# Working with Lab Investigations (QMS)

<a href="/en/gr/78610/">QualityOne Vaults</a> allow you to perform lab investigations for out-of-specification (OOS) and out-of trend (OOT) inspection sample test results. The Lab Investigations feature allows you to document, standardize, and track the process of performing Phase I and Phase II lab investigations and add information to the investigation about the initial lab test result, the root cause, risk assessment items, corrective actions, and more.

Depending on your <a href="/en/gr/577584/">Admin's configuration</a>, object, field, and section labels may appear differently than the labels mentioned in this article.

## About Lab Investigations Terminology {#terminology}

* **OOS test result**: Out-of-specification test results that do not meet the established specifications.
* **OOT test result**: Out-of-trend results conform to the specifications, but do not conform to the expected trend with respect to the initial or expected result.
* **Phase I investigation**: An investigation to ensure the irregular lab result was not caused by lab contamination or otherwise inaccurate data.
* **Phase II investigation**: An investigation to find the cause of the irregular lab analysis, including investigation of production, additional testing, and examination of data methods.

## About the Lab Investigations Process {#process}

The Lab Investigation process broadly consists of the following steps:
* Receive an OOS or OOT <a href="/en/gr/515321/#evaluate-inspection">test result</a>.
* [Create a new _Lab Investigation_][1]. You can relate the _Inspection_ record to the lab investigation.
* Start the [_Phase I Lab Investigation_ workflow][2], and if the Phase I investigation identifies that the result is not a lab error, start the _Phase II Investigation_ workflow.
* If there is a need for further investigation or an unidentifiable root cause, open an <a href="/en/gr/62417/">NCR</a>, <a href="/en/gr/75870/#objects">CAR/SCAR</a>, or <a href="/en/gr/57126/#working-with-rca">root cause analysis</a> directly from the _Lab Investigation_.

## Creating a Lab Investigation {#create}

To create a new _Lab Investigation_, do the following:

1. Navigate to **Business Admin > Lab Investigations.** 
2. Click **Create**. 
3. Set the status to **Active**.
4. Select an **Investigation Type**. 
5. Enter a **Title** for the investigation.
6. Enter a **Description** for the investigation.
7. Enter the necessary details about the sample, personnel, department, facility, material, inspection, master specification group, risk assessment, and root cause relating to the lab investigation.
8. Click **Save** or **Save + Create** to create another _Lab Investigation_.

Once you create a _Lab Investigation_, you can add related records and documentation to the different sections of the object details page, including the initial test sample result, risk assessment details, root cause analysis, and corresponding corrective actions.

To associate relevant documents with specific _Lab Investigation_ records, specify the investigation in the _Lab Investigation_ field on _Lab Investigation_ type documents.

## Starting, Approving, & Closing Lab Investigations {#workflows}

There are two (2) pre-defined _Lab Investigation_ workflows for opening, closing, and approving Phase I and Phase II investigations. You may be able to initiate a workflow from the **Workflow Actions** menu, if configured by your Admin.

[1]: #create
[2]: #workflows