Risk Assessment by the Market Surveillance Authorities Content - - PowerPoint PPT Presentation
Risk Assessment by the Market Surveillance Authorities Content risk/safety definitions and aspects risk assessment methodology risk calculation Dr. Jrg Windberg, Dortmund (Germany)
Principles of hazard, risk and danger
temporal and/or local separation: Safety temporal and/or local
Risikoansatz zur Beurteilung der technischen Sicherheit (nach Hosemann)
Safety Risk not higher than highest reasonable risk Danger risk higher than highest reasonable risk Highest reasonable risk residual risk risk without safety measures
minimum risk reduction actual risk reduction
risk
high low
steigendes Risiko Toleranzschwelle Akzeptanzschwelle Danger Safety Action State of the art no further action needed Further design- action recommended Common understanding that risk is not acceptable Width depending on technical and cultural powers in every single area
Risk assessment
Safety meaasures by the designer
resi dua risk
safety measures by the user (not to be dealt in this ISO standard) acceptable risk Step 1: inherent safety
Step 2: safeguarding
Step 3: information for use user feedback put into service by the designer Risk
Tendencies for reasonably foreseeable (mis)use: Situations which are reasonable by common sense and are in accordance with common life experience. (eg.: touching of hot oven doors by young children) A misuse cannot be recognized by the user. (eg.: combining of multiple power sockets risk of fire) The misuse will be recognized by the user but the risk will be underestimated. (eg.: fork lifts – driving too fast / driving with lifted load risk of tilting) The misuse is broadly common and will no more recognized by the user. (eg.: removing a plug by pulling the wire) A misuse can be expected because it is more comfortable for the user. (eg.: incomplete winding up of a cable roller) non rational behaviour in case of malfunction during use of a product. (eg.: removing of a blockage inside the opening of a garden shredder)
notified as RAPEX No. 0051/06
No transformer (reducing high voltage to low voltage) was provided with the child-appealing portable luminary. Thermal heating during normal
the highest measured temperature
the lamp) was 175,2°C.
Scenario
Questions How do you estimate the likelihood
scenario? What is your conclusion about the risk? Which is the severity class of that injury?
Injury scenario: Child takes lamp to play. During playing life parts become touchable. Child touches life parts and gets electric shock; child is electrocuted;
Table 2. Hazards and their typical injury scenario and typical injury Hazard group Hazard (product property) Typical injury scenario Typical injury Size, shape and surface Product is obstacle Person trips over product and falls; or person bumps into product Bruising; fracture, concussion Product is impermeable to air Product covers mouth and/or nose of a person (typically a child), or covers internal airway Suffocation Product is or contains small part Person (child) swallows small part; the part gets stuck in larynx and blocks airways Choking, internal airway obstruction Possible to bite off small part from product Person (child) swallows small part; the part gets stuck in the digestive tract Digestive tract obstruction Sharp corner or point Person bumps into sharp corner or is hit by moving sharp object; this causes a puncture or penetration injury Puncture; blinding, foreign body in eye; hearing, foreign body in ear Sharp edge Person touches sharp edge; this lacerates the skin
Laceration, cut; amputation Slippery surface Person walks on surface, slips and falls Bruising; fracture, concussion Rough surface Person slides along rough surface; this causes friction and/or abrasion Abrasion Gap or opening between parts Person puts a limb or body in opening and finger, arm, neck, head, body or clothing is trapped; injury occurs due to gravity or movement Crushing, fracture, amputation, strangulation Potential energy Low mechanical stability Product tips; person on top of product falls from height, or person near product is hit by the product; electrical product tips, breaks and gives access to live parts, or continues to work heating nearby surfaces Bruising; dislocation; sprain; fracture, concussion; crushing; electric shock; burns Low mechanical strength Product collapses by overloading; person on top of product falls from height, or person near product is hit by the product; electrical product tips, breaks and gives access to live parts, or continues to work heating nearby surfaces Bruising; dislocation; fracture, concussion; crushing; electric shock; burns High position of user Person at high position on the product loses balance, has no support to hold on to and falls from height Bruising; dislocation; fracture, concussion; crushing Elastic element or spring Elastic element or spring under tension is suddenly released; person in the line of movement is hit by the product Bruising; dislocation; fracture, concussion; crushing Pressurised liquid or gas, or vacuum Liquid or gas under pressure is suddenly released; person in the vicinity is hit; or implosion of the product produces flying objects Dislocation; fracture, concussion; crushing; cuts (see also under fire and explosion) Kinetic energy Moving product Person in the line of movement of the product is hit by the product or run over Bruising; sprain; fracture, concussion; crushing Parts moving against one another Person puts a body part between the moving parts while they move together; the body part gets trapped and put under pressure (crushed) Bruising; dislocation; fracture; crushing Parts moving past one another Person puts a body part between the moving parts while they move close by (scissor movement); the body part gets trapped between the moving parts and put under pressure (shearing) Laceration, cut; amputation Rotating parts A body part, hair or clothing of a person is entangled by the rotating part; this causes a pulling force Bruising; fracture; laceration (skin
Hazard group Hazard (product property) Typical injury scenario Typical injury Electrical energy High/low voltage Shock, Electrocution electric shock - burns 2nd degree on hand electric shock - electrocution
Severity of injury Type of injury 1 2 3 4 Electric shock (see also under burns as electric current can cause burns) Local effects (temporary cramp or muscle paralysis)
Burn/Scald 1º, up to 100% of body surface 2º, <6% of body surface 2º, 6-15% of body surface 2º, 16-35%
body surface, or 3º, up to 35%
body surface Inhalation burn 2º or 3º, >35% of body surface Inhalation burn requiring respiratory assistance
Table 3: Severity of injury electrocution 4 Table 2: Injury scenario Child takes lamp to play. During playing life parts become touchable. Child touches life parts and gets electric shock; child is electrocuted; Table 2: Hazard, typical injury Hazard Group: Electrical Energy Hazard: shock, electrocution Typical injury: electric shock electrocution - death
Probability of injury Child takes lamp 1/? Life parts become touchable 1/? Child touches life parts 1/? Child sustains electric shock 1/? Child is electrocuted 1/? Table 4: Overall probability 1/? > 1/? Overall probability: 1/? x 1/? x 1/? x 1/? x 1/? = 1/? Table 3: Severity of injury electrocution 4 Table 2: Injury scenario Child takes lamp to play. During playing life parts become touchable. Child touches life parts and gets electric shock; child is electrocuted; Table 2: Hazard, typical injury Hazard Group: Electrical Energy Hazard: shock, electrocution Typical injury: electric shock electrocution - death
Probability of injury Child takes lamp 1/10 Life parts become touchable 1/50 Child touches life parts 1/10 Child sustains electric shock 1 Child is electrocuted 1/100 Table 4: Overall probability 1/500,000 > 1/1,000,000 Overall probability: 1/10 x 1/50 x 1/10 x 1 x 1/100 = 1/500,000 = 2 children per million using this lamp
may be killed (?)/ hurt (?) by an electric shock
Table 3: Severity of injury electrocution 4 Table 2: Injury scenario Child takes lamp to play. During playing life parts become touchable. Child touches life parts and gets electric shock; child is electrocuted; Table 2: Hazard, typical injury Hazard Group: Electrical Energy Hazard: shock, electrocution Typical injury: electric shock electrocution - death
Severity of injury Type of injury 1 2 3 4
Basic treatment First Aid Emergancy room No hospitalisation hospitalisation Fatal outcome possible Electric shock Local effects… electrocution
Severity of Injury Probability of damage during the foreseeable lifetime of the product 1 2 3 4 high > 50 % H S S S > 1/10 M S S S > 1/100 M S S S > 1/1,000 L H S S > 1/10,000 L M H S > 1/100,000 L L M H > 1/1,000,000 L L L M low < 1/1,000,000 L L L L
S – Serious Risk H – High risk M – Medium risk L – Low risk
Table 5: Risk level Medium risk Risk management Corrective measure necessary no need for RAPEX! Probability of injury Child takes lamp 1/10 Life parts become touchable 1/50 Child touches life parts 1/10 Child sustains electric shock 1 Child is electrocuted 1/100 Table 4: Overall probability 1/500,000 > 1/1,000,000 Table 3: Severity of injury electrocution 4 Table 2: Injury scenario Child takes lamp to play. During playing life parts become touchable. Child touches life parts and gets electric shock; child is electrocuted; Table 2: Hazard, typical injury Hazard Group: Electrical Energy Hazard: shock, electrocution Typical injury: electric shock electrocution - death