Tag Archives: Quality Management

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.

ASQ Raleigh Six Sigma Special Interest Group meeting — September 23, 2025

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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: 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.

 

Register here.

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.