Guidance Standard - Consumer Product Safety: A Practical Guide for Suppliers

Transcription

1 NEW WORK ITEM PROPOSAL Date of presentation Proposer ISO/COPOLCO Secretariat ISO Central Secretariat Reference number (to be given by the Secretariat) A proposal for a new work item within the scope of an existing committee shall be submitted to the secretariat of that committee with a copy to the Central Secretariat and, in the case of a subcommittee, a copy to the secretariat of the parent technical committee. Proposals not within the scope of an existing committee shall be submitted to the secretariat of the ISO Technical Management Board. The proposer of a new work item may be a member body of ISO, the secretariat itself, another technical committee or subcommittee, or organization in liaison, the Technical Management Board or one of the advisory groups, or the Secretary-General. The proposal will be circulated to the P-members of the technical committee or subcommittee for voting, and to the O-members for information. See overleaf for guidance on when to use this form. IMPORTANT NOTE: Proposals without adequate justification risk rejection or referral to originator. Guidelines for proposing and justifying a new work item are given overleaf. Proposal (to be completed by the proposer) Title of proposal (in the case of an amendment, revision or a new part of an existing document, show the reference number and current title) English title French title (if available) Guidance Standard - Consumer Product Safety: A Practical Guide for FORM 4 (ISO) v Page 1 of 5

2 Scope of proposed project This proposal is intended to establish a consensus-based International Guidance Standard that will provide all those in the consumer product supply chain (including designers, manufacturers, importers, distributors, retailers, and other producers of consumers goods, as illustrated in Annex 1, with the practical tools to assist them in identifying, assessing and eliminating or reducing the risks associated with exposure to consumer products. The standard will provide guidance on how to carry out a systematic safety analysis of a consumer product or a product likely to be used by a consumer in order to assess the risks by identifying any associated hazards, the potential exposure of consumers to the hazard, and the consequences of that exposure. It will also aid them in determining, documenting and implementing the best approach to reducing the risks and consistently producing a safe product. The document should: - identify the information and data that needs to the considered (e.g. intended use, foreseeable use, ability of users, injury and malfunction data) when identifying and assessing any potential risks; - provide practical guidance on how to implement basic concepts such as those outlined in ISO/IEC Guide 51; - outline the steps to follow when assessing risks associated with consumer products including hazard identification, exposure to the hazard, probability of harm occurring, the severity of any harm, and the technical and human possibilities to avoid or limit the harm, etc; and - describe potential ways of negating or limiting the harm. Environmental safety will not specifically be covered in the document. However, some of the principles and processes contained in the standard may be applicable to environmental safety. Potential benefits The potential benefits of an International Standard that provides practical guidance for suppliers of consumer products include: - fewer preventable injuries and deaths associated with consumer products; - addressing the concerns of consumers internationally, leading to greater consumer confidence when purchasing; - providing stakeholders from developing countries with an international benchmark to facilitate their access to international markets; - serving as an adjunct to regulatory approaches; - providing a systems approach to product safety that addresses every step in the creation of a product from design to the known and predictable use behaviours of consumers; - assisting in the establishment of a level playing field that would benefit cross-border trade and reduce confusion and inefficiencies where a supplier has to comply with different processes in different countries; - helping standards developers, industry and governments apply the ISO/IEC Guides 37, 50, 51 and 71 and IEC Guide 104; - educating suppliers; and - highlighting and providing guidance in the multidisciplinary nature of making safer goods. It is, therefore, reasonable to expect that such an International Standard will promote the trade in consumer goods, promote consumer confidence and competitiveness, and at the same time protect consumers against adverse risks to their health and safety. Concerns known patented items (see ISO/IEC Directives Part 1 for important guidance) Yes No If "Yes", provide full information as annex Envisaged publication type (indicate one of the following, if possible) International Standard Technical Specification Publicly Available Specification Technical Report FORM 4 (ISO) v Page 2 of 5

3 Purpose and justification (attach a separate page as annex, if necessary) With the rapid pace of global change in product design, construction and materials, government regulatory authorities and standards writing bodies worldwide simply cannot keep pace to ensure that appropriate safety requirements for consumer products are in place. As a result, in all countries, standards and regulations only apply for a certain percentage of consumer products on the market. Some developing and transitional countries have few standards, if any. This further underscores the importance of developing a standard that provides guidance for safety across all consumer products. There is a need, therefore, for an International Standard that will provide universally applicable guidance on identifying potential safety problems in consumer products and addressing them before the product enters the market. By placing a greater emphasis on building safety into a consumer product at the design stage and on controlling the manufacturing and distribution processes, there will be fewer injuries among consumers and fewer legal problems for suppliers with dissatisfied customers and/or enforcement authorities Even in developed countries, national regulations and standards governing the safety of consumer products may not provide adequate consumer protection. Existing regulations and standards often only specify a minimum set of requirements to address known consumer products and associated hazards. A standard that provides guidance and principles across all consumer product types could facilitate a greater understanding and consciousness among suppliers, leading to an increase in overall levels of safety. Injury statistics in Europe, North America and Pacific countries indicate that design problems, malfunctions in consumer products or inadequate safety information are associated with many unintentional injuries. To address the problems, a number of governments have established or are establishing a requirement for suppliers to only place safe products on the market. In order to comply, suppliers need to assess the risks associated with consumer products and to mitigate these risks. currently have limited experience, few available resources, or practical reference documents to guide them through this process. A standard as proposed, would be particularly valuable to small and medium enterprises, retailers who import products and importers who do not manage the product design or production but are responsible for their safety. Consumer products are global in nature and an International Standard can play a significant role in supplementing national regulations without restricting trade. This proposed International Standard may be used by manufacturers and/or suppliers to establish confidence in the safety of the consumer products that they produce and to demonstrate compliance with legal requirements of many countries. Moreover, the trade of these goods across borders will not only be facilitated but technical barriers to trade will not inadvertently be introduced. Users of the standard could also include governments who have to assess whether or not a supplier has taken all reasonable steps to market safe products, distributors, buyers, educators and consumer groups. Target date for availability (date by which publication is considered to be necessary) Proposed development track 1 (24 months) 2 (36 months - default) 3 (48 months) Relevant documents to be considered See Annex 2 Relationship of project to activities of other international bodies Liaison organizations Consumers International, ANEC, Eurosafe Need for coordination with: IEC CEN Other (please specify) FORM 4 (ISO) v Page 3 of 5

4 Preparatory work (at a minimum an outline should be included with the proposal) A draft is attached An outline is attached. It is possible to supply a draft by The proposer or the proposer's organization is prepared to undertake the preparatory work required Yes No Proposed Project Leader (name and address) Comments of the TC or SC Secretariat Supplementary information relating to the proposal Other: This proposal relates to a new ISO document; Name and signature of the Proposer (include contact information) COPOLCO c/o COPOLCO Secretariat ISO Central Secretariat Geneva This proposal relates to the amendment/revision of an existing ISO document; This proposal relates to the adoption as an active project of an item currently registered as a Preliminary Work Item; This proposal relates to the re-establishment of a cancelled project as an active project. Voting information The ballot associated with this proposal comprises a vote on: Other: Adoption of the proposal as a new project Adoption of the associated draft as a committee draft (CD) (see ISO Form 5, question 2.3.1) Adoption of the associated draft for submission for the enquiry vote (DIS or equivalent) (see ISO Form 5, question 2.3.2) Annex(es) are included with this proposal (give details) Annex 1: Consumer Product Supply Chain Annex 2: Relevant Documents Annex 3: Example of a Draft Guidance Standard Date of circulation Closing date for voting Signature of the TC or SC Secretary Use this form to propose: a) a new ISO document (including a new part to an existing document), or the amendment/revision of an existing ISO document; b) the establishment as an active project of a preliminary work item, or the re-establishment of a cancelled project; c) the change in the type of an existing document, e.g. conversion of a Technical Specification into an International Standard. This form is not intended for use to propose an action following a systematic review - use ISO Form 21 for that purpose. Proposals for correction (i.e. proposals for a Technical Corrigendum) should be submitted in writing directly to the secretariat concerned. Guidelines on the completion of a proposal for a new work item (see also the ISO/IEC Directives Part 1) a) Title: Indicate the subject of the proposed new work item. b) Scope: Give a clear indication of the coverage of the proposed new work item. Indicate, for example, if this is a proposal for a new document, or a proposed change (amendment/revision). It is often helpful to indicate what is not covered (exclusions). c) Envisaged publication type: Details of the types of ISO deliverable available are given in the ISO/IEC Directives, Part 1 and/or the associated ISO Supplement. d) Purpose and justification: Give details based on a critical study of the following elements wherever practicable. Wherever possible reference should be made to information contained in the related TC Business Plan. 1) The specific aims and reason for the standardization activity, with particular emphasis on the aspects of standardization to be covered, the problems it is expected to solve or the difficulties it is intended to overcome. 2) The main interests that might benefit from or be affected by the activity, such as industry, consumers, trade, governments, distributors. 3) Feasibility of the activity: Are there factors that could hinder the successful establishment or global application of the standard? 4) Timeliness of the standard to be produced: Is the technology reasonably stabilized? If not, how much time is likely to be available before advances in technology may render the proposed standard outdated? Is the proposed standard required as a basis for the future development of the technology in question? 5) Urgency of the activity, considering the needs of other fields or organizations. Indicate target date and, when a series of standards is proposed, suggest priorities. 6) The benefits to be gained by the implementation of the proposed standard; alternatively, the loss or disadvantage(s) if no standard is established within a reasonable time. Data such as product volume or value of trade should be included and quantified. FORM 4 (ISO) v Page 4 of 5

5 7) If the standardization activity is, or is likely to be, the subject of regulations or to require the harmonization of existing regulations, this should be indicated. If a series of new work items is proposed having a common purpose and justification, a common proposal may be drafted including all elements to be clarified and enumerating the titles and scopes of each individual item. e) Relevant documents and their effects on global relevancy : List any known relevant documents (such as standards and regulations), regardless of their source. When the proposer considers that an existing well-established document may be acceptable as a standard (with or without amendment), indicate this with appropriate justification and attach a copy to the proposal. f) Cooperation and liaison: List relevant organizations or bodies with which cooperation and liaison should exist. FORM 4 (ISO) v Page 5 of 5

6 New Work Item Proposal: Consumer Product Safety: A Practical Guide for Annex 1: Consumer Product Supply Chain. Consumer Product Supply Chain Manufacturers Producers Primary suppliers who have the ability to influence the safety of consumer products or first to place product on Market Importer Brand Owner Importer/Retailer Importer/Distributor Retailers Distributors Secondary suppliers who have limited ability to influence the safety of consumer products Distributors Auctioneers/Service Deliverers For practical purposes, 'producer' is defined in two ways - either as the first placer of the product on a country s market or as someone whose activities may affect the safety of the product. 'Distributor', in contrast, is any professional in the supply chain whose activities do not affect the safety of a product. This can include wholesalers, retailers (shops), agents and auctioneers. It is noted, however, that a distributor or retailer who is involved in the assembly of a product may affect the safety of a product. jnb/

7 New Work Item Proposal: Consumer Product Safety: A Practical Guide for Annex 2: Relevant Documents: Australia: Review of the Australian Consumer Product Safety System, Australian Government, Productivity Commission Canada: CAN/CSA-Q Risk Management: Guideline for Decision Makers CAN/CSA-CEI/IEC Dependability management Part 3: Application Guide Section 9: Risk analysis of technological systems. Ragnar E. Lofstedt, How can better risk management lead to greater public trust in Canadian institutions: Some sobering lessons from Europe, Kings College, London, December 5, 2003 Integrated Risk Management Framework, Government of Canada, 2001 Europe: Designing Safety Into Products, University of Nottingham EC, 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, Annex II currently under revision. EC, Guide to the implementation of directives based on the New Approach and the Global Approach, 1999 (under revision). Product Safety in Europe: A Guide to Corrective Action Including Recalls Norway Norsk Standard NS 5814, Requirements for risk analyses. jnb/

8 Page 2 New Work Item Proposal: Consumer Product Safety: A Practical Guide for Guide on Market Surveillance and Safety of Consumer Products: Best Practices in Nordic Communities, Temanord 2006:511, Nordic Council of Ministers, Copenhagen 2005, ISPN Japan Recall Handbook: Guidelines on Consumer Product Recalls USA: Recall handbook, Consumer Product Safety Commission Regulated Products Handbook, 3rd edition, Consumer Product Safety Commission, Aug Risk Assessment towards a common methodology, Gene Rider, April 2005 International documents: ISO/IEC Guide 51 Safety aspects Guidelines for their inclusion in standards ISO/IEC Guide 50 Safety aspects Guidelines for child safety ISO/IEC Guide 71- Guidelines for standardization to address the needs of older persons and people with disabilities IEC Guide 104 The Preparation of safety publications and the use of basic safety publications and group safety publications ISO/TR Safety of machinery -- Risk assessment -- Part 2: Practical guidance and examples International documents under development: IEC s ACOS Development of a standard for safety related risk assessment in the area of low voltage. ISO/TMB/WG on Risk Management. - General Guidelines for Principles and Implementation jnb/

9 New Work Item Proposal: Consumer Product Safety: A Practical Guide for Annex 3: Example of a Draft Guidance Standard Purpose: The purpose of a guidance standard on Consumer Product Safety is to provide suppliers with the tools to assist them in assessing and managing the risks related to consumer products throughout the product lifecycle from the design, to the input of raw materials, to manufacture, to distribution and to the ultimate product end-use and disposal. The key issue for manufacturers is to identify the hazards in their products, to assess the risks, to manage these risks by eliminating them or, if that's not possible, to reduce any risks to an acceptable level and to provide consumers with the information they require to use and dispose of the products safely. This involves a shared and sustained commitment of responsibility so that issues are identified and corrective actions are implemented at any point in the design, production or distribution chain. The expectation is that companies will voluntarily incorporate the product safety culture and practices into their operations and/or existing management systems. By placing greater emphasis on safety at the design stage and on manufacturing process controls, there will be reduced frequency and severity of injuries for users and fewer legal problems for producers with dissatisfied customers or enforcement authorities. Moreover, the usability of the product and its quality will be improved. Outline of a proposed standard or guide In order for those in the supply chain to implement such a program, it is necessary that suppliers have specific and practical guidance on how it can be accomplished. This could take the form of a voluntary guidance standard on which this proposal is focused. A possible outline and content of the guidance standard is presented below. 1. Introduction - Necessity for risks to be effectively assessed, managed and communicated - Applicability to all organizations - Benefits of good risk assessment, management and communication 2. Scope - Provision of principles and practical guidelines of the risk assessment, risk management and risk communication processes for consumer products - Applicable to all organizations large and small, public and private - Applicable to all type of risks both positive and negative 3. Reference standards and documents jnb/

10 Page 2 New Work Item Proposal: Consumer Product Safety: A Practical Guide for 4. Definitions For the purposes of this guidance standard, a consumer product is defined as any article, component part thereof that is produced or distributed for sale through the retail market to the general public for personal use or use in or around a household or residence, a school, in recreation, or otherwise. It does not include, for example, food, drugs, medical devices, tobacco, industrial products, cars, airplanes, boats, firearms, etc 5. Explicit principles of risk assessment, management and communication 6. Implementing the risk assessment process in Organizations 6.1 Overview of product hazard and risk assessment analysis for the purpose of improving the safety of consumer products in terms of design, materials, components, manufacturing controls, distribution and sale. This would include assessing whether the product has the potential of causing harm to users and/or bystanders including forseeable use scenarios. The following elements are included in most risk assessment processes 1 in order to clearly define and describe the issue and its context. - Identification of all possible users and anyone who may come into contact with the product intended users, potential users, unintended users, vulnerable users - Physical and psychological characteristics of the users such as strength, motor skills, experience, anthropometrical characteristics - Identification of all potential hazards (e.g. Mechanical, ingestion, explosive, fire, electrical, thermal, noise, chemical, radiation) and how likely they are to cause acute or chronic injury by i) Reviewing regulations, standards and guides that will have identified some potential hazards. ii) Analyze injury statistics and studies who are being injured and how. iii) iv) What is the situation in other jurisdictions? Describe injury scenarios and/or observe how products are being used. v) Evaluate against ergonomics data and guidelines to assure compatibility with the capabilities of the users - Carry out design appraisal experts, user trials, focus groups 1 Beverly Norris and John R. Wilson, Designing Safety into Products, Making ergonomics evaluation a part of the design process, Product Safety and Testing Group, University of Nottingham, October jnb/

11 Page 3 New Work Item Proposal: Consumer Product Safety: A Practical Guide for - Assess exposure of the user to the hazard and what type of health outcomes might be expected and how quickly these effects might be expected. - Upon receipt of new information reassess the risk to ensure the interpretation of the data is still appropriate 6.2 Overview of risk management process including guidelines to implement the process. Regardless of the situation, the primary goal of any risk management strategy must be to ensure an appropriate level of safety for the user and/or potential users.. - Determine the needs, issues, and concerns of interested and affected parties, - Determine risk management goals. Goals may be risk-related (e.g. reduce the incidence of injury, may involve public values (e.g. protect vulnerable populations), may consider economic impacts (e.g. achieve an acceptable level of injury reduction without causing loss of jobs), or be determined by legislative requirements, or national or international obligations. - Identify options to reduce or mitigate risk - Determine cost and benefits of each option, and select the most appropriate option - Implement - Revise goals and risk management strategies as new information is obtained and considered - Take corrective action to reduce identified high risk, if the assessed risks are not being managed appropriately or are not considered to be acceptable 6.3 Risk communication and consultation. Risk Communication is an integral part of any decisions to be made to manage identified risks. Risk communication refers to any exchange of information concerning the existence, nature, form, severity of any risks to health and safety. Effective risk communication involves determining the types of information that interested and affected parties need and want and presenting the information to them in a useful and meaningful way. It is based on the premise that well-informed individuals can make better decisions about factors that could affect their health. - Function and necessity of this process - Provision of practical guide that may include the development of a risk communication plan such as the following: i. Goals and objectives of the plan ii. iii. The messages that the organization would like to convey Who the messages are intended for and how and when they should be delivered jnb/

12 Page 4 New Work Item Proposal: Consumer Product Safety: A Practical Guide for iv. Evaluation of the plan 6.4 Monitor, measurement and reviews - Function and necessity of this process - Provision of practical guide - Establish a database to store, update, and access product information including: product testing data, regulatory compliance and/or registration, complaints about products and related injuries Collect information from available sources, including internal R&D, industry partners, academia, and government sources - Prior to new purchases and on a recurring basis, assess how raw materials and purchased finished product impact the risk of the products. Considerations include: inherent hazards, exposure, and environmental fate. 7. Implementing Consumer Product Safety Concept into an Organization s Culture and Operations 1. Leadership & Accountability - Clearly state the long-term commitment of Senior Leadership to consumer product safety in written policies. Specifically, Leaders should: Ensure that employees across the organization understand consumer product safety concepts and incorporate these in their own roles and responsibilities. 2. Employee Training & Education - Include consumer product safety education into existing employee training and education programs throughout the company, and provide additional training to employees who have been assigned consumer product safety responsibilities. 3. Two-way communication with users - Through this dialogue, companies will understand market expectations for the product and social, safety and ethical concerns. Provide balanced and accurate information on risks presented by the product to second parties. Ensure customers and downstream users are aware of new developments and insights into safety/use information on the products. This feedback will help the company learn from others experiences and provide the opportunity to resolve potential problems at an early stage. 4. Performance Indicators - Integrate consumer product safety performance metrics and goals into employee assessment, recognition and reward processes. All employees need to demonstrate commitment to product safety in their daily work activities, by taking action to address poor consumer product safety performance, resolve difficult issues, change performance goals, modify support resources, or change a product commercial strategy. jnb/