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Report on study into National Safety Requirements in Member States in relation to the award of Part B Safety Certificates T24144-002

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AMENDMENTSAMENDMENTSAMENDMENTSAMENDMENTS

IIIISSUESSUESSUESSUE RRRREVISIONEVISIONEVISIONEVISION DDDDESCRIPTIONESCRIPTIONESCRIPTIONESCRIPTION DDDDISTRIBUTIONISTRIBUTIONISTRIBUTIONISTRIBUTION DDDDATEATEATEATE 1 Draft A First Draft Draft B Second Draft Draft C Third Draft Draft D Fourth Draft Andy Woodcock/Kevin

Sutton 18/07/10

Draft E Incorporating comments from AW

Karen Davies 18/07/10

Draft F Incorporating comments from KS/AW

Draft G Incorporating comments from AW and KD

Draft H Incorporating further ongoing changes by BM/AW/KS


Final Incorporating comments from ERA



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GLOSSARY OF TERMSGLOSSARY OF TERMSGLOSSARY OF TERMSGLOSSARY OF TERMS .................................................................................................................................................................................................................................................................................................... 5555

1111 EXECUTIVE SUMMARYEXECUTIVE SUMMARYEXECUTIVE SUMMARYEXECUTIVE SUMMARY ............................................................................................................................................................................................................................................................ 7777

1.11.11.11.1 GGGGENERALENERALENERALENERAL ............................................................................................................................................................................................................................................................................................................................................................................................................7777

2222 INTRODUCTIONINTRODUCTIONINTRODUCTIONINTRODUCTION.................................................................................................................................................................................................................................................................................... 10101010

2.12.12.12.1 BBBBACKGROUNDACKGROUNDACKGROUNDACKGROUND ........................................................................................................................................................................................................................................................................................................................................................................10101010 2.22.22.22.2 OOOOBJECTIVESBJECTIVESBJECTIVESBJECTIVES ........................................................................................................................................................................................................................................................................................................................................................................................11111111 2.32.32.32.3 MMMMETHODOLOGYETHODOLOGYETHODOLOGYETHODOLOGY ................................................................................................................................................................................................................................................................................................................................................................11111111 2.42.42.42.4 AAAACKNOWLEDGEMENTCKNOWLEDGEMENTCKNOWLEDGEMENTCKNOWLEDGEMENT ....................................................................................................................................................................................................................................................................................................................................14141414

3333 CURRENT SITUATIONCURRENT SITUATIONCURRENT SITUATIONCURRENT SITUATION........................................................................................................................................................................................................................................................ 15151515

3.13.13.13.1 GGGGENERALENERALENERALENERAL ....................................................................................................................................................................................................................................................................................................................................................................................................15151515 3.23.23.23.2 OOOOVERVIEW BY VERVIEW BY VERVIEW BY VERVIEW BY CCCCOUNTRYOUNTRYOUNTRYOUNTRY ........................................................................................................................................................................................................................................................................................................................15151515 3.33.33.33.3 SSSSUMMARY OF UMMARY OF UMMARY OF UMMARY OF RRRRESULTS FROM ESULTS FROM ESULTS FROM ESULTS FROM SSSSURVEYS AND URVEYS AND URVEYS AND URVEYS AND IIIINTERVIEWSNTERVIEWSNTERVIEWSNTERVIEWS ............................................................................................................................................................36363636 3.43.43.43.4 MMMMISCELLANEOUSISCELLANEOUSISCELLANEOUSISCELLANEOUS ................................................................................................................................................................................................................................................................................................................................................................47474747

4444 RECOMMENDATIONSRECOMMENDATIONSRECOMMENDATIONSRECOMMENDATIONS .................................................................................................................................................................................................................................................... 50505050

4.14.14.14.1 OOOOVERALL VERALL VERALL VERALL CCCCONCLUSIONSONCLUSIONSONCLUSIONSONCLUSIONS ....................................................................................................................................................................................................................................................................................................................50505050 4.24.24.24.2 RRRRECOMMECOMMECOMMECOMMENDATIONSENDATIONSENDATIONSENDATIONS ........................................................................................................................................................................................................................................................................................................................................52525252

5555 CONCLUSIONCONCLUSIONCONCLUSIONCONCLUSION................................................................................................................................................................................................................................................................................................ 55555555

APPENDICES Appendix A – Step One Survey Questions Appendix B – Step Two Survey Questions Appendix C – Interview Questions Appendix D – Summary of Results Appendix E – List of Problems Arising from Surveys and Interviews


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GLOSSARY OF TERMSGLOSSARY OF TERMSGLOSSARY OF TERMSGLOSSARY OF TERMS

ADIF Administrador de Infraestructuras Ferroviarias (ES IM) AEG Allgemeines Eisenbahngesetz (DE General Railway Act) ANSF Agenzia Nazionale per la Sicurezza Ferroviaria (IT NSA) AT Austria BE Belgium BMVIT Federal Ministry of Transport, Innovation and Technology (AT NSA) BU Bulgaria CSM Common Safety Method CT Channel Tunnel CZ Czech Republic DE Germany DK Denmark DGIF Dirección General de Infraestructura Ferroviaria (ES NSA) DUČR Drážni Úrad Česká Republika (CZ NSA) EBA Eisenbahnbundesamt (DE NSA) EE Estonia EPSF Enterprise Publique de Securitié Ferroviare (FR NSA) ERA European Railway Agency ERADIS European Railway Agency Database of Interoperability and Safety ES Spain EU European Union EVR Estonian Railways Ltd FI Finland FR France GR Greece HU Hungary IE Ireland IGC Intergovernmental Commission (CT NSA) IM Infrastructure Manager IT Italy IMTT Instituto da Mobilidade e dos Transportes Terrestres (PT NSA) Interfleet Interfleet Technology Ltd ITT Invitation to Tender IVW Inspectie Verkeer en Waterstaat (NL NSA) KET HU national law LT Lithuania LU Luxembourg LV Latvia MoT Ministry of Transport MS Member State NL Netherlands NO Norway NSA National Safety Authority NSR National Safety Rules


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NTA National Transport Authority (HU NSA) ORR Office of Rail Regulation (UK NSA) PL Poland PT Portugal RFF Réseau Ferré de France (FR IM) RFI Rete Ferroviaira Italiano (IT IM) RO Romania RSD Railway Safety Directive RSSB Rail Safety and Standards Board RU Railway Undertaking SE Sweden SL Slovenia SK Slovak Republic SMS Safety Management System SNCF Société National de Chemin de Fer Français (FR RU and delegated

IM) SRTI State Railway Technical Inspectorate (LV NSA) TEN-T Trans-European Transport Network TJA Technical Surveillance Authority (EE NSA) UK United Kingdom VPE Vasúti Pályakapacitás-elosztó Korlátolt Felelısségő Társaság (HU

independent organization for allocation of train paths)


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1111 EXECUTIEXECUTIEXECUTIEXECUTIVE SUMMARYVE SUMMARYVE SUMMARYVE SUMMARY

1.11.11.11.1 GGGGENERALENERALENERALENERAL

Commissioned by the European Railway Agency (ERA) in Autumn 2009, the assignment has been undertaken by a project team from Interfleet Technology Ltd (Interfleet) under the direction of a Project Leader based in the Interfleet London office. The report has been produced following two online surveys and interviews with representatives from the National Safety Authorities (NSA) from Member States (MS) selected for a more detailed analysis. Throughout the assignment the Interfleet team has kept the ERA Project Officer informed as to progress and has discussed the details of the questionnaires and interviews, to ensure that the Interfleet team interpreted the requirements of the brief correctly. The objective of the report is to inform the ERA about the current status of the Safety Certification process across the European Union (EU). This is to provide sufficient detailed information and evidence to enable the ERA to continue to develop the process for Safety Certification with a view to replacing the current generic Part A Certificate, which is valid throughout the EU and the country-specific Part B Certificate, with a single EU wide Certificate. Whilst the research focused on the Part B certificate and process, it also covered some aspects of the Part A, particularly the relationship between the two. The surveys consisted of two web-based questionnaires, which were sent to 25 MSs (plus Norway and the Channel Tunnel Safety Authority) plus interviews with 11 NSAs chosen in conjunction with the ERA Project Officer. The first of the questionnaires sought to establish the position with NSAs with regard to the processes for the issuing of Safety Certificates with particular emphasis on the Part B country-specific certificate. The second questionnaire focussed on the methodology for providing post-award supervision of Railway Undertakings (RU). The interview allowed more in depth questioning on topic areas and clarification of unclear responses from the surveys. The first survey generated responses from 23 NSAs and 19 responded to the second. The high level of response gives the team more confidence that the information received was representative of the views of the NSAs and, therefore, that the recommendations made are based on sound evidence. However, it is noted that that there was some contradiction between the surveys and interviews and also with the information found from other sources, including the various websites. The conclusions at the end of the study reflect that there is still much to be done to bring a consistent standard of assessment into the process; many of the NSAs are trying to deliver what is expected of them but are handicapped by a lack of experience, inadequate resource and lack of procedural guidance from within the MS and from the ERA. There is still a degree of non-compliance with Railway Safety Directive (RSD) requirements, which is surprising given the length of time the NSAs and MSs have had to comply.


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There is also a lack of trust between the NSAs, which is resulting in NSAs having a lack of confidence in the activities of fellow NSAs. One way that this manifests itself is that some of the NSAs examine parts or all of the Part A submission when there is no need to do this. This mistrust is likely to be compounded by the contradictions found in information as mentioned above. There is also a variation in the amount of information available to RUs on, or through, the NSAs’ (and others’) websites and in the ease of finding it. Again, this adds to mistrust in the RUs and NSAs. Certain NSAs are finding it difficult to relinquish the overall responsibility for safety on the rail network that they have had in the past. The RSD imposes the responsibility on individual RUs and Infrastructure Managers (IM) to control their risk through their risk management processes and the development of a Safety Management System (SMS). The NSAs’ role is then to oversee the management of safety through the certification and supervision processes to ensure that the RUs and IMs are fulfilling this responsibility. The findings of the study point to one of solutions being to simplify the existing processes. One way to achieve this would be to consider introducing a single certificate in place of the current two Part system. This could be put into effect with support from the ERA in checking that the NSAs are indeed following the requirements of the RSD. Another improvement is to undertake a thorough review of the policy and use of NSRs, with the possible aim of reducing them as much as possible. Again this would help with the simplification agenda. The role of the IMs also needs to be carefully observed, as in some cases they appear to be allowed to go beyond their remit in setting NSRs, internal requirements and even being involved in the SMS acceptance process. In Section 4, the report makes 11 recommendations for improving the current situation and facilitating the move to a single certificate. A summary of these recommendations is as follows: R1 R1 R1 R1 ERA to simplify the processes, where possible, including considering the advantages of a single certificate; provide more guidance and, perhaps, hands on assistance to NSAs, especially when new requirements are introduced. Consider ways to improve levels of trust between NSAs. R2R2R2R2 ERA to consider ways in which to check that the NSAs are delivering their role under Article 16 and 17 of the RSD to help build up trust between them. A stronger role for the NSA network may help, including developing specific task force groups on particular topics. R3R3R3R3 NSAs to adopt a process for targeting their resources and adopting a risk-based approach to the auditing of the RUs. For new RUs, this could start within the early days after the certificate is issued and operation commences. R4R4R4R4 NSAs to put an action plan in place when major new requirements are introduced such as the RSD, to demonstrate how they will be implemented and in what timescale. R5R5R5R5 ERA to conduct more research in certain identified areas. R6R6R6R6 NSAs to develop and implement a process for the safety validation of change.


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RRRR7777 ERA to consider ways in which to help simplify, clarify and possibly reduce the types of National Safety Rules (NSR). R8R8R8R8 ERA to complete the population of ERADIS and keep it up-to-date with accurate information. R9R9R9R9 NSAs to address concerns raised by the IM through its supervision process. R10R10R10R10 ERA to consider broadening its existing activities in providing support to NSAs. R11R11R11R11 ERA to consider monitoring the effectiveness of the Safety Certification process for new projects that cross boundaries within the EU.


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2222 IIIINTRODUCTIONNTRODUCTIONNTRODUCTIONNTRODUCTION

2.12.12.12.1 BBBBACKGROUNDACKGROUNDACKGROUNDACKGROUND

This study was commissioned by the ERA to gain a better understanding about the current position across Europe of the issuing and obtaining of Part B Safety Certificates under the requirements of Directive 2004/49/EC, the RSD. The ERA wishes to harmonise the decision making process across Europe and will use the output of this study to investigate the most effective way of migrating to a single certificate that is applicable in all MSs. The RSD mandates that RUs and IMs should have an SMS that is certificated by the NSA of each MS. The NSA awards a Part A Certificate to the RU when they are satisfied that the RU’s SMS demonstrates that it has the necessary skills and competence to operate throughout the EU. The IMs are awarded a safety authorisation under similar conditions but this is outside the scope of this study. The MSs that are within the scope of this study are the 25 that have a railway system plus the Channel Tunnel and Norway. Those chosen for interview are highlighted: Austria (AT)Austria (AT)Austria (AT)Austria (AT) Germany (DE)Germany (DE)Germany (DE)Germany (DE) Norway (NO) Belgium (BE) Greece (GR) Poland (PL)Poland (PL)Poland (PL)Poland (PL) Bulgaria (BU) Hungary (HU)Hungary (HU)Hungary (HU)Hungary (HU) Portugal (PT) Czech Republic (CZ) Czech Republic (CZ) Czech Republic (CZ) Czech Republic (CZ) Ireland (IE) Romania (RO) Channel Tunnel (CT) Italy (Italy (Italy (Italy (IT)IT)IT)IT) Sweden (SE) Denmark (DK)Denmark (DK)Denmark (DK)Denmark (DK) Latvia (LV) Slovak Republic (SK) Estonia (EE)Estonia (EE)Estonia (EE)Estonia (EE) Lithuania (LT) Slovenia (SL) Finland (FI) Luxembourg (LU) Spain (ES)Spain (ES)Spain (ES)Spain (ES) France (FR)France (FR)France (FR)France (FR) Netherlands (NL)Netherlands (NL)Netherlands (NL)Netherlands (NL) United Kingdom (UK) There is still, however, a need for an RU to comply with national requirements within each MS over whose network it wishes to operate. It is necessary, therefore, for the RU to obtain a Part B Certificate from the relevant NSA to demonstrate that it is capable of complying with the national safety requirements, NSRs and operational rules within the MS as listed in Annex IV of the RSD. This study, therefore, aims to gather information and evidence on the assessment processes in place in each MS and the role that national requirements play in the process of obtaining a Part B Certificate. It also includes an examination of the processes that each NSA has in place for conducting supervision after the certificates have been issued to ensure continued compliance with the commitments the RU has made in its application document. In order to conduct this study, Interfleet put together an integrated team of people from its UK, German and Swedish offices. The study commenced at the beginning of 2010 and over several months information was gathered through two surveys sent to the NSAs and through interviews with a selection of the NSAs. Other sources of information included EU and national legislation, NSAs’ websites and the ERA website, including the ERADIS database. This report contains the analysis of this information and offers steps and recommendations as to how migration to a single certificate may be achieved and on developing a high-level monitoring supervision framework for NSAs.


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2.22.22.22.2 OOOOBJECTIVESBJECTIVESBJECTIVESBJECTIVES

The following two objectives were identified by the ERA in the Invitation to Tender (ITT) as the focus of this study, although information and evidence on a much wider scale was gathered and analysed to develop the recommendations and conclusions:

• Objective 1: To identify, under the Safety Certification process, what role national requirements (rules, legislation) play in the MSs in assessing the suitability of applications for a Part B Safety Certificate for RUs

• Objective 2: To establish what post Safety Certificate award inspection powers and tools are available to NSAs under national legislation, which may be separate from the measures already required by the RSD. Also to identify whether these requirements allow for monitoring of safety performance to be undertaken by NSAs of RUs to assure continued compliance with the national requirements for the post-award inspection regime.

2.32.32.32.3 MMMMETHODOLOGYETHODOLOGYETHODOLOGYETHODOLOGY

2.3.1 Team and Overall Approach Initially a project team was established led by a Project Manager based in Interfleet’s London office, supported by a Project Assistant. The team also included staff from Interfleet’s offices in Germany and Sweden who could bring particular knowledge and expertise in the railway networks of other EU MSs and language skills. This core team was supported by other Interfleet staff from the London and Derby offices in research, IT, feedback, review and conducting interviews with the NSAs. Interfleet’s overall approach to the study involved the fundamental principle of encouraging co-operation and openness with the ERA and also with the NSAs. The ERA Project Officer was kept informed at all stages of the study through regular meetings, monthly progress reports and day-to-day correspondence. The survey questionnaires, interview questions and guidance issued to the interviewers were reviewed by the ERA Project Officer before they were finalised. The study comprised several steps, some of which were merged as the project developed over time. It began with data gathering from a variety of sources followed by the Step One Survey on the Part B Certificate acceptance process, the Step Two Survey on the post-award supervision regime, the interviews with the selected NSAs, the analysis of the results and the production of the report outlining Interfleet’s findings, recommendations and conclusions. These stages are described in more detail below.

2.3.2 Background Research Prior to embarking on the development of the questionnaires and targeted interviews, members of the Interfleet project team undertook background research via available sources on the Internet, such as the NSAs’ websites, and from work previously undertaken by Interfleet in preparing Safety Certificate applications for a number of clients. The ERA’s ERADIS database was also consulted to establish base information concerning, for instance, certificates issued in each of the MSs. The information gathered during this phase was used to inform the process for developing the questionnaires for the two surveys and the interview questions.


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2.3.3 Questionnaire development

Two separate questionnaires were developed for the study, one to address the issues surrounding the issuing of Part B Safety Certificates by the NSAs; the second addressed the issues surrounding the NSAs’ post-award supervision regimes. The questionnaires were developed with input from the Interfleet Software Solutions team, which enabled them to be accessed online via a link from the ERA website. The questionnaires were hosted on the Interfleet ‘clyx.net’ server. Feedback from the NSAs after the Step One Survey allowed improvements to be made for the Step Two Survey. The content of each of the questionnaires was determined by a group of colleagues from the UK, Swedish and German offices of Interfleet. Having a working knowledge and experience of the Safety Certification process as envisaged in the RSD, they were able to devise a series of appropriate questions suitable for inclusion in the questionnaire derived from a variety of sources. This group of six staff then refined the questions to ensure that they were appropriate and capable of being easily understood by respondents whose first language was not English. The finalised questions were then checked by, and agreed with, the ERA Project Officer to ensure that they were compatible with the overall objectives of the study. Before the questionnaires were finalised, a number of staff, who do not have a working knowledge of the subject, were asked to complete them on an online test site. This helped in ensuring that the questions were comprehensible to the respondents. Also, as they were completed on a test internet site, any practical issues associated with their completion were able to be addressed before they were placed in the live environment. As an additional test of ease of use, two NSAs were asked to complete the questionnaires online using the test site as a pilot exercise. The finalised questions were then uploaded onto the Interfleet ‘clyx.net’ internet portal and a link established from the ERA website. Once the questionnaires were in live status, a member of the Interfleet project team was available to provide assistance to respondents in case of difficulties completing them. Technical assistance was available through the Software Solutions help desk facility. The process was broadly similar for both questionnaires. Out of a total of 27 potential respondents, 22 responses were received for the Step One Survey and 18 for the Step Two Survey. In addition, the opportunity was taken during the interviews with HU and IT to ask the Step One Survey and Step Two Survey questions, respectively, as these NSAs had not previously responded, thus making 23 in total for the Step One Survey and 19 for the second. Whilst most of these were completed online, a few NSAs requested MS Word versions of the questions, as they had difficulties accessing the online survey. The Step Two Survey was, therefore, amended to facilitate access to a MS Word version. The MS Word versions were then input to the online survey by Interfleet staff in the London office. One reason for opting to use an online questionnaire, was to enable the results from the data input to be synthesised more easily and then analysed. This information was then used to inform the later part of the study, which was the interview stage.


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2.3.4 Interviews In the original project proposal as required by the Invitation to Tender (ITT), after each questionnaire, there was planned to be a series of targeted interviews with 12 individual NSAs to clarify any points raised in the responses to the surveys and also to obtain supplementary information if necessary. As the project evolved, however, it was agreed with the ERA Project Officer that it would be more appropriate to conduct a single set of interviews after completion of both surveys and the number of interviews was reduced to 11. The responses from the two surveys were, therefore, analysed and the results broadly categorised, enabling the Interfleet project team to establish the areas where more information was required and to develop a set of targeted questions as required by the ITT. A guidance document was created containing generic questions to ask of all the NSAs with guidance for the interviewers on the topics covered. This was designed to assist the interviewers in adopting a coherent approach to the interviews and in obtaining consistent responses. In addition to the generic questions, a set of bespoke questions was produced for each of the 11 NSAs selected for interview based on their responses to the two surveys to ensure that all the information requested had been captured and /or clarified. The selection of the NSAs for further interview was undertaken in conjunction with the ERA Project Officer towards the completion of the first survey. The criteria for the inclusion of a country were initially defined in the ITT and, where possible, the selection has reflected these criteria. One of the main determinants was the relevance of the MS to its position on a Trans-European Network-Transport (TEN-T) route. Other criteria included the experience of the NSA in Safety Certification and SMS assessment, although it became apparent in the Step One Survey that this differed widely amongst the MSs. The 11 interviews were conducted between May and July 2010. It must be emphasised that as this was not an audit; very little in the way of verification was undertaken of the information provided by the NSAs. Thus, the results reflect the NSAs’ responses at face value. In some cases, e.g. where contradictions were identified in the responses to the surveys and interviews or where the project team’s experience and knowledge indicated that there may be a discrepancy, then further clarification was sought where possible from the NSA’s and various other websites.

2.3.5 Analysis of the Results The responses to the two surveys were consolidated into spreadsheets that presented all the results for each question together for ease of reference. This information was then scrutinised to identify problems areas, overall themes and trends by question and by country. To give a visual representation of the overall level of ‘compliance’, a matrix was produced that is included as Appendix D of this report. A judgement was made by the analyser as to whether the NSAs’ responses were largely acceptable or not in terms of compliance with legislation and expected good practice where issues are not mandated. It is recognised that this may be somewhat subjective and the results should be used as a general indicator only. In some cases, the NSAs’ responses were unclear or incomplete. Where possible these were clarified during interview but, of course, only with those NSAs


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selected for interview. In order to protect the confidentiality of the NSAs, a code is used in this matrix for the MS that only the Interfleet Project Manager and Project Assistant can interpret.

2.42.42.42.4 AAAACKNOWLEDGEMENTCKNOWLEDGEMENTCKNOWLEDGEMENTCKNOWLEDGEMENT

The project team would like to thank all the staff in the NSAs who were involved in compiling the survey responses. We would especially like to thank those who took part in the interviews for their time, input and hospitality. Everyone was co-operative and open to providing the information requested. We would also like to thank the ERA for the continued support, advice and input we received throughout the project.


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3333 CURRENT SITUATIONCURRENT SITUATIONCURRENT SITUATIONCURRENT SITUATION

3.13.13.13.1 GGGGENERALENERALENERALENERAL

This section contains narrative on key issues arising from the study, where this is warranted. A summary of the findings is, however, contained in Sections 3.3 and 3.4, with a comprehensive list of the problems contained in Appendix E. All the MSs had fulfilled the RSD requirement to set up a NSA. The survey responses, however, indicated that there are different levels of resource and expertise across the MSs that are likely to have an impact on the consistency of approach in implementing the acceptance and supervision processes. This is likely, in turn, to affect the ease of adopting a single certificate. The MSs have also generally transposed the RSD into national legislation within each MS, however PL had only partially transposed the RSD; the supervision process is not yet included. Although this study focussed on the Part B process, a pre-requisite for obtaining a Part B Certificate is to have developed and implemented an SMS, based on the principle of risk assessment, and to have had it accepted through the Part A Certificate application process. This should demonstrate to any NSA that the RU concerned is able to find and comply with relevant safety standards and rules. The concept of SMSs is, however, new to many MSs and the responses to the survey indicated that some, admittedly a minority, have had difficulty in introducing and enforcing risk assessments and SMSs on their RUs. As this is a fundamental requirement of the RSD and its objective of harmonising rail transport across the EU, it is clear that this needs to be addressed before a single certificate can be adopted. It may indicate a need for greater assistance from the ERA in relation to producing guidance and briefing material to assist MSs and NSAs, and perhaps even visiting the NSA to give ‘on the spot’ guidance. Simplified guidance for RUs could then be produced by the NSAs.

3.23.23.23.2 OOOOVERVIEW BY VERVIEW BY VERVIEW BY VERVIEW BY CCCCOUNTRYOUNTRYOUNTRYOUNTRY

This section contains an overview of each country focussing on several key issues: NSRs, independence between the RU and NSA, role of the NSA, competence and independence of NSA, acceptance and post-award processes, availability of information, relationship between Part A and B and powers of the NSA and tools it can use.

3.2.1 Austria (AT) The NSA, the Federal Ministry of Transport, Innovation and Technology (BMVIT) responded to both surveys and was chosen for interview. Österreichischen Bundesbahnen, the Austrian National Railway, is the main organization in the rail industry both as an IM and provider of freight and passenger services. There are several other organizations which act as both IM and RU, including the Raaberbahn AG, which has a route through to HU and was established as a joint Austro-Hungarian enterprise in the 19th Century. The NSA is an independent organization and its website lists a further 24 RUs (both national and foreign) with Safety Certification to operate in AT, though most of these were not issued under the current regime.


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The IMs are not always independent of the RUs. The IMs’ requirements are in their network statements, and available to the RUs; the IMs can offer an opinion to the NSA before the certificate is issued but are not involved in the decision. Clearly those organizations that act as both IM and RU are not independent of each other and this may cause a conflict of interest and difficulty in demonstrating impartiality. The NSA has published its acceptance process and guidance documentation for RUs. The supervision process is, however, not published but the NSA plans to have one supervision activity during the validity of the certificate. This may change depending on the performance of the RU. Information for applicants can be found quite easily on the NSA’s website. Information is provided to applicants by the NSA and is structured into various subject areas. The NSRs are also available along with the published guidelines, together with clear instructions to be complied with for submissions. An additional requirement, however, that is not an NSR, is that occupational health and safety is taken into consideration by the NSA. This may be a problem if it is used as a barrier to new entrants. There is a marked difference between the acceptance process for Part A and Part B applications. BMVIT does not assess the SMS at all as it has to be certificated by an accredited organization to a standard such as ISO 9000 or EN 13816. This is claimed to be an interim measure until common guidance on SMSs come into force. It is not clear from the NSA’s response whether this requirement is also imposed on non-domestic RUs but the implication is that it is not. The assessment of Part B, therefore, would not include an assessment of Part A. Four members of the NSA staff are involved in the assessment and acceptance process. They are relatively inexperienced owing to the low number of applications that they have processed. There are, however, still 21 RUs that need certification by the end of 2010 deadline. There is a programme of inspections in place to enable this deadline to be met. The NSA mainly uses the recommended harmonised documents and forms. There are sometimes difficulties owing to lack of completeness of documentation produced by the RU, which can delay the process. The main national legislation, the Railway Act, contains certain provision for BMVIT to prosecute. It also has the power to revoke a certificate if necessary.

3.2.2 Belgium (BE) The NSA, the Department for Railway Safety and Interoperability, responded to the Step One Survey. This NSA was not one of those chosen for interview. The railway system in BE is principally divided between two organisations, Infrabel as the IM and the former state railway operator, Société Nationale des Chemins de fer Belges, as the predominant RU for freight and passenger operation. They are independent of each other. There are a small number of open access freight operators which have developed in BE. There are numerous examples of former state railways operating into


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BE using suitably compatible traction. This is often undertaken under a work sharing agreement between the RUs in each country and in most cases is done under the incumbent’s Safety Certification as a sub contractor. Owing to the regional language differences, there are limitations on how far this can apply in practice e.g. Dutch drivers from Nederlands Spoorwegen only work into the Dutch speaking area of BE, likewise French drivers from Société Nationale des Chemins de Fer Français (SNCF) work into the French speaking area and German speakers into the German speaking area. The NSA is an independent organisation and it has published on its website information about the process of Safety Certification together with guidance notes for RUs. There is also information about the supervision process. The assessment process constitutes a document review, not an on site visit/audit and does not involve a review of the Part A application at the same time as the Part B application. The NSA claims that the process takes over four months to complete but it is not clear why. The period of validity of the certification is three years. The NSRs are available from the IM, who has other requirements that must be observed. Advice is sought by the NSA from the IM on Part B applications only but it would not be allowed to block the decision. Staff of the NSA have experience in the application of the Safety Certification process as they have issued several certificates, including for non-domestic Part B Certificates. Further information on the competence and resource levels of the NSA was not available. There are only two RUs that are still operating on the previous certificates, so there should not be a problem with meeting the end of the year deadline. The NSA has the power to revoke certificates but no other information on its powers was available.

3.2.3 Bulgaria (BU) No responses were received to either survey and this NSA was not one of those chosen for interview. A summary of the requirements for RUs to apply for Safety Certificates is contained in the network statement of the National Rail Infrastructure Company. The ERADIS database lists the NSA as having issued eight Safety Certificates.

3.2.4 Channel Tunnel (CT) A response was received to both surveys but this NSA was not chosen for interview. The Treaty of Canterbury in 1986 put in place the arrangements for an Intergovernmental Commission (IGC) to manage the relations between the Governments of Britain and France with the CT concessionaire, Eurotunnel, which is the IM. The IGC acts as the NSA making decisions with advice from the CT Safety Authority. Given that this railway link between the two MSs is a key strategic route (and part of a TEN-T route), it is treated as if it were a separate MS for legislative aspects but as the geographic boundary between the two countries is mid tunnel, separate national


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legislation is required to be made simultaneously in UK and FR, to bring into force the specific legislation applicable to the CT. It is worth noting that the Eurotunnel operated freight and car shuttles, which operate between the Eurotunnel terminals at Calais and Folkestone, are treated as a link between the motorway networks in either country and have been exempted from the RU aspects of the RSD. They are, however, considered to be part of the infrastructure and are required to have an SMS and Safety Authorisation, along with the infrastructure used by the Eurostar services and freight trains. The IGC has a website where information concerning the requirements for Safety Certificates can be found. It has published guidance for RUs and an acceptance process in the same document. The NSA is comprised of staff drawn from the NSAs of UK and FR and as such they are experienced and knowledgeable in the certification process but the NSA does not issue Part A Certificates, only Part Bs and five have been issued to date. The process requires a document review rather than a detailed check. Eurotunnel publishes a list of requirements that RUs need to comply with in its network statement. Given the particular nature of the CT, Eurotunnel’s opinion is asked for at the start of the acceptance process for Part B Certificates. Specific security arrangements exist for the CT, and as such these can be considered as NSRs. They impose significant conditions on prospective RUs, both freight and passenger. The security arrangements are outside the scope of the NSA. There are also specific arrangements for the prevention of fire, which RUs need to take into account. It is does not appear that a supervision process has been published but supervision activity takes place. The IGC does not have inspectors of its own, however, as it uses inspectors from the Office of Rail Regulation (ORR), the UK NSA and Enterprise Publique de Securité Ferroviare (EPSF), the FR NSA. The NSA has powers to revoke a Safety Certificate but not to prosecute.

3.2.5 Czech Republic (CZ) The NSA, Drážni Úrad Česká Republika (DUČR) responded to both surveys and was selected for a follow up interview. The National Railway Act transposed the RSD into national legislation in Decree No 376 of 2006. Within the CZ the major player is the private, but government owned, České Dráhy (ČD). ČD is responsible for 99% of passenger transport. In 2008 the NSA stated that there were 43 RUs registered with the NSA, while in 2010 this figure has risen to 72. Many of these are private RUs with no regular scheduled service and with special trains (tourist lines). One of ČD’s subsidiaries is ČD Cargo, which operates 88.8% of the transported freight. The main IM is Správa železniční dopravní cesty but there are five regional IM/RU organizations as well.


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The NSA is an independent organization and it appeared from the interview that it has published guidance on its website, although this contradicts its survey response. It claims also to have published an acceptance process. Around eight people are involved in the process, all of whom have considerable background knowledge of the railway sector, but there is no requirement for specific qualifications. The NSA benefited from being part of an ERA-organised peer review, which assessed its acceptance process. The responses indicate that the timescale for issuing certificates is being exceeded but it is not clear why. Six non-domestic Part Bs have been issued but they are all companies that have a branch in CZ. There is no backlog to be issued by the end of the year. The NSA is aware of the difference between the Part A and B but its responses were not sufficiently clear to ascertain if there is any difference in how they are assessed or whether the SMS is checked during the assessment of Part B. NSRs are available on links from the NSA website. There are other additional requirements such as technical standards, labour code, environmental rules and fire protection. Also, the NSA claims that some RUs have difficulty complying with local CZ rules relating to specific technical equipment e.g. pressure vessels. The supervision process has not been published but RUs are advised of the topics to be inspected. The intention is to inspect once every five years unless the performance of the RU dictates otherwise. Many new RUs are being set up which have not previously been operational. Initially, these new RUs are issued with a certificate for one year. During which time the RU is visited and all requirements are checked. The NSA has the power to prosecute and in some cases can impose a penalty.

3.2.6 Denmark (DK) The NSA, Trafikstyrelsen, responded to both surveys and was chosen for interview. DK has nine IMs, the main one being Banedanmark. There are 14 RUs, the largest being Danske Statsbaner, the former State Railway Undertaking. The IMs and RUs are independent. The IMs set the framework for operational NSRs on their infrastructure but the RUs develop their own detailed ones based on this framework. The NSRs are then approved by the NSA and it is checked during the certification process that they are in place for each route, though not the content. The NSA is an independent organisation, staffed by a group of experienced staff who operate in small rotating teams, thus allowing the more experienced staff to train and mentor more junior staff. The team of six staff has audit and /or assessor training. The NSA appears to have adequate resources to cope with the number of RUs. Trafikstyrelsen has transposed the RSD into national legislation and published its acceptance process and guidance for RUs on its website. Most information that prospective RUs need is available on the NSA website, and once an RU has indicated that it will be seeking a Safety Certificate, the NSA nominates a dedicated contact person


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to manage the relations between the applicant and the NSA. The acceptance process takes less than four months and does not require an in depth audit of the company, nor does the acceptance process for Part B include checking the SMS apart from where it relates to Part B requirements. The NSA has a post-award supervision process but it is not yet published on the website. After an initial six month inspection, the supervision regime is based on risk. Trafikstyrelsen does not have a process for revocation of the certificate because a decision has not yet been made on what grounds this may be invoked. It was not clear whether the NSA itself has the power to bring prosecutions in the event of serious breaches but so far this has not arisen.

3.2.7 Estonia (EE) The NSA, is a part of the Estonian Technical Surveillance Authority (TJA). It responded to both surveys and was not chosen for interview. Until 2001 the Estonian railway system was state owned. In 2001 it was partially privatised when 66% of the shareholding was sold to Baltic Rail Services. In 2007 following a change of policy, the privately-held share was reacquired by the state. EE joined the EU in 2004 and the RSD was transposed into Estonian law through the Railway Act 2005. There are three main IMs, including AS Eesti Raudtee and AS Edelaraudtee Infrastrucktuuri. There appear to be four passenger operators, including one open access operator offering a daily service from Tallinn to Moscow. There are currently only two mainline freight RUs (several have closed recently owing to falling traffic levels), one of which is EVR Cargo, part of the AS Eesti Raudtee group. The NSA is independent of both the IMs and RUs and has a railways section comprising 11 people, of whom four deal with the operational safety aspects of the TJA’s work. They do not have specific safety or auditing qualifications but they have experience of working within the railway sector. The systems they have established follow closely the requirements of the RSD. TJA is aware of the difference between Part As and Part Bs but has had very limited experience due to the small number of RUs operating in Estonia and the only international operation is from outside the EU i.e. Russia. The NSA only examines the parts of the SMS that relate to the Part B topics during the acceptance process. The Part A and B assessments are both a documentation review and site visits. The application guidance and certificate acceptance processes are published on the TJA website with embedded links to primary legislation on the Ministry of Economic Affairs website, as are the NSRs. There is not a separate guidance document for the NSA’s inspectors but there is a check list of what needs to be verified during the acceptance process. The IMs do not have a role in assessing an application for a Safety Certificate. It appears that the information required by a new RU is relatively easy to find, either through the TJA’s, or the Ministry’s website. The NSA also provides guidance and assistance pre-submission and throughout the process. The supervision process is published by the MoT and is available on the TJA website. Supervision includes planned and random visits and the aim is to cover all SMS topics in


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the five-year cycle through a planned annual visit. The annual review published by TJA informs of developments in the railway sector and which topics may be subject to closer scrutiny if there are areas of concern. The NSA reported generally high levels of compliance in the sector. TJA does not have the power to prosecute but it can impose civil penalties.

3.2.8 Finland (FI) The NSA, the Finnish Rail Agency, responded to both surveys but was not chosen for interview. It would appear from the responses that in a number of areas the NSA has not fully implemented the requirements of the RSD; this may be owing to the fact that the NSA is still developing processes and procedures and is also in the process of being reorganised. No answer was given to several questions and some of the responses gave minimal and ambiguous information but because the NSA was not chosen for interview there was not the opportunity to clarify these areas. In Finland the IM and RUs are separate entities. Although the NSA has not published an acceptance process or guidance for RUs, it claims that information for prospective RUs on the Safety Certification process is available on its website and in the network statement of the IM, which is available online. There are links to the Government information portal for the detailed legislation. Details of NSRs are available through the ERADIS database. The NSA does not require full confirmation that everything is in place prior to issuing a certificate. It has not yet issued a Part B Certificate to a non-domestic RU. The NSA’s response indicates that it takes longer than four months for the acceptance process but there is no information about why this is the case. An explanation was not offered on the circumstances in which the Part A would be reviewed at the same time as a Part B, although it is likely that this is because the NSA has as yet only issued certificates to domestic RUs. The NSA states that the Railway Act, the main national legislation, contains the post-award supervision process but does not indicate the level of detail that is in it. Responses to other questions indicate that post-award supervision either takes place, or at least is planned to take place. The NSA does not have the power to prosecute but can revoke the certificate if necessary.

3.2.9 France (FR) The NSA, EPSF responded to both surveys and was the first NSA to be interviewed as a pilot. The structure of the railway industry in FR has seen the creation of Réseau Ferré de France (RFF) as the IM, with its activities performed by SNCF under contract as Gestionnaire Infrastructure Delegé. SNCF remains the only operator of passenger services and the main freight operator but in the last five years a number of new freight operators have commenced operation. More recently, following the cessation of certain local freight activities by SNCF, a new form of open access freight operator has emerged to provide a service between local sidings and the main line. These new Opérateurs


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Ferroviaire de Proximité are subject to the requirements of the RSD and represent a new development in FR. EPSF has a small team of staff that undertake assessments of Part B applications and around 30 inspectors to perform the supervisory function of the NSA. They have an appropriate mix of railway experience and qualifications. Information for applicants, including the acceptance process and guidance, is available on the EPSF and RFF websites with links to the Ministry of Transport (MoT) for the legislative texts. NSRs are available to the applicant once a request to access the network has been received by RFF. This information is a mix of data held on CDs and in some cases hard copy. RFF offers advice on applications but does not have a role in approving them. The NSA provides guidance to potential applicants during the period when the submission is being prepared to ensure that it is fit for purpose. Some pre-award checking is undertaken but not a detailed audit or check. Owing to a lack of confidence in other NSAs’ processes, the SMS of non-domestic RUs is reviewed during the assessment of Part B applications. It was not clear to what depth this review would go. A process for post-award supervision is published on the NSA’s website. Supervision is undertaken on a thematic basis and over a five-year cycle is expected to cover the whole of the SMS. Specific checks are made if problems are reported arising from the activity of a specific RU. EPSF does not have the power to prosecute but it can restrict, suspend or withdraw the certification under a revocation process.

3.2.10 Germany (DE) The NSA, Eisenbahnbundesamt (EBA) responded to both surveys and was chosen for interview. As the situation in the railway sector in DE is unique in the EU, further detail and comments can be found in Section 3.4.3. The state still owns the largest RU (Deutsche Bahn) and IM (Deutsche Bahn Netze) but the level of privatisation is high with hundreds of both passenger and freight RUs, some having their own infrastructure as well. The NSA is part of the MoT and can be considered independent. It claims that only six staff are employed on assessment but as it declared it had 1224 employees in its 2008 annual report, this seems rather curious. Some more are, however, to be trained; the competence and qualification requirements appear to be adequate. The RSD is transposed into German law through the Allgemeines Eisenbahngesetz (AEG) but there has been resistance to adopting the RSD requirements, especially the need for an SMS and risk assessment. Partly owing to this delay in adopting the RSD requirements, therefore, very few RUs have submitted Safety Certificate applications so there is a large backlog. The EBA has, however, made an agreement that for one year beyond the end of year deadline, companies certificated under the previous regime will be issued with a new one. The EBA declared that the main reason that the assessment


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process can take longer than four months is because the RUs do not always submit the correct documentation despite the information and guidance they receive. The acceptance process is published, available on the EBA’s website and apparently easy to follow, though anecdotal evidence from a German RU indicates that it is not easy to find out what all the NSRs are. The EBA’s website contains an NSR overview document in German and directs the viewer to ERADIS for the detail. Some of the NSRs are issued by the IM through the network statement, with which the RU commits to comply, and also through an organisation called Verband Deutscher Verkehrsunternehmer that represents all the RUs. The IM does not, however, have a role in making the decision as to whether an RU should be issued with a certificate. Guidance has been published for RUs and there is an internal document with guidance for inspectors. It seemed that the EBA’s role in the pre-award phase does not involve a full review of the SMS when reviewing a non-domestic Part B. The EBA, however, requests a summary of the SMS, as this is required by the AEG. A site visit is made to domestic RUs before issue of the certificates but it was not clear what level of verification takes place during this visit. The EBA reported that RUs have difficulty in meeting the requirements for submission even after help is given. They mainly request help on NSRs (identification, implementation and application), risk management, as it is a new concept, and verification of maintenance requirements. The supervision process is not published because EBA does not want to give the RUs warning of what or when to prepare for a visit, but an outline is contained in the AEG. They only plan one supervision visit in the five-year cycle and do not cover all the SMS topics only the important ones. The EBA does not have the power to prosecute only to issue an order to comply or to penalise if the offence is defined in law or to revoke the certificate in the event of repeated non-compliance.

3.2.11 Greece (GR) The NSA, the Department of Railway Safety, responded to the Step One Survey and was not chosen for interview. The Ministry of Infrastructure, Transport and Networks publishes ministerial decisions, one of which constitutes the acceptance process for obtaining a Safety Certificate. This has recently been made available on the NSA’s website and provides the information needed for an RU to apply for a Safety Certificate. Owing to the relatively isolated nature of the Greek network, the NSA has had very little experience of the Safety Certification process since the RSD was transposed into Greek legislation in May 2009. The only RU listed in the annual report of the NSA is the state-controlled operator, Organismos Sidirodromon Ellados, who has a subsidiary that is the IM. It was not clear whether the NSA, RUs and IM are independent each other. The NSA states that it undertakes a document review only and not a comprehensive check when assessing applications and the process takes four months. It has not issued a Part B to a non-domestic RU but stated that it would require the SMS to be submitted in order to check the requirements for equivalent activities.


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NSRs are notified and correspond to the RSD requirements. It is not clear how they are made available to the RU. The IM is involved only in the approval of rolling stock and possibly in the future with the safe operation of rolling stock. It is not directly involved with the certification process. There is a process to revoke a certificate but there is no information on whether the NSA has the power to prosecute or if it has any other powers.

3.2.12 Hungary (HU) The NSA is a part of the National Transport Authority (NTA) and it responded to the Step Two Survey. This NSA was one of those chosen for interview. The principal Step One Survey questions were covered in the interview and added to the results summary (Appendix D).

Until 2004 the railway in HU was state-owned and operated. HU joined the EU in 2004 and the RSD was transposed into Hungarian law through the Railway Act 2005. There are two main IMs, MAV and GySEV, which is part-owned by Austria. MAV is the main passenger RU and also has subsidiary companies for freight, traction, maintenance and heritage. GySEV also operates freight and passenger services. There are 33 other RUs, mainly freight, in addition to MAV, with three more going through the process; these are privately owned. Train paths are allocated by an independent body - Vasúti Pályakapacitás-elosztó Korlátolt Felelısségő Társaság (VPE) (Rail Capacity Allocation Office). The NSA is independent of the IMs and RUs. There are four people involved in the acceptance and supervision processes, although this is not full time as they are also involved in other NTA work. They do not have specific safety or auditing qualifications but they have many years’ experience working on the railways. They have set up the systems to follow closely the RSD requirements but have received little help or guidance from the MS or ERA in adopting systems that were quite different to the previous regime. The NSA is aware of the difference between Part As and Part Bs and only examines the parts of the SMS that relate to the Part B topics during the acceptance process. The Part A and B assessments are a documentation review only with the verification being left to the post-award supervision activities. The application guidance and certificate acceptance processes are published on the MoT’s website, as are the NSRs. There is not a separate guidance document for the NTA’s inspectors but there is a programme of what needs to be accomplished during the acceptance process. In addition to the NSRs that are notified to the ERA, there are company rules issued by the IMs. These are not notified NSRs but the RUs must comply with them to be given a contract with the IM. The IMs do not have a role in assessing an application for a Safety Certificate but an RU cannot obtain a contract without holding a Safety Certificate. The VPE then checks that the contract and certificate are held by the RU before it allocates train paths. It appears that the information required by a new RU is relatively easy to find, either through the NTA’s, the MoT’s or the IM’s website or through the IM’s network statement. The NSA also provides guidance and assistance pre-submission and throughout the process. Risk assessment seems to be the main area


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where help is needed by the RUs. It is a different approach to the previous rules-based regime of managing safety. The supervision process is not published but such inspection is a requirement in national law (Railway Act and KET) for all companies. Both domestic and non-domestic RUs are made aware of these laws. Supervision includes planned and random visits and the aim is to cover all SMS topics in the five-year cycle through a planned annual visit. The NSA does not have the power to prosecute; it must call in the police to deal with a serious breach but it can revoke a certificate if necessary.

3.2.13 Ireland (IE) The NSA, the Railway Safety Commission, responded to both surveys. This NSA was not chosen to be interviewed. The railway network is relatively small and has a connection to the railways of Northern Ireland. The track gauge is unique in that it is 1600mm. The train services and infrastructure are managed by Iarnród Éireann, the national railway operator, and currently there are no other operators. The NSA has had very little experience of the Safety Certification process, as to date there has been only one Part A Certificate issued and there have been no requests for Part B Certificates, including for the only RU. The most recent annual report states that as a priority for 2010, the heavy rail network in Ireland will be certified to EU requirements. The NSA was not able to answer many of the questions in the surveys as it has not yet either developed processes or had any experience; however, in some cases a hypothetical answer was provided on what the NSA intends to do in the future. The NSA appears to be well-resourced with staff experienced in the rail industry who hold a relevant post-graduate qualification. The NSA stated that it has not published an acceptance process, supervision process, revocation process or any guidance, as this has not yet been necessary. The RU received individual assistance with its application through discussions with the NSA. A supervision process is, however, currently being drafted. In the meantime, an annual audit programme is presented to the RU/IM. The NSA demonstrated good awareness of prioritisation criteria to be used in deciding what should be covered in the supervision activity. No information was provided in the surveys on the NSRs. The NSA has the power to prosecute and other powers include issuing an enforcement notice, prohibiting an activity and requesting an improvement plan, although the processes for these are not all currently formalised in documentation.

3.2.14 Italy (IT) The NSA, Agenzia Nazionale per la Sicurezza Ferroviaria (ANSF), responded to both surveys and was chosen for interview.


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The main infrastructure in Italy is owned by Rete Ferroviaira Italiano (RFI) and the main RU is Trenitalia but there are about 20 privately-owned concessionaires who own and operate their own infrastructure. ANSF is concerned that safety management has not been as rigorous on these networks owing to fewer funds. They have been regulated by the MoT but responsibility is due to transfer to ANSF in October 2010 when the tracks will be opened up to open access operators. The RSD has been transposed into national law through the Decreto Legislativo 10/8/07 no. 162. ANSF then issues more detailed documents that do not require approval from the MoT. ANSF states that of its 20 staff in Certification and Authorisation, there are about five full time equivalent staff who undertake the acceptance process. They are experienced in auditing and SMSs and receive support from specialists on personnel and rolling stock. ANSF acknowledges that there may be a stretch on resources in the last six months of 2010 as there are many RUs still to certificate under the new rules. Only new RUs have been assessed under the new requirements so far and SNCF Fret Italia, SNCF’s new company in Italy, will be the first non-domestic RU to be certificated. Although the concept of SMS and risk management is not new in Italy, under the previous regime most of the responsibility was on RFI to manage safety and RUs are reluctant to accept the change to taking more responsibility themselves. ANSF has run training courses to help the RUs through the transition. The NSA takes responsibility for safety on the network and needs to make sure that any gaps created by the new system are filled. It reports a degree of lack of cooperation on the part of the IM and main operator; they, and indeed, ANSF, do not see the point of having two certificates. In this way, ANSF is in favour of the move to a single certificate. The new acceptance regime seems to make use of recommended processes and guidance. Information is available through the ANSF’s and RFI’s websites, including the guidance documents and NSRs, which are included in Decreto 1/2009. ANSF provides support and guidance to the RU before they submit the application to try to ensure the application is as complete as possible but still there are omissions. They will sometimes audit before they issue the certificate as they say they cannot rely on the assessment of other NSAs. ANSF’s role also extends to maintenance and driver training. Risk management is one of the main issues raised as a problem by RUs as they are not used to managing their own risk. The NSA has not had much experience of undertaking any supervision yet so the process has not yet been published. It is not currently clear whether a frequency of visit is set or whether all the relevant issues will be covered in the five-year cycle. Unplanned visits will, however, be made if there is reason to believe there is a problem or after an incident. The NSA does not have the power to prosecute but it can revoke certificates and invoke sanctions. It works in conjunction with the MoT (who can revoke licences), RFI (who can withdraw train paths) and the transport police (who police the network and ensure a certain level of conformity in certain areas).

3.2.15 Latvia (LV) The NSA, State Railway Technical Inspectorate (SRTI), responded to the Step One Survey and was not chosen for interview.


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Within LV the railways remain organised under the umbrella of the state-controlled Latvijas dzelzceĜš – the Latvian National Railway, which is both an IM and an RU. In implementing the RSD an independent NSA has been created, which is responsible for issuing Safety Certificates as well as overseeing the general safety of the railway. Outline information on the procedure for issuing Safety Certificates is available in the network statement issued by Latvijas dzelzceĜš on behalf of the ‘Latvian Railway’. More detailed information is available on the website of the SRTI. Currently there are seven RUs with valid Part A and B certificates, none of which are non-domestic. In total, 19 people work in SRTI with a small number dedicated to the certification and supervision of RUs. The acceptance process is contained in a Cabinet Rule rather than being issued by the NSA. It is claimed that the process involves a document review rather than detailed checking and takes less than four months. The advice of the IM is sought during the assessment of Part B applications and it checks if the RUs’ fulfil the NSRs, but it appeared that the IM cannot block the decision to issue a certificate. SRTI stated that the NSRs are contained in the Cabinet Rules and cover the Annex IV areas. It is not clear, however, how they are made available to the RUs. Other national requirements relate to agreements with non-EU states and, presumably therefore, are outside the scope of this study. The process for inspection of RUs is contained within the applicable railway law and a comprehensive report on the activities of the NSA is available in Latvian. There is a process for revocation of the certificate and the NSA has the power to suspend the Safety Certificate in the event that an RU is working outside the scope of its SMS.

3.2.16 Lithuania (LT) The NSA, the State Railway Inspectorate, responded to the Step One Survey and was not chosen for interview. Within LT the railway system is largely operated by state-controlled companies being subsidiaries of the former state railway operator Lietuvos Geležinkeliai. It was not clear how many RUs there are. The NSA stated that there are still RUs operating under the previous Directive but does not give a figure or whether there is likely to be a problem with meeting the end of the year deadline. The NSA stated that it has published an acceptance process but not guidance for RUs, however, details of the information required for a Safety Certificate can be found on its website, together with the information a prospective RU needs to supply. Since the process was established in 2008, one Part A and Part B Safety Certificate have been issued and no non-domestic certificates. The NSA stated that it does a document review rather than a full check and the process takes four months. It says that it would sometimes review the Part A at the same time as the Part B but the implication is that this would be for a domestic RU. NSRs are notified but are in the process of being confirmed by the Ministry of Transport and Communications.


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It is not clear to what extent the IM is involved in the decision to accept an application. The IM produces a network statement with which the RU must comply. No information was available on the supervision process or whether a process has been published. There is a process to revoke certificates but it is not known whether the NSA has the power to prosecute or has any other powers.

3.2.17 Luxembourg (LU) The NSA, Administration de Chemins de Fer responded to the Step Two Survey and was not chosen for interview. The administration of the rail network is through the Ministry of Sustainable Development and Infrastructure, which publishes the network statement for LU. The main organisation involved in the operation of the railway is the state-owned Société Nationale des Chemins de Fer Luxembourgeois (CFL). This is the LU national railway and is the main RU and acts as the IM on behalf of the Ministry. Access to the infrastructure is managed through an independent organisation, which acts as the NSA. The RSD was transposed into national law in September 2009. Given the size and proximity of LU to other countries, there are numerous agreements concerning cross acceptance of locomotives and rolling stock between BE, FR, NL, Switzerland and LU. This is historic interworking and is conducted under the auspices of the CFL Safety Certificate. Open access operators would need to have the appropriate Part A and B certificates. According to the ERADIS database one RU has been issued with a Safety Certificate by the NSA. There is no indication that any Part B Certificates have been issued. The role of the NSA in terms of its supervision and monitoring activities is still being developed; it expects to use suitably experienced staff with a background in the railway industry. No information was available on whether relevant processes have been published or on the availability of guidance and information to RUs. It appears, however, that NSRs are provided to prospective RUs. Consequently, neither was there information on any differences in how Part A and Part B applications are dealt with, whether the review of a Part B includes a review of the SMS, or whether the assessment is a document review or full check. It is not clear whether a supervision process has been published, though a law of 22nd July 2009 contains the requirement to undertake supervision activities. It is not clear from the response to the Step Two Survey whether the NSA has undertaken any supervision to date but the implication is that it has not. The authority of the NSA is derived from the Law of 21 September 2009 and this defines the process for remedial action in the event of a default by the RU. The Minister has the power to suspend the Safety Certificate based on a recommendation of the NSA.


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3.2.18 Netherlands (NL) The NL railway system, which was operated as an integrated organization under the requirements of Directive 91/440, is now divided into a state-controlled private company to manage the infrastructure, ProRail, and a state-controlled private company to operate the majority of the passenger services, Nederlands Spoorwegen. ProRail was established under Section 16 of the Railways Act in 2003. There are several smaller private passenger operators that provide regional passenger services. The former Nederlands Spoorwegen freight business was sold to DB Cargo. Numerous open access freight operators provide links from the Dutch ports. The new freight-only Betuwe Line is managed by KeyRail on a concession from ProRail. In total, 31 RUs have been issued with Safety Certificates. The NSA, is a part of the Inspectie Verkeer en Waterstaat (IVW) and is independent of the IMs and RUs. There are seven people involved in the acceptance and supervision processes, which seems small given the number of RUs, but the market is virtually static with few new entrants emerging and a number ceasing to trade or being closed through mergers. The assessors and inspectors have a mixture of experience in the rail industry. No formal qualifications are required but some of the inspectors are accredited by Lloyds Register as auditors. The NSA has set up the systems to follow closely the RSD requirements but place a three-year limit on the duration of Safety Certificates. For new applicants, the initial certification may be for as short a period as 13 weeks. This depends upon the confidence the NSA has in the competence of the RU and its organisation. The NSA is aware of the difference between Part As and Part Bs and only examines the parts of the SMS that relate to the Part B topics during the acceptance process. Owing to delays within Germany issuing Part A Safety Certificates to German RUs, the NSA granted Part B Certificates for a period between 2007and 2009 without the applicant holding a Part A Certificate. The NSA accepted this temporary condition because of the legal requirement in Germany for companies to manage safety through the post of Eisenbahnbetriebsleiter (see 3.2.10). The NSA has stated that this arrangement can continue until the end of 2010, when German RUs must be in possession of a full Part A Safety Certificate otherwise the Part B for NL will be suspended. The Part A and B assessments are a mixture of documentation reviews and on site visits. For a Part B Certificate, this is limited to a visit to the Operational Headquarters of the RU. In NL a number of consultancy companies are available to assist RUs comply with the requirements. These companies maintain a dialogue with the NSA and are well placed to advise prospective RUs of the NSA requirements. The NSA offers limited assistance to prospective RUs as it does not want to be seen as a free consultancy, but inspectors will give informal advice. The application guidance and certificate acceptance processes are published on the IVW and/or ProRail websites. Links provided also give access to the Government’s information portal where the primary legislation can be found. Information concerning NSRs is available through this portal and from the ERADIS website. Guidance for


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inspectors is contained in internal documents only but there is a check list of what needs to be accomplished during the acceptance process. The NSRs that are notified to the ERA currently only partially comply with Annex IV of the RSD; this will be amended by a revision of the Railway Law in September 2010. The IM needs to ensure that prospective RUs comply with the emergency procedures and have approvals for the rolling stock to be used. These are not notified NSRs but the RUs must comply with them to be given a contract with the IM. The supervision process is not published but in NL, given the limited duration of Safety Certificates, the NSA and RUs are in frequent contact, as the renewal of a Safety Certificate is dependent on a satisfactory demonstration of compliance with the requirements. The NSA does not have the power to prosecute RUs, it must refer the matter to the MoT.

3.2.19 Norway (NO) The NSA, the Norwegian Railway Inspectorate, responded to both surveys but was not chosen for interview. In 1996 the former National State Railways was split into three, the Norwegian National Rail Administration (IM), the National State Railways (principal RU) and the NSA. Since deregulation in 2000 there have been a number of new freight operators. The NSA has not published an acceptance process but it has published guidance for RUs and states that its website contains all the information required by an RU. The NSA staff have experience in SMSs and hold auditing qualifications. The assessment process involves a document review rather than a full check and takes less than four months. The Part A SMS is not reviewed at the same time as a Part B application for non-domestic RUs. It is not clear whether there are NSRs in addition to the rules relating to technical aspects of the infrastructure and rolling stock or how they would be made available to RUs. The IM issues a ‘compatibility declaration’ for specific rolling stock, especially wagons but does not appear to be otherwise involved in the acceptance process. Post award supervision is risk-based depending on the nature and scope of the RU’s activities. It is published and available on the NSA’s website. The NSA does not have the power to prosecute an RU but can suspend or revoke the Safety Certificate or stop activities if it considers the RU to be in breach. This is likely to be a last resort if the RU has not corrected non-compliances.

3.2.20 Poland (PL) The NSA, Urząd Transportu Kolejowego, responded to both surveys and was chosen for interview.

Currently in PL there are 10 IMs, of which seven manage standard gauge networks available for open access operation. The state railway operator controls about 92% of that infrastructure. In addition, there are other IMs who are responsible for narrow


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gauge lines and one for a broad, 1520mm, gauge line. In 2009, 14 RUs provided passenger services and 40 provided freight services. There are also 20 licensed undertakings providing traction service (these are subject to licensing in PL). Although there are new entrants in PL, the predominant operator is Polskie Koleje Państwowe – the former state operator. Many RUs are still operating under the previous certification regime and the NSA declared that they are concerned about meeting the end of the year deadline. The RSD was transposed into law by the Polish Railway Act. The NSA states that it has not produced and published an acceptance or guidance process but provides the application form and information on how to complete it on its website. Documents and processes produced by the NSA would not be binding on the RUs as only national laws are mandatory. It is necessary, therefore, for the RUs to access these laws to find out, for instance, what documents must be submitted. It is reported that some RUs have difficulty with the notion of risk assessment and compiling an SMS and are reluctant to bide by requirements that are not laid down in law such as guidance documents. From the results of the interviews and information given in the survey, the timescales for issuing certificates may not always be met; this may in part be down to a low level of resources (five posts). The NSA’s staff have appropriate experience, skills and knowledge in specific railway fields but as their work is not limited to safety, they are struggling to fulfil the requirements. The level of pre-award checking is limited to a document review. The review of the Part B does not involve a thorough review of the Part A application and SMS. NSRs are available on the NSA website but some internal IM rules are not. These rules are, however, available to potential RUs once an application has been made. The application is made for a particular IM and covers all the lines of that IM. It appeared that the supervision process is not published and as it is still based on the previous regime, it needs to be updated. The NSA is basing the new process on the Common Safety Method (CSM) for Conformity Assessment and will undertake at least one audit during the five-year validity of the certificate. The NSA does not have the power to prosecute; it must inform the relevant security service of a breach. It has other limited sanctions available to it though, such as immediate enforcement to remove defects, putting vehicles out of service and imposing financial penalties.

3.2.21 Portugal (PT) The NSA, Instituto da Mobilidade e dos Transportes Terrestres (IMTT), did not respond to either survey and this NSA was not chosen for interview. The network statement of the IM, Rede Ferroviária Nacional, EPE contains outline details to enable RUs to apply for a Safety Certificate.


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The IMTT website contains the procedures necessary to apply for a Safety Certificate but does not appear to provide guidance to prospective applicants. Links are provided from the website to the legal reference documents. The ERADIS database suggests that four Safety Certificates have been issued.

3.2.22 Romania (RO) The NSA, the Romanian Safety Authority, responded to the Step One Survey and was not chosen for interview. Although the predominant RU in Romania is the former national railway company, Căile Ferate Române, there are numerous new entrant operators, which has resulted in many Safety Certificates being issued. Many of these seem to be for ‘Shunting Operations’ only, and have been issued to comply with Romanian legislation. It appeared that the process for accepting certificates is contained in national law but it was not clear whether there is an additional acceptance process and guidance published by the NSA. The NSA claims that information required is published on its website and in addition there is some information available in the network statement of the IM. The assessment includes a detailed check and takes less than four months to complete. The period of validity is set at two years for passenger and freight operators and one year for shunting. It also appeared that Part As are renewed after two years and Part Bs after one year. The NSA has issued hundreds of certificates between 2007 and 2009, the vast majority being Part Bs. Some of this is because Part Bs are renewed annually but it is not clear whether most of them are non-domestic RUs or whether there is another factor as well. NSRs are contained in an Order, which is made available to a prospective RU by the NSA. The IM is not involved in the acceptance process but has a contract with the RU after the certificate has been issued. It appeared, however, that two other bodies, the Romanian Railway Notified Body and the Romanian Railway Licensing Body are involved in approving the application. It was not clear what role these bodies play in the process or whether it could prove to be a barrier to new entrants. There is a process to revoke the Safety Certificate but there is no information on any other powers of the NSA.

3.2.23 Spain (ES) This NSA, Direccion General de Infraestrutura Ferroviaria (DGIF) responded to both surveys and was chosen for interview. In ES the main IM and RU are public companies created in 2005 by the Spanish Law 39/2003. The IM is Administrador de Infraestructuras Ferroviarias (ADIF) and the principal passenger and freight operator is Renfe-Operadora. Passenger operation is a monopoly by Renfe-Operadora but about 97% of rail freight is carried by Renfe Operadora, with 3% being carried by other RUs which have sought and been granted


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operating licences and Safety Certificates over the past few years. There are currently five freight RUs with a Safety Certificate, of which four have had Part A and B granted in ES, and one of which had part A from another member state and was granted a Part B by DGIF, which is part of the MoT. The plan to set up a separate State Agency to take on the duties of the NSA has been put on hold by the Government. This served to delay the introduction of the RSD requirements but the NSA recognises what needs to be done, is co-operative and has good intentions; it is not resistant to change. Safety Certificate applications are, therefore, currently being reviewed and certificates are issued by the IM with input from DGIF. DGIF recognises that this situation is not compliant or independent and intends to bring this duty in house by the end of 2010. As the competence of the current resource in DGIF may be an issue, however, it intends to continue to contract out some of the review, for specialist areas for the time being. The current competence in ADIF is based on the development of its SMS and acceptance of five Part A/B certificates and one Part B. Owing to this situation, the DGIF cannot demonstrate that it, or the current acceptance process, is impartial, objective, sound, transparent or consistent and several things about the process are not clear such as whether the harmonised format for application forms and certificates is being used. There is no guidance document to the process published yet but DGIF intends to do this by early 2011. Apart from legislation there are not many NSRs; most are generic and neither technical or detailed. . . . There is no guidance on NSRs but they are reported to be quite easy to apply and DGIF gives help if requested. It is not clear if they ask for documents on compliance with NSRs etc, or only those on competence of personnel and rolling stock. The NSRs are available on ERADIS but it is not clear if DGIF directs the RUs to them. The new requirements of risk assessment and SMSs are very different to the previous safety management regime and it has taken some time for the NSA, IM and RUs to adapt their systems. The NSA demonstrated, however, a good appreciation of the differences between a Part A and B but is concerned about whether it understands the level and depth of detail needed for the assessment of Part Bs. Although it trusts the other NSAs, it is not confident enough to review a Part B application without seeing some of the relevant Part A documentation. DGIF has not yet introduced a quality process but it has undertaken some level of assessment on ADIF and recognises that the process needs to be better. It would welcome more prescriptive guidance on what is required from a quality process, and indeed, on all the other processes required by the RSD. Neither is there a supervision process but one is planned. The current checks that take place on RUs are end product rather than system-based but at least the NSA has recognised the difference and knows what needs to be put in place. It is not clear how the DGIF/ADIF decide if a breach is, or would be, serious enough to prosecute or about any other tools that are available for offering assistance to the RU in managing safety.


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3.2.24 Slovak Republic (SK) The NSA, the Railway Regulatory Authority, responded to both surveys but was not chosen for interview. The majority of the railway system in SK remains state-controlled following the split of IM and RU activities. Železnice Slovenskej Republiky is the IM and Železničná Spoločnosť Slovensko (ZSSK) is the principal passenger operator. The main freight operator, ZSSK Cargo, is also state-controlled. Legislation transposing the RSD was enacted in July 2009 and the acceptance procedure for Safety Certificates is published on the website of the NSA. A summary of the arrangements are published in the network statement of the national railways of SK. The period for processing applications is less than four months and involves a document review not a detailed check. The SMS would only be reviewed in the case of a non-domestic RU if the RU submitted it with the application; it is not requested. No information was provided on the competence and experience of the NSA’s staff or on resourcing levels. NSRs have been notified to the ERA and are done so by the Ministry of Transport, Post and Telecommunications. Other requirements that have to be met include health and safety regulations but it is not clear how the RUs are informed, what is expected of them in this regard or whether such requirements could be a barrier to new entrants. The IM is not involved in the acceptance process but is required to give approval for rolling stock being used on the infrastructure. It was not clear from the response to the Step Two Survey whether the NSA has published a supervision process. It refers to the acceptance process but does not make it clear whether it also contains the supervision process. Post-award supervision is, however, undertaken on a risk-based approach based on the performance of the RU during the year. The NSA has the power to suspend a Safety Certificate and impose a fine in the event of a serious breach and there is a process for revocation of the certificate.

3.2.25 Slovenia (SL) The NSA did not respond to either survey and was not chosen for interview. The railway system in SL is operated by the state-controlled Slovenian National Railway company Slovenske železnice, which acts as both the IM and principal operator of passenger and freight trains. There are also several open access freight operators.

The SMS in SL incorporates elements of Directive 2004/49/EC, which have been customised to fit the characteristics, scale and other necessary requirements for carrying out its core function of rail traffic management.


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The Slovenian NSA is part of the Public Agency for Rail Transport, Javna agencija za železniški promet Republike Slovenije. Out of 22 staff working in the agency, six members of staff work in the NSA.

Basic information for RUs to apply for Safety Certificates is contained in the website of the NSA, however, no guidance appears to be available. The ERADIS database lists the NSA as having issued three Safety Certificates.

3.2.26 Sweden (SE) The NSA, Transportstyrelsen, responded to both surveys but was not chosen for interview. The former Statens Järnvägar, Swedish National Railway, now has a role solely as the operator of Intercity and local passenger services. Through its freight subsidiary, Green Cargo, a limited range of freight services are operated with links to NO and DK. There are several open access passenger operators along with a number of new entrant freight operators. The market appears to be relatively mature and the role of the IM, Banverket, is well defined. In total there are currently 25 RUs with valid Safety Certificates. The NSA is independent from the IM and RUs. The acceptance process and guidance is available on the NSA website. The NSA claims that it undertakes detailed pre-award checking but it is not clear if this actually involves more than a detailed document review. The process takes less than four months. NSA staff are safety inspectors with audit training in quality systems. The NSA has not issued a non-domestic Part B but states that it would not review the SMS at the same time as the Part B application. It is sometimes necessary for domestic RUs because they sometimes submit documents relevant to Part A and B and it can be difficult to distinguish them. The NSRs are available on the NSA website and appear to contain rules relating to other topics than are in Annex IV. Banverket has no role in the approval process other than to check that local operating procedures are in place. The NSA states that it has published a post-award supervision process. Inspections are risk-based depending on the activities of the RU in question. The NSA does not have the power to prosecute but informs the pubic prosecutor for serious breaches. It also has the power of injunction, prohibition and suspension of the certification. There is also a process to revoke the certificate.

3.2.27 United Kingdom (UK) The NSA, ORR, responded to both surveys and was not chosen for interview.


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The Department of Transport is responsible for the transposition of new EU legislation into UK law but would consult widely in the industry including with the ORR, which is an independent organisation. The main IM in the UK is Network Rail, although there are small privately-owned IMs that in the main do not interact with the mainline railway. There are several franchised and open access RUs, both passenger and freight. The NSA has published its acceptance process and guidance, which are available on the ORR’s website. There are other guidance documents as well, including for its inspectors and the assessment criteria that are used in the assessment. The inspectors have a wide variety of backgrounds including experience of the railway industry and post-graduate health and safety qualifications. NSRs are available through the Rail Safety and Standards Board’s (RSSB) website, which is the body responsible in the UK for the production and management of UK standards on behalf of the railway industry. They are also available on ERADIS. The assessment criteria document published by the ORR details how they check compliance with NSRs. In addition to NSRs there are Railway Group Standards, some of which do not meet the criteria of being NSRs. They are published by, and available through, the RSSB. New RUs would be informed of how to find them by the NSA. There is a requirement to send the applications to interested stakeholders, including the IM. The IM would not, however, have a say in the approval or otherwise of the application. The assessment process can include a level of pre-award checking that may involve a visit to the RU, if it is a domestic RU. Also, to assess a Part B application the ORR states it may need to refer to the Part A for certain elements relevant to the Part B. The ORR claims that the assessment process takes four months. The post-award supervision process is published on the ORR’s website. There are two related documents: one sets out the principles and approach and the other sets out the criteria that RUs must meet and evidence that will be sought. There is a five-year plan for each RU that includes key areas of risk important to the industry, supported by topics based on the risk of the individual RU. The ORR has the power to prosecute and can issue enforcement notices and suspend the Safety Certificate of an RU. There is also a process to revoke the certificate if necessary.

3.33.33.33.3 SSSSUMMARY OF UMMARY OF UMMARY OF UMMARY OF RRRRESULTS FROM ESULTS FROM ESULTS FROM ESULTS FROM SSSSURVEYURVEYURVEYURVEYS AND S AND S AND S AND IIIINTERVIEWSNTERVIEWSNTERVIEWSNTERVIEWS

It is clear from the responses to the surveys and the interviews that there is a wide variation in the methods of adoption of the RSD requirements and in the level of compliance with the RSD. The full list of findings can be found in Appendix E, but analysis of the survey results has highlighted the following areas where most of the problems seem to be concentrated. Each problem is cross-referenced to a recommendation in Section 4. The problem areas are:

• General • Assessment • Supervision


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• Difficulties in issuing Part Bs • Role and competence of the NSAs • Powers and tools of the NSA • Guidance • NSRs • Co-operation, co-ordination and trust • Role and independence of the IM.

3.3.1 General

A) Nearly half of the NSAs have RUs that are still operating using Safety Certificates issued under the previous Directive (2001/14/EC). Three of them have so many applications that there are likely to be problems before the deadline of 01/01/11 for issuing certificates under the current RSD. Some NSAs will struggle with levels of resource that are adequate for normal times but inadequate when so many RUs need to be certificated. PL in particular stressed its level of concern that it will not meet the deadline; DE has a contingency plan in place; IT has many to certificate but it is not known if they will struggle to complete them. This is of concern not only for the RUs involved, but also because it reflects on the NSAs’ (and possibly the MSs’) attitude to accepting new requirements and being able to react quickly and competently. Again, it emphasises the need for a simplification of the process and for more intervention from the ERA, especially in the early days of new legislation being issued to ensure that it is fully understood. Also, it may be beneficial for NSAs to develop an action plan to show how they intend to implement new requirements (see also 3.4.1 C).... This would be available for the ERA to inspect if necessary to give some assurance that the NSA has correctly interpreted the legislation and about how it intends to assist the RUs to comply. Recommendations 1 and 4Recommendations 1 and 4Recommendations 1 and 4Recommendations 1 and 4 B) Most NSAs have set a validity of five years maximum for the certificate. Of the three who have set a lower limit, one was interviewed and explained that this is because they audit soon after the certificate is issued and so control the perceived risk by having an option to identify problems and if necessary suspend or revoke the certificate in the early days of operation. This appears to be a good idea especially for new operators and one that could help other NSAs to have more confidence in the Part A Certificates issued by non-domestic NSAs, especially if there is a single certificate. Recommendation 3Recommendation 3Recommendation 3Recommendation 3 C) Although most NSAs have adopted the harmonised format for documentation and insist on the RUs using it too, there are some that do not. ES does not think that the documents are prescriptive enough. Recommendations 1 and 2Recommendations 1 and 2Recommendations 1 and 2Recommendations 1 and 2 D) Most NSAs have a process for revocation of the Safety Certificate but a small number advised that they do not. It is possible that this may be because the NSAs have not had the need to revoke a certificate but they should still be aware of the need for a process to do so. It indicates that the NSAs may require more guidance. Recommendations 1 and 2Recommendations 1 and 2Recommendations 1 and 2Recommendations 1 and 2


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(E) In FR and NL, RUs are known to employ consultants to produce their SMSs and compile their Safety Certificate applications. The NSAs need to ensure that the RUs in question either have the competence in house, or will continue to procure external competence, in order to maintain the documentation and manage safety within their operations. Checking by the ERA of the NSAs’ processes would enable the ERA to establish whether the NSAs cover this in their own audits. Recommendation 2Recommendation 2Recommendation 2Recommendation 2

3.3.2 Part A/Part B A) A significant number of NSAs did not demonstrate an adequate knowledge of, or process for, what they would do if a Part A expired before a Part B. This may well be because the situation has not arisen in their MSs and the problem would be overcome with a single certificate. It does, however, again indicate that the NSAs may require more specific guidance on issues such as this that are not obvious in the legislation. Recommendations 1 and 2Recommendations 1 and 2Recommendations 1 and 2Recommendations 1 and 2 B) All the NSAs claimed that they understood the differences between a Part A and a Part B Certificate but that sometimes the RUs were not so clear and need much assistance. Nearly half the NSAs, however, undertake some checking on the SMS when assessing a non-domestic Part B submission. Several NSAs stated that there is a difference in how Part As and Part Bs are assessed but on closer examination it appeared that it is the topics that are different rather than the process. The simplification of the certification system would eliminate this problem but in the meantime, a form of checking by the ERA would be of benefit. Recommendations 1 and 2 Recommendations 1 and 2 Recommendations 1 and 2 Recommendations 1 and 2 (C) Quite a significant number of NSAs did not know what they would do if the Part B covered activities not included in the Part A and none of them could demonstrate understanding of what criteria they would use to decide if an RU could demonstrate how they comply with NSRs. Again, this indicates that more guidance is needed for NSAs. Recommendation 1Recommendation 1Recommendation 1Recommendation 1

3.3.3 Assessment A) Several NSAs had not produced an auditable assessment and handling process for an application for certification (see Figure 1 below). This may be because these NSAs provide verbal guidance once the RU has contacted them, but this is not always clear from the survey results. If this is the case, then it makes it difficult for the NSA to demonstrate a consistent and non-discriminatory approach. Recommendations 1 and 2Recommendations 1 and 2Recommendations 1 and 2Recommendations 1 and 2


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Published acceptance process

Y

N

?

Figure1. Indication of NSAs with a published acceptance process (B) The survey answers indicated that a majority of NSAs seek confirmation that everything is in place before the certificate can be issued. Although it is not clear if this is a physical check or verbal/documentary, it is clear that the reason is because of the lack of trust between NSAs that is mentioned in more detail in Section 3.3.6. Nearly half of the NSAs undertake some level of checking of the Part A during assessment of Part Bs for non-domestic RUs, and three conduct a detailed check; some NSAs indicated that this only covers those issues relating to the three Part B criteria, which is acceptable, but there are NSAs that undertake a more detailed check because they do not trust the other NSAs. A simplification of the system will help improve this situation but it is essential that trust between the NSAs be built up beforehand. Recommendations 1 and 2Recommendations 1 and 2Recommendations 1 and 2Recommendations 1 and 2 (C) A small number of NSAs take over four months to assess the submissions and issue certificates. The reasons for this are unknown. Even for those NSAs who claim to take four months, there is scope for them to extend this period artificially by procrastinating over advising the RU on what documentation to submit and how. This was not explicit in the responses but can be implied in some cases. There is also some anecdotal evidence that this may be the case. If true, then it could deter new players from entering the market. More research may be required on this subject. Recommendation Recommendation Recommendation Recommendation 5555 (D) Some NSAs do not appear to be taking account of the risk of the RU in the assessment process; most assess all applications equally. This means that it is not clear if RUs with high risk activities are being assessed adequately or if the NSA is expending more effort than it need on low risk RUs at the expense of higher risk RUs. RecommenRecommenRecommenRecommendations 1 and 2dations 1 and 2dations 1 and 2dations 1 and 2 E) Some NSAs could not demonstrate that they have an adequate internal quality process to check that they have performed each stage of the process as required. There are sometimes checklists in use, which is a type of ongoing self-check but it is not an independent, objective assessment. Some NSAs undertake a final check through the


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documentation before issuing the certificate but this is not widespread. One NSA is audited by the MoT. Recommendations 1 and 2Recommendations 1 and 2Recommendations 1 and 2Recommendations 1 and 2 (F) It appeared that several NSAs do not keep a record of the RUs’ compliance with the assessment criteria during the assessment process. While this is not mandatory it is good practice and could be beneficial to the NSA to refer to at a later date to help amongst other things inform the supervision process. Recommendations 1 and 2Recommendations 1 and 2Recommendations 1 and 2Recommendations 1 and 2 (G) A small number of NSAs admitted to not checking the level of co-operation between RUs and other bodies when they undertake the post-award supervision. Rather more NSAs could not, however, give an adequate answer as to what constitutes this assessment, which calls into doubt the effectiveness of the assessment in over half of the NSAs. Co-operation is a requirement of the RSD and checks on the RUs’ processes for co-operating need to be made more robust. Recommendations 1 and 2Recommendations 1 and 2Recommendations 1 and 2Recommendations 1 and 2 (H) Some NSAs do not assess the overall ability of the RUs’ SMSs to control system risk. Several did not understand the question, indicating that they may not undertake such an assessment. This is an area where detailed guidance may be required to explain why this assessment is necessary and how it may be conducted. Recommendations 1 and 2Recommendations 1 and 2Recommendations 1 and 2Recommendations 1 and 2

3.3.4 Supervision (A) Some of the NSAs have not yet published or fully implemented a post-award supervision process, so their answers are based on theory rather than practical experience. Not all of the NSAs cover the entire SMS in their supervision regimes and it was not always clear how they prioritise what to include. It was clear that there are many different interpretations of what constitutes a supervision regime and different levels and frequency of activity with some NSAs making frequent inspections according to set programmes and others aiming to visit once in the five-year period of the certificates’ validity. Recommendations 1 and 2Recommendations 1 and 2Recommendations 1 and 2Recommendations 1 and 2 B) Although the NSAs demonstrate a general awareness of the post-award supervision process, many of them have not produced a written procedure. One MS (PL) has not yet transposed this part of the RSD into national legislation. Some refer to legislation, which may not be sufficiently detailed, or to their acceptance process but do not make it clear whether this document actually contains the supervision process as well. It appears, therefore, that many RUs may not be being made as aware as they should be of what to expect from the NSA in terms of intervention after the certificate has been awarded. Some NSAs argue that the process needs to be unannounced so that the RU cannot prepare, but this is no argument against producing a document that explains the process; it does not need to give detail of visit dates, for instance. Recommendations 1, 2 and 3Recommendations 1, 2 and 3Recommendations 1, 2 and 3Recommendations 1, 2 and 3 (C) One NSA (AT) currently requires RUs’ SMSs to be certificated to ISO 18001, with the implication being that there is then no need for the NSA to conduct any further checks or


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audits of its own either during the assessment or the supervision stages. The NSA in question stated that it is an interim measure until the CSM on Conformity Assessment is finalised as it cannot implement requirements that are non-mandatory. It does not appear to be a barrier to non-domestic RUs at the moment, as it only applies to domestic RUs but AT has not yet issued a Part B to a non-domestic RU. This situation could be further explored by the ERA if it decides to undertake checks of NSAs. Recommendation 2Recommendation 2Recommendation 2Recommendation 2 (D) Two NSAs (DK and NL) audit the RU within a short time of the certificate being issued to assure themselves that the commitments made in the applications are being met. In fact, NL has set a period of validity on the first certificate of three months to give it the power to revoke the certificate should the RU’s arrangements not prove satisfactory. This is a good idea that may be cited as good practice, though may be more difficult to apply in MSs where there are hundreds of RUs. Recommendation 3Recommendation 3Recommendation 3Recommendation 3 (E) Recording and close-out of issues raised did not appear to be a great problem but is an area that should be included in any check of the NSAs’ activities by the ERA. Recommendation 2Recommendation 2Recommendation 2Recommendation 2 (F) It appeared from the survey answers that many NSAs do not conduct an annual review of the RUs in order to assess progress and set priorities for the following year. While this is not mandatory, it can be regarded as good practice and is to be encouraged. The answers to the survey indicated that some NSAs confused an annual review with the annual report to the ERA. Again, more guidance and assistance is indicated. Recommendation 1Recommendation 1Recommendation 1Recommendation 1

3.3.5 Difficulties in issuing Part Bs (A) Several NSAs outlined the difficulties that they had encountered during the assessment process. Most of these relate to a lack of understanding in the RU of local legislation, new processes for acquiring certification, what to submit for a Part B and differences between the local concepts and philosophy of safety and risk management and those of the originating country when the SMS is aligned to those of the latter. There are different concepts of what constitutes risk and risk management across the MSs. It is quite new to many of them and they have been struggling. The full list of issues identified can be found in Appendix E. These problems will not be addressed by a move to a single certificate, so the RUs will need to develop a better understanding of how to address these issues through their SMSs and may need further guidance from the NSAs and in turn the NSAs may need more guidance from the ERA. Recommendation 1Recommendation 1Recommendation 1Recommendation 1 (B) Five NSAs claimed to have rejected a Part B application and some of the reasons are likely to reinforce issues of lack of confidence in the NSAs (see Appendix E for the full list of reasons). (C) Another area of difficulty mentioned by one NSA concerned the difficulty of ensuring that RUs can comply with maintenance NSRs when the rolling stock is registered in another country because the maintenance certification scheme is not yet harmonised.


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3.3.6 Role and competence of the NSAs A) All but one of the MSs have established NSAs; some were formed out of existing governmental organisations and some have been set up from scratch. The staff, therefore, have often come from a railway background within a state-run regulatory body, for instance. The NSAs appeared to be set up to work independently of the RUs and IMs and other related bodies, though in some cases the transition from a totally integrated railway system reliant on state-set rules to the current risk-based regime has proved difficult. ES has not yet fully established an independent NSA and the duties are being fulfilled in the interim by the IM. This is due to change by the end of 2010. It was not always clear from the responses whether or not the NSAs were sufficiently resourced with competent staff. Recommendation 5Recommendation 5Recommendation 5Recommendation 5 B) Some of the NSAs declared that they are in the process of reorganisation or it is planned that a reorganisation will take place in the near future. NL, for instance is planning to extend the scope of its NSA to be a multi-disciplinary approvals body for all modes of transport. The concern is that this may overstretch existing resources and make it harder for the staff to retain competence in the current areas. Times of change are always times of high risk and a procedure for the safety validation of change can ensure that systematic identification of the risks and necessary controls takes place. Recommendation 6Recommendation 6Recommendation 6Recommendation 6 C) Most NSAs do not require specific safety or audit qualifications for their staff who are involved in assessment or supervision. This could be detrimental to the performance of their roles. Some NSAs have had to learn and set up the new processes and regime from scratch, as their previous regimes were very different. They did not receive help from the ERA or internal organisations and several stated that more help and guidance would have been welcomed. The ERA may wish to consider the benefit of trying to encourage the NSAs to ensure that staff who are involved in the assessment and supervision processes have appropriate competence in safety and audit. This would be commensurate with the competence available in the MS and equivalent to competence achieved in equivalent work in other sectors. This would help ensure more consistency in skill level and thus help with the problem of lack of trust between NSAs. Recommendation 1Recommendation 1Recommendation 1Recommendation 1 D) The level of resource varies widely throughout the MSs, with some NSAs employing over one thousand individuals and others a fraction of this. The study did not probe into the reasons for this, although the responses seem to indicate that the disparity is in part funding related. One NSA suggested that guidance from the ERA on appropriate levels of resource for the various duties of the NSA, dependent on the scale and set up of the railway network in the MS, would be beneficial. Recommendations 1 and 5Recommendations 1 and 5Recommendations 1 and 5Recommendations 1 and 5 E) Some NSAs perceive their role as taking on the responsibility for the safety of the RU/IM operation and this can manifest itself in such areas as the need to check/audit an RU to ensure that it is fully compliant with its commitments prior to issuing a certificate. Similarly, some NSAs display a lack of trust in other NSAs and so are reluctant to accept Part A Certificates without reviewing the documentation supporting them i.e. the SMS. Recommendation 3Recommendation 3Recommendation 3Recommendation 3


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F) A few of the questions involved making a judgement on the NSAs’ ability to demonstrate certain principles, approaches and attitudes. For instance, that they are being impartial, objective, sound, transparent and consistent in the acceptance process. Other examples include the decision-making principles in Article 17 of the RSD and the principles to be applied in the supervision process. All of the NSAs interviewed claimed that they are adopting these principles (or in the case of ES intends to do so once the NSA is fully established). In practice, however, it was not possible in most cases to verify these claims, as the interviews were not audits. Recommendation 5Recommendation 5Recommendation 5Recommendation 5 (G) Some of the NSAs suffer from inadequate resources and a lack of experience of both the new assessment process and of the SMS and risk assessment regime. Again, guidance is required and also some indication of the level of resource that would be expected given the potential workload in each NSA. Recommendation 1Recommendation 1Recommendation 1Recommendation 1

3.3.7 Powers and tools of the NSA (A) The powers of the NSAs vary quite widely between MSs. Ten NSAs have no powers of prosecution, as they are required to report breaches to the police or relevant security service. Possibly partly because of this, about half the NSAs could not explain the criteria for deciding if a breach is serious or for how the criteria would be applied in practice. Many merely referred to the legislation but did not indicate whether there was any scope for the NSA to exercise judgement. In most cases the situation has not yet arisen and these NSAs gave hypothetical responses. Most NSAs gave examples of other powers that they have as well as or instead of prosecution e.g. revocation, enforcement notices, intervention strategies and financial penalties. The full list can be found in Appendix E. Recommendation 1Recommendation 1Recommendation 1Recommendation 1 (B) Several NSAs do not have any other tools to promote safety. In some NSAs this is because of the issue about not being allowed to use documents that are not legally binding (See Section 3.4.1); for another it is because they do not want to be a free consultancy. For a full list of tools described by the NSAs for the promotion of safety see the list in Appendix E. Examples include: meetings, presentations at conferences, discussions during audit and newsletters.

3.3.8 Guidance (A) A significant number of NSAs had not produced written guidance for RUs (see Figure 2 below) and even more had not done so for their inspectors, although unlike guidance for RUs, this is not mandatory Most NSAs appeared to demonstrate an awareness of what documentation should be submitted by an RU but many asked for more than is required, a few for less and some listed information required rather than documentation and it was not clear what documentation they asked for in addition. The reasons for these omissions are not known but it is concerning that mandated requirements are not always being adhered to. RecommendaRecommendaRecommendaRecommendations 1 and 2tions 1 and 2tions 1 and 2tions 1 and 2


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Figure 2. Indication of NSAs with published guidance

(B) While most of the NSAs claim to provide on their websites all the information required by an RU to prepare its submission, it was apparent that some do not do so. The degree of assistance requested by the RUs prior to submission also, perhaps, reflects that the information provided on the websites is not as comprehensive, clear and easy to follow as the NSAs claim. There is a list of examples of help requested by the RUs in Appendix E. Several NSAs do not offer additional advice or tools for assisting the RUs to comply with NSRs. This may be because they think that the information and assistance already available is sufficient. One NSA does not do so because it does not want to be a free consultancy. The difficulty of finding information easily or, indeed, the lack of information in some cases, is likely to be a contributory factor to the lack of confidence in other NSAs that is displayed by several of the NSAs. It is also, if not a barrier, then at least a hindrance, to new entrants trying to start up in a new MS. There is, therefore, scope for simplifying the processes, rationalising and condensing the information that is made available by the NSAs and that information that must be submitted by the RU, and checking the validity of any extra documentation asked for to ensure that unnecessary information is not being requested. The introduction of a single certificate and review of the NSRs would be of benefit in this area. Recommendations 1, 2 and 7Recommendations 1, 2 and 7Recommendations 1, 2 and 7Recommendations 1, 2 and 7 (C) The question of how NSAs interpret EU and/or national legislation to assist RUs with their compliance was misunderstood by a few of the NSAs and other answers were unclear. Many seem to be unaware that it is a legal requirement to issue guidance particularly for new entrants under Article 12 (2) and (3) of the RSD. Most create their own guidance documentation and make it available with varying degrees of ease and success. Some NSAs can both create and disseminate legislation. It may be necessary to conduct some more research on this area prior to any new EU legislation being issued

Published guidance on Safety Certificate submission

Y N ?


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to ensure that the MSs have appropriate processes in place to transpose the legislation and provide assistance to RUs with compliance. Recommendation 5Recommendation 5Recommendation 5Recommendation 5

3.3.9 NSRs (A) It was clear that there is a huge range of NSRs, not always correlated with Annex IV and not always easy to identify. Some of them are only available in the native language of the MS. There are also other national requirements that have not always been notified to the ERA as NSRs (see list in Appendix E); some of these may be set by the IM(s) and may present an obstacle to new entrants from other MSs. There is a danger that such safety rules/requirements may be used by the NSA as a barrier to issuing certificates and thus interfere with the move towards improved opening of the market. A move to a single certificate would be greatly facilitated by a thorough review of the specific NSRs in each MS in order to identify which are absolutely necessary and which can be disposed of. Recommendation 7Recommendation 7Recommendation 7Recommendation 7 (B) The study did not require detailed information on the specifics of the NSRs, only an evaluation of the ease of availability of them to RUs and how much assistance and guidance the NSA provides to the RU to enable them to understand and comply with the NSRs. The NSAs generally either provide the NSRs on their own websites or point the RU to another website or the ERA’s ERADIS database to find the NSRs. They are not always easy to find or interpret as implied in Section 3.3.8 (B) above. (C) The majority of NSAs either could not demonstrate what criteria they use to assess an RU’s ability to comply with the relevant NSRs based on the submitted documentation or they did not understand the question. This could be easier if the ERA did some form of review of the policy and type of NSRs, but it once again highlights the need for more guidance for the NSAs. Recommendation 1 and Recommendation 1 and Recommendation 1 and Recommendation 1 and 7777 (D) The NSAs are not always responsible for deciding on the NSRs and notifying the ERA, which, perhaps partly explains why half of the NSAs were not aware of the principles of deciding which NSRs should be notified. In PL, the national legislation is not yet fully aligned to EU strategy in this area as transposition of the RSD and other EU legislation is not complete. This has an impact on the NSR situation, which should be improved when the NSRs are reviewed and reduced. Recommendation Recommendation Recommendation Recommendation 7777 (E) Examples of potential problems associated with IMs setting rules include that in PL, the IM’s internal rules are not published and the NSA has to inform the RUs about them. Also, in DK the RUs develop their own NSRs using a framework set by the IM for the infrastructure over which they intend to operate. They are then approved by the NSA as being in place but not for their content, which is agreed with the specific IM. A few examples of specific requirements peculiar to an MS that may hinder an RU obtaining a certificate include issues about technical equipment requirements and the need in one MS to have a driver’s assistant on every train. Again, these issues would be mitigated by a thorough review of NSRs. Recommendation Recommendation Recommendation Recommendation 7777


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(F) Many of the NSAs interviewed gave the opinion that they think the NSRs are essential to the certification process. While this is encouraging in the current regime, it may mean that NSAs might be suspicious about reducing the NSRs and about RUs managing the remaining requirements through their SMSs and risk management processes i.e. through the single certificate rather than through the Part B. Potentially this could be an obstacle in the migration to a single certificate. The migration strategy, therefore, needs to include a way to assure and give confidence to the NSAs that the process(es) that is/are put in place to deal with local requirements will be robust and not dilute the management of safety on the rail network within their MSs. Recommendation 1 and 2Recommendation 1 and 2Recommendation 1 and 2Recommendation 1 and 2 (G) Conversely, however, DE stated that NSRs could be dealt with outside the certification process and DK stated that NSRs are already dealt with outside the process, as RUs must compile their own NSRs based on a framework provided by the IM(s) for the infrastructure over which they wish to operate. The NSA checks that the RU has done this but the content of the NSRs is agreed with the IM(s) concerned. Checking by the ERA would help to identify practices such as this that are not standard and could be a hindrance to greater interoperability. Recommendation 2Recommendation 2Recommendation 2Recommendation 2

3.3.10 Co-operation, co-ordination and trust (A) An issue of concern that has been identified in this study is the level of confidence NSAs have in the other NSAs. This is partially caused by NSAs tending to act in isolation and may in part be owing to language difficulties. A stronger more focused role for the NSA network may help with this, particularly with task forces dealing with issues that might help promote co-operation and trust. It is perhaps unfortunate that one of the ways of sharing information about railway sector activities in MSs, the ERA-hosted ERADIS database, is populated inconsistently. It is acknowledged that this database is still in its infancy but improvements in the quality and consistency of the information held there would assist in increasing the level of confidence amongst NSAs and other users. For instance, it would be helpful if there was a clear indication of whether the Certificate is a Part A or B and the date of expiry. Recommendation 2 and 8Recommendation 2 and 8Recommendation 2 and 8Recommendation 2 and 8 (B) The inability of most NSAs to trust each other also manifests itself in several NSAs expressing it as their duty to take on all responsibility for network safety within their MS, despite the fact that the RSD explicitly lays this with the RUs and IMs through the process of risk assessment and the development of SMSs. From this standpoint, the NSAs are often unwilling to accept Part A Certificates that have been issued by other NSAs who, in their opinion, may not have robust processes in place or who may not be competent or consistent in their approach. A list in Appendix E outlines areas which contribute to the NSAs’ lack of confidence in each other. Advances in harmonisation and interoperability of the networks, rolling stock and standards will assist in addressing this concern in the longer term; the forthcoming CSMs e.g. the CSM on Conformity Assessment should help with harmonisation of the assessment process for certificates and the CSM on Risk Assessment should give the NSAs more confidence that at least they should all be following the same requirements/guidance. Other methods to build up trust should be


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identified. Again, some form of checking by the ERA is recommended to increase further the confidence that NSAs have in each other and their processes. Recommendations Recommendations Recommendations Recommendations 1 and 21 and 21 and 21 and 2 (C) Although about half of the NSAs had issued a Part B Certificate to a non-domestic RU very few had been involved in any liaison with the NSA from the other MS. The problems raised (see list in Appendix E) appear to be more related to problems in issuing certificates rather than in the liaison process. A simplification of the certification system will require much closer liaison and cooperation between the NSAs, which should be encouraged. RecommendationRecommendationRecommendationRecommendations 1 ands 1 ands 1 ands 1 and 2 2 2 2

3.3.11 Role and independence of the IM (A) In some MSs, especially where the railways are, or were, state owned, there is some residual overlap between the IM(s) and RUs. The NSAs appear to be discouraging this situation but it is likely to take some time for attitudes and culture to change completely. Where IMs and RUs are not independent, it becomes more difficult to ensure and demonstrate impartiality, consistency and proportionality in any involvement that the IM may have in NSRs and in the acceptance process. This study could not look in detail at the extent and intricacies of the relationships between IMs and RUs in the MSs, but it does highlight some areas for concern in some MSs. This is, perhaps, an area where more research may be required. Recommendation 5Recommendation 5Recommendation 5Recommendation 5 (B) A small number of NSAs state that approvals are required from other bodies for an RU to operate. The main body, however, is usually the IM and some NSAs seemed to indicate that the role of the IM extends beyond that acceptable in the process i.e. to provide information on the infrastructure and information that the RU will need to operate its trains safely. Many IMs’ roles relate to interoperability and licensing issues but some set NSRs and other requirements. This can be through the network statements or as separate company rules/documents. It is difficult in these circumstances for the NSA to guarantee that the process is consistent and proportional if they are not the only body making an assessment. In one MS (ES), the IM is undertaking the entire assessment process until the NSA is fully established later in 2010. The IMs should not be setting NSRs or influencing the decision to accept a submission and any concerns that they might have in the documentation submitted could be addressed through the NSA’s post-award supervision process. A list of examples of roles performed by the IMs is provided in Appendix E and this area would, perhaps, warrant further investigation. Recommendation 5 and 9Recommendation 5 and 9Recommendation 5 and 9Recommendation 5 and 9

3.43.43.43.4 MMMMISCELLANEOUSISCELLANEOUSISCELLANEOUSISCELLANEOUS

3.4.1 Other points/issues for the ERA to consider: (A) Non-mandatory requirements One of the issues that has arisen from the study is that in some MSs, the NSAs are not allowed by internal legislation in their MSs to develop and promote documents that are not legally binding either for their own use or to promote to RUs. Also, there is a reluctance on the part of the RUs in some other MSs to adopt requirements that are not legally binding e.g. guidance documents. While this is not a widespread problem, it


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does raise a potential problem for the ERA in ensuring that any guidance that it produces is going to be able to be implemented in these MSs e.g. the CSMs. It may be necessary for the ERA to try to deal with this on an MS-specific basis. Recommendation Recommendation Recommendation Recommendation 5555 (B) Costs It became apparent looking through various NSAs’ websites that the costs of applying for a Safety Certificate vary between MSs. While this is not surprising, it may be an issue that the ERA should consider in case it is, or becomes, a barrier to new entrants. Recommendation 5Recommendation 5Recommendation 5Recommendation 5 (C) RSD This study has highlighted several areas where the NSAs are not in compliance with the RSD. The RSD has been issued for several years now so it is somewhat surprising that some of the MSs/NSAs have taken so long to adopt its requirements. It is likely that the RSD may need to be amended if the Agency undertakes a simplification of the certification scheme. In order to facilitate the new requirements that this, and any other new legislation, may bring, it is suggested that the NSAs be required to produce an implementation plan to demonstrate how and when they expect to deliver the requirements. This should be submitted to the ERA who could include it in their checking programme. Recommendation 4Recommendation 4Recommendation 4Recommendation 4

3.4.2 Role of the ERA It was apparent from many of the NSAs’ responses that there is a widespread call for the ERA to have a stronger role in certain areas. This does not mean taking over duties from existing organisations but it would be likely to involve making sure that these organisations are performing their duties adequately. It would also involve the ERA doing more of what it does already. Recommendation 1Recommendation 1Recommendation 1Recommendation 10000 The main areas where suggestions have been made about the role of the ERA include:

• Reviewing NSRs • Auditing NSAs – and acting as a central auditing body • More facilitation of activities to bring NSAs together to exchange experiences and share best practice

• Provision of more guidance to NSAs e.g. CSMs and other documents with more prescriptive criteria

• Provision of hands-on, one-to-one, step-by-step assistance for NSAs in applying mandatory requirements and guidance

• Provision of training in specific areas to NSAs e.g. risk assessment • Putting Part B Certificates on its website as well as Part As • Keeping ERADIS up-to-date with accurate information • Better understanding of the real practicalities of railway operations, and of differences between operating characteristics of different railways

• Assistance with interoperability.


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3.4.3 The Situation in Germany The organisation of the railway sector in DE is unique in Europe, in that it has a very large number of RUs. It also has a national and federal approval system, whereby certain regional RUs are certificated by the local Länder in which they are situated. This is not a problem for non-domestic RUs applying for a Part B Certificate but only for existing and potentially new German RUs. In total there are 394 approved RUs (although anecdotal evidence suggests that there are potentially many more), of which 264 have been deemed to require certification under the terms of the RSD. The rest are deemed to be exempt but, it can be argued, these RUs should be subject to the same certification and supervision process that is applicable in other MSs. Currently, according to the ERADIS database only four Safety Certificates have been issued and there is, therefore, a large backlog that will not be certificated by the end of year deadline. The arrangements to deal with this situation are described in Section 3.2.10 Traditionally, German law has placed the emphasis in safety management on having a competent person to manage all aspects of safety; in the rail industry this person is the Eisenbahnbetriebsleiter. This person is subject to rigorous training and examination over a period of several years to nationally recognised standards. There is a railway-specific add-on that is managed and examined by the NSA. There has, therefore, been no need for SMS procedures if the Eisenbahnbetriebsleiter does not deem them necessary. The hitherto reliance on this dedicated specialist in each RU and the apparent industry reluctance to move to a different system, has, perhaps, affected the attitude of the NSA and IMs/RUs to implementing the requirements of the RSD. This may, therefore, help to explain why there has been a delay in issuing Safety Certificates in Germany. It is a factor that the ERA should take into account when considering the introduction of any new requirements. Recommendation 4Recommendation 4Recommendation 4Recommendation 4

3.4.4 MSs with links outside the EU Any changes to the Safety Certification process, should consider the impact on countries outside the EU, which currently see significant cross-border traffic. This is particularly so in the case of Switzerland, which is located on a main transit route. In some cases this applies to traffic flows between two MSs e.g. IT and DE. Likewise NO has links to SE and has significant flows between the two countries. The Baltic States and FI also have links to Russia. Recommendation 11Recommendation 11Recommendation 11Recommendation 11

3.4.5 Baltic States Currently, the three Baltic States of EE, LV and LT are isolated from the remainder of the EU rail network, but are linked to the 1520mm gauge network of Russia. Operating rules are derived from those of the former Russian State Railway, as are certain technical aspects of the rolling stock and operating practices, thus creating a unique operational environment within the EU. The links between the countries are very limited, although there are plans in the Rail Baltica project to improve links between the three Baltic countries and provide a link to PL. Recommendation 5Recommendation 5Recommendation 5Recommendation 5


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3.4.6 Future strategic projects

The ERA should take an active interest in the Safety Certification process for future new projects which cross national boundaries. The arrangements are often put in place as a result of bi-national agreements between the governments of the two countries involved. Thus the CT and the Oresund Crossing have added levels of certification. Recommendation 11Recommendation 11Recommendation 11Recommendation 11

4444 RECOMMENDATIONSRECOMMENDATIONSRECOMMENDATIONSRECOMMENDATIONS

4.14.14.14.1 OOOOVERALL VERALL VERALL VERALL CCCCONCLUSIONS ONCLUSIONS ONCLUSIONS ONCLUSIONS

4.1.1 The most overwhelming conclusions from the information acquired during this study are: • The need to simplify processes e.g. including considering migrating to a

single certificate, reduce NSRs • The need for the ERA to provide more guidance to NSAs, both documentary

and hands on (and more prescriptive) • The need for some form of checking by ERA of the NSAs to ensure that they

are undertaking their activities as required by the RSD • The need for NSAs to produce guidance to help RUs • Possible broadening of the ERA’s role • The need to build trust between the NSAs • Conduct more research into several areas.

4.1.2 It is clear from the results outlined in Section 3 that the situation concerning Safety

Certification on the rail network across the EU’s MSs is variable. The aim of harmonising the certification process for use of the rail network by RUs is laudable but likely to be constrained by various factors, some of which have been mentioned above. Full harmonisation, as the ERA is aware, will take many years and the harmonisation of the Safety Certificates is seen as an incremental step on the way to achievement of this aim. The results of this study provide evidence of where the main problems are with the current processes and point to where improvements can be made, not only in simplifying the processes, but in the overall approach to the introduction of new requirements. The evidence presented points to one of the solutions to the problems identified being the simplification of the certification system and a way to achieve this may be the introduction of a single certificate. However, to do this a number of issues would need to be resolved such as a review of NSRs and the possible checking by the ERA of NSA activities. There will probably always be the need for a certain amount of local rules but, it is suggested, these should be able to be managed through the RUs’ risk management and SMS processes.

4.1.3 It is clear from the NSAs’ responses that more guidance is required in key areas of the processes. This should be at least partly addressed through the gradual adoption over the next few years of the CSMs and other guidance planned e.g. on SMSs. The CSMs cover Conformity Assessment, Monitoring and Supervision. Also the CSM on Risk Assessment is to be extended in scope to cover operational change. Judging by the NSAs’ responses, however, it is likely that some of them may require more hands on assistance to understand and implement practically the CSMs. The NSAs will then need


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to develop their own comprehensive and clear guidance documents for the RUs, publish all the requirements and ensure that they are easily available and easily implemented by the RU. This will be checked through the NSA’s supervision regime supplemented by the recommended checks of the NSAs by the ERA.

4.1.4 This study has identified several main areas where there are problems with the current

processes for Safety Certification and post-award supervision. It is clear that the level of implementation of RSD requirements varies widely between the NSAs despite the RSD having been issued since 2004. The report highlights some of the potential reasons for this and it is a problem that the ERA needs to address before any further new legislation is introduced.

4.1.5 Where MSs have come from a background prior to entering the EU of rigid, rules-based,

prescriptive regimes, it can prove difficult to adapt to a system that places responsibility on the companies to manage their own risk through a risk assessment approach. This was evident from the responses. The NSAs are not necessarily reluctant to accept the new SMS-based ‘predict and prevent’ approach, though in some of their opinions it appears to be less safe than rule-based ‘find and fix’ regime, but they have struggled to understand what is required. It is then difficult to explain to the RUs what is required. Many of the NSAs have expressed a concern that they have not received a great deal of help from the ERA in setting up their new systems and would have welcomed some more prescriptive guidance and even hands on assistance.

4.1.6 The CSMs on Conformity Assessment and Monitoring should help in making the

processes more consistent, and help to develop trust between the NSAs; however, some NSAs have problems complying with documents that are not mandatory owing to their internal legal framework. Also, having some insight into the working of the NSAs after this study, it is by no means certain that the NSAs will apply the CSM consistently. There will inevitably be different interpretations and twists to try to make the requirements fit the processes that are already in place. Hence the need for checking by the ERA is reinforced and simplifying systems as much as possible, including removing the Part B and having a single certificate, may help with this.

4.1.7 Suggestions are made for how the role of the ERA could be strengthened without it

taking on other bodies’ responsibilities. Some of these ideas should help to build more trust between the NSAs, which will be an important factor if there is a single certificate. There have also been highlighted several areas where further research may be beneficial. These are areas where the responses to the surveys and interviews were unclear, there was not time to delve deeper into the subject or they were outside the remit of this study.

4.1.8 In summary, in order to move towards a single certificate there are certain factors and

steps that must be taken into account in a migration strategy. These include: • Harmonising the current processes that require decision-making such as the CSMs and the NSRs

• Ongoing gradual harmonisation, including implementation of Technical Standards for Interoperability, of technical aspects across the EU rail network

• Ensuring any residual local requirements are clear and easily available. Consider use of cross-acceptance or Notified Bodies


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• Check of NSAs that all requirements are being applied as intended • Make any improvements to the processes that are necessary • Implement, check and evaluate the improvements • Once these have been put in place then a move to a single certificate should be possible.

4.24.24.24.2 RRRRECOMMENDATIONSECOMMENDATIONSECOMMENDATIONSECOMMENDATIONS

4.2.1 This section contains recommendations to address the problem areas identified in Sections 3.3, 3.4 and Appendix E. These problems have highlighted, among other things, the need for a simplified system, more help and guidance and a review of NSRs. These recommendations, if adopted, could facilitate the process of migration. They are not presented in any particular order of priority. NB: The recommendations that appear to be an action on the NSAs are for the ERA to consider imposing on the NSA rather than being a direct recommendation on the NSA, which would not be within the remit of this study. RefRefRefRef Recommendations to facilitate the migration to a single safety certificateRecommendations to facilitate the migration to a single safety certificateRecommendations to facilitate the migration to a single safety certificateRecommendations to facilitate the migration to a single safety certificate R1R1R1R1 ERA to simplify the processes, where possible, including considering the

advantages of a single certificate, provide more guidance and, perhaps, hands on assistance to NSAs, especially when new requirements are introduced. Examples of areas where simplification and guidance may be beneficial are:

• simplification of the existing certification scheme and moving to a single certificate, including identifying the building blocks needed to move to such a system

• producing and publishing processes for acceptance, supervision and quality checks

• producing more prescriptive guidance documentation and help for RUs, e.g. CSMs and SMS guidance

• keeping a record of compliance during assessment • competence of NSA staff involved in assessment and supervision • development and implementation of a post-award supervision process and prioritisation of topics

• conducting an annual review • criteria for deciding if a breach is serious enough to prosecute (even if the NSA does not have the power itself to prosecute).

(Sections 3.3.1 A, C, D, 3.3.2 A, B, C, 3.3.3 A, B, D, E, F, G, H, 3.3.4 A, B, F, 3.3.5 A, 3.3.6 C, D, G, 3.3.7 A, 3.3.8 A, B, 3.3.9 B, F, 3.3.10 B, C) ERA to develop techniques for helping to build up trust between the NSAs. Examples could include:

• more workshops & training • task forces or quality improvement teams to tackle particular problems • issue CSMs as soon as possible • checking NSA activities • encourage greater levels of liaison e.g. when issuing non-domestic Part


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Bs. (Sections 3.3.3 B, 3.3.7 B, C) Reasons: Some NSAs appear to have difficulty in implementing new mandatory and non-mandatory requirements even when guidance documents are provided. Lack of trust between the NSAs.

R2R2R2R2 ERA to consider ways in which to check that the NSAs are delivering their role under Article 16 and 17 of the RSD to help build up trust between them. A stronger role for the NSA network may help, including developing specific task force groups on particular topics. (Sections 3.3.1 C, D, E, 3.3.2 A, B, 3.3.3 A, B, D, E, F, G, H, 3.3.4 A, B, C, E, 3.3.8 A, B, 3.3.9 F, G, 3.3.10 A, B, C) Reasons: Some NSAs appear to have difficulty in implementing new mandatory and non-mandatory requirements even when guidance documents are provided. Lack of confidence in other NSAs’ processes.

R3R3R3R3 NSAs to adopt a process for targeting their resources and adopting a risk-based approach to the auditing of the RUs. For new RUs this could start within the early days after the certificate is issued and operation commences. (Sections: 3.3.1 B, G, 3.3. B, D, 3.3.6 E) Reasons: Lack of confidence in new RUs’ and other NSAs’ processes. Control of risk of RUs’ operations. Help to change the NSAs’ perception of them being responsible for all system risk.

R4R4R4R4 NSAs to put an action plan in place when major new requirements are introduced such as the RSD to demonstrate how they will be implemented and in what timescale. (Sections 3.3.1 A, 3.4.1 C, 3.4.3) Reasons: Some NSAs and MSs appear to have difficulty in implementing new mandatory requirements even when guidance documents are provided.

RRRR5555 ERA to conduct more research in certain identified areas: • transposition of EU legislation into national legislation and how the NSAs assist the RU to comply (Section 3.3.8 C)

• organization of and resourcing within the NSAs (Sections 3.3.6 A, D) • the NSAs’ adoption of the principles appertaining to the assessment process, decision-making criteria and the supervision process (Section 3.3.6 F)

• the length of time between an RU’s first enquiry and the beginning of the four-month assessment period (Section 3.3.3 C)

• relationship between the IM(s) and RUs in each MS and the roles of the IMs (Section 3.3.11 A, B)

• the laws in some MSs that prohibit the NSA from implementing requirements that are non-mandatory (Section 3.4.1 A)

• costs of applying for certification (Section 3.4.1.B) • links between Baltic States and non-EU countries (Section 3.4.5)

Reasons: The responses to the questions in the surveys and/or interviews were not always clear on these points or there was not sufficient time to probe deeper or they were not within the remit of the study.


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R6R6R6R6 NSAs to develop and implement a process for the safety validation of change. (Section 3.3.6 B) Reasons: Organizational changes are happening or are planned within NSAs that could have an effect on their ability to carry out their duties unless the risks are identified and controlled.

R7R7R7R7 ERA to consider ways in which to help simplify, clarify and where possible reduce types of NSRs. (Sections 3.3.8 B, 3.3.9 A, B, D, E) Reasons: The full extent and content of local requirements that could present an obstacle to greater interoperability are not known.

R8R8R8R8 ERA to complete the population of ERADIS and keep it up-to-date with accurate information. The NSAs should be encouraged to supply information to allow the ERA to keep ERADIS up-to-date. (Section 3.3.10 A) Reasons: Incomplete and inaccurate data in the main medium for sharing information in the EU rail sector could be a contributory factor in the NSAs’ lack of trust in each other.

R9R9R9R9 NSAs to address concerns raised by the IM through its supervision process. (Section 3.3.11 B) Reasons: IMs set rules and can be involved in the acceptance process. NSAs could as part of their supervision process check that IMs have adequate means of co-operation with RUs, including identifying problems and providing resolutions.

RRRR10101010 ERA to consider broadening its existing activities in providing support to NSAs. (Section 3.4.2) Reasons: Demand from NSAs for ERA to have a strengthened role. Help to improve level of compliance across the EU.

R1R1R1R11111 ERA to consider monitoring the effectiveness of the Safety Certification process for any future new projects that cross boundaries within the EU. (Section 3.4.4, 3.4.6) Reasons: Changes could have an impact on cross-border traffic.


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5555 CONCLUSIONCONCLUSIONCONCLUSIONCONCLUSION

In conclusion Interfleet would like to thank the NSAs for their cooperation and assistance during this study, both for their survey responses and for the interviews. Interfleet would also like to thank the ERA Project Officer for ongoing assistance and advice throughout the study. The findings of the study have addressed the objectives set in the ITT of examining the role of NSRs and national requirements in the acceptance process for Part B Safety Certificates and in examining the post-award supervision regimes. The study has also allowed the collation and analysis of other related information that supports the overall aim to harmonise the decision making process across the EU with a view to migrating to a single certificate that is applicable in all MSs. The country-specific summaries provide a snapshot of the situation in each of the 27 MSs in relation to certain key topics. The full results are then categorised into the main problem areas and recommendations made to address the problems. In total 11 recommendations have been made that aim to address the key areas of concern that have arisen from the study such as the need for simplification of processes, provision of more guidance and auditing by the ERA, strengthening the role of the ERA, building trust between the NSAs and conducting more research into selected areas.


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APPENDIX AAPPENDIX AAPPENDIX AAPPENDIX A STEP ONE SURVEYSTEP ONE SURVEYSTEP ONE SURVEYSTEP ONE SURVEY The following is reproduced from the online version of the Step One Survey: Introduction to ERA Questionnaire on Part B Introduction to ERA Questionnaire on Part B Introduction to ERA Questionnaire on Part B Introduction to ERA Questionnaire on Part B Safety CertificatesSafety CertificatesSafety CertificatesSafety Certificates Welcome to the ERA on-line questionnaire concerning the issue of Part B Safety Certificates. Under Directive 2004/49/EC (as amended by Directive 2008/110/EC) all relevant Railway Undertakings must have a Safety Management System certified by the National Safety Authority in each Member State. As well as the Part A Certificate issued by the Member State where the Railway Undertaking first establishes its operation, there is a need to demonstrate the ability to comply with national requirements. This is achieved through the issue of a Part B Certificate for each specific network over which the Railway Undertaking wishes to operate. Interfleet Technology Ltd has been commissioned by the European Railway Agency to undertake a study into the processes that each Member State has in place for issuing Part B certification to understand the current position. The purpose of the study is to investigate the possibility of introducing a common process for issuing Part B Certificates that is applicable to all Member States that would harmonise the process across Europe. The study comprises several parts:

• A preliminary questionnaire to identify key information relating to the Part B acceptance process

• A second questionnaire concerning the post-award monitoring process

• In depth interviews with a sample of Member States after both questionnaires

• Analysis of the results

• Production of a report for submission to the European Railway Agency.

This on-line questionnaire is the preliminary stage. The questionnaire is comprised of six sections, each containing a number of multiple choice questions and questions requiring a written response. Please answer all the questions to give as much information concerning the way your National Safety Authority manages this process. The space for responses is limited. Each written response is limited to 7500 characters. If The space for responses is limited. Each written response is limited to 7500 characters. If The space for responses is limited. Each written response is limited to 7500 characters. If The space for responses is limited. Each written response is limited to 7500 characters. If you need more space for your response or if you have any addyou need more space for your response or if you have any addyou need more space for your response or if you have any addyou need more space for your response or if you have any additional comments on the itional comments on the itional comments on the itional comments on the certification process please email additional information tocertification process please email additional information tocertification process please email additional information tocertification process please email additional information to [email protected]@[email protected]@interfleet.co.uk. In addition if you have any problems accessing the . In addition if you have any problems accessing the . In addition if you have any problems accessing the . In addition if you have any problems accessing the questionnaire please contact questionnaire please contact questionnaire please contact questionnaire please contact [email protected]@[email protected]@interfleet.co.uk....


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Section 1Section 1Section 1Section 1 Legislative Documentation Requirements Legislative Documentation Requirements Legislative Documentation Requirements Legislative Documentation Requirements 1.1 Has the National Safety Authority produced guidance on the documentation required for a Safety Certificate Part B submission? 1.2 Give the title and date. May be combined with Part A guidance. 1.3 Has the National Safety Authority issued guidance to its inspectors on the process

they must follow to assess a Safety Certificate application? 1.4 Give the title and date. Section 2Section 2Section 2Section 2 AcceptanceAcceptanceAcceptanceAcceptance Process Process Process Process 2.1 Has the National Safety Authority published an auditable acceptance process on

how to submit an application? 2.2 Give the title and date of any document/procedure that has been issued. 2.3 What role does the National Safety Authority have before the Part B Certificate is

issued (e.g. advice)? 2.4 Does the National Safety Authority's website contain all the information required

for a Railway Undertaking to be able to submit a Part B application? 2.5 If not, where can other information be found? List relevant organisations and

include the website addresses. 2.6 What documents are requested by the National Safety Authority to be submitted

for the Part B assessment process? 2.7 How thorough is the assessment process for the Part B Certificate? 2.8 If some pre-award checking takes place, how does the National Safety Authority

prioritise what should be included? 2.9 Does the National Safety Authority require confirmation that all measures are in

place before the certificate can be issued? 2.10 How does the National Safety Authority deal with problems in Part B applications? 2.11 If other, please specify. 2.12 Does the National Safety Authority keep a record of the compliance with the

assessment criteria for each of the national requirements or National Safety Rules listed by the Railway Undertaking in its application?


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2.13 Has the National Safety Authority issued a Part B Certificate to a Railway Undertaking with a Part A Certificate from another Member State?

2.14 Has the National Safety Authority needed to liaise with the National Safety Authority that issued the Part A Safety Certificate to the Railway Undertaking, to agree the action each will take to ensure compliance with the assessment criteria?

2.15 Were any problems encountered during this process?

2.16 Give a brief explanation of the types of problems.

2.17 What would the National Safety Authority do if the Railway Undertaking's Part A Certificate did not cover the activities/traffic types that the Railway Undertaking is applying for in the other Member State?

2.18 Is there a process for revocation of the Safety Certificate?

2.19 Does this differ between a Part A and a Part B?

2.20 How long does the assessment and certification process take on average for a Part B Certificate, from the submission of all documentation including comments from interested parties?

2.21 What is the period of validity before a Part B Safety Certificate has to be renewed?

2.22 Describe any difficulties that the National Safety Authority is encountering in processing and issuing Part B Certificates?

Section 3Section 3Section 3Section 3 National Safety RulesNational Safety RulesNational Safety RulesNational Safety Rules

3.1 What are the National Safety Rules with which the Railway Undertaking must comply?

3.2 What decision-making criteria are used by the National Safety Authority to assess whether a Railway Undertaking can comply with the National Safety Rules?

3.3 How do the National Safety Rules correspond with Annex IV of the Railway Safety Directive?

3.4 Are there any other national requirements that a Railway Undertaking would need to comply with in addition to the National Safety Rules?

3.5 What principles have been adopted for deciding what national standards should be notified to the ERA as National Safety Rules?

Section 4Section 4Section 4Section 4 Relationship between Part A and Part B Relationship between Part A and Part B Relationship between Part A and Part B Relationship between Part A and Part B Safety CertificatesSafety CertificatesSafety CertificatesSafety Certificates

4.1 Is there a difference in the process for how Part A and Part B Certificates are assessed?


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4.2 Briefly explain the differences for the assessment of Part B Certificates.

4.3 Does the National Safety Authority review the Part A at the same time as the Part B?

4.4 If yes, explain why the National Safety Authority does this.

4.5 When the National Safety Authority informs the ERA of certificates issued does it distinguish between a Part A and a Part B Certificate?

4.6 Has there been an example of when the National Safety Authority has not accepted a Part B Certificate?

4.7 If yes, what measures were taken? Briefly explain the occasion and action taken

4.8 What action does the National Safety Authority take if a Part A Certificate is due to expire during the time that a Part B is valid?

4.9 Does the National Safety Authority use the same process if the Railway Undertaking is only requesting a Part B Safety Certificate?

Section 5Section 5Section 5Section 5 Relationship to Infrastructure Managers and OthersRelationship to Infrastructure Managers and OthersRelationship to Infrastructure Managers and OthersRelationship to Infrastructure Managers and Others

5.1 Do Infrastructure Managers in your country have a role in assisting with the decision making process for Part B application?

5.2 If other, please specify. 5.3 Are there requirements on the Infrastructure Manager(s) to consider any

operational requirements for the Railway Undertakings, particularly the application of national rules?

5.4 Is the Part B route-specific? 5.5 Do applicants have to specify which routes their trains will be travelling over? 5.6 Are approvals required from any bodies other than the National Safety Authority

e.g. Infrastructure Managers? 5.7 If yes, list the bodies and their websites. Section 6Section 6Section 6Section 6 MiscellaneousMiscellaneousMiscellaneousMiscellaneous 6.1 Are there still any Railway Undertakings in your Member State that were authorised

to operate under the previous Directive (2001/14/EC)? 6.2 If yes, how many?


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6.3 Is there a process in place to ensure that they are all certificated under 2004/49/EC by 31 December 2010?

6.4 How many Part A and Part B Safety Certificates has the National Safety Authority

issued since the requirements were introduced?


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APPENDIX BAPPENDIX BAPPENDIX BAPPENDIX B STEP TWO SURVEYSTEP TWO SURVEYSTEP TWO SURVEYSTEP TWO SURVEY The following is reproduced from the online version of the Step Two Survey:

Welcome to the ERA onWelcome to the ERA onWelcome to the ERA onWelcome to the ERA on----line questionnaire cline questionnaire cline questionnaire cline questionnaire concerning the Part B Safety Certificate postoncerning the Part B Safety Certificate postoncerning the Part B Safety Certificate postoncerning the Part B Safety Certificate post----award supervision regimeaward supervision regimeaward supervision regimeaward supervision regime

Under Directive 2004/49/EC (as amended by Directive 2008/110/EC) all relevant Railway Undertakings must have a Safety Management System certified by the National Safety Authority in each Member State. As well as the Part A Certificate issued by the Member State where the Railway Undertaking first establishes its operation, there is a need to demonstrate the ability to comply with national requirements. This is achieved through the issue of a Part B Certificate for each specific network over which the Railway Undertaking wishes to operate and a supervision regime to check compliance with the Safety Management System after the certificate has been issued.

The purpose of the study is to investigate the possibility of introducing a common process for issuing and monitoring Part B Certificates that is applicable to all Member States that would harmonise the process across Europe.

The study comprises several parts:

• A preliminary questionnaire to identify key information relating to the Part B acceptance process

• A second questionnaire concerning the post-award monitoring process

• In depth interviews with a sample of Member States after both questionnaires

• Analysis of the results

• Production of a report for submission to the European Railway Agency.

The preliminary survey has been issued and responses submitted by 22 National Safety Authorities for which Interfleet Technology extends its thanks. Such a good response rate will increase the confidence that can be placed in the findings. The results are in the process of being analysed by Interfleet Technology and will be finalised after the responses to the second survey are submitted and the interviews have been held.

This on-line questionnaire is, therefore, the second survey and it covers the post-award supervision regime that is required by Article 16 of the Railway Safety Directive. The questionnaire is comprised of only one section, which contains a number of multiple choice questions and questions requiring a written response. Please answer all the questions to give as much information concerning the way your National Safety Authority manages this process.

The space for responses is limited. Each written response is limited to 7500 characteThe space for responses is limited. Each written response is limited to 7500 characteThe space for responses is limited. Each written response is limited to 7500 characteThe space for responses is limited. Each written response is limited to 7500 characters. If rs. If rs. If rs. If you need more space for your response or if you have any additional comments on the you need more space for your response or if you have any additional comments on the you need more space for your response or if you have any additional comments on the you need more space for your response or if you have any additional comments on the


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postpostpostpost----award supervision process, then please email additional information to award supervision process, then please email additional information to award supervision process, then please email additional information to award supervision process, then please email additional information to [email protected]. In addition if you have any problems accessing the [email protected]. In addition if you have any problems accessing the [email protected]. In addition if you have any problems accessing the [email protected]. In addition if you have any problems accessing the questioquestioquestioquestionnaire please contactnnaire please contactnnaire please contactnnaire please contact [email protected]@[email protected]@interfleet.co.uk....

1.1 Do you have an overall statement/policy of how you deliver your responsibilities

described in clauses e and f of Article 16 of the RSD? 1.2 Is this process published? 1.3 What is the title and date? 1.4 Please provide a summary of this statement 1.5 If not, is there any information available, and in what format, to enable Railway

Undertakings to find out about the process? 1.6 The draft Common Safety Method on Conformity Assessment describes a process

for post-award supervision. How does the NSA interpret what is meant by the post-award supervision process? Is it inspection, audit, visits, or a combination of these, for instance?

1.7 Is this ‘post-award supervision’ the same process or similar to the overall process you described in your response to question 1?

1.8 What criteria are used by the NSA to prioritise the issues it looks at during a post-award supervision activity? (Does it include the NSA's knowledge and experience of the Railway Undertaking (i.e. the risk profile)? What other criteria?)

1.9 How does the NSA decide the frequency for conducting post-award supervision activities?

1.10 Describe what the NSA does/reviews when it undertakes post-award supervision activity of a Railway Undertaking

1.11 Are the activities that you describe in 1.10 linked to the commitments made by the Railway Undertaking in its Safety Management System?

1.12 If not explain what is covered?

1.13 Give the job titles, relevant qualifications (e.g. audit and safety) and experience of the personnel who carry out the supervision activities.

1.14 On what basis does the NSA make a decision as to whether the part of the Safety Management System under examination is adequate?

1.15 Does the checking regime include assessing whether the railway undertaking is achieving the requirement to co-operate with others (infrastructure managers,


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railway undertakings) that use the network, and any other relevant body? (select one)

1.16 If yes, what does the assessment consist of?

1.17 Does the NSA consider the links between different railway undertakings’ Safety Management Systems to assess whether when taken together, they are controlling the overall system risk to the railway network?

1.18 How are the findings of post-award supervision activities recorded? (e.g. formal report, letter, email, corrective action request, other)

1.19 How are issues raised in a post-award supervision activity checked for completion and closed out? (e.g. return visit, submission of supporting documentation, word of mouth, involvement of inspectors' superiors)

1.20 Does the NSA have the power to prosecute for a serious breach of relevant legislation?

1.21 What other enforcement powers does the NSA have under the Railway Safety Directive or relevant national legislation?

1.22 What criteria does the NSA use to decide whether a serious breach has occurred? What criteria does the NSA apply when deciding whether or not to prosecute?

1.23 Explain how these criteria are applied in practice.

1.24 What advice/guidance/information tools are available to help the Railway Undertaking ensure that it meets the national requirements? (List each tool and describe its application)

1.25 Do you have any other tools/practices to help promote safety in the railway sector? Please describe

1.26 Does the NSA hold an annual review of progress and set priorities for the following year for each Railway Undertaking?

1.27 If yes, is this based on the information in the annual reports submitted by the Railway Undertaking?

1.28 If not, what is it based on?

1.29 If there is not an annual review, how does the NSA assess progress and set priorities for the following year?


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APPENDIX CAPPENDIX CAPPENDIX CAPPENDIX C INTERVIEW QUESTIONSINTERVIEW QUESTIONSINTERVIEW QUESTIONSINTERVIEW QUESTIONS INTERVIEWS WITH NATIONAL SAFETY AUTHORITIES FOR A STUDY ON THE INTERVIEWS WITH NATIONAL SAFETY AUTHORITIES FOR A STUDY ON THE INTERVIEWS WITH NATIONAL SAFETY AUTHORITIES FOR A STUDY ON THE INTERVIEWS WITH NATIONAL SAFETY AUTHORITIES FOR A STUDY ON THE SAFETY SAFETY SAFETY SAFETY

CERTIFICATECERTIFICATECERTIFICATECERTIFICATE PART B ASSESSMENT PART B ASSESSMENT PART B ASSESSMENT PART B ASSESSMENT PROCESS PROCESS PROCESS PROCESS AND POSTAND POSTAND POSTAND POST----AWARD SUPERVISION PROCESS AS MANDATED BY THE RAILWAY SAFETY AWARD SUPERVISION PROCESS AS MANDATED BY THE RAILWAY SAFETY AWARD SUPERVISION PROCESS AS MANDATED BY THE RAILWAY SAFETY AWARD SUPERVISION PROCESS AS MANDATED BY THE RAILWAY SAFETY

DIRECTIVE DIRECTIVE DIRECTIVE DIRECTIVE IntroductionIntroductionIntroductionIntroduction Following the completion of two on-line questionnaires concerning the Part B Safety Certification process by the NSAs of the EU Member States, 11 NSAs have been chosen in agreement with the ERA Project Manager for further in depth study. The choice of NSA for interview is largely driven by the country involved being on a key Trans-European Transport Network route and/or it being a country with specific issues to be addressed. The interviews with the Member State NSAs, represent an opportunity for Interfleet to clarify any points with the NSA which have arisen from the responses to questions in the questionnaires, together with general questions on process and procedures used. There are also specific questions relating to the responses of each NSA. The process is designed to assist the ERA in making proposals for migration to a single European Safety Certificate and this process enables the NSAs interviewed to express their views on the proposed migration. It is not intended to be an investigation into why a particular NSA operates in a certain way, it is more about trying to engage the NSA in the idea of a single certificate and the issues the NSA has with the existing process, which might be a barrier to the introduction of a single certificate. Good luck! Andy Woodcock Project Leader General GuidanceGeneral GuidanceGeneral GuidanceGeneral Guidance

• There is some research that can be done in advance in terms of checking There is some research that can be done in advance in terms of checking There is some research that can be done in advance in terms of checking There is some research that can be done in advance in terms of checking whether documentation containswhether documentation containswhether documentation containswhether documentation contains what it should. Many of these are what it should. Many of these are what it should. Many of these are what it should. Many of these are indicated in the guidance below and it is recommended that the interviewer indicated in the guidance below and it is recommended that the interviewer indicated in the guidance below and it is recommended that the interviewer indicated in the guidance below and it is recommended that the interviewer read through this guidance document in full straight away to make sure that read through this guidance document in full straight away to make sure that read through this guidance document in full straight away to make sure that read through this guidance document in full straight away to make sure that these areas can be dealt with in these areas can be dealt with in these areas can be dealt with in these areas can be dealt with in sufficientsufficientsufficientsufficient time before the interview time before the interview time before the interview time before the interview....

• The focus of the questioning should be around the issue of certificates to non-domestic RUs rather than domestic ones, although obviously domestic RUs should not be ignored.

• The assessment process is about ensuring the documentation submitted provides sufficient evidence of the RUs ability to operate safely. It is not confirmation that everything is in place before the certificate is issued – this is in the supervision process. Any concerns about the ability of the RU’s processes to deliver safety on the ground can be checked during the supervision activity, the areas of concern being given priority.


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• Bear in mind that the aim of the entire study is to make recommendations for moving to a single certificate, so be alert for anything that can contribute to this, even if it does not come out of the formal questions. Look for anything that could be considered to be an obstacle to the migration to a single certificate.

• Use the NSA’s responses to the two surveys for reference as needed throughout the interview. These have been provided to you in the interview pack.

• Where the response refers to documents and it is not clear from the title what it contains, check with the NSA that the document does what is claimed.

• It is recommended that the interviewer look on the NSA’s website prior to the interview to familiarise themselves with the documentation referred to in the responses and to check how easy it would be for a non-domestic RU to find the information needed to follow the submission process.

• In the main the interviewer will not be expected to ask for evidence to support the word of the NSA’s representative, although if in any doubt ask to see evidence to support what they say.

Reference DocumentsReference DocumentsReference DocumentsReference Documents

• Railway Safety Directive 2004/49/EC • 653/2007 Common Format for Safety Certificate and Application

Documents • CSM on Conformity Assessment • Suggested best practice process document (produced by Interfleet) • NSA’s responses to the two surveys • Obtain in advance Obtain in advance Obtain in advance Obtain in advance ---- Relevant documents and information from the NSA’s

website: o Submission guidance document for RUs o Assessment guidance document for inspectors o Assessment process document o NSRs and any reference to national requirements o IM’s network statement

GlossaryGlossaryGlossaryGlossary

CSM Common Safety Method EU European Union IM Infrastructure Manager MS Member State NSA National Safety Authority NSR National Safety Rules RSD Railway Safety Directive RU Railway Undertaking SMS Safety Management System TSI Technical Standards for Interoperability


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QuestionsQuestionsQuestionsQuestions The questions are for use as prompts for issues to cover and do not need to be used verbatim in exploring the topic areas. 0000 Introductory questionsIntroductory questionsIntroductory questionsIntroductory questions

0.1 Ask the NSA to provide a brief overview description of how the rail industry is structured in the MS.

The interviewer may already be familiar with the rail structure if it is their own MS but the question serves to open the session and put the interviewee at ease. It should take no more than a few minutes and cover such areas as whether the railway is vertically integrated, or are the IM and RUs separate and whether the NSA is part of the Ministry or part of the rail industry.

0.2 Ask the NSA to provide a brief description of the Safety Certification process and perceived areas of difficulty.

Again this should be no more than a brief overview as particular steps and issues will be explored in more detail in later questions but it will be useful at this stage to obtain a general view on the NSA’s understanding of the process.

1111 National Safety Authority ResourcingNational Safety Authority ResourcingNational Safety Authority ResourcingNational Safety Authority Resourcing GuidanceGuidanceGuidanceGuidance

1.1 What level of resource is available to the NSA to assess applications?

Ask how many full time equivalent posts are involved in the assessment process. Ask whether this is enough to be effective. If it is not enough, ask how much extra resource is needed and what is preventing these resources being found.

1.2 What experience do the staff have on the use and analysis of SMSs in a railway environment?

Need to find out what involvement the assessors have had in SMS development, implementation and assessment. Is this enough to give you confidence they know what they are looking for when assessing certificate applications? Is it a requirement for assessors and/or inspectors to have a certain level of railway safety experience and/or safety qualifications?


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1.3 How much time (on average) is invested in assessing documents for certification?

This is not the same as how long the overall process takes (which should be no longer than four months). Find out how much time in terms of person hours is spent on the actual document assessment and make a judgement about whether this is too much or too little. If too much time is spent, is it holding up the overall process and going over four months? If it is too little, is it sufficient to be able to make an adequate assessment of the ability of the RU to manage its operations safely?

1.4 What processes and/or procedures does the NSA have in place to ensure that new Directives and subsequent national legislation are adequately interpreted and requirements disseminated to those who need to know (e.g. RUs) to ensure the correct implementation of the Directives?

When a new Directive is made, each MS must transpose it into national legislation. This may involve another government department such as a Ministry for Transport. Ask whether the NSA has processes in place to interpret relevant railway legislation and ensure that the RUs and IMs are informed of what they need to know/do and that adequate guidance is published/provided. Use the RSD as an example and find out how/whether it has been transposed into national legislation and if there is a process to ensure its requirements were disseminated. If not, is there a plan for such a process to be put in place for future Directives/legislation? If not, how does the NSA ensure compliance with Directives/legislation? Be aware that as the RSD is now a few years old, the interviewee may not be fully aware of the answers to these questions but should be able to find out.

2222 Submission of ApplicationSubmission of ApplicationSubmission of ApplicationSubmission of Application

2.1 Establish the ease of finding the information an RU would need to submit an application for a Safety Certificate and of following the process through. Expand on the submission process, role of the NSA in the pre-award period and

The NSA should consider it as though it were an RU approaching the website for the first time. Ask them to describe the process, the NSA’s role and any problems it encounters. Is the process intuitive and easy to follow?


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information available to an RU. Take the submission guidance document from the NSA’s website and check it covers what the NSA claims. This can be This can be This can be This can be done in advance and any problems followed up in the done in advance and any problems followed up in the done in advance and any problems followed up in the done in advance and any problems followed up in the interview.interview.interview.interview.

2.2 Establish whether the submission guidance document includes, as a minimum, the harmonised requirements for the Part B Certificate?

The harmonised requirements are in the CSM on Conformity Assessment as follows: Appendix III criteria are under the headings:

• Compliance with network-specific rules

• Compliance with network-specific requirements for competence of staff

• Compliance with network-specific requirements for management of rolling stock. Establish whether there is guidance on these in the submission guidance document. This can be done in advance and any This can be done in advance and any This can be done in advance and any This can be done in advance and any problems followed up in the interview.problems followed up in the interview.problems followed up in the interview.problems followed up in the interview.

2.3 Is the harmonised format for the application form used by RUs? Is it recommended by the NSA that it should be used?

This is in 653/2007/EC. If not, what does the NSA advise the RU to use?

2.4 Check whether the NSA is aware of the Article 12 requirements in the RSD, and if there is no process/guidance document, ask what is the timescale for developing one. Ask if they understand the importance/key role that the NSA needs to play?

Article 12 requirement:

• make a decision on Safety Certificate application within four months

• guidance document to be available that explains the requirements for the Safety Certificate application and lists documents to be submitted

• special guidance to be given to RUs that apply for a Safety Certificate on a defined limited part of the infrastructure, specifically identifying the rules that are valid for the part in question. If the NSA says that the timescale is as soon as possible, then find out what progress they have made so far and assess how much longer it is going to take.


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2.5 Does the NSA receive many requests for further help from RUs – if so, what type of requests do they receive and do they record the request? What is the typical frequency and method of contact?

What issues are the RUs asking for help about? Record them. How significant are the issues raised in hindering the submission process? Make a judgement on how well the NSA has dealt with the request. Is there anything the NSA could do to improve its own process or the information provided in the beginning so that the RUs do not need to ask for as much help? Does the NSA feel that additional support from the ERA would be beneficial?

2.6 How comprehensive is the list of documentation requested to be submitted with the application? Does the NSA ask for anything additional to the list in the common format application form in 653/2007/EC?

Check the documentation requested against the list in the best practice document provided (which is taken from the application form). The NSA may have provided a list of documentation in its response to the Step 1 survey – check on the document provided. Make a judgement as to the adequacy of the NSA’s list. Is there anything missing that would clearly be needed? Is there anything that is requested that the RU would have difficulty in supplying? This can be This can be This can be This can be done in advance and any problems followed up in the done in advance and any problems followed up in the done in advance and any problems followed up in the done in advance and any problems followed up in the interview.interview.interview.interview.

3333 Acceptance ProcessAcceptance ProcessAcceptance ProcessAcceptance Process

3.1 Establish what the acceptance process involves. The process is to be impartial, objective, sound, transparent and consistent.

Take the acceptance process from the NSA’s website and the suggested best practice process document provided in the interview pack and check if the NSA’s process covers the expected items. This can be done in advance and any This can be done in advance and any This can be done in advance and any This can be done in advance and any problems followed up in the interview.problems followed up in the interview.problems followed up in the interview.problems followed up in the interview. Ask the NSA to talk through the process and make a judgement on its impartiality, objectivity, soundness, transparency and consistency. How does the NSA ensure consistency and proportionality?

3.2 Does the NSA monitor the quality of its own performance at key stages in the assessment process?

Is the monitoring process described in the assessment process document? If it is not in the document, then ask if monitoring takes place anyway. Who undertakes the monitoring?


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Monitoring is likely to include the following: setting performance standards, assigning responsibility for each one, establishing process/method of monitoring, keeping records.

3.3 Does the NSA have an assurance/quality control process before the final decision to ensure it has met every stage of the assessment process?

Is the assurance process described in the assessment process document? If it is not in the document, then ask if assurance activity takes place anyway. Who is involved? The assurance process is likely to include some kind of audit or check to make sure that the NSA has followed the process that it says it will. Assurance is likely to include the following: deciding the level of assurance needed (single person or panel), assigning a responsible assuror who is independent from the assessment process, reviewing the complete record of assessment, verifying that each stage of the process has been followed, all records kept and issues closed out, recording conclusion of the assurance and forwarding to whoever makes the final decision.

3.4 Can the NSA demonstrate that the assessment process is appropriate to the risk, character and extent of operations and that the decision is based on a judgement of the ability of the RU to operate safely as described in its SMS and documentation submitted as described in Annex IV of the RSD i.e. the Part B submission?

Does the NSA spend more time and effort on the higher risk RUs? Does the NSA have a process for identifying the higher risk RUs? How does the NSA make a judgement on whether the documentation submitted indicates that the SMS ensures compliance with Annex IV requirements and appears to be adequate for controlling the risk from the RU’s operations. Annex IV requires the following documents to be submitted to enable the NSA to deliver the network-specific part of the Safety Certificate:

• documentation from the RU on the TSIs or parts of TSIs and,


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where relevant, NSRs and other rules applicable to its operations, its staff and its rolling stock and how compliance is ensured by the SMS

• documentation from the RU on the different categories of staff employed or contracted for the operation, including evidence that they meet requirements of TSIs or national rules and have been duly certified

• documentation from the RU on the different types of rolling stock used for the operation, including evidence that they meet requirements of TSIs or national rules and have been duly certified.

3.5 Is the NSA using the assessment criteria for Part B Certificates that are listed in Appendix III of the draft CSM on Conformity Assessment?

See CSM on Conformity Assessment requirements from Appendix III in 2.2 above. This CSM is not mandatory yet but the NSA may be using the criteria already. If they are not used, then what criteria are being used instead? If this is the case, what will happen when the CSM is finalised in terms of transition to new criteria.

3.6 What level of confidence does the NSA have in the certificate assessment process across the EU?

Explore this with the NSA trying to find out what would give them more confidence in other countries’ processes? Has the NSA any direct evidence of poor compliance of another NSA that they would be willing to speak about?

3.7 Have there been examples of when the NSA has not accepted a Part B Certificate (check on the NSA’s response or ask the question again). If yes, then what measures were taken?

Were the decision and measures taken recorded?

3.8 Is the NSA aware of any problems encountered by its domestic RUs when applying for a Part B in another MS?

If so, what sort of problems are encountered? How easily are they overcome? Has an RU been turned down completely? If so, on what grounds?

3.9 Has the NSA issued a Part B for a non-domestic RU (check NSA’s response or ask the question again), what level of co-

Establish the extent and type of liaison that took place. Does the NSA feel that the liaison was effective? If not, how could


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operation and liaison took place to ensure that the RU could comply with the Part B assessment criteria?

it be improved?

3.10 Is the NSA aware of what the decision-making principles are that are contained in Article 17 of the RSD?

Explore the NSA’s understanding. The key principles in Article17 include: The NSA being open, non-discriminatory and transparent, prompt response, co-operation with other NSAs to harmonise decision-making criteria.

3.11 Does the NSA have a backlog in issuing certificates? If so, can the NSA guarantee that they will all be issued by 31/12/10?

Establish if there is a process in place to ensure that all necessary certificates will be issued before 31/12/10.

4444 National Safety Rules National Safety Rules National Safety Rules National Safety Rules This section is of particular importance to non-domestic RUs.

4.1 How easy is it for an RU to find the NSRs? Are they freely accessible on the NSA’s website, for instance? If not, is there a link or other signpost to where they can be found? What guidance, if any, is offered by the NSA? Try to obtain a list of the NSRs before the interviewTry to obtain a list of the NSRs before the interviewTry to obtain a list of the NSRs before the interviewTry to obtain a list of the NSRs before the interview or, if that is not possible, during the interview. Detail of the NSRs relevant to Part B applications is required here rather than a broad reference to a piece of legislation, which may contain a variety of requirements that are not specific to the RU’s Part B application.

4.2 What existing requirements in the NSRs, peculiar to the MS, would be likely to hinder the RU from obtaining certification?

Ask the NSA which NSRs, in its experience, do the RUs have most difficulty in demonstrating that they can comply with. What does the NSA do to make it easier for the RU to comply? Evaluate how much of a hindrance are the NSRs to the RU obtaining certification easily. Examples could include: specific training or competence requirements, for instance.

4.3 Are the national requirements clearly set out for the RUs in the NSRs?

Ask the NSA what guidance and assistance it gives to the RU in finding out the national requirements. Have there been any


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problems?

4.4 What is the NSA’s opinion on the importance of NSRs to the Part B assessment process?

For instance, is compliance with the NSRs crucial for the NSA’s confidence in how well the RU’s SMS manages its risk or does the NSA think that compliance with NSRs could be managed outside the Part B acceptance process?

4.5 What is the NSA’s opinion on how well the RUs adapt their Part Bs (and to a lesser extent Part As) to the NSRs?

Ask the NSA about best and worst cases. What lessons can be learnt for giving guidance to RUs in the future?

4.6 Are the NSRs correlated to Annex IV of the RSD? Is the NSA aware of the requirements of Annex IV in relation to NSRs? See 3.4 above for Annex IV requirements. These indicate that NSRs should be aligned to operations, staff and rolling stock.

4.7 What improvements does the NSA think could be made to the NSR process? Particularly with how the RU is made aware of requirements.

Consider the whole process, if possible, from identification of what should be included and notified as NSRs, to how the RUs are informed about them.

5555 Relationship between Part As and Part BsRelationship between Part As and Part BsRelationship between Part As and Part BsRelationship between Part As and Part Bs

5.1 Is it clear to the NSA what the differences are between the Part A and Part B Certificate requirements? Is it also clear to the RUs?

Is the NSA aware of any confusion in the RUs/IMs between the Part A and Part B? Do the questions asked and the documentation submitted by the RUs indicate that they are not fully aware of the differences between Part A and Part B requirements? How does the NSA overcome this problem? Has the published guidance been enhanced, for instance? Is there a difference in understanding between domestic and non-domestic RUs?

5.2 What aspects of the RUs’ SMSs does the NSA focus on in the review of the Part B? Is the Part B review just a review of the RU’s whole SMS as in Part A, or does it focus on the Part B topics?

The Part B acceptance process should not involve a complete review of the SMS as this is part of the Part A acceptance process. The Part B should contain sufficient information about how the SMS ensures compliance with Part B requirements but it is not necessary for the NSA to examine (or examine for domestic RUs) the Part A submission.


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5.3 If the NSA has declared that there is a difference in how Part A and Part B Certificates are assessed, then ask the NSA to expand.

What are the differences? For instance, non-domestic Part B applicants may be asked to provide additional information to show how their SMS ensures compliance with requirements and to demonstrate their competence to operate on the network in question. Do the same people assess Part As and Part Bs or is documentation distributed between different people for review? If different people look at each Part (for domestic RUs), is there any liaison between them? Do the people who assess domestic Part Bs assess non-domestic Part Bs too or can anyone do it?

6666 Relationship to InfrastrRelationship to InfrastrRelationship to InfrastrRelationship to Infrastructure Managers and Other Bodiesucture Managers and Other Bodiesucture Managers and Other Bodiesucture Managers and Other Bodies

6.1 Further explore the role of IMs and other bodies in the acceptance process where relevant.

IMs should not be setting the requirements for RUs but should provide information on the infrastructure and any information that the RU will need in order to operate their trains safely.

6.2 Ask the NSA whether the Part B needs to be route-specific and if all routes that the RU will operate over need to be specified. What happens if a change is required? What about diversionary routes? How do the RUs obtain route acceptance?

Some NSAs say the Part B is route-specific and others that it isn’t. Some RUs must specify which routes they will run over and others do not. This needs clarification in the interview.

7777 Risk ManagRisk ManagRisk ManagRisk Managementementementement

7.1 The concept of risk management that includes the need for RUs and IMs to put systems in place to control their own risks and liaise over joint risks, is a new concept in some MSs. Have the RUs and IMs adopted a risk management approach as required by the RSD?

Establish the NSA’s understanding of risk management as required by the RSD. How well does the NSA think that the RUs in the NSA’s MS have adopted a risk management approach? From any inspections undertaken so far, has the NSA received the impression that RUs are implementing the risk management approach described in their application


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documents in reality?

8888 SupervisionSupervisionSupervisionSupervision

8.1 Are the principles on NSA supervision activity that are contained in Appendix IV of the CSM on Conformity Assessment applied. If so, how?

The principles in Appendix IV are proportionality, consistency, targeting, transparency, accountability and co-operation. This is not mandatory yet but the NSA may be using them already. If so, try to establish how well the NSA is applying them from looking at the supervision procedure, if there is one, and examples of supervision activity.

8.2 Does the NSA publish its supervision process? Check the NSA’s response on the Step 2 Survey. This can be This can be This can be This can be done in advance. done in advance. done in advance. done in advance. If not, why not and does it intend to? If the reason given is that the RU should not know the detail of the process so that a more realistic picture can be obtained, then challenge this because there is no reason why the RUs should not know the structure of the process and what to expect. They do not need to be given dates of visits or topics at this stage, for instance.

8.3 At what stage does the NSA set the frequency of supervision activity and the priority of issues to be covered?

If these are not set soon after the issue of the Safety Certificate, then how long after? At what stage would the RU be informed and how? What issues are covered in the supervision? Establish how the NSA decides on the issues that are to be covered and what priority each has. Are all Part A and B commitments covered in the five-year cycle? What happens if the NSA reissues certificates more frequently than five-yearly? Is the supervision process adapted to fit the cycle?

8.4 Does the NSA check the level of co-operation between the RU and other industry bodies?

How is this checked? What evidence does the NSA ask for? What is the NSA’s opinion on the general level of co-operation?

8.5 Does the NSA check the ability overall of the RUs’ combined SMSs to control risk to the network?

How is this checked? What evidence does the NSA ask for? What is the NSA’s opinion on the general level of control?


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8.6 How does the NSA decide if a breach is serious enough to prosecute?

This was not always clear in the responses. Explore further with the NSA to establish if there have been any prosecutions. If so, what criteria were used and if not, what criteria would be used. Is it as simple as when there has been a breach of legislation however minor or does the NSA have discretion not to press for prosecution?

8.7 What other tools or guidance are available for the NSA to use to assist RUs in meeting requirements?

Is best practice shared between the NSAs? Does the NSA have any ideas for further tools etc that could be used? Survey responses include: Meetings with RUs on specific topics, handling of safety recommendations, presentations at conferences, joint meetings for sharing best practice, monthly reports on incidents, licences for infrastructure construction and demolition, issue driver licence and examine them, registration of rolling stock and infrastructure, information on the website, consultation, discussions during audit, supervise following the rules, authorise new subsystems. Could the NSA adopt any of these?

8.8 Does the NSA only evaluate RU compliance or does it also evaluate the effectiveness of the overall safety regulatory framework?

During supervision activities does the NSA obtain an opinion on whether the way the regulatory system is set up is working adequately, effectively and efficiently? If so, does it use this information in reviewing the safety regulatory framework? Is the NSA responsible for developing and monitoring the safety regulatory framework (i.e. changing the legislation) following any accidents/incidents?

9999 MiscellaneousMiscellaneousMiscellaneousMiscellaneous

9.1 What changes would the NSA like to see in the RSD Safety Certificate process to encourage it to adopt it?

Establish what are the barriers to an NSA adopting the RSD Safety Certificate process if it has not already done so. How


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can these barriers be reduced or eradicated? Does the NSA think that the move to a single Part B Certificate valid in all MSs is a good idea? If not, why not?

9.2 What would allow the NSA to have more trust in the process, as adopted by itself but especially as adopted by other NSAs, to give it more confidence about a move to a single certificate?

What are the NSA’s perceived barriers, internally and throughout the EU, to a move to a single certificate?

9.3 What changes are needed in the NSA’s approach, systems, policies and /or philosophy to facilitate the move to a single certificate?

Establish what internal changes, if any, in the NSA might be needed to make a move to a single certificate easier. Are there any external pressures (positive or negative) that might have an influence on the NSA in moving to a single certificate?

9.4 What additional role should/could the ERA play? Establish the NSA’s opinion on the role of the ERA and any further areas in which it could be of assistance with particular reference to the Part B acceptance and supervision processes.

9.5 What key steps are required in order to help the migration to a single certificate? What would help/not help?

Does the NSA have any ideas to offer on how it sees the move to a single certificate could be managed? What steps would make it easier or more difficult for an NSA to comply with requirements?

9.6 What best practice could you share to help the migration? Is the NSA aware of any areas/steps in the current processes that are well managed or where there are initiatives that could be shared as best practice in the move to a single certificate?


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APPENDIX DAPPENDIX DAPPENDIX DAPPENDIX D SUMMARY OF RESULTSSUMMARY OF RESULTSSUMMARY OF RESULTSSUMMARY OF RESULTS OF THE SURVEYS AND INTERVIEWS OF THE SURVEYS AND INTERVIEWS OF THE SURVEYS AND INTERVIEWS OF THE SURVEYS AND INTERVIEWS To maintain the confidentiality of the survey respondees, a code has been used in place of the MS abbreviation. The code is known only to the Project Manager and Project Assistant. Y = answer acceptable based on legislation and accepted good practice N = answer not acceptable or no answer provided ? = answer unclear or incomplete - = no response received n/a = not applicable Where possible, unclear or incomplete answers were clarified during the interviews. Some questions do not lend themselves to being ‘acceptable’ or not and these are indicated by a narrative summary rather than being country-specific. NB: NB: NB: NB: HU’s responses to Step 1 were compiled during the interview and, therefore, their answers to these questions have been incorporated retrospectively and where this has affected the total figures it is shown with an *. STEP OSTEP OSTEP OSTEP ONE SURVEYNE SURVEYNE SURVEYNE SURVEY MSMSMSMS 10101010 11111111 13131313 18181818 19191919 20202020 22222222 24242424 28282828 32323232 34343434 36363636 42424242 45454545 49494949 50505050 51515151 56565656 63636363 69696969 71717171 76767676 81818181 82828282 88888888 94949494 99999999 QQQQuestionuestionuestionuestion

1.1 - N Y N Y Y Y Y? Y - Y Y Y Y - N - Y N ? Y Y N Y N Y N 1.2 - N Y N Y Y Y N Y - Y Y Y Y - N - Y N ? Y Y N Y N Y N 1.3 - N n/a N Y Y Y N Y - N Y Y Y - N - Y N N N Y N N N Y N 1.4 - N n/a N Y Y Y N Y - N Y Y Y - N - Y N N N Y N N? N Y N

2.1 - N Y N Y? Y Y Y Y - Y N Y Y - N - Y N Y Y Y N N Y Y N 2.2 - N Y N N Y Y Y? Y - Y? N Y Y - Y? - Y N Y Y Y N N Y? Y N 2.3 - Y ? N Y Y Y Y Y - Y Y Y Y - Y - Y Y Y Y Y Y Y Y Y Y


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MSMSMSMS 10101010 11111111 13131313 18181818 19191919 20202020 22222222 24242424 28282828 32323232 34343434 36363636 42424242 45454545 49494949 50505050 51515151 56565656 63636363 69696969 71717171 76767676 81818181 82828282 88888888 94949494 99999999 QuestionQuestionQuestionQuestion

2.4 - Y Y N Y Y Y N Y - Y Y Y Y - Y - Y N Y N Y N Y Y Y Y 2.5 1 NSA gave an alternative website, that of the IM 2.6 - N Y? N Y Y Y N Y - Y Y Y? Y? - N - Y Y ? Y Y Y? Y Y Y Y 2.7 - Y Y Y N Y N Y N - Y Y Y Y - Y - N Y Y Y Y Y Y N N Y 2.8 - Y n/a N Y? Y N Y N - N N Y N - N - N Y N Y N N N N Y? ? 2.9 - Y N Y N Y Y? N? N - N N Y Y - N - N Y Y Y N N N N N Y

2.10/11 - Y Y Y ? Y Y Y Y - Y Y Y Y - Y - Y Y Y Y Y Y Y Y Y Y 2.12 - ? Y N Y N Y N Y - N Y Y N - N - Y Y Y - Y Y N Y Y N 2.13 13 NSAs had issued a Part B to a non-domestic RU and 10 had not* 2.14 1 NSA had needed to liaise with another NSA 2.15 4 NSAs had encountered problems, 14 had not and 5 did not know* 2.16 5 NSAs explained the problems. See separate list in Appendix E 2.17 - Y Y N Y Y Y Y? Y - Y? Y Y N - Y? - Y N Y - N Y? Y Y Y N 2.18 - Y Y N Y Y Y Y Y - Y Y Y Y - Y - N N Y Y Y Y Y Y Y Y 2.19 Error in the presentation of the survey results means that the results of this question do not show in the individual responses. 5 NSAs say

there is a difference, 16 say there is not and 2 do not know* 2.20 - Y Y Y Y Y N Y Y - N Y Y Y - Y - Y Y Y Y Y Y Y Y Y N 2.21 - Y Y N N Y Y Y Y - N Y Y Y - Y - Y N Y Y Y Y Y Y Y Y 2.22 13 NSAs describe difficulties. See separate list in Appendix E

3.1 - Y Y N Y Y Y Y Y - Y Y Y Y - ? - Y Y? Y Y ? Y Y Y? Y ? 3.2 - Y? N N Y Y Y N Y? - N Y? ? Y - N - ? N N Y ? N N N ? ? 3.3 - Y Y N Y Y Y N Y - Y Y Y N - Y - Y Y? Y ? N Y N Y Y N 3.4 15 NSAs list other requirements. See separate list in Appendix E 3.5 - N n/a N Y ? Y Y Y - N N N N - Y - N Y Y ? N Y N Y Y Y


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MSMSMSMS 10101010 11111111 13131313 18181818 19191919 20202020 22222222 24242424 28282828 32323232 34343434 36363636 42424242 45454545 49494949 50505050 51515151 56565656 63636363 69696969 71717171 76767676 81818181 82828282 88888888 94949494 99999999 QQQQuestionuestionuestionuestion

4.1 10 NSAs say there is a difference in how Part A and Bs are assessed, 12 say no difference and 1 does not know* 4.2 10 NSAs explained these differences. See separate list in Appendix E 4.3 - ? n/a N N Y N Y Y - Y Y N N - N - Y Y N Y N N N Y Y N? 4.4 Several responses indicate they only check domestic RUs’ Part As but overall at least 7 NSAs appear to check Part A for non-domestic too; 6

gave no reason 4.5 - Y Y N N Y Y Y Y - Y Y Y Y - Y - Y N Y - Y Y Y Y Y Y 4.6 5 NSAs have not accepted a Part B, 3 do not know 4.7 5 NSAs gave reasons why 4.8 - N Y N Y Y Y N Y - Y N ? Y - Y - Y Y N - N N Y Y Y N 4.9 - Y Y N Y Y Y Y - Y Y Y Y - Y - Y Y Y Y Y Y Y Y Y Y

5.1 - Y Y N Y Y Y Y Y - Y Y Y N - N - Y Y Y Y Y N N N Y Y 5.2 The answers are included in 5.1 5.3 11 NSAs seem to indicate that IMs do consider operational requirements 5.4 9 NSAs say the Part B is route-specific, 5 say it is not, 8 say sometimes and 1 does not know* 5.5 18 NSAs say that RUs must specify what routes they will be travelling over, 3 say no and 2 do not know* 5.6 - Y N N Y Y Y Y - Y N Y Y - Y - Y Y N N N Y Y Y Y Y 5.7 3 NSAs cite other bodies e.g. IM and licensing/notified bodies

6.1 10 NSAs say there are RUs operating under the previous directive, 12 say there are not and 1 does not know* 6.2 3 NSAs declare that the numbers of such RUs are likely to cause a problem 6.3 6 NSAs state that they do not have a process to ensure they are all certificated by 31/12/10 6.4 There are vast differences in numbers issued between the NSAs, from 0 to hundreds


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STEP TWOSTEP TWOSTEP TWOSTEP TWO SURVEY SURVEY SURVEY SURVEY MSMSMSMS 10101010 11111111 13131313 18181818 19191919 20202020 22222222 24242424 28282828 32323232 34343434 36363636 42424242 45454545 49494949 50505050 51515151 56565656 63636363 69696969 71717171 76767676 81818181 82828282 88888888 94949494 99999999 QuestionQuestionQuestionQuestion

1.1 - N Y N - Y Y N N N - ? Y Y - - - Y Y - Y ? Y Y - Y N 1.2 - N Y N - Y N N N N - ? Y Y - - - N N - N ? N Y - Y N 1.3 - N Y N - Y Y N N N - ? Y Y - - - Y N - Y ? N Y - Y N 1.4 - N N N - Y Y N N N - N Y Y - - - Y N - Y N N N - N N 1.5 2 are in the process of preparing guidance; 2 refer to websites but it is not clear what is on them 1.6 - Y Y Y - Y Y Y Y Y - Y Y Y - - - Y Y - Y Y Y Y - Y Y 1.7 14 NSAs say it is the same process; 4 say it is not; 1 does not know 1.8 - Y Y Y - Y Y Y Y Y - Y Y Y - - - Y Y - Y Y Y Y - Y N 1.9 - Y Y Y - Y Y Y N Y? - Y Y Y - - - Y Y - Y Y Y Y - Y N 1.10 - Y Y Y - Y Y Y Y Y - Y Y Y - - - Y Y - Y Y Y Y - ? N 1.11 17 NSAs say it is linked to SMS; 1 says no; 1 says do not know 1.12 No meaningful comments given on what it is linked to if not the SMS 1.13 - Y Y Y - Y Y Y N Y - Y Y Y - - - Y Y - Y ? Y Y - Y Y 1.14 - N Y? Y - Y Y Y N N - N Y Y - - - Y N - N Y Y Y - Y N 1.15 16 NSAs say they do check co-operation; 2 say no; 1 does not know 1.16 - N N N - Y Y Y N Y - Y Y Y - - - N Y - Y Y Y? Y - Y N 1.17 12 NSAs say that they assess control of overall risk; 6 do not;1 does not know 1.18 - N Y Y - Y Y Y Y Y - N Y Y - - - Y Y - Y Y Y Y - Y Y 1.19 - Y Y Y - Y Y Y Y? Y - Y Y Y - - - Y Y - Y Y Y Y - Y? Y 1.20 7 NSAs have the power to prosecute; 10 do not; 1 is not clear; 1 gave no reply 1.21 16 NSAs described other powers. See list in Appendix E 1.22 - Y N N - Y Y Y Y? Y? - Y Y Y - - - Y Y - Y Y? Y N - Y? N 1.23 - N N n/a - Y Y Y N N - Y Y Y - - - Y Y - N N n/a N - N n/a


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MSMSMSMS 10101010 11111111 13131313 18181818 19191919 20202020 22222222 24242424 28282828 32323232 34343434 36363636 42424242 45454545 49494949 50505050 51515151 56565656 63636363 69696969 71717171 76767676 81818181 82828282 88888888 94949494 99999999 QQQQuestionuestionuestionuestion

1.24 - N Y? Y - Y Y? N N Y - Y N Y? - - Y N - Y N N Y - Y Y 1.25 12 NSAs gave examples of other tools to promote safety. See list in Appendix E 1.26 14 NSAs hold an annual review; 4 do not; 1 does not know. Some misunderstand what an annual review is – confusion with the annual

report 1.27 13 NSAs say it is based on the RUs’ annual reports; 3 say it is not and 3 do not know 1.28 2 NSAs gave a meaningful answer to what it is based on if not on the annual report 1.29 No meaningful responses given on how progress is assessed and priorities set if not through annual review


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INTERVIEW RESULTSINTERVIEW RESULTSINTERVIEW RESULTSINTERVIEW RESULTS P = problem or potential problem/obstruction to the migration S = suggestion made by the NSA - = not discussed or NSA could not answer

MSMSMSMS 20202020 22222222 24242424 28282828 42424242 45454545 56565656 63636363 71717171 81818181 82828282 QQQQuestionuestionuestionuestion

0.1 Y Y Y Y Y Y Y Y Y Y Y 0.2 Y Y Y Y Y Y Y Y - Y Y

1.1 N Y Y Y Y Y Y Y Y Y P 1.2 N Y Y N? Y Y Y Y Y N Y 1.3 N Y N Y Y Y Y Y - Y Y 1.4 Y? N Y ? Y Y Y Y ? Y Y

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APPENDIX EAPPENDIX EAPPENDIX EAPPENDIX E SPECIFIC PROBLEMS HIGHLIGHTED IN THE TWO SURVEYS AND THE INTERVIEWSSPECIFIC PROBLEMS HIGHLIGHTED IN THE TWO SURVEYS AND THE INTERVIEWSSPECIFIC PROBLEMS HIGHLIGHTED IN THE TWO SURVEYS AND THE INTERVIEWSSPECIFIC PROBLEMS HIGHLIGHTED IN THE TWO SURVEYS AND THE INTERVIEWS There is some duplication between the sections below where the same or similar questions were asked in the interview as in the other surveys. A decision was made, however, to present the full results for each stage of the study to give the full picture. Step One SurveyStep One SurveyStep One SurveyStep One Survey –––– Safety CertificateSafety CertificateSafety CertificateSafety Certificate Acceptance Process Acceptance Process Acceptance Process Acceptance Process

• Eight of the NSAs had not published guidance for the RUs, although some of

these did have information available on the website • Eleven of the NSAs had not published guidance for the inspectors and one

was unclear. Some had internal documents or checklists instead • Eight NSAs had not produced an auditable acceptance process on

submitting an application. One says there is no need because it is an internal process (NL)

• One NSA offers advice but does not see its role to be a free consultant (NL) • Four of the NSAs did not list the documentation required by Annex IV of the

RSD and the common application form in 653/2007; five more were unclear. Only one specifically referred to TSIs though

• Six NSAs appear to undertake detailed pre-award checking but later questions (Q2.9) indicate that most NSAs seek confirmation that everything is in place before the certificate can be issued. It is not clear if this is a physical check or verbal/documentary. Some NSAs visit domestic RUs but not non-domestic

• Thirteen of the NSAs could not demonstrate an understanding of how they prioritise what to include in pre-award checking and three more gave unclear answers

• Thirteen of the NSAs require confirmation that everything is in place, which somewhat contradicts Q2.7, unless the confirmation is by word from the NSA

• Nine NSAs appear not to keep a record of the compliance with assessment criteria during the assessment process

• Thirteen NSAs had issued a non-domestic Part B but only one declared that it had needed to liaise with the other NSA that issued the Part A Certificate; five did not know whether they had liaised or not. Several NSAs explained problems that had arisen during liaison with other NSAs while assessing Part B applications: o difference in the level of implementation of Part A requirements o if the documents contain Part A and B requirements, it can be difficult to identify the fulfilment of Part B requirements o applicants may send in many documents that are not required o differences in ideas on what is required to be submitted, both between the RU and NSA and between NSAs – confusion over what is required for Part A and Part B o incorrect documentation submitted for proof of certification (letter instead of certificate in harmonised format)


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o clarification of criteria needed e.g. where aspects of Part A might be an interface with Part B

• Several NSAs gave examples of difficulties they have had in issuing Part B Certificates: o RUs not understanding legislation o RUs making mistakes on what should be submitted and what does not

need to be o NSAs must give lots of advice o processes in SMSs do not work in the country o compliance with maintenance NSRs for rolling stock not registered in

country because maintenance rules are not harmonised o producing training programmes where no standard exists o one NSA used to issue Part Bs though the RU did not have a Part A but

this no longer happens o lack of resources and experience of new process (PL) o low awareness by RU of new approach to safety and role of Safety

Certification (PL) o RUs do not want to, or are not allowed to, abide by non-mandatory

requirements (PL) o no training for RUs by NSA o differences in understanding what documents need to be submitted

with confusion over what is needed for Part A and Part B, both RUs and NSAs

o difficulties in explaining local concepts of safety processes when the certificate is aligned to those of the original country

o rail vehicle requirements – types, hired vehicles (answer not fully understood) (CZ)

• Five NSAs could not demonstrate a satisfactory answer to what they would do if the Part B covered activities not covered in the Part A

• Three NSAs do not have a process for the revocation of the Safety Certificate

• Three NSAs take over four months to assess the submissions and issue Part A and Part B certificates

• Three NSAs have validities of less than five years and one gave no reply. The rest are generally a minimum of five years depending on the validity of the Part A.

• Most NSAs demonstrated awareness of what the NSRs are and where they can be found. They referenced a source (website) or ERADIS but little detail on the types or content or ease of finding them was provided by any of the NSAs. More research is needed

• Very few of the NSAs demonstrated understanding of what constitutes decision-making criteria for establishing if the RUs are compliant with NSRs. Some confused the question with the post-award supervision rather than the assessment process (NL)

• Six NSAs have not explicitly correlated their NSRs with the Annex IV subject areas but most NSRs include these types. Some include others outside these types. Some answers were unclear even after interview (CZ)

• Some have additional requirements that RUs must comply with:


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o occupational health and safety (AT) o technical equipment such as pressure, gas, lifting and transportation devices, cableways and draglifts (CZ) o technical standards (CZ) o labour code (CZ) o environmental rule (CZ) o fire protection (CZ) o handling of subcontractors (DK) o holding a licence for the relevant operation (DK)

• One NSA said that the national legislation is not fully aligned to EU strategy; old solutions are still in place; transposition of RSD and other EU legislation is not complete (PL)

• Ten NSAs did not demonstrate adequate awareness of the principles for deciding on which national standards to notify to the ERA as NSRs. Two answers were unclear. Several NSAs say they are not responsible for notification as it is done by the relevant Ministry

• Nine NSAs stated that there is a difference in how Part A and Part B applications are assessed but the explanations mainly seemed to indicate that it is the topics that are different rather than the process and also, the IM may be consulted for the Part B. One NSA (AT) does not assess Part As, as it is done by an accredited body as a legal requirement

• Seven of the NSAs do at least some checking of the Part A application at the same time as the Part B for non-domestic RUs

• Three NSAs do not distinguish between a Part A and B when informing the ERA of how many certificates have been issued

• Five NSAs had not accepted a Part B application and the reasons given included: o An RU only required a certificate in case it want to operate in the future and could not describe its intended operation

o An RU had no control on the process o An RU did not have a Part A o An RU did not have a licence o An RU did not have documents according to national requirements o An RU did not apply in the appropriate language o Additional information from the RU may leave no time left before the deadline

• Eight NSAs did not demonstrate an adequate knowledge of, or process for, what they would do if a Part A expired before a Part B and one response was unclear

• Six NSAs indicate that the IMs have a say in the acceptance process • Several NSAs gave examples of the types of role that the IM performs:

o vehicle acceptance o route paths o giving opinion on infrastructure specifics o IMs have their own rules - may be included in NSRs or the network

statement o planning routes o check to ensure RU can operate on the infrastructure


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o consider operational requirements • Nine NSAs say that the applications are route specific, five say they are not,

eight say they sometimes are and one does not know • Three NSAs require approvals from other bodies – IM and licensing/notified

bodies • Ten NSAs have RUs operating under the previous directive and three of

those NSAs have so many that there are likely to be problems before the deadline of 31/12/10 (DE, IT, PL)

• Six NSAs say they do not have a process to ensure that all the RUs are certified by 31/12/10 but it is not clear whether this includes the three who may run into problems as mentioned above

• PL says that it is very worried as there is no chance that it will meet the deadline.

Step Two SurveyStep Two SurveyStep Two SurveyStep Two Survey –––– Post Award Supervision Process Post Award Supervision Process Post Award Supervision Process Post Award Supervision Process

• There is some confusion about what constitutes a statement of the supervision process. Many refer to the MS’s national legislation for a general statement. Many do not refer to post-award supervision but to the acceptance process without making it clear if this also contains the supervision process. Some refer to legislation, which may not contain sufficient detail. One says its process is not aligned to the RSD, as this part of the RSD has not yet been transposed into national legislation (PL). Eleven NSAs do not have a published process and two more responses were unclear

• The NSAs do demonstrate awareness of what constitutes the post-award process and all appear to be either doing some supervision activity or planning to do so. It appears that the problem is with describing the process in writing for assisting the RUs

• One NSA says the process is in the certification guidance as it is the same as the pre-award checking, which is undertaken by an external approved body (AT)

• All NSAs’ supervision processes include, or will include, the expected types of activity. Some, however, state that they do not follow the CSM because it is still in draft and not issued yet. Some will still not be able to use it when it is issued as it is not mandatory

• Most NSAs are aware of what to audit, have set a frequency and decided what to base the audits on in theory at least, as some have not yet begun a supervision regime and some are waiting for the CSM on Conformity Assessment to be issued. Some do not cover all the SMS topics, only the most important. There are different interpretations and levels of activity. Some aim for several visits, some only once in the cycle

• One NSA uses external assessors to audit the SMS during both the assessment and supervision phases (AT). It is not clear whether some NSAs have adequate resource to fulfil the NSA’s supervision function

• One MS requires domestic RUs’ SMSs to be certificated to ISO standards in order to obtain a certificate. It appears that this certification is also used as the supervision and the NSA does not undertake audits itself (AT). Seven


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other NSAs did not give an adequate response to how they decide if the part of the SMS under examination is adequate

• Two NSAs do not check co-operation between RUs and other bodies. One NSA does not know whether it does or not

• Although sixteen NSAs say that they do check for co-operation between the bodies, six gave inadequate answers on what constitutes the assessment

• Six NSAs do not assess overall system risk. Some misunderstood the question

• Two NSAs do not seem to record adequately the results of the supervision activity

• The NSAs seemed to have adequate processes for closing out issues found during the supervision activity

• Seven NSAs have the power to prosecute, ten do not and one is unclear and one gave no reply

• Some NSAs gave examples of other enforcement powers they have in addition to, or instead of, prosecution. One said that it has no powers at all: o revocation of certificate o suspension of licence o prohibition and improvement notices o economic penalties o temporary closure of the affected infrastructure o rolling stock disposal o intervention strategy o require correction o report to the police o issue safety directives

• Four NSAs do not give an adequate answer about criteria for deciding what is a serious breach. Four others’ answers were ambiguous

• Eight NSAs could not explain how the criteria for deciding if a serious breach has occurred are applied in practice. There are three other cases where this was because it has not yet been necessary

• Seven NSAs do not offer advice/tools etc for assisting a RU to comply and three replies were unclear. There are constraints on some NSAs who cannot use documents that are not legally binding. One NSA does not do it because it does not want to be a free consultancy

• Seven NSAs do not have any other tools to promote safety. Several gave examples of tools: o meetings with RUs on specific topics o handling of safety recommendations o presentations at conferences o joint meetings for sharing best practice o monthly reports on incidents o licenses for infrastructure construction and demolition o issuing driver licences and examining them o registration of rolling stock and infrastructure o information on the website o consultation o discussions during audit


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o supervising the following of rules o authorising new subsystems o newsletters

• Fourteen NSAs say that they hold an annual review but answers to subsequent questions indicated that there may be some uncertainty about what an annual review is. They seem to confuse it with the annual report.

InterviewsInterviewsInterviewsInterviews

• Some NSAs, although they have adequate resources for normal times, will struggle in the latter half of 2010 as there are many RUs who need certification before the deadline (IT, DE, PL). Competence may be an issue for some NSAs whose experience is limited to development of one SMS and acceptance of a handful of submissions (ES). A reorganisation planned in one MS to widen the scope of the NSA to all modes of transport, threatens to make it harder for NSA staff to maintain competence (NL)

• NSAs do not generally require specific safety or audit qualifications. They are deemed competent by railway experience. Some NSAs have had to learn the processes from scratch as their previous regimes were very different. They did not receive help from the ERA or internal organisations. Some would like guidance on how many people are appropriate to have working on the assessment and supervision processes (HU, PL). Some would have liked more help when getting started and on an ongoing basis, even training perhaps (HU, PL)

• NSAs that meet the four-month deadline may be taking years beforehand in advising the RU on what and how to submit. This would put off new players entering the market (FR mainly, but all to a certain extent). One claims a much more stringent timescale but then says it can be interrupted by official interruption and can take 184 days (CZ). One says there is a certificate still not issued after two years (PL)

• The question about whether the NSA assists in interpretation of legislation for RUs was misunderstood by some NSAs (DE, HU, AT). One NSA issues legislation and disseminates it (ES)

• Some NSAs do not use the harmonised format for documentation. One thinks it is not prescriptive enough (ES)

• Examples of RUs’ requests for help: o risk management (IT, DE, HU, CZ) o NSRs o verification of maintenance requirements (DE) o language assistance (ES) o difficulty documenting information in the SMS, especially when it is the

first time they have had to do so o one is reluctant to help as it does not want to be a free consultancy

(NL) • One NSA would like to see the Part B Certificates on the ERA website as only

Part As are there currently (DK) • In some MSs, the RUs tend to use consultants to develop their SMSs and

submission material. The question arises about how the NSA ensures that


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the RU can continue to manage safety when the consultant is dismissed (FR, NL)

• The question about documentation requested generated several points to note: o much more extensive documentation is requested than is specified in

653/2007 (FR) o minimum documentation not always requested (ES) o occupational health and safety to be considered (AT) o summary documents on implementation of TSIs (AT) o may be asking for more info on rolling stock than needed (CZ) o information on employees meeting national and EU requirements and

declaration that technical conditions of the vehicles are good (PL) • It was very difficult to assess through the questionnaires, and even through

the interviews, whether the NSAs are being impartial, objective, sound, transparent and consistent in the acceptance process. It was not possible to verify the NSAs’ claims (All). One NSA said it could not demonstrate that these principles are applied at the moment (ES)

• One NSA stated that there is a recent national requirement to issue Part B Certificates for non-public infrastructure (EE)

• Some NSAs could not demonstrate an adequate internal quality process (FR?, ES, AT, PL); some had a final check before issuing the certificate though (CZ, PL, DK). One of these had a final appraisal involving all departments (AT). One is audited by the MoT (CZ). One relies on checklists to ensure that the steps are undertaken but there is no independent check (EE)

• Some NSAs do not base the assessment on the risk of the RU, they appear to assess all equally (FR, ES, EE). Four responses were unclear (AT, CZ, HU). One NSA did not understand the question and gave a response that did not answer the question (PL)

• Some NSAs said that they are not yet using the CSM on Conformity Assessment as it is still in draft and not legally binding (HU, AT, CZ, PL). There is resistance to the SMS from the RUs in at least one MS because it is seen as a burden. RUs are reluctant to comply with documents that are not mandatory (PL)

• Some NSAs do not have confidence in the other NSAs’ processes: o there are different SMS processes in each MS (FR, IT, DE) o some procedures that are claimed to be in place were not when

checked (DE) o NSRs have not been identified properly (DE) o Part As had not been issued in DE (NL) o some NSAs do have confidence but feel they cannot assess the Part B

adequately without seeing some of the Part A documentation that is relevant to the Part B (ES, HU)

o some NSAs have not yet had any experience of other NSAs and cannot comment (AT, PL, EE)

o some NSAs do have confidence (CZ) o some have confidence but will have more when the CSM on

Conformity Assessment is finalised (DK)


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o or when there are standardised operating rules and SMS guidance (EE) • One NSA reported problems that its RUs had had in other MSs: DK’s DB

Schenker had problems in DE because of demands on wagon maintenance (now resolved) and in SE all processes had to be in Swedish (DK)

• Some NSAs are not holding adequate liaison with the NSAs of non-domestic RUs (FR)

• It was very difficult to assess through the questionnaires, and even through the interviews, whether the NSA is applying the decision-making principles in Article 17 of the RSD that are being open, non-discriminatory, transparent, giving prompt responses and co-operative. It was not possible to verify the NSAs’ claims (All). One stated that it was aware of the principles and is working towards them (ES)

• One NSA says the NSRs are on ERADIS but not clear if they direct the RU to them (ES). Some are easily available but only in the national language (AT, CZ). One says IM’s internal rules are not published and they have to tell the RUs about them (PL). In one MS, the RUs develop their own NSRs using a framework set by the IMs and then approved by the NSA (DK)

• The answers to the question about what existing requirements in the NSRs, peculiar to the MS and would be likely to hinder the RU from obtaining certification, were sometimes not very informative (FR, AT). Verification of maintenance requirements is a problem (DE). Specific requirements that may be a problem: o technical equipment requirements (CZ) o all doors have to be closed to get traction to the vehicle (DK) o driver’s assistant may be required (EE)

• The answers to the question about whether the national requirements are clearly set out for the RUs in the NSRs were sometimes not very informative (FR, NL) or the question may not have been understood (AT). Some claim that NSRs are clear but anecdotal evidence from an RU indicates that this may not be the case (DE). One NSA seems to rely on RUs seeking help from third parties as it does not want to offer free consultancy (NL)

• Many NSAs think the NSRs are essential (FR, IT, ES, CZ, EE, NL). One NSA (DE) stated that NSRs could be dealt with outside the certification process and one said that they already are (DK). One did not answer the question properly (PL)

• One NSA said in response to the question about RUs adapting their Part Bs to NSRs, that there had been a language problem with the only non-domestic RU (DK). In general answers were not very clear or not understood

• One NSA says NSRs are correlated to Annex IV of the RSD but repeatedly only referred to two not three areas (ES). One says the NSRs are correlated to Annex IV but there are rules relating to technical equipment in addition that cause problems (CZ)

• Suggested improvements to NSR process: o harmonisation of railway regulations (DE, AT, CZ) o clear list on website (ES) o TSIs will reduce the need for NSRs o one said NSRs will always be needed because they are fixed to the

national infrastructure (CZ)


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o taskforce to look at the different approaches in the MS and more harmonisation (PL)

• Some NSAs report the RUs being confused about the difference between a Part A and a Part B application (FR, ES, PL). Some said this was the case in the early days of new process (DE, NL) and RUs in NL rely on consultants to identify and address NSRs

• Some NSAs review the whole or part of the SMS or Part A application because they cannot rely on the review of the other NSAs (FR, IT). Some review some of the Part A SMS documents where relevant to Part B (ES, HU, NL). One NSA says that the SMSs are audited by an accredited body (AT)

• Some NSAs report problems with uncooperative IMs (IT). The IM in one MS currently reviews the submission and issues the certificates, though this is due to change by the end of 2010 (ES).

• In one MS there are two main IMs who produce company rules in addition to notified NSRs – RUs can find them in the network statements and must comply (and have a certificate) before they receive a contract with the IMs (HU). Two NSAs stated that their IMs have internal rules and the RUs obtain the information after they apply for a certificate but the IMs have no role in the assessment (PL, NL). IMs have a network statement where their requirements can usually be found

• If Part B applications have to be route-specific, is this a problem? Do RUs have to apply for a new certificate if routes change? This would be extra work for the RU and NSA. This happens in ES but they do not have many RUs. In AT and CZ it can be route-specific but is usually for the whole network. They are not route specific in PL but RUs specify the IM whose infrastructure they wish to access

• There are different concepts of what constitutes ‘risk’ and risk management across the MSs. It is quite new to many of them and they struggle (FR, IT, DE, ES, HU, PL, DK). AT’s answer was ambiguous and NL misinterpreted the question

• It was very difficult to assess through the questionnaires, and even through the interviews, whether the NSA is applying the principles of proportionality, consistency, targeting, transparency, accountability and co-operation to the supervision process. It was not possible to verify the NSAs’ claims (FR, IT, DE, HU, AT, DK, EE, NL). One NSA does not have a supervision process yet but says that it will apply these principles when it does (ES)

• Two NSAs do not comply with the CSM on Conformity Assessment because it is not issued yet (CZ, PL)

• Some NSAs refer to legislation for where the supervision process is published but this may not be detailed enough (IT, HU). Several have not published the process (ES, AT, CZ, PL, EE, NL), although they all undertake, or are planning to undertake (ES) supervision activities

• Some NSAs do not set frequencies of supervision activities and it was not always clear whether they cover all SMS issues within the validity of the certificate (IT, AT). Some NSAs have/intend to have one visit but it is not clear how much is/will be covered (DE, AT, CZ). One does end product type checks but recognises the need for a more system-based approach (ES). One undertakes ‘small’ annual inspections so the coverage was not clear


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(PL). Two audit very soon after the certificate is issued, which is a good idea (DK, NL)

• Some NSAs do not check co-operation between RU and industry bodies (FR, AT, NL)

• Some NSAs do not check the combined ability of RUs’ SMSs to control the system risk (FR, IT, AT, EE). Some did not understand the question (DE, CZ, PL). Some answers are unclear (ES, AT). Two do not check this because they think that if all the SMSs are compliant then there is no need (DK, NL)

• Some NSAs do not have criteria to decide if a breach is serious enough to prosecute because they do not have the power to prosecute (FR, IT, HU). DE does not have set criteria. Some answers were unclear or did not answer the question properly (ES, AT, PL, EE)

• Some NSAs have no additional tools or guidance to assist RUs in meeting requirements (FR, DE, HU, AT, CZ, NL). Some answers were unclear (ES, DK). One participates in conferences and meetings to inform of new requirements and it produces a ‘roadmap’ after an inspection with dates when action must be completed (PL)

• Some answers were unclear on the question about whether the NSA evaluates the effectiveness of the overall safety regulatory framework (ES, AT, CZ, PL). Some do not do this (DE, NL)

• Some NSAs gave examples of issues they perceive to be obstacles to the single certificate : o differences in operational conditions (FR, EE) o how the SMSs are developed and implemented (FR, EE) o different railway operations (IT) o lack of harmonised networks (IT, AT) o different rules and regulations (DE, AT) o too much regulation and bureaucracy (DE) o guidance not prescriptive enough (ES) o lack of harmonised safety and technical standards (ES, AT) o lack of harmonisation of gauge, electrification, signalling, operational

rules, visual aspects of signalling (interoperability issues) o language (HU) o safety related tasks/staff (HU) o differences in infrastructure (CZ) o lack of trust (EE)

• Ideas for giving NSAs more confidence include: o consistency in elements included in SMS (FR, EE) o harmonised network – start with the TEN (IT) o no mistrust at all (DE, AT, CZ) o harmonised standards o exchanging information with other MSs (PL) o workshops to discuss and amend the certification process (PL) o standardised assessment process - issue the CSM on Conformity

Assessment (DK, NL) o one supervisory body e.g. the ERA (DK)

• On the question about what the NSAs think they may need to do to facilitate the migration, some NSAs did not recognise that they might need to change


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their attitudes and requirements (FR, DK, NL). One misunderstood the question (DE). Some answers were unclear (ES, AT). Two NSAs say it is impossible to change or improve while there are such differences in the systems and heritage in the MSs (CZ, PL).

• Ideas for role of ERA: o better understanding of the real practicalities of railway operations,

and of differences between operating characteristics of different railways (IT)

o more guidance and better documentation for how to apply RSD (ES, HU, NL)

o set more prescriptive criteria for e.g. resourcing levels (HU) o existing role is sufficient (CZ) o be a forum for exchanging experiences with all MSs (PL) o focus on the practical work (PL) o central supervisory/auditing role (DK) o assistance with interoperability (EE)

• Ideas for migration include: o adopting a cross acceptance process as is used for rolling stock (FR) o harmonise the network starting with the TEN (IT) o continue collaboration between NSAs (DE) o harmonisation of regulations (DE, AT, CZ) o NSRs could be managed outside the certification process (DE) o harmonisation of technical and safety standards (ES, AT, CZ) o ensure harmonised standards are applied in each MS (ES, AT, CZ) o help NSAs to apply more objective criteria (ES) o setting up regional groupings to facilitate local co-operation and

sharing best practice (HU) o clearness of regulations (AT) o an EU-wide high speed net to share experiences from the very

beginning of the new regulations o improvement in the process for certifying rolling stock (NL).

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