# Working with Quality Issues You can track, manage, and report on quality issues in your Vault using a document lifecycle state user action and the _Quality Issue_ object. The _Quality Issue_ object is a standard Vault object that allows you to create and assign issues and quality checks, track who is responsible for fixing specific issues, and report on the number of open issues in your Vault, among many other valuable applications.

Note: This feature is only available on Clinical Operations eTMF and Clinical Operations Study Startup Vaults. Some configuration by an Admin is required before you can start logging Quality Issues for documents.

## Creating Quality Issues Imagine for a moment that, upon reviewing a document in your Vault, you realize there are inconsistencies with a document that Joe is responsible for. You would like Joe to resolve this issue, so you decide to create a _Quality Issue_.

Note: You should only create and track Quality Issues on the most recent versions of Classified documents. Using Quality Issues for Unclassified documents may cause Issue Count fields to be out of sync.

To create a _Quality Issue_: 1. From the document's **Actions** menu, select **Log Quality Issue**. 2. In the dialog, select a user for the **Assigned To** field. Note that the _Assigned To_ field defaults to the document owner, and the drop-down menu for the field lists only users with at least view permission and a role on the document when an Admin configures the _Securing Assigned To_ application control field. In this case, you select Joe. 3. Select the **QC Issue Type** and enter **QC Issue Comments**. 4. Optional: If you create a _Quality Issue_ from the object records page, manually select the _Related Document_. A _Quality Issue_ can only have a single _Related Document_, but a document can have multiple _Quality Issues_. 5. If study and blinding security is enabled in your Vault, Vault defaults the **Study** and **Content** fields to the corresponding fields on the document. If the document has multiple _Study_ field values, you must select one. 6. Click **Save**.

Note: Depending on your Vault’s configuration, the Content document field may be labeled Blinding.

Upon saving, Vault automatically assigns Joe a _Quality Issue Task_ to fix the issue, sends him an email notification, and populates the following fields on the _Quality Issue_ object record: * **Quality Issue ID**: The ID of the _Quality Issue_ (QI-{#####}) * **Due Date**: Defaulted to the created date plus 28 days. An Admin can change this number when they configure _Quality Issues_. * **Number of Days Open** * **Days until Due** You can view all _Quality Issues_, open or closed, for a particular study from the TMF Homepage. ### Creating Self-Evident Corrections (SECs) Self-Evident Corrections allow Quality Control (QC) Specialists to correct specific errors on documents while also having Vault track the occurrence of these _Quality Issues_, leading to a more streamlined quality review process. When a QC Specialist corrects specific errors on document metadata, Vault creates and resolves a _Quality Issue_ outlined by the different _Self-Evident Correction_ records. _Self-Evident Correction_ configurations generate _Quality Issues_ of a defined _QC Issue Type_ based on a document's lifecycle state and the document fields a user modifies. Vault flags these _Quality Issues_ as _Self-Evident Corrections_ through the _SEC Issue_ (`sec_issue__v`) field on the _Quality Issue_ object. _Self-Evident Correction_ configurations trigger Vault to generate _Quality Issues_ of the _Pre-Approval Issue_ and _Post-Approval Issue_ object types, based on the related document's lifecycle state. Vault only creates one _Self-Evident Correction Quality Issue_ when users change more than one document field defined under the same _Self-Evident Correction_ configuration record. Vault will not create a new _Self-Evident Correction Quality Issue_ if a user changes a document field defined under a _Self-Evident Correction_ with the same _Quality Issue Type_ as an open _Quality Issue_. 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. An admin must activate these _Self-Evident Corrections_ configurations to allow their use in your vault. Additionally, an Admin can configure new _Self-Evident Correction_ records to generate additional _Self-Evident Correction Quality Issues_. ## Resolving Quality Issue Tasks As with other tasks, Joe sees the newly created _Quality Issue_ in **Home > My Tasks**. Joe can click on the task to view the related document, issue type, and issue comments. He can also re-assign the task using the **Reassign** action on the task in the _Workflow Timeline_. Once Joe decides how to handle the issue, it's time for him to close it. Joe navigates back to **My Tasks** and clicks **Complete** for the _Quality Issue_. He can also do this from the _Quality Issue_ object record. At this point, Vault prompts Joe to provide a verdict for the issue: **Resolved**, **Unresolved**, or **Non-Issue**. Vault requires a reason for the **Unresolved** and **Non-issue** verdict.