The Railways and Other Guided Transport Systems (Safety) Regulations 2006 No. 599

[F1 SCHEDULE 10 U.K. System of certification of entities in charge of maintenance in respect of Great Britain

Textual Amendments

F1 Schs. 8-11 inserted (31.12.2020) by The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/837), reg. 1, Sch. para. 1 (as amended in Sch. 11 paras. 14, 16, 17 by S.I. 2019/1310, reg. 1(2)(c), Sch. 1 paras. 2, 3, 4); 2020 c. 1, Sch. 5 para. 1(1)

PART 4 U.K. Requirements and assessment criteria for organisations applying for a UK-issued ECM certificate or for a certificate in respect of maintenance functions outsourced by an entity in charge of maintenance

Section 1 U.K. Management function requirements and assessment criteria

Leadership: commitment to the development and implementation of the maintenance system of the organisation and to the continuous improvement of its effectiveness U.K.

21.   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;

(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 Part;

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

(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;

(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.

Risk assessment: a structured approach to assess risks 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 U.K.

22.— (1) The organisation must have procedures for—

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

(b) evaluating the risks referred to in paragraph (a);

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

(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.

(3) The organisation must have risk assessment procedures to manage changes in equipment, procedures, organisation, staffing or interfaces, and to apply Commission Implementing Regulation (EU) No 402/2013, as it has effect in Great Britain.

(4) When assessing risk, an organisation must have procedures to take into account the need to determine, provide and sustain an appropriate working environment.

Monitoring: a structured approach to ensure that risk control measures are in place, working correctly and achieving the organisation's objectives U.K.

23.— (1) The organisation must have a procedure to regularly collect, monitor and analyse relevant safety data, including—

(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.

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

(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;

(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.

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 U.K.

24.   The organisation must have procedures to ensure that—

(a) identified shortcomings are rectified;

(b) new safety developments 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;

(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;

(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;

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

Structure and responsibility: a structured approach to define the responsibilities of individuals and teams for secure delivery of the organisation's safety objectives U.K.

25.— (1) The organisation must have procedures to allocate responsibilities for all relevant processes throughout the organisation.

(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.

(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.

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

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

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 U.K.

26.— (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 Part;

(b) the identification of posts involving safety tasks;

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

(2) Within the organisation's competence management system, there must be procedures to manage the competence of staff, including at least—

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

(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.

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

27.— (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, railway 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.

(2) To ensure an adequate exchange of information, the organisation must have procedures—

(a) for the receipt and processing of specific information;

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

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

(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.

(4) The requirements set out in paragraph 7(1), (2) and (3) apply in particular to the following operational information—

(a) checks of the accuracy and completeness of the National Vehicle Register 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 and 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;

(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 a safety authority or the safety authority for the tunnel system.

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

28.— (1) The organisation must have adequate procedures in place to ensure that all relevant processes are duly documented.

(2) The organisation must have adequate procedures in place to—

(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.

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

29.— (1) The organisation must have procedures in place to ensure that safety related products and services are identified.

(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;

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

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

(4) The organisation must have procedures to monitor the awareness of suppliers and/or contractors of risks they entail to the organisation's operations.

(5) When the maintenance/management system of a contractor or supplier is certified, the monitoring process described in paragraph 23 may be limited to the results of the contracted operational processes referred to in paragraph 23(1)(b).

(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;

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

(c) the traceability of safety-related documents.

SECTION 2 U.K. Requirements and assessment criteria for the maintenance development function

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

31.   The organisation must have procedures to guarantee conformity with the essential requirements for interoperability, including updates throughout the lifecycle, by— U.K.

(a) ensuring compliance with the specifications related to the basic parameters for interoperability as set out in the relevant [F2 NTSNs];

(b) verifying in all circumstances the consistency of the maintenance file with the authorisation of placing-in-service, including the requirements of a safety authority or the safety authority for the tunnel system, the declarations of conformity to [F2 NTSNs], the declarations of verification, and the technical file;

(c) managing any substitution in the course of maintenance in compliance with the requirements of the relevant [F2 NTSNs];

(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.

Textual Amendments

F2 Word in Sch. substituted (31.12.2020 immediately before IP completion day) by The Railways (Safety, Access, Management and Interoperability) (Miscellaneous Amendments and Transitional Provision) (EU Exit) Regulations 2019 (S.I. 2019/1310), regs. 1(2)(c), 7(8)(a); 2020 c. 1, Sch. 5 para. 1(1)

32.   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. U.K.

33.   When freight wagons start operations, the organisation must have procedures to— U.K.

(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.

34.   To keep the maintenance file updated throughout the lifecycle of a freight wagon, the organisation must have procedures to— U.K.

(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;

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

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

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

(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;

(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.

36.   When the documentation process is applied to the maintenance development function, the traceability of at least the following elements needs to be guaranteed— U.K.

(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.

SECTION 3 U.K. Requirements and assessment criteria for the fleet maintenance management function

37.   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. U.K.

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

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

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

41.   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. U.K.

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

43.   When the competence management process is applied to the fleet maintenance management function, at least the return to operation must be taken into account. U.K.

44.   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— U.K.

(a) applicable rules and technical specifications;

(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.

45.   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. U.K.

46.   When the documentation process is applied to the fleet maintenance management function, at least the following elements need to be recorded— U.K.

(a) maintenance orders;

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

SECTION 4 U.K. Requirements and assessment criteria for the maintenance delivery function

47.   The organisation must have procedures to— U.K.

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

(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;

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

(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 (e.g. they are contained in internal working instructions).

48.   The organisation must have procedures to ensure that— U.K.

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

(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.

49.   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— U.K.

(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.

50.   Where necessary to ensure valid results, the organisation must have procedures to ensure that its measuring equipment is— U.K.

(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.

51.   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. U.K.

52.   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. U.K.

53.   When the risk assessment process, in particular paragraph 22.4, 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. U.K.

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

(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, such as tanks, valves, etc.;

(e) other identified specialist areas affecting safety.

55.   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— U.K.

(a) works performed in accordance with the maintenance orders;

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

(c) the release to service.

56.   When the documentation process is applied to the maintenance delivery function, at least the following elements must be recorded— U.K.

(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;

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

(iii) 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.]