**Source URL:** https://qualityone.veevavault.help/en/gr/57162/index.md

# Configuring 5 Whys Analysis (QMS)

<a href="/en/gr/78610/">QualityOne Vaults</a> help users to identify the root cause of a problem using a cause-and-effect technique. The <a href="/en/gr/57126/">5 Whys Analysis</a> 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.

## Configuring 5 Whys Analysis {#configure}

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 <a href="/en/gr/36919/">configuration migration package</a>. Contact your Veeva Representative to access a VPK to deploy the workflow configuration.
5. Configure the lifecycle stage group using a <a href="/en/gr/36919/">configuration migration package</a>. 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 <a href="/en/gr/36919/">configuration migration package</a>. Contact your Veeva Representative to access a VPK to deploy the layout.
7. Configure the _View 5 Whys Analysis_ [record action][1] 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.

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      <p><strong>Note</strong>: 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.</p>
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## Configuring 5 Whys Analysis Object Action {#configure-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 <a href="/en/gr/43127/#assign-actions">record action</a> on the _Root Cause Analysis_ object.

Optionally, select the **Available in All Lifecycle States** checkbox to apply <a href="/en/gr/47850/#Atomic_Security_Actions">atomic action security</a> defaults for the applicable lifecycle states. If you do not select the checkbox, you must configure the action as a <a href="/en/gr/59885/#user-actions">user action</a> on any [_Root Cause Analysis_ lifecycle state][6] required.

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      <p><strong>Note</strong>: In Vaults created prior to 22R1, the legacy user action <em>View 5 Whys Analysis (Legacy)</em> from the <strong>Actions</strong> menu may be displayed. We recommend that you remove this legacy user action and replace it with the <em>View 5 Whys Analysis</em> record action. Contact your Veeva Representative for more details.</p>
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## Defining Cause Categories and Cause Sub Categories {#define}

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 {#workflows}

QualityOne uses <a href="/en/gr/33498/">workflows</a> 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][6]. 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 {#lifecycle-states}

_5 Whys Analysis_ object records use the _Root Cause Analysis_ <a href="/en/gr/29798/">object lifecycle</a>, 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 {#user-permissions}

You must ensure users have the appropriate read and create <a href="/en/gr/22824/">permissions</a> to access the appropriate objects and object fields in addition to the permissions outlined below:

* For the _Root Cause Analysis_ object: 
    * _Read_ permission
    * _Read_ permission on the _Problem Statement_ field
* For the _Root Cause_ object: _Read_ permission
* For the _Why_ object:
    * _Read, Create_, _Edit_, and _Delete_ permission
    * _Read_ permission on the following fields, including <a href="/en/gr/39108/">object field-level</a> and <a href="/en/gr/47850/#configuring-atomic-security-on-fields">atomic security</a> permissions if a lifecycle is configured on the object:
        * _Level Code_
        * _Parent Why_
        * _Root Cause Analysis_
    * _Read and Edit_ permission on the following fields, including <a href="/en/gr/39108/">object field-level</a> and <a href="/en/gr/47850/#configuring-atomic-security-on-fields">atomic security</a> permissions if a lifecycle is configured on the object:
        * _Answer_
        * _Cause Category_
        * _Cause Sub-Category_
        * _Is Expected?_
        * _Is Root Cause?_
        * _Justification_
    * If your Vault utilizes <a href="/en/gr/33946/">DAC</a>, _Read_ and _Edit_ access to _Why_ records

## Related Permissions {#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 <a href="/en/gr/22824/">permissions</a>:

<table>
  <tr>
    <th><strong>Type</strong></th>
    <th><strong>Permission</strong></th>
    <th><strong>Controls</strong></th>
  </tr>
  <tr>
    <td>Security Profile</td>
    <td>Admin: Configuration: Object Lifecycles: Create, Edit</td>
    <td>Ability to create and modify object lifecycles.</td>
  </tr>
  <tr>
    <td>Security Profile</td>
    <td>Admin: Configuration: Object Workflows: Create, Edit</td>
    <td>Ability to create and modify object workflows.</td>
  </tr>
  <tr>
    <td>Security Profile</td>
    <td>Admin: Configuration: Objects: Create, Edit</td>
    <td>Ability to create and modify Vault objects.</td>
  </tr>
</table>

[1]: #configure-action
[2]: #user-permissions
[3]: #configure
[4]: #define
[5]: #workflows 
[6]: #lifecycle-states