EUROPEAN RAILWAY AGENCY Safety Unit

Application guide for the design and implementation of a Railway Safety Management System

BUILDING KNOWLEDGE TEXTS

ERA/GUI/05-2011/SAF Version 1 13/12/2010

Version Control
Document elaborated by: Released by: Reviewed by: Authors: European Railway Agency 120 rue Marc Lefranq - F-59300 Valenciennes - France Anders LUNDSTRM, Head of Unit, Safety Bart Accou Anna Patacchini

Type of document:

Supplement to application guide for the design and implementation of Safety Management System, addressed to railway undertakings and infrastructure managers in order to implement a SMS compliant with Article 9 and Annex III of Directive 2004/49/EC
Public 1 13/12/2010

Status of document: Version:

Date:

Introduction
The Directive 2004/49/EC1 (hereinafter referred as the Railway Safety Directive if not otherwise specified) clearly stipulates in Article 4 that the responsibility for safe operation is with the railway undertakings (RU) and infrastructure managers (IM) and, to fulfil this responsibility, it requires that they establish a safety management system (SMS), in accordance with Articles 9 and Annex III of the Directive itself. The adequate implementation of an SMS by all RUs/IMs is a key element for success for the entire safety regulatory framework as foreseen by the Railway Safety Directive, since it forms the basis on which the National Safety Authorities (NSAs) issue safety certificates and safety authorisations. For the assessment of an SMS, NSAs can rely on the Regulations 1148/2010/EU2 and 1169/2010/EU3. Such Regulations contain the framework principles for assessing an SMS, the criteria to be used for this assessment and principles for sup ervision after the award of Safety certificates or authorisations. Although these CSM can already give clear guidance on the adequate implementation of an SMS, with a view to Article 9 and Annex III of the Railway Safety Directive, there are no provisions specifically addressed to RUs and IMs, to be used as reference document to support the design and implementation of their SMS. The Agency has the intention to provide this practical guidance through a set of complementary SMS guidelines of which this document is a part of deliverables. The purpose of the SMS is to ensure that the organisation achieves its business objectives in a safe manner. These objectives need to be fulfilled in todays ever changing and complex railway environment. In addition, the SMS should ensure that the organisation complies with all of the safety obligations that apply to it.
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DIRECTIVE 2004/49/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004 on safety on the Community's railways and amending Council Directive 95/18/EC on the licensing of railway undertakings and Directive 2001/14/EC on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification (Railway Safety Directive)
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Commission Regulation (EU) No 1158/2010 of 9 December 2010 on a common safety method for assessing conformity with the requirements for obtaining railway safety certificates. OJ L 326, p.11
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Commission Regulation (EU) No 1169/2010 of 10 December 2010 on a common safety method for assessing conformity with the requirements for obtaining railway safety authorisations. OJ L 327, p.13

Adopting a structured approach enables the identification of hazards and the continuous management of risks related to an organisations own activities, with the aim of preventing accidents. When appropriate it should take into account the interfaces with other RUs and IMs in the railway system. Implementing all relevant elements of an SMS in an adequate way can provide an organisation with the necessary trust that it controls and will continue to control all the risks associated with its activities, under all conditions. Mature organisations thereby recognise that an efficient control of its risks can only be achieved through a process that brings together three critical dimensions: a technical component with the used tools and equipment, a human component of front line people with their skills, training and motivation and an organisational component consisting of procedures and methods defining the relationship of tasks. Consequently, an adequate SMS succeeds in monitoring and improving all three dimensions of its risk control measures. The implementation of a SMS is legally binding after Articles 4(3) and 9(1) of the Directive 2004/49/EC. Nonetheless, there are other good reasons for implementing and delivering an effective SMS: Many features of the railway SMS are very similar to management practice advocated by proponents of quality, health and safety at work, environmental protection and business excellence. Therefore principles of good management can be easily integrated and may not need a complete re-design of organisations that already have those systems in place; It has been recognised that structured management systems add value to business helping to improve overall performances, introduce operational efficiencies, enhance relations with customers and regulatory authorities and build a positive safety culture.

The building knowledge texts

To improve knowledge on the SMS, as far as general principles and specific elements are concerned, quite a lot of literature is available. As follows, a list of texts that can be useful for building knowledge of Safety Management Systems either as a general issue and focused to specific elements of the SMS is provided. None of the following document is mandatory in order to implement a SMS compliant with the Directive 2004/49/EC, and their use is only for growing awareness and information. Please note that documents marked with are not available for free, so the web-site is mentioned to provide indication for purchase.

1 GENERALITIES ON SAFETY MANAGEMENT SYSTEMS

Successful health and safety management, Health and Safety Executive, HSE Books 1997, available at: http://www.hse.gov.uk/pubns/books/hsg65.htm Reducing error and influencing behaviour, Health and Safety Executive, HSE Books 1999, available at: http://www.hse.gov.uk/pubns/priced/hsg48.pdf ICAO Doc 9859, Safety Management Manual (SMM), V.2, International Civil Aviation Organisation (ICAO) 2009, available at: http://www.icao.int/anb/safetymanagement/DOC_9859_FULL_EN_V2.pd/ ISM Code (International Safety Management Code) and guidelines on implementation of the ISM Code , International Maritime Organisation, 2010, can be purchased at http://www.marisec.org/catalogue.html [ISBN 978-92-801-5151-0]

2 GENERALITIES ON RAILWAY SAFETY MANAGEMENT SYSTEMS

Guidelines for the implementation of the EU Safety Directive in the form of a management system for railway undertakings , UIC Quality Study Group, UIC 2007, can be purchased at: www.uic.asso.fr [ISBN 2-7461-1383-X (FR) - ISBN 2-7461-1383-8 (DE) - ISBN 2-7461-1383-6 (EN)] Railway Safety Management Systems System Documents (Guide for Developing, Implementing and Enhancing Railway Safety Management Systems; Annex 1: Best Practices; Annex 2: Best Practices for Small Railways; Safety Culture Checklist; Overview: Railway Safety Management Systems) Ministry of Transport Canada - Transport Canada 2010, available at: http://www.tc.gc.ca/eng/railsafety/guide-sms.htm
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National Rail Safety Guideline. Preparation of a Rail Safety Management System, National Transport Commission Australia-Rail safety Panel (NTC), 2008, available at: http://www.ntc.gov.au/filemedia/Reports/NRSG_SafetyManagementSystemSMS_J.pdf AS4292.1:2006 Railway safety management - general requirements , Standards Australia, SAI Global 2006, can be purchased at: http://infostore.saiglobal.com/ SANS 3000-1:2009 Railway safety management general requirements , Standards South Africa 2009, www.stansa.co.za (ISBN -978-0-626-225) Engineering Safety Management Issue 4, Various authors, RSSB 2007, available at: http://www.yellowbook-rail.org.uk/ IRIS International Railway Industry Standard V 0.2 UNIFE, 2009, to be purchased at: www.iris-rail.org SQAS Transport Service Guidelines, SQAS-CEFIC, CEFIC 2006, available at: http://www.sqas.org/ts/index.html

3 ELEMENTS OF THE RAILWAY SAFETY MANAGEMENT SYSTEMS

The headings refer to the position of the element in the relevant part of Chapters 7, 8 and 9 of the document A system approach.
7.1 - Leadership 7.1.1 - Management Commitment HSE Leading Health and Safety at Work, available at: http://www.hse.gov.uk/pubns/indg417.pdf 7.1.2 - Safety Policy Managing health and safety Five steps to success, available at: http://www.hse.gov.uk/pubns/indg275.pdf 7.1.3 - Corporate safety targets == 7.1.4 - Decision Making Ethical basis of rail safety decisions, , available at: http://www.rssb.co.uk/SiteCollectionDocuments/pdf/reports/research/T230a%20Ethical%20basis%20of%20railway%20decisions.pdf

Taking Safe Decisions (in three parts), available at: http://www.rssb.co.uk/SiteCollectionDocuments/pdf/vtsic_presentations/Taking%20safe%20decisions%20-%20Part1.pdf http://www.rssb.co.uk/SiteCollectionDocuments/pdf/vtsic_presentations/Taking%20safe%20decisions%20-%20Part%202.pdf http://www.rssb.co.uk/SiteCollectionDocuments/pdf/vtsic_presentations/Taking%20safe%20decisions%20-%20Part%203.pdf 7.1.5 - Management Control Anthony, R. and Govindarajan, V.. Management Control Systems, Chicago, Mc-Graw-Hill IRWIN, 2007 7.2 - Risk Assessment 7.2.1 - Control of risks associated with the activity of the railway undertakings / infrastructure managers ISO 31000:2009 Risk Management - Principles and Guidelines IEC 31010:2009 Risk Management - Risk Assessment Techniques ISO/IEC 73: Risk Management Vocabulary EN 50126: 1999 Railway applications. The specification and demonstration of reliability, availability, maintainability and safety (RAMS) Guidance on 'Outsourced processes' Document: ISO/TC 176/SC 2/N 630R3, October 2008, available at: http://www.iso.org/iso/iso_catalogue/management_standards/iso_9000_iso_14000/iso_9001_2008/guidance_on_outsourced_processes.htm The RSSB Safety Risk Model and Risk Profile Bulletin , available at: http://www.safetyriskmodel.co.uk/ RSSB Industry Shared Risk Database, available at: http://isrd.rssb.co.uk/ Guidance on the preparation and use of company risk assessment profiles for transport operators, available at: http://www.safetyriskmodel.co.uk/Bulletin/Risk%20Documents/Guidance%20on%20preparation%20and%20use%20of%20company%20rsk%20assessment %20profiles%20for%20transport%20oerators%20-issue1-small.pdf Railway safety and the ethics of the tolerability of risk, available at: http://www.rssb.co.uk/SiteCollectionDocuments/pdf/reports/research/T230b%20Railway%20Safety%20and%20the%20Ethics%20of%20the%20Tolerability %20of%20Risk.pdf Risk in management systems, available at: http://www.rssb.co.uk/SiteCollectionDocuments/pdf/reports/research/Risk%20in%20management%20systems.pdf

7.2.2 - Risks arising from the activities of other parties (external to the railway system) ISO 31000:2009 Risk Management - Principles and Guidelines IEC 31010:2009 Risk Management - Risk Assessment Techniques ISO/IEC 73: Risk Management Vocabulary EN 50126: 1999 Railway applications. The specification and demonstration of reliability, availability, maintainability and safety (RAMS) Guidance on 'Outsourced processes' Document: ISO/TC 176/SC 2/N 630R3, October 2008, available http://www.iso.org/iso/iso_catalogue/management_standards/iso_9000_iso_14000/iso_9001_2008/guidance_on_outsourced_processes.htm A guide to RSSB research in Road-Rail Interface Safety, available at: http://www.rssb.co.uk/SiteCollectionDocuments/pdf/reports/research/T907_guide_final.pdf Development of a universal level crossing risk tool, available at: http://www.rssb.co.uk/SiteCollectionDocuments/pdf/reports/research/T028_rb_final.pdf Understanding human factors and developing risk reduction solutions for pedestrian crossings at railway stations, available at: http://www.rssb.co.uk/SiteCollectionDocuments/pdf/reports/research/T730_rpt_final.pdf Improving road user and pedestrian behaviour at level crossings, available at: http://www.rssb.co.uk/SiteCollectionDocuments/pdf/reports/research/T335_rpt_final.pdf 7.2.3 - Procedures / Methods for risk evaluation and implementation of risk control measures (change management) A guide to RSSB research into Health, available at: http://www.rssb.co.uk/SiteCollectionDocuments/pdf/reports/research/T822_guide_final.pdf 7.2.4 - Compliance with legislation, rules and standards === 7.2.5 - Co-ordination of tasks for IM === at:

7.3 - Monitoring 7.3.1 - Data collection and analysis Development of methods for pooling data, and procedures for structured expert judgement, available at: http://www.rssb.co.uk/SiteCollectionDocuments/pdf/reports/research/A%20statistical%20review%20of%20the%20RSSB%20Safety%20Risk%20Model_WP 2.pdf HSG254 Developing Process Indicators, available at: http://books.hse.gov.uk/hse/public/saleproduct.jsf?catalogueCode=9780717661800 Leading Performance Indicators, Guidance for Effective Use, available at: http://stepchangeinsafety.net/stepchange/News/StreamContentPart.aspx?ID=1517 7.3.2 - Accident/incident reporting and investigation T635 An analysis of formal inquiries and investigations to identify human factors issues, available at: http://www.rssb.co.uk/SiteCollectionDocuments/pdf/reports/research/T635_HFrpt_final.pdf HSG48 Reducing error and influencing behaviour, available at: http://books.hse.gov.uk/hse/public/saleproduct.jsf?catalogueCode=9780717624522 HSG245 Investigating accidents and incidents by HSE, 2004, available at: http://books.hse.gov.uk/hse/public/saleproduct.jsf?catalogueCode=9780717628278 GO/RT3119 Accident and Incident Investigation, Oct 2008, available at: http://www.rgsonline.co.uk/Railway_Group_Standards/Traffic%20Operation%20and%20Management/Railway%20Group%20Standards/GORT3119%20Iss %201.pdf GO/GN3519 Guidance on Accident and Incident Investigation Oct 2008, available at: http://www.rgsonline.co.uk/Railway_Group_Standards/Traffic%20Operation%20and%20Management/Guidance%20Notes/GOGN3519%20Iss%201.pdf The report- The BP U.S. Refineries independent safety review panel, available at: http://sunnyday.mit.edu//Baker-panel-report.pdf 7.3.3 - Internal auditing ERA SMS Application Guide Internal audit EN ISO 19011:2002 Guidelines for quality and/or environmental management systems auditing Arto Kuusisto Safety Management Systems Audit tools and reliability of auditing (VTT Publications, 2000), available at: http://www.vtt.fi/inf/pdf/publications/2000/P428.pdf

7.4 - Organisational Learning 7.4.1 - Continuous Improvement ISO 9004:2009 Managing for the sustained success of an organization - A quality management approach 7.4.2 - Safety recommendations ISO 9001:2008 Quality Management System http://www.iso.org/iso/iso_catalogue/management_standards/iso_9000_iso_14000/iso_9001_2008.htm 7.4.3 - Change management As strong section on change management is found in: IAEA Safety Standards, Application of the Management System for Facilities and Activities http://www-pub.iaea.org/MTCD/publications/PDF/Pub1253_web.pdf

8.1 - Structure & responsibility 8.1.1 - Distribution of responsibilities === 8.1.2 - Management accountability === 8.1.3 - Organisational structure === 8.1.4 - Workload planning Human factors study of fatigue and shift work, available at: http://www.rssb.co.uk/SiteCollectionDocuments/pdf/reports/research/T059%20Main%20Report.pdf Mental workload assessment for train drivers, available at: http://www.rssb.co.uk/SiteCollectionDocuments/pdf/reports/research/T147_rpt2_final.pdf

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8.2 - Competence Management 8.2.1 - Competence management system training programmes for staff Developing and Maintaining Staff Competence, available at: http://www.rail-reg.gov.uk/upload/pdf/sf-dev-staff.pdf Brochure on RSSB Competence Projects, available at: http://www.rssb.co.uk/SiteCollectionDocuments/pdf/reports/research/T937_guide_final.pdf Managing the competence of transport maintenance staff, available at: http://www.rssb.co.uk/SiteCollectionDocuments/pdf/reports/research/T049%20Managing%20the%20competence%20of%20transport%20maintenance%2 0staff.pdf Competence assessment and verification standards, available at: http://www.rssb.co.uk/SiteCollectionDocuments/pdf/reports/research/Competence%20assessment%20and%20verification%20standards.pdf Development of competence assessment criteria for supervisors in safety critical roles, available at: http://www.rssb.co.uk/SiteCollectionDocuments/pdf/reports/research/Development%20of%20competence%20assessment%20criteria%20for%20supervis ors%20in%20safety%20critical%20roles.pdf A competence needs analysis for trainers and their line managers, available at: http://www.rssb.co.uk/SiteCollectionDocuments/pdf/reports/research/T588_rpt_final.pdf Competences of staff taking part in interoperability (second part), CER, 2000

8.3 - Information 8.3.1 - Configuration control of safety information Human factors study of railway worker information requirements, available at: http://www.rssb.co.uk/SiteCollectionDocuments/pdf/reports/research/Human%20factors%20study%20of%20railway%20worker%20information%20requir ements.pdf 8.3.2 - Involvement of staff === 8.3.3 - Internal/external communication Safety critical communications, available at: http://www.rssb.co.uk/SiteCollectionDocuments/pdf/reports/research/Safety%20critical%20communications.pdf

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8.4 - Documentation 8.4.1 - SMS documentation === 8.4.2 - Document Management Company Safety Plans, A Good Practice Guide, available at: http://www.rssb.co.uk/SiteCollectionDocuments/pdf/Csp_agpg.pdf 8.4.3 Annual safety report ===

9.1 - Operational arrangements / procedures 9.1.1 - Procedures to meet applicable rules for type of service delivered Procedures to assure compliance throughout lifecycle of equipment/operation (delivery phase) Yellow book Engineering railway safety Issue 4 RSSB, 2007, available at: http://www.yellowbook-rail.org.uk/ A guide to RSSB research in Operational Safety, available at: http://www.rssb.co.uk/SiteCollectionDocuments/pdf/reports/research/T838_guide_final.pdf 9.1.2 - Use of contractor and control of suppliers GCU (General contract for the use of private wagons) , available at: http://www.gcubureau.org/resource/file/pdf/Demission/GCU_EN%20oct09%20MIN(1).pdf http://www.gcubureau.org/index.php?lang=fr&pageid=27 (French) http://www.gcubureau.org/index.php?lang=de&pageid=27 (German) Supply chain safety management , available at: http://www.rssb.co.uk/SiteCollectionDocuments/pdf/reports/research/Supply%20chain%20safety%20management.pdf 9.1.3 - Asset management PAS 55-1:2008 Part 1 and 2 Asset management. Specification for the optimized management of physical assets http://shop.bsigroup.com/en/ProductDetail/?pid=000000000030171836

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9.2 - Emergency Plans 9.2.1 - Emergency Management Review of US requirements for passenger train emergency systems and their relevance to GB, available at: http://www.rssb.co.uk/SiteCollectionDocuments/pdf/reports/research/T814_rpt_final.pdf 9.2.2 - Co-ordination tasks for IM Duty of Cooperation (RSSB, 2009), available at: http://www.rssb.co.uk/SiteCollectionDocuments/national_programmes/RSSB%20Duty%20of%20Cooperation%20Guide%20Parts/RSSB%20Duty%20of%20 Cooperation%20Guide%20Part%201.pdf

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