Add the following user action:
    • Always > Execute Checklist Rules > Execute Checklist Rules
11. Select Save.

(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. Go 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. Save the page.

Configure the Checklist Creation Rule Object Layout

Follow the steps below to insert the Checklist Creation Rule Criteria and the Case Checklists Created with this Rule sections to the Checklist Creation Rule object:

1. Go to Admin > Configuration > Objects > Checklist Creation Rule > Layouts > Checklist Creation Rule Detail Page Layout.
2. Hover over the area where you want to insert a new section and then select the Plus icon > Insert Section > Related Object to 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. Save the page.

Set the Post-Closure QC Interval Setting

Follow the steps below to set the interval at which the system should identify closed Cases for post-closure QC checklist generation:

1. Go to Admin > Settings > Safety General Settings.
2. Select Edit.
3. In the Post-Closure Quality Control section, set an interval value in the Post-Closure QC Interval field.
4. Save the page.

The Generate Post-Closure QC Checklists action can generate ad-hoc post-closure checklists for testing purposes. For more information, see Next Steps.

Update the Case Accepted Workflow

Follow the steps below to update the Case Accepted workflow, which will be used to complete QC checklists:

1. Go to Admin > Configuration > Workflows > Case Accepted (case_version_accepted_wf__sys).
2. Configure the Case Accepted workflow according to Configuring Checklist Workflows.
3. After configuring the workflow, select Make configuration active.

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 Safety 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 go back to the Create a Checklist Design section to 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. Alternatively, you can manually generate post-closure QC checklists for quick testing purposes.

To do this:

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 is starting.

Vault sends you a notification when the generation job is complete. If you trigger the action multiple times, Vault consecutively runs each job in a queue.