Out of Specification (OOS) Events Dashboard

Compliance · OOS Events Dashboard · Step by Step

An Out of Specification (OOS) event occurs when a test result falls outside predefined acceptance criteria for a product or process. These events require investigation to determine root cause and ensure ongoing product quality, safety, and compliance.

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Accessing the OOS Events Dashboard

1. Click the FileMaker Pro icon to open FileMaker.
2. When FileMaker opens, locate the large menu bar on the left.
3. Click SiCompounding (near the top).
4. From the center icons, click Pharmacy to open the Dashboard.
5. From the blue sidebar menu, click Compliance.
6. Select Out of Specification Events.

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OOS Event Widgets

The Out of Specification Events area displays the following widgets:

• OOS Dashboard
• OOS
• OOS Reports

Clicking OOS Dashboard opens the OOS Events window.

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OOS Dashboard Main Menu

Located at the top-right of the OOS Events window:

• + New OOS
  Start a new OOS investigation
  See: How to Add a New OOS Report

• OOS Reports
  Access reporting options
  See: OOS Reports

• General Features
  Includes:

  • Search
  • Lookup
  • < Go Back
  • Help
  • Notifications (Bell icon)
    See: General Features of SiCompounding

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OOS Dashboard Status Widgets

The dashboard includes seven status widgets used to track progress:

• New
  OOS reports ready to begin investigation

• Under Investigation
  OOS reports actively being investigated

• View All
  Displays a List View of OOS reports under investigation

  • Filter by Progress Status
  • Print or export results
  • Click a record to open Detail View

• Need Review
  OOS reports awaiting review

• Pending Approval
  OOS reports awaiting approval

• CAPA New
  Newly created Corrective and Preventive Action (CAPA) reports

• CAPA In Progress
  CAPA reports actively addressing identified quality issues

• CAPA Pending Approval
  Proposed CAPA actions awaiting official approval
  (Search available)

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Searching OOS Records

• Click the Search tab at the top
  or
• Click View All next to the Search bar

This opens the Search window displaying related records in List View.

Filter by Progress Status

Use the Progress Status dropdown to filter records by:

• Canceled
• Closed
• Moved to CAPA
• New
• Pending Approval
• Under Investigation
• Under Review

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Reporting & Printing OOS Records

To the right of the Progress Status filter, you will see three report/print icons. Each action applies to the current found set of records.

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PDF Report

1. Click the PDF Report icon.
2. Confirm the dialog:

   Exporting data from the found set of ### records to a PDF file on your desktop?

3. Click OK.
4. The PDF is generated and saved to your desktop.

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CSV Report

1. Click the CSV Report icon.
2. Confirm export to CSV.
3. The Select Columns window opens.

Column Selection Options

• Clear – removes all selected columns
• Select All – selects all columns
• Set as Custom – saves selected columns as default
• Use Custom – reloads saved column preferences

Recommended workflow:

1. Click Clear
2. Select commonly used columns
3. Click Set as Custom
4. Test by clicking Clear, then Use Custom

Export Options

• Stop and Close – cancels export
• Export and No Wait – background export (may take longer)
• Export and Wait – waits for completion

Once complete:

• A dialog appears: “Generating Report”
• Then: “Your Report Is Ready!”
• Click the report name to download
• Choose save options:
  • Rename file
  • Change save location
  • Automatically open file
  • Create email with attachment
• Click Save, then Close

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Printed Report

1. Click the Printer icon.
2. Confirm export to printer.
3. The document preview opens.
4. Use the Print dialog to configure:
   • Printer
   • Presets
   • Copies
   • Pages
   • File format
5. Click Print.

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Detailed View

• Click the Detailed View button
• Opens the selected OOS record in full Detail View for review and action

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Summary

The OOS Events Dashboard enables teams to:

• Track OOS events by status
• Manage investigations and CAPA processes
• Search and filter records efficiently
• Export reports in PDF or CSV formats
• Maintain compliance and product quality

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This completes the step-by-step guide for the Out of Specification (OOS) Events Dashboard.