“It’s too often confused with risk management itself. Part of the risk-based approach is just the mindset, the thinking about risk, and then deciding ‘so what should we do?’, the answer to which might be a formal risk management.”

In this Let’s Talk Risk! conversation, Steve Gompertz clarifies a subtle difference between a risk-based approach and formal risk management according to standards such as ISO 14971. Risk-based approach is more about a mindset and a set of behaviors that lead to risk-based decisions, rather than application of specific risk management tools such as FMEAs.

Steve advises manufacturers to consider adding a section in each procedure to describe a risk-based approach appropriate to that process. Another good practice is to create an alignment matrix to map differences in the risk-based approach to different processes of the quality system.

Listen to this Let’s Talk Risk! conversation with Steve Gompertz, which also includes an open discussion with a live audience. Jump to a section of interest using these timestamps.

00:01:40 Introduction

00:03:38 What is risk-based approach and why it is not the same as risk management

00:06:22 How to practice and demonstrate a risk-based approach

00:08:15 A practical way to document risk-based approach

00:11:23 How auditors assess the practice of risk-based approach

00:13:41 Striking the right balance between documentation and operating culture

00:17:38 Audience Q&A and general discussion

00:32:57 Closing comments and key takeaways

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Suggested links:

Understanding risk-based thinking

Risk-based approach to building a QMS in a startup

Tips for applying a risk-based approach to auditing Quality Systems

About Steve Gompertz

Steve Gompertz is a Partner at QRx Partners, providing consulting services to medical device companies in quality system assessment, development and remediation, audit preparation, SOP and forms development, regulatory body response guidance and quality system education. He has over three decades of industry experience at many leading organizations including Medtronic, Boston Scientific and Canon. He is also a Senior Adjunct Instructor at St. Cloud University. Steve has a Bachelor’s degree in Mechanical Engineering, a mini-MBA certificate in Medical Technology, and multiple certifications including ASQ Manager of Quality/Organizational Excellence, Medical Device Auditor, EU-MDR auditor and MDSAP.

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

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