ERA-GUI-100.pdf - Europa

Guide for the application of the Art 14 (a) of the Safety Directive and Commission Regulation (EU) No 445/2011
on a system of certification of entities in charge of maintenance for freight wagons – VERSION 1.0
Change management
Other technical modifications
STILL UNDER DISCUSSION
Situations where no possibility to strictly follow the technical file:
‣ Obsolescence of the parts
‣ Replacement by parts conform to other specifications than those in technical
file
Always considered as a major change
Application of the process related to renewal and upgrading (Article 20 of
the Interoperability Directive 2008/57)
Remark:
The ECM may play the role of the applicant in the sense of Interoperability
Directive 2008/57 but:
‣ Not mandatory
‣ This role is not taken into account in the ECM certification
If the specification of the new parts impairs the design operating state, it is considered as a major
change of the technical design and possibly leads to a new authorisation for placing in service
according to the Interoperability Directive.
In case of such major change, the ECM could be the applicant for this new authorisation. In any
case, the ECM should manage it through contractual arrangements with the RU/keeper and taking
in consideration:
The existing authorisation for placing in service;
The guarantee of the vehicle by the manufacturer.
Other different question is if the fact, that the specification of the new parts impairs the design
operating state, could be considered as a significant change affecting safety. In this case it is
necessary to evaluate by the proposer (ECM) of the change if the change is relevant and, if it is the
case, to apply the Common safety Method on Risk Assessment and Evaluation.
There are other situations under discussion if it would be necessary a new authorisation.
For instance, in case of a second transformation of wagons to a previous state already
authorised by NSA: on the one hand, it is a modification but on the other hand there are the
“rights of the grandfather”.
Page | 75