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.