sikkerhedscasen

The term sikkerhedscasen, literally “the safety case” in Danish, refers to a structured argument supported by evidence that a system or product meets its safety requirements. It is used in many regulated industries such as aviation, nuclear, medical devices and transport, where demonstrating that risks have been adequately understood and mitigated is essential for certification and operational approval.

A typical sikkerhedscasen follows a hierarchical structure. At the top level, the safety case states the overall safety claim, often expressed as a safety goal or performance objective. Each goal is broken down into sub‑goals that address specific aspects of the system, such as reliability of critical components, boundary conditions, and operational procedures. The evidence for each sub‑goal consists of data from analysis, testing, simulation, and, where appropriate, operational experience. Links between claims and evidence are recorded in a traceability matrix, making it possible to audit the argument and to update it when the system changes.

The creation of a sikkerhedscasen typically occurs early in the development life cycle and is updated through design reviews, safety audits, and post‑market surveillance. This process ensures that safety is continuously considered, rather than being a separate check at the end. The argument is formally reviewed by safety engineers, quality managers, and external auditors, and the final safety case is documented in a formal safety assessment report.

Benefits of adopting a sikkerhedscasen approach include higher confidence in claim validity, a clearer regulatory communication path, and a centralized repository for safety evidence that supports maintenance and upgrades. Challenges arise from the effort required to maintain the documentation, the need for precise traceability, and the potential for over‑engineering in pursuit of completeness. Despite these challenges, many organizations consider the sikkerhedscasen indispensable for managing complex safety-critical products.