Volunteering at Food Bank of CENC

Volunteering at Food Bank — November 2025

Event, Volunteering

 Proud Moment for the ASQ Raleigh Section

We are thrilled to share a powerful example of what happens when quality professionals come together to serve their communities.

On Saturday, November 8, a few dedicated ASQ members rolled up their sleeves to package canned food donations for shipment to distribution centers across the region. Our efforts at the Food Bank of Central & Eastern NC contributed to packaging an incredible 48,000 pounds of food — enough to provide 40,000 meals to individuals and families in need!

This is quality in action. It’s about more than systems and standards — it’s about people, purpose, and impact.

Thank you to everyone who contributed their time and energy, looking forward to our next volunteering day together.

Please visit our Events calendar for future volunteering opportunities.

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 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 Six Sigma SIG meeting

Six Sigma SIG — September 2025

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ASQ Raleigh held its second Six Sigma Special Interest Group (SIG) meeting of the year in the NC Biotech Center on September 23. Eleven people, including five non-ASQ members, came to the meeting for an evening of discussion. We were pleased to see seven first-timers who came because of interest in Quality Management Systems (QMS), the Shingo Model, or just Six Sigma and Continuous Improvement in general.

Our speaker, Tim Whetten, had previously led the discussion on QMS and the Shingo Model during our March SIG meeting. This time Tim went deeper and compared the Shingo Model to other frameworks, such as Baldrige, EFQM, and ISO9001.

While each of the frameworks has their unique design, components, primary markets and audience, they share many principles in quality and organization excellence, such as value, customer focus, and systems thinking.

After the initial presentation by Tim, the participants formed small groups and discussed the challenges and opportunities in implementing or improving QMS in their organizations. The participants shared their experience in QMS (or lack thereof) and pitfalls in its implementation. Many questions were raised during the discussion, for example

  • How is QMS different or related to general management?
  • How do organizations know which framework is best for them?
  • What is the right path given the organization’s current state?
  • What are some elements that are critical to QMS implementation?

As Tim continued his presentation, many discussion points converged to organization’s purpose, culture, leadership, cross-functional alignment, and employee engagement. All seemed to agree that QMS is not a tool or check-box exercises. It’s easy to fall into the mindset that “if we had a QMS tool, we have a QMS. ” QMS is much more central and integral to the entire organization than a software system.

Tim concluded the meeting by offering suggestions for next steps in “making it real” — what can we start doing now? One piece of his advice was Quality needs to “be helpful” to other stakeholders. Simple, but hard to do.

After over 2 hours of engaging discussion, the participants left the meeting with many thought-provoking questions and shared ideas.

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

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

ASQ Raleigh Special Interest Group Meeting

Life Sciences SIG — May 2025

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ASQ Raleigh had its second Life Sciences Special Interest Group (SIG) meeting of the year on May 20 at the NC Biotech Center. Dr. Alan Touch gave a presentation titled “THE CLINICAL QUALITY MANAGEMENT PLAN — GCP Clinical Trial Site Compliance Mandatory to Study Data Integrity.”

Fifteen people, including non-members, attended the meeting and participated in networking and discussion. During the introduction, Dr. Touch emphasized how much clinical studies and patients count on the Quality professionals to ensure safety and integrity.

Dr. Touch first covered the key concepts, including

  • The GCP framework and ICH E6 R3
  • What’s the Clinical Quality Management Plan (CQMP)
  • Key components of CQMP
  • Site considerations
  • Typical content of a CQMP template

To help illustrate the critical role of a CQMP, Dr. Touch shared a case study in which highly respected medical sites failed in several aspects in the GCP audit when no CQMP was in place. The example led to a number of questions and comments from the audience, for example

  • the roles and responsibilities of the sponsors, Contract Research Organizations (CROs), and medical sites in developing and implementing the CQMP
  • the role of the Quality functions
  • how to evaluate and select sites

If you are interested in clinical quality management or related topics, please let us know.

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.