Risk Assessment
Risk Assessment is the systematic process of identifying hazards and evaluating the risks associated with machinery throughout its lifecycle. For North American manufacturers exporting to the EU, this is a non-negotiable requirement under the Machinery Directive (and the new Machinery Regulation). It ensures that equipment satisfies the Essential Health & Safety Requirements (EHSRs) before it is placed on the market.
The process usually follows the methodology outlined in ISO 12100. Engineers must determine the limits of the machinery, identify hazards (such as mechanical, electrical, or thermal), and estimate the severity and probability of harm. Unlike typical US facility inspections, this assessment focuses specifically on the inherent design and construction of the unit.
If a risk is deemed unacceptable, manufacturers must implement specific Risk Mitigation Measures to reduce it to a safe level. This entire analysis, including the residual risks, must be fully documented within the Technical File. Without a rigorous risk assessment, a Declaration of Conformity (DoC) is legally invalid.
