2012/SCSC/WKSP/013 ASEAN EEE Risk Assessment Guidelines

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1 2012/SCSC/WKSP/013 ASEAN EEE Risk Assessment Guidelines Submitted by: ASEAN Workshop on Developing a Harmonised Electrical Equipment Regulatory Risk Assessment Tool Singapore May 2012

2 ASEAN EEE Risk Assessment Guidelines 12 May

3 TABLE OF CONTENTS I. Foreword II. III. IV. Scope and Objective Normative References Terms and Definitions V. Risk Calculation for Electrical and Electronic Equipment (EEE) Consequence of non-compliance (C) Probability of non-compliance (P) Population of Product in Marketplace (N) Final computation of the level of Risk (R) VI. VII. Identification of the Risk Level. Conformity Assessment Procedure to be applied to the EEE. VIII. Annexes Annex A Annex B Annex C Annex D Annex E Annex F Annex G Electric Hazard Table Extreme Temperature Hazard Table Fire Hazard Table Mechanical Hazard Table Special Hazard Table Severity of Injury Table Probability of Non Compliance Table 2

4 I. Foreword The ACCSQ through the Joint Sectoral Committee on Electrical and Electronic Equipment (JSC EEE) developed the Agreement on the ASEAN Harmonized Electrical and Electronic Equipment (EEE) Regulatory Regime hereinafter referred as AHEEERR which is signed by the ASEAN Economic Ministers in Malaysia in December It is the intention that the AHEEERR will further facilitate the trade of EEE in ASEAN and would contribute to the goal of ASEAN towards achieving an ASEAN Economic Community by 2015 particularly on Electrical and Electronic Sector. The AHEEERR defines the Essential Requirements (requirements on safety, environment and electromagnetic compatibility) that an EEE shall meet to protect life, health, safety and property of ASEAN consumers while facilitating the trade in the region. While there are different conformity assessment regimes in ASEAN, the Agreement stipulates two (2) conformity assessment systems applicable for the product depending on the level of risk of the EEE. These conformity assessment systems are System 1 and System 5 as described in ISO/ IEC Guide 67. The determination of products applicable conformity assessment system (system 1 or system 5) will be done through risk assessment. This document entitled ASEAN EEE Risk Assessment Guidelines hereinafter referred as Guidelines, stipulate the procedures in determining the level of risk of the product as well as the applicable relevant conformity assessment system. High risk products will be subjected to system 5 conformity assessment while medium risk products will be subjected to system 1 conformity assessment. For low risk products the conformity assessment procedure SDoC based on ISO/IEC or any other procedure/scheme may be used. II. Scope and Objective These Guidelines which cover EEE as defined in the AHEEERR were developed in support of the implementation of the AHEEERR. These guidelines determine the conformity assessment regime applicable for EEE based on the level of risk of the product, and are also designed to harmonize the identification of risk level of EEE through a uniform method of evaluation of risk regardless of the application, utilization and situation of the product in Member States. III. Normative References The following reference materials were used for these guidelines: ASEAN Harmonized Electrical and Electronic Equipment Regulatory Regime (AHEEERR). Papers presented during the First and Second Meetings of the Joint Sectoral Committee on Electrical and Electronic Equipment (JSC EEE) held in Manila on 5-7 July 2006; in Singapore on November 2006 and updated version of computation of risk for the product, respectively. 3

5 Papers presented during the Second Good Regulatory Practice Workshop Electrical / Electronics Safety, Yangon, Myanmar, 6-7 September 2006 Papers presented during the special meeting of the JSC EEE held in Manila on Aug 11-14, APEC Information Notes on Good Practice for Technical Regulation. ISO/IEC Guide 67:2004 Conformity Assessment Fundamentals of Product Certification. ISO/IEC Conformity assessment Supplier s declaration of conformity. EU Risk Assessment Guidelines For Consumer Non-Food Products (November 2008). EU Approaches and Methods for The Assessment of The Safety of Consumer Products.(Final Report February 2006) IV. Terms and definitions The following terms and definitions are used throughout the document Electrical and Electronic Equipment (EEE) - all new electrical and electronic equipment supplied by that are intended to be either directly connected or plugged-in to the low voltage power supply or is battery powered, but does not include any equipment covered by the ASEAN Sectoral Arrangement on Conformity Assessment of Telecommunication Equipment and does not apply to medical equipment. Risk - undesirable situation or circumstance that has both likelihood of occurring and a potentially negative consequence on a project. Risk is the chance of something happening that will have an impact Risk Assessment is a means of analysing the risk and consequences of an undesirable event. This can include assessing the relative impact of the available options on the risk level. Conformity Assessment means a systematic examination to determine the extent to which a product, process or service fulfills specified requirements System 1 Product certification system that includes testing; samples of the product are assessed for conformity. The sampling may or may not be statistically significant of the entire population of product. This certification system includes the following: a) samples requested by the certification body; b) determination of characteristics by testing or assessment; c) evaluation of the test or assessment report; d) decision; e) attestation. System 5 Product certification system that includes testing and assessment of the quality system involved. Surveillance of the quality system is conducted and samples of the product may be taken from either the market or the point of production, or both, and are assessed for ongoing conformity. This certification system includes the following: a) samples requested by the certification body; b) determination of characteristics by testing or assessment; c) initial assessment of the production process or the quality system, as applicable; 4

d) evaluation of the test and assessment reports; e) decision; f) license; g) surveillance of the production process or quality system or

Supplier s Declaration of Conformity (SDoC): A declaration by the manufacturer or his authorized representative that the product meets

RISK Calculation for Electrical and Electronic Equipment (EEE) The risk calculation to determine the level of risk for EEE can be

probability of non-compliance occurring for a given product N = The likely population of the product in the marketplace x =

The Consequence of Non-compliance (C) Hazard is the intrinsic property of the product that may cause an injury to the consumer who uses

6 d) evaluation of the test and assessment reports; e) decision; f) license; g) surveillance of the production process or quality system or both of the organization; h) surveillance by testing or inspection of samples from the factory or the open market, or both. Supplier s Declaration of Conformity (SDoC): A declaration by the manufacturer or his authorized representative that the product meets all the specified requirements of the applicable rules and regulations. V. RISK Calculation for Electrical and Electronic Equipment (EEE) The risk calculation to determine the level of risk for EEE can be obtained using the formula: R = C x P x N where: R = The level of Risk of the product C = The consequence of non-compliance P = The probability of non-compliance occurring for a given product N = The likely population of the product in the marketplace x = multiplication sign 1. The Consequence of Non-compliance (C) Hazard is the intrinsic property of the product that may cause an injury to the consumer who uses the product. It can appear in the following forms: Electric Extreme temperature Fire Mechanical Special (radiation, toxicity, etc.) Extreme temp. Mechanical Electric Fire Special Visual representation of inherent hazard of products For the purpose of these Guidelines, hazards were grouped according to the following: size, shape and surface potential energy 5

7 kinetic energy electrical energy extreme temperature radiation fire and explosion product operating hazards toxicity Inherent hazard of products are identified and from which a typical injury scenario is chosen to derive the typical injury. The injury that a hazard can cause can have different degrees of severity. The severity of injury thus reflects the effects of the hazard which is considered as the Consequence of Non-Compliance (C). To get the (C), the following steps are to be observed: a. Describe the product, determine the product s hazards, the typical injury scenario and potential injury (refer to Hazard Group Table, Annex A, B, C, D, E) b. Determine the severity of injury and identify the severity score (refer to Severity of Injury Table, Annex F); For each hazard and injury, the severity scores are compared. The highest score shall be considered the score for such hazard. As in the electrical hazard, the highest of the severity score among the four possible injuries will be the severity score for the electrical hazards. c. The consequence of non-compliance (C) is the highest severity score among the hazard grouping. Below is the sample illustration of determining the consequence of non-compliance (C). Hazard Grouping Extreme Product Electric temperature Fire Mech Special C Product * * 4 Product 2 2 * 2 * 3 3 Product 3 1 * 4 1 * 4 Product * 2 Product 5 5 * 2 * * 5 hazard is not inherent to the product. 2. Probability of non-compliance (P) A number of probability factors P have been identified that contribute to the probability of noncompliance. Factors that improve or reduce compliance have been initially identified. Using the Probability of Non-compliance Table, Annex G evaluate a product by assigning a value to each factor. A scale of 1 5 will be used, 1 being the lowest and 5 the highest probability of noncompliance. Average the score of all the factors to get the value of the Probability of noncompliance. 3. Population of Product in Marketplace (N) Population N of product in market place refers to the quantity of electrical and electronic 6

8 equipment purchased and utilized within the ASEAN member states. The value for population of product N, referring to is set as: N= 1.00 for item normally used in most household N= 0.75 for item commonly used in most households N= 0.5 for item used in many households N= 0.25 for item occasionally used in many households N= 0.1 for item occasionally used in some households 4. Final computation for the value of risk factor R. To determine the risk factor of a product the equation: R = CxPxN will be used. Below is a table, containing all the elements to determine the risk factor. Product Risk factor C P N (e.g.) (R ) Product Product Product Product Product VI. Identification of the Level Risk The value of risk will be the basis to identify the risk level of the product whether it is high, medium or low risk product. Level of Risk Risk Factor High Risk Medium Risk Low Risk VII. The conformity assessment regime to be applied on the product based on the level of risk are as follows. HIGH Risk - uses System 5 as described in ISO/ IEC Guide 67. MEDIUM Risk - uses System 1 as described in ISO/ IEC Guide 67. LOW Risk - may use Supplier s Declaration of Conformity (SDoC) based on ISO/IEC or any other conformity assessment procedure/scheme. 7

9 ANNEX A Electric Hazard Table HAZARD TYPE HAZARD CHARACTERISTICS ( Product/Property) Typical injury scenario Potential Injury ELECTRIC Live parts Person can touch part of the product that is at high voltage; the person receives an electric shock and may be electrocuted Electric shock 8

10 ANNEX B Extreme Temperature Hazard Table HAZARD TYPE HAZARD CHARACTERISTICS ( Product/Property) Typical injury scenario Potential Injury EXTREME TEMPERATURE Hot Surfaces Person does not recognise the hot surface and touches it; the person sustains burns Burn EXTREME TEMPERATURE Hot liquids Person handling a container of liquid spills some of it; the liquid falls on the skin and causes scalds Scald EXTREME TEMPERATURE Hot gases Person breathes in the hot gases emitted from a product; this causes lung burn; or prolonged exposure to hot air causes dehydration Burn EXTREME TEMPERATURE Cold surfaces Person does not recognise the cold surface and touches it; the person sustains frostbite Burn EXTREME TEMPERATURE Heat production Product becomes hot; a person touching it may sustain burns; or the product may emit molten particles, steam etc. that hits a person Burn, scald 9

11 ANNEX C Fire Hazard Table HAZARD TYPE HAZARD CHARACTERISTICS ( Product/Property) Typical injury scenario Potential Injury FIRE Ignition sources or flammable materials The ignition source sets the Product s flammable materials to fire which causes fire; a person is injured by flames, or intoxicated by gases FIRE Overheating Product overheats; fire, explosion FIRE Live parts too close Electric arc or sparks occur between the live parts. This may cause a fire and intense radiation Burn, poisoning, scald Burn, scald; eye injury, foreign body in eye; hearing, foreign body in ear Eye injury; burn, scald 10

12 ANNEX D Mechanical Hazard Table HAZARD HAZARD CHARACTERISTICS ( Product Property) Typical injury scenario Potential Injury MECH, SIZE, SHAPE, &, SURFACE Sharp corner or point Person hits sharp corner or is hit by moving sharp object; this causes a puncture or penetration injury Puncture; blinding, foreign body in eye; hearing, foreign body in ear MECH, SIZE, SHAPE, &, SURFACE Sharp edge Person touches sharp edge; this lacerates skin or cuts through tissues Laceration, cut; amputation MECH, SIZE, SHAPE, &, SURFACE Gap or opening between elements Person puts a limb or body in opening and is trapped with finger, arm, or clothing; injury occurs due to gravity or movement Crushing, fracture, amputation, strangulation MECH, POTENTIAL ENERGY Low mechanical strength & Stability Person near product is hit by the product; electrical product tips, breaks and gives access to live parts, or continues to work heating nearby surfaces Bruising; dislocation; fracture; crushing; electric shock; burns MECH, POTENTIAL ENERGY Elastic element or spring Elastic element or spring under tension is suddenly released; person in the line of movement is hit by the product Bruising; MECH, POTENTIAL ENERGY Pressurised liquid or gas, or vacuum Liquid or gas under pressure is suddenly released; person in the vicinity is hit; or implosion of the product produces flying objects Bruising; Cuts MECH, KINETIC ENERGY Rotating parts A body part, hair or clothing of a person is entangled by the rotating part; this causes a pulling force Bruising; fracture; laceration (skin of the head); strangulation 11

13 ANNEX E Special Hazards Table HAZARD HAZARD CHARACTERISTICS ( Product Property) Typical injury scenario Potential Injury SPECIAL HAZARD, RADIATION & CONTAMIATION Ultraviolet radiation, laser Skin or eyes of a person are exposed to radiation emitted by the product Eye injury; SPECIAL HAZARD, TOXICITY Toxic solid or fluid, gas, vapour or dust, Irritating or corrosive solid or fluid, gas or vapour Person ingests or inhale substance from product, e.g. by mouthing; and/or substance gets onto skin or in eyes, Person aspirates (breathes in) solid, fluid or emetic mass (pulmonary aspiration) Acute poisoning; irritation, dermatitis, Acute poisoning in lungs (aspiration pneumonia); infection; eye injury, foreign body in eye 12

14 ANNEX F Severity of Injury Table Injury Consequence of Non Compliance ( C ) Slight = 1 Moderate = 2 Serious = 3 Very Serious = 4 Fatal Injury / Death = 5 Burn, Scald 1º, up to 100% of body surface 2º, <6% of body surface 2º, 6-15% of body surface 2º, 16-35% of body surface, or 3º, up to 35% of body surface Inhalation burn 2º or 3º, >35% of body surface Inhalation burn requiring respiratory assistance Injury Causes Death Eye injury, foreign body in eye; Partial loss of sight Permanent loss of sight (one eye) Permanent loss of sight (both eyes) Not Applicable Electric Shock Neurological (brain) damage, (see also under burns as electric current can cause burns) Local effects (temporary cramp or muscle paralysis) More serious local effects, but not resulting in permanent injuries Triggered epileptic seizure Neurological effects of EMF Electrocution- Permanent Injuries Electrocution, Death Not Applicable hearing injury Partial loss of hearing Complete loss of hearing (one ear) Complete loss of hearing (both ears) Not Applicable Laceration, Cut Superficial External (deep) (>10cm long on body) (>5cm long on face) requiring stitches Tendon or into joint White of eye or Cornea Optic nerve Neck artery Trachea Internal organs Bronchial tube Oesophagus Aorta Spinal cord (low) Deep laceration of internal organs Severed high spinal cord Brain (severe lesion/dysfunction) Injury Causes Death Bruising (abrasion/ contusion, swelling, oedema) Sprain, strain, musculoskelet al disorder Superficial 25 cm² on face 50 cm² on body Extremities Joints Spine (no dislocation or fracture) Major >25 cm² on face >50 cm² on body Knee ligaments strain Trachea Internal organs (minor) Heart Brain Lung, with blood or air in chest Ligament or tendon rupture/ tear Muscle tear Whiplash Brain stem Spinal cord causing paralysis Not Applicable Injury Causes Death Not Applicable 13

15 Dislocation Extremities (finger, toe, hand, foot) Elbow Jaw Loosening of tooth Ankle Wrist Shoulder Hip Knee Spine Spinal column Not Applicable Fracture Extremities (finger, toe, hand, foot) Wrist Arm Rib Sternum Nose Tooth Jaw Bones around eye Ankle Leg [femur and lower leg] Hip Thigh Skull Spine (minor compression fracture) Jaw (severe) Larynx Multiple rib fractures Blood or air in chest Neck Spinal column Not applicable Crushing Extremities (fingers, toe, hand, foot), Elbow, Ankle, Wrist, Forearm, Leg, Shoulder, Trachea, Larynx, Pelvis Spinal cord Mid-low neck Chest (massive crushing) Brain stem Injury Causes Death Amputation Finger(s), Toe(s), Hand, Foot, (Part of) Arm, Leg, Eye Both extremities _ Piercing, puncturing Ingestion, Internal airway obstruction, Suffocation / Strangulation Limited depth, only skin involved Deeper than skin Abdominal wall (no organ involvement) Eye Internal organs Chest wall Internal organ injury (refer also to internal airway obstruction in case the ingested object gets stuck high in the oesophagus) Aorta Heart Bronchial tube Abdominal Organs (liver, kidney, bowel, etc) deep Oxygen flow to brain blocked without permanent consequences Injury Causes Death Fatal suffocation / strangulation injury Causes Death Poisoning from substances (ingestion, inhalation, dermal) Diarrhoea, vomiting, local symptoms Reversible damage to internal organs, e.g. liver, kidney, slight haemolytic anaemia Irreversible damage to internal organs, e.g. oesophagus, stomach, liver, kidney, haemolytic anaemia, reversible damage to nerve system Irreversible damage to nerve system Fatality Injury Causes Death 14

16 Irritation, dermatitis, inflammation or corrosive effect of substances (inhalation, dermal) Local slight irritation, Reversible eye damage Reversible systemic effects Inflammatory effects Lungs, respiratory insufficiency, chemical pneumonia Irreversible systemic effects Partial loss of sight Corrosive effects Lungs, requiring respiratory assistance Asphyxia Injury Causes Death 15

17 ANNEX G Probability of Non Compliance Table Probability of Non-compliance Table. Rate P01. Product uses new technology or lacks a relevant international Standard. Mature Technology & w/ applicable International Standard =1, New Technology,...Lacks a relevant International Standard= 3 Mature Technology but lacks availability of standard= 5 P02. Product is not controlled in international markets, or market of dominant supplier. if all markets in the ASEAN regulates the product, score= 5 if not regulated in all ASEAN markets = 1 if regulated in majority of the ASEAN market= 3 P03. Product considered safe in local market only, with significant variations to applicable international Standard No, (Product considered safe in all markets with minimum or no variations with International Standard) = 1 Product considered safe in some markets with minimum variations with International Standard = 3 Yes, = 5 P04. Product not suitable for safe local use can be converted to local supply conditions w/o significant alterations No Alterations =1, Minimum Alterations =3 Significant Alterations =5 P05. Product is controlled internationally using standards considered inadequate for local application Using Standards Adequate for Local Application=1, Using Standards which require Modification for Local Application= 3 Using Standards Inadequate for Local application=5 P06. Product Standard has recently been updated to address a significant safety issue Product Standard Exists, & no significant safety issue =1, Product Standard recently updated due to minor issue = 3 Product Standard recently updated due to significant issue =5.. P07. Dominant supplier's market does not use international Standard or local standard Dominant Supplier's Market use International or Local Standard =1, Dominant Supplier's Market use International Standard, with Modification =3, Dominant Supplier's Market does not use International or Local standard =5 P08. Compliance with the applicable Standard is complex or difficult Compliance is easy=1, Compliance is neither easy nor difficult..3 Compliance is difficult=5 P09.There are cost disincentives for compliance 16

18 There are No Cost Disincentives for Product Compliance =1 There are some Cost Disincentives for Product Compliance =3, Compliance Disincentive Cost High=5 Average=Sum of the rates/# of probability of compliance factors 17

First Aid - immediate care that is given to the victim of an injury or illness until experts can take over - Oftentimes, it s the difference between

First Aid First Aid - immediate care that is given to the victim of an injury or illness until experts can take over - Oftentimes, it s the difference between life and death or recovery vs permanent disability