Tag Archives: Quality

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 SIG meeting

SIG Meeting — November 13, 2025

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A group of seven people attended the November Special Interest Group (SIG) at Frontier RTP. Two people were first-time attendees at ASQ Raleigh SIG events.

One of the benefits of small group in-person events is the opportunity to get to know each other, whether to meet new people or catch up with old friends. The two-hour event provided plenty of time for personal introductions and various discussion topics.

One attendee brought up the topic of “Living Quality” — a company initiative to drive a Quality Culture from a product lifecycle perspective. The quality culture topic has repeatedly come up in many meetings. “Quality is everyone’s responsibility” seems obvious but hard to realize in an organization — from the top management to the shop floor and across all functions.

What’s also interesting was that the company was in the middle of splitting into two entities, potentially involving mergers and acquisitions. Participants agreed that Quality cannot be separate from the process that creates value. Quality is not a shared service like Information Technology (IT).

As usual, in addition to quality culture, several participants talked about their jobs, customers, products, and processes involved. It’s always enlightening to learn about other businesses and see similar challenges.

One of the new attendees was a recent Ph.D. graduate in life sciences looking into Quality as a potential career path. Several participants shared their career journeys and answered the question “How did you get into Quality?” A common answer is “That wasn’t my plan when I started!” There are always plenty of personal stories to share.

The next monthly SIG meeting will be on December 19, 2025 (at the same time and location).

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.

ASQ Raleigh SIG meeting

SIG meeting — October 9, 2025

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On October 9, 2025, a small group of six people attended ASQ Raleigh’s monthly Special Interest Group (SIG) meeting at Frontier RTP. One person was a first-time attendee and non-member, who has many years of experience in Quality and was interested in joining ASQ.

Alexia Storey led the discussion around Change Control with a number of real-world questions and scenarios. A key question was “how much do we want a robust Change Control process versus people who have the competency to perform a change control effectively?”

A benefit of having a small group is that everyone has more opportunity to contribute to the discussion. The participants brought up their questions and perspectives. Overall, many questions were related to impact assessment, risk management, and roles & responsibilities of the quality manager and various stakeholders, including the Change Control Review Board or Committee.

One of the scenarios was about changes allowed after the initial approval — how much flexibility do we have during implementation without going through another change control? How much feasibility study and impact assessment should be done before approval and how much unspecified change or risk is expected? Some participants shared the practice of using amendments to address additional changes.

Another key point of discussion was defining and evaluating the change effectiveness. This will help us ensure that the implementation does what we intended to accomplish with the change.

The next monthly SIG meeting will be on November 13, 2025.

ASQ Raleigh Networking Happy Hour — October 30, 2025

Join ASQ Raleigh (American Society of Quality) at Rosecomb Beer Garden on Thursday, October 30 at 5:30 for Networking Happy Hour! Light refreshments will be provided.

Interested in quality? Join us! We often have folks from all industries, including pharma, the EPA, robotics, and electrical component manufacturing.

Register here.

ASQ Raleigh Networking October 30, 2025

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

SIG Meeting – July 2025

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On July 10th 9 people gathered at Frontier RTP – Building 800, to “talk quality” in an informal atmosphere.

We had a newcomer to the group who is a weld inspector. He is working on getting trained in ISO9001 and is interested in ASQ Certifications and quality auditing. We had a lively discussion about the process and purpose of the different why one obtains certifications. Along the way we discussed why companies would want to be ISO9001 registered and a little about the history of the ISO9000 family.

We also had an interesting discussion about work that a couple of the attendees were doing.

The next SIG meeting at Frontier RTP will be on August 14, 2025.

Tim Whetten