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.
Join ASQ Raleigh (American Society of Quality) at Rosecomb Beer Garden on Thursday, October 30 at 5:30 for Networking Happy Hour! Light refreshments will be provided.
Interested in quality? Join us! We often have folks from all industries, including pharma, the EPA, robotics, and electrical component manufacturing.
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?
Join us online for a time to meet with other ASQ Raleigh members! Please register on LinkedIn or email Berkley at berkley612@gmail.com to receive the link to the virtual event. We will meet on September 25, 2025 at 5:30! Grab a drink and we will “see” you there!
This event is free and open to the public. No ASQ membership is required. ASQ members will receive RU credits for attending.
Title: Quality Management Systems (QMS) and the Shingo Model
Presenter/facilitator: Tim Whetten
Summary:
Tim will define what a Quality Management System is and discuss its importance. He will compare the most prominent systems. To illustrate the importance of a system, Tim will describe the Shingo Model and how the various components and principles work together to result in meeting customer and regulatory requirements, enhancing customer satisfaction, and driving continual improvement.
Presenter Bio:
Tim has worked for decades in the semiconductor industry, with extensive experience in manufacturing technology development, process improvement, technology transfer, and supplier management. He has spent the last 10 years working for Broadcom, improving quality systems and tools.
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.
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.
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.
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!
This event is free and open to the public. No ASQ membership is required. ASQ members will receive RU credit for attending.
Title: The crucial role of The Clinical Quality Management Plan (CQMP) in establishing site-based protocol integrity
Presenter: Dr Alan Touch
Summary:
The Clinical Quality Management Plan (CQMP) for clinical trials is a structured approach to ensuring the integrity, reliability, and compliance of clinical research at the site level. It is core to maintaining Good Clinical Practice (GCP)standards and regulatory requirements throughout the trial process.
CQMP establishes the quality management guidelines for tasks related to the Sponsor, CRO and Study Site for responsibilities for a defined Clinical Trial Protocol. This plan is normally the responsibility of the Sponsor Quality Assurance department although its development and implementation can be facilitated by a Quality and GCP Audit Partner.
This presentation will delineate the critical role of CGMP in GCP, a delineation of the actual types of content for a CGMP, the steps to the development of the CQMP and the effect the 21st Century Cures Act on these responsibilities and current US FDA expectations regarding site responsibility for clinical trial protocol data integrity.
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.
