Configuring 5 Whys Analysis (QMS)

QualityOne Vaults help users to identify the root cause of a problem using a cause-and-effect technique. The 5 Whys Analysis feature allows users to create a visual representation of a root cause analysis which they can use to perform an investigation by iteratively asking and answering the question “Why?” until the root cause is identified.

Users assign Cause Categories and Cause Sub Categories to Why items which are marked as Root Cause. Each organization must define its own Cause Categories and Cause Sub Categories before users can complete 5 Whys Root Cause Analysis diagrams. You can use Cause Categories and Cause Sub Categories to evaluate the areas for improvement which are most commonly identified as root causes.

5 Whys Analysis Objects

QualityOne uses the following core objects and object types to support 5 Whys Analysis:

• Quality Event (quality_event__qdm): This object represents individual quality events.
• CAR (car__v): This object represents corrective action requests.
• NCR (ncr__v): This object represents nonconformances.
• HSE Event (ehs_event__v): This object represents environmental, health, safety, and vehicle or property damage incidents.
• Root Cause Analysis (rca__v): This object represents the root cause analysis.
  • 5 Whys Analysis (5whys_analysis__v): This Root Cause Analysis object type represents the 5 Whys Analysis.
• Why (why__v): This object represents individual Why items.
• Cause Category (cause_category__v): This object represents a library of cause categories which users can assign to leaf Why items marked as Root Cause.
• Cause Sub-Category (cause_subcategory__v): This object represents a library of cause sub-categories which users can assign to leaf Why items marked as Root Cause.

Depending on your data model, 5 Whys Analysis may use Quality Event object type records, NCR object records, HSE Event object records, or CAR object records.

Configuring 5 Whys Analysis

Configuring your Vault to perform 5 Whys Analysis involves the following steps:

1. If applicable, rename the Root Cause Analysis (root_cause_analysis__qdm) object to “Root Cause”.
2. Enable fields for the newly named Root Cause (root_cause_analysis__qdm) object for any standard fields or custom fields in use.
3. Edit the Quality Event (quality_event__qdm), NCR (ncr__v), HSE Event (ehs_event__v), or CAR (car__v) object layout to include the Root Cause Analysis (rca__v) related object section and configure the appropriate visibility based on the lifecycle states. We recommend inserting this section above the Root Cause section and making it visible from the Investigation state until the Closed state.
4. Configure the QualityOne 5 Whys Analysis workflow using a configuration migration package. Contact your Veeva Representative to access a VPK to deploy the workflow configuration.
5. Configure the lifecycle stage group using a configuration migration package. Contact your Veeva Representative to access a VPK to configure the lifecycle stage group.
6. Configure the layout for the 5 Whys Root Cause (5Whys_root_cause__v) object type using a configuration migration package. Contact your Veeva Representative to access a VPK to deploy the layout.
7. Configure the View 5 Whys Analysis record action on the Root Cause Analysis (rca__v) object.
8. If you have any existing VQL criteria for the Quality Event (quality_event__qdm) object configured on the Root Cause (root_cause_analysis__qdm) object, ensure you copy and paste the existing VQL criteria to the Root Cause Analysis (rca__v) object.
9. Make the Why field (why__v) required on the 5 Whys Root Cause (5Whys_root_cause__v) object type of the Root Cause (root_cause_analysis__qdm) object.

Configuring 5 Whys Analysis Object Action

The Root Cause Analysis object lifecycle contains the View 5 Whys Analysis action. View 5 Whys Analysis triggers Vault to display the 5 Whys Root Cause Analysis diagram for users to view and interact with. Add this action as a record action on the Root Cause Analysis object.

Optionally, select the Available in All Lifecycle States checkbox to apply atomic action security defaults for the applicable lifecycle states. If you do not select the checkbox, you must configure the action as a user action on any Root Cause Analysis lifecycle state required.

Defining Cause Categories and Cause Sub Categories

To define a Cause Category or Cause Sub Category, create the appropriate object record. Cause Categories and Cause Sub Categories are available for users to assign to Why items which are marked as Root Cause. You must create at least one (1) Cause Sub Category for each Cause Category. You must create Cause Categories and Cause Sub Categories before users can complete 5 Whys Root Cause Analysis diagrams.

To create Cause Categories:

1. Navigate to Business Admin > Objects > Cause Categories.
2. Click Create.
3. Enter a Name appropriate to your organization, for example, “Material” or “Machine”.
4. Click Save. To create another Cause Category, click Save + Create.

To create Cause Sub Categories:

1. Navigate to Business Admin > Objects > Cause Sub-Categories.
2. Click Create.
3. Select the appropriate Cause Category.
4. Enter a Name appropriate to the Cause Category, for example, “Storage condition” or “Maintenance”.
5. Click Save. To create another Cause Sub Category, click Save + Create.

You can modify the name of existing Cause Categories and Cause Sub Categories; however, modifications appear in any Why items using the Cause Categories or Cause Sub Categories.

You can delete Cause Categories and Cause Sub Categories only if they are not assigned to Why items. Deleting a Cause Category deletes all of its Cause Sub Categories.

Using Workflows

QualityOne uses workflows to manage 5 Whys Analyses. 5 Whys Analyses are performed during the Containment & Investigation lifecycle state of a Quality Event. 5 Whys Analysis goes through the *Q1 – 5 Whys Analysis workflow, which moves the analysis from Analysis to Approval to Closed. Users can modify the 5 Whys Root Cause Analysis diagram as long as it is not locked by its current lifecycle state. The 5 Whys Analysis must be closed in order for the associated Quality Event, NCR, HSE Event, or CAR to proceed through its workflow.

Your organization can modify these workflows or add custom workflows appropriate to your specific needs.

Lifecycle States

5 Whys Analysis object records use the Root Cause Analysis object lifecycle, and contain the following states:

• Initiated: Construct the 5 Whys Root Cause Analysis diagram in this state.
• In Analysis: 5 Whys Root Cause Analysis diagrams are unlocked when in this state.
• In Approval: 5 Whys Root Cause Analysis diagrams are locked when in this state.
• Approved: 5 Whys Root Cause Analysis diagrams are locked when in this state.
• Closed: 5 Whys Root Cause Analysis diagrams are locked when in this state.

Your organization may add custom lifecycle states to suit your specific needs.

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 Root Cause Analysis object: Create, Edit, and Delete permission.
• For the Root Cause object: Create, Edit, and Delete permission.
• For the Why object: Create, Edit, and Delete permission.

Related Permissions

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: Create, Edit	Ability to create and modify object lifecycles.
Security Profile	Admin: Configuration: Object Workflows: Create, Edit	Ability to create and modify object workflows.
Security Profile	Admin: Configuration: Objects: Create, Edit	Ability to create and modify Vault objects.