QualityOne Vaults 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 Admin’s configuration, object, field, and section labels may appear differently than the labels mentioned in this article.

About Lab Investigations 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

The Lab Investigation process broadly consists of the following steps:

Creating a Lab Investigation

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

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.