Episode
LTR 162: Using HHE for Risk-Based Decisions
- Podcast
- Let's Talk Risk! Podcast
- Published
- Jul 31, 2026
- Duration seconds
- 1661
- Processing state
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Summary
Summary “When done well, HHE evolves from a procedural requirement into a strategic tool that reflects how your organization makes risk-based decisions.” In this episode of the Let’s Talk Risk! conversation , host Naveen Agarwal speaks with Kerry Flecknoe, Senior Manager, Global Quality – HHE at Getinge, about the role of Health Hazard Evaluations in postmarket risk management. Kerry explains that although organizations may use terms such as HHE, HHA, or HRA, the terminology is less important than having a structured and documented process for evaluating health risk. In the QMSR era, organizations must be able to demonstrate that risk-based decisions are made consistently and intentionally—not only within formal risk management activities, but across the quality management system. The conversation explores how ISO 14971 can provide a defensible framework for HHEs, why field actions should themselves be evaluated as risk control measures, and how teams can make responsible decisions when complaint data, probability estimates, or other evidence are incomplete. Kerry also shares practical guidance for smaller manufacturers, cross-functional teams, and distributors of third-party products. Listen to the full 25-minute podcast or jump to a section of interest listed below. Chapters 00:00 – Introduction and Why HHE Matters in the QMSR Era 01:24 – What HHE Is, FDA Terminology, and the Need for Documentation 05:04 – Building an HHE Process Around ISO 14971 06:18 – HHE as Postmarket Risk Management and Field Action as a Risk Control 08:41 – Evaluating Probability When Postmarket Data Are Limited 14:08 – Cross-Functional Roles and the Mechanics of an HHE 16:49 – Feeding Postmarket Evidence Back into the Risk Management File 18:42 – Building a Lean HHE Process and Defining Clear…