natgillin/translations-raw huggingface dataset:
The risk management process covered by this Regulation shall start from a definition of the system under assessment and comprise the following activities:
Postopek upravljanja s tveganji iz te uredbe se prične z opredelitvijo sistema, ki se ocenjuje, in vključuje naslednje dejavnosti:
the risk assessment process, which shall identify the hazards, the risks, the associated safety measures and the resulting safety requirements to be fulfilled by the system under assessment;
postopek ocenjevanja tveganja, v katerem se opredelijo nevarnosti, tveganja, z njimi povezani ukrepi in iz njih izhajajoče varnostne zahteve, ki jih mora izpolnjevati sistem, ki se ocenjuje;
demonstration of the compliance of the system with the identified safety requirements; and
dokaz, da sistem izpolnjuje ugotovljene varnostne zahteve;
management of all identified hazards and the associated safety measures.
upravljanje vseh ugotovljenih nevarnosti in z njimi povezanih varnostnih ukrepov.
This risk management process is iterative and is depicted in the diagram of the Appendix.
Postopek upravljanja s tveganji je iterativen in je prikazan na diagramu v Dodatku.
The process ends when the compliance of the system with all safety requirements necessary to accept the risks linked to the identified hazards is demonstrated.
Postopek se konča, ko se dokaže, da sistem izpolnjuje vse varnostne zahteve, potrebne za sprejetje tveganj, ki so povezana z ugotovljenimi nevarnostmi.
This iterative risk management process:
Ta iterativni postopek upravljanja s tveganji:
shall include appropriate quality assurance activities and be carried out by competent staff;
obsega ustrezne dejavnosti za zagotavljanje kakovosti, izvaja pa ga pristojno osebje;
shall be independently assessed by one or more assessment bodies.
neodvisno oceni eno ali več ocenjevalnih teles.
The proposer in charge of the risk management process required by this Regulation shall maintain a hazard record according to section 4.
Predlagatelj, ki je odgovoren za postopek upravljanja s tveganji, ki je zahtevan v tej uredbi, vodi evidenco nevarnosti v skladu z oddelkom 4.
The actors who already have in place methods or tools for risk assessment may continue to apply them as far as they are compatible with the provisions of this Regulation and subject to the following conditions:
Udeleženci, ki že uporabljajo metode ali orodja za ocenjevanje tveganj, lahko te uporabljajo še naprej, če so ti skladni z določbami te uredbe in naslednjimi pogoji:
the risk assessment methods or tools are described in a safety management system which has been accepted by a national safety authority in accordance with Article 10(2)(a) or Article 11(1)(a) of Directive 2004/49/EC; or
metode ali orodja za ocenjevanje tveganj so opisani v sistemu varnega upravljanja, ki ga je sprejel nacionalni varnostni organ v skladu s členom 10(2)(a) ali členom 11(1)(a) Direktive 2004/49/ES; ali
the risk assessment methods or tools are required by a TSI or comply with publicly available recognised standards specified in notified national rules.
metode ali orodja za ocenjevanje tveganj so zahtevani v TSI ali pa so skladni z javno dostopnimi priznanimi standardi, opredeljenimi v priglašenih nacionalnih predpisih.
Without prejudice to civil liability in accordance with the legal requirements of the Member States, the risk assessment process shall fall within the responsibility of the proposer.
Brez poseganja v civilnopravno odgovornost v skladu z zakonskimi zahtevami držav članic, je za postopek ocenjevanja tveganj odgovoren predlagatelj.
In particular the proposer shall decide, with agreement of the actors concerned, who will be in charge of fulfilling the safety requirements resulting from the risk assessment.
Predlagatelj v dogovoru z zadevnimi udeleženci zlasti odloči, kdo je odgovoren za izpolnjevanje varnostnih zahtev, ki izhajajo iz ocene tveganj.
This decision shall depend on the type of safety measures selected to control the risks to an acceptable level.
Ta odločitev je odvisna od vrste varnostnih ukrepov, izbranih za zmanjševanje tveganj na sprejemljivo raven.
The demonstration of compliance with the safety requirements shall be conducted according to section 3.
Skladnost z varnostnimi zahtevami se dokaže v skladu z oddelkom 3.
The first step of the risk management process shall be to identify in a document, to be drawn up by the proposer, the different actors’ tasks, as well as their risk management activities.
Prvi korak v postopku upravljanja s tveganji je, da predlagatelj pripravi dokument, v katerem določi naloge različnih udeležencev ter njihove dejavnosti v zvezi z upravljanjem s tveganji.
The proposer shall coordinate close collaboration between the different actors involved, according to their respective tasks, in order to manage the hazards and their associated safety measures.
Predlagatelj usklajuje tesno sodelovanje med različnimi aktivnimi udeleženci glede na njihove naloge, ter tako upravlja z nevarnostmi in z njimi povezanimi varnostnimi ukrepi.
Evaluation of the correct application of the risk management process described in this Regulation falls within the responsibility of the assessment body.
Za oceno pravilne uporabe postopka upravljanja s tveganji iz te uredbe je odgovoren ocenjevalni organ.
Interfaces management
Upravljanje vmesnikov
For each interface relevant to the system under assessment and without prejudice to specifications of interfaces defined in relevant TSIs, the rail-sector actors concerned shall cooperate in order to identify and manage jointly the hazards and related safety measures that need to be handled at these interfaces.
Za vsak vmesnik, povezan s sistemom, ki se ocenjuje, in ne glede na specifikacije vmesnikov, opredeljene v ustreznih TSI, zadevni udeleženci v železniškem sektorju sodelujejo, z namenom, da bi skupaj določili in upravljali nevarnosti in z njimi povezane varnostne ukrepe, ki jih je treba izvajati na teh vmesnikih.
The management of shared risks at the interfaces shall be coordinated by the proposer.
Upravljanje skupnih tveganj na vmesnikih usklajuje predlagatelj.
When, in order to fulfil a safety requirement, an actor identifies the need for a safety measure that it cannot implement itself, it shall, after agreement with another actor, transfer the management of the related hazard to the latter using the process described in section 4.
Če udeleženec, ki želi izpolniti varnostne zahteve, ugotovi, da je potreben varnostni ukrep, ki ga ne more izvesti sam, zadevno upravljanje nevarnosti po dogovoru z drugim udeležencem prenese nanj, in sicer z uporabo postopka iz oddelka 4.
For the system under assessment, any actor who discovers that a safety measure is non-compliant or inadequate is responsible for notifying it to the proposer, who shall in turn inform the actor implementing the safety measure.
Vsak udeleženec, ki ugotovi, da varnostni ukrep v sistemu, ki se ocenjuje, ni skladen z zahtevami ali je nezadosten, mora o tem obvestiti predlagatelja, ki obvesti udeleženca, ki izvaja varnostni ukrep.
The actor implementing the safety measure shall then inform all the actors affected by the problem either within the system under assessment or, as far as known by the actor, within other existing systems using the same safety measure.
Udeleženec, ki izvaja varnostni ukrep, nato obvesti vse udeležence, ki jih zadeva težava v sistemu, ki se ocenjuje, ali, kolikor je udeležencu znano, drugih obstoječih sistemih, pri katerih se uporablja isti varnostni ukrep.
When agreement cannot be found between two or more actors it is the responsibility of the proposer to find an adequate solution.
Če se dva ali več udeležencev ne more dogovoriti, mora predlagatelj najti ustrezno rešitev.
When a requirement in a notified national rule can not be fulfilled by an actor, the proposer shall seek advice from the relevant competent authority.
Če upravičenec ne more izpolniti zahteve iz priglašenega nacionalnega predpisa, se predlagatelj posvetuje z ustreznim pristojnim organom.
Independently from the definition of the system under assessment, the proposer is responsible for ensuring that the risk management covers the system itself and the integration into the railway system as a whole.
Neodvisno od opredelitve sistema, ki se ocenjuje, mora predlagatelj zagotoviti, da upravljanje s tveganji obsega sistem kot tak in njegovo vključitev v celoten železniški sistem.
DESCRIPTION OF THE RISK ASSESSMENT PROCESS
OPIS POSTOPKA OCENJEVANJA TVEGANJA
The risk assessment process is the overall iterative process that comprises:
Postopek ocenjevanja tveganja je splošen iterativen postopek, ki vključuje:
the system definition;
opredelitev sistema;
the risk analysis including the hazard identification;
analizo tveganj, vključno z ugotavljanjem nevarnosti;
the risk evaluation.
ocenjevanje tveganj.
The risk assessment process shall interact with the hazard management according to section 4.1.
Postopek ocenjevanja tveganj poteka skladno z upravljanjem z nevarnostmi iz oddelka 4.1.
The system definition should address at least the following issues:
Pri opredelitvi sistema je treba upoštevati vsaj naslednje vidike:
system objective, e.g. intended purpose;
cilj sistema, tj. predvideni namen;
system functions and elements, where relevant (including e.g. human, technical and operational elements);
po potrebi funkcije in elemente sistema (vključno z npr. človeškimi, tehničnimi in operativnimi elementi);
system boundary including other interacting systems;
razmejitev sistema, vključno z drugimi sistemi, s katerimi poteka interakcija;
physical (i.e. interacting systems) and functional (i.e. functional input and output) interfaces;
fizične (npr. sisteme, s katerimi poteka interakcija) in funkcionalne (tj. vložek in rezultati) vmesnike;
system environment (e.g. energy and thermal flow, shocks, vibrations, electromagnetic interference, operational use);
sistemsko okolje (npr. pretok energije, toplotni pretok, sunki, vibracije, elektromagnetna interferenca, funkcionalna uporaba);
existing safety measures and, after iterations, definition of the safety requirements identified by the risk assessment process;
obstoječe varnostne ukrepe in v primeru iteracij opredelitev varnostnih zahtev, določenih v postopku ocenjevanja tveganja;
assumptions which shall determine the limits for the risk assessment.
predpostavke, na podlagi katerih se določijo meje za oceno tveganja.
A hazard identification shall be carried out on the defined system, according to section 2.2.
Za opredeljeni sistem se opredelijo nevarnosti v skladu z oddelkom 2.2.
The risk acceptability of the system under assessment shall be evaluated by using one or more of the following risk acceptance principles:
Sprejemljivost tveganj sistema, ki se ocenjuje, se ovrednoti z enim ali več od naslednjih načel sprejemanja tveganja:
the application of codes of practice (section 2.3);
uporabo kodeksov ravnanja (oddelek 2.3);
a comparison with similar systems (section 2.4);
primerjavo s podobnimi sistemi (oddelek 2.4);
an explicit risk estimation (section 2.5).
eksplicitnim ovrednotenjem tveganja (oddelek 2.5).
In accordance with the general principle referred to in section 1.1.5, the assessment body shall refrain from imposing the risk acceptance principle to be used by the proposer.
V skladu s splošnim načelom iz oddelka 1.1.5 ocenjevalni organ od predlagatelja ne bo zahteval uporabe načela sprejemanja tveganja.
The proposer shall demonstrate in the risk evaluation that the selected risk acceptance principle is adequately applied.
Predlagatelj v oceni tveganja dokaže, da se izbrano načelo sprejemanja tveganja pravilno uporablja.
The proposer shall also check that the selected risk acceptance principles are used consistently.
Predlagatelj tudi preveri, ali se izbrano načelo sprejemanja tveganja uporablja dosledno.
The application of these risk acceptance principles shall identify possible safety measures which make the risk(s) of the system under assessment acceptable.
Z uporabo teh načel sprejemanja tveganja se opredelijo morebitni varnostni ukrepi, s katerimi se tveganja v sistemu, ki se ocenjuje, zmanjšajo na sprejemljivo raven.
Among these safety measures, the ones selected to control the risk(s) shall become the safety requirements to be fulfilled by the system.
Tisti od teh varnostnih ukrepov, ki se izberejo za nadzor tveganj, se pretvorijo v varnostne zahteve, ki jih mora sistem izpolnjevati.
Compliance with these safety requirements shall be demonstrated in accordance with section 3.
Skladnost s temi varnostnimi zahtevami se dokaže v skladu z oddelkom 3.
The iterative risk assessment process can be considered as completed when it is demonstrated that all safety requirements are fulfilled and no additional reasonably foreseeable hazards have to be considered.
Iterativni postopek ocenjevanja tveganja se konča, ko se dokaže, da so izpolnjene vse varnostne zahteve in da ni treba upoštevati dodatnih možnih nevarnosti.
Hazard identification
Določanje nevarnosti
The proposer shall systematically identify, using wide-ranging expertise from a competent team, all reasonably foreseeable hazards for the whole system under assessment, its functions where appropriate and its interfaces.
Predlagatelj s pomočjo obsežnega strokovnega znanja pristojne skupine sistematično ugotovi vse možne nevarnosti za celoten sistem, ki se ocenjuje, po potrebi pa tudi njegove funkcije in vmesnike.
All identified hazards shall be registered in the hazard record according to section 4.
Vse ugotovljene nevarnosti se navedejo v evidenci nevarnosti v skladu z oddelkom 4.
To focus the risk assessment efforts upon the most important risks, the hazards shall be classified according to the estimated risk arising from them.
Da se ocenjevanje tveganja osredotoči na najbolj pomembna tveganja, se nevarnosti razvrstijo glede na ocenjeno tveganje, ki izhaja iz njih.
Based on expert judgement, hazards associated with a broadly acceptable risk need not be analysed further but shall be registered in the hazard record.
Na podlagi strokovne presoje ni treba nadalje analizirati nevarnosti, povezanih s širše sprejetimi tveganji, vendar jih je treba navesti v evidenci nevarnosti.
Their classification shall be justified in order to allow independent assessment by an assessment body.
Njihova razvrstitev se utemelji, s čimer se zagotovi neodvisna ocena ocenjevalnega organa.
As a criterion, risks resulting from hazards may be classified as broadly acceptable when the risk is so small that it is not reasonable to implement any additional safety measure.
Kot merilo se lahko tveganja, ki izhajajo iz nevarnosti, razvrstijo kot širše sprejemljiva, če je tveganje tako majhno, da izvajanje dodatnih varnostnih ukrepov ni smiselno.
The expert judgement shall take into account that the contribution of all the broadly acceptable risks does not exceed a defined proportion of the overall risk.
Pri strokovni presoji se upošteva, da vsa širše sprejemljiva tveganja ne presegajo opredeljenega deleža skupnih tveganj.
During the hazard identification, safety measures may be identified.
Med določanjem nevarnosti se določijo tudi varnostni ukrepi.
They shall be registered in the hazard record according to section 4.
Navedejo se v evidenci nevarnosti v skladu z oddelkom 4.
The hazard identification only needs to be carried out at a level of detail necessary to identify where safety measures are expected to control the risks in accordance with one of the risk acceptance principles mentioned in point 2.1.4.
Nevarnosti je treba določiti le tako podrobno, kot je to potrebno za določitev, v katerih primerih lahko varnostni ukrepi nadzorujejo tveganja v skladu z enim od načel sprejemanja tveganja iz točke 2.1.4.
Iteration may thus be necessary between the risk analysis and the risk evaluation phases until a sufficient level of detail is reached for the identification of hazards.
Zato je lahko potrebna iteracija med analizo tveganja in fazami ovrednotenja tveganja, dokler se ne doseže ustrezna raven podrobnosti za določanje nevarnosti.
Whenever a code of practices or a reference system is used to control the risk, the hazard identification can be limited to:
Če se za nadzor tveganj uporabi kodeks ravnanja ali referenčni sistem, se lahko ugotavljanje nevarnosti omeji na:
the verification of the relevance of the code of practices or of the reference system;
preverjanje pomembnosti kodeksa ravnanj ali referenčnega sistema;
the identification of the deviations from the code of practices or from the reference system.
ugotavljanje odstopanj od kodeksa ravnanj ali referenčnega sistema.
Use of codes of practice and risk evaluation
Uporaba kodeksov ravnanja in ovrednotenje tveganj
The proposer, with the support of other involved actors and based on the requirements listed in point 2.3.2, shall analyse whether one or several hazards are appropriately covered by the application of relevant codes of practice.
Predlagatelj ob podpori drugih aktivnih udeležencev in na podlagi zahtev iz točke 2.3.2 analizira, ali so ena ali več nevarnosti ustrezno zajete z uporabo ustreznih kodeksov ravnanja.
The codes of practice shall satisfy at least the following requirements:
Kodeksi ravnanja morajo izpolnjevati vsaj naslednje zahteve:
be widely acknowledged in the railway domain.
biti morajo širše sprejeti na železniškem področju.
If this is not the case, the codes of practice will have to be justified and be acceptable to the assessment body;
Če temu ni tako, morajo biti upravičeni in sprejemljivi za ocenjevalni organ;
be relevant for the control of the considered hazards in the system under assessment;
biti morajo primerni za nadzor obravnavanih nevarnosti v ocenjevanem sistemu;
be publicly available for all actors who want to use them.
biti morajo javno dostopni za vse udeležence, ki jih želijo uporabljati.
Where compliance with TSIs is required by Directive 2008/57/EC and the relevant TSI does not impose the risk management process established by this Regulation, the TSIs may be considered as codes of practice for controlling hazards, provided requirement (c) of point 2.3.2 is fulfilled.
Če se na podlagi Direktive 2008/57/ES zahteva skladnost s TSI in ustrezna TSI ne predpisuje uporabe postopka upravljanja s tveganji, določenega s to uredbo, se lahko TSI šteje za kodeks ravnanja za nadzor nevarnosti, če je izpolnjena zahteva (c) iz točke 2.3.2.
National rules notified in accordance with Article 8 of Directive 2004/49/EC and Article 17(3) of Directive 2008/57/EC may be considered as codes of practice provided the requirements of point 2.3.2 are fulfilled.
Nacionalna pravila, priglašena v skladu s členom 8 Direktive 2004/49/ES in členom 17(3) Direktive 2008/57/ES, se lahko štejejo za kodeks ravnanja, če so izpolnjene zahteve iz točke 2.3.2.
If one or more hazards are controlled by codes of practice fulfilling the requirements of point 2.3.2, then the risks associated with these hazards shall be considered as acceptable.
Če se ena ali več nevarnosti nadzoruje s kodeksom ravnanja, ki izpolnjuje zahteve iz točke 2.3.2, veljajo tveganja, povezana s temi nevarnostmi, za sprejemljiva.
these risks need not be analysed further;
da teh tveganj ni treba nadalje analizirati;
the use of the codes of practice shall be registered in the hazard record as safety requirements for the relevant hazards.
da se uporaba kodeksa ravnanja navede v evidenci nevarnosti kot varnostna zahteva za ustrezne nevarnosti.
Where an alternative approach is not fully compliant with a code of practice, the proposer shall demonstrate that the alternative approach taken leads to at least the same level of safety.
Če sprejeti alternativni pristop ni popolnoma v skladu s kodeksom ravnanja, predlagatelj dokaže, da zagotavlja vsaj enako stopnjo varnosti.
If the risk for a particular hazard cannot be made acceptable by the application of codes of practice, additional safety measures shall be identified applying one of the two other risk acceptance principles.
Če tveganja za določeno nevarnost z uporabo kodeksa ravnanja ni mogoče zmanjšati na sprejemljivo raven, se z uporabo enega od ostalih dveh načel sprejemanja tveganja določijo dodatni varnostni ukrepi.
When all hazards are controlled by codes of practice, the risk management process may be limited to:
Če so vse nevarnosti nadzorovane s kodeksi ravnanja, je lahko postopek upravljanja s tveganji omejen na:
the hazard identification in accordance with section 2.2.6;
ugotavljanje nevarnosti v skladu z oddelkom 2.2.6;
the registration of the use of the codes of practice in the hazard record in accordance with section 2.3.5;
registriranje uporabe kodeksov ravnanja v evidenco nevarnosti v skladu z oddelkom 2.3.5;
the documentation of the application of the risk management process in accordance with section 5;
dokumentiranje uporabe postopka upravljanja s tveganji v skladu z oddelkom 5;
an independent assessment in accordance with Article 6.
neodvisno oceno v skladu s členom 6.
Use of reference system and risk evaluation
Uporaba referenčnih sistemov in ovrednotenje tveganja
The proposer, with the support of other involved actors, shall analyse whether one or more hazards are covered by a similar system that could be taken as a reference system.
Predlagatelj ob podpori drugih aktivnih udeležencev analizira, ali so ena ali več nevarnosti zajete v podobnem sistemu, ki bi se lahko uporabljal kot referenčni sistem.
A reference system shall satisfy at least the following requirements:
Referenčni sistem mora izpolnjevati vsaj naslednje zahteve:
it has already been proven in-use to have an acceptable safety level and would still qualify for approval in the Member State where the change is to be introduced;
v praksi se je že izkazalo, da je njegova raven varnosti zadovoljiva, v državi članici, kjer se sprememba uvaja, pa bi bil odobren;
it has similar functions and interfaces as the system under assessment;
ima podobne funkcije in vmesnike kot sistem, ki se ocenjuje;
it is used under similar operational conditions as the system under assessment;
se uporablja pod podobnimi operativnimi pogoji kot sistem, ki se ocenjuje;
it is used under similar environmental conditions as the system under assessment.
se uporablja pod podobnimi okoljskimi pogoji kot sistem, ki se ocenjuje.
If a reference system fulfils the requirements listed in point 2.4.2, then for the system under assessment:
Če referenčni sistem izpolnjuje zahteve iz točke 2.4.2, za sistem, ki se ocenjuje, velja:
the risks associated with the hazards covered by the reference system shall be considered as acceptable;
tveganja, povezana z nevarnostmi, ki so zajete v referenčnem sistemu, veljajo za sprejemljiva;
the safety requirements for the hazards covered by the reference system may be derived from the safety analyses or from an evaluation of safety records of the reference system;
varnostne zahteve za nevarnosti, ki so zajete v referenčnem sistemu, lahko izhajajo iz analiz varnosti ali ovrednotenja evidenc o varnosti referenčnega sistema;
these safety requirements shall be registered in the hazard record as safety requirements for the relevant hazards.
te varnostne zahteve se navedejo v evidenci nevarnosti kot varnostne zahteve za ustrezne nevarnosti.
If the system under assessment deviates from the reference system, the risk evaluation shall demonstrate that the system under assessment reaches at least the same safety level as the reference system.
Če sistem, ki se ocenjuje, odstopa od referenčnega sistema, se z ovrednotenjem tveganja dokaže, da sistem, ki se ocenjuje, dosega vsaj enako raven varnosti kot referenčni sistem.
The risks associated with the hazards covered by the reference system shall, in that case, be considered as acceptable.
Tveganja, povezana z nevarnostmi, ki spadajo v referenčni sistem, veljajo v tem primeru za sprejemljiva.
If the same safety level as the reference system cannot be demonstrated, additional safety measures shall be identified for the deviations, applying one of the two other risk acceptance principles.
Če ni mogoče dokazati enake ravni varnosti, kot jo ima referenčni sistem, se za odstopanja določijo dodatni varnostni ukrepi z uporabo enega od ostalih dveh načel sprejemanja tveganja.
Explicit risk estimation and evaluation
Eksplicitna ocena in ovrednotenje tveganja