Tag Archives: Culture

SIG Meeting – Sept 10, 2026

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Overview

The meeting introduced attendees and focused on quality auditing, supplier risk, quality culture, and upcoming ASQ events.

Event Updates

Tim shared information about the October 6 Quality in the Triangle conference and other ASQ Raleigh activities. Info, the preliminary program, and registration are available at https://app.memberplanet.com/#/event/asqraleighsection/asqraleighqualityinthetriangleqitconference_1.

Remember that the ASQ Raleigh Event page is available at https://www.asqraleigh.org/events/!

Quality Discussion

Attendees talked about work in pharmaceutical manufacturing, medical devices, computerized-system auditing, supplier quality, post-market surveillance, and quality consulting.

There was some discussion around whether current audit methods reveal an organization’s commitment to quality improvement and future risk. People seemed to think that escalating severity upon recurrence forces organizational improvement.

It was mentioned that ISO 9001: 2026 requires top management to actively promote quality culture and ethical behavior (Clause 5.1.1) and requires employees to demonstrate awareness of both as part of their general QMS awareness (Clause 7.3). How will quality culture and management responsibility be measured and audited? Maybe a topic for future discussion!

We discussed an AI platform for quality investigations, including triage, root-cause analysis, reporting, and CAPA documentation

The group distinguished ISO 9001 conformance from regulatory compliance, noting that regulated organizations face additional legal obligations.

Key Concerns

Supplier audits may identify gaps but may not show whether suppliers learn from failures or improve their systems.

Aug 13 2026 SIG Meeting

SIG Meeting — August 13, 2026

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Attendance: 9 members participated in this month’s Special Interest Group (SIG) meeting, including 4 newcomers!

Poimapper App Demonstration

The meeting featured a live demonstration of Poimapper, a mobile data collection app currently under review. Discussion centered on three potential quality applications:

Standardizing audit forms across sites or teams
Tracking non-conformance processes from identification through closure
Real-time reporting, using field-collected data to support faster decision-making

The group agreed that Poimapper’s strongest fit is likely for organizations that don’t yet have an established electronic QMS, where it could serve as a lightweight, accessible entry point into digital data collection rather than a replacement for a mature system.

Hybrid Meeting Format Discussion

The group discussed shifting the monthly SIG meeting to a hybrid format (in-person and online). Overall sentiment was open to the idea, with two practical concerns raised:

Background noise from the space outside the meeting room
Audio clarity for remote attendees trying to follow the discussion

These will need to be addressed (for example, through room changes or an improved microphone setup) before adopting a hybrid format.

Future Event Ideas

Members shared ideas for future SIG and section events, including:

Company tours
Dinner meetings
Educational courses, with specific interest in a multi-session course on AI basics for quality professionals

Next Steps

Explore solutions for hybrid meeting audio quality
Gauge interest in and scope out a possible multi-session AI basics course

Next Meeting

Our next SIG meeting will be Thursday, September 10, 2026, at 4:30 PM, at the same location, Frontier RTP. A floor plan will be included in the meeting announcement to help everyone find the room easily. Register here: https://www.asqraleigh.org/event/asq-raleigh-special-interest-group-meeting-september-10-2026/#rsvp-now

Quality in the Triangle (QIT) Conference: Registration is now open for the QIT Conference! Register here: https://app.memberplanet.com/#/event/asqraleighsection/asqraleighqualityinthetriangleqitconference_1

Stay Connected: For a full list of upcoming section events, visit the ASQ Raleigh Events Calendar: https://www.asqraleigh.org/events/

ASQ Raleigh Special Interest Group Meeting — September 10, 2026

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This Special Interest Group (SIG) event is participant-driven—we will have open discussions on topics related to the quality profession. Talal Hossain will provide a short presentation on the theory of validated AI for Biotech. 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 4:30 pm 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. We’ll provide more information to registered attendees before the event.

Please contact Tim Whetten at Tim@aligncollaboration.com with questions. As a trial, this meeting will be hosted in a hybrid fashion, online as well as in person. If you would like to attend online, please let me know, and I will provide you with a Google Meet address.

ASQ Raleigh Life Sciences SIG meeting

Life Sciences SIG — March 26, 2026

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ASQ Raleigh had its first Life Sciences Special Interest Group (SIG) meeting of 2026 on March 26th. The event was held at the NC Biotech Center, where we are one of the Intellectual Exchange Groups that help build the vibrant Life Sciences community in North Carolina.

Despite the bad evening traffic, eleven people were able to make it to the meeting, where Dr. Elizabeth Gilbert presented “Beyond CAPA: Closing the Quality–Culture Gap in Regulated Industries.”

One of the points of discussion was the increasing number of FDA warning letters in the recent years. What are the potential causes? Dr. Gilbert led the discussion on the gaps in documented systems and lived behavior in many organizations.

Culture, systems, management, and leadership can influence employee behavior and therefore quality outcomes. Many of the participants could relate to these interacting factors from experience. Trust and psychological safety was a critical consideration, e.g. can operators stop the production or bring up issues? It’s hard to have a quality and Continuous Improvement culture without engaged employees who feel valued and empowered.

The meeting ended with a group photo with our new ASQ Raleigh banner! Thanks Dr. Gilbert for the thought-provoking presentation.

ASQ Raleigh Life Sciences SIG attendees gathering at the NC Biotech Center

Want to know more about what we discussed? Come to our next event!

Are you interested in presenting at our SIG meetings? Do you know someone who might be interested in presenting? Please let us know. ASQRaleigh@sections.asq.org

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

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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: 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 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).