Commission Implementing Regulation (EU) 2019/779Show full title

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

1. The organisation shall have a procedure to identify and manage: U.K.

(a)

all maintenance activities affecting safety;

(b)

all safety-critical components.

2. The organisation shall 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 technical specifications for interoperability (TSIs);

(b)

verifying in all circumstances the consistency of the maintenance file with the authorisation related to the vehicle (including any national safety requirements), including the conformity to the technical file and the type of records as in the European Register of Authorised Types of Vehicles (ERATV);

(c)

managing any substitution in the framework of maintenance;

(d)

identifying the need for risk assessment of the potential impact of the change in question on the safety of the railway system, by application of the common safety methods related to the risk evaluation and assessment methods as adopted pursuant to point (a) of Article 6(1) of Directive (EU) 2016/798;

(e)

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

3. The organisation shall have a procedure to design and support the implementation of maintenance facilities, equipment and tools specifically developed and required for maintenance delivery. The organisation shall 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.

4. When vehicles start operations, the organisation shall have procedures to: U.K.

(a)

obtain access to the recommendations for maintenance of the initial documentation and to collect sufficient information on planned operations;

(b)

analyse those recommendations for maintenance of the initial documentation and to provide, by application of the common safety methods related to the risk evaluation and assessment methods as adopted pursuant to point (a) of Article 6(1) of Directive (EU) 2016/798, the first maintenance file, also taking into account the information contained in any associated guarantees;

(c)

ensure that the implementation of the first maintenance file is done accordingly.

5. To keep the maintenance file updated throughout the lifecycle of a vehicle, the organisation shall 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 accidents, serious accidents and incidents, as defined in Directive (EU) 2016/798;

(ii)

the detected failures on components;

(iii)

the type and extent of operations planned;

(iv)

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 performed by application of the common safety methods related to the risk evaluation and assessment methods as adopted pursuant to point (a) of Article 6(1) of Directive (EU) 2016/798;

(d)

ensure that the implementation of changes is done accordingly;

(e)

monitor the effectiveness of the changes through a process in consistency with the methods for assessing the safety level and the safety performance of railway operators at national and Union level as adopted pursuant to point (d) of Article 6(1) of Directive (EU) 2016/798.

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

(a)

application of the common safety methods related to the risk evaluation and assessment methods as adopted pursuant to point (a) of Article 6(1) of Directive (EU) 2016/798 for assessment of changes of the maintenance file;

(b)

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

(c)

maintenance activities on safety-critical components;

(d)

joining techniques (including welding and bonding);

(e)

non-destructive testing.

7. 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 framework of maintenance;

(b)

the configuration of vehicles, including, but not limited to, safety-critical components and on-board software modifications;

(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.