1. Slide n° 1 EU railway legislation - Safety regulatory framework NAB/RB training workshop in Valenciennes, April 2016 NAB/RB Training Workshop In Valenciennes, April 2016 European railway legislation Safety regulatory framework Jean-Marie DECHAMPS, European Railway Agency

2. Slide n° 2 EU railway legislation - Safety regulatory framework NAB/RB training workshop in Valenciennes, April 2016 Reminder from previous presentation Relations between the different railway stakeholders CUSTOMER ECM IM RU Track Access Safety Certification Safety Authorisation Transport Contract Maintenance Contract Renting Contract Contract of use - GCU KEEPER ECM CERTIFICATION BODY NSA Surveillance of MSSupervision of SMS ECM CERTIFICATION BODY NSA Certification of MSCertification of SMS

3. Slide n° 3 EU railway legislation - Safety regulatory framework NAB/RB training workshop in Valenciennes, April 2016  Existing national railway systems usually based on use of rules and retrospective review of «bad experiences» from past Harmonised way of thinking in terms of «risk» «Risk based approach» and proactive Management of Safety  Directive 2004/49 introduces concepts of:  (Safety) Management System (SMS/MS), and;  proactive way of thinking «predicting and preventing» possible events (i.e. risks) that have not yet happened  To ensure the safe Operation & Maintenance of the railway system, looking both FORWARD and RETROSPECTIVE, the SMS/MS shall enable to:  «predict» unwanted events that can happen during the operation and maintenance of the railway system;  «prevent» those unwanted events to happen in addition to «reacting and fixing» only those that occurred in the past, and;  control (all) risks associated with RU, IM & ECM activities

4. Slide n° 4 EU railway legislation - Safety regulatory framework NAB/RB training workshop in Valenciennes, April 2016 Comparison of Proactive vs. Reactive approaches Accidents are used to prevent repetition of similar accidents Costly with high impact on the system and society Unable to control unknown risks Reactive approach (React & Fix) Competence and knowledge are used to control risks and then to prevent accidents Limited impact on the system and society Can effectively prevent the occurrence of events Proactive approach (Predict & Prevent)

5. Slide n° 5 EU railway legislation - Safety regulatory framework NAB/RB training workshop in Valenciennes, April 2016 Risk based approach In a proactive system based on control of risks the key question is: «What are the likely risks and the risk control measures I should put in place to manage safely my business?» Safe Operation & Maintenance (i.e. all risks are under control) Activities undertaken by RUs, IMs & ECMs SMS MS Risks

6. Slide n° 6 EU railway legislation - Safety regulatory framework NAB/RB training workshop in Valenciennes, April 2016 SMS/MS provides a structured framework to ensure that: 1)PLAN: the company is designed (i.e. organised) to deliver safely the operation 2)DO: the company actually deploys the operational and support processes 3)CHECK: the company measures the effectiveness of the processes 4)ACT/ADJUST: the company takes preventive or corrective measures on detection of non-compliances SMS/MS is not an alternative to the existing set of safety related technical, operational & maintenance rules. It is a structured way to apply and improve them taking into account the risks related to the specific activities of the RU, IM, ECM Objective of an SMS/MS: keep "set rules" up to date SMS MS DOCHECKACTPLAN  

7. Slide n° 7 EU railway legislation - Safety regulatory framework NAB/RB training workshop in Valenciennes, April 2016 Risk Manage ment Processes (Existing) Rules Procedures Human Factors  A documented and structured framework for safe management of all company activities  Ensures appropriate processes, procedures and rules exist for controlling all company risks  Enables identification of hazards and continuous management of risks related to the company activities, with the aim of preventing accidents  Uses scientific "risk manage- ment" tools to support company managers in taking consciously decisions for their business What is an SMS/MS?

8. Slide n° 8 EU railway legislation - Safety regulatory framework NAB/RB training workshop in Valenciennes, April 2016 A common risk assessment process with: (a)System definition (b)Identification of hazards/risks & associated safety measures (c)Risk analysis based on exiting risk acceptance principles (CoP, Ref. Syst, Explicit Risk Estimation) (d)Risk evaluation for checking acceptance of risk(s) (e)Definition of safety requirements from identified safety measures Demonstration of system compliance with identified safety requirements Requirements for mutual recognition: (a)Hazard Management (b)Independent Assessment (Body) Iterative Risk Management Process “triggered” by a Significant Change CSM for risk assessment - Regulation 402/2013 Iterative risk assessment process to be applied when change is significant Demonstration of Compliance with Safety Requirements Preliminary System Definition INDEPENDENT ASSESSMENT HAZARD MANAGEMENT RISK ANALYSIS RISK EVALUATION (vs. Risk Acceptance Criteria) Safety Requirements (i.e. safety measures to be implemented) SYSTEM DEFINITION RISK ASSESSMENT Significant Change? HAZARD IDENTIFICATION AND CLASSIFICATION Codes of Practice Similar Reference Systems Explicit Risk Estimation Justify and document decision

9. Slide n° 9 EU railway legislation - Safety regulatory framework NAB/RB training workshop in Valenciennes, April 2016 Management System 1)Define a strategy, priorities and plan(s) for monitoring of Management System; 2)Collect, analyse and evaluate any necessary information; 3)Draw up an action plan for identified non-compliances that are inacceptable; 4)Implement action plan for those non- compliance; 5)Evaluate effectiveness of measures contained in action plan CSM for monitoring [i.e. Reg. 1078/2012] applies to RUs, IMs and ECMs Collect of necessary information Analysis and evaluation of non-compliances NO YES Acceptable? Draw up an Action Plan Implementation of Action Plan Strategy, Priorities and plan(s) Qualitative and/or Quantitative Indicators Non-compliances identified? Overall objective: improve Management System and review Strategy, Priorities and Plan(s) for monitoring based on experience Evaluation of effectiveness of Action Plan Improvement of Management System: Review of Strategy, Priorities & Plan(s ) Processes, procedures and technical, operational and organisational risk control measures within the

10. Slide n° 10 EU railway legislation - Safety regulatory framework NAB/RB training workshop in Valenciennes, April 2016 Pilars for managing railway safety and taking safe decisions Risk Assessment & Monitoring within the framework of Change Management Presentation by CSM for risk assessment & CSM for monitoring of the links between Reg. 1078/2011 Reg. 402/2013

11. Slide n° 11 EU railway legislation - Safety regulatory framework NAB/RB training workshop in Valenciennes, April 2016 Regulations 1058/2010, 1169/2010 & 1077/2012 Roles of Public Authorities (NSAs) Safety Certification/Authorisation & Supervision of RU/IM SMS IM RU Co-operation Monitoring of Safety Performance Implementation of SMS Procedures Monitoring of Safety Performance Implementation of SMS Procedures IM RU Safety Performance SMS Procedures Safety Authorisation Safety Certificate NSA SMS Certification SMS Post-award surveillance Reg. 1169/2010 Reg. 1077/2012 Reg. 1158/2010 Reg. 1077/2012 High level assessment (CSM for conformity assessment) Post award supervision of delivery (CSM for supervision)

12. Slide n° 12 EU railway legislation - Safety regulatory framework NAB/RB training workshop in Valenciennes, April 2016 ECM Regulation 445/2011 - Roles of ECM Certification Bodies Certification & Surveillance of Maintenance System of ECMs ECM Monitoring of Safety Performance Implementation of System of Maintenance Procedures Monitoring of Safety Performance Implementation of SM Procedures ECM Safety Performance Maintenance System (MS) Procedures Safety Certification Accredited or Recognised ECM Certification Body or NSA MS Certification MS Post-award surveillance Reg. 445/2011 Assessment of MS Post award surveillance of delivery

13. Slide n° 13 EU railway legislation - Safety regulatory framework NAB/RB training workshop in Valenciennes, April 2016 Safe Operation European Railway Legislation Safety Regulatory Framework – How many CSMs? Railway Safety Directive 2004/49/EC ² CSM for Conformity Assessment - Regulations 1158/2010 & 1169/2010 ECM Regulation 445/2011 CSM for Supervision Regulation 1077/2012 ECM Regulation 445/2011 SMS/ MS Do Check ActPlan AssessmentMonitoring/Supervision/Surveillance Freight wagons CSM for Risk Assessment Regulation 402/2013 CSM for Monitoring Regulation 1078/2012

14. Slide n° 14 EU railway legislation - Safety regulatory framework NAB/RB training workshop in Valenciennes, April 2016 Many thanks for your attention! E-mail: CSM.risk_assessment@era.europa.eu