Page 72 - 捷運技術 第43期

66 Andrea Colini 系統保證歐規與美規之介紹

At the end of design phase all safety related documentation required to assure the safety level

will be organized in a comprehensive document which forms the ¨Safety Case©. Here CENELEC
has all the advantages that allow to consider that European approach totally covers the U.S. one:

ha clear safety case structure;

h considerations for the cross-acceptance of safety cases by following a structured standardised
life cycle and harmonised documentation set;

h support for reuse and modularisation by defining different types of approvals: generic

product, generic application and specific application;

hconcise independence requirements for designer, verifier, validator and assessor.

Main scope of this part of the process is to demonstrate that all the main risk of the Metro
system are assessed, giving evidence of the fulfilments of the safety requirements and details on

risk assessment and risk ranking. The document will be updated during the entire life cycle of the

project.

Figure 5cSafety Demonstration