About Hazards

Hazards define risks for patients which can occur because of the failure/fault in the design of the product.

When conducting a risk analysis, manufacturers typically identify possible hazards associated with the design in both normal and fault conditions. The risks associated with the hazards, including those resulting from user error, should be calculated in both normal and fault conditions. If any risk is judged unacceptable, it should be reduced to acceptable levels by the appropriate means, for example, by redesign or warnings. An important part of risk analysis is ensuring that changes made to eliminate or minimize hazards do not introduce new hazards.

Hazards associated with products can be related to requirements in the traceability matrix. See Working With Traceability and Hazard Details. Hazard details include processing hazards through the various stages of Analysis, Evaluation, Reduction, Verification, and Completion.

Hazards can be managed and controlled directly from the product context as described in Hazard Control for a Product.