“Before making a decision, we have to look at the issues end-to-end. We have to consider how our actions will impact the customer.”
In this Let’s Talk Risk! conversation (naveenagarwalphd.substack.com/podcast) , Rajesh Kathuria emphasizes the need to consider the full impact of our actions on safety of customers and users and quality of performance. As an example, when working at the component level, we should consider the impact of any changes at the system level and how it could affect the safety of end user or the patient.
Rajesh advises industry colleagues to take the emotions out, and rely on data as much as possible. If you don’t have good quality data, your first decision could be to take the time and gather more information, especially when the potential consequences of failure could be catastrophic. He also recommends to consider diverse viewpoints from a cross-functional experienced team as part of the decision making process.
Listen to this Let’s Talk Risk! conversation with Rajesh Kathuria which also includes an open discussion with a live audience. Jump to a section of interest using these timestamps.
00:02:10 Introduction
00:05:42 Considering risks in decision making
00:08:25 An example of missing long-term factors in decision making
00:10:09 Taking a systems approach to finding solutions
00:12:13 An example of a difficult decision to delay a project to ensure safety
00:14:30 Difficult decisions require courage to do the right thing
00:16:30 Leadership advice for QA/RA professionals
00:17:50 Audience Q&A and open discussion
00:35:50 Closing comments and key takeaways
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Suggested links:
LTR podcast: Understanding risk-based thinking (naveenagarwalphd.substack.com/p/understanding-risk-based-thinking)
LTR podcast: Getting comfortable with a probabilistic way of thinking about risk (naveenagarwalphd.substack.com/p/risk-management-needs-probabilistic-thinking)
About Rajesh Kathuria
Rajesh Kathuria (www.linkedin.com/in/rajesh-kathuria-599546/) is a currently the Owner and Director at KMS Solutions, B.V, providing strategic consulting services in Quality and Regulatory for medical device companies. He is a seasoned leader with over 20 years of industry experience in senior leadership positions. He holds a Bachelors degree in Mechanical Engineering and Graduate degree in Management with specialization in International Marketing and Finance. He is also a certified ISO 13485 lead auditor and has extensive experience of auditing/working in various geographies and different global regulations.
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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