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# Risk-Based Inspection Approach Explained
- URL: https://www.fdaweb.com/risk-based-inspection-approach-explained/
- Published: 2019-08-21T12:00:00.000Z
- Updated: 2026-09-15T01:45:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144815

An Avoca Group white paper defines and describes a risk-based approach to clinical trial inspection readiness, based on activities related to risk-based quality management (RBQM). The [paper](http://theavocagroup.com/wp-content/uploads/2019/07/Avoca%5FWhite-Paper%5FRiskBasedInspection.pdf?ref=fdaweb.com) says RBQM is a “systematic process put in place to identify, assess, control, communicate, and review the risks associated with the clinical trial during its lifecycle.”

A risk-based approach to inspection readiness, Avoca says, can be thought of as a demonstration of intentional, thoughtful, systematic assessment and analysis of the risks. It applies not only to study planning and conduct, but also to inspection preparation and keeping abreast of the specific areas of focus of regulatory agencies worldwide.

“As with other risk-based approaches,” the paper says, “risk-based inspection readiness involves the identification, evaluation, control, review, reporting, and communicating of risks, and especially those risks pertaining to inspections. The aim is to always evaluate risks and focus on mitigating and managing those that will likely have the greatest impact should they manifest.”