Cenelec Standard Training Part 1
Cenelec Standard Training Part 1
ISARail Spa
Introduction to EN 50126-1 & -2
Organization & Independence of Roles
Roles & Responsibilities
System Life Cycle Phases
Risk Concept
Verification & Validation Activities
EN 50126-1 considers the generic aspects of the
RAMS (Reliability, Availability, Maintainability &
safety) life cycle and defines a process, based on the
system life cycle and tasks within it, for managing
RAMS.
EN 50126-2 considers the safety-related generic
aspects of the RAMS life-cycle and defines methods
and tools which are independent of the actual
technology of the systems and subsystems.
Safety Plan shall define how the roles defined
in EN 50126-2 are covered by project
organization and who is assigned to the roles.
Independence of the roles in early phases (1
to 4) and later phases ( Phase 5 onwards) can
be same or different as shown in next slides.
Project Manager
ISA
Designer Verifier Validator
Project Manager
ISA
Verifier/
Designer Validator
Responsibilites and competencies of each
role is detailed in Annex G of EN 50126-2.
Roles & the assigned personel should ideally
remain unchanged throughout the
development project.
ISA shall evaluate the competency of the
project staff and organization for the
development.
Concept
System
Definition
System
System
Requirements Validation Validation
System level
Sub-system level
Requirements
Apportionment
Installation
Design and
Implementation
Manufacture
Hourglass model is detailed in EN 50126-2 §5.
It provides an overview of the major safety
related activities that are needed to ensure an
acceptable safety level for a technical system.
The purpose of this model is to highlight the
seperation between risk analysis as part of risk
assessment from Hazard analysis as part of
Hazard control.
In Hourglass model, Part A is associated with
Phases 1-3 ,Part B corresponds to Phase 4 & Part
C to Phases 5-9.
A
C
The objective of the verification is to
demonstrate that the requirements of each
life cycle phase have been fulfilled.
Verification of the activities and deliverables
of each phase defined in clause 7 of EN
50126-1 shall be conducted.
ISA shall evaluate the verification and
validation activities and the supporting
evidence.
Validation activities are performed at Life
cycle Phase 4 “ Specification of System
Requiements” to assure that system
requirements have been properly specified
and at Life cycle phase 9 to assure that the
system under consideration meets the
specific requirements for the intended use or
application.
Validation reports are produced at the end of
Phase 4 & Phase 9 of the lifecycle.
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