Electrical Product Safety in Ontario Consultation on Guidelines for Risk Assessment Methodology

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1 Electrical Product Safety in Ontario Consultation on Guidelines for Risk Assessment Methodology presented by Peter Jackson CA, ORMP

2 What is risk and risk assessment? Risk is something that may occur or come into existence or effect and in so doing affect the achievement of objectives Risk assessment is the overall process of identifying, analysing and evaluating risks 2

3 Why does ESA need a risk assessment methodology? To have a consistent framework for making judgments To enhance the transparency of its decision processes To provide guidance to stakeholders and enable them to to use the same framework where useful 3

4 ESA use of risk assessment methodology to determine whether an accident or incident should have been reported; to determine ESA s response to reports received; to determine whether the public should be notified regarding the potential risk of injury or property damage; to determine what, if any, corrective action is warranted to address the risks identified. Equivalent use for Manufacturers, wholesalers, importers, distributors, retailers, certification bodies, and field evaluators of electrical products 4

5 What are the steps in risk assessment? There are four steps Understand the nature of the product defect, if any Assess the severity of the potential impact Assess the likelihood of the potential impact Determine how to act based on the resulting risk rating 5

6 What is a product defect? A product should be considered defective if its intended or foreseeable use results in or could result in injury, death or property damage. Product defect may result from manufacturing or production error; design of, or the materials used in, the product; product's contents, construction, finish, packaging, warnings, and/or instructions; could also consist of failure to meet applicable electrical standards 6

7 Defective? Matters to consider What is the utility of the product? What is it supposed to do? What is the nature of the injury or damage that the product might cause? What is the need for the product? What is the population exposed to the product? What is the experience with the product and similar products? Finally, what other information sheds light on the product and patterns of consumer use? 7

8 How should the severity of the impact be estimated? Severity of impact Impact on people Impact on property Catastrophic Death or severe injury Extensive damage, major damage to the entire property or several properties. Recovery is not possible. Example The whole house or a major part of the house is damaged Major Moderate Minor Insignificant Multiple and severe injuries, resulting in critical injury Single or multiple injuries to a person or persons, but none are critical in nature Minor injury requiring first-aid treatment Casual treatment, a flash or shock resulting in no medical treatment Major damage to the facility or dwellings, more likely involve structural damage or more than one piece of equipment. Damage is between 30% to 60% of the facility or dwelling, more than $30,000 damage Local damage, for example damage to a section of a room, or burn that destroyed a piece of furniture. Cost more than $2,000 but not more than $30,000. Damage is not structural Minor damage and the damage is contained, Example fire that causes some damage to a table or floor or a piece of furniture. Damage is less than $2000 Slight damage and the damage is contained locally. Example receptacle is burnt as a result of a flash or a pop corn machine caught on fire. 8

9 Should consideration be given to the intended use of the product or to foreseeable use? Both the intended use of a product and to how a reasonable person might use a product in the absence of any indications to the contrary. Reasonable person use / misuse Inadequate warnings or unclear instructions Safe use of the product requires a level of care or supervision that is unlikely or unreasonable Product is promoted in a way that encourages or facilitates unsafe use Usage history provides evidence that warnings are not followed The average consumer could be expected to use the product in a way that is dangerous Unreasonable person use / misuse Deliberate harm to self or another Reckless disregard for safety - adequate warnings not heeded - safeguards removed or not used - use while under the influence of drugs or alcohol Product not serviced or maintained as required 9

10 What severity of impact qualifies as a serious injury or substantial property damage? Definition affects reporting of serious electrical incident or accident serious injury means permanent impairment of a body function or permanent damage to a body structure, any injury requiring hospitalization and actual medical treatment, injuries necessitating absence from school or work of more than one day, or chronic health effects 10

11 Serious injury / substantial property damage Severity of impact Impact on people Impact on property Catastrophic Death or severe injury Extensive damage, major damage to the entire property or several properties. Recovery is not possible. Example The whole house or a major part of the house is damaged Major Moderate Minor Insignificant Multiple and severe injuries, resulting in critical injury Single or multiple injuries to a person or persons, but none are critical in nature Minor injury requiring first-aid treatment Casual treatment, a flash or shock resulting in no medical treatment Major damage to the facility or dwellings, more likely involve structural damage or more than one piece of equipment. Damage is between 30% to 60% of the facility or dwelling, more than $30,000 damage Local damage, for example damage to a section of a room, or burn that destroyed a piece of furniture. Cost more than $2,000 but not more than $30,000. Damage is not structural Minor damage and the damage is contained, Example fire that causes some damage to a table or floor or a piece of furniture. Damage is less than $2000 Slight damage and the damage is contained locally. Example receptacle is burnt as a result of a flash or a pop corn machine caught on fire. 11

12 Why bother with likelihood? (1) 1.(1) serious electrical incident or accident means an electrical incident or accident that, (a) results in death or serious injury to a person, (b) has the potential to cause death or a risk of serious injury to a person, or (c) causes or has the potential to cause substantial property damage. When assessing potential future impacts, consideration should be given to the combined assessments of severity of impact and likelihood. (Guideline) 12

13 Why bother with likelihood? (2) 8.(1) A manufacturer, wholesaler, importer, product distributor or retailer that becomes aware of a serious electrical incident or accident or a defect in the design, construction or functioning of an electrical product or device that affects or is likely to affect the safety of any person or cause damage to property, shall report to the Authority as soon as practicable after becoming aware of the serious electrical incident or accident or defect. 8.(2) A certification body or field evaluation agency that becomes aware of a serious electrical incident or accident or a defect in the design, construction or functioning of an electrical product or device that was the subject of a report given by the certification body or field evaluation agency that affects or is likely to affect the safety of any person or cause damage to property shall report to the Authority as soon as practicable. 13

14 How should the likelihood of injury or damage be estimated? The likelihood of injury or damage should be estimated as the combination of the likelihood of the product being or becoming defective, and the likelihood of the negative effect materializing. Except where: likelihood of defect is known (e.g. through batch or serial numbers) Statistical information is available for either likelihood 14

15 Estimating likelihoods review the list of factors and add any that are relevant to the particular case under consideration check off all factors that are known to apply enter the score for each checked-off factor in the score column, using the suggested weighting or another judged more suited to its significance in the case under consideration Total the score column and rate the likelihood accordingly. 15

16 Factors for likelihood of defect Factor Product Certification History of Compliance or Previous Product Issues Ability to detect defect prior to use Use Environment Pattern of Incidents Not certified to any Canadian standard Not certified to a Canadian standard but certified to another jurisdiction s standard (e.g. certified to U.S. standard but no Canadian identifier is included with certification mark) Manufacturer, distributor or retailer has a history of non-compliance with approval requirements or previous track record with manufacture, distribution or sale of defective products Product used or installed by nonskilled persons Exposed to extremes of weather, humidity, air quality or temperature. Exposed to rough usage or commercial usage. Pattern of individually small incidents that may be warning signs of more serious problems Relevant? Suggested weight Score 50+ = high = medium <25 = low Total score Rated likelihood 16

17 Factors for likelihood of effect materializing 60+ = high = medium <35 = low 17

18 Combining likelihoods Likelihood of product being or becoming defective Low Medium High Likelihood of the serious negative effect materializing High medium high very high Medium low medium high Low very low low medium 18

19 Determining the risk rating Likelihood of Injury or Damage Very High High Medium Low Very low Severity of impact Insignificant Minor Moderate Major Catastrophic High risk Medium risk Low risk 19

20 What action should be taken based on the risk rating? ESA expects that any risk that is assessed as high or medium will be reported to ESA by the manufacturer, wholesaler, importer, distributor, retailer, certification body or field evaluator that is assessing the risk. Additional action may also be appropriate, such as notifying other public authorities, withdrawing product from sale, initiating a product recall and publishing warning notices. Refer to the Reporting Guideline, the Notification Guideline and the Corrective Action Guideline. 20

21 What action will ESA take based on the risk rating? High Medium Low Refer to Appendix 1 to the Guideline 21

22 What issues need to be addressed Any stakeholder feedback Should serious injury be defined as a single level? Should substantial property damage be defined as a single level? Should risk evaluation be considered separately from risk estimation? What factors should be considered in estimating the likelihood of injury and property damage? What weighting should be given to each of the factors? Can rules of thumb be developed for reporting to ESA? 22

23 Questions of clarification? 23

24 Next steps Up to four one-day meetings of the Working Group. November 5 November 19 December3 December 17 24