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.