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
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.
Hazard vs. risk: Why confusing them leads to poor decisions
Hazard and risk are not the same. Discover why understanding the difference leads to better risk assessments, stronger controls, and more informed decisions.
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.
Why HazCom breaks down: Information lives in too many places
Disconnected SDSs, training, and records can create hidden compliance risks. Learn why connected information is critical to an effective HazCom program.
Risk-based quality systems across industries
Industries from manufacturing to aerospace are adopting risk-based quality systems. By shifting from compliance-focused processes, organizations now have integrated systems that manage risk across the entire lifecycle.
What risk-based quality systems mean for manufacturing, food safety, and compliance teams
Risk-based quality systems are reshaping manufacturing, food safety, and other regulated industries. Organizations must move beyond periodic audits to continuous, system-level risk control.
How suppliers can move quality upstream
Customer audits don’t have to disrupt operations. Learn how suppliers can move quality upstream by managing controls continuously and reducing audit burden.
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.