Practical application of Risk assessment and Risk management tools

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1 UN ECE WP6 Workshop Practical application of Risk assessment and Risk management tools

2 UN ECE WP6 Workshop Work by the European Commission on Risk Assessment Guidelines and Injury scenario Kvetoslava Steinlová, Slovak Office of Standards, Metrology and Testing

3 UN ECE WP6 Terminology ISO/IEC Guide 51 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

4 UN ECE WP6 Starting point Commission decision 2004/418/ES laying down guidelines for the management of Community information system RAPEX guidelines (published in OJ L 208, , p. 73) Risk Assessment - based on previous experience related to the consumer products from: US Australian and New Zealand Europe

5 UN ECE WP6 Methods used for risk assessment taken in consideration 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: Nomograph methods (New Zealand). Matrix Method (BE) EN, ISO : i.e. ISO /TR

6 Usage of matrix in the standards

7 RAPEX Guidelines published 2004 severity of injury probability of accident Simple tool for estimating risk vulnerability risk level guards warnings low, moderate or serious risk

8 slight serious very serious RAPEX Guidelines published 2004 < 2% incapacity usually reversible 2% - 15% incapacity hospital treatment > 15% incapacity usually irreversible Severity minor cuts minor fractures serious cuts loss of finger, toe damage to sight serious injury internal organs loss of limbs loss of sight damage to hearing loss of hearing

9 RAPEX Guidelines published 2004 Probability of hazardous product 1% 10% 100% (All) overall probability Probabili ty of health/ Hazard is always present and injury is likely to occur in foreseeable use Medi um High Very High safety damage from regular exposur e to hazardo us product Hazard may occur under one improbable or two possible conditions Hazard only occurs if several improbable conditions are met Low Very Low Medi um Low High Mediu m

10 Severity of injury Overall gravity of outcome Slight Serious Very Serious Very High High Very High Probability Very High High Medium High Medium Low Medium Low Very Low High Moderate Low Low Very Low Very Low

11 Overall gravity of outcome Very High High Moderate Vulnerable people Very Vulner able Vulner able no no Normal adults yes no no yes serious risk - rapid action required yes yes warnings/guar ds? obvious hazard? Low Very Low moderate risk - some action required low risk - action unlikely

12 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

13 Better standardised approach Results after 8 WG meetings List of hazards: electric shock.. List of injuries and their severity Severity of injury EMARS project (PROSAFE) Step-by-step injury scenario Step-by-step estimation of probability Overall probability RISK

14 Results after 8 WG meetings 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

15 Results after 8 WG meetings Approach developed is not easy overviewed 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

16 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

17 Outline of draft RA Guidelines Building a risk assessment step by step The product The product hazard The consumer: Intended/nonintended 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

18 Outline of draft RA Guidelines Examples From risk to action Tables 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

19 serious moderate low acceptable Hazard Scenario Type of injury Severity of injury Probability Probability class Risk complete description of all steps in the path from hazard to injury injury and body part slight moderate serious very serious calculated from estimates of all relevant factors in scenario > 50% > 1/10 > 1/100 > 1/1,000 > 1/10,000 > 1/100,000 > 1/1,000,000 1/1,000,000

20 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

21 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

22 Outline of draft RA Guidelines Probability of damage during the foreseeable lifetime of the product Severity of Injury Very S e ri o u s Seriou s Modera te Slight Almost certain, might well be expected > 50 % S S S M Quite possible > 1/10 S S S L Unusual but possible > 1/100 S S S L Only remotely possible > 1/1.000 S S M A Conceivable, but highly unlikely > 1/ S M L A Practically impossible > 1/ M L A A Impossible unless aided > 1/ L A A A (Virtually) Impossible < 1/ A A A A

23 Factors in estimating exposure/probability/ Dirk van Aken 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

24 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?

25 Fit for usage in the framework of new EU Regulatory package for goods Dates? 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

26 Further information REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND TO THE COUNCIL on the implementation of Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety COM(2008) 905 final Thank you for your attention

TABLE OF CONTENTS. Annexes: I. Notification form II. Methodological framework for facilitating consistent risk estimation and evaluation

TABLE OF CONTENTS. Annexes: I. Notification form II. Methodological framework for facilitating consistent risk estimation and evaluation ANNEX GUIDELINES FOR THE NOTIFICATION OF DANGEROUS CONSUMER PRODUCTS TO THE COMPETENT AUTHORITIES OF THE MEMBER STATES BY PRODUCERS AND DISTRIBUTORS IN ACCORDANCE WITH ARTICLE 5(3) OF DIRECTIVE 2001/95/EC