Introduction to Out of Specifications
Out of Specification (OOS) results are test results that fall outside the predefined acceptance criteria.
OOS results indicate potential issues with product quality, process control, or laboratory procedures.
Regulatory Expectations
A thorough and timely investigation must be conducted.
The FDA provides guidance on investigating OOS results to ensure compliance.
Investigation Process
Initial Laboratory Investigation
Verify the accuracy of the test procedures.
Review analyst performance, equipment calibration, and environmental conditions.
Full-Scale Investigation
If no lab errors are found, expand the investigation to manufacturing processes.
Examine batch records, raw materials, and process parameters.
Root Cause Analysis
Identify the underlying cause of the OOS result.
Use tools like fishbone diagrams and the 5 Whys method.
Corrective Actions
Implement measures to correct the identified issue.
Update procedures or provide additional training as needed.
Preventive Actions
Take steps to prevent recurrence.
May involve process changes or enhanced monitoring.
Documentation
Record all findings, actions taken, and conclusions.
Maintain transparency for regulatory review.
Impact on Product
Assess whether the OOS result affects other batches or products.
Determine if product recall or additional testing is necessar.