natgillin/translations-raw huggingface dataset:
A range of methods have been used to quantify risk for consumer products, such as a nomograph method [22], a matrix method [23], and the method previously recommended for the EU’s RAPEX rapid alert system [24].
Stopnjo tveganja je mogoče določiti z vrsto metod, kot so nomografska metoda [22], metoda matrik [23] in metoda, ki je bila predhodno priporočena za sistem hitrega obveščanja EU RAPEX [24].
While the general principles for risk assessment have always been agreed, how to quantify risks has been under permanent development.
Medtem ko so bila splošna načela za oceno tveganja vedno dogovorjena, pa se je način, kako določiti stopnjo tveganja, stalno razvijal.
This has led to diverging results and ensuing discussions, as well as to consideration of what the best possible practice might be.The purpose of these risk assessment guidelines is therefore to improve the situation and, within the framework of the Directive on General Product Safety [25], to provide a transparent and practicable method for appropriate use by Member States’ competent authorities when they assess the risks of non-food consumer products.
Posledica tega so bili različni rezultati in razprave, ki so temu sledile, ter preučevanje, katere bi lahko bile najboljše prakse.Namen teh smernic za oceno tveganja je izboljšati stanje ter v okviru Direktive o splošni varnosti proizvodov [25] zagotoviti pregledno in praktično metodo, ki jo bodo pristojni organi držav članic ustrezno uporabljali pri ocenjevanju tveganj neživilskih proizvodov za široko porabo.
These guidelines are based on a risk assessment method developed for other purposes [26], adapted to the specific requirements of non-food consumer products.
Smernice temeljijo na metodi za oceno tveganja, ki je bila razvita za druge namene [26] in prilagojena posebnim zahtevam neživilskih proizvodov za široko porabo.
A certain amount of training will of course be needed before these guidelines can be put into practice, but expertise in risk assessment will greatly facilitate this task.
Pred uresničevanjem teh smernic bo potrebno usposabljanje, vendar bo strokovno poznavanje ocene tveganja to nalogo močno olajšalo.
This will be backed by exchanges of views between risk assessors, since expertise and experience accumulated through the years is invaluable.
To bo podkrepljeno z izmenjavo stališč med ocenjevalci tveganja, ki imajo dragoceno strokovno znanje in dolgoletne izkušnje.
In building up a risk assessment method in small, manageable steps, these guidelines help to focus on the relevant issues of a product, its user(s) and its use(s), and to identify possible divergences of views between risk assessors from the onset, thus avoiding time-consuming discussions.
Pri oblikovanju metode za oceno tveganja v majhnih, obvladljivih korakih so te smernice v pomoč pri usmerjanju pozornosti na pomembna vprašanja v zvezi s proizvodom, njegovimi uporabniki in uporabami ter pri ugotavljanju možnih razlik med stališči ocenjevalcev tveganja od samega začetka, da se izogne dolgotrajnim razpravam.
They should thus lead to consistent and robust risk assessment results based on evidence and science, and consequently to widely acceptable consensus on the risks that the many non-food consumer products may present.
Smernice bi torej morale pripeljati do doslednih in trdnih rezultatov ocene tveganja, ki bi temeljili na dokazih in znanosti, in posledično do splošno sprejemljivega soglasja glede tveganj, ki jih lahko predstavljajo številni neživilski proizvodi za široko porabo.
A quick overview and a flow chart on how to prepare a risk assessment pursuant to these guidelines is provided in section 5 – ‘Consumer products’ mean non-food consumer products throughout these guidelines.
Hiter pregled in diagram o tem, kako pripraviti oceno tveganja v skladu s temi smernicami, sta vključena v oddelek 5. – „Proizvodi za potrošnike“ pomeni v celotnem besedilu teh smernic neživilske proizvode za široko porabo.
These guidelines do not set out to replace other guidelines that may address very specific products or may be specifically provided for in legislation, such as in the area of chemicals, cosmetics, pharmaceuticals or medical devices.
Namen teh smernic ni nadomestiti drugih smernic, ki bi obravnavale posebne proizvode ali bi bile posebej predpisane v zakonodaji, kot npr. na področju kemikalij, kozmetike, farmacevtskih izdelkov ali medicinskih pripomočkov.
It is highly recommended to use this specific guidance, since it is tailor-made, but it will always be for the risk assessor to decide how best to assess the risks of a product.
Uporaba teh posebnih smernic je zelo priporočljiva, saj so prilagojene, še vedno pa se bo ocenjevalec tveganja odločil, kako najbolje oceniti tveganje, ki ga predstavlja proizvod.
Nor are these guidelines to be used by manufacturers ‘just to avoid serious risks’ when designing and manufacturing products.
Proizvajalci ne smejo uporabljati teh smernic samo zato, „da bi se izognili resnim tveganjem“ pri snovanju in izdelavi proizvodov.
Consumer products have to be safe, and these guidelines aim at helping authorities to identify serious risks when, despite the best efforts of the manufacturer, a product is not safe.
Proizvodi za potrošnike morajo biti varni in cilj teh smernic je pomagati organom pri ugotavljanju resnih tveganj, ko proizvod, kljub najboljšim prizadevanjem proizvajalca, ni varen.
Risk is generally understood as something that threatens the health or even the lives of people, or that may cause considerable material damage.
Tveganje se na splošno razume kot nekaj, kar ogroža zdravje ali celo življenje ljudi ali lahko povzroči znatno materialno škodo.
Nevertheless, people take risks while being aware of the possible damage, because the damage does not always happen.
Kljub temu pa ljudje tvegajo, čeprav se zavedajo možnosti nastanka škode, saj se škoda ne pojavi vedno.
Climbing a ladder always includes the possibility of falling off and injuring oneself.
Plezanje po lestvi vedno vključuje možnost padca z lestve in poškodbe.
‘Falling off’ is therefore ‘built into the ladder’; it is an intrinsic part of using a ladder and cannot be excluded.
„Padec“ je torej „vgrajen v lestev“, je samo na sebi del uporabe lestve in se ne da izključiti.
‘Falling off’ is thus called the intrinsic hazard of a ladder.
„Padec“ se torej imenuje vsebovana nevarnost lestve.
This hazard, however, does not always materialise, since many people climb ladders without falling off and injuring themselves.
Ta nevarnost se ne uresniči vedno, saj veliko ljudi pleza po lestvah, ne da bi padli z njih in se poškodovali.
This suggests that there is a certain likelihood (or probability), but no certainty, of the intrinsic hazard materialising.
To pomeni, da obstaja neka verjetnost, ne pa gotovost, da se vsebovana nevarnost uresniči.
Whereas the hazard always exists, the probability of it materialising can be minimised, for example by the person climbing the ladder being careful.
Čeprav nevarnost vedno obstaja, pa se lahko verjetnost njenega uresničenja zmanjša, če na primer oseba previdno pleza po lestvi.
Using a household cleaner with sodium hydroxide to free blocked sewage water pipes always entails the possibility of very severe damage to the skin, if the product comes into contact with skin, or even of permanent blindness if drops of the product get into the eye.
Uporaba čistila za gospodinjstvo z raztopino natrijevega hidroksida, ki očisti zamašene vodovodne cevi, vedno vključuje možnost zelo resne poškodbe kože, če pride proizvod v stik s kožo, ali celo trajne slepote, če kapljice proizvoda pridejo v oko.
This is because sodium hydroxide is very corrosive, meaning that the cleaner is intrinsically hazardous.
Poškodba nastane zaradi močne jedkosti natrijevega hidroksida, kar pomeni, da je čistilo samo po sebi nevarno.
Nevertheless, when the cleaner is handled properly, the hazard does not materialise.
Vendar se ob pravilni uporabi čistila nevarnost ne uresniči.
Proper handling may include wearing plastic gloves and protective glasses.
Pravilna uporaba vključuje uporabo plastičnih rokavic in zaščitnih očal.
Skin and eyes are then protected, and the probability of damage is much reduced.
Tako zavarujemo kožo in oči, verjetnost poškodbe pa se močno zmanjša.
Risk is thus the combination of the severity of possible damage to the consumer and the probability that this damage should occur.
Tveganje je torej kombinacija resnosti možne poškodbe potrošnika in verjetnosti, da se ta poškodba zgodi.
It takes three steps to determine the risk:
Določanje tveganja poteka v treh korakih:
Anticipate an injury scenario in which the intrinsic product hazard harms the consumer (see table 1).
Predvidite scenarij poškodbe, v katerem nevarnost proizvoda samega po sebi škoduje potrošniku (glej preglednico 1).
Determine how severe the consumer’s injury is.
Določite resnost poškodbe potrošnika.
A yardstick for quantifying the intrinsic product hazard is the extent of the adverse effect that it can cause to the health of a consumer.
Merilo za količinsko opredelitev nevarnosti proizvoda samega po sebi je obseg škodljivih učinkov, ki jih ta lahko povzroči za zdravje potrošnika.
The risk assessor therefore anticipates an ‘injury scenario’ that describes step by step how the hazard leads to the injury of a consumer (see table 2).
Ocenjevalec tveganja zato predvidi „scenarij poškodbe“, ki v več korakih opisuje pot od nevarnosti do poškodbe potrošnika (glej preglednico 2).
In short, the injury scenario describes the accident that the consumer has with the product in question, and the severity of the consumer’s injury caused by that accident.
Na kratko, scenarij poškodbe opisuje nesrečo, ki jo doživi potrošnik z zadevnim proizvodom, in resnost poškodbe potrošnika, ki jo povzroči nesreča.
An injury can vary in severity, depending on the hazard of the product, on the way the product is used by the consumer, on the type of consumer who uses the product, and much more (see section 3).
Resnost poškodbe je lahko različna, odvisno od nevarnosti proizvoda, načina uporabe proizvoda s strani potrošnika, vrste potrošnika, ki uporablja proizvod, in številnih drugih dejavnikov (glej oddelek 3).
The more severe the injury, the more severe the hazard that caused it, and vice versa.
Resnejša, kot je poškodba, resnejša je nevarnost, ki je povzročila poškodbo, in obratno.
The ‘severity of the injury’ is therefore a means of quantifying the hazard.
„Resnost poškodbe“ zato pomeni količinsko opredelitev nevarnosti.
These guidelines propose 4 levels of severity, from injuries that are normally completely reversible to very serious injuries that cause more than approximately 10 % of permanent disability or even death (see table 3).
Te smernice predlagajo štiri stopnje resnosti, od poškodb, ki so običajno v celoti reverzibilne, do zelo resnih poškodb, katerih posledice so hujše kot približno 10-odstotna trajna invalidnost ali celo smrt (glej preglednico 3).
Determine the probability of the consumer being injured in practice by the intrinsic product hazard.
Določite verjetnost dejanske poškodbe potrošnika zaradi nevarnosti proizvoda samega po sebi.
While the injury scenario describes how the consumer is injured by the hazard, the scenario only happens with a certain probability.
Medtem ko scenarij poškodbe opisuje, kako nevarnost poškoduje potrošnika, pa obstaja določena verjetnost, da se bo ta scenarij res zgodil.
The probability can be expressed as a fraction, such as ‘> 50 %’ or ‘> 1/1000’ (see left-hand side of table 4).
Verjetnost se lahko izrazi z deležem, kot je „> 50 %“ ali „> 1/1000“ (glej levo stran preglednice 4).
Combine the hazard (in terms of severity of the injury) with the probability (in terms of a fraction) to obtain the risk.
Združite nevarnost (glede na resnost poškodbe) in verjetnost (glede na delež), da dobite tveganje.
This combination can be made by looking up both values in the appropriate table (see table 4); the table will provide the level of risk in terms of ‘serious’, ‘high’, ‘medium’ and ‘low’ risk.
Kombinacija lahko nastane iz obeh vrednosti, ki ju poiščete v ustrezni preglednici (glej preglednico 4). Preglednica navaja stopnjo tveganja, izraženo kot „resno“, „veliko“, „srednje“ in „majhno“ tveganje.
Where different injury scenarios are foreseeable, the risk for each of those scenarios should be determined the highest risk being labelled as ‘the risk’ of the product.
Kadar so predvideni različni scenariji poškodbe, je treba tveganju za vsakega od teh scenarijev določiti največje tveganje, ki označuje „tveganje“, ki ga predstavlja proizvod.
The highest risk is normally crucial because only action on the highest risk can effectively provide a high level of protection.
Največje tveganje je običajno bistvenega pomena, saj lahko samo ukrep v zvezi z največjim tveganjem učinkovito zagotavlja visoko raven zaščite.
On the other hand, an identified risk may be lower than the highest risk, but require specific risk reduction action.
Po drugi strani pa je lahko ugotovljeno tveganje manjše od največjega tveganja, vendar zahteva poseben ukrep za zmanjšanje tveganja.
It is then important also to take measures against that risk so that all risks are effectively reduced.
Takrat je treba ukrepati tudi proti temu tveganju, tako da se vsa tveganja učinkovito zmanjšajo.
Once the above steps have been carried out, the risk assessment is basically complete.
Ko so opisani koraki opravljeni, je ocena tveganja končana.
A flow chart on building a risk assessment is at the end of section 5.
Na koncu oddelka 5 je shema za pripravo ocene tveganja.
Seek information
Poiščite informacije
As can be seen from the above examples, each of the above steps of a risk assessment requires anticipation of what might happen and how likely it is to happen, since the product under consideration will normally not have caused an accident, and thus the risk will not have materialised (yet).
Kot je razvidno iz navedenih primerov, je treba pri vsakem od navedenih korakov ocene tveganja predvideti, kaj bi se lahko zgodilo in kako verjetno je, da se bo to zgodilo, saj preučevani proizvod običajno ne bo povzročil nesreče in se tveganje zato (še) ne bo uresničilo.
Previous experience with similar products will help in this exercise, as will any other information about the product, such as design, mechanical stability, chemical composition, operation, instructions for use, including possible risk management advice, type of consumers it is intended for (and those for which it is not), test reports, accident statistics, the EU Injury Database (IDB) [27], information about consumer complaints, about the behaviour of different consumers when they are using the product, and about product recalls.
Pri tem so v pomoč predhodne izkušnje s podobnimi proizvodi in druge informacije v zvezi s proizvodom, kot so zasnova, mehanska trdnost, kemična sestava, delovanje, navodila za uporabo, vključno z nasveti za upravljanje možnega tveganja, vrsta potrošnikov, katerim je proizvod namenjen (in vrsta potrošnikov, katerim proizvod ni namenjen), poročila o preskusih, statistični podatki o nesrečah, baza podatkov EU o poškodbah (IDB) [27], informacije o pritožbah potrošnikov, vedenju različnih potrošnikov med uporabo proizvoda in odpoklicih proizvoda.
Product requirements laid down in legislation, in product standards or in checklists (such as in ISO 14121: Safety of machinery – Risk assessment) can also be useful sources of information.
Zahteve za proizvod, določene v zakonodaji, standardih za proizvode in kontrolnih seznamih (kot je ISO 14121: Varnost strojev – Ocena tveganja), so lahko tudi koristen vir informacij.
Nevertheless, the products to be assessed may be quite specific and thus these sources may not contain the information required.
Vendar so lahko proizvodi, ki jih je treba oceniti, precej specifični in zato navedeni viri ne vsebujejo zahtevanih informacij.
The information collected may also be incomplete, inconsistent, or not fully plausible.
Zbrane informacije so lahko tudi nepopolne, neskladne ali ne v celoti verodostojne.
This may be the case in particular for accident statistics, when only the product category is registered.
To se lahko zgodi v primeru statističnih podatkov o nesrečah, ko je registrirana samo kategorija proizvoda.
The absence of an accident history, a small number of accidents or low severity of accidents should not be taken as a presumption of low risk.
Če ni bilo nesreč ali se je zgodilo malo nesreč ali je bila resnost nesreč majhna, ne bi smeli domnevati, da je tveganje majhno.
Product-specific statistics also have to be viewed with great care, since the product may have changed over time, be it in design or composition.
Statistične podatke za določen proizvod je treba natančno pregledati, saj se je lahko proizvod s časom spremenil, bodisi glede zasnove ali sestave.
The information must always be critically assessed.
Informacije je treba vedno kritično oceniti.
Feedback from expert colleagues can be particularly useful, since they can draw from their real-life experience and provide suggestions that are not immediately obvious when assessing a product risk.
Povratne informacije strokovnih sodelavcev so lahko še posebej koristne, saj črpajo iz izkušenj iz resničnega življenja in ponujajo predloge, ki pri ocenjevanju tveganja, ki ga predstavlja proizvod, niso takoj očitni.
They may also give advice when assessing the risk for different types of consumers, including vulnerable consumers such as children (see table 1), since the latter may handle a product differently.
Prav tako lahko ponujajo nasvet pri ocenjevanju tveganja za različne vrste potrošnikov, vključno z ranljivimi potrošniki, kot so otroci (glej preglednico 1), saj ti s proizvodom ravnajo drugače.
They may also help to assess the risk for different injuries that a product may cause, and the way in which those injuries emerge through the use of the product.
Pomagajo lahko tudi pri ocenjevanju tveganja za različne poškodbe, ki jih lahko povzroči proizvod, in načinu nastanka teh poškodb z uporabo proizvoda.
They can also judge whether an injury scenario is ‘totally unperceived’, too unlikely, and then guide the risk assessor towards more realistic assumptions.
Lahko tudi presodijo, ali je scenarij poškodb „popolnoma nepričakovan“, preveč neverjeten, in vodijo ocenjevalca tveganja do bolj realnih domnev.
Thus, feedback from experienced colleagues, although not an obligation, can be helpful in several aspects.
Čeprav niso obvezne, so lahko povratne informacije izkušenih sodelavcev v pomoč v več ozirih.
A risk assessor from an authority could seek advice from colleagues in that same authority, in other authorities, in industry, in other countries, in scientific groupings, and elsewhere.
Ocenjevalec tveganja iz organa lahko poišče nasvet pri sodelavcih v istem organu, drugih organih, v panogi, drugih državah, znanstvenih združenjih ali drugje.
Conversely, any risk assessor in industry could use his contacts with authorities and others when a new or improved product is to be assessed before it is placed on the market.
Nasprotno pa lahko vsak ocenjevalec tveganja v panogi uporabi svoje stike z organi in drugimi, kadar je treba oceniti nov ali izboljšan proizvod, preden se da na trg.
New information obtained should of course be used to update any existing risk assessment.
Z novimi podatki se seveda posodobijo vse obstoječe ocene tveganja.
Make a sensitivity analysis of your risk assessment
Naredite analizo občutljivosti svoje ocene tveganja
If all information searches and queries to expert colleagues do not provide the required, very specific data, a so-called sensitivity analysis might help.
Kadar iskanja in poizvedovanja pri strokovnih sodelavcih ne zagotovijo zahtevanih, zelo specifičnih podatkov, si lahko pomagamo z analizo občutljivosti.
In this analysis a lower and a higher value than previously chosen is assumed for each parameter of the risk assessment, and taken through the entire risk assessment procedure.
Pri tej analizi se za vsak parameter ocene tveganja predvidita nižja in višja vrednost od predhodno izbrane vrednosti in se obdelata v celotnem postopku za oceno tveganja.
The resulting risk levels will show how sensitive the risk level reacts to the input of lower and higher values.
Pridobljene stopnje tveganja pokažejo, kako občutljiva je reakcija stopnje tveganja na vložek nižjih in višjih vrednosti.
In this way the range in which the real risk of the product will be can be estimated.
Na ta način se lahko oceni razpon dejanskega tveganja, ki ga predstavlja proizvod.
If the most likely value of each parameter can be estimated, then those most likely values should be taken through the procedure, and the resulting risk level will be the most likely risk.
Če je mogoče oceniti najverjetnejšo vrednost vsakega parametra, je treba za najverjetnejše vrednosti izpeljati celotni postopek in pridobljene stopnje tveganja so najverjetnejše tveganje.
An example of a sensitivity analysis is illustrated in section 6 below.
Primer analize občutljivosti je ponazorjen v oddelku 6 spodaj.
Let others check your risk assessment
Naj drugi preverijo vašo oceno tveganja
Feedback from colleagues will also help when finalising the risk assessment.
Ob koncu ocene tveganja bo v pomoč tudi povratna informacija sodelavcev.
They will be able to provide advice on the assumptions and estimations made during the three steps above.
Lahko vam bodo pomagali z nasveti glede domnev in ocen med izvajanjem treh opisanih korakov.
They will feed in their experience and thus help to generate a more robust, more solid, more transparent and ultimately more acceptable risk assessment.
Uporabili bodo svoje izkušnje in tako pripomogli k trdnejši, preglednejši in sprejemljivejši oceni tveganja.
It is therefore recommended that, ideally, advice be sought from expert colleagues, possibly in the form of a group discussion, before concluding a risk assessment.
Zato je pred dokončanjem ocene tveganja priporočljivo poiskati nasvet strokovnih sodelavcev, najbolje v obliki skupinske razprave.
These groups, of perhaps 3 to 5 members, should include a combination of expertise appropriate to the product under assessment: engineers, chemists, (micro-)biologists, statisticians, product safety managers, and others.
Te skupine, z morda 3 do 5 člani, morajo vključevati kombinacijo strokovnih znanj, ki so ustrezna za proizvod v postopku ocenjevanja: inženirje, kemike, (mikro)biologe, statistike, vodje služb za varnost proizvodov in druge.
Group discussion will be particularly useful when a product is new on the market and has never been assessed before.
Skupinske razprave so zlasti koristne, kadar je proizvod na trgu nov in še ni bil ocenjen.
Risk assessments should be solid and realistic.
Ocene tveganje morajo biti trdne in realne.
However, since they require a number of assumptions, different risk assessors may come to different conclusions in view of the data and other evidence they have been able to find or because of their diverging experience.
Ker pa zahtevajo več domnev, se lahko ugotovitve več ocenjevalcev tveganja med seboj razlikujejo zaradi podatkov in drugih dokazov, ki so jih našli, ali pa zaradi razhajanj v izkušnjah.
It is thus necessary for risk assessors to talk to one another in order to reach agreement or, at least, consensus.
Zato se morajo ocenjevalci tveganj med seboj pogovarjati, da dosežejo dogovor ali vsaj soglasje.
The step-by-step risk assessment described in these guidelines, however, should make such discussions more productive.
Ocena tveganja korak za korakom, kot je opisana v teh smernicah, bi morala prispevati k plodnejšim razpravam.
Each step in a risk assessment must be clearly described in detail.
Vsak korak v oceni tveganja je treba opisati jasno in natančno.
Thus, any point of disagreement can be quickly identified, and consensus can more easily be reached.
Tako je mogoče hitro prepoznati vsako nestrinjanje in lažje doseči soglasje.
This will make risk assessments more acceptable.
Ocena tveganja postane s tem sprejemljivejša.
Document your risk assessment
Dokumentirajte svojo oceno tveganja