# Configuring Quality Issues

With the standard _Quality Issue_ object, users can track, manage, and report on quality issues via a user action or [Self-Evident Corrections](/en/lr/64444/#config-self-sevident-corrections) on specified document lifecycle states.

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      <p><strong>Note</strong>: This feature is only available on Clinical Operations eTMF and Clinical Operations Study Startup Vaults.</p>
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## Configuration Overview

* Add the _\# of Open Issues_, _\# of Closed Issues_, and _\# of Total Issues_ [document fields to document types](/en/lr/4884/#use-shared-field) that need quality issue tracking.
* Add the _Create Related Record_ [user action to document lifecycle states](/en/lr/12339/) where you want quality issues available. Enter an **Action Label** and select **Quality Issue** as the _Object_, and **Related Document** as the **Field** to **Default**.
* [Add **Read**](/en/lr/23647/) permission for the _Quality Issues_ object on relevant permission sets.
* Optional: Set the **Disable Document Requiredness on Quality Issues** setting to true to make the _Related Document_ field optional. If selected, when users delete a document referenced by a _Quality Issue_, Vault allows the deletion and updates the _Related Document_ field to be blank on the _Quality Issue_.
* Optional: Adjust the **Default Value** for the _Due Date_ field on the _Quality Issue_ object.
* Optional: Secure the _Study_ and _Blinding_ fields.
* Optional: Activate or configure [_Self-Evident Corrections_](/en/lr/64444/#config-self-sevident-corrections) to generate _Quality Issues_.
* Optional: Add the _Securing Assigned To_ application control field to the _Quality Issue_ page layout to default the _Assigned To_ field value to the document owner and limit the users available in the _Assigned To_ drop-down menu to users with at least view permissions and a role on the document. Configuring a criteria VQL to constrain records based on the _Assigned To_ field prevents the _Securing Assigned To_ field from functioning properly when creating Quality Issues.


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      <p><strong>Note</strong>: A one way flag enables the <strong>Disable Document Requiredness on Quality</strong> setting. You must enable this feature to use the <a href="/en/lr/769620/"><em>Document Deletion Log</em></a>. Once you enable the setting, you cannot disable it at a later time.</p>
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## Securing the Study & Content Fields {#securing}

You can enable study and blinding security to automatically populate the _Study_ and _Content_ (`blinding__v`) fields on _Quality Issues_.

1. Navigate to **Admin** > **Settings** > **Application** **Settings** > **Edit**. Set the **Enable Study and Blinding Security on Quality Issues** checkbox and click **Save**.
2. Add the _Securing Study_ and _Securing Content_ fields to the _Quality Issue_ page layout.
3. If there are existing _Study_ and _Content_ fields, remove them from the _Quality Issue_ page layout.

Once enabled, you can configure [Dynamic Access Control](/en/lr/36122/) for the _Study_ and _Content_ fields.

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      <p><strong>Note</strong>: Adding field level security to the <em>Study</em> field may prevent users from resolving <em>Quality Issue</em> tasks.</p>
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## Configuring Self-Evident Corrections (SECs) {#config-self-sevident-corrections}

You must enable an existing Self-Evident Correction configuration or create a custom Self-Evident Correction record to use the Self-Evident Corrections feature. Vault provides two standard _Self-Evident Correction_ configurations: _SEC Metadata Correction_ (`sec_metadata_correction_v`) and _SEC Misfiled_ (`sec_misclassified_v`). These _Self-Evident Corrections_ are inactive in Vault by default.

To enable a _Self-Evident Correction_ configuration:
1. Navigate to **Admin > Configuration > Self-Evident Corrections**.
2. Select a **Self-Evident Correction** record.
3. From the **All Action** menu, select **Edit**.
4. In the **Status** drop-down menu, select **Active**.
5. Click **Save**.

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      <p><strong>Note</strong>: To prevent the creation of unnecessary SECs, we recommend temporarily inactivating SEC configurations when you plan to perform bulk updates that may result in the creation of a large number of SECs.</p>
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      <p><strong>Note</strong>: The standard fields <em># Days Open</em> (<code class="language-plaintext highlighter-rouge">num_of_days_open__v</code>) and <em>Days Until Due</em> (<code class="language-plaintext highlighter-rouge">days_until_due__v</code>) on the <em>Quality Issue</em> object are formula fields. SEC <em>Quality Issue</em>s may be created and closed without a <em>Verdict Date</em>, resulting in inaccurate values in these fields when using the standard template formulas. When enabling <em>Self-Evident Corrections</em>, it is recommended these formulas be updated to set <em># Days Open</em> and <em>Days Until Due</em> to blank if <em>SEC Issue = Yes</em>. For example:</p>

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  <li><em># Days Open</em>: <code class="language-plaintext highlighter-rouge">If(sec_issue__v = TRUE, NULL, (If(isNull(verdict_date__v), today(), verdict_date__v) - created_date__v))</code></li>
  <li><em>Days Until Due</em>: <code class="language-plaintext highlighter-rouge">If(sec_issue__v = TRUE, NULL, (if(isNull(verdict_date__v), (due_date__v-today()), 10000 + 1)))</code></li>
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You can create additional custom _Self-Evident Correction_ records in Vault. To create a new _Self-Evident Correction_ record:

1. Navigate to **Admin > Configuration > Self-Evident Corrections**.
2. Click **Create**. 
3. Enter a **Name** and **Label** for the _Self-Evident Correction_.
4. In the **Lifecycle State Types** field, select the document lifecycle states when Vault can generate _Self-Evident Corrections_.
5. Select a **Quality Issue Type** for the _Self-Evident Correction_. This field corresponds to the _QC Issue Type_ (`qc_issue_type__v`) on _Quality Issues_.
6. In the **Document Fields**, select the fields that trigger _Self-Evident Correction_ generation when a user modifies them.
7. Click **Save**.

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      <p><strong>Note</strong>: A <em>Self-Evident Correction</em> cannot contain the same document field in the same lifecycle state as another <em>Self-Evident Correction</em>.</p>
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