Aligning R&D Risk Management Through a Single Source of Truth

One Truth, One Quality Risk Register: Aligning R&D for Effective Risk Management

A source of truth is a source of Truth. I can’t have my truth, you can’t have your truth, and he can’t have his truth. Yet in many pharmaceutical organizations, that’s exactly what I see happening — especially in R&D functions.

Different teams document potential risks in their own ways. Some rely on Risk-Based Study Management (RBM) tools, others on Quality by Design (QbD) principles, and others still use Design FMEA. Each method has value in its own context, but when teams operate in silos, multiple “truths” emerge — and that creates challenges for transparency, decision-making, and effective risk mitigation.

The Problem: Fragmented Risk Documentation

Using different tools across teams is not inherently wrong. Each approach provides insights, identifies critical factors, and helps manage potential risks. The challenge comes when these risks are not connected to a single source of truth.

Without a unified approach, important risks can be overlooked, mitigation strategies may be inconsistent, and compliance gaps can emerge. Multiple “truths” in the organization undermine the goal of robust risk management.

The Solution: One Source of Truth

The Quality Risk Register (QRR) is that single source of truth. All potential risks — whether identified via RBM, QbD, or Design FMEA — must be documented, assessed, mitigated, and monitored in the QRR.

Alignment matters. The QRR ensures that everyone in the organization has a clear, shared view of risks, their impact, and the actions taken to control them. It is the bridge between tools and organizational clarity.

Our Strategy to Achieve Alignment

To create one truth, one QRR, and an aligned organization, our strategy focuses on three pillars:

1. Align
   • Make sure everyone understands the “why” behind using the QRR.
   • Leadership emphasizes the importance of a single source of truth and sets expectations for documentation and risk management practices.
2. Develop Consistency
   • Standardize documentation methods while maintaining connection points with the tools teams already use.
   • For example, RBM entries, QbD insights, and FMEA results all feed into the QRR in a structured, traceable way.
3. Enable
   • Provide practical support through templates, training, and a Community of Practice (CoP).
   • Offer a playbook to guide teams on how to capture, triage, and monitor risks effectively.
   • Encourage collaboration, knowledge sharing, and continuous improvement.

The Outcome: Transparent and Effective Risk Management

By aligning, standardizing, and enabling, organizations can achieve:

• One truth, one QRR, and a consistent view of all potential risks.
• Transparent risk management that enables informed decision-making.
• A culture where tools serve as enablers, not barriers, to alignment and quality.

Risk management is not just about compliance — it’s about ensuring clarity, accountability, and resilience across the organization.

Reflection

How does your team ensure alignment in documenting and managing risks? Are all your risks captured in one source of truth, or are multiple “truths” driving decisions?

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