OOS Investigation Decision Matrix Template

Instructions:
Scoring Guide:
1: No concern/Minimal impact | 2: Low concern | 3: Moderate concern | 4: High concern | 5: Critical concern/Maximum impact

Phase I: Laboratory Error Assessment Matrix

Assessment Criteria Weight Score (1-5) Weighted Score Comments/Rationale
Analyst Experience/Training 15% 0
Equipment/Instrument Issues 20% 0
Calculation/Transcription Errors 25% 0
Sample Handling Issues 20% 0
Method/Procedure Deviations 20% 0
TOTAL WEIGHTED SCORE 100% - 0 Phase I Decision
Phase I Decision Outcome:
Enter scores to see recommendation

Phase II: Full Investigation Assessment Matrix

Assessment Criteria Weight Score (1-5) Weighted Score Comments/Rationale
Manufacturing Process Deviation 25% 0
Environmental/Facility Issues 20% 0
Raw Material/Component Issues 20% 0
Equipment/Utility Malfunction 15% 0
Sampling/Storage Issues 10% 0
Personnel/Training Issues 10% 0
TOTAL WEIGHTED SCORE 100% - 0 Phase II Decision
Phase II Decision Outcome:
Enter scores to see recommendation

Risk Assessment & Batch Disposition Matrix

Risk Assessment Criteria Weight Score (1-5) Weighted Score Comments/Rationale
Patient Safety Impact 30% 0
Critical Quality Attribute Affected 25% 0
Regulatory Compliance Risk 20% 0
Historical Trend/Pattern 15% 0
Investigation Confidence Level 10% 0
TOTAL RISK SCORE 100% - 0 Final Decision
Final Decision Outcome:
Enter scores to see recommendation

Decision Outcome Guidelines

Score Range Risk Level Recommended Action Regulatory Consideration
1.0 - 2.0 Low Risk Proceed to next phase or accept batch with standard monitoring Standard documentation
2.1 - 3.5 Medium Risk Enhanced investigation or accept with additional controls Enhanced documentation required
3.6 - 5.0 High Risk Reject batch or initiate Phase III investigation Regulatory notification may be required