Practical applicationof Risk assessment and Risk management tools

UN ECE WP6

Workshop

23.11. 2009

Work by the European Commission on Risk Assessment

Guidelinesand

Injury scenario

Kvetoslava Steinlová,

Slovak Office of Standards, Metrology and Testing

kvetoslava.steinlova@normoff.gov.sk

UN ECE WP6

Workshop

23.11. 2009

RISK – Combination of the probability of occurrence of harm and the severity of harm

HARM – Psychical injury or damage to the health of people or damage to property or environment

HARMFUL EVENT – Occurrence to which a hazard situation results in harm

HAZARD – Potential source of harm

HAZARD SITUATION – Circumstances in which people, property or the environment are exposed to one or more hazard

UN ECE WP6

Terminology

ISO/IEC Guide 51

Commission decision 2004/418/ES laying down guidelines for the management of Community information system –RAPEXguidelines(published in OJ L 208, 10.6.2004, p. 73)

Risk Assessment - based on previous experience related to the consumer products from:•US•Australian and New Zealand•Europe

UN ECE WP6

Starting point

US liability (burden of precaution to avoid the risk or loss B < L x P)•ANSI Standards and technical reports•Risk assessment Benchmark 2000: Getting starting, making progress: www.designsafe.comNomograph methods (New Zealand). Matrix Method (BE) EN, ISO : i.e. ISO /TR 14121-2

UN ECE WP6

Methods used for risk assessment

taken in consideration

Usage of matrix in the standards

RAPEX Guidelines published 2004

Simple tool for estimating risk

severity of injury

risk level

probability of accident

low, moderate or serious risk

vulnerabilityguards

warnings

RAPEX Guidelines published 2004

Severity

> 15% incapacity usually irreversible

2% - 15% incapacityhospital treatment

< 2% incapacity usually reversible

serious injury internal organsloss of limbsloss of sightloss of hearing

serious cutsloss of finger, toedamage to sightdamage to hearing

minor cutsminor fractures

very serious

seriousslight

RAPEX Guidelines published 2004

overall probability

Medium

LowVery Low

Hazard only occurs if several improbable conditions are met

HighMedium

Low

Hazard may occur under one improbable or two possible conditions

Very High

HighMedium

Hazard is always present and injury is likely to occur in foreseeable use

Probability of health/safety damage from regular exposure to hazardous product

100% (All)

10%1%

Probability of hazardous

product

Very LowVery Low

Low

LowVery Low

LowMedium

ModerateLowMediumHigh

HighMediumHighVery High

Very HighHighVery High

Very Serious

SeriousSlight

Overall gravity of outcome

Severity of injuryP

rob

abili

ty

Very Low

Low

Moderate

High

Very High

Overall gravity of outcome

obvious hazard?

yesyesnono

warnings/guards?

yesnoyesnoVulnerable

Very Vulnerable

Normal adultsVulnerable people

moderate risk - some action

required

low risk - action unlikely

serious risk - rapid action required

Review of current RAPEX risk assessment (RA) • To eliminate diverging risk assessment

results

• Member State (MS) experts group set up

at end of 2005: 21 experts from 13 MSs

(IRAG WG)

• 8 meetings: 2006, 2007

• Iterative review: new ideas, RA trials;

further ideas, further RA trials; etc.: 3 RA

trials carried out (folding chair, socket

protectors, hammer)

• Co-ordination with PROSAFE, EMARS

Results after 8 WG meetings

Better standardised approach

List of hazards:electric shock..

List of injuriesand their severity

Step-by-stepinjury scenario

Step-by-stepestimation ofprobability

OverallprobabilitySeverity of

injury

RISKE

MA

RS

pro

ject

(PR

OS

AF

E)

� Increased complexity? – Only seemingly, because risk assessment was always that complex.

�Standardised lists and tables -> Computer program -> Simplification, and an inspiration for the risk assessor.

�Risk assessor to use his experience and imagination more than ever.

�3 steps, as always:

Injury * Probability = Risk

Results after 8 WG meetings

�Develop several injury scenarios – easier to determine the highest risk (= risk of the product)

�Divide an injury scenario into several steps (“shortest path to injury”) – easier to find points of disagreement, but also eventual consensus

�Make sensitivity analysis if risk is at the edge of « serious » to « moderate », etc. – easier to determine the right risk level

�Check whether the risk level identified is plausible

Results after 8 WG meetings

Approachdeveloped is not easy overviewed

Outline of draft RA Guidelines

Risk assessment – An overview� Risk = the combination of hazard and

probability

� Three core steps

Some useful tips� Seek information

� Make a sensitivity analysis

� Let other check your RA – i.e.colleagues

� Several hazards, several injuries – but only one risk

� Can risks cumulate?

� Compliance with limit values in legislation or in standards

Outline of draft RA Guidelines

Building a risk assessment step by step� The product

� The product hazard

� The consumer: Intended/non-intended user, Vulnerable consumers, Intended and reasonably foreseeable (mis-) use, Frequency and duration of use, Hazard recognition, etc.

� Injury scenario: Steps to the injury(ies) that a hazard can cause

� Severity of injury

� Probability of injury

� Determination of the risk

Outline of draft RA

Guidelines

Examples

From risk to actionTables in the annex

�Vulnerable consumers

�Hazards, typical injury scenario, typical injury

� Injuries, Severity of injury

�Probability of injury: Almost certain, Quite possible, Unusual but possible, …

�Risk level

Hazard Scenario Type of injury

Severity of injury

Probability Probability class

Risk

serious

moderate

low

acceptable

> 50%

> 1/10

> 1/100

> 1/1,000

> 1/10,000

> 1/100,000

> 1/1,000,000

≤ 1/1,000,000calculated from

estimates of all

relevant factors in

scenario

slight

moderate

serious

very serious

injury and

body partcomplete

description of all

steps in the

path from

hazard to injury

Example

Scenario: inadequate material of hammer head. Parts of head fly off when person uses hammer and hits hard surface. Part flies into eye

� Injury: Foreign body in eye, blindness in 1 eye

� Injury severity: Serious� Probabilities: Breaking: 1/10. Hitting

person: 1/10. Hitting head: 1/3. Hitting eye: 1/20

� Overall probability: 1/6,000 � class > 1/10,000’:‘Conceivable, but highly unlikely’

� Overall conclusion: Moderate risk

Elements Risk assessment

�Clear injury scenario� Include and analyse multiple

scenarios�Small steps in scenarios to

include all relevant factors�Tables for guidance on

scenarios and injury severity�Use quantitative data about

probability of each step�Be explicit about uncertainty, do

sensitivity analysis�Compare results from several

experts

Outline of draft RA Guidelines

AAAA< 1/1.000.000(Virtually) Impossible

AAAL> 1/1.000.000

Impossible unless aided

AALM> 1/100.000

Practically impossible

ALMS> 1/10.000

Conceivable, but highly unlikely

AMSS> 1/1.000

Only remotely possible

LSSS> 1/100

Unusual but possible

LSSS> 1/10

Quite possible

MSSS> 50 %

Almost certain, might well be expected

SlightModera

teSeriou

s

Very Serious

Probability of damage during the foreseeable lifeti me of the product

Severity of Injury

Product

a product hazards including features that induce unintended use b conditions in which hazards may manifest themselves c product lifespan and possible changes in product during the lifecycle d appropriate and sufficient warnings and/or instructions for assembly, use, and/or disposal

Persons

a characteristics of intended users of the product (relevant to the hazards) b characteristics of other persons that can be foreseen to be in contact with the product c contact groups variation: age, capabilities etc (adult, young child, elderly, disabled, professional) d users’ awareness, experience and perception of the product hazards

Interaction

a attractiveness of the product (e.g. child appealing) b intended uses, including assembly, use, and disposal stage c frequency of use, e.g. per year d duration of use e unintended (but reasonably foreseeable) uses that person may apply the product for f conditions outside product that may influence the interaction g types of use, in particular critical paths to injury

Factors in estimating exposure/probability/ Dirk van Aken

Next Steps

� Consultation within Commission service on the revised Guidelines

� Stakeholder Approval� Developing scenarios with ADCO

identified hazards and risks� Avoidance or mitigation of damage to

the environment and property� New actions organized by

PROSAFE?

Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing Decision No 3052/95/EC

Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93

Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC

Fit for usage in the framework of

new EU Regulatory package for goods

Dates ?

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND TO THE COUNCILon the implementation of Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safetyCOM(2008) 905 final

Thank you for your attention

Further information