Episode
LTR 153: Sherita Black on Building a Practical Policy for Risk Acceptability
- Podcast
- Let's Talk Risk! Podcast
- Published
- May 1, 2026
- Duration seconds
- 1764
- Processing state
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Summary
Summary “Just having a policy in place is one thing. Having a QMS that aligns to it is the next.” In this Let’s Talk Risk! conversation , host Naveen Agarwal speaks with Sherita Black about one of the most challenging and often misunderstood topics in ISO 14971: creating a policy for risk acceptability. The conversation goes beyond the standard’s wording and gets into the practical questions that many teams struggle with: who top management really is, how to involve them, and how to turn policy into something that actually drives decisions. Sherita brings a strong cross-functional perspective shaped by years of experience in pharmaceutical validation, medical device design quality, complaint handling, and enterprise risk management. In her current role as Risk Management Business Process Owner at BD, she focuses on maintaining risk management procedures, aligning stakeholders, and supporting an effective risk management program across the organization. Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters 00:00 – Introduction 02:48 – What ISO 14971 expects from top management 03:54 – Why a risk management policy matters 05:56 – Three approaches to risk control and acceptability 08:44 – How to identify the right top management group 14:32 – Risk management policy vs. quality policy 18:10 – What evidence auditors expect to see 24:31 – Why strong risk management can become competitive advantage If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter . Suggested links: LTR: ISO 14971 Fundamentals - Risk Acceptability Policy LTR: Top Management Responsibility for Risk Management . LTR: LTR Risk Coach - AI-Powered Decision Support Tool . Key Takeaways * A risk management policy sets the framework for how an…