Risk assessment Nemko, 2018-02-06 Geir Hørthe Jon Ivar Tidemann
2 13.06.2017
Risk? Probability x Speed? Severity Dark? = Car? Wet? Risk Size? Distance? Speed? Fire Truck? 3
Risk? Probability Severity 4
Risk? Risk analysis = what are the risks? Risk evaluation = is risk acceptable? Risk assessment 5
Risk level – what is ok? Probability Severity 6
Risk standard - Inherent Hazard - User - Location - Use / Misuse - Faults - Statistics 7
Risk report Product’s hazards: User: - Sharp - Age, disability , trained .. - Kinetic energy - Intended / non intended user - Fire - Use / Misue - etc - etc Describe scenario: Find Risk level: - Child breaks lamp - use risk table. and gets a burn - etc. Level of Severity: Probability: - cut - e.g. < 1/100 000 Acceptable - burn risk? - etc 8
Risk reduction 1. Reduce inherent hazard 2. Safeguarding 3. Information 9
Risk reduction – a practical example 1. Reduce inherent hazard 2. Safeguarding 3. Information 10
Risk assessment, Part II Nemko, 2018-02-06 Jon Ivar Tidemann
Yes it is- mandatory to do risk analysis from April 20 th , 2016 • LVD Directive 2014/35/EU, Annex III, 2. The technical documentation shall include an adequate analysis and assessment of the risk(s). The Blue Guide This analysis has to be documented and included in the technical documentation, unless risk assessment is included in the harmonized standard. 12
The Risk Process step by step – identify the scope and target users of the product 1. – identify the intended use and reasonably foreseeable misuse 2. – identify the hazards during each life cycle, such as during: 3. design, manufacture, installation, maintenance, repair and disposal – estimate the risks caused by each identified hazard 4. – if the results of the risk assessment show that the remaining risk 5. is at a tolerable level, no further action is needed – if not, risk reduction has to be implemented 6. – the loop is repeated until the remaining risk is reduced to a tolerable level. 7. TITLE 13
Adviced start: Brainstorming
Where to find Cenelec Guide 32 https://www.cenelec.eu/membersandexperts/referencematerial/cenelecguides.html TITLE 15
Annex A of the guide
Annex D of the guide
Example 1- defining hazards with a product and calculate the risk 19 07.02.2018
What is the risk for this to happen? • Assumptions: • It is a child of age 1-3 in 5% of homes having an iron • User of the iron is away for some seconds in 1% of situations. • Child try to raise and catch the iron in 10% of situations • Iron need to tilt and fall down-50% probability TITLE 20 07.02.2018
Scenarios • What happens then? • Hit in the head • Falls down and brakes so child can get electrical shock • Falls down on the body of the child • Does not brake and child take it up and get burned. If child grips cord-then it falls down TITLE 21 07.02.2018
Overall probability and severity Probability: 1/20 x1/100x 1/10 x 1/2 = 1/ 40 000 (5% X 1% X 10% X 50% ) Ref: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32010D0015 TITLE 22 07.02.2018
Result – Low risk TITLE 23 07.02.2018
Example of risk reduction
Tolerable level and the 3 step method Step Reducing hazard 1 2 3
Tolerable level and the 3 step method Step Reducing hazard 1 - LED instead of Incandescent, - Plastic enclosure instead of Glass, - Avoid child appealing design 2 3
Tolerable level and the 3 step method Step Reducing hazard 1 - LED instead of Incandescent, - Plastic enclosure instead of Glass, - Avoid child appealing design 2 - Batteries or below 42 volts , - Fixed instead of movable 3
Tolerable level and the 3 step method Step Reducing hazard 1 - LED instead of Incandescent, - Plastic enclosure instead of Glass, - Avoid child appealing design 2 - Batteries or below 42 volts , - Fixed instead of movable 3 Not recommended
Final documentation to put into technical file • Cenelec Guide 32, Annex D: NEMKO EUROPE 29 13.06.2017
Listing of hazards and calculations Injury scenario Injury type Severity Probability of injury Overall possibility Risk (include user) and body (1-4) (L/M/H/S) part Are all the risks tolerable for your company? Use the 3 step method for reduction of risk
Any questions? For assistance contact: geir.horthe@Nemko.com jonivar.tidemann@Nemko.com nemko.com COMPANY PRESENTATION 31 15.05.2013
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