Navigating Through OOS Reports

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 formal investigation to identify root causes, ensure product quality, and maintain patient safety and regulatory compliance.

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Accessing OOS Reports

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. In the blue sidebar menu, click Compliance.
6. Select Out of Specification Events.

Available widgets include:

• OOS Dashboard
• OOS
• OOS Reports

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OOS Reports Overview

Click OOS Reports to open the OOS Reports window, displaying all new OOS reports in List View.

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OOS Statistics & Filters

OOS Stats

Use the Period dropdown or specify a From Date and To Date range.
Apply the Context filter to select:

• Clinical Trials
• Pharmacy

Widget Statistics

Five summary widgets are displayed:

• Total OOS – Total number of OOS events reported
• New – Newly reported OOS events
• Invest – OOS events under investigation
• Review – OOS events under review
• Close – OOS events closed through the CAPA process

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Creating a New OOS Report

1. Click + New OOS.
2. Enter:
   • Report Date
   • Occurrence Date
   • Department
   • OOS Description
3. Click:
   • Submit and Start Investigation
     or
   • Submit (if reporting an additional occurrence)

The report opens in Detailed View with a status of Under Investigation.

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OOS Detailed View Structure

The OOS Detailed View contains four main sections.

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1. Summary

• Displays the OOS reference number (example: 101262)

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2. Report Information

1. Click Edit
2. Enter:
   • Group (dropdown)
   • Type (dropdown)
   • Category (dropdown)
   • Sub Category (dropdown)
3. Click Save

Additional Fields

• Risk Analysis: Critical | Major | Minor
• Reported to State: Yes | No

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3. Staff Related

1. Click Edit
2. Search for staff members
3. Select staff using the right arrow icon
4. Selected staff appear in the Staff Selected area
5. Click Close

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4. Related Records (Paper Clip Icons)

Attach related records as applicable:

• Patient
• Provider
• Prescription
• Order
• Dispense
• Lot
• Product
• Study
• Equipment
• Area
• Formula

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OOS Progress Table

The OOS Progress Table contains five tabs:

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OOS Description

OOS results may arise at any stage of pharmaceutical manufacturing, from raw materials to finished products. Each event requires a thorough investigation to ensure quality and patient safety.

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Investigation

• Assign an Investigator using the pencil icon
• Document investigation details and findings
• Identify initial observations and potential causes

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Root Cause

Common root causes include:

• Laboratory errors
• Equipment malfunctions
• Human error
• Raw material issues
• Manufacturing process deviations

Click + New and enter:

• Description
• Department (dropdown)
• Element (dropdown)
• Root Cause (dropdown)

Click Save

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Correction / Containment

Document corrective and containment actions:

• Enter Cost
• Provide a detailed Corrective Action description

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SOP

1. Search the SOP list
2. Select applicable SOPs using the right arrow icon
3. Selected SOPs move to the SOP Selected area
4. Click Close

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Documents

1. Use the Search bar to locate documents by filename
2. Click + Document
3. In the Add Document window:
   • Drag and drop documents
   • Select document type
   • Enter a description
4. Click Save

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Communication Notes

1. Click + Note
2. Select document type:
   • Email
   • Note
   • Phone Call
   • SMS
3. Enter communication details
4. Add supporting documents or images (drag and drop)
5. Click Save

Communication Actions

• Print Note
• Fax Note (enter recipient details and attach documents)
• Fax as PDF
• Open Document
• Dismiss

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OOS Actions

Available actions include:

• Submit for Review
• Move to CAPA
• Quality Report (printable OOS Report)
• QRE Report (Confidential Report of an Occurrence)
• Access Logs
• Change Logs
• Progress Log
• Discard OOS Event

Each action includes confirmation dialogs where applicable.

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Summary

The OOS Reports module provides a structured, compliant workflow to:

• Track and investigate OOS events
• Assign accountability
• Document root causes and corrective actions
• Generate regulatory and quality reports
• Maintain full audit and change history

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This completes the step-by-step guide on Navigating Through OOS Reports.