Category Archives: SIG

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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.

Photo of ASQ Raleigh SIG meeting attendees

Six Sigma SIG — February 2025

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It’s been a while since we had our Six Sigma Special Interest Group (SIG) meeting. This month’s topic was “How Effective is Lean Six Sigma?” We had 18 people attending at the NC Biotech Center, which sponsors ASQ Raleigh and has a state-of-art conference center for the event.

The attendees represented various industries such as life sciences, semiconductors, and manufacturing. About one third were non-ASQ members, and 40+% were first-time attendees.

To help build the Quality community, four ASQ Raleigh member leaders (i.e. volunteers who make things happen) welcomed the audience and gave an introduction of ASQ and ASQ Raleigh.

Given the range of attendee’s experience in Continuous Improvement, the meeting started with a 30-minute refresher on the Lean and Six Sigma methodologies, prompting reactions and ideas on the challenges and opportunities in the current environment, which was the focus of the break-out session.

After about 50 minutes of active discussion, three break-out groups shared their key takeaways, touching various questions, such as

  • How to help change the culture?
  • How can Lean Six Sigma help drive change?
  • How do we address the challenges related to bringing back manufacturing to the US?
  • How do we gain buy-in from senior management?
  • How to apply Lean and/or Six Sigma in non-manufacturing, such as R&D and IT?
  • What kinds of incentives are effective for different demographics?

A few ideas emerged as potential topics for future events.

  • What is a Kaizen event? How do you lead such events?
  • How do you align or prioritize Continuous Improvement effort or projects?
  • What could business process re-engineering look like now (compared to the 90’s)?
  • How can Lean Six Sigma help R&D, Quality, and tech transfer?
  • How do we engage people in Continuous Improvement?

Thanks to all participants for their contributions. We will have many ideas to work from.

The next event will be the monthly Quality Special Interest Group at Frontier RTP on Thursday, March 13.

Photo of ASQ Raleigh SIG meeting attendees

SIG Meeting — February 2025

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This month we had a smaller group of six participants at our regular time (Thursday evening) and location (Frontier RTP). As usual, we had a very active discussion on a variety of topics as well as the opportunity to get to know each other.

One of the participants worked in software quality, which triggered much discussion about the challenges in understanding and managing quality when so much of what we do depends on technology — automation, software, artificial intelligence, etc.

When the discussion moved to R&D management, a key question was “what are considered in R&D management?” [R&D here refers to scientific discovery and development for commercialization.] It could include vision and strategy for the organization, product portfolio (or in pharma the pipeline!), project management, facility/laboratory management, knowledge and data management, talent, … and certainly quality management.

What’s interesting was that the discussion often brought up the role of Quality, quality culture, and how Quality could/should enable cross-functional activities involving marketing, R&D, and manufacturing.

Are you interested in these topics? Do you have some perspectives to share with others? We hope you join us in future events.

We will have our next meeting on March 13, 2025.

Photo of ASQ Raleigh SIG meeting attendees

First SIG Meeting of 2025

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The ASQ Raleigh Special Interest Group (SIG) kicked off the New Year with a meeting at Frontier RTP on January 9. We welcomed some new faces and non-members and had a record turnout of 11 people representing mostly the life sciences and semiconductor industries.

We had two hours of active discussion while enjoying free beverages offered by Frontier RTP’s weekly Out of Office event. The meeting’s theme was Failure Mode and Effects Analysis (FMEA), a topic many quality professionals deal with regularly. Some points of discussion included

  • What is risk?
  • How do we deal with assessor’s bias?
  • How do we prioritize risks?
  • Who are the stakeholders, and what are their interests and perspectives on risk?
  • What other tools are used to manage risks?

Since launching this monthly in-person event in 2024, we have seen an increasing number of participants. Thanks to all who led and contributed to the discussion!

We will have our next meeting on February 13. The theme will be R&D Management. Hope to see you there!