Download RAPEX

RISK ASSESSMENT
How to perform the risk assessment
for one product covered by LVD
(in accordance with the Commission Decision 2010/15/EU)
Evert van Wilgenburg
Senior Product Safety Expert and Policy
new Food and Consumer Product Safety Authority
Netherlands
Guidance
• Guidelines for the ‘RAPEX’ assessment procedure (2010/15/EC)
• RAPEX > Rapid exchange procedure
Quick exchange of information
Prevents to supply products with a serious risk
Effectiveness and consistency of market surveillance
Helps to ensure a high uniform level of consumer health
• Notification procedure Article 12 and and Article 11 of the GPSD
(2001/95/EC)
Article 11 > non-compliant products > notification
Article 12 > products with a serious risk > RAPEX
notification
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Guidance
• The Guidelines are addressed to all the authorities of Member
States
• RAPEX criteria
the product is a consumer product,
the product is subject to measures that prevent, restrict or
impose specific conditions on its possible marketing or use
(‘preventive and restrictive measures’),
the product poses a serious risk to the health and safety of
consumers,
the serious risk has a cross-border effect.
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Product assessment – Power supply
Isolation separation
via a transformer
230 V
SELV
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terminals
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RAG MODEL – IRAG WG
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General information
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Product hazards
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Injury scenarios
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Type of injuries
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Severity of injuries
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Probability factors
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Calculated probability
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Probability value
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Risks
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Assumptions
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Another scenario/risk
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General notes
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Information sheets
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For example
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Product assessment – Power supply
Break down during the
high voltage test
Isolation separation
via a transformer
230 V
SELV
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terminals
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Risk assessment model – Product hazards
 Identify all hazards that may lead to a consumer injury or health
damage. Consider all consumers, including the vulnerable.
Electric shock
Overheating
Fire
……
(see Hazard sheet of model)
(use for every identified hazard a new row)
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Risk assessment model – Injury scenarios (1)
The exact hazard or defect in this product and the event that may result;
the interaction of a person with the product during the intended and
reasonably foreseeable use and the exposure to the hazard; the mechanism
of injury.
Connection to the power supply
Phase is connected in most onerous way
Transient (high power peak) on supply side
High percentage of moisture
Transformer isolation break down
A person makes contact to the SELV circuit encompass
The hands are wet
An electric shock follows
An earth leakage protection device shut down the supply
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Risk assessment model – Injury scenarios (2)
The exact hazard or defect in this product and the event that may
result; the interaction of a person with the product during the
intended and reasonably foreseeable use and the exposure to the
hazard; the mechanism of injury.
Blue: the
Connection to the power supply
shortest
Phase is connected to in most onerous way
possible
Transient (high power peak) on supply side
scenario
High percentage of moisture
Transformer isolation break down
A person makes contact to the SELV circuit encompass
The hands are wet
Red: the
An electric shock follows
result
An earth leakage protection device shut down the supply
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Risk assessment model – Injury scenarios (3)
The exact hazard or defect in this product and the event that may
result; the interaction of a person with the product during the
intended and reasonably foreseeable use and the exposure to the
hazard; the mechanism of injury.
Connection to the power supply
Transformer isolation break down
A person makes contact to the SELV circuit engripped
(There are more scenario’s possible)
(use for every scenario a new row)
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Blue: the
shortest
possible
scenario
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Risk assessment model – Type of injuries
For each hazard identified, describe the injury resulting from the
injury scenario. If you select a hazard form the Hazard List, a
typical injury(ies) will be filled in here. Make this more specific by
describing both the injury and the body part. Click here to consult
the Injury Scale.
Electric shock
(See also under burns as electric current can cause burns)
Local effects (temporary cramp or muscle paralysis)
Electrocution
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Risk assessment model – Severity of injuries
Assign from the Injury Scale: 1 to 4. Click into cell below.
1 Electric shock
(See also under burns as electric current can cause burns)
2 Local effects (temporary cramp or muscle paralysis)
34 Electrocution
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Risk assessment model – Probability of factors
For each hazard identified, estimate the probability for each step in
the scenario (event, interaction and injury) e.g.: 1/10; 1/100; 1/8
Connection to the power supply 1/1
Transformer isolation break down 1/1000
A person makes contact to the SELV circuit engripped
1/4
For one product during the total life time
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Risk assessment model – Calculated probability
Calculated value of probability factors, e.g. 1/10 x 1/100 x 1/8 =
1/8.000
(Connection to the power supply) 1/1 X (Transformer
isolation break down) 1/1000 X (A person makes contact to
the SELV circuit engripped) 1/4 = 1/4000
For one product during the total life time
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Risk assessment model – Probability value
Select the scale value corresponding to the calculated value, e.g.
1/8.000 corresponds to "> 1/10.000"
(Connection to the power supply) 1/1 X (Transformer
isolation break down) 1/1000 X (A person makes contact to
the SELV circuit engripped) 1/4 = 1/4000 = > 1/10 000
For one product during the total life time
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Risk assessment model – Assumptions
Connection to the power supply 1/1
Every product has the construction failure
Transformer isolation break down 1/1000
Transients in the power source OR pollution of the transformer OR
ageing of isolation layers, which can lead to bridging of the isolation in
the transformer (in time the probability of failure increases); one off
ten overall possibilities of a product becoming defect
A person makes contact to the SELV circuit engripped 1/4
The terminals on the outside of the product OR extension leads
connected to those terminals Or the connected external peripheral
equipment parts under main voltage become directly accessible. If
peripheral equipment is metal encased with a common earthing also
the encasing can become connected to the main voltage.
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Risk assessment model – Risks (1)
Combined result from the risk table: Serious to Low Risk
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Risk assessment model – Risks (2)
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Risk assessment model – Risks (3)
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Actions if necessary
All categories of preventive and restrictive measures ….., including measures:
• marking a product with appropriate warnings on the risks it may
present;
• making the marketing of a product subject to prior conditions;
• warning consumers of the risks that could be posed by a product for
certain persons;
• temporary ban on the supply, offer to supply and display of a
product;
• ban on the marketing of a product and any accompanying
measures;
• withdrawal of a product from the market;
• recall of a product from consumers;
• destruction of a withdrawn or recalled product.
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(see par. 2.2.1 of the guide)
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Thank you for your attention
Evert van Wilgenburg
Senior Product Safety Expert and Policy
Chairman LVD-AdCo 2010
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Division Primex
new Food and Consumer Product Safety Authority
Westelijke Parallelweg 4 | 3331 EW | Zwijndrecht | TVE
Postbus 3000 | 3330 DC | Zwijndrecht | Netherlands
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T 0031 (0)78 6112100
F 0031 (0)78 6112200
[email protected]
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The AID, PD and VWA are building one new Food and Consumer Product Safety Authority.
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