Raising the Bar in GxP Compliance – Part 33: QRM in Supplier Qualification and Audits.
Welcome to the thirty-third instalment of Raising the Bar in GxP Compliance, Rephine’s expert-led blog series for QA and regulatory professionals. In this edition, we explore how Quality Risk Management (QRM) can be practically applied to supplier qualification and audits. Moving beyond theory, QRM provides a structured way to segment suppliers, tailor audits, and prioritise findings based on impact and risk. Discover how Rephine helps organisations embed QRM into supplier oversight, ensuring efficient resource allocation, stronger compliance justification, and supply chain resilience.
Supplier oversight is evolving.
Regulators now expect QRM to be embedded in every stage of supplier qualification and audits — from segmentation to monitoring. Risk-based approaches are no longer optional; they are essential for compliance, efficiency, and patient safety.
Why QRM is Critical in Supplier Qualification and Audits
Supplier qualification and audits are critical for ensuring compliance, quality, and supply chain resilience. Yet many organisations still apply Quality Risk Management (QRM) in a theoretical way, without embedding it in daily supplier oversight.
Practical Applications of QRM in Supplier Audits
- Risk-based supplier segmentation: classifying suppliers by criticality (API, excipients, packaging, services) and applying differentiated oversight.
- Audit scoping and planning: tailoring the depth and focus of audits according to supplier risk profiles.
- Defining criticality of findings: ensuring audit observations are prioritised based on product impact and patient safety.
- Supplier change management: applying QRM when suppliers introduce new materials, sites, or processes.
- Continuous monitoring: combining QRM with metrics such as on-time delivery, deviations, and complaints to adjust oversight dynamically.
Benefits of Using QRM in Supplier Qualification
- More efficient allocation of audit resources
- Stronger justification for audit frequency and scope
- Better alignment with EMA/FDA expectations on risk-based supplier oversight
- A clear, documented rationale for supplier-related decisions
How Rephine Supports Risk-Based Supplier Audits
We support clients by:
✅ Designing QRM-based supplier qualification frameworks
✅ Running audits with risk prioritisation in mind
✅ Training teams in QRM tools for supplier oversight
✅ Providing benchmarking insights from our global audit experience
Dr. Eduard Cayón
CSO (Chief Scientific Officer)
About the Author:
Dr. Eduard Cayón is the Chief Scientific Officer (CSO) at Rephine, a global leader in GxP compliance and quality assurance.
We don’t just deliver audits or consultancy services — we partner with clients at every stage of their quality journey, offering end-to-end solutions that empower confidence and compliance.
With over 25 years of experience, Rephine has built an enviable reputation as the gold standard in the industry operating from four primary locations: Stevenage in the UK, Barcelona in Spain, India, and Shanghai in China.
Dr. Cayón, who holds a Ph.D. in Organic Chemistry, is a deeply experienced pharmaceutical industry consultant and auditor.
He is dedicated to supporting pharmaceutical, biotech, and medical device companies in meeting the highest standards of manufacturing and supply chain integrity.