Insights
Expert perspectives on quality management, regulatory compliance, audits, and risk-based systems to help teams improve performance and manage risk.
BROWSE: All Articles | Audits and Inspections | Quality Management | Regulatory Compliance
How do we recognize when something is wrong?
Effective process control means recognizing issues, missing information, and unexpected conditions early enough to act before problems escalate.
What does it mean for a process to be “under control”?
What does it mean for a process to be under control? Explore the difference between proving control through records and maintaining it in real time.
AI can increase capacity without replacing human expertise
Learn how AI can increase organizational capacity while preserving human expertise, consistent processes, and institutional knowledge.
AI changes how we put expertise to work
AI isn't replacing subject matter experts; it's helping them accomplish more. Discover how AI speeds up the transformation of operational knowledge, giving experts more time to apply their expertise where it matters most.
Digital transformation of institutional knowledge
Discover why digitizing documents isn't enough. Learn how operational systems help organizations preserve institutional knowledge and improve continuously.
Continuous improvement or continual improvement? Does the difference matter?
Continuous improvement and continual improvement are often treated as interchangeable, but understanding the difference leads to clearer audits, better management systems, and more accurate interpretation of quality requirements.
The most overlooked opportunity for continuous improvement
Every audit reveals opportunities to improve the assessment itself. Learn why continuous improvement should apply to audit and assessment programs.
Why shared understanding takes time
Sometimes the most valuable outcome of standards development isn't changing the standard; it's developing a shared understanding of what it already says.
Separating requirements, intent, and implementation
An ASTM Committee Week discussion revealed why many quality management disagreements arise from confusing requirements, intent, and implementation—and how separating them leads to clearer audits, standards, and decisions.
Process problem or people problem? How to find the root cause of issues
When issues repeat, fixing the symptom isn’t enough. Discover how process-focused management uncovers root causes, strengthens accountability, and prevents problems from happening again.