Risk Assessment

Risk Assessment

From Assumptions to Actionable Insights

In the pharmaceutical industry, risk isn’t just a possibility—it’s a parameter that must be measured, managed, and mitigated. Agon’s Risk Assessment services enable organizations to proactively identify vulnerabilities in systems, processes, and products. Using globally recognized QRM (Quality Risk Management) methodologies, we help you turn uncertainty into informed decisions that protect compliance, safety, and business continuity.

What We Deliver

Quality Risk Management Framework

Deployment of ICH Q9-aligned QRM models
Integration of risk-based thinking into operations, validations, and change contro
Cross-functional risk ownership and governance planning

Risk Assessment Tools & Techniques

FMEA (Failure Modes & Effects Analysis) for equipment, process, and utilities
HACCP models for contamination and cross-contamination contro
Fault Tree Analysis and Fishbone (Ishikawa) diagram facilitation

Product, Process & Supplier Risk Profiling

Risk ranking of suppliers, raw materials, production lines, and equipmen
Control strategy development and mitigation action planning
Periodic risk review mechanisms and real-time risk dashboards

Why It Matters

Regulatory bodies expect risk-based decisions in validations, audits, and change controls
Reduces the likelihood of deviations, recalls, and quality failures
Enables better resource allocation based on risk criticality
Builds a proactive culture of compliance, safety, and continuous improvement
Essential for designing control strategies in new or evolving operations

Categories

We understand the importance of approaching each work integrally and believe in the power of simple.

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