INTEROPERABILITY UNIT COMPLEMENTARY STUDY INTERCHANGEABLE SPARE PARTS

Transcription

1 INTEROPERABILITY UNIT COMPLEMENTARY STUDY INTERCHANGEABLE SPARE PARTS Reference: ERA/REP/ /INT Document type: Final Report Version: 3 Date: 26 September 2011 Edited by Checked by Approved by Name Hubert LAVOGIEZ Denis BIASIN J-C. PICHANT Airy MAGNIEN Position Interoperability Unit Project Officer Rolling stock Interoperability Unit Head of RST Sector Interoperability Unit Head of Unit Economic Evaluation Unit Date & Signature [signed] [signed] [signed] The following document has been produced by the European Railway Agency as a Final Report of the complementary study on the issue of the interchangeable spare parts, aimed at ascertain whether the TSIs related to the rolling stock subsystem should include specific provisions about these spare parts. This issue was raised in section 2.2 d) of the Annex of the Commission Decision of concerning a mandate to the European Railway Agency to develop and review Technical Specifications for Interoperability with a view to extending their scope to the whole rail system in the European Union (Commission Decision C(2010)2576 final). This document is intended to inform the European Commission on the analysis carried out. Where appropriate, on the basis of the results of this complementary study along with the results of the other three complementary studies listed in section 2.2 of the Commission Decision C(2010)2576 final, the mandate will be up-dated by the Commission in accordance with the procedure set out in Article 29(3) of Directive 2008/57/EC. ERA/REP/ /INT Version 3 Page 1 of 56

2 AMENDMENT RECORD Version Date Section number Modification/description Author March 2011 All Creation of first draft issue for internal review April 2011 All 6 and April 2011 All 8 9 Modifications Additions Internal draft used as a basis for ESG meeting on 14/04/2011 Modifications Case studies (information from RBs) Draft conclusions Draft preliminary report issued for comments of RBs May 2011 All Editorial modifications and clarifications Preliminary report issued to Commission July 2011 All Editorial modifications and clarifications Annex 5 added Final report for ERA internal consultation Sept , 3.2, Editorial modifications Final report issued to Commission H Lavogiez A Magnien JM Dechamps H Lavogiez A Magnien H Lavogiez A Magnien H Lavogiez A Magnien H Lavogiez A Magnien JM Dechamps H Lavogiez CONTENTS EXECUTIVE SUMMARY INTRODUCTION MANDATE TO THE AGENCY REFERENCE DOCUMENTS DEFINITIONS Reference documents Abbreviations and definitions SCOPE AND LEGAL FRAMEWORK Scope and Objectives of the study Legal framework New approach and rail market regulation WORKING METHOD AND REPORTING Working method Reporting GENERAL ANALYSIS Expectations from the sector ERA/REP/ /INT Version 3 Page 2 of 56

3 5.1.1 Outcome from meeting with Representative Bodies (held on 01/03/2011) Questionnaire Purpose Synthesis of answers received outcomes Definition of interchangeable spare part Definition of a spare part for the purpose of the study Common definition of interchangeability Definition of ISP for the purpose of the study Categorisation of spare parts for the purpose of the study Comparison with interoperability constituents Current status for ICs Contribution of the concept of IC to harmonisation Comparison between IC and ISP Summary Conformity assessment TSI framework for conformity assessment Proposal from a representative body for ISP Summary Use of spare parts: maintenance, renewal Maintenance and renewal Technical file provided with the EC declaration of verification Responsibility of stakeholders; Safety directive Summary Concept of ISP in normative documents and in research projects EN standards UIC leaflets MODTRAIN project Other normative documents ISP CONCEPTS ALREADY EXPERIMENTED Historical background in the Railway sector Top down approach Bottom up approach Concept of ISP in other sectors Example of EU Directives Automotive sector Aviation sector Summary ERA/REP/ /INT Version 3 Page 3 of 56

4 7. ECONOMIC ASPECTS General Cost drivers Vendor lock-in Technical and commercial obsolescence cost of diversity / economies of scale Maintenance costs About standardisation Costs Outlook CASE STUDIES Purpose and Selection of case studies Cab display unit Contact strips Door control Wheel Summary CONCLUSIONS Proposal on how ISP should be managed Pertinence of provisions about ISP in RST TSIs ANNEXES LIST OF RESPONDENTS SUMMARY OF ANSWERS Technical aspect (questions A1 to A6) Conformity assessment (questions B1 to B4) Current practice (questions C1 to C2) Other comments (question D) ERA/REP/ /INT Version 3 Page 4 of 56

5 EXECUTIVE SUMMARY Mandate to the Agency Annex, Section 2.2. of the [1] Commission Decision C(2010)2576 final concerning a mandate to the European Railway Agency to develop and review Technical Specifications for Interoperability with a view to extending their scope to the whole rail system in the European Union states that: The Agency shall carry out the following complementary study: d) Complementary study on the issue of the interchangeable spare parts, aimed at ascertain whether the TSIs related to the rolling stock subsystem should include specific provisions about these spare parts. The final report concerning the abovementioned complementary study shall be delivered as set out in section 3.2 of the mandate (12 months after its notification). Where appropriate, on the basis of the results of this study, the mandate will be updated by the Commission in accordance with the procedure set out in Article 29(3) of Directive 2008/57/EC. Summary The need, identified by some stakeholders of the railway sector, for EN standards covering the concept of interchangeable spare parts (ISP) is not put in question; concerned stakeholders have already taken initiatives, and may address any request to standardisation bodies. Economic aspects linked to spare parts are recognised, but can only be assessed on a case by case basis with consideration of various business issues, in which ERA has no leading role. The specification of the ISP being seen as an optional requirement, the TSI does not appear to be the right support; standards applied on a voluntary basis are appropriate. The definition of additional regulatory technical specifications covering interchangeability, without any link to essential requirements from the interoperability directive, would be difficult to achieve in a transparent and nondiscriminatory way. The concept of ISP can already be implemented within the current legal framework (maintenance documentation, definition of the area of use for interoperability constituents ) without any specific provision in RST TSIs. Therefore, RST TSIs should not include any additional specific provision regarding interchangeability of spare parts above those that may already be indirectly covered in the current framework. ERA/REP/ /INT Version 3 Page 5 of 56

6 1. INTRODUCTION MANDATE TO THE AGENCY This report has been prepared by the Interoperability Unit of the European Railway Agency, together with the Economic Evaluation Unit for the impact assessment. Article 1 of the [1] Commission Decision C(2010)2576 final concerning a mandate to the European Railway Agency to develop and review Technical Specifications for Interoperability with a view to extending their scope to the whole rail system in the European Union, hereafter referred to as Mandate 2010, states that: The mandate for extending the scope of technical specifications for interoperability ("TSI") to be issued in accordance with Article 8(2) of Directive 2008/57/EC is hereby adopted by the Commission. Annex, Section 2.2. of the [1] Mandate 2010 states that: The Agency shall carry out the following complementary studies: d) Complementary study on the issue of the interchangeable spare parts, aimed at ascertain whether the TSIs related to the rolling stock subsystem should include specific provisions about these spare parts. [...] The final reports concerning the abovementioned complementary studies shall be delivered as set out in section 3.2 below. Where appropriate, on the basis of the results of these studies, the present mandate will be updated by the Commission in accordance with the procedure set out in Article 29(3) of Directive 2008/57/EC. ERA/REP/ /INT Version 3 Page 6 of 56

7 2. REFERENCE DOCUMENTS DEFINITIONS 2.1. REFERENCE DOCUMENTS Ref. Document Reference Official Journal Version/ Modifications [1] Commission Decision C(2010)2576 final of concerning a mandate to the European Railway Agency to develop and review Technical Specifications for Interoperability with a view to extending their scope to the whole rail system in the European Union NA Dated [2] Directive 2008/57/EC of the European Parliament and of the Council of 17 June 2008 on the interoperability of the rail system within the Community [3] Directive 2004/49/EC on Safety on the Community s railways, [4] Regulation (EC) No 881/2004 of the European Parliament and of the Council of 29 April 2004 establishing a European Railway Agency (Agency Regulation). L 191, page L164, page L 164, page 1, 30 April 2004 As amended by Commission Directive 2009/131/EC of 16 October 2009 (OJ L 273, , p. 12) Commission Directive 2011/18/EU of 1 March 2011 (OJ L 57, , 21) As amended by Directive 2008/57/EC of the European Parliament and of the Council of 17 June 2008 (OJ L , p.1) Directive 2008/110/EC of the European Parliament and of the Council of 16 December 2008 (OJ L 345, , p. 62) Commission Directive 2009/149/EC of 27 November 2009 (OJ L 313, , p.65) Corrected by Corrigendum (OJ L 220, , p.47) As amended by Regulation (EC) No 1335/2008 of the European Parliament and of the Council of 16 December 2008 (OJ L 354, , p.51) ERA/REP/ /INT Version 3 Page 7 of 56

8 Ref. Document Reference Official Journal Version/ Modifications [5] Commission decision N 2011/291/EU of 26 April 2011 concerning a TSI relating to Locomotives and Passenger rolling stock of the trans- European conventional rail system. [6] Commission decision N 2006/861/EC of 28 July 2006 concerning a TSI relating to Freight wagons of the trans-european conventional rail system. L 139, page L 344, page NA As amended by Commission decision N 2009/107/EC of 23 January 2009 (OJ L 45, , p.1) [7] Work Programme of the Agency for implementing the Commission Decision C(2010)2576 concerning a Mandate to the European Railway Agency to Develop and Review Technical Specifications for Interoperability with a View to Extending Their Scope to the Whole Rail System in the European Union NA July 2010 Update in June 2011 (intermediate report; midterm review) [8] Commission regulation (EU) N 445/2011 of 10 May 2011 on a system of certification of entities in charge of maintenance for freight wagons [9] Document from the Commission referenced DV77 EN06 dated titled Interoperabilty constituents L 122, page NA NA DV77 EN06 (status I informative) [10] Economic benefits of standardisation: Summary of results. Published by DIN (German Institute for Standardization), Beuth Verlag, 2000 (ISBN [11] Directive 97/23/EC of the European Parliament and of the Council of 29 May 1997 on the approximation of the laws of the Member States concerning pressure equipment NA OJ L 181, , p. 1 NA As amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, , p. 1) Corrected by Corrigendum (OJ L 265, , p. 110 (97/23/EC)) and Corrigendum (OJ L 93, , p. 38 (97/23/EC)) ERA/REP/ /INT Version 3 Page 8 of 56

9 Ref. Document Reference Official Journal Version/ Modifications [12] Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC [13] Decision N 2006/14/R of the executive director of the European Aviation Safety Agency of 20 december 2006 (acceptable means of compliance and guidance material) OJ L 157, , p. 24 As amended by Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 (OJ L 188, , p. 14) Directive 2009/127/EC of the European Parliament and of the Council of 21 October 2009 (OJ L 310, , p. 29) Corrected by Corrigendum (OJ L 76, , p. 35 (2006/42/EC)) NA 2.2. ABBREVIATIONS AND DEFINITIONS Table 3: Abbreviations and Definitions ABBREVIATION / FULL TEXT / DEFINITION TERM APS CCS CEN CENELEC ECM ERA ERTMS ETCS IC IEC Authorisation for placing in service Control-Command and Signalling European Committee for Standardization European Committee for Electrotechnical Standardisation Entity in charge of maintenance The European Railway Agency European Rail Traffic Management System European Train Control System Interoperability Constituent International Electro-technical Commission ERA/REP/ /INT Version 3 Page 9 of 56

10 Table 3: Abbreviations and Definitions ABBREVIATION / FULL TEXT / DEFINITION TERM ISP IU IA LOC & PAS Mandate 2010 NA NB-Rail NoBo NSA OEM Interchangeable Spare Part Interoperability Unit of the European Railway Agency Impact Assessment Locomotives and Passenger Rolling Stock [1] Commission Decision C(2010)2576 final concerning a mandate to the European Railway Agency to develop and review Technical Specifications for Interoperability with a view to extending their scope to the whole rail system in the European Union Not Applicable Co-ordination group of Notified Bodies for Railway products and systems Notified Body National Safety Authority Original Equipment Manufacturer RB Representative bodies from the railway sector referred to in Article 3 paragraph 2 of [4] Regulation (EC) 881/2004, as modified by Regulation (EC) 1335/2008 RFS RST RST TSIs RU Stakeholders TCMS TSI Request for a standard issued by ERA to Standardisation bodies Rolling Stock For the purpose of the report, this term in plural refers to the following TSIs: Freight Wagons TSI, HS RST TSI and CR LOC&PAS TSI Railway Undertaking For the purpose of the report, stakeholders are all the bodies impacted by the study Train control and monitoring system Technical Specification for Interoperability ERA/REP/ /INT Version 3 Page 10 of 56

11 3. SCOPE AND LEGAL FRAMEWORK 3.1. SCOPE AND OBJECTIVES OF THE STUDY The study provides an analysis to the European Commission aimed at evaluating if specific provisions related to interchangeable spare parts (ISP) should be included in rolling stock TSIs. This analysis is based on a structured approach covering legal, technical and economic aspects. The CCS subsystem and ETCS components are not required to be covered in this study (the Mandate mentions explicitly TSIs related to the rolling stock subsystem ). They were mentioned by some RBs, but ERA s view it that they cannot be dealt with in the same way as other spare parts due to the particularity of the CCS TSI (more prescriptive than other TSIs); additionally, specialized experts groups are in charge of specifying and managing modifications, and all technical issues relating to CCS should be dealt with by these groups LEGAL FRAMEWORK The interoperability directive [2] includes the following articles, which have to be taken into account in the scope of the present study on ISP: Article 1 Purpose and scope : 2. The pursuit of this objective must lead to the definition of an optimal level of technical harmonisation and make it possible to: (b) contribute to the progressive creation of the internal market in equipment and services for the construction, renewal, upgrading and operation of the rail system within the Community; Article 2 Definitions : (b) interoperability means the ability of a rail system to allow the safe and uninterrupted movement of trains which accomplish the required levels of performance for these lines. This ability depends on all the regulatory, technical and operational conditions which must be met in order to satisfy the essential requirements; (i) technical specification for interoperability (TSI) means a specification adopted in accordance with this Directive by which each subsystem or part subsystem is covered in order to meet the essential requirements and ensure the interoperability of the rail system; (f) interoperability constituents means any elementary component, group of components, subassembly or complete assembly of equipment incorporated or intended to be incorporated into a subsystem, upon which the interoperability of the rail system depends directly or indirectly. The concept of a constituent covers both tangible objects and intangible objects such as software; ERA/REP/ /INT Version 3 Page 11 of 56

12 Annex III Essential requirements : No requirements have been identified as relevant for the scope of the study on ISP. ERA view is that only the Article 1(2) may be referred to as a legal framework for the inclusion in TSIs of provisions about ISP; this is further analysed and argued in the following sections of this report. As described in section of this report, the safety directive [3], defines the responsibilities between the actors of the railway sector, including those related to maintenance activities, which have to be taken into account in the scope of the present study on ISP NEW APPROACH AND RAIL MARKET REGULATION The aim of the new approach (1985) to EU regulation was to limit, as far as possible, EU legal requirements to functional requirements, leaving it to Industry to set harmonised standards as sufficient means of compliance with these requirements. Additionally, the new approach introduced the harmonisation of essential requirements. In the case of rail market regulation, the interoperability directives were based on the principles of the new approach, but an intermediate layer was recognized necessary, namely TSIs. This was due to the extent of technical compatibility issues inherent to the railway system. TSI drafting aims at functional specifications, as far as possible, in order to avoid market distortions and freeze of innovation. TSIs are not meant to become full industrial specifications. The optimum level of technical harmonisation brought about by TSIs should contribute to the progressive creation of the internal market. TSIs may enforce detailed specifications, under the condition (governed by the subsidiarity and proportionality principles) that these means are necessary to achieve the aims of the policy (expressed by the interoperability directive), and that the means must be proportionate to the sought effects. ERA/REP/ /INT Version 3 Page 12 of 56

13 4. WORKING METHOD AND REPORTING 4.1. WORKING METHOD The analysis was carried out by the rolling stock sector of the interoperability unit of ERA in collaboration with other sectors and units of ERA, particularly the economic evaluation unit and the safety unit. The main stages are the following: 1. Qualitative analysis A preliminary analysis was performed within ERA in order to identify the information available and the different aspects to be covered. In particular: - legal framework - former correspondence (letters from the sector) and activities (workshops) on the subject of interoperability constituents and spare parts have been taken into account. A preparatory working meeting was organised on 01/03/2011 with RBs in order to better understand their expectations. A questionnaire was sent to NSAs, RBs and NB-Rail in order to collect the views and expectations of the different actors of the railway sector. This qualitative analysis presents the different aspects to be considered when addressing the subject of interchangeable spare parts in the legal framework in force in the railway sector. 2. Former experiences, experiences in other sectors and global economic aspect The subject of interchangeable spare parts was then analysed globally, on the basis of various experiences, with the objective of identifying the why and how. 3. Identification of case studies, for technical and economic analysis. Considering the different nature and complexity of spare parts, a global analysis presents limitations; as mitigation, case studies were selected with RBs, and were analysed by ERA with support of RBs. 4. Drafting of the conclusions: - Technical feasibility of including specific provisions about interchangeable spare parts in rolling stock TSIs. - Legal framework for such provisions. - Economic aspects. - Impact on the work programme of the mandate 2010 [7]. The findings and conclusions of ERA are presented in this report. ERA/REP/ /INT Version 3 Page 13 of 56

14 4.2. REPORTING The preliminary report (version 1.0) summarises the findings of the study and proposes a conclusion. It was submitted to the Commission as a preliminary report in May The preliminary report was also presented to the organisations consulted by the questionnaire: NSAs, RBs and NB-Rail (NoBos), for their feedback. The comments provided to ERA are presented in the annex 5 of the report and the relevant sections of the preliminary report have been updated accordingly. The up-dated version of the report is provided to the Commission as final report (current version 3.0). ERA/REP/ /INT Version 3 Page 14 of 56

15 5. GENERAL ANALYSIS This section of the report presents the context of this study on interchangeable spare parts. It covers: - Expectations from the sector, - Definition and categorisation of a interchangeable spare part, - Comparison between specification for interoperability constituents and specifications for ISP. - Conformity assessment, - Use of spare parts and responsibilities, and possible benefits of an EC certificate. - Relevant normative documents and research projects EXPECTATIONS FROM THE SECTOR OUTCOME FROM MEETING WITH REPRESENTATIVE BODIES (HELD ON 01/03/2011) CER considers the ISP concept as part of the objectives of the interoperability directive, because it contributes to the creation of an internal market and to a reduction of life cycle cost for rolling stock. The regulatory approach and ERA role are seen as levers to develop standardisation in this field. Some initiatives were taken in the past, through calls for tender, through development based on a unique specification required to different manufacturers, through the drafting of standards; results have not been those expected, due to a lack of common objectives between the different stakeholders (mainly between RUs and manufacturers). The ISP concept is a step forward to implement clear interfaces for components, with the effect to open the market of these components to more suppliers in Europe. CER proposes to apply the following principle in the definition of ISPs: - The definition of ISPs needs to allow the use of the Russian doll principle (e.g. ISP wheel in an ISP bogie ). - ICs have to be checked against 5 essential requirements (safety, reliability and availability, health, environmental protection, technical compatibility). - ISPs need to be checked against the 5 essential requirements and a 6 th requirement called interchangeability, the latter is optional and may have 3 levels (see also sections and 5.3). CER considers the concept of ISP as an extension of the concept of IC, to be applied on a voluntary basis (option in the TSI). The detailed specifications of ISPs should be available in EN standards to be developed upon request from ERA to standardisation bodies. CER has provided a list of components to which the concept of ISP may apply; this list can be found in annex 3 of this report. ERA/REP/ /INT Version 3 Page 15 of 56

16 UITP does not support any additional mandatory requirement and considers the ISP concept as a pure market/business issue. UIP thinks the ISP concept is necessary for freight wagons because they are operated and have to be maintained in different locations. UNIFE thinks the ISP concept should remain in the voluntary domain, by means of EN standards. They don t see any general reason, nor any general legal ground, for inclusion or reference of such standards in TSI s or involvement of ERA in the standardisation decision process (see also section 5.3). UNIFE points out that: - An economic positive impact of standardisation cannot by itself be a justification for the intervention of public authorities in the competitive domain. - The respective responsibilities, including the liability of the product supplier, have to be considered in the study QUESTIONNAIRE PURPOSE ERA has prepared a questionnaire in order to collect information related to legal aspects that have to be analysed in this study on ISP. The aim is to receive the opinion of the interested parties regarding the possible evolution of the legal framework (TSIs) that regulates the conformity assessment: EC declaration of conformity (constituents) and/or EC declaration of verification (rolling stock). The questionnaire was distributed to all representative bodies, the national safety authorities of the EU and EEA Member States and NB-Rail, in order to get a feedback from the interested parties who might be impacted in their activity by a potential regulation of some spare parts related to rolling stock. This questionnaire is not the unique source of information for ERA to perform the study; in particular, the concerned representative bodies have already expressed their expectations to the Commission or to ERA, and have provided technical and economic data (see sections 4.1 and of this report). The questionnaire can be found in annex 1 of this report SYNTHESIS OF ANSWERS RECEIVED The answers received to the questionnaire are summarised in annex 2 of this report OUTCOMES Among the 12 NSAs who answered, 5 of them answered that the concept of ISP should not be dealt with in TSIs. ERA/REP/ /INT Version 3 Page 16 of 56

17 Among the 7 NSAs who are in favour of this concept in TSIs, 5 of them answered also that the specification for the verification of the ISP should be available through the technical file; among those, 1 suggested to have a list of approved spare parts in the technical file, and 1 mentioned the responsibility of the ECM in the choice of spare parts. All reported the following expected benefits: opening of the market and increase of quality. These answers show that for spare parts, the distinction between TSI requirements and maintenance recommendations given in the technical file should be clarified; ERA will provide the necessary explanations in the different working groups (TSI drafting, ECM recommendation, definition of a RST type ). If we were to specify the ISP characteristics in the TSI, these should be sufficient, and additional information (specification, list of approved spare parts) should not be necessary in the technical file. CER answered that the TSI should include a list of components considered as ISP, and the corresponding specification for conformity assessment. For complex ISP, TSIs should describe the functionalities and list the different interfaces to be taken into account (mechanical / electrical ) and then refer to standards for the detailed specification. The information given in the technical file should be limited to the use (or not) of the ISP concept (considered as optional) for components identified as ISP in the TSI. CER answered also that the concept of ISP may also apply to other components (not listed) in the TSI, based on EN standard or UIC leaflets. UNIFE is not in favour of any additional regulatory provision regarding ISP (no clear legal basis) DEFINITION OF INTERCHANGEABLE SPARE PART DEFINITION OF A SPARE PART FOR THE PURPOSE OF THE STUDY Spare parts are materials, components or sub-assemblies that are used for replacement following: - Consumption (oil, sand ) - Criteria for limit of use reached (including wear) - Failure - Accident They are usually identical to the original components, but may be different provided that the functionalities and the interfaces are ensured. New spare part may need to be developed in case the original spare part cannot be found anymore on the market COMMON DEFINITION OF INTERCHANGEABILITY The following common definitions have been found: IEC: Situation where two or more items are so similar in functional and physical ERA/REP/ /INT Version 3 Page 17 of 56

18 characteristics that they are considered equivalent in performance and durability. Each is capable of replacing the other(s) without causing a need for alteration or adjustment to fulfil the same requirement. Wikipedia: Interchangeable parts are parts that are, for practical purposes, identical. They are made to specifications that ensure that they are so nearly identical that they will fit into any device of the same type. One such part can freely replace another, without any custom fitting (such as filing). This interchangeability allows easy assembly of new devices, and easier repair of existing devices, while minimizing both the time and skill required of the person doing the assembly or repair. These definitions may apply to the spare parts in the railway sector DEFINITION OF ISP FOR THE PURPOSE OF THE STUDY The common definitions given above are restrictive, in comparison with the work done up to now by the sector (see section 5.7). CER and UNIFE have proposed to consider a definition of a interchangeable spare part, with different levels of interchangeability, allowing a flexible application to different spare parts: - Level 3: plug & play full physical and functional interchangeability - Level 2: adaptable partial interchangeability - Level 1: only functional interchangeability CER has pointed out that the levels correspond to steps in the approach, each step representing an increase in interchangeability; considering only level 3 would be too ambitious, and premature in a number of cases (considering the time that would be needed to develop relevant standards). Additionally, considering that a TSI is not a comprehensive technical specification of a product, ERA notes that it may not be always possible to cover a full interchangeability (for which all aspects have to be considered). It has been agreed to consider in this study the definition and levels proposed by CER and UNIFE CATEGORISATION OF SPARE PARTS FOR THE PURPOSE OF THE STUDY UNIFE has proposed the following segmentation that has been used in the standardisation work with UIC and CER: - Parts for which possible interchangeability is only a matter of simple mechanical interfaces, with no significant impact on vehicle system design or on safety (e.g. cab door handles, grab bars, steps etc. ), or materials subject to simple specification such as sand, lubricants - Subsystem with complex interfaces, and with therefore a significant impact on system design (e.g. toilet modules, doors) - Part or sub-systems having a significant impact on functional safety ERA/REP/ /INT Version 3 Page 18 of 56

19 - Parts of which the behaviour can hardly be described and having a significant impact on safety (e.g. brake pads or disks) This segmentation gives the degree of complexity of the specification of the spare part as stand-alone component. UNIFE view is that for the 2 highest level of complexity, interchangeability level 3 cannot be achieved on the simple basis of compliance with a standard (see their comment on respective responsibilities in section 5.1.1, and section 5.6). Additionally, for the second highest level (subsystems with high impact on system design), UNIFE thinks the ISP concept would preclude innovation and badly jeopardise competitiveness. The proposal made by CER is to classify the spare parts according to the following categories: - Consumables at operating level (sand, grease, ) - Consumables at maintenance level (brake pads, ) - Line replaceable units (hardware with mechanical, electrical, pneumatic, data and other interfaces) - Software modules (like in the IC definition) The technical feasibility to define ISP specifications is reflected by the segmentation proposed by UNIFE. The benefits expected from the concept of ISP depend on the category of spare part, as defined above, but also on the expected frequency of replacement during the lifetime of the rolling stock. For the purpose of the study, the categories above are considered, together with a degree of complexity (illustrated in the section 8 case studies ) COMPARISON WITH INTEROPERABILITY CONSTITUENTS CURRENT STATUS FOR ICS Interoperability constituents are defined in article 2(f) of the interoperability directive (quoted in section 3.2 of this report). Interchangeability was clearly identified as an objective for IC in a working document issued in 2005 by AEIF ( Association européenne pour l interopérabilité ferroviaire in charge of drafting TSIs before the creation of ERA). The subject was discussed with the Commission from 2006 to 2008, and a document [9] was issued in November 2008 (DV77 EN06; status I informative), stating: An IC is not per definition interchangeable since not all product parameters are defined. ICs may be interchangeable in the defined circumstances, but interchangeability is not necessary condition (requirements). The interchangeability may depend on the area of use. The interchangeability of an IC as a spare part may be described in the maintenance file of the subsystem. Any additional requirements which are not related to the interoperability should remain in voluntary EN standards. ERA/REP/ /INT Version 3 Page 19 of 56

20 The last statement is consistent with the new approach, which aims at opening the market, in avoiding any superfluous regulatory provision (see section 3.3 of the present report). On another hand, this study analyses the need for additional regulatory provisions related to ISP, in order to contribute to the creation of a market of spare parts. We have here two opposite views. Additionally, the issue of the voluntary use of the concept of IC was discussed at the same time. The conclusion of this discussion was reported in the TSIs recently drafted: IC not covered by the relevant EC declaration of conformity or suitability for use (non-certified ICs) can only be incorporated in a subsystem during a transition period of 6 years; in that case, the corresponding TSI requirements have to be checked at the level of the subsystem. Indeed, TSI requirements are mandatory by nature, and their application is not left to the choice of the applicant; this applies also to requirements set up for constituents. For freight wagons, the former regime (RIV, UIC code applied on a voluntary basis) has contributed to create a market of components which is still effective, so that advantages of the IC concept defined in the TSI [6] are not clearly identified. It is likely that the IC concept could present more advantages to the sector for locomotives and passenger rolling stock, for which there is a wider variety of designs (UIC code has not provided the same level of technical harmonisation than for freight wagons). Since the CR LOC&PAS TSI [5] is applicable from 1 June 2011, there is no feedback available on its effect on the market. In general, ERA view is that the concept of IC might not have been up to now sufficiently used in order to influence the market CONTRIBUTION OF THE CONCEPT OF IC TO HARMONISATION As soon as a component has technical characteristics that have to be verified against TSI requirements independently of the RST subsystem, this component may be considered as covered by the concept of IC. If declared as IC in the TSI, the component will be certified independently of any application (rolling stock project). When a new rolling stock is designed, it seems credible that components already certified will be chosen in priority, in order to simplify the conformity assessment. This should lead indirectly to a harmonisation of characteristics that are not specified in the TSI (like mechanical interfaces if they are not relevant to «interoperability»), and should contribute to the development of a market of components. In the CR LOC&PAS TSI, the IC characteristics that are in interface with the rolling stock are described (area of use); these characteristics define at least a functional interchangeability (level 1 as defined by the sector); they have to be covered by the EC declaration of conformity or suitability for use covering the ERA/REP/ /INT Version 3 Page 20 of 56

21 component (see section 5 of the CR LOC&PAS TSI). Therefore there is already a framework defined for an ECM to use a component different than the original one or not listed in the maintenance documentation (technical file); this is covered by the ECM regulation [8], annex III section II.2.c &d (to be of mandatory application for freight wagons) COMPARISON BETWEEN IC AND ISP It is already allowed to integrate e.g. mechanical interface specifications into IC specifications. Such specifications would promote interchangeability of ICs. This question was raised several times, e.g. during the drafting of the first release of the CR LOC&PAS TSI. No such interfaces could be agreed upon; roof mounting of pantographs is a typical example. The reasons for not finding an agreement were that in the legal context of TSIs, mechanical interfaces would represent an over specification that would prevent project designers to develop and implement the best solution for their project, additionally there was no clear criteria to select the particular mechanical interface to be specified. Mechanical interfaces specified in the context of standards or other normative documents (see section 5.7 of this report) are of voluntary application, and therefore do not present this burden. When a standard is drafted for the conformity assessment of TSI requirements applicable to an IC, this standard can also include additional specifications in order to ensure interchangeability (level 1, 2 or 3); these additional specifications would be of voluntary use, and would not all be covered by the EC certificate (but are part of the component specification). The view of CER is to consider the concept of ISP as an extension of the concept of IC, applicable as an option, with 3 levels of interchangeability, and to have a conformity assessment procedure as for ICs, under the responsibility of the component manufacturer, covering all characteristics, including those for interchangeability purpose that are not related to the area of use of the component defined in the TSI. The technical specification should clearly describe the level of interchangeability reached, in order to have clear information in the EC certificate SUMMARY When comparing the IC and ISP concepts, the following issues are identified: - From a legal point of view, unlike the specification for ICs, the specification of the ISP being seen as an optional requirement, the choice to apply that requirement would be left to the applicant; therefore the TSI might not be the right support. An information would be necessary in the technical file for the corresponding spare part: ISP concept applied, with selected level of interchangeability. In the current framework, the specification to be applied to the spare part (including interchangeability if relevant) can be mentioned in the technical ERA/REP/ /INT Version 3 Page 21 of 56

22 file (maintenance documentation), provided that the relevant specification (EN standard) is available. - From a technical point of view, the decision criteria to define a particular technical solution as interchangeable, with a particular status recognised in the TSI, may be not transparent. - From a technical point of view, the level of interchangeability reached (if different than 3 for interfaces with high level of complexity) may present some uncertainties. - From an economic point of view, the efficiency of an optional requirement for interchangeability, additionally with different levels, cannot be predicted globally (see also section 8 of this report) CONFORMITY ASSESSMENT TSI FRAMEWORK FOR CONFORMITY ASSESSMENT A TSI shall allow independent conformity assessment against a clear technical basis by a notified body. The compliance to harmonised EN standards may give presumption of conformity. When necessary in order to have a clear basis for verification of conformity to TSI requirements, ERA may issue requests for standards to standardisation bodies. The application of the TSI results in: - EC declaration of conformity or suitability for use for interoperability constituents, drawn up by the manufacturer. - EC declaration of verification for rolling stock, with associated technical file, drawn up by the applicant. These declarations are both based on a certificate delivered by a notified body (excepted when module CA Internal production control is applied). In case TSI requirements are defined for ISPs, the conformity assessment process should be similar to the process for ICs; it is expected that the same modules as for ICs could be used PROPOSAL FROM A REPRESENTATIVE BODY FOR ISP Among the Representative Bodies, CER made a proposal regarding the conformity assessment procedure that may apply to ISP. CER suggested a conformity assessment procedure similar to those used for ICs, pointing out that a notified body should not systematically be involved; for example, the application of the module CA for ICs internal production control is under the responsibility of the manufacturer. CER also suggested defining the role of the notified body according to the type of quality management system applied by the manufacturer, and to the type of ISP: - no role if the quality management system in place allows that - choice of a module depending on level of interchangeability ERA/REP/ /INT Version 3 Page 22 of 56

23 - choice of a module depending on criticality/complexity - choice of using a notified body depending on cross-border traffic SUMMARY ERA has not identified any particular issue regarding conformity assessment. A procedure similar to those already in place for ICs may apply, provided that a clear technical specification defines the level of interchangeability to be reached, and its limitations (see section 5.4.4); this is a condition for a NoBo to be in a position to deliver a certificate USE OF SPARE PARTS: MAINTENANCE, RENEWAL MAINTENANCE AND RENEWAL A distinction should be made between spare parts for routine maintenance, for which the maintenance documentation apply, and spare parts for refurbishment, that may be subject of additional legal provision. Renewal is defined in article 2(n) of the interoperability directive as any major substitution work, which does not change the overall performance. The substitution of a component by another one not identical (ISP) may fall under this definition. Processes to be applied are described in the article 20 of the interoperability directive. Obsolescence of components may require the development of new spare parts, and may lead to triggering a renewal of the rolling stock (in the sense of the interoperability directive) in case the component may have an impact of the conformity assessment of the rolling stock against the TSI. The on-going work on the definition of a type for a vehicle (in the framework of the type register ERATV working party) will clarify the process to be followed for modifications to a type; this aspect is therefore not covered in the present report TECHNICAL FILE PROVIDED WITH THE EC DECLARATION OF VERIFICATION The clause of the CR LOC&PAS TSI (taken as example, other TSIs have a similar requirement) requires as part of the maintenance description file: Parts list: The parts list shall contain the technical descriptions of the spare parts (replaceable units) and their references, in order to allow identification and procurement of the correct spare parts. The list shall include all parts specified for changing on condition, or which may require replacement following electrical or mechanical malfunction, or which will foreseeable require replacement after accidental damage (e.g. windscreen). It is possible in the technical file to reference several ISP, or to include the specification for interchangeability of a spare part; this is consistent with the extract of the document DV77 for ICs given above in section ERA/REP/ /INT Version 3 Page 23 of 56

24 The technical file is lodged with the applicant, and is part of the declaration of verification necessary to get an authorisation for placing in service (APS). It is not publicly available, in order to protect the intellectual property rights; the applicant is responsible for the information contained in this technical file. Modifications after the APS are managed as described below in section 5.6.3; there is no imposition to have the original technical file updated RESPONSIBILITY OF STAKEHOLDERS; SAFETY DIRECTIVE The safety directive [3] includes the following articles, which have to be taken into account in the scope of the present study on ISP: Article 4(3): Without prejudice to civil liability in accordance with the legal requirements of the Member States, each infrastructure manager and railway undertaking shall be made responsible for its part of the system and its safe operation, including supply of material and contracting of services, vis-à-vis users, customers, the workers concerned and third parties. Article 4(4): This shall be without prejudice to the responsibility of each manufacturer, maintenance supplier, keeper, service provider and procurement entity to ensure that rolling stock, installations, accessories and equipment and services supplied by them comply with the requirements and the conditions for use specified, so that they can be safely put into operation by the railway undertaking and/or infrastructure manager. Article 9(2): It (the SMS) shall ensure the control of all risks associated with the activity of the infrastructure manager or railway undertaking, including the supply of maintenance and material. Article 14a(3): Without prejudice to the responsibility of the railway undertakings and infrastructure managers for the safe operation of a train as provided for in Article 4, the entity shall ensure that the vehicles for which it is in charge of maintenance are in a safe state of running by means of a system of maintenance. To this end, the entity in charge of maintenance shall ensure that vehicles are maintained in accordance with: (a) the maintenance file of each vehicle; (b) the requirements in force including maintenance rules and TSI provisions. This article introduces the responsibilities and the rules for ECM, which have been further developed in the regulation on system of certification of ECM [8], making the certification mandatory to any ECM of freight wagons; the specified rules may be used as good practices by any maintenance organisation, dealing with any type of vehicles. Point 2 b) - d) in section II of Annex III of the regulation on system of certification of ECM [8]: In case of changes brought to the maintenance with deviation from the maintenance documentation (part of the technical file), this regulation for certification of ECM specifies tasks the ECM is responsible for: Verifying in all circumstances the consistency of the maintenance file with the authorisation of placing-in-service (including any national safety authority requirements), the declarations of conformity to TSIs, the declarations of verification, and the technical file; ERA/REP/ /INT Version 3 Page 24 of 56

25 Identifying the need for risk assessment regarding the potential impact of the substitution in question on the safety of the railway system; Managing the configuration of all technical changes affecting the system integrity of the vehicle. The concept of ISP, if implemented in RST TSIs, will not impact the respective responsibilities of the different stakeholders, including the liability of the product supplier, the responsibility of the applicant, the responsibility of the rolling stock manufacturer, the responsibility of the end user (RU and ECM) SUMMARY The following issues relating to the use of spare parts are identified: - When replacing a component by another component considered as ISP, it shall be ensured that no new risk is introduced at rolling stock level. The risk assessment to be performed by the initial applicant, by the user or by the ECM requires a case by case analysis; the conformity to an EN standard defining parameters for interchangeability may facilitate this analysis. - In case of partial interchangeability (level 1 or 2), the added value of the conformity to such standard (verified under the responsibility of manufacturer of the component) needs to be clarified. - In many cases, a replacement may lead to the revision of maintenance instructions (e.g. considering the result of in service behaviour tests), to be done under the responsibility of the ECM. This is normal practice, and interchangeability specifications (depending on their depth ) may only contribute to reduce such tests and maintenance rules revisions CONCEPT OF ISP IN NORMATIVE DOCUMENTS AND IN RESEARCH PROJECTS EN STANDARDS Interfaces are covered in current EN standards, but in general, interchangeability of components is not seen as a normative requirement, and is not fully covered. The following EN standards are listed as examples: - EN 15020: rescue coupler (dimensions of coupler type 10 given as informative) - EN : brake indicator (dimensions given as informative) - EN : brake discs (dimensions given as informative) The standard EN : wheels gives a checklist of aspects to be considered in order to ensure interchangeability of wheels (see the case study wheel in section 8.5); the approach is similar to those for IC in TSIs (definition of area of use; see section 5.4.2). ERA/REP/ /INT Version 3 Page 25 of 56