Piotr CUKIERSKI, Krzysztof ZUBILEWICZ Prague, 26th of November 2019

Piotr CUKIERSKI, Krzysztof ZUBILEWICZ Prague, 26th of November 2019
Workshop on the Technical Pillar of the 4th RP SSC in the framework of the 4th RP Piotr CUKIERSKI, Krzysztof ZUBILEWICZ Prague, 26th of November 2019

Abbreviations used Increase your attention MS: Member State
ERA: European Union Agency for Railways NSA: National Safety Authority SCB: Safety Certification Body (ERA or NSA) SSC: Single Safety Certificate SMS: Safety Management System ECM: Entity in Charge of Maintenance OSS: One-Stop Shop RU: Railway Undertaking IM: Infrastructure Manager PE: Pre-engagement PA: Practical Arrangements for issuing SSC Increase your attention

Agenda of the presentation
Overview of the 4th Railway Package – technical pillar (SSC) What is new? Transitional period New legal framework The safety certification process under the 4th RP Safety Management Systems Outline of the safety assessment process Update, renewal and revocation of the certificate Single Safety Certificate delivery by ERA: organisational aspects Language and communication Fees and charges Appeal process One-Stop Shop OSS Applicants’ perspective OSS demonstration for SSC

What is new? What is new?

OSS and ERA as new certification body
area of operation in more than one Member State (compulsory) or area of operation in one Member State if the applicant so requests June or June 2020 OSS Single Safety Certificate NSA OR APPLICANT ALL APPLICATIONS VIA ONE-STOP SHOP The issuing authority could be either the Agency or the NSA according to the intended area of operation. Area of operation in one Member State if the applicant so requests

Previous legal framework
Main changes Previous legal framework Safety certificate part A issued by the relevant NSA One or more safety certificates part B issued by the relevant NSAs Applications managed in accordance with national arrangements Assessment process defined by each NSA in accordance with its own rules Assessment based on EU criteria (to be applied by NSAs) and national rules No obligation from authorities to pre-engage with the applicant New legal framework Single safety certificate issued by a safety certification body: either the NSA or the Agency All applications managed through the one-stop shop IT tool in accordance with arrangements set out in EU law Harmonised assessment process set out in the EU law Assessment based on homogeneous safety management system requirements (aligned with ISO management system standards), to be applied by both the authorities and the applicants and cleaned up national rules Authorities must pre-engage on request of the applicant

Safety Certification Changes (summary)
Summary of the main changes in the system: SINGLE SAFETY CERTIFICATE Board of Appeal Process approach with more guidance EU HARMONISED PROCESS Fees and Charges Close alignment with ISO Standards EU Harmonised Process One-Stop Shop (OSS) ERA as Safety Certification Body Possibility of pre-engagement Closer cooperation between ERA and NSAs

Transitional period Transitional period

Transitional period Key principles:
As of 16 of June 2019, ERA is responsible for issuing single safety certificates when the area of operation entails at least one Member State that has transposed Directive (EU) 2016/798 by that date The national safety authorities of the Member States that postponed the transposition of the new legal framework by one year continue to issue safety certificates in accordance with Directive 2004/49/EC until 16 June 2020 Transposition 16/06/2019 Transposition 16/06/2020 Single Safety Certificate Certificate Part A and B

Transitional period The single safety certificate has to be issued in the following situations: Part A or any of Parts B expire in the Member State that transposed the 4th Railway Package by the 16 June 2019. Part A or any of Parts B is updated in the Member State that transposed the 4th Railway Package by the 16 June 2019. RU extends its area of operation to the Member State that transposed the 4th Railway Package by the 16 June 2019 During that period some of the RUs need to follow in parallel: two different legal frameworks two different assessment processes r. r.

Transitional period Scenarios for RUs whose certificates (either Part A or B) expire after r.: Registration country Foreign country (1) MS 1 (Part A+B) 06/2019 MS 2 (Part B) 06/2020 ERA issues singe safety certificate ERA issues single safety certificate MS 2 issues Part B certificate MS 1 issues Part A and Part B certificate ERA issues single safety certificate for MS 2 ERA involved as of 06/20 for update / renewal (2) (3) (4) MS 1 (Part A+B) 06/2020 MS and certificates it issues Transposition date in the MS Color reflecting transposition date

Transitional period Main scenarios for railway undertakings registered in CZ or SK: Netherlands France Italy Slovenia Finland Romania Bulgaria Greece CZ / SK 06/2020 MS 2 06/2020 NSA CZ/SK issues Part A and Part B (for MS 1) NSA 2 issues Part B (for MS 2) ERA issues SSC (for MS 3) MS 3 06/2019 06/2019 – 06/2020 CZ / SK 06/2020 MS 2 06/2020 NSA CZ/SK issues Part A and B (for MS 1) MS 2 issues Part B (for MS 2) ERA involved as of 06/2020 (for all MS) CZ / SK 06/2019 MS 2 06/2019 New Updates Renewals from 06/2020 ERA issues SSC

Transitional period Delays in transposition (real life example):
Negative impact on some of the international RUs Uncertainty Two applications two assessments processes in parallel Two set of requirements applicable (1158/2010 and 2018/761) Infringement procedure against the Member State RO 06/2019 EL 06/2019 NSA RO issues Part A and B (for RO) ERA issues SSC for EL Delayed transposition (2020 instead of 2019) If there was no delay = only one application and assessment

New legal framework New legal framework

Applicable legislation
Directive 2016/798 – Railway Safety Directive Regulations 2018/762 – Common safety methods on safety management system requirements 2018/763 – Practical arrangements for issuing single safety certificates to railway undertakings 2015/995 – Technical specification for interoperability relating to the ‘operation and traffic management’ subsystem 2019/773 – Technical specification for interoperability relating to the ‘operation and traffic management’ subsystem 402/2013 – Common safety method for risk evaluation and assessment 1078/2012 – Common safety method for monitoring 2018/761 – Common safety method for supervision 2019/779 – System of certification of entities in charge of maintenance (ECM) Key message: this is the summary of the applicable legislation Script: Commission Implementing Regulation (EU) 2018/763 establishing practical arrangements for issuing single safety certificates to railway undertakings pursuant to Directive (EU) 2016/798 of the European Parliament and of the Council, and repealing Commission Regulation (EC) No 653/2007 . Note: Directives need to be transposed by the Member States. Regulations are directly applicable without being transposed by the Member States. eur-lex.europa.eu

Auxiliary legislation
Directives 2016/797 – Interoperability Directive 2007/59 – Train Drivers Directive Regulations 2016/796 – Agency (ERA) Regulation 2018/764 – Fees and charges payable to the Agency (ERA) and their conditions of payment 2018/867 – Rules of procedure of the Board(s) of Appeal of the Agency (ERA) Regulation concerning the International Carriage of Dangerous Goods by Rail (RID) Technical specifications for interoperability relating to the structural subsystems (ETCS, wagons, etc.) eur-lex.europa.eu

New legal framework (outline)
CSM Supervision (Reg. 2018/761) CSM Risk Assessment (Reg. 402/2013) CSM Monitoring (Reg. 1078/2012) TSI OPE (Reg. 2015/995 Reg. 2019/773) TRAIN DRIVERS DIRECTIVE (2007/59/WE) ERADIS Practical Arrangements (Reg. 2018/763) CSM for SMS Requirements (Reg. 2018/762) NOTIF IT OSS Criteria for the recognition of training centres (2011/765) RAILWAY SAFETY DIRECTIVE (2016/798) ECM Certification (Reg. 2019/779) Board(s) of Appeal (Reg. 2018/867) INTEROPERABILITY DIRECTIVE (2016/797) ERA REGULATION (2016/796) Fees and charges (Reg. 2018/764)

+ Agency Guidance NSA application guides
Including i.e.: List of national requirements Description of requirements Language policy Border stations Fees and charges process description appeal procedures Responsibility of the NSAs to publish the guides AGENCY GUIDANCE General principles of supervision Coordination between NSAs Management maturity model for NSAs Enforcement management model for NSAs Application guides for the granting of single safety certificates SMS Require-ments Competence management framework for ERA/NSAs The guidance is on the Agency website and freely downloadable This is a much more comprehensive and complete set of guidance than was available under the 3rd RP and it represents a step change in the assistance that ERA is providing to users. The guidance covers application, assessment, supervision ,competence, coordination management maturity and enforcement models For authorities (ERA and NSAs) For applicants

Agency Guidance Application guides The two guides are complementary
One is for applicants and one is for authorities (NSA/ERA) Process description from two different perspectives Description of the application process Other practical information Please read carefully Chapter 5 of the ‘guide for applicants’ and Chapter 2 of the ‘guide for authorities’, as it is about the safety assessment process Available in all EU languages (incl. CS and SK) Guide for the applicants: CZ, SK Guide for authorities: CZ, SK

Agency Guidance Guide on SMS requirements:
Much more extensive guidance on all the requirements in the new CSM Available in all EU languages Guide structure: Introduction Main part - requirements: Purpose and explanatory notes Evidence and examples of evidence References and standards Supervision issues Annexes – Additional information: Annex 1 – Correlation tables (between old and new CSMs) Annex 2 – Cross-acceptance of authorisations, recognitions or certificates of products or services granted in accordance with Union law Annex 3 – Siding operations, contractual arrangements and partnerships Annex 4 – Safety Culture Annex 5 – Human and organisational factors Annex 6 – Definitions Guidance available at the ERA Website: CZ, SK

New legal framework – summary
Regulation 2018/763 (Practical arrangements) Regulation 2018/762 (SMS Requirements) Regulation 2019/779 (ECM Requirements) Regulation 2015/995 Regulation 2019/773 (TSI Operations and Traffic Mgt.) + + + EU LEGISLATION ERA GUIDES + + Guides to be published by the NSAs (to explain national safety rules + fees and charges) Safety certification process is regulated at the EU level (requirements + procedural aspects) The EU regulations are directly applicable in all of the Member States (harmonization) National provisions (if contradictory) shall not apply to this specific process

Single Safety Certificate (link for applicants) 4th Railway Package

New legal framework New legal framework ECM

ECMs for freight wagons and other vehicles
Article 3 (1) All ECMs (for locomotives, freight and passenger wagons) must fulfil the requirements of Annex II ECM maintains freight wagons ECM is RU/IM and maintains vehicles other than freight wagons operated by other RU/IM ECM is not RU/IM and maintains vehicles other than freight wagons ECM is RU/IM, maintains vehicles other than freight wagons exclusively for its own operations Article 3 (2) a) Mandatory certificate Article 3 (2) b) Mandatory certificate Article 3 (2) b) Mandatory certificate Articles 3 (3) and 3 (4) 2 possibilities for Annex II requirements checks Article 3 (4) Annex II requirements: to be checked via ECM-certification process Article 3 (3) Voluntary ECM certificate Article 3 (5) (if relevant) ECM certificate deemed evidence for compliance with CSM SMS 5.2.4, during safety certification / authorisation process. Article 3 (4) Verification of Annex II requirements as part of safety certification / authorisation process

ECMs for freight wagons and other vehicles
06/19 06/20 06/22 06/23 06/25 Attestation of conformity with requirements annex III Reg. 445/2011 * National attestation of conformity for ECM (vehicles other than wagons) National attestation of conformity for maintenance functions (Vehicles other than wagons) From 06/2022 an ECM certificate is mandatory ECM CERTIFICATE (Vehicles other than wagons) ECM CERTIFICATE For wagons Application of Regulation 779/2019 Possible period of validity of attestations/certifications Possible extensions of validity of attestations/certificates * Attestations of conformity issued before 06/2019 can be valid until 06/2023 at the latest. Attestations of conformity issued after 06/2019 are valid until 06/2022 at the latest.

New legal framework New legal framework TSI OPE

Operations and Traffic Management TSI
Commission Regulation (EU) 2015/995 of 8 June 2015 Current version of TSI OPE (amending Decision 2012/757/EU) Implementation according to Annex I, Section 7 National Implementation Plans (NIP) – if provided Regulation 2015/995 together with the Decision 2012/757/EU ends validity on (with some exceptions)

Commission Implementing Regulation (UE) 2019/773 of 16 May 2019 Applied from 16 June 2021 with some exceptions (art. 6): rear end signals for freight trains ( ) – from 16/06/2019; operating rules (4.4): EU railway system operational principles and rules, national rules, Acceptable Means of Compliance (AMoCs) – from 16/06/2019; During the transition from the application of national rules to the implementation of this Regulation, railway undertakings and infrastructure managers shall review their safety management systems to ensure the continuation of safe operations. If necessary, they shall update their safety management systems (4.4.4) route compatibility checks ( i Appendix D1) – from 16/06/ or 16/06/2020, depending on 4th RP transposition date; Appendix A (ERTMS operational principles and rules) and C (Safety related communications methodology) – at the latest from 16/06/2024

Date From 16 June 2019/2020 To 16 June 2021 From 16 June 2021 To 16 June 2024 From 16 June 2024 onwards TSI OPE applied TSI OPE 2015 applied Scope of application described in the National Implementation Plan (NIP) In case of no NIP, whole regulation applies (to be checked with the proper NSA) TSI OPE 2019 applied with regards to: rear end signals for freight trains ( ) and operating rules (4.4) – from 2019 route compatibility check ( and Appendix D1) – according to the 4th RP transposition date TSI OPE 2019 as main TSI to be applied TSI OPE 2015 applied only with regards to Appendices A and C: Check NIP together with the responsible NSA In case of no NIP check application of Appendices A and C with the NSA TSI OPE 2019 applied – all the sections with no exceptions

In case of applying TSI OPE 2015 (2015/995) the National Implementation Plan should be used as a reference – with support from the NSA In case of applying TSI OPE 2019 (2019/773) applicability rules and dates described in the legal text – especially in art. 6 – should be considered In case of applying for a certificate in other MS in the period before 16/06/2024 it is advised to establish with the responsible NSA the scope of TSI OPE 2015 implementation and the rules for applying TSI OPE 2019

New legal framework Border Stations New legal framework

Border stations Principle of border station = SSC valid without extension of the area of operation In case of absence of border agreements (permanent or ad-hoc), the applicant must apply for an area of operation covering the second MS If MS has not transposed this means an application for a Part B If the applicant has already submitted an application which includes border station(s) and no agreement can be found, the applicant shall re-submit a new application with an extended area of operation Border station can also encompass areas of track (border section) for which it makes sense that agreement is reached SK CZ CZ SK Application to NSA or ERA SSC Covering CZ + border station Application to ERA SSC Covering CZ + SK

Border stations YES YES YES NO NO NO Does the RU operate only in 1 MS?
Applying to ERA is not obligatory NO YES Applying to ERA is not obligatory Does the RU operate only in 1 MS + to border stations in a neighboring MS? Conditions: signed cross-border agreement or ad-hoc agreement between NSAs + consultation with relevant NSA NO YES Does the RU operate in only 1 MS + has a partnership agreement with a certified RU in other MS? Applying to ERA is not obligatory NO operations based on partnership agreements to be managed through the SMS of both RUs capability of manage such operations to be assessed by the safety certification body Applying to ERA is obligatory

Safety Management Systems
SMS

Safety Management Systems (SMS)
The safety management system (SMS) is a living system of linked processes and procedures, which control risk to ensure the safe management of rail operations Risk means the frequency of occurrence of accidents and incidents resulting in harm (caused by a hazard) and the degree of severity of that harm (Regulation (EU) 402/2013, Art. 3(1)) SMS RISK Process Przepis krajowy Przepis krajowy Przepis krajowy National Rule Przepis krajowy Company Rule

SMS document architecture
SMS is an arrangement of higher level processes and procedures, which links to more detailed operational procedures/company operational rules/work instructions. Safety Reporting Safety Policy Safety Policy Top management SMS Manual Assessment Organisational Procedures Operational Procedures SMS does not replace existing rules, as: National rules: rules issued by the Public authorities Company rules: internal rules issued by the company, covering their own specific activities Whoever is entrusted for issuing rules, one of the key activities in the SMS is the identification of applicable rules and procedures to assure compliance. Which rules to apply? Technical and operational standards or other prescriptive conditions as laid down in safety rules (permanent operational rules – to be respected by train drivers, accompanying staff, train composition, shunting, loading, etc…); in technical rules (concerning construction and maintenance of infrastructure and rolling stock); in other relevant rules (e.g.: transport of dangerous goods), or in regulatory authority decisions (temporary orders, recommendations, …) Work Instructions Operational staff Templates, Forms, Records Safety Information and Communication Policy Process Activity Task

Outline of the new certification framework
Structure of the new CSM on SMS Requirements (762/2018) Context of the organisation Leadership 2.1. Leadership and commitment 2.2. Safety policy 2.3. Organisational roles, responsibilities, accountabilities and authorities 2.4. Consultation of staff and other parties Planning 3.1. Actions to address risks 3.2. Safety objectives and planning Support 4.1. Resources 4.2. Competence 4.3. Awareness 4.4. Information and communication 4.5. Documented information 4.6. Integration of human and organisational factors

Structure of the new CSM on SMS Requirements (762/2018) Operation 5.1. Operational planning and control 5.2. Asset management 5.3. Contractors, partners and suppliers 5.4. Management of change 5.5. Emergency management Performance evaluation 6.1. Monitoring 6.2. Internal auditing 6.3. Management review Improvement 7.1. Learning from accidents and incidents 7.2. Continual improvement

New requirements in the legal framework Leadership Human and organisational factors Safety Culture

New requirements in the legal framework Leadership Involvement of the top management in the implementation, development and improvement of the SMS Includes strategic decision-making, providing resources, promoting continual improvement, risk-based approach and a positive safety culture Covered partially in the previous CSM as [G] Management commitment Human and organisational factors Safety Culture

New requirements in the legal framework Leadership Human and organisational factors HOF are a theoretical concept of including human behavior and it’s organisational context in safety related activities The way people behave and execute (safety related) tasks is taken into consideration from the design phase to monitoring and improvement of safety critical systems and processes Important aspects: a strategy, expertise and recognized methods, managing risk related to human performance Previously implicitly included in a number of criteria, now explicitly mentioned in 4. Support; additional part in the SMS requirement guidance (Annex 5) Safety Culture

New requirements in the legal framework Leadership Human and organisational factors Safety Culture Safety culture refers to the interaction between the requirements of the safety management system, how people make sense of them, based on their attitudes, values and beliefs and what they actually do, as seen in decisions and behaviors Mentioned explicitly in requirements on leadership and improvement Explained in Annex 6 of the SMS requirements guidance

Extended requirements in the legal framework Context of the organisation Evidence that the RU manages all the interfaces with other stakeholders Operations Evidence on the connection between safety requirements and operational activities (link with TSI OPE and other relevant TSIs) Support All the activities required for the safe conduct of railway operations Human and organisational factors are included here, as well as requirements on awareness, competence, resources, information and documentation

SMS Wheel Previous structure of SMS requirements

SMS Wheel – new version / mobile app
Click here to see the video New structure of SMS requirements

SMS application – leadership
Demonstration of commitment Communication Safety culture Risk management and responsibility

SMS application – safety culture
Positive attitudes values and beliefs Safety culture is the glue that holds the SMS together

SMS application – safety culture
era.europa.eu

SMS application – Human and organisational factors (HOF)
Those HOF factors which influence safe decision making Ensuring HOF is included in the risk analysis

SMS application - operations
Arrangements to manage activities Processes to manage risks Staff understand and apply Vehicles are operated safely under different operating conditions

Outline of the safety assessment process

Stages of the safety assessment process
Pre-engagement Receipt of application Initial screen Detailed assessment Decision-making Closing of the assessment

Pre-engagement Receipt of application Initial screen Detailed assessment Decision-making Closing of the assessment (+) Facilitating early contact Developing the relationship between assessors and applicant Applicant gaining familiarity with process and requirements SCB gaining familiarity with applicant’s SMS level of maturity Mitigating the risks of delays in issuing the SSC One-stop shop used to submit the request, info can be re-used for later submission ( - ) Long-time perspective Additional and constant commitment by the applicant and the SCB Subject to charges NOT MANDATORY BUT RECOMMENDED The applicant chooses a safety certification body when requesting pre-engagement but this can be changed at later stage

Pre-engagement Receipt of application Initial screen Detailed assessment Decision-making Closing of the assessment Content of the stage: Confirmation of the receipt of application (automatically through the OSS) Setting the starting date of the assessment (automatically through the OSS) If NSA is SCB = first working day following the submission of application If ERA is SCB = first working day common for all involved authorities Appointing the assessment team Kick-off meeting (if necessary) working language cooperation principles planning of the process

Pre-engagement Receipt of application Initial screen Detailed assessment Decision-making Closing of the assessment The assessment team: VERIFICATION AGAINST CZECH NOTIFIED NATIONAL SAFETY RULES CZ OSS + VERIFICATION AGAINST SMS REQUIREMENTS (Reg. 2018/762) SK VERIFICATION AGAINST SLOVAK NOTIFIED NATIONAL SAFETY RULES

Pre-engagement Receipt of application Initial screen Detailed assessment Decision-making Closing of the assessment Content of the stage: To check that the documents submitted by the applicant (i.e. the evidence) are sufficient, relevant and consistent to carry out the assessment If not, the safety certification body (NSA or ERA together with relevant NSAs) may request for additional information (through the „issue log” of the OSS) The timeframe for the provision of missing evidence is agreed with the applicant In the case of significant deficiencies or a significant number of minor deficiencies, the timeframe of the stage may be extended (1 month +) The results of the initial screen are summarized in the initial screen reports The acknowledgement of completeness is notified through the OSS

Pre-engagement Receipt of application Initial screen Detailed assessment Decision-making Closing of the assessment Content of the stage: To check that the evidence complies with the legal requirements set by the EU legislation (SMS Part) and national ones (notified national safety rules) If not, the safety certification body (NSA or ERA together with relevant NSAs) may request for additional information (through the „issue log” of the OSS) The timeframe for the provision of missing evidence is agreed with the applicant In the case of significant deficiencies or a significant number of minor deficiencies, the timeframe of the stage may be extended (4 month +) The certification body may carry out an audit or inspection as part of the certification process

Pre-engagement Receipt of application Initial screen Detailed assessment Decision-making Closing of the assessment Content of the stage: Not all identified issues need to be resolved before completing the assessment of the application and issuing the decision: Issues classified as residual concerns can be checked during supervision The certificate can also be issued with restrictions or conditions of use The results of the initial screen are summarized in the initial screen reports If the Agency is the safety certification body, it aggregates the information form different reports in the final assessment report This report available in the language of the applicant

Pre-engagement Receipt of application Initial screen Detailed assessment Decision-making Closing of the assessment Content of the stage: To notify the applicant of the safety certification body’s decision The Notification is made through the OSS Negative decision means: Rejection of the application Issuing of the certificate with restrictions or conditions of use Negative decision can be subject to review and then subject to appeal and actions before the competent court

Pre-engagement Receipt of application Initial screen Detailed assessment Decision-making Closing of the assessment Content of the stage: Recording lessons learned Recording all of the relevant documents in the OSS (e.g. invoice) Formal closing of the application in the OSS (>1 month after the decision)

Update, renewal and revocation

Update and renewal of the certificate
Certificate update might be needed in case of: extension of the area of operation or substantial change proposed to the type or extent of operation or substantial change to the legal framework if the Agency or the NSA so requires RU is responsible for engaging with the safety certification body when it plans a change to the conditions under which the single safety certificate was issued. The information provided by an RU shall cover: Clear description of the planned change Evidence of the assessment of potential safety risks The safety certification body (in the case of ERA in agreement with the NSA) informs the RU about the need to update the certificate. The safety certification body and the NSA(s) shall take proportional approach to the re-assessment based on the degree of changes proposed Update. Changes can be of technical, operational or organisational nature (see Article 10(13) and Article 10(14) of Directive (EU) 2016/798). Other possible changes might involve: The safety regulatory framework (see Article 10(15) of Directive (EU) 2016/798) The conditions under which the CCS was issued, even if without any impact on the type, extent or area of operation.

Update and renewal of the certificate
Changing the type of operation means adding or removing: Passenger transport (including high speed services) Freight transport (including dangerous good services) Shunting services Changing the extent of operation means increasing or decreasing: The number of passengers and/or volume of goods The estimated size of the company in terms of the number of employees (micro, small, medium sized, large) Renewal of the certificate is required in the case of expiry of its validity The safety certification body and the NSA(s) shall take proportional approach to the re-assessment (inputs form past assessment and supervision) Information in the certificate Context of organisation The terms “type” and “extent” of operation are defined in Article 3 of Directive (EU) 2016/798

Restricting or revoking a single safety certificate
A SSC may be restricted or revoked by the safety certification body that has issued it (either Agency or the NSA). Such a restriction or revocation happens when the safety certification body is notified that the holder of the certificate no longer satisfies the conditions under which it has been certified. In case of certificates granted by ERA, such notification always comes from the NSA that is responsible for supervision of the RU. Furthermore: If the NSA identifies a serious safety risk it may decide to take proportionate enforcement action, including where necessary suspending the rail operations

Restricting or revoking a single safety certificate
Information on restriction or revocation of the certificate SUPERVISION PROCESS CERTIFICATION PROCESS INPUTS NSA SK NSA SK Cooperation between the NSAs SMS NSA CZ INPUTS NSA CZ Information that an RU no longer satisfies conditions for certification

SSC delivery by ERA: organisational aspects

Single safety certificate
Content of the certificate generated in the one-stop shop Issued certificate automatically transferred to ERADIS Validity period: maximum 5 years Validity dates set manually, to accommodate to the expiry date of the previous certificate Single safety certificate replaces all previous certificates issued by the Member States that transposed the 4th railway package

Language and communication
Language of the application: PART OF APPLICATION COVERING SMS Any language selected by the Applicant European Union Agency for Railways NATIONAL PART OF APPLICATION Language specified by the NSA (Information in the NSA guide) SAFETY CERTIFICATION BODY PART OF APPLICATION COVERING SMS Language specified by the NSA (Information in the NSA guide) National Safety Authority NATIONAL PART OF APPLICATION Language specified by the NSA (Information in the NSA guide) Working language: Agreed communication language within the assessment team (and if agreed also with the applicant). For example for application covering FR + DE + NL it can be English.

Language and communication
The exchange of information between the applicant, the Agency and the NSA(s) concerned with the area of operation is managed through the one-stop stop or via other communication channels (phone, videoconferencing, etc.) The information supporting the decision must be recorded in the OSS, regardless of the form in which it was obtained Response to issue in the issue log Minutes of coordination meeting Report form audit / inspection / visit The project manager is responsible for coordinating the assessment This is the contact person for both the applicant and the competent NSAs

Language and communication (issues)
Problems / questions are communicated to the Applicant through the ISSUE LOG (in the OSS) Identified issues are classified based on four types Type 4 issues lead to the rejection of application restrictions or conditions Type 3 issues may be checked during later supervision The applicant responds to issues in the ISSUE LOG (4) Major non-compliance (3) Minor non-compliance or residual concern for supervision (2) Observation or remark (1) Query Remarks about the categories of issue: Type 1 query: the applicant is requested to provide additional information to clarify some aspects of the application file Type 2 observation or remark: left to the judgement of the applicant but this will be checked at renewal Type 3 minor non-compliance or residual concern: the SSC is granted, but the applicant must sort out the issue according to a timetable agreed with the NSA . The NSA will address the issue during supervision and will indicate to the relevant SCB whether the applicant has addressed the matter either at certificate renewal or if they have not addressed the issue the NSA could request the SCB to restrict or revoke the certificate. Type 4 major non-compliance due to important absence of information or lack of clarity thereof. Thus, the application cannot be accepted as it stands and a SSC cannot be issued unless the issue is closed

Language and communication (audits, visits, inspections)
The authorities involved in the safety assessment may conduct audits, inspections or visits on the site of the applicant in order to: Collect additional evidence Close out issues identified within the assessment Ascertain applicant’s awareness on some areas of concern Audits, visits and inspections have to be coordinated between ERA, the relevant NSAs Audits, visits and inspections do neither replace nor duplicate the supervision carried out by the NSAs AUDITS WITHIN ASSESSMENT = SUPERVISION Audit: structured intervention where the RU is examined against a particular safety management standard or against a particular audit protocol Inspection: use of an authorised and competent staff member of the safety certification body or relevant NSA, as appropriate, to examine a particular and limited aspect of the activity of a RU (e.g., establishing compliance with the SMS requirements and the notified national rules, verifying that the process is in place and examining how well it works) Visits to the site of the applicant: short notice interventions to specific parts of the site of the RU aimed at observing the correct implementation of an SMS procedure Examples of areas of concern: applications never surveyed by the authority; new applications which the RU asked the SSC renewal for

Fees and charges (introduction)
OSS Fees and charges set at the national level and explained in the NSA Guide CZ 1 NSA CZ Fees and charges set at the national level for the assessment of CZ part + NSA CZ OSS CZ + 2 Fees and charges set at the national level for the assessment of SK part NSA SK + SK Fees and charges set in the Regulation 2018/764 for the assessment of SMS ERA

Fees and charges (applications submitted to ERA)
Regulation 2016/796 (ERA Regulation) The level of fees and charges (...) should cover the full cost of services delivered The fees and charges should be equal to or lower than the current average Regulation 2018/764 (Fees and charges) The fees and charges payable to the Agency should be set in a transparent, fair and uniform manner, in particular with the objective of simplification. They should not result in the imposition of unnecessary financial burden on enterprises and should not jeopardise the competitiveness of the European railway sector. The Agency shall, at the request of the applicant, issue a non-binding estimate of the amount of the fees and charges related to the application / pre-engagement. ERA and NSA(s) shall: monitor the cost vs. the estimate inform the applicant when the costs risk exceeding the estimate by >15%

Fees and charges (applications submitted to ERA)
NSA 1 NSA 2 NSA 3 + + (No. of hours) x (… EUR) Flat rate of …. CZK No fee STATEMENT OF COSTS STATEMENT OF COSTS + (No. of hours) x (130 EUR) Denominated in EUR. Number of hours (ERA) Cost of each of the NSAs Right to appeal (BoA)

Fees and charges (workload estimate and reporting)
Workload estimates: Generic workload estimates for each type of project (80 hrs.– 320 hrs.) Adapted individually for each submitted application by the Project Manager Workload reflected in the MS Project planning Workload reporting: Daily basis MS Project as a reporting tool Verification and validation by the Project Manager / Programme Manager

Means of appeal In case of issuing a negative decision (refusal of the single safety certificate or issuing a certificate with restrictions other that those requested in the application) following means of appeal are available: Request a review of the application (in the OSS) Appeal to an appeal body In case of applications to ERA: Board of Appeal In case of applications to NSA: national appeal body for the concerned MS Actions for the annulment In case of applications to ERA: Court of Justice of the EU In case of applications to NSA: national court The applicant must first submit a request for the review of the decision taken by the authority before lodging an appeal The case can be brought before the EU Court of Justice only if all other remedies (review, appeal) have been exhausted.

Means of appeal Timeframe for an appeal (applications to ERA) T0 T0+1m
2 months for ERA 3 months for BoA T0 T0+1m T0+3m T0+5m T0+8m T0+8m Negative decision Request for review The Agency confirms or reverses its decision Appeal Findings of the Board of Appeal Final decision taken by the Agency * Deadlines

Introduction to the OSS

One-stop shop (applicants’ perspective)
OSS = IT tool supporting all applications Allows submission of applications Allows communication on issues Allows update of application Allows issuing of the SSC All applications addressed to ERA or NSA have to be submitted through the OSS It’s recommended to submit applications at least 6 months in advance to Expiry date of current certificate Starting date of new operations

All applicants follow the self-registration process Registration process is individual (registration of a person not an entity) RUs are invited to set their internal rules for applying through the OSS Who is entitled to draft and submit the application How is the continuity of processing of application is ensured How access to previous files is ensured in the case of staff turnover Potential solution: Register a number of users Appoint one user as a „lead user” Initiate all applications by the „lead user” Share initiated applications with other registered users (the same rights)

Application process in 5 steps with 2 sub-steps: 1 Fill in the application form (organizational data + scope of the request) 2 Upload evidence for establishing of the safety management system Map uploaded evidence with all SMS and TSI OPE requirements 3 Upload evidence for compliance with notified national safety rules Map uploaded evidence with the requirements in the national rules 4 Upload additional documents (e.g. financial or administrative ones) 5 Check the content of your application and submit it

Navigation tab: 1 2 3 4 1. Application: preview of the submitted application + update through issue 2. Issues: issues logged by the assessment team + responses to issues 3. Dashboard: progress of the assessment (key milestones) 4. Library: all documents (application file + assessment file)

Application issues: Issue log: To get to know the issue To understand if update of an application is required To reply to issue

OSS to be available in all languages. The pre defined language is the language of the internet browser used by the user. But this may be easily changed either at log-in stage or later (see upper right box with language selection or user profile at later stage).

Piotr CUKIERSKI, Krzysztof ZUBILEWICZ Prague, 26th of November 2019

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Piotr CUKIERSKI, Krzysztof ZUBILEWICZ Prague, 26th of November 2019

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