FAQs for "Adding an Out of Specification Report (OOS)"


1. What is an Out of Specification (OOS) Report and why is it important?
A: An OOS Report records and investigates any test results or measurements that fall outside predefined specifications. It is essential for maintaining product quality, ensuring regulatory compliance, and preventing the release of non-conforming products.


2. How do I start creating an OOS Report in the Isolocity system?
A: Log in to Isolocity, navigate to the CAPA sub-menu, select "Out of Specification Reports," and click "Create an OOS Report" to begin.


3. What information is required to create an OOS Report?
A: Required information includes:

  • OOS Number: Unique identifier for the report.

  • Date Requested: Date the investigation was initiated.

  • Batch Number: Associated batch for the OOS event.

  • Owners: Individuals responsible for managing the OOS.

  • Subscribers: Optional individuals who can follow progress.

  • Impact Assessment: Potential impact of the OOS.

  • Sample Name and ID: Information about the failed sample.

  • COA Number: Certificate of Analysis number.

  • Error Code: Predefined code categorizing the OOS.

  • Description of Laboratory Investigation: Detailed lab findings.


4. Why is the OOS Number important?
A: It uniquely identifies the report for tracking, referencing, and retrieving throughout the investigation.


5. How do I document the date the OOS was requested?
A: Enter the date the investigation began in the "Date Requested" field to track the timeline and ensure timely follow-up.


6. What should I include in the Impact Assessment?
A: Detail potential effects on product quality, patient safety, and regulatory compliance. This helps determine severity and guide decisions.


7. How do I assign owners to the OOS Report?
A: Click "Add Owners" to assign individuals responsible for managing the investigation, coordinating corrective actions, and completing the report.


8. What is the role of subscribers in an OOS Report?
A: Subscribers follow the report’s progress but cannot make changes, ensuring transparency and effective communication.


9. How do I upload associated files to the OOS Report?
A: Click "Upload Files" to attach lab results, photos, or other supporting documents.


10. How do I document the sample information in an OOS Report?

A: Enter the sample name, sample ID, and COA number in the designated fields to identify the affected sample and track investigation results.


11. How do I categorize the OOS using an error code?
A: Select the appropriate code from the predefined list to categorize the OOS for trend analysis and preventive measures.


12. What should be included in the description of the laboratory investigation?
A: Include tests conducted, observations, and potential causes to explain why the sample failed specifications.


13. How do I determine if an assignable cause was found?
A: After investigation, select "Yes" or "No" in the relevant section. If a cause is identified, document it in detail.


14. What should I do if recommended actions are needed?
A: Document corrective actions, additional testing, or process changes in the "Recommended Actions" section.


15. How do I finalize and approve the OOS Report?
A: Complete all fields, ensure accuracy, and click "Approve" to add an e-signature and officially close the investigation.


16. Can I add additional comments to the OOS Report?
A: Yes, use the "Comments" section to provide extra context or observations.


17. How do I determine if further testing is required?
A: Assess based on investigation results and document plans for additional tests, including labs and expected outcomes.


18. How do I handle situations where results remain out of specification after further testing?
A: Document outcomes and escalate to a Corrective Action, Change Control, or Deviation Report as needed.


19. What is the process for closing the OOS investigation?
A: Ensure all actions are completed and documented. Department manager approval and e-signature close the report.


20. How do I reopen an OOS Report if new information becomes available?
A: Select "Reopen" to update the report and continue the investigation.


21. What are the final steps after closing an OOS Report?
A: Review for completeness and accuracy. Reports may be used for auditing, management review, or regulatory submission.


22. How do I ensure that the OOS process effectively prevents future occurrences?
A: Review closed OOS Reports for trends or recurring issues. Use findings to refine processes, update training, and implement preventive measures.


23. How do I escalate an OOS Report to a Corrective Action or other related reports?
A: Select the appropriate option to link the OOS to a Corrective Action, Change Control, or Deviation Report for further investigation and resolution.


24. What is the role of the activity tracker in the OOS Report?
A: Logs all actions, updates, and user activities to ensure transparency and easy monitoring of progress.


25. How do I manage the impact of an OOS event on other processes or products?
A: Document potential impacts in the Impact Assessment section to ensure all affected areas are addressed.