The Railways and Other Guided Transport Systems (Safety) Regulations 2006

• (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 — 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.

31

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 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 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 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.

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.

33

When freight wagons start operations, the organisation must have procedures to—

• (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—

• (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—

• (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—

• (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 — 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.

38

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

39

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

40

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

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.

42

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

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.

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—

• (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.

46

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.

SECTION 4 — Requirements and assessment criteria for the maintenance delivery function

47

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;

• (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—

• (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—

• (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—

• (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.

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.

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.

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—

• (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—

• (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—

• (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.

SCHEDULE 11 — Common Safety Targets

Application

1

This Schedule applies to the mainline railway.

Interpretation

2

In this Schedule—

• “fatalities and weighted serious injuries” (“FWSIs”) means a measurement of the consequences of significant accidents combining fatalities and serious injuries, where 1 serious injury is considered statistically equivalent to 0.1 fatalities;

• “level crossing users” means all persons using a level crossing to cross a railway line by any means of transportation or by foot;

• “national reference value” (“NRV”) means a reference measure indicating the maximum tolerable level for a railway risk category;

• “others” means all persons who are not passengers, staff or employees including the staff of contractors, level crossing users or unauthorised persons on railway premises;

• “passenger-km” means the unit of measure representing the transport of one passenger by rail over a distance of one kilometre;

• “passenger train-km” means the unit of measure representing the movement of a passenger train over one kilometre;

• “risk category” means one of the railway risk categories specified by Article 7(4)(a) and (b) of the Directive;

• “risk to society as a whole” means the collective risk to all categories of persons listed in Article 7(4)(a) of the Directive;

• “safety enhancement plan” means a plan to implement the organisational structure, responsibilities, procedures, activities, capabilities and resources required to reduce the risk for one or more risk categories;

• “staff or employees including the staff of contractors” means any persons whose employment is in connection with a railway and is at work at the moment of the accident; it includes the crew of the train and persons handling rolling stock and infrastructure installations;

• “track-km” means the length measured in kilometres of the railway network where each track of a multiple track railway line is to be counted;

• “train-km” means the unit of measure representing the movement of a train over one kilometre; the distance used is the distance actually run, if available, otherwise the standard network distance between the origin and destination must be used;

• “unauthorised persons on railway premises” means any persons present on railway premises where such presence is forbidden, with the exception of level crossing users;

Measurement units for NRVs and CSTs

3

The measurement units for NRVs must be expressed in compliance with the mathematical definition of risk. The consequences of accidents which must be considered for each of the risk categories are the FWSIs.

4

For the purpose of assessment of achievement of the NRVs for the passenger and level crossing user risk categories, compliance with one or both of these NRVs must be considered sufficient.

Principles for the assessment of achievement of NRVs and CSTs

5

The following principles apply for assessing achievement of NRVs and CSTs—

• (a) for each risk category for which the NRV is equal to or lower than the corresponding CST, the achievement of the NRV also automatically implies the achievement of the CST;

• (b) the assessment of achievement of the NRV must be carried out according to the procedure described in paragraph 8 and the NRV represents the maximum tolerable level of the risk to which it refers, without prejudice to provisions of the range of tolerance laid down in paragraph 10;

• (c) for each risk category for which the NRV is higher than the corresponding CST, the CST represents the maximum tolerable level of the risk to which it refers;

• (d) the assessment of achievement is to be carried out in compliance with the requirements deriving from the impact assessment.

6

The assessment of achievement of the NRVs and CSTs must be carried out annually by the Office of Rail and Road, taking into consideration the most recent four preceding reporting years, including those years in which the assessment of achievement of the NRVs and CSTs in the United Kingdom was conducted by the European Railway Agency.

7

The outcome of the assessment of achievement referred to in paragraph 5 is to be classified as follows—

• (a) acceptable safety performance;

• (b) possible deterioration of safety performance; or

• (c) probable deterioration of safety performance

and published by the Office of Rail and Road.

Procedure for assessment of achievement of NRVs and CSTs

8

The procedure for the assessment of achievement of NRVs is composed of four different steps as described in the following paragraphs. The overall decisional flowchart of the procedure is shown in paragraph 15, where positive and negative decisional arrows correspond respectively to a ‘passed’ and a ‘failed’ result of the different assessment steps.

9

• (1) The first assessment step must verify whether the observed safety performance is complying with the NRV or not.

• (2) The observed safety performance must be measured by using the measurement units listed in paragraph 14 and data gathered by the Office of Rail and Road in respect of railway accidents and related consequences, with time series which must include the most recent years of observations as specified in paragraph 6.

• (3) The observed safety performance must be expressed in terms of—

• (a) safety performance in the single most recent reported year; and

• (b) moving weighted average (MWA), as specified in paragraph 13.

• (4) The values returned must then be compared with the NRV, and if one of these values does not exceed the NRV, the safety performance is to be considered acceptable. If this is not the case, the procedure must continue with the second assessment step.

10

• (1) The second assessment step must consider the safety performance to be acceptable if the MWA does not exceed the NRV plus a 20% range of tolerance.

• (2) If this condition is not satisfied, the Office of Rail and Road must obtain the specifics of the single highest-consequence accident, in terms of FWSIs, in the most recent years of observation as referred to in paragraph 6, excluding the years used to set the NRV.

• (3) If this single accident is more severe, in terms of consequences, than the most severe single accident included in the data used for setting the NRV, it must be excluded from the statistics.

• (4) The MWA must then be recalculated to check whether it lies within the abovementioned range of tolerance.

• (5) If this is the case, the safety performance must be considered acceptable. If this is not the case, the procedure must continue with the third assessment step.

11

The third assessment step must verify whether it is the first time in the last three years that the second assessment step did not return evidence of acceptable safety performance. If this is the case, the outcome of the third assessment step must be classified as ‘passed’. The procedure shall continue with the fourth step, whatever the outcome of the third step may be.

12

• (1) The fourth assessment step must verify whether the number of significant accidents per train-km, with respect to the previous years, remained stable or decreased. The criteria for this appraisal are whether there has been a statistically significant increase in the number of relevant significant accidents per train-km. This must be evaluated by using an upper Poisson tolerance bound which will determine the acceptable variability based on the number of accidents that occurred in the member States of the European Union.

• (2) If the number of significant accidents per train-km does not exceed the abovementioned tolerance bound, it is assumed that there has not been a statistically significant increase, and the outcome of this assessment step must be classified as passed.

• (3) Depending on the risk category to which the different NRVs under assessment of achievement refer, the significant accidents to be considered for carrying out this assessment step are as follows—

• (a) risks to passengers: all relevant significant accidents;

• (b) risks to staff or employees, including the staff of contractors: all relevant significant accidents;

• (c) risks to level crossing users: all relevant significant accidents included in the risk category of level crossing accidents;

• (d) risks to unauthorised persons on railway premises: all relevant significant accidents included in the risk category of accidents to persons caused by rolling stock in motion;

• (e) risks to others: all relevant significant accidents;

• (f) risk to society as a whole: all significant accidents.

Moving weighted averaging process for the annual assessment of achievement of NRVs

13

For each of the risk categories to which the MWA is applied for carrying out, in each year Y (starting from Y = 2010), the assessment steps described in paragraphs 9 to 12, the following phases must be applied for calculating the MWAY

• (a) calculation of the annual observations OBSi returned by the corresponding indicators in paragraph 14 after providing as input the relevant data for the relevant years (the index i takes the values as defined in the formula in sub paragraph (e));

• (b) calculation of the 5-year average (AV) of annual observation OBSi;

• (c) calculation of the absolute value of the difference ABSDIFFi between each annual observation OBSi and the AV. If ABSDIFFi < 0.01 * AV, the ABSDIFFi is attributed a constant value equal to 0.01 * AV;

• (d) calculation of the weight Wi by taking the inverse of ABSDIFFi;

• (e) calculation of the MWAY as follows—

$$M W A Y Y = ∑ i = x N W i × O B S i ∑ i = x N W i$where i is a natural number and x = Y – 6; N = Y – 2.$

Measurement units for NRVs and CSTs

14

The following table sets out the measurement units for NRVs and CSTs.

Decision flowchart

15

The flowchart referred to in paragraph 8 follows.

Values for NRVs

16

The following table sets out the values of the NRVs for the purposes of this Schedule.

Values for CSTs

17

The following table sets out the values for the CSTs.