1. Welcome Добродошао Sveiki atvykę 1

2. Workshop on Safety Management System, Safety Certification, Safety Authorisation and Supervision Day 2 : 14 November 2014, Serbia Mr. Antanas Dubikaitis 2

3. Agenda 1.Safety Authorisation 2.CSM for Supervision 3.CSM for Monitoring 3

4. CSM CA 1169/2010 Format of the SA Practice example Safety authorisation 4

5. SA 5 Safety Authorisation

6. Who can be granted a SA?  If a company is considered as an IM (i.e. it establishes and maintains railway infrastructure which may include the management of infrastructure control and safety systems), it shall have a SA according to the RSD to be authorised to carry out its maintenance activities on an infrastructure. 6

7. Common safety method for assessing conformity with the requirements for obtaining a railway safety authorisation CSM CA 1169/2010 7

8. CSM CA 1169/2010 Development  Started by ERA in 2005.  Initial draft criteria were made available for all NSAs in 2007.  Official SA evaluation by criteria started from 2011. 8

9. Criteria for assessing applications by IM for SA 9

10. Differences between SC and SA criteria  The elements from A to S are common either to RU’s or to IM’s SMS.  In SA case, there are no criteria for “Part B” as in SC  However there are additional criteria only for IM 10

11. Additional criteria for assessing applications by IM for SA The elements of SMSReference to the RSDReference in the CSM CA 1169/2010 SAFE DESIGN OF THE RAILWAY INFRASTRUCTURE Article 11(1)(b)T SAFE OPERATION OF THE INFRASTRUCTURE Article 11(1)(b)U PROVISION OF MAINTENANCE & MATERIAL Article 11(1)(b)V MAINTENANCE AND OPERATION OF THE TRAFFIC CONTROL AND SIGNALLING SYSTEM Article 11(1)(b)W 11

12. Procedures for assessing conformity with requirements for obtaining SA 12

13. NSA has to establish procedures for assessment of applications for obtaining SA 13 Framework principles Setting up and reviewing QualityScopeTiming Decision making

14. A. Setting up and reviewing the assessment process 14 Structured and auditable processes should be undertaken by competent persons. Applications should be scrutinised against the assessment criteria for SMS set out in Annex II. All decisions should be recorded and justified Process should be periodically internally reviewed and continuously improved

15. B. Quality of the assessment process  NSAs shall monitor the quality of their own performance at key stages in the processing of applications for safety authorisations. 15

16. C. Scope of the assessment 16 In case of deficiencies, NSA shall outline the points which need to be enhanced. Shall be appropriate to the risks, character and extent of operations of the IM. Shall be based on judgments of the IM’s overall ability to operate safely as described in its SMS.

17. C. Scope of the assessment 17 The NSA shall assess whether the attached summary of the SMS allows an initial judgment and shall decide in which areas further information is necessary. The NSA may seek as much detailed information as it deems reasonably necessary to help its assessment of the application. Compliance of the applicant's SMS with the assessment criteria shall be documented in relation to each assessment criterion.

18. D. Timing of the assessment  NSAs shall complete the assessment within the time of 4 months whilst ensuring that the evidence provided by the applicant is sufficiently examined.  The NSA shall inform IMs of issues of major concern as early as practically possible during the assessment phase. 18

19. E. Decision making during the assessment  A decision to accept or reject an application for a SA shall be based on: -the evidence provided by the applicant and on -whether compliance with the relevant requirements has been shown or not. 19

20. Format for Safety Authorisation 20

21. ERA GUIDANCE 21

22. Practice example of Lithuania Legal framework State Railway Inspectorate assessment of SA JSC “Lithuanian Railways” application for SA Good practice 22

23. Legal framework 23

24. IM definition  ‘infrastructure manager’ means any body or undertaking that has legal basis for managing railway infrastructure.  In Lithuania there are approximately 150 IM (sidings) and 1 IM for public railway infrastructure.  All of them are oblige to obtain SA. 24

25. SA definition PART A PART B Safety authorisation 25

26. State Railway Inspectorate (VGI) assessment of SA 26

27. VGI assessment process Receive application Initial assessment Formal assessment Recording and confirmation Award of SA 27 4 MONTHS

28. Receive an application  VGI receipts documents and notifies applicant.  Applicant can submit application via IT system or by submitting documents to VGI office by e-mail, mail, fax.  VGI assigns the assessors to assess the application. 28

29. Initial assessment  Within 3 days after receiving application, assessor reviews documentation and gives feedback to the applicant if necessary.  In case submitted documents are not complete/correct or insufficient, applicant is oblige to provide requested information within 30 days.  The aim of initial review is to undertake initial screen of application to check that all the documentation is correct/complete. 29

30. Example of checklist of initial review Part A 30 NumberDocumentYes/NoNotes 1.Application for SA Part ANoApplication submitted, but not in the right form 2.Documents which proves applicant’s entity Yes- 3.Documents which proves that applicant owns and/or manages railway infrastructure Yes- 4.Description of SMSNo-

31. Example of checklist of initial review Part B 31 NumberDocumentYes/No/NANotes 1.Application for SA Part BYes 2.List of NSRs and TSIs which are related to SMS processes Yes- 3.List of applicant’s staff categories Yes- 4.List of vehicles types (if applicable) NA- 5.Copies of APIS of vehicles if they were granted in other MSs (if applicable) NA-

32. Example of content of the document for additional information 1)Identified deficiencies 2)Legal base 3)Justification for identified deficiencies 4)List of additional documents or descriptions of SMS which applicant has to provide 5)Suggestions to the applicant how identified deficiencies could be closed 32

33. Formal assessment  When the application and submitted documents are correct/complete, the assessors start formal assessment of SMS against criteria set in CSM CA 1169/2010 Annex II.  First meeting of the assessors to review the assessment has to be organized within one month after start of formal assessment of SMS. 33

34. Formal assessment  During the formal assessment of applicant’s SMS, assessors can request additional information if necessary and determine timetable to provide it.  During the assessment of SA, assessors also check the CSM on monitoring implementation in the SMS.  During the assessment, assessors can suggest which sections of SMS should be checked during supervision. 34

35. Example of checklist of SA assessment Number of criteria Criteria descriptionDocument section/paragraph Result of the assessment (conform/not conform) Justification if deficiencies were identified Notes and suggestions to conform with assessment criteria for applicant S. PROVISIONS FOR RECURRENT INTERNAL AUDITING OF THE SAFETY MANAGEMENT SYSTEM S1There is an internal auditing system which is independent and impartial and which acts in a transparent way. SMS chapter internal auditing paragraph 7.5 Conform-- S2There is a schedule of planned internal audits which can be revised depending on the results of previous audits and monitoring of performance. SMS chapter internal auditing chapter 7.5 Not conformSchedule of internal audits is missing Prepare the schedule of SMS internal audit …….……….. 35

36. Example of checklist of CSM MO assessment Number of criteria Criteria descriptionDocument section/paragraph Result of the assessment (conform/not conform) Justification if deficiencies were identified Notes and suggestions to conform with assessment criteria for applicant 2.1Based on their management system, each railway undertaking, infrastructure manager and entity in charge of maintenance shall be responsible for defining its strategy, priorities and plan(s) for monitoring. SMS paragraph 8.9Not conformStrategy for monitoring is missing Prepare and describe the strategy for monitoring processes …….……….. 36

37. Recording and confirmation  All assessors after formal assessment is finalised issue an opinion during the meeting of assessors (or via IT system) to the Director of NSA to issue/not issue the SA.  Director of NSA confirms (signs) the decision of assessors. 37

38. Award of SA  Applicant within 3 days is informed that decision to issue a SA is adopted.  Applicant has to pay a fee for SA assessment.  VGI issues formal SA form and provides it to applicant.  VGI informs ERA within 30 days. 38

39. Format of SA Part A 39

40. Format of SA Part B 40

41. JSC “Lithuanian Railways” application 41

42. JSC “Lithuanian railways”  Public IM and Main RU  1767 km of railway lines: A.122 km of electrified lines B.391 km of double tracks C.22 km of 1435 mm D.The rest 1520 mm  104 railway stations  545 level crossings  10.6 thousand people  100 % state owned 42

43. JSC “Lithuanian Railways” SA Timetable  Applied for Part A in 2008/11  VGI Issued Part A in 2008/12  Applied for Part B in 2009/02  VGI Issued Part B in 2009/02  Applied for renewal Part A and Part B 2013/12  VGI reassessment of Part A and Part B 2013/12 - till now 43

44. JSC “Lithuanian Railways” SA assessment, 1 Story  Was difficult for VGI and IM  There were no CSM on CA 1169/2010 and national criteria either  SA granted on RSD Annex III SMS elements basis 44

45. JSC “Lithuanian Railways” SA assessment, 2 Story  From 2011 change of legislation  VGI started an audit of SMS, element S  SMS didn’t comply with 1169/2010 criteria  IM was oblige to renew the SMS 45

46. JSC “Lithuanian Railways” SA assessment, 3 Story  Application for renewal Part A and Part B in 2013/12  VGI started reassessment and audited practical implementation of all SMS criteria within the IM  SMS didn’t comply with 51 criteria of 105  IM produced the plan to close deficiencies  Process is still going on.. 46

47. Good practice 47

48. Good practice  Help/Guidance to applicants in all possible ways  Typical SMS for small IMs  Guidance on SMS internal auditing  Internal auditing of SMS (S criteria) is the most important  Development of IT systems  Be not afraid to seek guidance and help from NSAs/ERA/COM if necessary 48

49. Reference list http://www.era.europa.eu/Core-Activities/Safety/Regulatory- Framework/Pages/CSM-for-Conformity-Assessment.aspx 49

50. Thank you for your attention! Any Questions? 50