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RIS RIS-2708-RST Rail Industry Standard Freight Technical Committee Audit Protocol Issue One: March 2015 Rail Industry Standard Published by: RSSB Block 2 Angel Square 1 Torrens Street London EC1V 1NY © Copyright [2015] Rail Safety and Standards Board Limited Uncontrolled When Printed Document comes into force 07/03/2015

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Page 1: Uncontrolled When Printed RIS - RSSB Iss 1.pdf · Appendix C Non-Conformance Report form 54 Appendix D. Observation record sheet ... 2.3.1 At the end of the audit the auditor and

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© Copyright [2015] Rail Safety and Standards Board Limited

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Issue record

Issue Date Comments

One March 2015 Original document produced at request of Freight Technical Committee based on their Business Standard BS005 and Commission Regulation (EU) number 445/2011.

Superseded or replaced documents

This Rail Industry Standard does not supersede or replace any other Railway Group documents.

Supply

The authoritative version of this document is available at www.rgsonline.co.uk. Uncontrolled copies of this document can be obtained from Communications, RSSB, Block 2, Angel Square, 1 Torrens Street, London EC1V 1NY, telephone 020 3142 5400 or e-mail [email protected]. Other Standards and associated documents can also be viewed at www.rgsonline.co.uk.

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Contents

Section Description Page

Part 1 Introduction 4 1.1 Purpose of this document 4 1.2 Application of this document 4 1.3 Health and safety responsibilities 4 1.4 The structure of this document 4 1.5 Copyright 4 1.6 Approval and authorisation of this document 4

Part 2 Requirements for auditing 5 2.1 Audit protocols 5 2.2 Auditing 6 2.3 Completion of audit 6

Appendices Appendix A Audit Protocol Sheets 8 Appendix B Audit Summary Sheet 53 Appendix C Non-Conformance Report form 54 Appendix D Observation record sheet 55

Definitions 56 References 57

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Part 1 Introduction

1.1 Purpose of this document

1.1.1 This document is a standard for an audit protocol provided by the Freight Technical Committee (FTC), for the rail industry to use if they so choose to do so.

1.1.2 This document is of specific application to wagon Entities in Charge of Maintenance (ECMs) embraced by Commission Regulation number 445/2011 and provides Appendices as an audit protocol. This document can be used by ECMs for internal audit, for audit of their suppliers, or for others to audit ECMs.

1.2 Application of this document

1.2.1 A member of RSSB may choose to adopt all or part of this document through internal procedures or contract conditions. Where this is the case the member of RSSB will specify the nature and extent of the application.

1.2.2 Therefore specific compliance requirements and dates have not been specified since these will be the subject of internal procedures or contract conditions.

1.3 Health and safety responsibilities

1.3.1 Users of documents published by RSSB are reminded of the need to consider their own responsibilities to ensure health and safety at work and their own duties under health and safety legislation. RSSB does not warrant that compliance with all or any documents published by RSSB is sufficient in itself to ensure safe systems of work or operation or to satisfy such responsibilities or duties.

1.4 The structure of this document

1.4.1 This document is set out as a series of requirements, in some cases followed by relevant guidance. The guidance is indicated by prefixing the paragraph number with the letter ‘G’.

1.5 Copyright

1.5.1 Copyright in the Railway Group documents is owned by Rail Safety and Standards Board Limited. All rights are hereby reserved. No Railway Group document (in whole or in part) may be reproduced, stored in a retrieval system, or transmitted, in any form or means, without the prior written permission of Rail Safety and Standards Board Limited, or as expressly permitted by law.

1.5.2 RSSB members are granted copyright licence in accordance with the Constitution Agreement relating to Rail Safety and Standards Board Limited.

1.5.3 In circumstances where Rail Safety and Standards Board Limited has granted a particular person or organisation permission to copy extracts from Railway Group documents, Rail Safety and Standards Board Limited accepts no responsibility for, nor any liability in connection with, the use of such extracts, or any claims arising there from. This disclaimer applies to all forms of media in which extracts from Railway Group documents may be reproduced.

1.6 Approval and authorisation of this document

1.6.1 The content of this document was endorsed by the Freight Technical Committee on 27 November 2014.

1.6.2 The content of this document was approved by Rolling Stock Standards Committee on 16 January 2015.

1.6.3 This document was authorised by RSSB on 30 January 2015.

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Part 2 Requirements for auditing

2.1 Audit protocols

2.1.1 The 14 audit protocols prepared by the FTC are set out in Appendix A. They are:

a) A.1 Management function.

b) A.2 Maintenance development function.

c) A.3 Fleet maintenance management function.

d) A.4 Maintenance delivery function.

e) A.5 Competence.

f) A.6 Standards, procedures and document control.

g) A.7 Contracts and interfaces.

h) A.8 Engineering change.

i) A.9 Risk assessment.

j) A.10 Audit and compliance.

k) A.11 Materials procurement and management.

l) A.12 Site assessment.

m) A.13 Vehicle condition audit.

n) A.14 Holistic audit questions.

2.1.2 Each individual audit protocol shall be used as stipulated by the audit commissioner or as agreed between auditor and auditee, selecting the relevant protocols as appropriate. Clauses 2.1.3, 2.1.4 and 2.1.5 set out the purpose and scenarios under which the different protocols are to be used.

2.1.3 The first four audit protocols are for the four ECM functions as defined in EU Regulation 445/2011 on a system of certification of ECMs for freight wagons.

G 2.1.3.1 The EU Regulation 445/2011 of 10 May 2011 on a system of certification of Entities in Charge of Maintenance (ECM) for freight wagons describes how companies can undertake the ECM management function and / or the maintenance development function and / or the fleet management function and / or the maintenance delivery function, or any combination of these.

G 2.1.3.2 It is possible, therefore, for only one of the first four protocols to be applicable to a specific company. In practice in GB the usual situations are for an ECM to cover all four functions, or for an ECM to cover the first three with maintenance delivery being contracted to a second company.

2.1.4 The audit protocols A.5 to A.11 are topic-specific assessments of company processes and procedures. These protocols are able to be used alone or in conjunction with any of the four ECM function protocols in A.1 to A.4.

2.1.5 Protocols A.12 and A.13 are for physical site assessment of the facilities and ‘product audit’ of wagons. Appendix A.14 gives example questions to investigate relationships and communications across boundaries to establish that the ECM arrangements are holistically robust.

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2.2 Auditing

2.2.1 The auditor shall be suitably qualified, independent and experienced to make a valid judgement as to whether the auditee demonstrates knowledge, practices, processes, facilities, records, equipment and procedures to adequately comply with each of the questions asked.

2.2.2 The audit commissioner shall consider the size, scope and nature of the operation concerned and the level of safety risk involved to decide on the breadth and depth of the audit sample required. These criteria shall be specified to the auditor.

2.2.3 During the audit the auditor shall decide, for each audit question considered, whether the auditee has demonstrated adequate compliance taking account of the criteria specified by the audit commissioner.

G 2.2.3.1 The auditor should continue to probe and ask questions, and seek evidence, until in their professional opinion they are able to decide compliance or otherwise.

2.2.4 If adequate compliance has not been demonstrated the auditor shall either:

a) Stop the audit and inform the auditee, if the auditor decides that the non-compliance leads to an immediate unacceptable safety risk.

Or

b) Issue a Non-Conformance Report (NCR). The auditor shall decide whether the NCR is of a major or minor nature, and agree timescales for rectification.

G 2.2.4.1 It is anticipated that if the auditor has to stop the audit, as shown in 2.2.4 a), consideration will be given to alerting the industry to the problem found by using the NIR-online system described in GE/RT8250.

G 2.2.4.2 The definitions of major and minor NCR are given in the ‘Definitions’ section.

2.2.5 The auditor shall complete the NCR form shown in Appendix C for each non-compliance found.

2.2.6 The auditor shall issue an observation if they decide that the risk is acceptable but that improvements could or should still be made.

2.2.7 The auditor shall complete the observation form shown in Appendix D for each observation made.

2.3 Completion of audit

2.3.1 At the end of the audit the auditor and auditee shall have a close out meeting. If any NCRs are issued then a timescale to close each NCR shall be recorded.

G 2.3.1.1 It is preferable for the timescale to be agreed at the meeting.

2.3.2 The audit findings, including any observations of the auditor shall be made at the close out meeting.

2.3.3 The results of the audit shall be recorded and the auditor shall complete an audit summary sheet, as shown in Appendix B.

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2.3.4 The audit summary sheet shall be updated by the auditor when any major NCRs are closed out, and again when all the minor NCRs (if any) are closed out.

G 2.3.4.1 The summary sheet should be made available on request to all railway industry companies represented at FTC with a legitimate interest in the outcomes of the audit.

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Appendix A Audit Protocol Sheets

A.1 Management function

Commission Regulation 445/2011 Annex III Requirement Possibly Evidenced By /

Notes Evidence Considered Compliant?

1. Leadership — commitment to the development and implementation of the maintenance system of the organisation and to the continuous improvement of its effectiveness.

1.1 The organisation must have procedures for:

(a) establishing a maintenance policy appropriate to the organisation’s type and extent of service and approved by the organisation’s chief executive or his or her representative;

Maintenance Policy Document.

(b) ensuring that safety targets are established, in line with the legal framework and consistent with an organisation’s type, extent and relevant risks;

(c) assessing its overall safety performance in relation to its corporate safety targets;

(d) developing plans and procedures for reaching its safety targets;

(e) ensuring the availability of the resources needed to perform all processes to comply with the requirements of this Annex;

Organisation Chart, job descriptions etc.

(f) identifying and managing the impact of other management activities on the maintenance system;

Organisation Chart, job descriptions etc.

(g) ensuring that senior management is aware of the results of performance monitoring and audits and takes overall responsibility for the implementation of changes to the maintenance system;

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(h) ensuring that staff and staff representatives are adequately represented and consulted in defining, developing, monitoring and reviewing the safety aspects of all related processes that may involve staff.

2. Risk assessment — a structured approach to assess risk associated with the maintenance of freight wagons, including those directly arising from operational processes and the activities of other organisations or persons, and to identify the appropriate risk control measures.

2.1 The organisation must have procedures for:

(a) analysing risk relevant to the extent of operations carried out by the organisation, including the risk arising from defects and construction non-conformities or malfunctions throughout the lifecycle;

Procedures / sample risk assessments.

(b) evaluating the risk referred to in point (a);

(c) developing and putting in place risk control measures.

2.2 The organisation must have procedures and arrangements in place to recognise the need and commitment to collaborate with keepers, railway undertakings, infrastructure managers, or other interested parties.

Meetings / day-to-day communications.

2.3 The organisation must have risk assessment procedures to manage changes in equipment, procedures, organisation, staffing or interfaces, and to apply Commission Regulation (EC) No. 352/2009 which established a 'common safety method on risk evaluation and assessment' (CSM RA) . Commission Implementing Regulation (EU) No 402/2013 establishes a revised common safety method for risk evaluation and assessment. The revised CSM RA has been in force since 23 May 2013 (meaning it can be used from that date), and will apply from 21 May 2015 (meaning that it must be used from that date), at which time Commission Regulation (EC) No. 352/2009 is repealed.

Engineering and other change procedures.

2.4 When assessing risk, an organisation must have procedures to take into account the need to determine, provide and sustain an appropriate working environment which conforms to Union and national legislation, in particular EU Workplace Health and Safety Directive 89/391/EEC.

The Health and Safety at Work Act applies in the UK.

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3. Monitoring — a structured approach to ensure that risk control measures are in place, working correctly and achieving the organisation’s objectives.

3.1 The organisation must have a procedure to regularly collect, monitor and analyse relevant safety data, to apply Commission Regulation (EU) No 1078/2012 which establishes a common safety method for monitoring. This includes:

Safety defect reporting and monitoring procedures and processes.

(a) the performance of relevant processes;

(b) the results of processes (including all contracted services and products);

(c) the effectiveness of risk control arrangements;

(d) information on experience, malfunctions, defects and repairs arising from day-to-day operation and maintenance.

3.2 The organisation must have procedures to ensure that accidents, incidents, near-misses and other dangerous occurrences are reported, logged, investigated and analysed.

Monitoring, investigation and NIR processes.

3.3 For a periodic review of all processes, the organisation must have an internal auditing system which is independent, impartial and acts in a transparent way. This system must have procedures in place to:

(a) develop an internal audit plan, which can be revised depending on the results of previous audits and monitoring of performance;

Audit procedure and plans.

Sample audits and follow-up.

(b) analyse and evaluate the results of the audits;

(c) propose and implement specific corrective measures / actions;

(d) verify the effectiveness of previous measures / actions.

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4. Continuous improvement — a structured approach to analyse the information gathered through regular monitoring, auditing, or other relevant sources and to use the results to learn and to adopt preventive or corrective measures in order to maintain or improve the level of safety.

4.1 The organisation must have procedures to ensure that:

(a) identified shortcomings are rectified;

(b) new developments that improve safety are implemented;

(c) internal audit findings are used to bring about improvement in the system;

(d) preventive or corrective actions are implemented, when needed, to ensure compliance of the railway system with standards and other requirements throughout the lifecycle of equipment and operations;

Process for Monitoring of Railway Group Standards, legislative changes etc.

(e) relevant information relating to the investigation and causes of accidents, incidents, near-misses and other dangerous occurrences is used to learn and, where necessary, to adopt measures in order to improve the level of safety;

NIR review.

(f) relevant recommendations from the national safety authority, from the national investigation body and from industry or internal investigations are evaluated and implemented if appropriate;

Review of RAIB reports etc.

Internal investigations.

(g) relevant reports / information from railway undertakings / infrastructure managers and keepers or other relevant sources are considered and taken into account.

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5. Structure and responsibility — a structured approach to define the responsibilities of individuals and teams for secure delivery of the organisation’s safety objectives.

5.1 The organisation must have procedures to allocate responsibilities for all relevant processes throughout the organisation.

Procedures, job descriptions, competence management process.

5.2 The organisation must have procedures to clearly define safety-related areas of responsibility and the distribution of responsibilities to specific functions associated with them as well as their interfaces. These include the procedures indicated above between the organisation and the keepers and, where appropriate, railway undertakings and infrastructure managers.

5.3 The organisation must have procedures to ensure that staff with delegated responsibilities within the organisation have the authority, competence and appropriate resources to perform their functions. Responsibility and competence should be coherent and compatible with the given role, and delegation must be in writing.

5.4 The organisation must have procedures to ensure the coordination of activities related to relevant processes across the organisation.

Procedures.

5.5 The organisation must have procedures to hold those with a role in the management of safety accountable for their performance.

Performance monitoring process.

6. Competence management — a structured approach to ensure that employees have the competences required in order to achieve the organisation’s objectives safely, effectively and efficiently in all circumstances.

6.1 The organisation must set up a competence management system providing for:

(a) the identification of posts with responsibility for performing within the system all the processes necessary for compliance with the requirements of this Annex;

Competence management procedure and processes.

(b) the identification of posts involving safety tasks;

(c) the allocation of staff with the appropriate competence to relevant tasks.

6.2 Within the organisation’s competence management system, there must be procedures to manage the competence of staff, including at least:

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(a) identification of the knowledge, skills and experience required for safety-related tasks as appropriate for the responsibilities;

Competence management procedure and its application.

Drugs and alcohol and fatigue policies.

Human Resources processes.

(b) selection principles, including basic educational level, mental aptitude and physical fitness;

(c) initial training and qualification or certification of acquired competence and skills;

(d) assurance that all staff are aware of the relevance and importance of their activities and how they contribute to the achievement of safety objectives;

(e) ongoing training and periodical updating of existing knowledge and skills;

(f) periodic checks of competence, mental aptitude and physical fitness where appropriate;

(g) special measures in the case of accidents / incidents or long absences from work, as required.

7. Information — a structured approach to ensure that important information is available to those making judgments and decisions at all levels of the organisation.

7.1 The organisation must have procedures to define reporting channels to ensure that, within the entity itself and in its dealings with other actors, including infrastructure managers, railways undertakings and keepers, information on all relevant processes is duly exchanged and submitted to the person having the right role both within its own organisation and in other organisations, in a prompt and clear way.

Do procedures and processes include requirements for information flow across boundaries with other organisations?

7.2 To ensure an adequate exchange of information, the organisation must have procedures:

(a) for the receipt and processing of specific information; Document control procedure etc.

(b) for the identification, generation and dissemination of specific information;

(c) for making available reliable and up-to-date information.

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7.3 The organisation must have procedures to ensure that key operational information is:

(a) relevant and valid;

(b) accurate;

(c) complete;

(d) appropriately updated;

(e) controlled;

(f) consistent and easy to understand (including the language used);

(g) made known to staff before it is applied;

(h) easily accessible to staff, with copies provided to them where required.

7.4 The requirements set out in points 7.1, 7.2 and 7.3 apply in particular to the following operational information:

(a) checks of the accuracy and completeness of national vehicle registers regarding the identification (including means) and registration of the freight wagons maintained by the organisation;

(b) maintenance documentation;

(c) information on support provided to keepers and, where appropriate, to other parties, including railway undertakings / infrastructure managers;

(d) information on the qualification of staff and subsequent supervision during maintenance development;

(e) information on operations (including mileage, type and extent of activities, incidents / accidents) and requests of railway undertakings, keepers and infrastructure managers;

(f) records of maintenance performed, including information on deficiencies detected during inspections and corrective actions taken by railway undertakings or by infrastructure managers such as inspections and monitoring undertaken before the departure of the train or en route;

(g) release to service and return to operation;

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(h) maintenance orders;

(i) technical information to be provided to railway undertakings / infrastructure managers and keepers for maintenance instructions;

(j) emergency information concerning situations where the safe state of running is impaired, which may consist of:

(i) the imposition of restrictions of use or specific operating conditions for the freight wagons maintained by the organisation or other vehicles of the same series even if maintained by other entities in charge of maintenance, whereby this information should also be shared with all involved parties;

(ii) urgent information on safety-related issues identified during maintenance, such as deficiencies detected in a component common to several types or series of vehicles;

(k) all relevant information / data needed to submit the annual maintenance report to the certification body and to the relevant customers (including keepers), whereby this report must also be made available upon request to national safety authorities.

8. Documentation — a structured approach to ensure the traceability of all relevant information.

8.1 The organisation must have adequate procedures in place to ensure that all relevant processes are duly documented.

8.2 The organisation must have adequate procedures in place to:

Document control procedure.

(a) regularly monitor and update all relevant documentation;

(b) format, generate, distribute and control changes to all relevant documentation;

(c) receive, collect and archive all relevant documentation.

9. Contracting activities — a structured approach to ensure that subcontracted activities are managed appropriately in order for the organisation’s objectives to be achieved.

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9.1 The organisation must have procedures in place to ensure that safety related products and services are identified.

9.2 When making use of contractors and / or suppliers for safety related products and services, the organisation must have procedures in place to verify at the time of selection that:

(a) contractors, subcontractors and suppliers are competent;

Supplier approval and contract letting procedure / processes.

(b) contractors, subcontractors and suppliers have a maintenance and management system that is adequate and documented.

9.3 The organisation must have a procedure to define the requirements that such contractors and suppliers have to meet.

9.4 The organisation must have procedures to monitor the awareness of suppliers and/or contractors of risk they entail to the organisation’s operations.

9.5 When the maintenance / management system of a contractor or supplier is certified, the monitoring process described in point 3 may be limited to the results of the contracted operational processes referred to in point 3.1(b).

9.6 At least the basic principles for the following processes must be clearly defined, known and allocated in the contract between the contracting parties:

(a) responsibilities and tasks relating to railway safety issues; Are these items covered in sample contract specifications?

(b) obligations relating to the transfer of relevant information between both parties;

(c) the traceability of safety-related documents.

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A.2 Maintenance development function

Commission Regulation 445/2011 Annex III Requirement Possibly Evidenced By / Notes

Evidence Considered Compliant?

1. The organisation must have a procedure to identify and manage all maintenance activities affecting safety and safety-critical components.

2. The organisation must have procedures to guarantee conformity with the essential requirements for interoperability, including updates throughout the lifecycle, by:

(a) ensuring compliance with the specifications related to the basic parameters for interoperability as set out in the relevant technical specifications for interoperability (TSIs);

(b) 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;

(c) managing any substitution in the course of maintenance in compliance with the requirements of the Directive 2008/57/EC and the relevant TSIs;

(d) identifying the need for risk assessment regarding the potential impact of the substitution in question on the safety of the railway system;

(e) managing the configuration of all technical changes affecting the system integrity of the vehicle.

3. The organisation must have a procedure to design and to support the implementation of maintenance facilities, equipment and tools specifically developed and required for maintenance delivery. The organisation must have a procedure to check that these facilities, equipment and tools are used, stored and maintained according to their maintenance schedule and in conformity with their maintenance requirements.

4. When freight wagons start operations, the organisation must have procedures to:

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Commission Regulation 445/2011 Annex III Requirement Possibly Evidenced By / Notes

Evidence Considered Compliant?

(a) obtain the initial documentation and to collect sufficient information on planned operations;

(b) analyse the initial documentation and to provide the first maintenance file, also taking into account the obligations contained in any associated guarantees;

(c) ensure that the implementation of the first maintenance file is done correctly.

5. To keep the maintenance file updated throughout the lifecycle of a freight wagon, the organisation must have procedures to:

(a) collect at least the relevant information in relation to:

(i) the type and extent of operations effectively performed, including, but not limited to, operational incidents with a potential to affect the safety integrity of the freight wagon;

(ii) the type and extent of operations planned;

(iii) the maintenance effectively performed;

(b) define the need for updates, taking into account the limit values for interoperability;

(c) make proposals for and approve changes and their implementation, with a view to a decision based on clear criteria, taking into account the findings from risk assessment;

Engineering change procedure.

(d) ensure that the implementation of changes is done correctly.

6. When the competence management process is applied to the maintenance development function, at least the following activities affecting safety must be taken into account:

(a) assessment of the significance of changes for the maintenance file and proposed substitutions in the course of maintenance;

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Commission Regulation 445/2011 Annex III Requirement Possibly Evidenced By / Notes

Evidence Considered Compliant?

(b) engineering disciplines required for managing the establishment and the changes of maintenance file and the development, assessment, validation and approval of substitutions in the course of maintenance;

Competence management system.

(c) joining techniques (including welding and bonding), brake systems, wheel sets and draw gear, non-destructive testing techniques and maintenance activities on specific components of freight wagons for the transport of dangerous goods such as tanks and valves.

7. When the documentation process is applied to the maintenance development function, the traceability of at least the following elements needs to be guaranteed:

(a) the documentation relating to the development, assessment, validation and approval of a substitution in the course of maintenance;

(b) the configuration of vehicles, including, but not limited to, components related to safety;

(c) records of the maintenance performed;

(d) results of studies concerning return on experience;

(e) all the successive versions of the maintenance file, including risk assessment;

(f) reports on the competence and supervision of maintenance delivery and fleet maintenance management;

(g) technical information to be provided to support keepers, railway undertakings and infrastructure managers.

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A.3 Fleet maintenance management function

Commission Regulation 445/2011 Annex III Requirement Possibly Evidenced By / Notes

Evidence Considered Compliant?

1. The organisation must have a procedure to check the competence, availability and capability of the entity responsible for maintenance delivery before placing maintenance orders. This requires that the maintenance workshops are duly qualified to decide upon the requirements for technical competences in the maintenance delivery function.

Supplier Approval Procedure (or equivalent review process if maintenance is ‘in house’).

2. The organisation must have a procedure for the composition of the work package and for the issue and release of the maintenance order.

3. The organisation must have a procedure to send freight wagons for maintenance in due time.

4. The organisation must have a procedure to manage the removal of freight wagons from operation for maintenance or when defects have been identified.

5. The organisation must have a procedure to define the necessary control measures applied to the maintenance delivered and the release to service of the freight wagons.

6. The organisation must have a procedure to issue a notice to return to operation, taking into account the release to service documentation.

7. When the competence management (CM) process is applied to the fleet maintenance management function, at least the return to operation must be taken into account.

Supplier approval Procedure or Competence management procedure if maintenance is ‘in house’.

8. When the information process is applied to the fleet maintenance management function, at least the following elements need to be provided to the maintenance delivery function:

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Commission Regulation 445/2011 Annex III Requirement Possibly Evidenced By / Notes

Evidence Considered Compliant?

(a) applicable rules and technical specifications;

Are these items all included in the contract / documentation formally provided to the organisation carrying out the maintenance delivery function?

(b) the maintenance plan for each freight wagon;

(c) a list of spare parts, including a sufficiently detailed technical description of each part to allow like-for-like replacement with the same guarantees;

(d) a list of materials, including a sufficiently detailed description of their use and the necessary health and safety information;

(e) a dossier that defines the specifications for activities affecting safety and contains intervention and in-use restrictions for components;

(f) a list of components or systems subject to legal requirements and a list of these requirements (including brake reservoirs and tanks for the transport of dangerous goods);

(g) all additional relevant information related to safety according to the risk assessment performed by the organisation.

9. When the information process is applied to the fleet maintenance management function, at least the return to operation, including restrictions on use relevant to users (railway undertakings and infrastructure managers), needs to be communicated to interested parties.

10. When the documentation process is applied to the fleet maintenance management function, at least the following elements need to be recorded:

(a) maintenance orders;

(b) return to operation, including restrictions on use relevant to railway undertakings and infrastructure managers.

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A.4 Maintenance delivery function

Commission Regulation 445/2011 Annex III Requirement Possibly Evidenced By / Notes

Evidence Considered Compliant?

1. The organisation must have procedures to:

(a) check the completeness and appropriateness of the information delivered by the fleet maintenance management function in relation to the activities ordered;

Is internal review undertaken at commencement of contract or work package?

(b) control the use of the required, relevant maintenance documents and other standards applicable to the delivery of maintenance services in accordance with maintenance orders;

Document control process.

(c) ensure that all relevant maintenance specifications in the maintenance orders are available to all involved staff (eg they are contained in internal working instructions);

Process control documentation / job cards, information, instructions etc. issued to staff undertaking the work.

(d) ensure that all relevant maintenance specifications, as defined in applicable regulations and specified standards contained in the maintenance orders, are available to all involved staff (eg they are contained in internal working instructions).

2. The organisation must have procedures to ensure that:

(a) components (including spare parts) and materials are used as specified in the maintenance orders and supplier documentation;

Materials ordering, supply, management and storage procedures and processes.

(b) components and materials are stored, handled and transported in a manner that prevents wear and damage and as specified in the maintenance orders and supplier documentation;

(c) all components and materials, including those provided by the customer, comply with relevant national and international rules as well as with the requirements of relevant maintenance orders.

Possibly an unreasonable requirement, particularly for

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Commission Regulation 445/2011 Annex III Requirement Possibly Evidenced By / Notes

Evidence Considered Compliant?

customer supplied or specified items.

3. The organisation must have procedures to determine, identify, provide, record and keep available suitable and adequate facilities, equipment and tools to enable it to deliver the maintenance services in accordance with maintenance orders and other applicable specifications, ensuring:

(a) the safe delivery of maintenance, including the health and safety of maintenance staff;

(b) ergonomics and health protection, also including the interfaces between users and information technology systems or diagnostic equipment.

4. Where necessary to ensure valid results, the organisation must have procedures to ensure that its measuring equipment is:

(a) calibrated or verified at specified intervals, or prior to use, against international, national or industrial measurement standards — where no such standards exist, the basis used for calibration or verification must be recorded;

(b) adjusted or re-adjusted as necessary;

(c) identified to enable the calibration status to be determined;

(d) safeguarded from adjustments that would invalidate the measurement result;

(e) protected from damage and deterioration during handling, maintenance and storage.

5. The organisation must have procedures to ensure that all facilities, equipment and tools are correctly used, calibrated, preserved and maintained in accordance with documented procedures.

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Commission Regulation 445/2011 Annex III Requirement Possibly Evidenced By / Notes

Evidence Considered Compliant?

6. The organisation must have procedures to check that the performed maintenance tasks are in accordance with the maintenance orders and to issue the notice to release to service that includes eventual restrictions of use.

7. When the risk assessment process (in particular point 2.4 of section I) is applied to the maintenance delivery function, the working environment includes not only the workshops where maintenance is done but also the tracks outside the workshop buildings and all places where maintenance activities are performed.

Health and Safety at Work Act applies in the UK.

8. When the competence management process is applied to the maintenance delivery function, at least the following activities affecting safety must be taken into account:

Competence management procedure and processes.

(a) joining techniques (including welding and bonding);

(b) non-destructive testing;

(c) final vehicle testing and release to service;

(d) maintenance activities on brake systems, wheel sets and draw gear and maintenance activities on specific components of freight wagons for the transport of dangerous goods, for example tanks and valves;

(e) other identified specialist areas affecting safety.

9. When the information process is applied to the maintenance delivery function, at least the following elements must be provided to the fleet maintenance management and maintenance development functions:

(a) works performed in accordance with the maintenance orders; ‘sign off’ and audit processes.

(b) any possible fault or defect regarding safety which is identified by the organisation;

(c) the release to service.

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Commission Regulation 445/2011 Annex III Requirement Possibly Evidenced By / Notes

Evidence Considered Compliant?

10. When the documentation process is applied to the maintenance delivery function, at least the following elements must be recorded:

(a) clear identification of all facilities, equipment and tools related to activities affecting safety;

(b) all maintenance works performed, including personnel, tools, equipment, spare parts and materials used and taking into account:

(i) relevant national rules where the organisation is established; Eg Railway Group Standards.

(ii) requirements laid down in the maintenance orders, including requirements regarding records;

(ii) final testing and decision regarding release to service;

(c) the control measures required by maintenance orders and the release to service;

(d) the results of calibration and verification, whereby, for computer software used in the monitoring and measurement of specified requirements, the ability of the software to perform the desired task must be confirmed prior to initial use and reconfirmed as necessary;

(e) the validity of the previous measuring results when a measuring instrument is found not to conform to requirements.

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A.5 Competence

Where competence requirements are shown in A.1 to A.4, then the following protocol is available for use (note that questions A.5.3 and A.5.4 are specific to only one function). Competence management — a structured approach to ensure that employees have the competences required in order to achieve the organisation’s objectives safely, effectively and efficiently in all circumstances.

Ref No. Question Comments Compliant?

5.1

Does the organisation have a competence management system and how does this:

a) Identify posts that have responsibilities for undertaking the requirements of Annex III?

b) Identify posts involving safety related tasks?

c) Ensure that work is only undertaken by staff having the appropriate competencies for the relevant tasks?

d) Relate to personal safety and that of others?

5.2

How does the competence management system:

a) Identify the knowledge, skills and experience required for the various safety related tasks?

b) Have selection principles, including basic educational level, mental aptitude and physical fitness?

c) Identify initial training and/or qualification?

d) Assess/recognise acquired competence and skills?

e) Make staff aware of the relevance and importance of their activities and how they contribute to the achievement of safety objectives?

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f) Make staff aware of the limitations of their competence?

g) Achieve on-going assessment with additional briefing, training or periodical updating of existing knowledge and skills?

h) Undertake periodic checks of competence, mental aptitude and physical fitness where appropriate?

i) Undertake special briefing/ training measures in the case of accidents / incidents or long absences from work, as required?

5.3

Additionally, for the Maintenance Development Function (internal or contracted in) does the competence management system:

a) Ensure that staff are competent to undertake assessment of engineering change and any proposed substitutions in the course of maintenance?

b) Ensure that staff have the appropriate engineering disciplines required for managing the establishment and the changes of maintenance file and the development, assessment, validation and approval of substitutions in the course of maintenance?

c) Ensure that staff have appropriate engineering disciplines and relevant experience for the design, maintenance and understanding of:

d) Cover joining techniques (including welding and bonding)?

e) Cover brake systems?

f) Cover wheel sets?

g) Cover draw gear?

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h) Cover non-destructive testing techniques?

i) Cover maintenance activities on specific components of freight wagons, including where applicable for the transport of dangerous goods such as tanks and valves?

5.4

Additionally, for the Maintenance Delivery Function (internal or contracted in) does the competence management system:

a) Ensure that staff have appropriate engineering competence for undertaking tasks involving:

b) Joining techniques (including welding and bonding)?

c) Brake systems?

d) Wheel sets?

e) Draw gear?

f) Non-destructive testing techniques?

g) Maintenance activities on specific components of freight wagons, including where applicable for the transport of dangerous goods such as tanks and valves?

h) Other identified specialist areas affecting safety?

i) Ensure that staff are aware of the need for assessment of engineering change and any proposed substitutions in the course of maintenance?

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A.6 Standards, Procedures and Document Control

Where document requirements are shown in A.1 to A.4, then the following protocol is available for use: Industry and company standards, and other semi-quasi sources, along with other processes and procedures is core to engineering activities to ensure minimum standards are met, and best practise applied.

Ref No. Question Comments Compliant?

6.1

Does the organisation have a structured approach to document and standards control and the traceability of documents?

How are revisions managed and cascaded?

6.2

How is important information communicated to staff involved in the decision making processes in the organisation? Is the information accessible to end users in all parts of the organisation including outstations?

6.3

Does the organisation have processes for the communication of relevant information internally and to its suppliers and customers?

Does the company have procedures for circulation of relevant information to the point of use within the organisation and externally?

6.4 Are there mechanisms for acknowledgement or confirmation of receipt for important information relating to safety, for example NIRs and safety bulletins?

6.5 Do the organisation’s processes ensure that communication of important safety information occurs in a timely manner?

6.6 Does the organisation have processes or procedures that ensure key operational information is distributed in a timely manner to assure its relevance at point of use?

6.7 Is the information distributed in a format that ensures it is retrievable and clearly understood by the end user?

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6.8 Is the control and change managed effectively?

6.9 Does the organisation have systems in place to ensure that the NVR data is updated to reflect correct status of its wagons and ECM assigned to its wagons?

Does the company understand its legal obligations in respect of the information contained in the NVR?

6.10 In respect of maintenance documentation, does the organisation have a structured approach to the issue, amendment and receipt of pertinent relevant maintenance documentation?

6.11 Does the organisation have effective processes for setting up and administering maintenance orders?

6.12 Does the organisation have adequate processes for the creation, capture and management of records of maintenance performed?

6.13 Does the organisation have effective processes for the management of records of information on deficiencies detected during inspections and corrective actions taken by transport undertakings or by infrastructure managers such as inspections and monitoring undertaken before the departure of the train or en route? (or example monitoring of red / green card issued).

6.14 Does the organisation have robust documented processes for releasing the vehicle after maintenance / repair?

6.15 Does the organisation have adequate documented processes for deferring work and / or releasing the vehicle with restrictions if applicable?

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A.7 Contracts and Interfaces

Where contractual requirements are found in A.1 to A.4, then the following protocol is available for use. This section of the audit is to check the management of the contract by the ECM, not the performance of the contractor.

Ref No. Question Comments Compliant?

7.1

Does the organisation identify all situations where safety related products and services are provided by contractors and is this decision made by a competent person?

7.2 Does the organisation have a documented, adequate and robust process to assess and approve contractors, subcontractors and suppliers before use and does the supplier approval procedure at least establish that adequate arrangements are in place to satisfy all requirements found in A.1 to A.4 as relevant to the intended scope of supply including, but not limited to organisation, facilities, management systems, staff competence and fitness?

7.3 Has the organisation adequately defined details of the scope of supply, specification and requirements to contractors, sub-contractors and suppliers?

(Note: this must also include clear definition of the following:

a) Clear agreement of responsibilities and tasks relating to railway safety issues.

b) obligations relating to the transfer of relevant information between both parties.

c) the traceability of safety related documents.)

7.4 Is the performance and effectiveness of the supplier / contractor routinely monitored to confirm:

a) The performance of relevant processes?

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b) The results of processes?

c) The effectiveness of risk control arrangements?

d) Information on experience, malfunctions, defects and repairs arising?

7.5 Does the organisation monitor the awareness of suppliers / contractors to risks that may be imported to its operations?

7.6 Are there periodic formal contract reviews between the organisation and its suppliers / contractors?

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A.8 Engineering Change

Where Engineering Change requirements are shown in A.1 to A.4, then the following protocol is available for use applicable to the function being audited. Engineering Change documents how change particularly to safety critical services and systems are managed. Risks from change needs to be identified and thought through to ensure safety levels are not compromised.

Ref No. Question Comments Compliant?

8.1 Does an effective procedure exist to consider and approve engineering change?

8.2 Does the engineering change procedure cover the potential for requirement to comply with Interoperability Directive (for example TSI, NoBo, DeBo, AsBo) requirements?

8.3 Does the engineering change procedure make reference to the CSM RA (EC/352/2009 and EC/402/2013)?

8.4 Does the Engineering Change Procedure embrace maintenance policy or plan changes as well as physical engineering change?’

8.5 Are Engineering Changes developed, assessed and approved by personnel with adequate competence?

8.6 Does the organisation have procedures in place to recognise the changes to standards, for example TSI and RGS?

8.7 Is there a process for communication of such changes to relevant people and departments, and evidence of receipt of such changes?

8.8 How does the organisation determine if changes to conformity affect them, and communication of such changes?

8.9 How are such changes to risk communicated through the organisation?

8.10 Is there an understanding of the impact of changes of existing maintenance documents?

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8.11 If there are changes to the maintenance files what are the processes that exist to approve and implement the change?

8.12 If there are amendments to technical instructions how are these approved and implemented?

8.13 Is there a periodic review of the maintenance file?

8.14 Is there a robust process for updating the maintenance file to reflect changes throughout the vehicle life cycle?

8.15 Is the configuration of vehicles (especially for safety related components) traceable in the maintenance file?

8.16 Is there a robust process for amending the technical file to reflect changes throughout the vehicle life cycle?

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A.9 Risk Assessment

Where risk assessment requirements are shown in A.1 to A.4, then the following protocol is available for use. Note that A.9.10 is specific to Maintenance Delivery function only. Risk assessment — a structured approach to assess risks associated with the maintenance of vehicles, including those directly arising from operational processes and the activities of other organisations or persons, and to identify the appropriate risk control measures.

Ref No. Question Comments Compliant?

9.1 Does the organisation have a policy or procedure in place setting out the strategy for risk identification and assessment and does this meet the requirements of the CSM RA (EC/352/2009 and EC/402/2013)?

9.2 Does this encompass risks arising from defects and construction non-conformities and malfunctions throughout the lifecycle?

9.3 Does the organisation have procedures for developing and putting in place risk control measures?

9.4 Is it evident that the organisation recognises the need and has the commitment to collaborate with keepers, railway undertakings, infrastructure managers or other interested parties?

9.5 Does the organisation have robust processes or procedures to manage changes to:

a) Organisation?

b) Engineering change to vehicles, including introduction of new vehicles and maintenance specification change?

c) Equipment?

d) Procedures?

e) Staffing?

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f) Interfaces?

9.6 Is a systematic and structured process in place for identifying the major hazards associated with undertaking maintenance activities?

9.7 Have suitable and sufficient risk assessments been undertaken for each of the reasonably foreseeable hazards identified?

9.8 Are adequate control measures in place to control the risks arising from the identified hazards?

9.9 Have the risks arising from degraded or emergency situations been considered?

9.10 When applied to the maintenance delivery function has the risk assessment process been applied to all places where work is performed and the tracks outside the workshop buildings?

(Note: Directive 89/391/EEC is primarily implemented in Great Britain by the Management of Health and Safety at Work Regulations 1999).

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A.10 Audit and Compliance

Where auditing requirements are shown in A.1 to A.4, then the following protocol is available for use Audit and Monitoring — a structured approach to ensure that risk control measures are in place, working correctly and achieving the organisation’s objectives. How an ECM carries out internal and external critical assessments is a prime factor in good governance.

Ref No. Question Comments Compliant?

10.1 Does the organisation have a robust procedure to audit safety critical processes and procedures?

10.2 Is the process in accordance with the CSM on Monitoring EU regulation 1078/2012?

10.3 Is the process adequately:

a) Independent?

b) Impartial?

c) Clearly understood?

d) Documented?

e) Risk based?

10.4 Does the process cover both internal audit and suppliers of safety critical products and services?

10.5 Is there an audit plan?

10.6 Are records of audits kept?

10.7 Is there evidence of adequate action review and timely close-out of audits appropriate to the evaluated risk?

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10.8 Does the Internal Audit cover all the relevant aspects described in Annex III of EU Directive 445/2011 (including the implications of Engineering Change of wagons)?

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A.11 Materials Procurement and Management

Where materials requirements are identified in A.1 to A.4, then the following protocol is available for use.

Ref No. Question Comments Compliant?

11.1 Does the organisation identify safety critical components and is this decision made by a competent person?

11.2 Are safety critical components and materials obtained only from suppliers that have been adequately assessed as competent?

11.3 Are specifications for components and materials adequately defined and agreed between the organisation and its suppliers?

(Including that the specifications for components and materials embrace any applicable national and international rules.)

11.4 Are wheelset suppliers / maintainers assessed / approved by an adequate means or accredited organisation?

11.5 Are bearing suppliers / overhaulers adequately assessed / approved?

11.6 Are brake equipment suppliers / overhaulers adequately assessed / approved?

11.7 Are handling, transportation and storage requirements for components and materials specified in maintenance orders and documentation to prevent damage / wear?

11.8 Are components and materials handled, transported and stored in a manner that prevents wear and damage and as specified in the maintenance orders and supplier documentation?

11.9 Are there any customer supplied components or materials and if so are these compliant with the defined specifications and requirements?

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11.10 Are effective appropriate on-going monitoring and supervision arrangements in place for suppliers of safety critical components and materials?

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A.12 Site Assessment

This protocol is able to be used to assess a workshop or working area (for example sidings)

Ref No. Question Comments Compliant?

12.1 How does the organisation ensure that facilities are available as required by the maintenance plan for each vehicle type?

12.2 For the site is there an effective documented safe system of work?

12.3 Are the following available where applicable for the site being assessed?

a) Safe Working Area.

b) Straight and Level Track.

c) Road site access.

d) Hard standing available, and suitability for jacking.

e) Rail network connection suitability.

f) Covered Accommodation.

g) Electrical power available.

h) Lighting of buildings and sidings.

i) Pit (include drainage and lighting).

j) Access to Workshop Facilities (for example, may be back of a van, etc).

k) Welfare and sanitary facilities availability.

l) Facilities for working at height.

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m) Secure storage facilities (including, but not limited to, requirement for wheelsets).

n) Staff competent for the tasks.

o) Staff aware of Health and Safety requirements.

p) Where required, staff in possession of Site Access Authority.

q) Where required, staff in possession of Track Safety Handbook (or equivalent).

r) Maintenance Specification.

s) Other documentation, as called up within MTCE specification.

t) Lifting / Jacking Equipment.

u) Supply of Clean, Dry Air (psi range to be stated).

v) Air Brake Test Rig (or locomotive).

w) Brake Test Gauges.

x) Wheelset Gauges.

y) Flange Height and Thickness Gauge.

z) Wheelset Back to Back Gauge.

aa) Wheelset Diameter Gauge.

bb) Drawbar Gauge(s), Coupling Gauge(s).

cc) Other specialist Gauges (for example, for Bogies / Suspensions).

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dd) Suitable range of Hand and Power Tools (including, but not limited to, welding).

ee) NDT Equipment, Equipment to Check for Frame Twist.

ff) Records completed and suitably retained.

gg) Is there a ‘Fitness To Run’ process.

hh) Method for correct stopping and release of vehicles.

ii) Gauges and tools in date for calibration.

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A.13 Vehicle Condition Audit

This protocol is able to be used to carry out a product audit on a wagon that has received maintenance / repair. To assess Vehicle condition and to record if the vehicle is within its declared maintenance condition and against the certificated or registered details and Certificated Maintenance Plan. The list below might need adaptation for specific vehicles and/or circumstances; it should be used by the auditor as an aid memoire.

Ref No. Question Comments Compliant?

13.1 Underframe

a) Is the vehicle level on straight and level track?

b) Is the vehicle inspected for underframe twist?

c) Does the underframe show any signs of twist?

d) Has the Measurement and Compensation for Frame Twist been applied?

e) Are there any signs of fractures?

f) Have there been any similar fractures previously recorded? If so what actions were taken?

g) Are all structural fasteners present and sound? This may include, but not limited to, rivets, nuts and bolts and huck bolts.

h) Is the underframe and body structure free from undue corrosion?

13.2 Wheels and Axles

a) Are wheel / tyre profiles identified on the vehicle, are they correct?

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b) Are wheel / tyre profiles within the specified limits for the vehicle type?

c) Is there any wheel or tread damage?

d) Are there any defects obvious on the wheel? (For example, flats; thin flanges and rollover pitting).

e) Are the wheelsets within limits of wear for wheel profiles, flange height and thickness, toe radius build up, back to back?

f) Are the axles free from defects, paint damage / corrosion?

g) Are brake discs fitted securely and free from fractures/defects?

h) Has the vehicle been standing more than 6 months? (Do the bearings require a specific check, for example lift and spin).

i) Are wheelsets in date for testing and how is this identified?

j) Check MPI/NDT records dates on w/sets (tagged) or on wheelset data panels for fitment details.

k) Are the wheelsets stored, handled and transported to / from site in such a manner so as not to cause damage (check for paint damage / corrosion)?

13.3 Axleboxes

a) Are there any signs of axlebox overheating?

b) Are axlebox covers secure and free of damage?

c) Are wheelset bearings being overhauled? (Bearing dates to be checked and recorded).

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d) Are there any signs that the axlebox bump stop has been in contact during normal operation?

e) Are there any signs of lubricant loss?

f) Are there any signs of axlebox damage or loss of fasteners?

g) Check that axlebox to bogie earth bond is secure?

13.4 Axleguards and suspension

a) Are all suspension linkages present and secure?

b) Are the axle guards free from defects and are the clearances correct?

c) Security of wear plate liners?

d) Are any suspension springs fractured or Laminated Springs displaced?

e) Are any friction pads / surfaces contaminated with lubricant?

f) Are there any obvious signs of excessive wear on friction surfaces?

g) Check for missing, loose or leaking dampers?

13.5 Bogies

a) Are the bogie frames free from defects (including fractures)?

b) Are liners or horn guides free from defects and all present (none missing)? Are tolerances correct?

c) Is suspension springs free from defects or any displaced?

d) Are any friction pads / surfaces contaminated with lubricant?

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e) Are there any obvious signs of excessive wear on friction surfaces?

f) Are the centre pivots present and secured correctly?

g) Are sidebearers correctly set up?

h) Security of fasteners?

i) Check for missing, loose or leaking dampers?

13.6 Brakes

a) Brake blocks free from cracks, fitted correctly, within tolerance, positioned correctly (for example, not flanging) and correct clearance to wheel?

b) Brake pads within tolerance and fitted correctly and calliper condition, security and wear?

c) Rigging security and condition?

d) Air brake equipment security condition and wear. Check within date?

e) Air brake hoses correct style, security, condition and in date?

f) Handbrake condition, operation and security?

g) Brakes operational with no leaks, Brake test witnessed?

13.7 Buffers, Drawgear and Couplings

a) Is the correct type of buffer fitted and are the buffers correctly fastened and free from defects? (for example, leaks and buffer projection)

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b) Are buffer heights correct and in the specified range?

c) Are buffer faces lubricated?

d) Drawhooks gauged for wear and twist?

e) Condition of drawbar rubbers / spring pack?

f) Is the correct type of draw gear and coupling fitted and free from defects and is the drawgear correctly fastened?

g) Gauging for wear limits?

h) Lubrication of couplings?

i) Buckeyes gauge mouth and mechanism?

j) Rotating couplers?

13.8 Body, Floor, Roof and Barrel

a) Check that the body, floor, roof, barrel, is free from defects and fastened correctly to the underframe / superstructure?

b) Have the tank barrel(s) and associated equipment been tested in accordance with current regulations?

c) Is there a provision for an earth bond for vehicles conveying dangerous goods?

d) Are ladders, platforms, step irons, doors, hatches and discharge valves correctly secured and free from defects?

e) Check for body deformation? (Is it within gauge?)

f) Signs of product leakage?

g) Are lamp irons fitted and of the correct type?

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h) Is a label clip fitted?

i) Is all ancillary equipment relative to the operation of the wagon/ loading / discharge present and in accordance with the maintenance plan?

j) Verify primary and secondary locking of doors and seals and correct function of indicators?

k) Legibility of mandatory markings, including dangerous goods vehicles markings compliant with UK / UN and the (pink pages)(GO/RT3053)

13.9 Load Securing Equipment

a) Is the load securing equipment of the correct type, free from defects, in position and correctly secured?

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A.14 Holistic Audit Questions

In addition to checking the discrete audit elements covered by A.1 to A.13 it can be helpful to trace selected themes across the various ECM functions and organisations involved to establish that relationships and communications across boundaries are robust. Examples of such themes are given below.

Ref.No. Question Comments Compliant?

14.1 a) How has the ECM ensured that the maintenance plan is robust and achievable?

b) How has the ECM ensured that the maintenance plan is capable in practice of delivering adequate levels of safety performance and any relevant mandatory TSI or legislative requirements?

14.2 How are maintenance policy / plan requirements for facilities, equipment, competencies etc. specified to the organisation carrying out the maintenance?

Are they being reviewed and enforced and are the defined requirements being met in practice?

14.3 How does the ECM specify the detailed maintenance requirements to the organisation carrying out the Maintenance Delivery Function?

How does this organisation communicate the detail of specific maintenance tasks defined in the maintenance plan to the operatives who will be carrying these out?

How does it ensure that the tasks are carried out by competent staff, as intended and to the specified limits?

14.4 Are changes to the maintenance plan authorised through the ECM’s change management process?

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Are derogations or non-conformities being properly authorised?

Is any deferral of safety critical work effectively authorised and controlled?

14.5 Is there a process for operatives carrying out maintenance plan tasks to feedback suggested improvements or alterations to the maintenance plan to the ECM Management Development function?

Are there examples of this happening?

14.6 Are there adequate descriptions of spare parts provided by the ECM to the organisation carrying out the Maintenance Delivery Function?

How does this organisation ensure that the correct parts are always obtained?

If a specified part is unavailable is there an effective process to inform the ECM and how is the use of an alternative approved?

14.7 a) How are vehicles removed from service for planned maintenance in a timely manner and what processes are in place to allow vehicles back into service?

b) If limitations are applied, how are they managed and controlled?

c) How are safety related defects found in service and managed to resolution?

14.8 Is the responsibility for keeping maintenance records and documentation including wheelset records defined by the ECM and controlled by adequate procedures?

14.9 How are drawings, documents, schedules etc. affected as a consequence of modification, maintenance or repair procedure change kept up to date?

Are configuration control processes effective?

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Does the ECM ensure that the organisation carrying out the Maintenance Delivery Function is aware of any pertinent changes to documentation issued to them?

14.10 For those vehicles subject to the requirement for a Technical File, where is this file kept and how it is updated?

Is the relationship between the Maintenance and Technical files being effectively managed in both directions?

14.11 How are Wheelchex, Gotcha and HABD alerts managed?

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Appendix B Audit Summary Sheet

RIS-2708-RST FTC Audit Protocol Summary Sheet

XXXXXX (name of auditee)

Has been audited on:

Date

NNNNNNNNNN (audit report reference)

The scope of the audit was:

The following protocol audit sheets were fully completed: (delete as necessary)

A.1 A.2 A.3 A.4 A.5 A.6 A.7 A.8

A.9 A.10 A.11 A.12 A.13 A.14

Number of major NCRs issued nn All have been closed out Date

Number of minor NCRs issued nn All have been closed out Date

Number of observations issued nn

Signed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (post audit)

Signed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (when major NCRs closed out)

Signed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (when minor NCRs closed out) PRINT AUDITOR NAME AND SIGN

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Appendix C Non-Conformance Report form

NON-CONFORMANCE REPORT

NCR Date: NCR No: of

AUDIT of:

Audit Ref No:

ORGANISATION: Ref. Documents (Doc/issue/clause)

SECTION ONE – Non Conformance:(description of deficiency or reason for corrective action)

NCR Category: MAJOR / MINOR* (delete as appropriate)

Responsible Managers Name: *Auditor/Investigator Name:

Signature: Date: Signature: Date:

SECTION TWO – IMMEDIATE CORRECTIVE ACTION

SECTION THREE – ACTION TO PREVENT RECURRENCE

(Attach additional sheet if necessary)

Responsible Managers Name: Signature: Date:

Agreed completion date for section

Completion Dates and requires actions accepted by *Auditor/Investigator:

2) Name: Signature: Date: 3)

SECTION FOUR – CLOSE OUT REPORT: (details of action undertaken)

(Attach additional sheet(s) if necessary)

Auditor Name:

(close out agreed)

Signature: Date:

*delete as appropriate

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Appendix D Observation record sheet

OBSERVATION RECORD

Company/Department/Discipline Audited: Audit Number:

Date of Audit:

Scope: Auditor

Criteria:

Page of

Obs No.

Observation Location / Area

Observations numbered ____ to _ __ have been drawn to the attention of

Auditee: Signature: ________________________

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Definitions

Major non-compliance

Issued when the auditor judges that there is an unacceptable and significant risk to safety or the environment or where there is a total absence of necessary control arrangements that could lead to significant risk.

Minor non-compliance

Issued when the auditor judges that there are one or more lapses in complying with the specified requirements that warrant mandatory corrective action but the non-conformance does not give rise to an unacceptable significant risk.

Observation

An observation is given where there is room for improvement but insufficient evidence exists to justify raising a Non-Conformance Report.

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References

The Catalogue of Railway Group Standards give the current issue number and status of documents published by RSSB. This information is also available from www.rgsonline.co.uk.

RGSC 01 Railway Group Standards Code

RGSC 02 Standards Manual

Documents referenced in the text

Railway Group Standards

GE/RT8250 Reporting High Risk Defects

GO/RT3053 Working Manual for Rail Staff, Handling and Carriage of Dangerous Goods

Other References

352/2009 Commission Regulation (EC) No 352/2009 of 24 April 2009 on the adoption of a common safety method on risk evaluation and assessment as referred to in Article 6(3)(a) of Directive 2004/49/EC of the European Parliament and of the Council (Text with EEA relevance).

445/2011 Commission Regulation (EU) No 445/2011 of 10 May 2011 on a system of certification of entities in charge of maintenance for freight wagons and amending Regulation (EC) No 653/2007.

1078/2012 Commission Regulation (EU) No 1078/2012 of 16 November 2012 on a common safety method for monitoring to be applied by railway undertakings, infrastructure managers after receiving a safety certificate or safety authorisation and by entities in charge of maintenance (Text with EEA relevance).

402/2013 Commission Regulation (EU) 402/2013 on the CSM for risk assessment and repealing Regulation 352/2009

89/391/EEC Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work.

2008/57/EC 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 (Recast) (Text with EEA relevance).

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