Transcript Slide 1

A new safety regulatory
framework for the European
Union is taking shape
Anders Lundström
Head of Unit, the European Railway Agency
[email protected]
7-10-2008
International Railway Safety Conference 2008, Denver
N° 1
Content of the presentation
1. EU railway policy and legislation
2. The safety directive
3. The European Railway Agency
4. Common Safety Methods (CSM)
5. Safety certification and safety
management systems
6. Moving forward
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EU railway legislation
• Creation of a single market for rail transport
services
– First directive published in 1991
– Completed for freight transport in 2007
– Continues with passenger transport from 2010
• Technical standardisation and harmonisation
–
–
–
–
Interoperability of trans-European networks
Gradually developed since 1996
Applicable to new and upgraded subsystems
Long-term implementation
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The safety directive
• Complements market opening and technical
legislation
• Deals with the existing railway system:
– Harmonises the regulatory structure in member states
– Defines responsibilities between actors
– Sets a framework for developing common safety
targets and common safety methods
– Requires the establishment of a safety authority and
an investigation body in each member state
– Defines principles for management, regulation and
supervision of safety
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A framework for further development
• Some of the provisions of the directive are to be
developed in detailed decisions:
– Common safety targets and methods
– Assessment of safety management systems
– Safety certification provisions
• Annexes of the directive to be updated with
technical progress
– In particular common safety indicators (Annex I)
The European Railway Agency has been
mandated to carry out the technical work
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The European Railway Agency
• A regulatory agency to develop proposals for
secondary technical legislation
– Final adoption is the task of the European
Commission
• The main activity areas are safety and
interoperability
• Brings together all the relevant actors of the
European railway sector
– Representatives of European associations are
nominated for each working party of the Agency
– Consultation of social partners and customers
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The process to decisions
No decision power for the Agency, the
Agency gives recommendations to the
Commission and technical opinions
upon specific request!
Decision
Comitology
(Article 21
Committee)
Commission
Agency
Working party …
NSA Network …
Social Partners
Internal reconcilement …
Passengers / customers
NSA = National Safety Authority
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Safety as a barrier for market opening
• Historically rail safety in Europe has been driven
by national developments
– Requirements and rules have often been derived from
lessons learnt from accidents
• Resulted in fragmentation of the market for rail
products and services
NOW:
• Gradual technical harmonisation through the
interoperability directives
• The safety directive sets out to harmonise
processes and procedures (methods)
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Common Safety Methods
• Recommendation developed by the Agency
based on existing methods:
– Application of codes of practice
– Comparison with reference system
– Explicit risk estimation
• To be applied only to significant changes
– Technical, operational and organisational
• The objective is to achieve a higher degree of
mutual recognition and thus facilitate market
opening and cross-border traffic
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Risk management process
Risk Management is an iterative
process that comprises:
(I) The decision on the significance
of the change
(II) Risk Assessment Process that
shall identify:
 the hazards;
 the associated safety measures;
 the resulting safety requirements;
(III)Demonstration of compliance
with the safety requirements;
(IV)Management of all identified
hazards and associated safety
measures;
(V) Risk management shall be
assessed independently by an
assessment body
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Decision on the significance of the change
Change
 CSM shall be applied only to
assess predicatively the safety
of significant changes.
Safety Relevance
Is it safety related?
 When notified national rules do
not define what is significant
change, the significance of the
change shall be evaluated
based on expert's judgement
and defined criteria.
 Decision shall be documented
to allow NSA monitoring
No
C: Not significant
Yes
Other criteria
1.
2.
3.
4.
5.
low failure consequence?
low complexity?
easy monitoring?
high reversibility?
low innovation?
Yes
B: Not significant
No
A: Significant Change
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The way forward
• The recommendation of the Agency has been
transformed into a draft Commission Regulation
– Submitted to the Committee of member states for
opinion (November 2008?)
– Applicable to vehicles from July 2010 and for all
changes from 2012
• Still widely debated in certain member states not
fully acquainted with a risk based approach
– The opposition indicates that adoption will lead to real
harmonisation
• The Agency is preparing dissemination and
promotion activities from next year
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Safety certification
• All railway undertakings required to hold a safety
certificate, granted in two parts:
– Part A for the safety management system, mutually
recognised across Europe
– Part B related to requirements for the specific network
• The Agency works on several aspects to
facilitate safety certification and to harmonise
requirements and assessment criteria:
– Common safety method for conformity assessment
– Harmonised Part B requirements
– Common formats for application guidance documents
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Safety management systems
European Legislation (Railway Safety Directive 2004/49/EC):
Responsibility for the safe operation of the railway system and the
control of risks associated with it is laid upon the infrastructure
managers and railway undertakings – through risk control
measures, application of national safety rules and standards,
establishment of a safety management system (SMS).
General aim of the SMS:
Railway undertakings and Infrastructure Managers shall be in the position
to fulfil their roles and responsibilities as given in the Railway Safety
Directive by establishing an SMS – built according to harmonised
principles.
Introducing the SMS helps to maintain the high level of safety within the
railway sector by ensuring safe interfaces between the players in a newly
organised open market.
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Content and structure
European Legislation (Railway Safety Directive 2004/49/EC):
Infrastructure managers and railway undertakings shall establish a safety
management system.
It shall ensure the control of all risks associated with the respective
activity (including supply of maintenance and material, use of contractors).
Where appropriate and reasonable, the risks arising as a result of
activities by other parties shall be taken into account.
Structure of the SMS:
The safety management system for the railway sector follows the riskbased process-oriented approach of well-established management
systems in general.
Preparation is under way to develop a European standard to facilitate the
implementation of the SMs and to allow for 3rd party assessment.
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Assessment of the SMS
European Legislation (Railway Safety Directive 2004/49/EC):
National Safety Authorities need to confirm their acceptance with the
provisions of the railway undertakings and infrastructure managers.
From 2010 on, the NSA certification will be carried out according to a
harmonised Common Safety Method (CSM for Conformity Assessment).
The National Safety Authority’s Certificate is split into two parts:
Part A – Confirmation of acceptance with the general SMS
Part B – Confirmation of acceptance with the network-related adaptation
Not to be forgotten:
Part A of the safety certificate is – once obtained in one Member State –
valid all over the European Union without re-assessment, which is to
facilitate market entrance!
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Working with the safety authorities
• Safety certificates are granted by national safety
authorities
• Part A for safety management systems are valid
across Europe
– Thus, it is important to create confidence among
authorities that processes and applied criteria are
comparable and to avoid re-assessments
• Therefore the authorities have agreed to carry
out peer reviews to learn from best practices
– The Agency is participating as observer and is
overlooking the process
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Moving towards a common approach
• The Agency has given new impetus to the
development of European-wide standards
• More important, the Agency represents a centre
of competence bringing together the sector for:
– Exchange of experience and demonstration of good
examples
– Leading discussions based on facts
– Understanding of differences in safety culture
– Collecting and publishing information
• More on the website: www.era.europa.eu
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