Ep. 09: Tips for a risk-based approach to auditing quality systems

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Medical device manufacturers face an enormous burden of audits and inspections. Even regulators around the world recognize the enormous burden that the numerous audits and inspections place on manufacturers, stealing resources and time that they could otherwise invest in new product development and continuous improvement efforts.

In the area of regulatory compliance, there is a movement towards a least burdensome approach to regulatory decision making throughout the device lifecycle. In this context, testing practices in the industry are moving from an element-based approach to a risk-based approach.

In this episode, Rick Rios explains what risk-based auditing is and shares best practices for conducting a risk-based audit with maximum effectiveness. We also discuss common challenges related to the CAPA process in the industry.

About Rick Rios

Rick Rios began his career in the defense industry as a systems engineer for nuclear programs. Inspired by the Total Quality Management movement, he moved into a quality and regulatory role and later worked as an independent auditor in the automotive and aerospace industries. He has served as an independent auditor in the medical device industry for nearly 15 years. He has successfully developed, integrated, implemented and audited quality systems based on ISO 13485, 21CFR820, MDSAP, EUMDR, DOE QC-1, NQA-1, ISO 9001, ISO 17025, NCSL Z540 and the Baldrige Performance Excellence Program.

About “Let's Talk Risk” with Dr. Naveen Agarwal

Let's Talk Risk with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn where we discuss risk management topics in a relaxed, informal atmosphere. Join us every Friday at 11:00 a.m. EST on LinkedIn.

Disclaimer

The information and insights presented in this podcast are for educational purposes only. The views expressed by all speakers are their own and do not reflect the views of their respective organizations.

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