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Safety Case Regime (It is a document produced by the operator of a major…

- - - - Appropriate performance standards must be defined for the operation of the safety critical aspects
        
        The work force must be involved so that they do the right thing, not just relying on a 'rules-based' culture
        
        This is produced in the knowledge of the competent and independent regulator
- - - - Safety requirements
        
        Risk Assessment
        
        Risk reduction measures
        
        Safety analysis
        
        Safety management system
        
        Development process justification
        
        2 more items...
        
        Refers to contents of safety plan for roles, responsibilities, procedures
        
        How the project intends to provide evidence of successful deployment of risk reduction measures, meeting failure rate targets, etc
        
        How the project plans to tackle each identified risk - design measures, protection systems, redundancy etc
        
        Results of risk estimation exercise, accident sequences etc
        
        Description of Top-level safety requirements, emerging from the study of standards
      - Key credible hazards (these might change later for submission of safety case)
- - - - Safety case acceptance (Commencement of work)
        
        Proposed change or revision
        
        Agree scope of validation for modification or decommissioning
        
        submission of revised safety case
        
        safety case acceptance
        
        Cease operation
        
        1 more item...
        
        Outdated technical knowledge
        
        1 more item...
        
        Defining development procedures
        
        Sources of supportive evidence
        
        Defining the approach
      - Key safety issues and objectives
- - - - Definition of the key safety processes, roles, and responsibility to be enacted during system development
    - - Identification of applicable safety standards, the requirements from these standards that apply to the system under developed safety properties
    - - Identification of potential system hazards through systematic review
    - - Estimation of the level of risk posed by each of the identified system hazards
        
        Example: Through qualitative description of both the severity and likelihood of hazard consequences and use of a hazard risk index matrix
    - - Identifying the principle requirements implied by the risks identified in the risk estimation exercise
        
        Tolerable failure rate targets for each risk category