QMSR QuickTake #38: "Documented" Does Not Mean Paper-Only
Under QMSR, a documented QMS processes must be more than written; it must be established, implemented, and maintained.
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TAI #38: Are We Asking Too Much of FMEA?
FMEA is valuable, but complex risks of harm may require pathway-based analysis to understand how events combine and controls interact.
LTR 163: FDA’s New Risk Lens Under QMSR
Allyson Mullen examines how QMSR is changing FDA’s approach to risk, inspections, quality agreements, and accountability across the quality system.
QMSR QuickTake #37: FDA Removed the Definitions, Not the Expectations
QMSR removes explicit definitions for process and design validation, but not the underlying validation obligations.
TAI #37: Do We Really Understand Risk Control Effectiveness?
If we cannot explain how controls change the pathway to harm, we cannot confidently define, measure, or monitor their effectiveness.
Deep Dive: First FDA Warning Letter Under QMSR
What the Linemaster warning letter reveals about FDA’s emerging inspection and enforcement approach.
QMSR QuickTake #36: Why Batch and Lot Still Matter
FDA retained the batch/lot definition because QMSR needs clarity around the affected product population when manufacturers evaluate nonconformity, correction, CAPA, traceability, and risk.
TAI #36: When The Average Hides Uneven Benefit-Risk
A device may appear safe and effective overall while vulnerable patient subgroups experience a meaningfully less favorable benefit-risk balance.
LTR 162: Using HHE for Risk-Based Decisions
Kerry Flecknoe explains how ISO 14971 can turn Health Hazard Evaluations into consistent, defensible postmarket risk decisions.
QMSR QuickTake #35: CAPA Effectiveness Is Not a Closure Checkbox
CAPA effectiveness is not proven by completion alone; it requires predefined criteria and evidence scaled to the underlying risk.