Click here to view the "Adding an Out of Specification Report" Video


Note: Some fields may be missing or labeled differently in your database if your Admin has customized the Out of Specification Report.

Customizing your Out of Specification Report


To customize a field in your Out of Specification Report, hover next to the field name and click the pencil icon. This lets you change the label to better suit your organization’s needs.




Your Out of Specification Report can also be customized within Team Settings. For more information,

click here.


Within Team Settings, you can: 

  • Change the module name and icon
  • Update e-signature settings
  • Modify the abbreviation in the list view
  • Hide or require specific fields


Can't customize the Out of Specification Report? That's because your not an Admin.  See Isolocity's User Permissions, here.

Creating an Out of Specification Report

Step #1

Click here to access the "CAPA" sub-menu.


Step #2

Click "Out of Specification".


Step #3

Click "Create Report".


Step #4

Complete the "Administrative Details" section by completing the following fields:

  • OOS #
  • Date Requested
  • Batch Number


Step #5

Complete the "Owners and Subscribers" section by completing the following fields:

  • Owners (those who can edit the report)
  • Subscribers (those who can only view the report)
  • Process Owners
  • QA Reviewers
  • Impact
  • Departments


Step #6

Complete the "Phase I - Laboratory Investigation" section by completing the following fields:

  • Sample Name
  • Sample ID
  • COA Number
  • Date Request Sent to Contact Lab
  • Error Code
  • Name of Laboratory Used
  • Description of Laboratory Investigation
  • Assignable Cause Found
  • Recommended Actions


Step #7

Click "Create Report" to save your progress.


Step #8

Complete the "Phase II - Expanded Investigation" by completing the following fields:

  • Review of:
    • Batch Records
    • Environmental Conditions
    • Sampling
    • Labelling 
    • Previous OOS
    • Raw Materials
    • Stability
    • Equipment Maintenance
    • Equipment Calibration
    • Training
  • Other
  • Assignable Cause Found
  • Details
  • CAPA #
  • Conclusion
  • Recommended Action
  • Plan For Additional Testing
  • Number of Tests
  • Number of Laboratories
  • Results from Additional Testing
  • Results
  • CAPA Number
  • OOS Investigation Closed By


Step #9

Click "Save and Close"


Step #10

Click here to download a PDF of your report.