natgillin/translations-raw huggingface dataset:
New information obtained should of course be used to update any existing risk assessment.
Vsak korak v oceni tveganja je treba opisati jasno in natančno.
Make a sensitivity analysis of your risk assessment
Tako je mogoče hitro prepoznati vsako nestrinjanje in lažje doseči soglasje.
If all information searches and queries to expert colleagues do not provide the required, very specific data, a so-called sensitivity analysis might help.
Ocena tveganja postane s tem sprejemljivejša.
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.
Dokumentirajte svojo oceno tveganja
The resulting risk levels will show how sensitive the risk level reacts to the input of lower and higher values.
Pomembno je, da svojo oceno tveganja dokumentirate ter opišete proizvod in vse parametre, ki ste jih izbrali med ocenjevanjem, kot so rezultati preskusov, vrste potrošnikov, ki ste jih izbrali za scenarije poškodb, ter verjetnosti z osnovnimi podatki in domnevami.
In this way the range in which the real risk of the product will be can be estimated.
Tako boste lahko nedvoumno prikazali, kako ste ocenili stopnjo tveganja, pomagalo pa vam bo tudi pri posodabljanju ocene med spremljanjem vseh sprememb.
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.
Več nevarnosti, več poškodb – vendar le eno tveganje
An example of a sensitivity analysis is illustrated in Section 6 below.
Kadar je ugotovljenih več nevarnosti, več scenarijev poškodb ali različnih resnosti poškodb ali verjetnosti, je treba v zvezi z vsemi opraviti celotni postopek ocene tveganja, da se določi tveganje za vsakega posebej.
Let others check your risk assessment
Zato ima lahko proizvod več stopenj tveganja.
Feedback from colleagues will also help when finalising the risk assessment.
Skupno tveganje, ki ga predstavlja proizvod, je tako najvišja ugotovljena stopnja tveganja, saj je ukrepanje na najvišji stopnji tveganja običajno najučinkovitejši način za njegovo znižanje.
They will be able to provide advice on the assumptions and estimations made during the three steps above.
Tveganje na nižji stopnji je posebej pomembno samo v posebnih primerih, saj lahko zahteva posebne ukrepe za obvladovanje tveganja.
They will feed in their experience and thus help to generate a more robust, more solid, more transparent and ultimately more acceptable risk assessment.
Primer več tveganj je kladivo, ki ima lahko slabo pritrjeno glavo in slab ročaj, zaradi česar lahko eden ali drugi med uporabo počita in potrošnik se lahko poškoduje.
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.
Kadar vodijo ustrezni scenariji do različnih stopenj tveganja, je treba navesti najvišje tveganje kot „tveganje“, ki ga predstavlja kladivo.
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.
Mogoče je trditi, da:
Group discussion will be particularly useful when a product is new on the market and has never been assessed before.
je očitno najpomembnejša nevarnost odločilna, saj lahko povzroči najresnejše poškodbe.
Risk assessments should be solid and realistic.
V navedenem primeru bi bila to glava kladiva, ki bi se zlomila, saj lahko koščki zlomljene glave odletijo v oko uporabnika in ga morebiti oslepijo.
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.
Zlomljeni ročaj kladiva pa ne bi nikoli razpadel na majhne koščke, ki bi lahko povzročili takšno škodo očem.
It is thus necessary for risk assessors to talk to one another in order to reach agreement or, at least, consensus.
Zato bi bila to ocena nevarnosti in ne ocena tveganja.
The step-by-step risk assessment described in these guidelines, however, should make such discussions more productive.
Ocena tveganja upošteva tudi verjetnost, da se bo poškodba v resnici zgodila.
Each step in a risk assessment must be clearly described in detail.
Tako lahko „najpomembnejša nevarnost“ povzroči poškodbo, ki je precej manj verjetna kot pri manjši nevarnosti in zato predstavlja manjše tveganje.
Thus, any point of disagreement can be quickly identified, and consensus can more easily be reached.
Obratno pa je lahko scenarij, ki vodi do manj resne poškodbe, precej bolj verjeten kot scenarij, katerega izid je smrt, zato lahko manj resna poškodba predstavlja večje tveganje;
This will make risk assessments more acceptable.
mora biti največja verjetnost, da se bo scenarij poškodbe zgodil, odločilen dejavnik za „tveganje“, ki ga predstavlja proizvod.
Document your risk assessment
Če je v navedenem primeru kladiva ročaj kladiva zelo krhek, je najverjetnejši scenarij poškodba zaradi zlomljenega ročaja, zato je ta odločilna.
It is important to document your risk assessment, describing the product and all the parameters that you chose while developing it, such as test results, the type(s) of consumers you chose for your injury scenario(s), and the probabilities with the underlying data and assumptions.
Vendar se ne upošteva resnost poškodb oči, ki jih lahko povzroči zlom glave kladiva.
This will enable you to demonstrate unambiguously how you estimated the level of risk, and it will also help you to update your assessment while keeping track of all changes.
Zato si zgolj na podlagi same verjetnosti ne moremo ustvariti celotne slike.
Several hazards, several injuries — but only one risk
Tveganje je torej uravnotežena kombinacija nevarnosti in verjetnosti poškodbe, ki jo nevarnost lahko povzroči.
When several hazards, several injury scenarios or differing severities of injuries or probabilities have been identified, each of those should be carried through the entire risk assessment procedure in order to determine the risk for each.
Tveganje ne opisuje niti nevarnosti niti verjetnosti, ampak obe hkrati.
As a result, the product may have several risk levels.
Z upoštevanjem največjega tveganja kot „tveganja“, ki ga predstavlja proizvod, se zagotovi najučinkovitejša varnost proizvoda (razen pri posebnih tveganjih, ki zahtevajo posebne ocene tveganja, kot je navedeno zgoraj).
The overall risk of the product is then the highest risk level identified, because action on the highest risk level is normally the most effective way of risk reduction.
Ali se lahko tveganja seštevajo?
Only in special cases may a less-than-highest risk be considered particularly important, since it may require specific risk management measures.
Za skoraj vsak proizvod je mogoče razviti več scenarijev, ki vodijo do resnih tveganj.
As an example of several risks, a hammer may have a weak head and a weak grip, each of which may break when the hammer is used, and the consumer may be injured.
Kotni brusilnik lahko na primer predstavlja tveganje električnega šoka, ker so električne žice preveč izpostavljene, in tveganje požara, ker se lahko stroj med normalno uporabo pregreje in vname.
If the relevant scenarios lead to different risk levels, the highest risk should be reported as ‘the risk’ of the hammer.
Če štejemo obe tveganji za „veliki“, ali se seštejeta, tako da predstavlja brusilnik „resno tveganje“?
It could be argued that:
Kadar je isti proizvod povezan z več tveganji, obstaja za eno od njih večja verjetnost, da se uresniči in povzroči poškodbo.
the apparently most significant hazard should be decisive, since it would lead to the most severe injuries.
Celotna verjetnost poškodbe je zato večja.
In the above example of the hammer, this could be the hammer head breaking, since pieces of the broken head could fly into one's eye, possibly blinding the user.
To pa ne pomeni, da je celotno tveganje avtomatično večje:
The hammer grip breaking, on the other hand, would never split into small pieces that could do as much damage to the eyes,
Celotna verjetnost se ne izračuna s seštevanjem verjetnosti.
however, this would be a hazard assessment, not a risk assessment.
Potrebni so zahtevnejši izračuni, katerih rezultat je vedno manjši od vsote vseh verjetnosti.
A risk assessment also looks at the probability of an injury actually happening.
Dve zaporedni stopnji verjetnosti se razlikujeta za faktor 10 (preglednica 4).
Thus, the ‘most significant hazard’ might cause an injury that is much less likely than a lesser hazard, and therefore present a lower risk.
To pomeni, da je za večjo celotno verjetnost (in možno tveganje) potrebno večje število različnih scenarijev za isto stopnjo.
Conversely, a scenario leading to a less severe injury may be much more likely than a scenario resulting in death, and the less severe injury may therefore present a higher risk,
Vrednosti verjetnosti so ocene, ki morebiti niso povsem točne, saj so zaradi zagotavljanja visoke ravni zaščite pogosto„na varni strani“.
the highest probability for an injury scenario to happen should be the decisive factor for ‘the risk’ of the product.
Zato je namesto seštevanja grobih ocen verjetnosti iz raznovrstnih scenarijev koristnejše upoštevati bolj točne ocene verjetnosti scenarija, ki vodi do največjega tveganja.
In the above example of the hammer, if the hammer grip is very weak, the most likely injury scenario would be from the grip breaking, and that should therefore be decisive,
Z nekaj truda je mogoče razviti na stotine scenarijev poškodb.
however, this would not consider the seriousness of eye injuries that the hammer head breaking could cause.
Če bi tveganja preprosto seštevali, bi bilo celotno tveganje odvisno od števila pripravljenih scenarijev poškodb in bi raslo „v neskončnost“.
Looking at probability alone would not therefore give the whole picture.
To pa ni smiselno.
In conclusion, risk is a balanced combination of both the hazard and the probability of the injury that the hazard can cause.
Zato tveganj ne moremo preprosto seštevati.
Risk describes neither the hazard, nor the probability, but both at the same time.
Če obstaja več kot eno ustrezno tveganje, bo morda treba hitreje sprejeti ukrep za njegovo obvladovanje ali pa bo moral biti ukrep bolj izrazit.
Taking the highest risk as ‘the risk’ of the product will ensure the most effective product safety (apart from specific risks requiring specific risk management, as mentioned above).
Proizvod z dvema tveganjema bo na primer morda treba takoj umakniti s trga in odpoklicati, medtem ko bi v primeru enega tveganja zadoščalo ustaviti prodajo.
Can risks cumulate?
Obvladovanje tveganja je odvisno od številnih dejavnikov, ne le od števila tveganj, ki jih lahko proizvod predstavlja naenkrat.
Several injury scenarios leading to several risks can be developed for virtually every product.
Zato je treba usmeriti pozornost na povezavo med tveganjem in obvladovanjem tveganja (oddelek 4).
For example, an angle grinder may present the risk of an electric shock, because electrical wires may be too exposed, and the risk of fire, because the machine may overheat and ignite during normal use.
Skladnost z mejnimi vrednostmi v zakonodaji in standardih
If both risks are considered to be ‘high’, do they add up to the grinder posing an overall ‘serious risk’?
Pri nadzoru trga se proizvodi za potrošnike pogosto preskušajo glede na mejne vrednosti ali zahteve v zakonodaji in varnostnih standardih za proizvode.
Where several risks are linked to the same product, one of them is obviously more likely to materialise and causes an injury.
Proizvod, ki je skladen z mejnimi vrednostmi ali zahtevami [27], se šteje za varnega v smislu lastnosti glede varnosti, ki so zajete v teh vrednostih ali zahtevah.
The overall likelihood of an injury is therefore greater.
Ta domneva je mogoča na podlagi upoštevanja tveganj, ki jih predstavlja proizvod in ki izhajajo iz njegove nameravane in upravičeno predvidene uporabe ter se upoštevajo pri ugotavljanju mejnih vrednosti ali zahtev.
This does not mean that the overall risk is automatically higher, however:
Proizvajalci zagotavljajo, da so njihovi proizvodi v skladu s temi vrednostmi ali zahtevami, saj morajo tako paziti le še na tveganja v zvezi s proizvodi, ki jih te mejne vrednosti ali zahteve ne zajemajo.
the overall probability is not calculated by simply adding up probabilities.
Primer mejne vrednosti v
More complex calculations are necessary, and these always result in a probability that is lower than the sum of all probabilities,
zakonodaji je meja 5 mg/kg benzena v igračah, ki ne sme biti presežena v skladu s točko 5 Priloge XVII k Uredbi REACH [28], kakor je bila nazadnje spremenjena z Uredbo (ES) št. 552/2009 [29];standardu je valj za majhne dele: majhni deli igrač za otroke, mlajše od 36 mesecev, se ne smejo v celoti prilegati valju, opisanem v standardu za igrače [30].
there is difference of a factor of 10 between two succeeding probability levels (Table 4).
Če se prilegajo, predstavljajo tveganje.
This means that a lot of different scenarios of the same level would be needed to result in higher overall probability (and possibly risk),
Šteje se, da proizvod ni varen, kadar ni v skladu z določenimi mejnimi vrednostmi.
probability values are estimations which may not be totally accurate, as they often err on the ‘safe’ side in order to ensure a high level of protection.
Za mejne vrednosti, določene v:
It is therefore more useful to look at a more accurate estimation of the probability of a scenario leading to the highest risk than to add up rough estimations of probabilities of all sorts of scenarios,
zakonodaji, na primer za kozmetične proizvode ali omejitve glede trženja in uporabe, proizvod ne sme biti na voljo na trgu;
with a little effort hundreds of injury scenarios could be developed.
standardih, proizvajalec lahko kljub vsemu poskuša dokazati, da je njegov proizvod tako varen, kot če bi bil skladen z mejnimi vrednostmi iz standarda, z izvedeno popolno oceno tveganja za svoj proizvod.
If risks were simply added together, the overall risk would depend on the number of injury scenarios generated and could increase ‘endlessly’.
Vendar se lahko zgodi, da je v to treba vložiti več truda kot v izdelavo proizvoda v skladu z mejnimi vrednostmi iz standarda, v nekaterih primerih, kot je navedeni valj za majhne dele, pa je to lahko nemogoče.
This does not make sense.
Neskladnost z mejnimi vrednostmi ne pomeni samodejno, da proizvod predstavlja „resno tveganje“ (ki je največja stopnja tveganja, ki jo zajemajo te smernice).
Thus, risks are not simply cumulated.
Da se zagotovijo ustrezni ukrepi za zmanjšanje tveganja, je zato treba izvesti oceno tveganja tistih delov proizvoda, ki niso v skladu z zakonodajo ali standardom oziroma jih zakonodaja ali standard ne zajemata.
However, if more than one relevant risk exists, action to manage the risks may need to be taken more rapidly or may need to be more pronounced.
Poleg tega je treba v zvezi z nekaterimi proizvodi, kot so kozmetični proizvodi, izvesti oceno tveganja tudi, če so v skladu z mejnimi vrednostmi, določenimi v zakonodaji.
For example, with two risks, a product may need to be immediately taken off the market and recalled, whereas, with a single risk, halting sales could be sufficient.
Ocena tveganja mora navajati dokaze za varnost celega proizvoda [31].Skladnost z mejnimi vrednostmi v zakonodaji ali standardih torej omogoča domnevo varnosti, vendar se lahko zgodi, da takšna skladnost ne zadošča.
Risk management depends on many factors, not only on the number of risks that a product may present at one and the same time.
Smernice za posebno oceno tveganja v posebnih primerih
Thus, consideration is given below to the link between risk and risk management (Section 4).
Za kemikalije obstajajo posebna navodila o tem, kako pripraviti oceno tveganja [32] [33], zato v teh smernicah niso obravnavane podrobno.
Compliance with limit values in legislation and standards
Vendar te smernice sledijo istim načelom kot v primeru „običajnih“ proizvodov za potrošnike:
In market surveillance, consumer products are often tested against limit values or requirements laid down in legislation and in product safety standards.
opredelitev in ocena nevarnosti – enako kot pri določanju resnosti poškodbe, kot je prej opisano,
A product that complies with the limit value(s) or requirement(s) [27] is presumed to be safe in terms of the safety characteristics covered by those value(s) or requirement(s).
ocena izpostavljenosti – v tem koraku je izpostavljenost izražena kot verjetni odmerek kemikalije, ki ga lahko potrošnik zaužije peroralno, z vdihavanjem ali skozi kožo, ločeno ali skupaj, če uporablja proizvod v skladu s predvidevanji v scenariju poškodb. – Ta korak je enak kot določanje verjetnosti, da se bo poškodba v resnici zgodila,
This assumption can be made because the risks of a product from its intended and reasonably foreseeable use are taken into account when establishing the limit value(s) or requirement(s).
opredelitev tveganja – ta korak je v osnovi sestavljen iz primerjave odmerka kemikalije, ki ga bo potrošnik verjetno zaužil (= izpostavljenost) in izpeljane ravni brez učinka (DNEL) te kemikalije.
Manufacturers thus need their products to comply with these values or requirements, because they then only have to look at risks with their products that are not be covered by those limit value(s) or requirement(s).
Če je izpostavljenost ustrezno manjša od DNEL oziroma če je stopnja opredelitve tveganja (RCR) znatno manjša od 1, se šteje, da je nadzor tveganja ustrezen. – To je enako določanju stopnje tveganja.
An example of a limit value in:
Ukrepi za obvladovanje tveganja morda ne bodo potrebni, če bo stopnja tveganja ustrezno majhna.
legislation is the limit of 5 mg/kg benzene in toys which must not be exceeded, as per point 5 of Annex XVII, to the REACH Regulation [28], as amended by Commission Regulation (EC) No 552/2009 [29],a standard is the small parts cylinder: small parts of a toy for children under 36 months must not fit entirely into the cylinder described in the Toys Standard [30].
Ker lahko kemikalija vključuje več nevarnosti, se tveganje običajno določi za „glavni učinek na zdravje“, ki je učinek na zdravje (ali „končna točka“, kot so akutna toksičnost, draženje, senzibilizacija, rakotvornost, mutagenost, strupenost za razmnoževanje), ki se šteje za najpomembnejšega.
If they do, they present a risk.
Za kozmetične proizvode obstajajo posebna navodila [34], lahko pa bi obstajala posebna navodila tudi za druge proizvode in namene.Uporaba posebnih navodil je zelo priporočljiva, saj so prilagojena posebnim obravnavanim primerom.
The product is presumed not to be safe where it fails to comply with established limit values.
Kadar pa podatki, ki jih zahtevajo posebna navodila, ne obstajajo ali jih ni mogoče oceniti, se lahko te smernice uporabijo za izvedbo predhodne ocene tveganja.
For limit values laid down in:
Da bi se izognili napačni razlagi, je treba oceno tveganja izvesti skrbno in pazljivo.
legislation, such as on cosmetics or restrictions on marketing and use, the product must not be made available on the market,
DO OCENE TVEGANJA KORAK ZA KORAKOM
standards, the manufacturer may nevertheless try to provide evidence that his product is as safe as if it were compliant with the standard's limit value by way of a fully fledged risk assessment on his product.
V tem oddelku je natančno opisano, katere točke je treba upoštevati in katera vprašanja je treba zastaviti pri pripravljanju ocene tveganja.
However, this may require more effort, and may be impossible in cases such as the small parts cylinder referred to above, than actually manufacturing the product in compliance with the standard's limit value.
Proizvod mora biti nedvoumno prepoznaven.
Non-compliance with limit values does not automatically mean that the product presents a ‘serious risk’ (which is the highest risk level covered by these guidelines).
To vključuje ime proizvoda, blagovno znamko, ime modela, številko tipa, morebitno serijsko številko proizvodnje, vsa potrdila, ki so lahko priložena proizvodu, za otroke varno zapiralo, če obstaja, identiteto osebe, ki je dala proizvod na trg in državo porekla.
Therefore, to ensure appropriate risk reduction measures, a risk assessment will be required for those parts of a product that do not comply with or are not covered by legislation or a standard.
Za del opisa proizvoda se lahko štejejo tudi slika proizvoda, embalaža, označba (če je to ustrezno) in poročila o preskusu za identifikacijo nevarnosti proizvoda.
Furthermore, some products, such as cosmetics, require a risk assessment even when they are compliant with the limit values laid down in legislation.
V posebnih primerih je lahko nevarnost omejena na poseben del proizvoda, ki je lahko ločen od njega in tudi ločeno na voljo potrošnikom.
This risk assessment should provide evidence of the safety of the whole product [31].In conclusion, compliance with limit values in legislation or in standards provides presumption of safety, but such compliance may not be sufficient.
V takih primerih zadostuje samo ocena posebnega dela proizvoda.
Specific risk assessment guidelines in specific cases
Primer so baterije za notesnike za ponovno polnjenje, ki se lahko pregrejejo.
For chemicals there are specific instructions on how to prepare a risk assessment [32] [33], and therefore they are not dealt with in detail in these guidelines.
Opis proizvoda vključuje vse oznake, ki so lahko pomembne za oceno tveganja, in zlasti oznake z opozorili.
Nevertheless, they follow the same principles as for ‘normal’ consumer products:
Tudi navodila za uporabo lahko vsebujejo ustrezne informacije glede tveganja, ki ga predstavlja proizvod, in o tem, kako to tveganje vzdrževati na čim manjši ravni, na primer z uporabo osebne varovalne opreme ali z izključitvijo otrok iz uporabe proizvoda.
hazard identification and assessment — this is the same as determining the severity of the injury, as described above,
Takšen primer je verižna žaga.
exposure assessment — in this step, exposure is expressed as the likely dose of the chemical that the consumer may take up via oral, inhalation or dermal routes, separately or jointly, when using the product as anticipated in the injury scenario — this step is the same as determining the probability that the injury will indeed occur,
Nekatere proizvode morajo potrošniki pred uporabo sami sestaviti, kot na primer pohištvo.
risk characterisation — this step basically consists of comparing the dose of the chemical that the consumer is likely to take up (= exposure) with the derived no-effect level (DNEL) of that chemical.
Ali so navodila za sestavljanje dovolj jasna za proizvod, pripravljen za uporabo, da izpolnjujejo vse ustrezne varnostne zahteve?
Should the exposure be sufficiently lower than the DNEL, in other words, should the risk characterisation ratio (RCR) be clearly below 1, risk is considered to be adequately controlled — this is the same as determining the risk level.
Ali pa lahko potrošniki pri sestavljanju proizvoda delajo napake, ki lahko povzročijo nepredvidena tveganja?
Risk management measures may not be needed if the level of risk is sufficiently low.
Ocena tveganja mora vedno upoštevati celotno življenjsko dobo proizvoda.
Since a chemical may possess several hazards, risk is normally determined for the ‘leading health effect’, which is the health effect (or ‘endpoint’ such as acute toxicity, irritation, sensitisation, carcinogenicity, mutagenicity, toxicity for reproduction) considered to be the most important.
To je še posebej pomembno, kadar je bil razvit nov proizvod in se ocenjujejo njegova tveganja.
For cosmetics, there is also specific guidance [34], and there may be specific guidance for other products or purposes.It is highly recommended to use such specific guidance, since it is tailored to the specific cases in question.
Ali bosta starost in uporaba spremenila vrsto ali obseg nevarnosti?