Belgrade, 6-7 May 2010

Transcription

1 Belgrade, 6-7 May 2010 RISK ASSESSMENT - METHODOLOGY RAG - RISK ASSESSMENT GUIDELINES FOR NON-FOOD CONSUMER PRODUCTS Prof. Maurizio Mensi Academy of Economy and Finance ITALY 1

2 OVERVIEW OF THE PRESENTATION 1. The new RAG - Risk Assessment Guidelines - Comm. Dec. 16/12/ Main features - Risk Combination of hazard and probability 3. Basic notions: hazard, product hazard and risk 4. Risk assessment, step by step 5. The product, the consumer, the injury scenario (severity and probability) 6. Determination of risk 7. From risk to action 2

3 THE NEW RISK ASSESSMENT GUIDELINES 3 Commission Decision of 16 Dec Public Internet Consultation (15 July-!5 Oct. 2008) 25 questions - 68 replies received Some interesting statements It is reasonably foreseeable that consumers do not read the instructions Some never do, most have a look at them after meeting a problem Only old engineers and lawyers read all Products should be used safely without instructions for a basic use Dangerous misuses should be prevented by the design, not by instruction

4 THE NEW RAG (2) Better convergence of terminology needed New RAGs do not erase national perceptions of risk, but provide more transparency Measuring risk [ ] is an empirical scientific activity, judging safety judging the acceptability of risks is a normative, political activity, W. Lowrence,

5 THE NEW RAG (3) Divergent risk assessments of the same consumer product from: 1. Different authorities 2. Authorities and manufacturers Different perceptions of risks Application of previous Guidelines not always clear Who developed the new Guidelines? Commission expert Working Group 21 experts nominated by Member States 5

6 MAIN FEATURES More clarity Elements of a risk assessment clearly separated Step-by-step instructions Standard tables for each step Computer progamme planned 6

7 MAIN FEATURES (2) More transparency and communication Documentation of each step obligatory Outside world can better accept/discuss the assessment More flexibility Any risk scenario allowed: severity of injury and its probability provide for balance 7

8 SERIOUS RISK Before an authority of a MS decides to submit a RAPEX notification, it always performs the appropriate risk assessment in order to assess whether a product to be notified poses a serious risk to the health and safety of consumers and thus whether one of the RAPEX notification criteria is met 8

9 SERIOUS RISK (2) RISK ASSESSMENT METHOD Appendix 5 to the Guidelines sets out the risk assessment method to be used by MS authorities to assess the level of risks posed by consumer products to the health and safety of consumers and to decide whether a RAPEX notification is necessary ASSESSING AUTHORITY The risk assessment is always performed by an authority of a MS that either carried out the investigation and took appropriate measures or monitored voluntary action taken with regard to a dangerous product by a producer or a distributor 9

10 ASSESS THE RISK 10 This risk can be assessed in different ways How to quantify risks has been under permanent development The purpose of RAG is to improve the situation and, to provide a transparent and practicable method for appropriate use by MS competent authorities when they assess the risks of non-food consumer products

11 ASSESS THE RISK (2) 11 RAG do not set out to replace other guidelines that may address very specific products or may be specifically provided for in legislation (chemicals, cosmetics, pharmaceuticals or medical devices) RAG are not to be used by manufacturers just to avoid serious risks when designing and manufacturing products Consumer products have to be safe and RAG aim at helping authorities to identify serious risks when, despite the best efforts of the manufacturer, a product is not safe

12 RISK ASSESSMENT 12 Risk Combination of hazard and probability Risk is generally understood as something that threatens the health or even the lives of people, or that may cause considerable material damage Nevertheless, people take risks while being aware of the possible damage, because the damage does not always happen Notion of Hazard, Product hazard Risk, Risk Assessment, Risk level, Risk Management

13 RISK ASSESSMENT (2) Risk is the combination of the severity of possible damage to the consumer and the probability that this damage should occur THREE STEPS 1. Anticipate an injury scenario in which the intrinsic product hazard harms the consumer - Determine how severe the consumer s injury is 2. Determine the probability of the consumer being injured in practice by the intrinsic product hazard 3. Combine the hazard (in terms of severity of the injury) with the probability (in terms of a fraction) to obtain the risk 13

14 RISK ASSESSMENT (3) Some useful tips 1. Seek information 2. Make a sensitivity analysis of your risk assessment 3. Let others check your risk assessment 4. Document your risk assessment 5. Several hazards, several injuries but only one risk 14

15 RISK ASSESSMENT (4) 15 In conclusion, risk is a balanced combination of both the hazard and the probability of the injury that the hazard can cause - Risk describes neither the hazard, nor the probability, but both at the same time Can risks cumulate? Several injury scenarios leading to several risks can be developed for virtually every product Where several risks are linked to the same product, one of them is obviously more likely to materialise and causes an injury Risks are not simply cumulated Risk management depends on many factors, not only on the number of risks that a product may present at one and the same time

16 RISK ASSESSMENT (5) Compliance with limit values in legislation and standards A product is presumed not to be safe where it fails to comply with established limit values Non-compliance with limit values does not automatically mean that the product presents a serious risk Specific risk assessment guidelines in specific cases 16

17 BUILDING A RISK ASSESSMENT STEP BY STEP THE PRODUCT The product should be clearly identified (the product name, the brand, the model name, the type number, a possible production lot number, any certificate that may come with the product) A risk assessment should always consider the entire life time of a product and its packaging 17

18 BUILDING A RISK ASSESSMENT STEP BY STEP (2) THE PRODUCT HAZARD Hazard is the intrinsic property of the product that may cause an injury to the consumer who uses the product It can appear in different forms: mechanical, choking, suffocation, electrical, thermal, chemical or microbiological hazard, etc. Hazard identification by tests and standards Products may still present a risk even though they do not cause injuries 18

19 BUILDING A RISK ASSESSMENT STEP BY STEP (3) 19 THE CONSUMER The abilities and behaviour of the consumer using the product may greatly influence the level of risk It is of prime importance to have a clear idea of the type of consumer pictured in the injury scenario Consideration should also be given to people who are not actually using the product, but who may be in the vicinity of the user A product that is normally safe for an average adult may not be safe for vulnerable consumers

20 BUILDING A RISK ASSESSMENT STEP BY STEP (4) 20 INJURY SCENARIO: STEPS LEADING TO INJURY Most injury scenarios consist of the following three main steps: 1. the product has a defect or can lead to a dangerous situation during its foreseeable lifetime 2. the defect or dangerous situation results in an accident 3. the accident results in an injury SEVERITY OF INJURY: different degrees of severity

21 BUILDING A RISK ASSESSMENT STEP BY STEP (5) Probability of injury: the probability that injury scenario may indeed materialise during the expected lifetime of the product It is not easy to estimate Determination of risk 21

22 FROM RISK TO ACTION Once the risk assessment is complete it will normally be used to decide whether action needs to be taken to reduce the risk and thus prevent harm to a consumer s health Measures to reduce the risk may include withdrawal from the market or recall Lower levels of risk normally lead to less rigorous measures Nevertheless, there is no automatic link from risk to action 22

23 HOW TO PREPARE A RISK ASSESSMENT 1. Describe the product and its hazard 2. Identify the type of consumer you want to include in your injury scenario with the hazardous product 3. Describe an injury scenario in which the product hazard(s) you have selected causes an injury(ies) or adverse health effect(s) to the consumer you selected 4. Determine the severity of the injury 5. Determine the probability of the injury scenario 6. Determine the risk level 7. Check whether the risk level is plausible 8. Develop several injury scenarios to identify the highest risk of the product 9. Document and pass on your risk assessment 23

24 Author l Prof. Maurizio Mensi (SSEF) Academy of Economy and Finance Ministry of Economy and Finance Rome - ITALY mamensi@tin.it Tel/Fax: Mobile: