Risk Assessment

For almost every potentially dangerous product, risk assessments during the creation phase of the product are necessary. How can this be handled?

We are within the product life cycle of a manufacturer. The goal is to reduce product risks to an unavoidable minimum.

Risks arise out of the interaction between products and people, or through external effects, failure of protective measures, or electricity, pressure etc.!

With this in mind, conceivable risks and sources of danger, as well as requirements by standards and laws, are compiled. It is necessary to proceed systematically and comprehensibly. For example, it is practical to refine this compilation with a Mind Map in a table.

Risks have both the characteristics “extent of damage” and “probability of occurrence”!

We estimate the risks, e.g. with a procedure according to extent of damage (comp. e.g. ANSI Z 535). We sort the risks according to the most serious combination (extent of damage and probability of occurrence). Subsequently, risks must be remedied constructively or through protective measures. The process is gone through several times iteratively. Residual risks and protective measures are described on the product itself and in the user information. For further information, comp. ISO/TR 14121-2, ISO 12100, IEC 60204-1 and ISO 13849-1.