Capture hazards and hazardous situations

This article explains the terminology used in a manufacturer's risk-management file. Complya does not capture hazards or hazardous situations as platform records.

A hazard is a potential source of harm. A hazardous situation is the circumstance where people, property, or the environment are exposed to that hazard. The harm is the injury or damage that can result.

Write risk entries in clinically meaningful language. “Software issue” is too broad; “incorrect dose recommendation shown to clinician” is easier to evaluate and control.

Include normal use, foreseeable misuse, maintenance, cleaning, cybersecurity where relevant, use environment, accessories, and patient or user characteristics.