Out-of-Specification (OOS) is a very critical subject indicating non-conformance. QuaLIS triggers the OOS module once an OOS has been reported for a specific sample/test. A detailed investigation is conducted in a structured workflow and the findings are documented.
Out-of-Specification (OOS) goes through a rigorous workflow path. The activity workflow can be configured with Roles as per your SOP.
User configurable checklists can be created and maintained. They are a first level screening for the OOS incident that has happened. Checklists are predefined and kept. Required checklists can be associated during the OOS review.
It is possible to assign roles/personnel to start investigations on the OOS. While investigating any number of re-tests, re-sample & re-test etc. can be ordered.
The investigations are verified and based on that one can move forward with the workflow or can raise an objection and move back.
The root cause of the OOS incident when identified is reported. Details of root cause and action taken is recorded. Multiple cause records can be added to the OOS record.
Evaluation and Closure
Once all the steps are completed, the final evaluation is done by reviewing all the record details captured and concluded.
- All OOS situations are recorded – Detailed investigation recording
- Cause & correction is recorded– Tracking and follow up on OOS
- Reporting with detailed investigation & results – Reduce OOS incidents