Purpose: This interactive decision matrix provides a structured, risk-based approach for evaluating Out-of-Specification (OOS) test results during pharmaceutical manufacturing investigations. The tool aligns with current FDA and MHRA regulatory requirements for OOS investigations and supports objective decision-making through weighted scoring criteria.
Key Benefits: Standardizes investigation decisions, provides audit trail documentation, ensures regulatory compliance, reduces subjective bias, and supports scientific justification for batch disposition decisions
I’ve created a comprehensive decision matrix template that complements the OOS decision tree. This interactive tool provides: https://pres.net.in/wp-content/uploads/2025/06/Investigation-_Index.html
Key Features:
Three-Phase Assessment Structure:
- Phase I: Laboratory Error Assessment (aligns with FDA/MHRA Phase I requirements)
- Phase II: Full Manufacturing Investigation Assessment
- Risk Assessment & Batch Disposition: Final decision matrix
Scoring System:
- Weighted Criteria: Each factor has appropriate weight based on regulatory importance
- 1-5 Scale: Clear scoring from minimal to critical concern
- Automatic Calculations: Real-time weighted score calculations
- Decision Outcomes: Color-coded recommendations based on total scores
Regulatory Compliance:
- FDA/MHRA Aligned: Criteria match latest OOS investigation requirements
- Documentation Support: Comment fields for rationale documentation
- Risk-Based Decisions: Patient safety prioritized in weighting
- Regulatory Triggers: Clear guidance on when notification is required
Decision Outcome Ranges:
- Low Risk (1.0-2.0): Proceed with standard controls
- Medium Risk (2.1-3.5): Enhanced investigation/controls needed
- High Risk (3.6-5.0): Batch rejection or regulatory notification required
Usage Benefits:
- Objective Decision Making: Removes subjective bias from critical decisions
- Audit Trail: Documents rationale for each scoring decision
- Consistency: Standardizes decision-making across different investigations
- Regulatory Defense: Provides scientific justification for decisions
This matrix template can be saved, filled out for each OOS investigation, and maintained as part of the investigation file to demonstrate systematic, science-based decision making that meets FDA and MHRA expectations.
⚠️ IMPORTANT DISCLAIMER
This tool is for guidance purposes only and does not replace professional judgment or regulatory requirements.
- Regulatory Compliance: Users must ensure compliance with applicable FDA, MHRA, EMA, or other relevant regulatory guidelines in their jurisdiction
- Professional Oversight: All decisions must be reviewed and approved by qualified Quality Assurance personnel
- Company Procedures: This tool should supplement, not replace, established company SOPs and procedures
- Risk Assessment: Final decisions must consider all relevant factors beyond those captured in this matrix
- Documentation: Complete investigation documentation is required regardless of matrix outcomes
- No Liability: Users assume full responsibility for decisions made using this tool
Version: 1.0 | Last Updated: June 2025 | Regulatory Basis: FDA OOS Guidance & MHRA Guidelines
