2025 - October ASQ Orange Empire, Section 0701, Monthly Meeting

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Quality professionals in every industry strive to ensure that products are safe, effective, and perform as expected. But what happens when validation processes, assumed to be comprehensive, inadvertently exclude entire segments of real-world users?

This talk explores a critical, often overlooked risk in validation: when products are tested on a limited population, but deployed to everyone. This issue is highly visible today in the medical device space, and the rise of AI has made it more so. But the root causes of design bias, incomplete testing, and unchecked assumptions are common across sectors.

We’ll discuss two case studies from healthcare: how early AI-based dermatology tools failed to detect skin cancer in patients with darker skin due to non-representative training data, and how pulse oximeters overestimated oxygen saturation in people with more melanin, contributing to delayed care during COVID-19.

We can draw on these examples to take away lessons in risk management, product validation strategy, and regulatory expectations that cross industries. Whether in medical technology, manufacturing, or software, it's always worth taking a second look at who you are really testing your products for, and who might be left out..

Jay Vaishnav, PhD, RAC, FRAPS brings over 20 years of experience in academia, government, and industry to medical device regulation. She earned her PhD in Physics from Harvard, contributed to standards and measurement as a postdoctoral fellow at NIST, and has served as Director of Regulatory Affairs at RefleXion Medical and Canon Medical Informatics.
Jay is a Fellow of the Regulatory Affairs Professionals Society. She is a co-editor of two books: From X‑Rays to AI: Navigating US Regulations in Radiological Health and the widely used industry reference Fundamentals of Medical Device Regulations: A Global Perspective. She also teaches “Negotiating and Communicating with FDA” at UCSC’s Silicon Valley Extension and serves on RAPS’ Devices RAC Board and Editorial Advisory Committee.
In this talk, Dr. Vaishnav will draw on her technical and regulatory expertise to explore how incomplete validation, especially in AI and medical devices, can compromise safety, performance, and public confidence, highlighting why validating for everyone matters .

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This presentation explores emerging trends, industry applications, and the strategic benefits of AI-driven Quality Assurance, with a focus on value creation and customer centricity.

As customer expectations evolve and markets become increasingly experience-driven, quality assurance must move beyond basic compliance to deliver measurable business value. The session examines how artificial intelligence (AI) is enabling a new generation of quality systems that not only enhance operational accuracy but also contribute directly to customer satisfaction, brand trust, and market performance.

By embedding AI into assurance frameworks, organizations can better align quality practices with their brand promise: creating seamless, customer-centric experiences that foster long-term loyalty and competitive advantage. Attendees will gain insights into how AI-powered quality strategies can enhance perceived value, reduce risk, and strengthen the connection between internal performance and external brand reputation.

Sean Keyani is a program management and operations-quality professional with extensive experience in aerospace, defense, and advanced manufacturing. Throughout his career, he has led cross-functional teams in program execution, MRO, product development, and quality assurance, ensuring efficiency and compliance in complex engineering environments.

With a background in engineering and business management, Sean has contributed to large-scale projects, focusing on risk management, process optimization, cost efficiency, and CRM strategies. His research includes the role of AI and digital transformation across several industries, particularly AI’s impact on quality assurance and operational improvement.

As a certified Project Management Professional (PMP) and ASQ-certified Manager of Quality and Quality Engineer (CMQ/OE, CQE), Sean has played a key role in driving continuous improvement initiatives and strategic planning. In addition to his industry work, he also delivers lectures on business topics, sharing his expertise to develop the next generation of professionals and leaders .

Host or Publisher ASQ Orange Empire Section 0701