Tag Archives: Quality

ASQ Raleigh SIG meeting

SIG Meeting — April 9, 2026

Event, SIG, , , , ,

The monthly ASQ Raleigh Special Interest Group (SIG) meeting at Frontier RTP in April had seven participants, all ASQ members who had attended SIG meetings regularly.

We had a discussion theme on “human error” led by Tim Whetten, who planned to submit an abstract around this topic for the annual ASQ Raleigh “Quality in the Triangle” (QIT) conference in October. This in-person SIG meeting was a perfect forum for him to get some feedback and ideas.

Tim started his presentation (a draft version) with understanding various types of work and then common errors associated with each type. Much of the discussion went into the potential causes of each kind of errors and how we might prevent or reduce such errors.

All attendees actively participated in the discussion by asking questions or sharing their personal experiences. One question was simple but profound: “what is human [vs non-human] error?” We all learned from Deming that quality is mostly determined by the systems or processes as designed. Defining and identifying “human” errors is not as trivial as one might think.

Not surprisingly, work involving humans requires cognition, such as perception, memory, and decisions. How people learn and use their knowledge and skills to get work done right in a given environment is complex and fascinating.

We are looking forward to seeing Tim Whetten present at the QIT conference and share his personal story and perspectives on this important topic.

Our next SIG meeting will be on May 14, 2026 at the same place and time.

ASQ Raleigh SIG meeting

SIG Meeting — March 14, 2026

Event, SIG, ,

We gathered on March 12th at 4:30 PM for the Second Thursday SIG (Special Interest Group) Six Sigma meeting, held at Frontier RTP. Eleven participants, including both regular attendees and a few new faces, came together for an upbeat and engaging discussion of current quality topics.

A large portion of the conversation focused on auditing practices, including internal audits aligned with ISO 9001 and other standards, the role of the auditor versus the process owner, and practical approaches to sampling and evidence collection. Participants also shared insights on supplier audits, FDA-related risk considerations, and cultural challenges in global supply chains, along with practical tips helpful for those preparing for ASQ certifications.

The group also explored cybersecurity and software validation, particularly risks in regulated environments such as medical devices. The conversation included emerging AI-related concerns, liability, hallucinations, and model drift, alongside practical applications such as document gap analysis, NCR structuring, and early detection signals, with a clear emphasis on maintaining human oversight.

The next SIG Six Sigma meeting will be held April 9th at 4:30 PM, when Tim Whetten will open the discussion with a short session on dealing with human error when it is a cause in a nonconformance investigation. Register here!

ASQ Raleigh Life Sciences Special Interest Group Meeting — March 26, 2026

, , , , ,

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

 

Title: Beyond CAPA: Closing the Quality–Culture Gap in Regulated Industries

Abstract:

Regulatory findings rarely stem from a lack of procedures — they stem from gaps between documented systems and lived behavior. FDA warning letters and inspection trends increasingly point to weaknesses in quality culture, psychological safety, and leadership accountability rather than technical deficiencies alone.

This interactive session explores how Continuous Improvement professionals can move beyond reactive CAPA management toward proactive quality culture integration. Participants will examine common root causes behind recurring deviations, explore the role of psychological safety in error reporting, and discuss practical tools for strengthening governance maturity.

The format would include presentation content followed by facilitated group discussion to encourage participant engagement.

Presenter:

Dr. Elizabeth Gilbert, DBA, ASQ CQA

President, Trinity National Consulting | Senior Advisor & Executive Consultant, PQE Group

Bio:

Dr. Elizabeth Gilbert is President of Trinity National Consulting and a Senior Advisor and Executive Consultant with PQE Group, supporting organizations in regulated industries with quality systems strategy, governance maturity, and regulatory readiness. She is an American Society for Quality (ASQ) Certified Quality Auditor (CQA), CQIA Subject Matter Expert, ASQConnEx course instructor and DBA Chair with more than 20 years of experience in pharmaceutical, biotechnology, medical device quality systems, and academia.

Throughout her career, Dr. Gilbert has led high-risk GMP investigations, environmental monitoring programs, and inspection readiness initiatives across global life sciences organizations, supporting compliance with FDA, EU GMP, and ISO quality standards.

Her research and consulting focus on the intersection of quality culture, leadership accountability, and system maturity, examining how psychological safety and governance structures influence deviation reporting, CAPA effectiveness, and continuous improvement outcomes in regulated environments.

Register here.

 

For questions, contact Life Sciences Special Interest Group (SIG) Chair, Fang Zhou, at ASQRaleighSIG@gmail.com

 

ASQ Raleigh Meet and Greet with the Leadership Team

ASQ Raleigh Meet and Greet with the Leadership Team — February 18, 2026

Event, Networking, , ,

On February 18, the ASQ Raleigh Leadership team held a “meet and greet” networking session at the NC Biotech Center to welcome and engage quality professionals in the Triangle area. The attendees included long-term ASQ members and some newcomers.

One exciting addition at this meeting was the brand new ASQ Raleigh banner (see the photo) showing who we are and what we do! Thanks to our Section Chair Maria Mahrukh for designing and bringing it to the meeting.

We had almost the entire Leadership team in person at this meeting, which was incredible, given how far many had to travel from their work or home. Each member of the Leadership team, including several new Member Leaders, introduced themselves and their volunteering roles in the ASQ Raleigh Section. We celebrated what the team had accomplished in the past year and shared our ideas and plans for 2026.

After every attendee gave their introduction, we naturally gathered into small groups and got to know each other. Many of the topics discussed were centered around improving the Quality culture at the workplace, engaging members, and increasing the impact of ASQ Raleigh in the local community. As a result, many new ideas for collaboration and action came out, and the room was full of energy and enthusiasm about what’s coming in 2026.

Many thanks to our Member Leaders and to the participants!

If you are interested in Quality and Continuous Improvement, please join us in future events to learn and share your passion. Contact any of the ASQ Raleigh team if you have any questions or suggestions.

We look forward to seeing you and hearing from you!

Quality in the Triangle (QIT) Conference — October 6, 2026

, ,

Theme: Leading with Quality

In a fast-moving world, how do you best meet the moment?

From leveraging cutting-edge technology to mastering effective communication and fostering cross-functional collaboration, professionals like you are using quality tools and insights to thrive in an ever-evolving landscape. At QIT, you can connect with quality leaders, dive into fresh ideas, and discover bold new ways to drive meaningful, measurable impact for your organization. Join us to learn how to lead with Quality!

The 2026 Quality in the Triangle conference will offer actionable strategies and deep insights into organizational excellence, new or disruptive technologies, leadership and change management, and quality fundamentals. Attendees will come away with vital tools and tactics to affect change, increase value, and drive their organizations toward quality goals. We are looking for innovative, exciting, and knowledgeable education sessions focused on quality topics and initiatives for the 2026 QIT.

Agenda and registration information will be added as they become available.

If you are interested in presenting at the conference, please read Call for Proposals and submit your proposal by April 17th.

ASQ Raleigh 2026 Quality in the Triangle Conference: Call for Proposals

Event, QIT

Quality in the Triangle (QIT) – Oct 6, 2026, McKimmon Center, Raleigh, NC

Theme: Leading with Quality


In a fast-moving world, how do you best meet the moment?

From leveraging cutting-edge technology to mastering effective communication and fostering cross-functional collaboration, professionals like you are using quality tools and insights to thrive in an ever-evolving landscape. At QIT, you can connect with quality leaders, dive into fresh ideas, and discover bold new ways to drive meaningful, measurable impact for your organization. Join us to learn how to lead with Quality!

The 2026 Quality in the Triangle conference will offer actionable strategies and deep insights into organizational excellence, new or disruptive technologies, leadership and change management, and quality fundamentals. Attendees will come away with vital tools and tactics to affect change, increase value, and drive their organizations toward quality goals. We are looking for innovative, exciting, and knowledgeable education sessions focused on quality topics and initiatives for the 2026 QIT.

Below are some example topic areas:

  • Incorporating new techniques/technologies into your processes/systems
  • New or unique applications of existing tools and techniques
  • Managing the impact of innovation and disruptive technologies
  • Advocating for quality and quality programs with leadership
  • Moving beyond audit/compliance to drive improvement
  • Personal/career development and leadership skills

Call for Proposals:

Do you have a quality story or project that you would like to share? The QIT committee is accepting proposals for 1-hour concurrent sessions that fit with the theme of this year’s conference. To submit, write a summary to introduce your proposed topic and its learning objectives, and develop a high-level outline of your proposed presentation. Send this writeup to Stephanie Parker at stephanie.csd@gmail.com by April 17th to be considered for this year’s conference.

SIG Meeting — January 8, 2026

Event, SIG, , , , ,

The first ASQ Raleigh Section open discussion meeting of 2026 was well attended, with 14 participants, several of whom were newcomers! Following the lively discussion on AI in quality at our December meeting, Chris Andrassy volunteered to lead a session on integrating AI into nonconformance investigations and reporting. We discussed his implementation in which data is collected, guided by AI, followed by AI analysis, suggested likely root causes, and report generation.

ASQ Raleigh SIG meeting
Chris Andrassy shares his thoughts

There was extensive discussion about the interaction and roles of humans and AI. While AI can provide consistency, efficiency, and sometimes insights, it can also make mistakes and requires human oversight. Is there an issue with “oversight fatigue”, where human experts don’t notice AI errors? One suggestion was to use the interaction between the AI agent and the human, in which the AI agent asks the human probing questions.

It seemed as though a similar capability could be created for change control.

It was noted that, as with other quality areas, a process needs to be established with valid data before automating it with AI. To analyze the problem and identify potential root causes, AI needs a sufficient volume of accurate historical data.

Tim Whetten

ASQ Raleigh Special Interest Group Meeting — December 10, 2026

,

The Special Interest Group (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.

Registration will be available 3-4 weeks before the event.

For questions, please contact Fang Zhou at ASQRaleighSIG@gmail.com.

Pre-meeting Office Hour

If you have some questions and would like to have a one-on-one discussion or consultation with someone who has relavent knowledge and experience, you can simply stop by before the SIG meeting and talk to one of the ASQ Raleigh member volunteers who will be there 3:30 – 4:30 pm. No appointment or registration is required, and you are welcome to attend the group meeting to gain additional perspectives from other attendees. For more details, please visit our Consultation page.

ASQ Raleigh Special Interest Group Meeting — November 12, 2026

,

The Special Interest Group (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.

Registration will be available 3-4 weeks before the event.

For questions, please contact Fang Zhou at ASQRaleighSIG@gmail.com.

Pre-meeting Office Hour

If you have some questions and would like to have a one-on-one discussion or consultation with someone who has relavent knowledge and experience, you can simply stop by before the SIG meeting and talk to one of the ASQ Raleigh member volunteers who will be there 3:30 – 4:30 pm. No appointment or registration is required, and you are welcome to attend the group meeting to gain additional perspectives from other attendees. For more details, please visit our Consultation page.

ASQ Raleigh Special Interest Group Meeting — October 8, 2026

,

The Special Interest Group (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.

Registration will be available 3-4 weeks before the event.

For questions, please contact Fang Zhou at ASQRaleighSIG@gmail.com.

Pre-meeting Office Hour

If you have some questions and would like to have a one-on-one discussion or consultation with someone who has relavent knowledge and experience, you can simply stop by before the SIG meeting and talk to one of the ASQ Raleigh member volunteers who will be there 3:30 – 4:30 pm. No appointment or registration is required, and you are welcome to attend the group meeting to gain additional perspectives from other attendees. For more details, please visit our Consultation page.