1. Critical OOS/Incident
2. Initiated
2.1. Reviewed- Reviewer
2.1.1. HOD Review
2.1.1.1. QA review
2.1.1.1.1. HOD- INvestigation Team Assign
3. Phase-I
3.1. Preliminary Investigation-Phase-I-part-A
3.1.1. PhaseI-part-B-Remeasurement
3.1.1.1. Assinable Cause
3.1.1.1.1. Yes
3.1.1.1.2. NO
3.1.2. Analyst Interview
3.1.2.1. Telephonic
3.1.2.2. In person
3.1.3. Questainnnaire
3.1.4. FIshbone Analysis Method for Investigation
4. Phase -II Investigation
4.1. IIA- Production Investigation
4.1.1. QA Head Authorization
4.1.1.1. Production Head Investigation Team Formation
4.1.1.1.1. Lead Investigator-PRD
4.2. Phase IIB-Additional Laboratory Testing
4.2.1. Additional Hypothesis Testing
4.2.1.1. Assignable Cause Identified
4.2.1.1.1. Yes
4.2.1.1.2. No
4.2.2. Repeat
4.2.2.1. Analyst-II
4.2.2.1.1. i
4.2.2.1.2. ii
4.2.2.1.3. iii
4.2.2.2. Analyst-I
4.2.2.2.1. I
4.2.2.2.2. II
4.2.2.2.3. III
4.2.2.3. Original Result
4.2.2.3.1. Valid
4.2.2.3.2. Invalid
4.3. Assignable cause Idebtified
4.3.1. Yes
4.3.1.1. Invalidate OOS Result
4.3.1.1.1. Repeat Analysis
4.3.2. No
4.3.2.1. Phase-III
5. Phase-III - Evaluation
5.1. Review Phase I & II
5.1.1. Phase-IIA Review
5.1.2. Phase IIB Review
5.2. Review Method Validation
5.3. Review of all other tests related to the batch and other batch historical data
5.4. Impact of OOS result on other batches
5.5. Impact of OOS result on going stability studies
5.6. Impact of OOS result on validated processes and testing procedures
5.7. Evaluation & Final Batch Disposition
5.7.1. Reject
5.7.1.1. Rejetcted
5.7.1.1.1. Send To CQ head for Authorization
5.7.1.2. Customer Communication
5.7.2. Furthefr Investigation To Identify RCA
5.7.2.1. CAPA