Tag Archives: Continuous Improvement

ASQ Raleigh Life Sciences SIG meeting

Life Sciences SIG — November 2025

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ASQ Raleigh held its last Life Sciences Special Interest Group (SIG) meeting of 2025 at the NC Biotech Center on the evening of November 19, 2025. We had thirteen attendees representing a range of professional backgrounds, including a recent graduate, seasoned Quality professionals, and industry consultants. Four were first-time attendees of our SIG events.

Our speaker, Nathan Blazei, is an experienced life sciences leader with a background in Quality and Regulatory Affairs. He presented his perspectives on Quality 4.0, titled “Unlocking Efficiency, Consistency, and Insight: Potential Use Cases for Artificial Intelligence in Quality Assurance.”

After a brief introduction to Quality 4.0 and associated technology, Nathan presented three potential use cases and led the discussion beyond these applications.

  • Event investigation
  • Procedure creation
  • Inspections

A common theme of the applications is automation and artificial intelligence (AI) tool’s ability to process large amounts of data. Generative AI tools can also help summarize the information from diverse data sources and answer queries quickly, saving time and improving performance.

Participants recognized that while promising, most AI systems and tools were new and in development, and few had been tested or validated in the real world. To be truly useful, the AI systems have to be integrated with the business and be trained with domain-specific data.

The fact that many AI tools are “black box” solutions was also a concern — how much can we trust the information or answers? Can we interpret it? How do we validate it? Participants seemed to agree that the tools are useful for generating the initial documents, solutions, or recommendations, which can be a time-saver, but human experts still have to fill the gaps and make the final decisions.

Despite concerns about limitations of the current technology, the participants were enthusiastic about its potential applications in Quality and Continuous Improvement, bringing up many ideas on their wish lists: pulling knowledge embedded in the organization, performing root cause analysis, creating video-based Standard Operating Procedures (SOPs), integrating skills from different experts, AI-assisted procedures, etc.

We would have continued our discussion beyond the two hours if the building security didn’t ring the bell. More is to come next year, so check our events calendar often.

ASQ Raleigh Life Sciences Special Interest Group Meeting — November 19, 2025

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This event is free and open to the public. No ASQ membership is required. ASQ members will receive RU credits for attending.

Title: Unlocking Efficiency, Consistency, and Insight: Potential Use Cases for Artificial Intelligence in Quality Assurance

Abstract:

As regulated manufacturing operations embrace modern digital tools and advanced analytics, Quality Assurance (QA) faces mounting pressure to manage greater complexity and faster decision cycles. Artificial intelligence (AI) offers powerful tools to meet these challenges by enhancing efficiency, consistency, and insight across the quality landscape.

This collaborative discussion explores practical use cases where AI tools can be deployed to deliver value in QA. By connecting these applications under the broader framework of Quality 4.0, this session will illustrate how AI can shift QA from a reactive, compliance-focused role to a proactive, data-informed partner in manufacturing excellence.

Attendees will have the opportunity to share how AI tools may be gaining traction within their own QA organizations to provide real-world examples that may resonate with the entire group.

Presenter: Nathan Blazei, ASQ-CQA, RAC-US, Senior Director, Strategic Solutions at Kymanox

Bio:

Nathan is a versatile life sciences professional with nearly 25 years of experience across biopharmaceuticals, medical devices, and combination products in individual contributor and leadership roles. He has experience working for start-ups and global manufacturers, as well as in professional services/consulting. He is passionate about commercializing safe and effective products that will improve the quality of life for patients and their caregivers.

Nathan’s career foundation began in engineering, product and process development, manufacturing, continuous improvement, and program management roles. Over time, he made a transition to focus on quality and regulatory compliance to complement his technical experience. At the intersection of these disciplines is where he has found success over the years, as he can provide solutions that are not only technically sound, but also compliant with evolving regulatory requirements and at the leading edge of industry best practices.

Nathan acquired the Certified Quality Auditor (CQA) designation through the American Society for Quality (ASQ) and hold a Regulatory Affairs Certification (RAC-US) through the Regulatory Affairs Professionals Society (RAPS). Additionally, he is currently a Board Member for the Parenteral Drug Association (PDA), Southeast Chapter. Nathan has presented at domestic and international industry events on various topics relevant to the life sciences to share best practices, lessons learned, and new approaches to solving problems.

 

Register here.

SIG Meeting – September 2025

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A group of 11 of us met to “talk quality” in an informal atmosphere over beer and wine on Thursday, September 11, at Frontier RTP – Building 800. Frontier’s Thursday OOO event provided drinks.

We had exciting news to share: one of our first-time attendees in July secured new employment through a connection he made with us!

There was no pre-scheduled topic for discussion, but one of our members asked how those attending thought AI would be used in Quality. It was pointed out that there are different types of AI such as:

  • Generative AI: Capable of creating new content such as text, images, music, or code
  • Machine Learning: Allows systems to learn from data and improve without explicit programming
  • Deep Learning: Uses artificial neural networks to learn complex patterns from large datasets.
  • Natural Language Processing: Understands, interprets, and generates human language
  • Computer Vision: Interprets visual information from images and videos
  • Exper Systems: Emulates decision-making

We expect our companies to experiment with and utilize all of these capabilities. We wonder about supervision and control, though. For example, suppose a vision system is continually updating its defect detection capability. How can we ensure process control and prevent unintended changes that might allow more or different types of defects to slip through or introduce new false failures?

Tim Whetten

ASQ Raleigh Six Sigma Special Interest Group meeting — September 23, 2025

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This event is free and open to the public. No ASQ membership is required. ASQ members will receive RU credits for attending.

 

Title: Quality Management Systems (QMS) and the Shingo Model

Presenter/facilitator: Tim Whetten

Summary:

Tim will define what a Quality Management System is and discuss its importance. He will compare the most prominent systems. To illustrate the importance of a system, Tim will describe the Shingo Model and how the various components and principles work together to result in meeting customer and regulatory requirements, enhancing customer satisfaction, and driving continual improvement.

 

Presenter Bio:

Tim has worked for decades in the semiconductor industry, with extensive experience in manufacturing technology development, process improvement, technology transfer, and supplier management. He has spent the last 10 years working for Broadcom, improving quality systems and tools.

 

Register here.

SIG Meeting – August 2025

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On August 14th, 10 of us gathered at Frontier RTP – Building 800, to “talk quality” in an informal atmosphere over beer and wine provided by Frontier’s Thursday OOO event.

ASQ Raleigh Section SIG meeting
We had an engaging discussion at the August 2025 SIG meeting of the Raleigh Section of ASQ

We didn’t have a specific topic to discuss, but it turned out that one of us lost their job due to their company’s bankruptcy. Another didn’t have a temporary contract renewed. We talked for a while about the current job market, which is a struggle for those of us in the quality field. It is commonly the case that who you know is important to finding your next job, and there was some feeling that this may be more true here than in other areas of the country.

We had a lively discussion about defect reduction in the medical device and pharma industries. This is a complex topic, as a single defect can be a critical issue for a customer. The discussion was on the dual problems of eliminating and controlling issues in production, and also how to prevent single defect escapes. We discussed visual inspection and supplier management. In particular, how can we work with suppliers to improve performance and get them to tighten specs and expectations?

We had a short discussion about topics for future meetings. There was interest in benchmarking, centers of quality, and the impact of AI on Quality. 

The next SIG meeting at Frontier RTP will be on September 11th, 2025.

Tim Whetten

Photo of ASQ Raleigh SIG meeting attendees

SIG Meeting — May 2025

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On May 8th, nine people gathered at Frontier RTP for our monthly Special Interest Group (SIG) meeting. Again, we had some regular attendees and welcomed new ones, including a non-member.

The attendees represented mostly the life sciences industry but shared prior experience in other industries, such as automotive. It’s always interesting to hear the similarities and differences between industries in terms of quality management practices, challenges, and terminology used.

One discussion point was related to customer complaints — how do we handle them effectively, who are responsible, what actions do they trigger, etc.? Having the right or sufficient information from the end users is critical but often lacking, making understanding the symptoms and identifying root causes difficult.

One attendee was looking for a job in Quality and received many helpful suggestions from the others, including the type of jobs to start with, e.g. Quality Control, and the ASQ certifications available. The in-person events like this really help people connect and build a network. If you are interested in or new to the profession, please join us and learn more from people who have worked in Quality for decades!

The next SIG meeting at Frontier RTP will be on June 12, 2025.

Photo of ASQ Raleigh SIG meeting attendees

SIG Meeting — April 2025

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On Thursday, April 10th, eight people attended the Raleigh Section of ASQ Special Interest Group (SIG) meeting and had a lively discussion, led by Tim Whetten.

Tim gave a brief introduction to CAPA (Corrective and Preventive Action) which was followed by discussion of experiences and frustrations with the process. Frustrations tended to be around bureaucracies that tend to create too many CAPA projects and that keep CAPA projects open for a long time.

It was pointed out that an organization can perform an investigation for each nonconformance and only launch CAPA projects when the organization determines that the impact and likelihood of recurrence justifies it. Focusing on a few CAPA projects allows an organization to provide attention and resources to those improvement projects that are needed.

In addition, the discussion inevitably touched on various problem-solving tools and factors influencing a Continuous Improvement culture, for example, the roles and responsibilities of CAPA owners, coordinator, and review board. Participants also pointed out common mistakes and misunderstanding in CAPA concepts and practices. For example, a correction is not the same as a corrective action.

The next SIG meeting at Frontier RTP will be on Thursday, May 8, 2025.

ASQ Raleigh Special Interest Group Meeting — December 11, 2025

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The SIG event is participant-driven — we will have open discussion around topics related to the quality profession. We may have a theme but no formal speakers or agenda. Everyone is encouraged to participate in the discussion. So bring your questions and ideas to share with other participants.

This event is free and open to anyone who is interested in the quality profession. No ASQ membership is required. ASQ members will receive RU credits for participation.

We will meet at Frontier RTP (first floor) at 4:30pm or whenever you can join us. It will be during Frontier RTP’s weekly Out of Office event. It’s a great opportunity to connect with people in the triangle community. More information will be provided to the registered attendees before the event.

Register here.

ASQ Raleigh Special Interest Group Meeting — November 13, 2025

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The SIG event is participant-driven — we will have open discussion around topics related to the quality profession. We may have a theme but no formal speakers or agenda. Everyone is encouraged to participate in the discussion. So bring your questions and ideas to share with other participants.

This event is free and open to anyone who is interested in the quality profession. No ASQ membership is required. ASQ members will receive RU credits for participation.

We will meet at Frontier RTP (first floor) at 4:30pm or whenever you can join us. It will be during Frontier RTP’s weekly Out of Office event. It’s a great opportunity to connect with people in the triangle community. More information will be provided to the registered attendees before the event.

Register here.

ASQ Raleigh Special Interest Group Meeting — October 9, 2025

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The SIG event is participant-driven — we will have open discussion around topics related to the quality profession. We may have a theme but no formal speakers or agenda. Everyone is encouraged to participate in the discussion. So bring your questions and ideas to share with other participants.

Theme of the month: Change Control

This event is free and open to anyone who is interested in the quality profession. No ASQ membership is required. ASQ members will receive RU credits for participation.

We will meet at Frontier RTP (first floor) at 4:30pm or whenever you can join us. It will be during Frontier RTP’s weekly Out of Office event. It’s a great opportunity to connect with people in the triangle community. More information will be provided to the registered attendees before the event.

Register here.