safety_case

Information requirement	Business Object(s)
Identification of the PSE to which the safety case relates.	Safety Case, PSE
Reference to all proposed PSE modes of operation to which the safety case applies.	Safety Case, Hazard Register, Hazard, Required PSE Constituent Usage Pattern, Product Role, Task
Reference to context of the usages of PSE (that conform to the design) including the environment and/or theatre in which the safety case applies.	Safety Case, Hazard Register, Hazard, Environmental Characteristic, Operational Theatre
Definition of hazards in respect of the PSE in consideration, in specified modes of use and environment/theatre of operation.	Hazard
Definition of risks that may derive from the hazards identified	Risk, Hazard, Hazard Risk Relationship
Identification of the preventive and mitigating actions planned to reduce the incidence and/or the impact of risk to an acceptable level.	Risk, Risk Mitigation, Plan
One or more assertions on the assessed safety of the aspect of the PSE under consideration, each assertion being regarded as a ‘Safety Claim’.	Safety Claim, Hazard
Definition of each Safety Claim made for the PSE. Each claim will relate to a different aspect of the PSE and may include for example: reliability and availability security (from external attack) functional correctness time response maintainability usability (by the operator) fail-safety accuracy robustness to overload modifiability	Safety Claim
Definition of the type of argument that supports the safety claim. This may be: Deterministic - application of predetermined rules to derive a true/false claim (given some initial assumptions), e.g. formal proof of compliance to a specification, or demonstration of a safety requirement (such as execution time analysis or exhaustive test of the logic). Probabilistic - quantitative statistical reasoning, to establish a numerical level (e.g. MTTF, MTTR, reliability testing). Qualitative - compliance with rules that have an indirect link to the desired attributes (e.g. compliance with QMS standards, staff skills and experience).	Safety Argument, Safety Claim, Document, Document Association
Reference to the evidence that supports the safety argument. This may be drawn from: the product design development processes, simulated experience (via reliability testing), prior field experience of similar products, field experience of actual product, compliance with existing standards.	Safety Argument, Safety Argument Evidence, Safety Evidence
Recording of “release to service” approval of the PSE for which the safety case is defined.	Status Assignment, Safety Case, PSE

safety_case Business Information Requirements