Challenges in the Context of the Development and Application of Risk-informed Regulations in the Domain of Safety Technology

Safety regulations have a long historical perspective. Organizations like DIN, German Institute for Standardization (founded in 1917), ISO, International Organization for Standardization (founded in 1947), IEC, International Electrical Commission (founded in 1906) are promoters in that domain. The new era and the main focus of the paper are the transition of regulations from the descriptive format towards to a proactive format considering prognostic elements like: “what can happen if”. The transition to risk-informed regulations creates numerous challenges for the development and application on both performers, the inventor of the regulation and the user working at the industry. A successful transition is not only a typical technical and organisational achievement but also a legislative and juristic problem which has to be resolved. In the central part of the paper are typical challenges and drawbacks between the wishes of the regulators and the reality in industries representing the various domains of safety technologies. A substantial challenge is to gain the prerequisite for utilizing risk-infirmed regulations, namely to learn from the past for the prediction into the future. The learning from the past must be realised twofold. First, qualitatively based on verbal descriptions, underlined by physical data of abnormal events, incidents and accidents, perceived in the past, and secondly, quantitatively based on statistical evidence of probabilities of the occurrences. A significant category of statistical information needed is the so-called failure rate Lambda (λ) of a specific failure mode of the component of interest. Obviously, to payback lessons learned and to utilise and publish it in failure reports is in contrary to the strategic attitude of traditional industries. Finally, the paper summarizes some recommendations, were the leading focus of the diverse industrial endeavours should be to apply the selected examples of risk-informed regulations successfully.