Category Archives: Event

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.

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

Life Sciences SIG — March 2025

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Last Friday, fifteen people gathered at the NC Biotech Center, where Dr. Milton Krivokuca, an ASQ Fellow, led the discussion on integrating data science and quality to achieve organizational excellence.

After each attendee introduced themselves, Dr. Krivokuca shared his personal journey and decades of association with ASQ and its members. A key message was that connections created by ASQ could lead to new opportunities!

The first half of Dr. Krivokuca’s presentation was focused on the technical, social, personal, and managerial aspects of Quality 4.0 — how does technology enable the organization? Specifically, how do organizations achieve different levels of data/digital maturity? It’s certainly challenging for an organization to respond and adapt quickly to technological advancement while staying focused on its business, customers, and employees.

In addition to understanding what data science (or big data, machine learning, artificial intelligence, etc.) means, the discussion of digital transformation again pointed to organizational culture and how people respond to change.

The first breakout session had three key questions:

  • What are your perspectives of where the data scientist should reside in an organization?
  • Do these quality-data science concepts align with your organization’s digital transformation?
  • What next steps wold be most appropriate for your organization?

Three breakout groups shared their perspectives, for example

  • How to communicate change to employees and customers?
  • How to manage varying levels of digital maturity within the organization? Where do we start?
  • How to overcome the tendency of implementing technology in silos without considering the value stream?
  • What systems or governing structures do we need?

The second half of the presentation and breakout discussion moved into understanding data science and data scientists, making the connection between continuous learning (data science) and continuous improvement (quality).

A key question was “what’s the role of a data scientist?” The related questions are

  • What skills (technical and non-technical) are needed for successful transformation?
  • Which skills do quality professionals already have?
  • How should the organization be designed to develop data science capability?
  • How do Quality and IT organizations fit in the transformation?

The discussion could definitely use more time than scheduled. We look forward to more sessions on such topics. Let us know if you have any suggestions!

Photo of ASQ Raleigh SIG meeting attendees

SIG Meeting — March 2025

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This month we had a theme: Shingo — How does it avoid “improvement fatigue.” Seven people (all ASQ Raleigh members) participated in the discussion.

The discussion started with the term QMS. Are we talking about Quality Management Software or Quality Management Systems? They aren’t the same. A tool to assist compliance vs. a system or framework to advance quality?

Who is Shingo? What is the Shingo Model?

Most of us are familiar with TQM, JIT, SMED, Gemba, etc. in Continuous Improvement (CI) but may not know how much Shingo contributed to the knowledge and practice. It’s time to learn more about the concepts/tools and some history of quality by reading a few books by Shingo!

The discussion went around the core elements of the Shingo Model — results, tools, systems, and finally guiding principles and culture. How are these elements connected and what are the most critical?

A common challenge in CI is that it’s often reactive, not built in the structure and operations of the organization. We all heard Deming saying “A bad system will beat a good person every time.” Obviously, creating systems that support the people using the CI tools is management’s responsibility.

The Shingo Model could be a solution to building a sustained CI culture. But why are so few organizations embracing it? We wished that we had more time to discuss how leadership, value, purpose, scientific thinking, and organizational alignment come into play. To be continued…

The next SIG meeting at Frontier RTP will be on Thursday, April 10.