Dissemination on CSM on monitoring, CSM on risk assessment and certification of ECMs

Transcription

1 Dissemination on CSM on monitoring, CSM on risk assessment and certification of ECMs Day 2 Borlänge 12th and 13th November 2013

2 Agenda

3 2 nd day: 08:30 to 16:00 08:30 09:00: Registration and coffee 09:00 09:15: Opening of the workshop 09:15 10:45:CSM on monitoring Agenda 2 nd day of workshop 10:45 11:30: The central role of the SMS in the regulatory framework 11:30 12:00: Presentation of the answers from NSA SE letter to ERA 12:00 13:00: Lunch Break 13:00 13:15: ECM maintenance system 13:15 14:00: Allocation of responsibilities 14:00 14:30: ECM certification scheme 14:30 15:00: Coffee Break Slide n 3

4 2 nd day: 08:30 to 16:00 14:30 15:00: Coffee Break 15:00 15:30: ECM certification in Sweden 15:30 15:45: ERADIS ECM certification dedicated space 15:45 16:00: Discussion and conclusion Agenda 2 nd day of workshop Slide n 4

5 CSM for monitoring to be used by RUs, IMs and ECMs An overview on the Regulation 1078/2012

6 The CSM for Monitoring does not introduce substantial novelties in the monitoring process as it is traditionally intended in the management systems. Aim of the CSM Definition of an harmonised scheme to monitor and improve management systems, shaped on the criticalities of railway Scope of the CSM Railway Undertakings Infrastructure Managers Entities in Charge of Maintenance EC Regulation 1078/ CSM for Monitoring Slide n 6

7 5 steps for the harmonisation Management System 1. definition of a strategy, priorities and plan(s) for monitoring; 2. collection and analysis of information; 3. definition of an action plan, for the identified non-compliances that are not acceptable; 4. implementation of the action plan, if such plan is defined; 5. evaluation of the effectiveness of the action plan measures, if such plan is defined. Data collection NO Non Compliances YES Strategy, priorities and plans Qualitative and quantitative Indicators Analysis of Non Compliances Acceptable NO YES Definition Action Plan Implemen. Action Plan Evaluation Action Plan Slide n 7

8 Key points of the CSM for Monitoring The CSM contains some specific requirements concerning: Prioritisation Proactivity Coordination Traceability These requirements were defined considering the following key processes: Risk Management Interface management Supervision and Surveillance Slide n 8

9 Prioritisation CSM requires to monitor implementation and effectiveness: all the processes and procedures the management system as a whole In a real business scenario, a finite amount of resources is normally allocated on the monitoring process: the actors need to prioritize to grant appropriate setup of monitoring concerning safety critical processes. A risk based prioritization is recommended Slide n 9

10 Monitoring the management system as a whole Input Sub-Process 1 Monitoring the activities Input Sub-Process 2 Input Sub-Process 3 Input Sub-Process 4 Sub-Process 5a Output Sub-Process 5b Output Monitoring the system Slide n 10

11 EXAMPLE: Priority defined using Risk Assessment ID Hazard Events RPN Wrong shunting operation Shunting operation not authorized Irregular shunting operation 0,214. 0,199. 0, Prioritizing can mean: Definition of the tools used for monitoring Prioritisation Risk Priority Number R= Frequency x Severity Used in Risk Management to prioritise risk control measures Usable in Monitoring to prioritise monitoring of processes and procedures Definition of the sufficient level of detail (e.g. safety indicators) Definition of the correct frequency of checks, audits, etc. Slide n 11

12 Proactivity The monitoring process shall be designed in order to prevent the occurrence of unwanted events. Early warnings on possible safety degradation One possible strategy: identification and detection of precursors Risk Management Monitoring Slide n 12

13 Proactivity EXAMPLE: The use of FTA allows to identify causes improving the proactivity of the system CRACKED SPRING AND ID Hazardous Events 6 Cracked Springs PRECURSOR PRECURSOR ID Causes Intermediate Events OR AND 6.2 Missed check of the suspension PRECURSOR PRECURSOR PRECURSOR 6.3 Mismanagement in the staff competence OR AND 6.4 Workshop Staff is not fit-for-work BASIC BASIC BASIC RCM RCM Slide n 13

14 Coordination Railway is a complex system with many interfaces. RUs, IMs and ECMs using contractors, remain responsible for their safety performance. The CSM requests: Exchange of information between railway actors concerning new risks; Contractual arrangements to define an exchange of information necessary to monitor and control the railway risks. Slide n 14

15 Traceability The monitoring process shall be sufficiently documented to manage the process and to allow: Supervision activity, by the competent NSA, on RUs and IMs; Surveillance activity by the ECM Certification Body. Essentials: Organisation and responsibilities for monitoring Records and reports Corrective and preventive measures Slide n 15

16 Using the CSM for Monitoring WHAT for and WHO shall use it? Regulation 1078/2012 CSM for Monitoring Aim: To provide an Harmonised scheme to monitor the performances and to improve the Management System according to the objectives. Scope: The CSM shall be used from RUs/IMs/ECMs. Keywords: Monitoring, performances, early warnings, strategy, priority, plan, improvement, process, interfaces. Slide n 16

17 CSM for Monitoring PRACTICAL IMPLEMENTATION Slide n 17

18 Disclaimer IMPORTANT DISCLAIMER The content of this presentation it s not intended to be exhaustive and it is not a legal reference or a mandatory way to design or implement the Maintenance System of an ECM. With this presentation the European Railway Agency means to support ECMs in the implementation of a Maintenance System through the understanding of the basic principles of the European legislation. Slide n 18

19 About this presentation Introduction: Example concerning the design of indicators to be used in the monitoring process. Contents: Definition of Strategy for monitoring; Process Identification (to be monitored); Tools to collect data; Setup of indicators. Slide 19 Slide n 19

20 Designing monitoring Strategy Where do we start from? From the Maintenance Policy: to preserve the business it s crucial to provide a safe maintenance service in order to avoid the occurrence of accidents As consequence the GOAL is: The monitoring process, must be capable to give early warnings allowing the management to correct and improve maintenance. Slide 20 Slide n 20

21 Designing monitoring Strategy The strategy to achieve the goal is: Identification of the processes designed within the Maintenance system. Definition of the approach to design monitoring process Definition of the tools to collect information and data Setup of indicators Data Analysis Involvement of the management in the Safety Review Definition of Action Plans and Responsibilities. Only these points are reported in this presentation Slide n 21

22 Designing monitoring Process identification How do we identify processes? Legal requirements: The inputs to the monitoring process shall be all the processes and procedures contained in the management system EC Regulation n.1078/2012 CSM for Monitoring List of processes contained in the System of Maintenance Maintenance delivery; Monitoring; Staff Recruitment and Training; Document management; Risk Management; From the Maintenance Manual of the ECM Slide n 22

23 Designing monitoring Approach for designing the monitoring process Possible approaches to design the monitoring process: Design based on the results of Risk Assessment: Proactive and systematic; Time consuming, Resource demanding. Design based on technical expertise: Use of internal resources, faster, cheaper; Experience based, new issues will not be foreseen. Which approach should be used? Slide n 23

24 Approach for designing the monitoring process Both of them, it depends from your PRIORITIES! Design based on the results of Risk Assessment: Proactive and systematic; OPERATIONS Time consuming, Resource demanding. Designing monitoring Design based on technical expertise: Use of internal resources, faster, cheaper; OTHER PROCESSES Applied to the remaining processes. Slide n 24

25 Designing monitoring Tools for data collection Technical tools: Database; Intranet; IT devices;. To be defined in the Maintenance System: Data input: Data reliability; Data availability; Traceability of the information; Exchange of information; Access rights for users; Responsibilities; Slide n 25

26 Designing monitoring Tools for data collection Organizational tools Internal Audits Investigations Hierarchical check Systematic Feedback from the staff Non Systematic (but necessary) These are the most common tools to support monitoring Slide n 26

27 Designing monitoring Tools for data collection Organizational tools: Internal Audits; Investigations; Hierarchical check; Feedback from the staff. To be defined in the Maintenance system: Scheduling; Planning; Responsibilities; Instructions; Reporting; Management of Non Conformities; Collection of information; Use of the technical tools; Slide n 27

28 Designing monitoring Indicators What is an indicator? An indicator can reveal the trend, the state or the level of an event or a parameter: How fast is it? What is the trend? Type of indicators: For our purpose the indicators will be classified in: Quantitative 100kph, 1000rpm, etc. Qualitative fast, cold, positive or negative trend, etc. Slide n 28

29 How indicators can be defined? Designing monitoring Setup of indicators 2004/49/EC* National Rules Risk Management Business Common Safety Indicators (CSI)* National Safety Indicators Internal Safety Indicators Safety Indicators Others *= Indicators are designed to be used by the RUs/IMs but can be partially adapted to the Monitoring of a Maintenance System Slide n 29

30 Failures that provoked accidents: European Legislation and National Safety Rules E.g. Directive 2004/49/EC (Safety Directive); National Safety Rules. Hazardous events and Risk Control Measures (RCMs): Risk Assessment: Hazard Log to identify main events; Fault Tree Analysis to enhance proactivity and details of hazardous events. Technical Expertize: Designing monitoring Set up of indicators Process analysis to define indicators to verify the implementation and the efficiency of RCMs. Slide n 30

31 Designing monitoring Example of Indicators EXAMPLE - Indicators: Broken axles Broken Axles (BA) Maintained Axles (MA) BA MA ,0E-03 5,0E-04 4,0E-04 2,0E-04 2,3E-04 3,3E-04 The figures are not real Slide n 31

32 Designing monitoring Example of Indicators EXAMPLE - Indicators: Broken axles Broken Axles (BA) Maintained Axles (MA) BA MA ,0E-03 5,0E-04 4,0E-04 2,0E-04 2,3E-04 3,3E-04 The figures are not real Slide 32 Slide n 32

33 Designing monitoring Example of Indicators Maintained Axles (MA) Broken Axles (BA) BA / MA The chart has an illustrative purpose, figures are intentionally omitted Slide 33 Slide n 33

34 Designing monitoring Set up of indicators using Risk Assessment Use of the results of Risk Assessment to define indicators: Risk Assessment by the Manufacturer ID Hazard Events Hot Axle boxes. Hazard Record (Log) 7 Axle Failure Fire. N. Slide n 34

35 Designing monitoring Set up of indicators using Risk Assessment WAG TSI + CSM for Risk Assessment + Technical Standards ID Hazard Events Hot Axle boxes. 7 Axle Failure. Risks Managed through the design of the wagon Risks exported with operational instructions Fire. N. Risks exported with technical file Slide n 35

36 Designing monitoring Set up of indicators using Risk Assessment Maintenance file Use of the results of Risk Assessment to define indicators: Risks exported by the manufacturer with technical file Keeper Scheduling based on mileage and time ECM Instructions for assembling/disassembling List of maintenance operations (inspection, replacement, etc.) Slide n 36

37 Designing monitoring Set up of indicators using Risk Assessment The maintenance operations foreseen in the Maintenance File are the result of a Risk Assessment process. Type: Subsystem Flat Wagon Description of the maintenance activity Maintenance Level A B C Running Gear Check the presence of defects and damages on the wheel sets X X X Wagon Frame Check of the wagon against the presence of corrosion and worn parts How indicators can be defined? X X X Slide n 37

38 Indicators from Maintenance Operations Designing monitoring Set up of indicators using Risk Assessment Type: Running Gear Running Gear Wagon Frame Flat Wagon Check the presence of defects and damages on the wheel sets Suspension springs: Removal, cleaning, cracks verification, etc. Check of the wagon against the presence of corrosion and worn parts ID Indicator 1 8 Defects and Damages on the wheel set 9 Cracked springs Corrosion in the frame of the wagon N Slide n 38

39 Designing monitoring Set up of indicators using Risk Assessment Indicators defined trough the use of the technical or maintenance file can be used to monitor different aspects of the ECM activity. ID Indicator 1 8 Defects and Damages on the wheel set 9 Cracked springs N Corrosion in the frame of the wagon e.g.: Indicator n. 9 Cracked Springs It can be used as follow: A lot of cracked springs CAN reveal a problem in the QMS of the supplier; The detection of cracked springs during an audit on a wagon, ready to be released to service, CAN reveal a problem in the competence of the workshop operators. Slide n 39

40 Designing monitoring Set up of indicators with Process Analysis The FTA allows to identify causes improving the proactivity of the system, and it can be used to support prioritization: CRACKED SPRING AND ID Hazardous Events 6 Cracked Springs PRECURSOR PRECURSOR ID Causes Intermediate Events OR AND 6.2 Missed check of the suspension PRECURSOR PRECURSOR PRECURSOR 6.3 Workshop Staff not competent OR AND 6.4 Workshop Staff is not fit-for-work BASIC BASIC BASIC RCM RCM How to setup indicators for RCM? Slide n 40

41 Designing monitoring Set up of indicators with Process Analysis Training process (a short extract) Unskilled staff Health check Classroom training EXAM Practical training EXAM Trained staff GOAL: Check on efficiency and Implementation of RCMs Process analysis with experts; Use of expertise to identify indicators. ID EXAMPLE: Health Checks Example of indicators for health checks Missing or wrong health check Missed check and documentation regarding health checks and requirements Health issues = Risk Control Measure Slide n 41

42 Designing monitoring Set up of indicators Definition for indicators A definition was given to each of the indicators; The definition contains: Event that must be monitored; When the operator/system will feed the indicator. ID 6 Name of the Indicator Cracked Springs Event Failure of springs belonging to the suspension of the wagon Criterion to feed the indicator The indicator must be fed when the staff of the RU dedicated to predeparture check detects the fault. The exchange of data concerning monitoring between the RU and the ECM shall be ruled in each of the management systems and defined via contractual arrangements. Slide n 42

43 The definition applied to the indicators is VERY important. Designing monitoring Set up of indicators Maintained wagon EXAMPLE: comparison between definitions Criterion to feed the indicator - 1 The indicator must be fed when the issue is detected during inspection done by the RU. Criterion to feed the indicator - 2 The indicator must be fed when the issue is detected during pre-departure checks. There is no right definition, it depends from what needs to be monitored. Release to service Inspection by the RU or other checks RU takes in charge the wagon Pre-departure checks (wagon master - RU) Running wagon Return to operations Slide n 43

44 Conclusions The output of the last step, Setup Indicators, is the list of all the indicators defined. It is important to grant the traceability of the origin of the indicator. From Hazard Log From Fault Tree Analysis From National Safety Rules From Railway Safety Directive For relative Values Slide n 44

45 Conclusions The example doesn t include the whole process! Identification of the processes designed within the SMS Definition of the approach to design monitoring process Definition of the tools to collect information and data Setup of indicators Data Analysis Only these points are reported in this example Involvement of the management in the Safety Review Definition of Action Plans Assignment of responsibilities in Monitoring Slide n 45

46 Any doubt? Any question? Slide n 46

47 The SMS and the regulatory framework A description of the regulatory context of the SMS

48 Where the SMS fits into the regulatory framework Overview on the European legislation for safety CSM for Risk Assessment Reg. (EU) 402/2013 CSM for Monitoring Reg. (EU) 1178/2012 Railway Safety Directive Dir. 2004/49/EC SMS ECM Reg. 445/2011 CSM for Conformity Assessment Reg. (EU) 1158/2010 RUs Reg. (EU) 1169/ IMs Safe Operations CSM for Supervision Reg. (EU) 1077/2012 Slide n 48

49 RSD - Basic elements Introduction to ERA SMS guidelines The SMS wheel Processes for design and improvement Processes for implementation Operational activities Processes classification Processes and activities Slide n 49

50 Fundamental principles: CSM describes a process for managing changes The aim is to harmonise the process mutual recognition Where the SMS fits into the regulatory framework CSM for Risk Evaluation and Assessment (EC) No 402/2013 The Risk Assessment process shall be defined within the SMS Slide n 50

51 Fundamental principles: CSM defines basic elements for a monitoring process The aim is to harmonise the process mutual recognition Where the SMS fits into the regulatory framework CSM for Monitoring The Monitoring process shall be defined within the SMS Reg. (EU) N. 1078/2012 Dissemination Workshop of on the SMS, CSM ECM for Regulation, Risk Assessment CSM on and monitoring CSM for Monitoring and CSM on risk assessment Copenhagen Borlänge 12- th May and rd th, 2013 November 2013 Slide n 51

52 Fundamental principles: ECM regulation defines structured and auditable approach to maintenance management Harmonised approach to asset management Harmonised way to select and control suppliers and contractors Harmonised maintenance delivery Where the SMS fits into the regulatory framework ECM Regulation Reg. (EU) N. 445/2011 Slide n 52

53 Fundamental principles: CSM to assess the conformity of SMS Aim - Harmonization of the process building mutual trust among the NSAs Where the SMS fits into the regulatory framework CSM for Conformity Assessment Reg. (EU) N. 1158/2010 Reg. (EU) N. 1169/2010 Slide n 53

54 Fundamental principles: The content ensures that safety performance is managed by RUs/IMs Focus of the NSA activities Aim - Harmonization of the process building mutual trust among the NSAs Where the SMS fits into the regulatory framework CSM for Supervision Reg. (EU) N. 1077/2012 Slide n 54

55 Any doubt? Any question? Slide n 55

56 Presentation of the answers from NSA SE letter to ERA

57 Questions regarding CSM monitoring + The central role of the SMS in the regulatory framework: A general presentation about ERA s strategy for monitoring and supervision would be very helpful for our work. The CSM for Monitoring is to be applied by RUs, IMs and ECMs to monitor their safety performances and to improve the management system, if necessary. Excluding the annual reporting from NSAs, the Agency is actively involved in the monitoring process, then the Agency has no strategy for monitoring. The CSM for Supervision is to be applied by the NSAs to supervise the implementation of the SMS by RUs and IMs. For this reason, the Agency doesn t an active role in the implementation of the supervision process and as consequence the Agency has no strategy for Supervision. For further information please refer to the TF on supervision, which you are part of. Slide n 57

58 According to 1078/2012 the effectiveness of the action plans shall be evaluated. It would be very helpful if ERA could explain how that can or shall be done? Further explanations will be given in the Guidance. How will 1078/2012 be applied by ECMs? How and by whom will it be supervised that ECMs apply 1078/2012? The regulation 1078/2012 shall be applied by the ECMs defining a monitoring process within their management systems. Please note that the regulation applies also to non-certified ECMs. The supervision will be done by the ECM certification body, as stated in the EC Regulation 445/2011. Will there be a guideline for 1078/2012? If so, when will it be published? A guideline is under development; its publication is foreseen before the end of January Slide n 58

59 Further explanations will be given in the Guidance. How will 1078/2012 be applied by ECMs? How and by whom will it be supervised that ECMs apply 1078/2012? The regulation 1078/2012 shall be applied by the ECMs defining a monitoring process within their management systems. Please note that the regulation applies also to non-certified ECMs. The supervision will be done by the ECM certification body, as stated in the EC Regulation 445/2011. Will there be a guideline for 1078/2012? If so, when will it be published? A guideline is under development; its publication is foreseen before the end of January Slide n 59

60 According to 1078/2012 the effectiveness of the action plans shall be evaluated. It would be very helpful if ERA could explain how that can or shall be done? The regulation 1078/2012 is to be applied at the company level. It defines a harmonized set of activities composing the process for monitoring and continuous improve the management system. Please note that nothing new has been introduced by the above mentioned regulation, in fact monitoring and continuous improvement were already foreseen in the Directive 2004/49/EC. The regulation 1078/2012 is only providing essential requirements to be fulfilled to support the mutual recognition. The regulations 1158 and 1169 are to be applied at the level of the NSA to assess the SMS of RUs and IMs to issue (if the case) the safety certificate/authorization. The aim is to harmonise the assessment of the SMS within the European Union. The regulation 1077/2012 provides the essential requirement for an harmonisation of the supervision of RUs and IMs by the NSA. The concept of supervising RUs and IMs activities was already stated in the Directive 2004/49/EC. Slide n 60

61 According to 1078/2012 the monitoring strategy and plan(s) shall define either quantitative or qualitative indicators or a mixture of both. It would be very helpful if ERA could give examples of quantitative and qualitative indicators. Further explanations will be given in the Guidance. By the way, a minimum set of leading and lagging indicators is already defined in the Annex 1 of the Directive 2004/49/EC. Slide n 61

62 Questions regarding CSM RA : How to ensure that all NSA does similar assessments in the supervision of the companies applying the CSM? There is a task force organized by the Agency to work on this issue. The first meeting was in September What determines who becomes the proposer of the change. Example: if an RU proposes a change in an IM rules - becomes the RU or IM the proposer? Can you be proposer for something that one has no control over? If you are the proposer, you must have control over the change to be able to define correctly the change and the control measures that you will put in place, specially the control of interfaces with other railway stakeholders. What is the schedule for the ERA guidelines related to CSM? It is foreseen to publish a guideline on the revision 402/2013, specially explaining the role of ASBO by the end of March 2014 Slide n 62

63 Questions regarding the approval process : Is it possible for NoBo to issue EG-certificate with restrictions, conditions provisions and constrains? The Agency has provided an advice to EC on this subject (ERA-ADV published in ERA web-site). Summarising, we think that the legislation today, in case of not full compliance with a TSI, allows a NoBo to issue a certificate only in cases foreseen by the Directive (and, in some cases this means that derogations must be granted, according to the provisions of the Directive). National rules may be applied when required by the TSI (open points) or as a consequence of a derogation. What is the definition of a vehicle type according to art. 26 in 2008/57/EU? E.g. will it be a new type if there is a new version (Bl2/Bl3) of subsystem CCO installed in the vehicle? absolutely YES (the compatibility of the vehicle with trackside changes a lot) Slide n 63

64 Shall the NoBo technical file also contain the DeBo report and the CSM-RA safe integration report? it is the responsibility of the applicant to put everything together Slide n 64

65 The maintenance system of an ECM An overview on maintenance management system

66 The different actors RU Train path purchase IM Contract of use GCU CUSTOMERS NSA ECM CERTIFICATION BODY certify KEEPER Maintenance contract ECM Slide n 66

67 Railway Safety Directive 2004/49 (Article 14a) Legal framework of ECM certification Commission Regulation 445/ maintenance system and certification of ECM and maintenance workshops for freight wagons Implementation documents: guidelines, accreditation and certification schemes mandatory (Art. 6 of EU Regulation 445/2011) Cooperation of certification bodies (Art. 6 of EU Regulation 445/2011) Public database of ECM certificates (Art. 10 of EU Regulation 445/2011) OTIF rules (ATMF annex A) = identical to Commission Regulation 445/2011 Slide n 67

68 On-going activities Dissemination: (National) workshops organised by NSAs (Sectoral) workshops organised by Sector Associations Trainings to accreditation bodies and certification bodies Guidance Feedback process related to implementation of ECM certification (Article 14a of Safety Directive) Public database of ECM certificates (Art. 10 of EU Reg. 445/2011) Includes also certificates of maintenance workshops Update of ERADIS in force on 01 June ECM certification = European certification Slide n 68

69 Past workshops: Poland - January 2013 Hungary - February 2013 Macedonia - March IPA Project Germany - March UIP seminar Portugal - April 2013 Denmark - May 2013 Turkey - June 2013 IPA Romania - October 2013 Sweden - November 2013 ECM dissemination workshops in 2013 In green: ECM dissemination organised by NSA In yellow: No ECM dissemination In white: other ECM dissemination ( IPA-UIP.) Future workshop: Slovenia - December 2013 Slide n 69

70 Transitional provisions Beginning of self-declared ECM Article 10(1) 30/11 Member States Accreditation Recognition NSA Article 12(6) 31/05 ECM End of validity of any self-declared ECM 4th railway package?? Revision Regulation 445/2011/EC Revision Regulation 445/2011/EC Article 12(2) Article 12(3) Beginning of ECM MoU certificate Regulation 445/2011/EC 31/05 ECM Start validity of ECM certificates 445/2011/EC Certification according to ECM MoU no longer accepted 31/05 ECM End of validity of any ECM MoU certificate Slide n 70

71 The scope of the ECM certification An overview on the ECM certification

72 Scope of ECM certification Maintenance functions Establish the maintenance file Remove from operation and return to operation Deliver the technical maintenance tasks MANAGEMENT PROCESS Slide n 72

73 Scope of ECM certification Maintenance functions Remove to operation Slide n 73

74 Scope of ECM certification 3. Maintenance functions (IV) Slide n 74

75 Scope of ECM certification 5. scenario 1 Maintenance management Fleet maintenance management Maintenance development The 4 functions Maintenance management Maintenance development Fleet maintenance management Maintenance delivery are carried out y the ECM itself Maintenance delivery ECM Slide n 75

76 Scope of ECM certification 6.scenario 2- annex1-445 Fleet maintenance management Maintenance development Fleet maintenance management Maintenance development Maintenance management Maintenance delivery Maintenance management Maintenance delivery ECM ECM The function Maintenance management is carried out y the ECM itself (mandatory) the other functions may be outsourced Fleet maintenance management Maintenance delivery Maintenance management Maintenance development The ECM may outsource a function but not the responsability! ECM Slide n 76

77 Example : Derailment in Bressanone The 1 st wagon derailed (type: Eaos, EVN n ) Keeper: Rail Cargo Austria, registered in the Austrian NVR ECM: ÖBB Technische Services GmbH Slide n 77

78 Example : Derailment in Bressanone Both wheels (monoblock) of the 1 st axle and one wheel (monoblock) of the 4 th axle displaced. Accidental displacement of the wheels Slide n 78

79 Main feedback from the incident For the wheels of the first wheelset, the value of interference was also smaller than the prescription of the ECM (inferior limit value of interference smaller than the established inferior limit value in the maintenance rules) the exchange of information and transmission of documents between maintenance development function and maintenance delivery function was not good; The activity of internal control of ECM, in particular concerning the maintenance delivery function (priority in the case this function is external), should be improved; article 5(5) of regulation 445/2011 Exchange of information ECM to react in right way after an incident where the lack in the maintenance process is evident (important the activity of supervision of Certification Body Slide n 79

80 Any doubt? Any question? Slide n 80

81 The Role of the ECM and the allocation of responsibilities An overview on the certification process and requirements

82 Allocation of responsibilities Scenario - Some business models Contract of use Contract of Maintenance RUs Keeper ECM Slide n 82

83 Allocation of responsibilities Scenario - Some business models Internal ECM RU Contract of Maintenance Contract of use Keeper Slide n 83

84 Allocation of responsibilities Scenario - Some business models RU Contract of use Keeper = ECM Slide n 84

85 Allocation of responsibilities ECM Maintenance is under the responsibility of ECM Design operating state USE Degradation of performance Maintenance ECM Slide n 85

86 Allocation of responsibilities The role of the ECMs 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. The entity in charge of maintenance shall carry out the maintenance itself or make use of contracted maintenance workshops. Safety Directive 2004/49, Article 14a(3), 2 nd part The ECM must: set up and keep updated the maintenance file (maintenance development); ensure that the maintenance file is effectively applied (fleet management and delivery); coordinate all those activities and supervise its subcontractors. Slide n 86

87 Allocation of responsibilities ECM Exchange of information: Article 5(2) of Regulation (EC) 445/2011 The ECM has to address return to operation issues to RUs and keepers. Certification - Commission Regulation 445/2011 For FREIGHT WAGONS: The ECM must be certified against the Commission Regulation 445/2011; The ECM must inform its partners, RUs, IMs and Keepers, about all changes related to its certification, e.g. amendment, renewal, suspension, revocation. Slide n 87

88 Allocation of responsibilities Railway Undertaking RU Design operating state USE Degradation of performance Maintenance ECM Slide n 88

89 Allocation of responsibilities Railway Undertaking The Railway Undertaking (RU) shall be made responsible for safe operation and associated control of risks. Safety Directive 2004/49, Article 4(3) Through its SMS, the RU shall control all risks associated with its activities including supply of maintenance and use of contractors. Safety Directive 2004/49, Article 9(2) ECM certification provides assurance to RU that ECM is competent to address the risks associated to supply of maintenance; Article 5(1) of Commission Regulation 445/2011 imposes to RU to ensure that the ECM is registered in the NVR and appropriately certified. Slide n 89

90 Railway Undertaking/Infrastructure Manager ECM certificate assures these two requirements are met RU/IM RU/IM Allocation of responsibilities - Contracts Railway Undertaking Define what you need to control your risks and include it clearly in the contract (Supported by Risk Assessment) Check that the contractor is organised to deliver what you want Check contractor is competent to deliver what you want Monitor that the contractor is delivering what you want (Supported by Risk Assessment) Slide n 90

91 1. Certification is not a full guarantee of absence of errors; 2. Between maintenance interventions, risks of degradation of performance. Example of Risks to be controlled trough the Safety Management System Design operating state Allocation of responsibilities RU RU USE SMS control measures Degradation of performance Maintenance e.g. pre-departure checks, restrictions in operations, etc. ECM Slide n 91

92 The surface damages should have been detected and measures should have been taken at least on the following occasions : Feb 2002, wheels reprofiling at workshop; Oct 2002, wheelset overhaul at workshop; July 2004, wheels reprofiling at workshop; Feb 2008, on pit examination during wagon overhaul at workshop. Example : Derailment at Artenay (1) The 9 th march 2011, the 17 th and 19 th wagon of the freight train n derail in open track on the 4 track electrified line between Paris and Orleans, before the station of Artenay. The 17 th wagon has its first 3 axles derailed. The first wheelset axle is broken in two parts. Slide n 92

93 Example : Derailment at Artenay (2) SMS of RU Risk Control Measures such as pre-departure and en route inspections, restriction in operations. Relevant? The Safety Management System shall also take into account, where appropriate and reasonable, the risks arising as a result of activities by other parties Safety Directive 2004/49, Article 9(2) Appropriate? Reasonable? Slide n 93

94 Allocation of responsibilities Keeper RU KEEPER Design operating state USE Degradation of performance Maintenance ECM Slide n 94

95 Allocation of responsibilities Keeper keeper means the person or entity that, being the owner of a vehicle or having the right to use it, exploits the vehicle as a means of transport and is registered as such in the National Vehicle Register (NVR) provided for in Article 33 of Interoperability Directive 2008/57/EC. Safety Directive 2004/49, Article 3(s) According to NVR legal rules, the keeper is the registration holder in the sense of article 33 of Interoperability Directive 2008/57 (if not otherwise mentioned). Slide n 95

96 The keeper has contracts with ECM and RU Allocation of responsibilities Keeper Contract of use Contract RUs Keeper ECM The keeper is responsible for all its allocated contractual tasks Contractual tasks may be related to exchange of information between RU and ECM (keeper = intermediate) The keeper is also responsible to the RU to provide vehicles in conformity with the legislation: Vehicles with a valid authorisation for placing in service Freight wagons with ECM duly certified Slide n 96

97 Allocation of responsibilities Exchange of information The exchange of information It is an important requirement taken in account in the ECM Regulation for the 3 parts: RUs, keepers and ECMs. Some references and means TSI Telematic Application for Freight (TAF TSI), in order to harmonise all the information systems related to the transport of freight wagons; Private initiative: e.g. UIP, is developing a Rolling Stock reference Database (RSRD²) in order to respond to the TAF TSI requirements (Telematic Application Freight); Database ERADIS; NVR. Slide n 97

98 Any doubt? Any question? Slide n 98

99 The ECM certification scheme An overview on the ECM activities and relations with other actors

100 1. Context 2. State of play 3. Mandatory and voluntary certification 4. Certification process 5. Certification requirements 6. Relevant standards for certification 7. Why accreditation or recognition? 8. Type of certification bodies in EU ECM certification scheme Content Slide n 100

101 ECM certification scheme 1. Context Slide n 101

102 ECM certification scheme 2. State of play ISO Regulation 765/2008/EC European cooperation accreditation Supervises, monitors (cross auditing) Accreditation scheme EN National Accreditation Body Certification body Recognition by Member State Cooperation of Certification bodies (ERA) Designation by Member State NSA as Certification body Certification scheme Chap.9 and Chap ECM Certificate Slide n 102

103 ECM certification scheme Type of certification bodies NSA / Safety authority Accreditation Recognition by Member State NSA + accreditation Slide n 103

104 The different schema THE DIFFERENT SCHEMA (EU + EEA) 14 MS 3 MS 7 MS 3 MS ACCREDITATION RECOGNITION NSA NSA AND ACCREDITATION 104 Slide n 104

105 ECM certification scheme 3. Mandatory and voluntary certification Maintenance development and fleet management + Entity in charge of maintenance Maintenance development Fleet maintenance management Maintenance delivery Article 2.1 : the system of certification shall apply to any ECM for freight wagons Maintenance workshop Maintenance delivery function Article 2.2 : Maintenance workshop may apply the system of certification on a voluntary basis Slide n 105

106 ECM certification scheme 4. Certification process The process is similar to ISO 9001, the requirements are specific ( Annex 3) Initial application review Document review On-site audits On-site inspections Surveillance activities Review of the application collected to ensure that: Information is sufficient Certification activities can be prepared Assessment of maintenance documentation Evaluate presence of necessary processes (requirements) Evaluate implementation of maintenance system Evaluate appropriatness of competences in place Coherence between activities (sampling) Activities affecting safety Regular monitoring of representative areas and functions covered by the scope of the maintenance system Once a year starting of certification process 4 months DECISION Granting of ECM Certificate Slide n 106

107 ECM certification scheme 6. Relevant standards Initital application review Document review On-site audits On-site inspections Surveillance activities Review of the application to ensure that: Information is sufficient Certification activities can be prepared Collect necessary information on scope of maintenance system Evaluate presence of necessary processes (requirements) Evaluate implementation of maintenance system Evaluate appropriatness of competences in place Check sample of activities Regular monitoring of representative areas and functions covered by the scope of the maintenance system ISO 17021:2011 Chapter 7 Personnel -Resource requirements Competence Outsourcing Management ISO 17021:2011 ISO 17021:2011 ISO 17021:2011 EN 45011:1998 ISO (17065:2012) ISO 17021: (review of application) (stage 1 audit) (stage 2 audit) Chapter 8 part b 9.3 (surveillance) Slide n 107

108 ECM certification scheme 7. Why accreditation or recognition? Requirement of mutual recognition necessitates sufficient trust in the work performed by ECM certification bodies ACCREDITATION IS THE WAY PRIVILEGED BY THE EUROPEAN LEGISLATION TO ACHIEVE THIS TRUST BUT Regulation 765/2008 Article 5(2): when a MS decides not to use accreditation it shall demonstrate, to the Commission and the other MS, the equivalence of the national recognition scheme with the ECM accreditation The ECM accreditation scheme is the reference document for the demonstration Slide n 108

109 Any doubt? Any question? Slide n 109

110 ERADIS and ECMs The space dedicated to the certification

111 Welcome page ERA main website Registers ERADIS Slide n 111

112 Safety documents: Safety Certificates part A and B Licences ECM certificates and certification bodies Safety Indicators and Investigation reports moved to ERAIL NSA and NIB Annual Reports Interoperability documents: EC declarations of verification of subsystems EC declaration of conformity of interoperability constituents EC declaration of suitability for use of interoperability constituents Authorisation for placing in service Link to Virtual Vehicle Register Link to National Rules database of the Commission (Notif-IT) List of NSAs, NIBs and ECM organisations Content Slide n 112

113 Accessibility and developments Available for public, no login required Start of developments in 2006 First release launched in 2007 Continuously developed and upgraded with new functionality Latest upgrade in June 2012, including ECM module Schemas chosen in MS to award ECM certificates Certification Bodies accredited or recognized Certificates: ECM certificates ECM-MoU certificates Maintenance functions certificates Slide n 113

114 Getting access to ERADIS To submit information ERADIS user account required Accreditation Bodies and Recognition Bodies to inform ERA about users, who need access: First name Surname address ERA create user accounts Accreditation Bodies Recognition Bodies access to certification bodies part: Submit a new Certification Body or Recognised Body Amend/renew/suspend/revoke existing Certification Body Accreditation bodies to inform ERA on every change in users (create new or delete existing user) Slide n 114

115 195 ECM Certificates 445/ October 2013 The Netherlands; 5 Romania; 8 Slovenia; 1 United kingdom; 9 Norway; 1 Austria; 11 Sweden; 2 Ireland; 1 Croatia; 1 Belgium; 1 Spain; 10 Luxembourg; 1 Slovak Republic; 16 Poland; 20 Czech republic; 31 France; 4 Germany; 44 Switzerland; 7 Italy ; 8 Hungary ; 13 Greece; 1 Slide n 115

116 ECMs certified per country 09 October 2013 The United kingdom The Netherlands Spain Slovak Republic Luxembourg Poland Switzerland Italy Hungary Greece Germany France Czech Republic Belgium Austria Croatia Ireland Norway Sweden Romania Slovenia ECM/445 Accredited body 106 ECM/445 NSA 8 23 ECM/445 Recognised body 30 MoU Slide n 116

117 250 ECM/445 NUMBER ( May 2012-September2013) ECM NUMBER 50 0 June 2012 October 2012 November 2012 December 2012 January 2013 February 2013 March 2013 April 2013 May 2013 september 117 Slide n 117

118 Freight wagons covered by certified ECMs Origin of data: NVRs of 15 MS (FR, PL, IT, AT, CZ, DK, EE, LT, LU,NL, PT, RO, SK, SI, BE) August freight wagons freight wagons covered by certified ECMs (70%) freight wagons without registration of any ECM in NVRs (6,5%) Origin of data: UIP (covers 14 countries)- May freight wagons 92% of the total fleet of UIP members is covered by certified ECMs Slide n 118

119 129 Maintenance workshops certificates 445/ October 2013 Luxembourg; 1 Switzerland; 7 Italy ; 2 Romania; 2 Slovenia; 1 The Netherlands; 7 Poland; 2 Slovak republic ; 8 Portugal ; 1 Bulgaria; 2 Sweden; 8 Norway; 2 Ireland; 1 Austria; 19 Greece; 0 Hungary; 4 Belgium; 3 Czech republic; 20 Germany; 35 France; 4 Slide n 119

120 The implementation of the ECM certification is a success But there are areas that need improvement: Monitoring of the implementation: Quality of data collected by ERA to have a clear and complete image. Exchange of information between RUs, Keepers and ECMs should be improved. Clean-up of national rules addressing maintenance of freight wagons that might adversely impact the value of ECM certification. Further steps in 2014 Change from certification of ECMs to surveillance of certified ECMs. Facilitation activities (workshops, guidelines). Monitoring of the implementation. Implementation report by mid 2014 according to art 14 of Safety Directive 2004/49 Start of the revision process of Reg 445/2011 including the extension of scope. Slide n 120

121 Any doubt? Any question? Slide n 121

122 Discussion on relevant issues emerged from the presentations, general conclusions from the workshop

123 Many thanks for your attention! Slide n 123