Technical Risk Assessment (TRA) & Root Cause Analysis (RCA)

Home

Service Details

Operational Reliability

TRA & Root Cause Analysis

Predict, prevent and resolve technical risks in pharmaceutical manufacturing.

Technical Risk Assessment (TRA) anticipates problems before they occur, while Root Cause Analysis (RCA) addresses issues that have already happened. UDQS integrates both to build a culture of high-reliability manufacturing.

The Purpose of TRA

  • Predict potential technical failures
  • Design scientific mitigation strategies
  • Improve process robustness
  • Strengthen product knowledge

The TRA Process

  • Stakeholder technical engagement
  • Process status documentation
  • Risk area identification
  • Product Control Strategy development

When to Deploy TRA

  • New Product Introduction (NPI)
  • Major equipment or HVAC changes
  • Chronic or recurring process issues
  • Post-audit remediation projects

The Path to Root Cause Resolution

Our structured RCA and CAPA facilitation follows a rigorous 7-step model designed to reduce issue recurrence and ensure full regulatory compliance.

  • 01 Define the Problem
  • 02 Data Review & Gathering
  • 03 Technical Gap Analysis
  • 04 Root Cause Identification
  • 05 Action Planning (CAPA)
  • 06 Implementation of Solutions
  • 07 Follow-up & Verification

Science-driven resolution for complex manufacturing challenges.

Let’s Build Your Path to Regulatory Excellence.