ISO/PC 243 N080

Committee Draft: May 12, 2011

Committee Draft (V2)

INTERNATIONAL STANDARD ISO/CD 10377

ISO/PC 243 Secretariat: CC/CSA

Consumer Product Safety: Practical Guidance for Suppliers

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Contents
Foreword ............................................................................................................................................................. 1 Introduction ........................................................................................................................................................ 2 Note to the Reader ............................................................................................................................................. 3 1. Scope...................................................................................................................................................... 4 2. Normative references ........................................................................................................................... 4 3. Terms and Definitions .......................................................................................................................... 5 4. Basic Principles for Addressing Consumer Product Safety ............................................................ 9 4.1. General ........................................................................................................................................ 9 4.1.1 Promoting a Product Safety Culture within the Supplier Organization........................................ 9 4.1.2. Promoting a Product Safety Culture outside the Suppliers Organization................................... 9 4.1.3. Committing to Providing Safe Products....................................................................................... 9 4.1.4. Ensuring Continuous Improvement ........................................................................................... 10 5. General Requirements ........................................................................................................................ 10 5.1. General ...................................................................................................................................... 10 5.2. Commitment to Providing Safe Products .................................................................................. 11 5.2.1. Competency and Training 11 5.2.2. Adequate resource allocation 11 5.2.3. Records Management and Document Control 12 5.3. Continuous Improvement................................................................................................................ 13 5.4. Applicable Laws, Regulation and Standards............................................................................. 14 5.5. Product Identification and Traceability ...................................................................................... 14 5.6 Understanding the Role of Consumers ..................................................................................... 15 5.6.1. General 15 5.6.2. Pre-Purchase 16 5.6.3. Pre-Use 16 5.6.4. Use 16 5.6.5. Post-Use 16 5.6.6. Vulnerable Consumers 16 6. Safety in Product Design ................................................................................................................... 17 6.1. General ...................................................................................................................................... 17 6.2 Design specification................................................................................................................... 17 6.3 Safety Considerations in Design ............................................................................................... 18 6.3.1 Predictable Use 18 6.3.2. Predictable Misuse 18 6.3.3 Unpredictable Misuse 18 6.3.4 Exposure analysis 18 6.3.5 Hazard identification 19 6.3.6 Risk Evaluation 19 6.3.7 Risk Treatment 22 6.3.8 Risk Communication 23 6.4 Documenting the Design Specification Process ...................................................................... 24 7. Safety in Production ................................................................................................................................. 24 7.1. Basic Principles during Production ............................................................................................ 24 7.1.1. Developing a Culture of Product Safety in the Production Facility 24 7.1.2 Minimize or Reduce Product Defects 25 7.1.3. Commitment to Product Safety 25 7.1.4. Best Manufacturing Practices 25 7.2. Production Planning .................................................................................................................. 25 7.2.1. Design validation 26 7.2.2. Production Readiness 26 7.3. Production Runs ........................................................................................................................ 27 7.3.1. Raw Materials, Components, and Subassemblies 27

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7.3.2. Production 28 7.4. Post Production ......................................................................................................................... 28 7.5. Production Support .................................................................................................................... 29 7.5.1. Audits 29 7.5.2. Regulations and Laws 29 7.5.3. Risk-based testing 29 7.5.4. Documentation 29 8. Safety in the Marketplace ................................................................................................................... 29 8.1. General ...................................................................................................................................... 29 8.2. Pre-Purchase Assessment ........................................................................................................ 29 8.3 Proactive Data Collection and Analysis..................................................................................... 30 8.4 Ongoing Assessment of Product Conformance ........................................................................ 31 8.5. Warranty and Servicing ............................................................................................................. 31 8.6. Product Incident Investigation ................................................................................................... 31 Annex A (Informative): Information and Guidance for Small Businesses ................................................ 32 A.1. General ...................................................................................................................................... 32 A.2. Questions for suppliers to consider when designing, producing or supplying consumer products. .................................................................................................................................... 32 A.2.1. General Questions 32 A.2.3. Questions Related to Production 33 A.2.4. Questions Related to the Marketplace 33 A.4. Example of Risk Level Evaluation: ............................................................................................ 35 A.5. Product Incident Investigation ................................................................................................... 35 Annex B: Informative - List of Some Common Hazards ............................................................................ 37 Annex C: Informative, Sources of Information ............................................................................................ 41 C.1. Laws and Regulations ............................................................................................................... 41 C.2. Standards .................................................................................................................................. 41 C.3. Accredited Laboratories ............................................................................................................ 42 C.4. Consumer Product Recalls ........................................................................................................ 42 C.5. Injury Data ................................................................................................................................. 42 C.6. Risk Assessment Methodologies .............................................................................................. 42 C. 7. Safe Design ............................................................................................................................... 43

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Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electro technical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 10377 was prepared by Project Committee ISO/PC 243, Consumer Product Safety: Practical Guidance for Suppliers.

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Introduction
A number of governments have established or are establishing laws or requirements for suppliers to only place safe products on the market. In this way, they are trying to deal more broadly with dangers associated with consumer products rather than developing standards or regulations for every single product. To supply safe consumer products and to comply with this broader type of legislation and regulation, suppliers must be able: to identify the hazards; to assess the risks; and to manage any risks present. Yet many suppliers have limited experience, few available resources, or practical reference documents to guide them through this process. This International Standard provides practical guidance for suppliers to assist them in assessing and managing the safety of the consumer products they supply from the design of the product, to the input of raw materials, to production, to distribution, to retail and to the ultimate product end-user and disposal. This guidance standard should be particularly valuable to small and medium sized enterprises and suppliers who do not design or produce products but are responsible for their safety in many jurisdictions. The supply chain for consumer products is made up of a number of players often in different parts of the world where products or product components are being designed in one country, produced in another and sold in yet another. Therefore, it is important that the guidance provided is aligned with international best practice, easy to understand and applied consistently across jurisdictions. By following internationally consistent guidance, it is anticipated that there will be fewer product safety incidents, deaths and injuries, product recalls, problems for suppliers with dissatisfied customers and/or enforcement authorities and reduced costs for those who supply consumer products to many countries. It should also assist governments by improving consumer product safety for its citizens, lead to increased consumer confidence in the safety of consumer products and provide consumers with the information they need to make informed choices with respect to the safe use and disposal of consumer products. This standard is not intended to be used for the purpose of certification. Nor does it cover issues such as worker safety, protection of the environment, or social and ethical issues which are covered extensively by other standards such as ISO 26000: Social Responsibility and the ISO 14000 family of standards on Environmental Management. This standard instead focuses on consumer products and helping to ensure that they do not harm consumers and users. It was developed as one component of a wider package of inter-connected standards. The other standards are: ISO 10393: Guidance standard on Consumer product recall and corrective action: Code of good practice; ISO 12931: Anti-counterfeiting Tools; and ISO 20245: Standard for Cross-Border Trade of Second-Hand Goods.

The relationship between these standards is illustrated in Figure 1.

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Figure 1: Package of Standards Related to Consumer Product Safety It is the responsibility of all those supplying consumer products to maintain an awareness of and comply with the legislation and regulations of the countries in which the products are manufactured, sold, or distributed. ISO/IEC Guide 51 has been taken into account as far as practicable at the time of drafting of this International Standard.

Note to the Reader

The standard is presented and written as practical guidance supplemented with application normative references in Clause 2. Clauses 4 and 5 provide principles and general requirements that apply to all members of the supply chain, while Clauses 6, 7 and 8 are targeted to specific sectors of the supply chain. Useful information for business, a list of common hazards and sources of information are provided in Annexes A, B and C, respectively.

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Consumer Product Safety: Practical Guidance for Suppliers 1. Scope

This International Standard provides practical guidance to suppliers on decisions to be made about the safety of consumer products and the type of documentation required to verify that the assessment and management of risks was carried out and will assist organizations to meet applicable regulatory requirements. More specifically, it describes how to: identify, assess, reduce and eliminate hazards; manage risks by reducing them to a tolerable level; and. provide consumers with warnings about hazards and instructions essential to the safe use and disposal of consumer products. This standard complements ISO/IEC Guides 50, 51 and 71. Examples of the types of hazards in consumer products to which the standard applies include but are not limited to biological, chemical, electrical, explosion, fire, physical and mechanical, thermal, fire, and radiation. This Guidance Standard was drafted for consumer products but may be useful for decisions of the safety of other product sectors.

2.

Normative references

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. Other documents that could assist suppliers are referenced in Annex C: Sources of Information. ISO/IEC Guide 14, 2003 - Purchase information on goods and services intended for consumers ISO/IEC Guide 37:1995 - Instructions for use of products of consumer interest. ISO/IEC Guide 41:2003 - Standards for packaging Consumer requirements. ISO/IEC Guide 50:2002 - Safety aspects - Guidelines for child safety. ISO/IEC Guide 51:1999 - Safety aspects - Guidelines for their inclusion in standards1. ISO/IEC Guide 71:2001 - Guidelines for standards developers to address the needs of older persons and persons with disabilities. ISO/IEC Guide 73:2009 - Risk management Vocabulary Guidelines for use in standards ISO/IEC Guide 74: 2004 - Graphical symbols Technical guidelines for the consideration of consumers' need ISO 3864: 1, 2002 - Graphical Symbols - Safety Colours and Safety Signs Package

ISO/IEC Guide 51 has been identified for revision

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ISO 2859-10: 2006 - Sampling procedures for inspection by attributes -- Part 10: Introduction to the ISO 2859 series of standards for sampling for inspection by attributes ISO/TR 8550-3: 2007 - Guidance on the selection and usage of acceptance sampling systems for inspection of discrete items in lots -- Part 3: Sampling by variables ISO 9000 2005 - Quality management systems -- Fundamentals and vocabulary ISO 10002: 2004 - Quality Management Customer satisfaction Guidelines for complaint handling in organizations ISO 10393 - Guidance standard on Consumer product recall and corrective action: Code of good practice ISO/FDIS 12100: 2010 -Safety of Machinery- General principles for design Risk assessment and risk reduction ISO 31000: 2009 - Risk management Principles and guidelines 3. Terms and Definitions

For the purpose of this document, the following terms and definitions apply. 3.1. consumer individual member of the general public purchasing or using property, products or services for private purposes. (ISO 26000, Guidance on Social Responsibility (MOD) 3.2. consumer product product designed and produced primarily for, but not limited to, personal use, including its components, parts, accessories, instructions and packaging. NOTE: Individual countries may establish different specific definitions in law. 3.3. competent suitably trained or qualified by knowledge and practical experience to enable the required task or tasks to be carried out properly 3.4. corrective action (definition from ISO 10393) any action to remove potential for harm and reduce risk. Note 2: In addition some corrective action can include public notification 3.5. intended use use of a product in accordance with information provided by the supplier NOTE: Adapted from ISO/IEC Guide 51, 1999 3.6. harm physical injury or damage to the health of people, or damage to property or the environment

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ISO/IEC Guide 51, 1999 3.7. harmful event occurrence in which a hazardous situation results in harm ISO/IEC Guide 51, 1999 3.8. hazard potential source of harm NOTE: The term hazard can be qualified in order to define its origin or the nature of the expected harm (e.g. electric shock hazard, biological hazard, crushing hazard, cutting hazard, toxic hazard, fire hazard, drowning hazard). ISO/IEC Guide 51, 1999 3.9 hazardous situation

circumstance in which people, property or the environment are exposed to one or more hazards ISO/IEC Guide 51, 1999 3.10 organization a person or group of people that has its own functions with responsible authorities and relationships to achieve its objectives. 3.11 predictable use use of a product that is capable of being known or anticipated in advance based on a suppliers actual knowledge about the product. 3.12. predictable misuse improper or incorrect use of a product that is capable of being known or anticipated in advance based on a suppliers actual knowledge about the product and human behaviour (e.g. children, elderly).

3.13. product recall any corrective action taken post production to address consumer health and safety issues associated with a product ISO 10393 under development 3.14. protective measure means used to reduce risk

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NOTE Protective measures include risk reduction by inherently safe design, protective devices, personal protective equipment, information for use and installation, and training. ISO/IEC Guide 51, 1999 3.15 residual risk risk remaining after protective measures have been taken ISO/IEC Guide 51, 1999 3.16. risk combination of the probability of occurrence of harm and the severity of that harm ISO/IEC Guide 51, 1999 3.17. risk analysis systematic use of available information to identify hazards and to estimate the risk ISO/IEC Guide 51, 1999 3.18 risk assessment overall process comprising a risk analysis and a risk evaluation ISO/IEC Guide 51, 1999 3.19 risk communication exchange or sharing of information about risk between the decision maker and other stakeholders ISO/IEC Guide 73, 2009 3.20 risk control actions implementing risk management decisions ISO/IEC Guide 73, 2009 3.21. risk evaluation

procedure based on the risk analysis to determine whether the tolerable risk has been achieved ISO/IEC Guide 51, 1999 3.22 risk management coordinated activities to direct and control an organization with regard to risk 73, 2009)

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NOTE Risk management includes risk assessment, risk treatment, risk acceptance and risk communication. ISO/IEC Guide 73, 2009 3.23. risk treatment process of selection and implementation of measures to modify risk NOTE 1 The term risk treatment is sometimes used for the measures themselves. NOTE 2 Risk treatment measures can include avoiding, optimizing, transferring or retaining risk. ISO/IEC Guide 73, 2009 3.24. safety freedom from unacceptable risk ISO/IEC Guide 51, 1999 3.25. supplier

organization or person that provides a product Examples: Designer, producer/manufacturer, importer, distributor, retailer or vendor of a product Note 1. A supplier can be internal or external to the organization Note 2: In a contractual situation, a supplier is sometimes called "contractor". ISO 9000 (MOD) 3.26. supply chain the network that designs, manufacturers, imports, distributes and sells a product. 3.27. tolerable risk risk which is acceptable for a specific user group based on the current values of society. ISO/IEC Guide 51, 1999 (MOD) 3.28 traceability the process of maintaining records of all materials, components and products from purchasing to finished goods where a unique number identifies a part, batch, or finished product. Traceability also provides the ability to identify and track a product or component to its point of origin.

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3.29. unpredictable misuse improper or incorrect use of a product in a manner that a supplier cannot know or anticipate. 3.30. user person who interacts with the product, service or environment ISO/IEC Guide 71: Guidelines for standards developers to address the needs of older persons and persons with disabilities.

4.

Basic Principles for Addressing Consumer Product Safety

4.1. General Adherence to the following basic principles will assist members of the supply chain to develop and maintain a shared commitment to consumer product safety. This includes a commitment to the prompt implementation of corrective action when hazards are identified as a result of incorrect design, deficiencies in the production process and problems during distribution or storage. 4.1.1 Promoting a Product Safety Culture within the Supplier Organization

Consumer product safety should be a key consideration in a suppliers organizational and governance structure by means of a consumer product safety compliance management program implemented and endorsed by the governing body and top management. The supplier should understand and comply with the laws, regulations and standards that cover the product produced and the legal and regulatory requirements of the marketplace in which the product is manufactured or sold. Responsibility for compliance should be clearly stated and assigned with appropriate resources allocated to develop, maintain, monitor and continually improve the product safety compliance program. 4.1.2. Promoting a Product Safety Culture outside the Suppliers Organization

A supplier should exercise its influence to promote consumer product safety in the supply chain. Methods of exercising influence may include setting contractual provisions or incentives, promoting good industry-wide practices, and forming partnerships with sector organizations and others and providing consumers with the information they need to assembly, use, maintain and dispose of a product safely. (Reference ISO 26000 Social Responsibility) 4.1.3. Committing to Providing Safe Products

Product safety issues should be addressed at the design stage to reduce the risk from hazards and to avoid the need to expend resources to deal with the recall of unsafe products. Management is accountable for assigning responsibilities for implementing the principles and guidance set out in this standard, including providing appropriate resources for training, records management, and product traceability.

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4.1.4.

Ensuring Continuous Improvement

A structured approach for continuous improvement that defines objectives for the improvement of products and processes through the analysis of data should be applied to safety in product design, production and the marketplace. Continuous improvement activities and their outcomes should be documented and regularly reviewed by management to ensure continuous improvement objectives are being met. 5. General Requirements

5.1. General The key issues for all members in the supply chain including designers, manufacturers, importers, distributors and retailers are: to design safety into the consumer product; to identify the hazards associated with their products; to determine or estimate exposure to the hazard; to assess the risks to consumer health and safety; to manage these risks by eliminating or reducing them to a tolerable level; and to provide consumers with warnings about hazards and instructions essential to the safe use and disposal of the products. The functions carried out by members of the supply chain are outlined below and, identified in Figure 2. Design the development of the requirements and specifications to make a product, taking into consideration the products intended use and predictable misuse. Material Manufacture the production of materials to be used in the manufacturing process. Component Manufacture the production of component products to be used in the manufacture of another product. Assembly the production of a product by assembling components that may be used to manufacture another product, or may be a final product. Manufacture the production of a product to be supplied to a purchaser Transport the movement of products from one location to another. Storage the temporary storage of products, intended for distribution. Import/Export the movement of products into and out of a jurisdiction. Distribute the logistics function to store and move products, which may employ transport and import/export functions. Retail the marketing and sales of products to consumers, which may employ transport, import/export, distribute and storage functions, in getting the product to its final destination.

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Figure 2: The Supply Chain

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The Organization should ensure that those involved, in product safety, whether they are internal or external to the Organization, have the necessary education, training, technical knowledge and experience for carrying out their responsibilities. The Organization should establish and maintain a procedure(s) to: define the competency requirements for those responsible for product safety; ensure competency to carry out duties and responsibilities for product safety including product safety specifications; and inform those involved in the safety of products about the potential consequences of providing unsafe products. Training activities maybe provided either within the Organization or by external sources and should include elements that are: based on the competency requirements and the duties and responsibilities for ensuring product safety; conducted by competent persons; updated as required to ensure that information remains current; evaluated and modified as necessary to ensure relevance and effectiveness; and recorded appropriately and kept by the organization. 5.2.2. Adequate resource allocation An Organization should ensure that appropriate technical, financial and human resources are allocated to safety in design, production and/or the marketplace such as:

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financial and human resources; access to expertise and relevant reference documents on consumer product safety; training of staff on consumer product safety issues; records management and document control; and verification and testing production continues to meet relevant safety requirements. 5.2.3. Records Management and Document Control

The Organization should establish and maintain procedures to record, control, retain, and retrieve all principal documents and data that reflect safety in design, production, and the marketplace. These items should include: records arising from the implementation of this standard; documents created during management of Safety in Design, such as: o Hazard Analysis and Hazard Reduction Plan; o significant design choices and safety decisions; o drawings, product specifications, and bill of materials; o product quality tests and approved product samples; o validation of the design; o warnings and instructions and language(s) in which they are produced; o design testing and inspection; o cost-benefit analysis of corrective action options; o compliance with regulatory requirements and product specific industry standards; and o third-party testing and conformity assessment, as required; documents created during management of Safety in Production, such as: o good manufacturing practices; o quality assurance records; o purchase orders and instructions to the supply chain; o testing and inspection at the factory; o production plan, design validation, and creation of the product prototype; o change requests and subcontracting; o contamination incidents; and o production readiness, including supply chain management, tooling, commissioning the factory, training, and product specifications; documents created during management of Safety in Marketplace, such as: o consumer complaints and product safety incidents; o records from the sale and distribution of products throughout the supply chain; o product literature, including advertising, marketing, and packaging; o communications with customers and end users, including product registration, post-sale warnings, market surveys, and feedback from buyers; o reasons for returned products and service records; and o corrective actions. Documents created during Safety in Design, Safety in Production, and Safety in Marketplace should reflect information and documents retained from the original design and production and that were generated as a response to potential issues, complaints, reviews about the Organizations products. In addition, records about the expiry date of a product and its useful life should be recorded. Organizations should Close the Loop by responding in writing to all hazards or safety concerns raised during product design, production, or those received from the marketplace. All written responses should be placed in the Organizations own product files to

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record that the Organization considered all available information about the product, its hazards, and its risks. Documents created during Safety in Design, Safety in Production, and Safety in the Marketplace should be retained by the Organization for the reasonable useful life of the product and should be consulted before the next production cycle of the product as part of the Organizations continuous improvement process. 5.3. Continuous Improvement

The Organization should ensure that continuous improvement becomes established as a part of the organizational culture of product safety. These activities can range from minor to major improvements in the Organization and/or its supply chain. Fundamental to effective and efficient improvement is making informed decisions on the basis of data analyses and the incorporation of lessons learned. The Organization should define objectives for the improvement of its products and processes through the analysis of data. In particular continuous improvement should apply to safety in product design, production and the marketplace such as improvement activities in: design might include using small groups to anticipate the products use in different situations and determining how the product performs or is viewed by different groups; production might include obtaining feedback from staff or testing of the product post production; and marketplace might include but not be limited to customer or consumer comments or complaints and gathering a small team to propose design or production changes or other corrective actions. All continuous improvement activities and their outcomes should be documented and reviewed by management regularly to ensure continuous improvement is occurring and that changes do not inadvertently cause another safety problem. The Organization should follow a structured approach for continuous improvement as outlined in its quality management plan, many models exist, and information sources are listed in Annex C: Informative - Sources of Information.

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Figure 3: Continuous Improvement 5.4. Applicable Laws, Regulation and Standards The Organization should identify, monitor, understand and comply with applicable legislative, regulatory or standard requirements by: identifying applicable laws, regulations and standards of the marketplace where the product will be sold and/or manufactured; assigning a resource to identify and access the laws, regulations and standards that apply to the product; and attending training sessions, conferences or monitoring the regulatory and standards environment. Note: see Annex C: Informative Sources of Information on Laws, Regulations and Standards. 5.5. Product Identification and Traceability

Suppliers should be able to trace back to the direct supplier of the product (or component) and be able to identify the direct recipient of the product (or component). Note: the supplier may want to have traceability down to the consumer level if appropriate or required by law taking into consideration privacy laws. Suppliers should use unique product identification and product traceability to fulfill business needs such as:

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supporting product safety; ensuring compliance with various regulatory requirements for product identification, traceability, recall and the establishment and maintenance of records; reducing business risks above and beyond legal compliance; recalling or withdrawing products - notably to achieve a greater degree of precision, Questions to be Considered re: Traceability Does the supplier know the traceability regulations or standards of the countries to which its products are delivered? Does the supplier know the traceability requirements of the other members of the supply chain? Are all the product components or products distributed by the supplier, which needs to be traced, identified with a globally unique identification and a description? Are there products received by the supplier, which need to be traced, globally and uniquely identified?

to demonstrate control, increase efficiency and reduce the cost of product recall or withdrawal for; o compliance with specifications; o efficient supply chain management; o effective quality management; o providing information to consumers and business stakeholders; o verifying the presence or absence of product attributes (e.g., organic, child safe); o protecting brands; and o establishing product authentication and anti-counterfeit policies;

The suppliers in the supply chain should put in place processes to globally and uniquely identified products. The supporting traceability processes should: utilize a unique global identifier (part number) allocated to the item and labeled, marked, or tagged at the source of the traceable item; provide the product with a Serial, Batch or Lot Number to comply with legal requirements that relates the item back to a specific manufacturer, facility location, date of production and quality control records; maintain information that links inputs (e.g. materials, components, etc) with the output (e.g. product or component); maintain information and records relating to consumer level product identification including identification of components and sub-assemblies, contractual agreements, technical specifications and test data; and product identification should remain on the traceable item or attached to it until the traceable item is consumed, returned or destroyed. 5.6 Understanding the Role of Consumers General

5.6.1.

Suppliers should obtain information from consumers and should provide information to them so that they have a better understanding of their role in consumer product safety. This occurs in two ways. First, suppliers should understand the decisions and actions taken by consumers during purchasing, assembling, using, storing, and maintaining a consumer product because these consumer actions may have a significant impact on whether or not the product causes harm. Second, suppliers should provide product information to consumers that will enable them to make good decisions during the purchase, use, assembly, maintenance, and disposal of the product.

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5.6.2. Pre-Purchase Suppliers should provide sufficient information to consumers that will allow them to make informed purchasing decisions based on the safety features of the product. This may include labeling or advertising that addresses product use. Examples of topics addressed in labeling or advertising are age-appropriate use, potential choking, noise, suffocation, product contents, or other product hazards. Also, suppliers should identify their name and address on the product packaging. Suppliers should be aware of laws and regulations that require particular labeling or advertising in the jurisdiction where their product will be sold. 5.6.3. Pre-Use

Consumers should examine their products prior to use to ensure obvious safety hazards are not present. Suppliers should provide consumers with information along with the product that warns and instructs consumers about predictable use and predictable misuse. 5.6.4. Use

Consumers should follow instructions for assembly, use, maintenance, storage, and disposal. Consumers also should heed warnings about the product and use the product as intended by the supplier. Consumers also should comply with the limits on the length of time that a consumer product can be used. Suppliers can assist consumers in these actions by ensuring that instructions are clear and complete and by providing special instructions, where necessary. Suppliers should ensure the durability and availability of this information by: printing it on the product and on the package as space allows; including package inserts or other materials distributed with the product; and providing information through a website or through a telephone contact centre. 5.6.5. Post-Use

Suppliers should obtain information from consumers about their use of the product. Examples where this information may be obtained include consumer feedback during marketing, consumer complaints to the supplier, consumer information provided during claims and lawsuits, and consumer reports made to regulatory bodies. Suppliers should catalog this consumer information for use during the Continuous Improvement of the product. (See 5.3) Consumers should be proactive in reporting consumer product safety hazards and safety incidents and in participating in product recall procedures. Suppliers may assist consumers in providing information about product use by providing clear instructions on how to report incidents to the supplier and how to detect potential safety hazards. For example, suppliers should encourage consumers to fill out warranty cards and provide information about national and international product recall and data base websites. 5.6.6. Vulnerable Consumers Certain consumer groups may not be able to fulfill their responsibilities and participate in consumer product safety initiatives or provide feedback about their product use. For example, consumers experiencing low levels of literacy, children or the elderly may be unable to understand written instructions, warnings, and symbols. Low income or isolated consumers may not have access to internet or telecommunication that would connect them with government or supplier product safety initiatives. Suppliers should work with government officials and civil society

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groups to help these vulnerable consumers understand and participate in providing feedback about their product use.

6.

Safety in Product Design

6.1. General Safety should be a primary concern at every step in the supply chain, especially at the beginning of the process where consumer product design specifications are developed. Lack of consumer product safety considerations at the design state leads to many product safety failures. It is the responsibility of the Organization to ensure safety in product design, recognizing that design defects are highly preventable. 6.2 Design specification

The design specification is a critical element to ensure the safety of products and is comprised of the following items, including but not limited to: drawings; description of product; a bill of materials; components and parts listing; raw material selection and sourcing; model name/ number and additional traceability information; features, functions, or characteristics of the product product instructions and warnings; and compliance with mandatory safety requirements. The entire life cycle of the product leading to design specification should take into account the following: product life expectancy; environmental factors such as climatic conditions; packaging; transportation to market and storage; post-use disposal; and end of life failure in a safe manner. The safety-related considerations that contribute to the design specification should include, but are not limited to the following activities: description of product; intended use; predictable user behaviour; exposure analysis; hazards identification and characterization; risk assessment evaluation; risk reduction ; and risk communication. For the purpose of accurate and confident decision making, the organization should undertake market intelligence, gathering and analyzing information to identify the markets to be targeted for its product, the potential users, and the sources and suppliers of raw materials, components and parts.

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6.3

Safety Considerations in Design Predictable Use

6.3.1

The supplier should predict the intended use of a product based on the suppliers actual knowledge. Actual knowledge of intended use held by the supplier is derived from the following sources, such as: use of a product consistent with its function and design, including its technical data on the function and design of the product; use of a product based on factual human behaviour, (e.g., a young child placing all toys in his/her mouth) or measurements of the human body (; e.g., a childs head is trapped between the bars of a crib because of the size of the childs head); use of a product based on feedback from consumers, including their claims, returns warranties, repairs, lawsuits, etc; use of a product based on the institutional knowledge of the supplier (e.g. actual knowledge held by the supplier and accumulated over many years); use of the product that is consistent with the laws and regulations in the location where the product will be used; and use of a product that is consistent with industry knowledge for that particular product. 6.3.2. Predictable Misuse

A supplier should predict the misuse of a product based on the suppliers actual knowledge. Actual knowledge of misuse that is held by the supplier is derived from the following sources, such as: use of a product based on factual human behaviour or measurements of the human body (e.g. children, elderly); use of a product based on feedback from consumers, including their claims, returns, warranties, repairs, lawsuits, etc. and demographics information from marketing and consumer trends; use of a product based on the institutional knowledge of the supplier; and use of a product that is consistent with industry knowledge for that particular product. 6.3.3 Unpredictable Misuse

A supplier cannot predict the use of a product that is not known by the supplier, however, suppliers should ensure feedback from the field and this feedback should be monitored and tabulated to ensure there are no repeatable patterns. 6.3.4 Exposure analysis

The Organization should conduct an exposure analysis to determine the likely user population and their exposure to the product taking into account the following: Who are the possible users of the product, and who could come into contact with it intended users, potential users, unintended users, vulnerable users? What are the physical capabilities and psychological characteristics of the users such as strength, motor skills, experience, and physical dimensions? What is the duration that users may be in contact with or exposed to the product?

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What is the critical path to injury by taking a step-by-step approach to identify all possible scenarios that may lead to incidents or adverse effects? How likely is each product hazard to actually happen? How obvious is the hazard to the user? For example, the blade on a sharp knife or a sharp metal edge inside a childs toy. Are there cumulative, long term risks such as those that may be associated with chemical products or additives? NOTE: When determining the needs, physical and psychological characteristics of vulnerable users. Reference should be made to the following documents. ISO/IEC Guide 50 50:2002 - Safety aspects - Guidelines for child safety ISO/IEC Guide 71:2001 - Guidelines for standards developers to address the needs of older persons and persons with disabilities 6.3.5 Hazard identification

Hazard identification aims at gaining insight about the product regarding potential hazards that may result in injury. Hazard identification refers to the identification of all potential hazards associated with the product, its components and packaging. This can be assessed through various types of analysis such as Scenario Analysis, Fault Tree Analysis (FTA), Failure Mode and Effects Analysis (FMEA), Failure Mode, Effects and Criticality Analysis (FMECA), or Event Tree Analysis (ETA). Sources of information on the different types of analysis can be found in Annex C. Data and information for hazard identification may come from various sources such as: consumer complaints and returns from similar products; incident reports, and injury data, and analysis of data bases; recall data from various government and independent sources; requirements in regulations and international, national and industry standards; product or raw material test reports or certificates, as appropriate; independent industrial, expert and scientific advice; relevant ergonomic principles; and other sources of information related to the product and similar products. A list of potential hazards is presented in Annex B: Informative List of Common Hazards. When identifying the potential sources of machinery-related hazards (e.g. power tools, lawn mowers), reference can be made to the following international standard: ISO/FDIS 12100: 12000 Safety of machinery General Principles for design Risk Assessment and risk reduction 6.3.6 Risk Evaluation

This standard refers to risk evaluation in many places. It should not intimate users as risk evaluation is just a logical evaluation of any hazards that a product may pose, determining how likely a consumer or user will be exposed to them, and how severe any harm that may result will be. In some instances but not all, it may require research or obtaining knowledge and expertise to help with the evaluation.

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The Organization should use the exposure analysis and hazard identification during the process to evaluate the potential risk level. In evaluating the elements associated with risk, the following should be considered: the type of hazard; the severity of harm caused by the hazard; and probability of exposure including number of and/or vulnerability of those exposed as well as technical and/or human ability to avoid or limit the harm. The Organization should establish a process for conducting risk evaluation when it is determined that there is a hazard posed which has the potential to cause harm as described in 6.3.5. The risk evaluation process will generally include the following steps: evaluate the type of injury that may occur and the corresponding severity, level such as, fatal vs. non-fatal, serious vs. minor injury; estimate the probability of the harm occurring taking in to consideration consumer behaviour and the frequency and duration of use of the product; estimate the risk to each of the identified user groups from the hazards identified; conduct a sensitivity analysis to see if the level of risk is impacted by changes in assumptions or probabilities; document the risk evaluation; have experts in the field check the application of the risk evaluation method and conclusions reached; and if the risk is not tolerable, then continue with risk reduction by redesigning the product or by providing protective measures against the hazard. Figure 5 below illustrates the risk evaluation process while in Annex B a list of potential common hazards is presented and Annex C provides sources of information for methods that provide guidance on quantifying the severity of injuries.

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1011 1012 1013 1014 1015 1016 1017 Figure 4. Schematic Flow of Risk Evaluation by the Organization (Based on EU Risk Assessment Guidelines for non-food Consumer Products

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6.3.7 Risk Treatment The ultimate goal of carrying out a risk evaluation is to enable the Organization to determine how best to reduce the risk and what action needs to be taken. The Organization should compare the risk evaluation results against what is determined to be tolerable risk with consideration of social and public benefit. If a tolerable risk is not achieved, it may be necessary to take further steps to reduce the risk to a tolerable level. If the risk cannot be reduced to a tolerable or acceptable level, the product should not be permitted to reach the marketplace. The options to reduce or eliminate the risk may include: examining the risk evaluation (hazard identification and exposure to determine which aspects of the product are contributing to the risk; evaluating the extent to which the treatment options will reduce the risk; incorporating protective measures into the product at the design stage e.g. adding a protective cover to a table saw; reducing risk by providing users with safe use information through the provision of instructions for use, assembly and maintenance; and warnings and labels; only if incorporating protective measures into the product at the design stage cannot eliminate residual risk; weighing the costs and benefits of each option, in order to select the most appropriate option to implement; and the risk reduction action could range from redesigning the product to preventing it from reaching the market, if the risk cannot be managed appropriately or reduced to a tolerable level. Figure 5: Risk Reduction Process of Organization

Child safety gate In the example of a child safety gate, a potential hazard might be the ability of a child to open the catch. The performance criterion for this hazard would be that the catch cannot be opened by any child under five years old. If a hazard cannot be completely designed out, performance criteria may have to be set for an acceptable level of risk. For instance, a catch on a safety gate that can be opened by 15% of two-year-old children would be an unacceptable risk, but a mechanism

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6.3.8

Risk Communication

Warnings are an integral part of managing product risks. Organizations should give warnings about a product where the risks it presents cannot be reduced or eliminated and where use of the product based on predictable user behavior will present risks to the health or safety of consumers. Warnings are brief safety messages about the existence, nature, form, or severity of product hazard that could adversely affect health and safety of the user. The content of a warning must describe the product hazard, the harm presented by the hazard, and the consequences if the harm is not avoided. Each product hazard should be presented in a separate warning. Effective warnings attract attention by using signal words, safety alert symbols, and a font in a type size and color that is suitable to the product hazard. Warnings should be placed on the product in labels that are durable, in product manuals, in safety data sheets, and on organization websites. Instructions also are integral to the safe use of a product. Organizations should provide product users with instructions about the use, assembly, maintenance, and disposal of the product. The content of an instruction should give product users the means to avoid a harm presented by a product hazard that has not been reduced or eliminated and directions to avoid the misuse of the product. For example, Do not use the camping lantern inside a tent. Instructions may also give direction about remedial action if the product is misused such as ingesting bleach. Instructions and warnings with safety messages about product hazards should be written and presented separately to avoid confusing directions about product use. Other considerations that may govern the content or presentation of a warning or instruction include: safety messages required by a law or regulation; industry standards that give specific guidance about the risk associated with a product or its use; other languages in which the warning or instruction should also be given; the ability of vulnerable consumers to read and understand the warnings (e.g. children and elderly); the location where warnings should be placed on the product; the prominence of warnings in the product manual; symbols that should be used in product warnings; obtaining feedback from a focus group about the content of the warning or instruction; and whether the products technology (e.g. software) should provide warnings or instructions to the user. NOTE: Where there are no identified regulatory requirements for labelling or instructions refer to labelling standards. ISO/IEC Guide 14, 2003 - Purchase information on goods and services intended for consumers ISO/IEC Guide 37, 1995 - Instructions for use of products of consumer interest ISO/IEC Guide 74, 2004 - Graphical symbols Technical guidelines for the consideration of consumers' need ISO 3864, 2002 - Graphical Symbols - Safety Colours and Safety Signs Package

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6.4

Documenting the Design Specification Process

Documentation of the design specification process is important to demonstrate both that it was done and how it was done. It is important to document the history of the product design and development, including evolution of the product design, the history of other similar products and history of incidents or problems with the product or similar products. By creating, maintaining and updating these documents the Organization can ensure that information is available to be used during subsequent risk evaluation activities and for traceability, product redesign, and legal and regulatory compliance. Thus, the Organization should establish and maintain procedures to record, control, retain, and retrieve all principal documents and data related to safety in design, production, and the marketplace. These should include: records arising from the implementation of this standard; documents created during Safety in Design, such as; o risk assessment including data and information used, o significant design choices and safety decisions, o drawings, specifications, and Bill of Materials, o product quality and safety tests and approved product samples, o validation of the design, o warnings and instructions, o design testing and inspection, o cost-benefit analysis of corrective action options, o compliance with regulatory requirements and product specific industry standards, and o third-party testing and conformity assessment , as required; and the options considered and actions taken to reduce or eliminate any risk.

7.
7.1.

Safety in Production
Basic Principles during Production

The identification and reduction of product safety risks during production will reduce total cost, improve efficiency, and advance the overall safety and quality of the final products. Safety should be a major concern during all aspects of production, including Production Planning, Production Runs, Post-Production, and Production Support. This section provides guidance about integrating steps into these phases of production and establishing a culture of product safety resulting in reduced risks to consumers.

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7.1.1.

Developing a Culture of Product Safety in the Production Facility

Developing a product safety culture in a multi-constituent supply chain will improve product safety. A product safety culture requires organizations to go beyond

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traditional concepts in the design, prototyping, testing, inspection and training approaches to one where rapidly identifying, managing and mitigating risks in product safety are of paramount importance. The developing of a product safety culture should be a priority within the organization and the following practices give evidence of this: know the risks associated with the products they handle and how those should be managed; dedicate resources to evaluate supplier practices; stay up-to-date on emerging product safety issues; foster a value system within the organization that focuses on avoiding any possible injuries or harm as a result of using the companys products; communicate compelling and relevant messages about risk reduction activities, and empower others to put them into practice; promote effective product safety systems before an incident occurs; don't blame customers, including commercial buyers and consumers, when illnesses are linked to their products; and involvement in standardization work in matters related with consumer product safety (e.g.: at level of technical committees and national mirror committees) 7.1.2 Minimize or Reduce Product Defects

Defects and the introduction of hazards that affect the safety of products may occur during production and are preventable. The Organisation should ensure that actions necessary to reduce or eliminate product defects are incorporated into every step of production. Examples of actions that could be taken include identifying and controlling the critical steps in the production process such as annealing temperature of glass, torque of screws, or the hygiene standards in the facility. 7.1.3. Commitment to Product Safety

The Organization should ensure that all necessary facets of product safety, including training, exist during and for all phases of its production process. Equally important, the Organization should ensure that its supply chain providers of raw materials, components, and subassemblies have incorporated all necessary facets of product safety into their individual production practices. 7.1.4. Best Manufacturing Practices

The Organization should follow industrys Best Manufacturing Practices (BMP) during production of consumer products. These are practices that provide continual measures of safety and quality that can uncover problems due to inconsistency and fluctuations in the production process as they occur and before the product is shipped. Thus, BMPs are a more immediate and consistent way to ensure that they meet the design specifications. 7.2. Production Planning Planning before production begins will remove product defects during production. A production facility should plan its production before the start of manufacturing by validating the final design and preparing for actual production. These steps should be performed regardless whether the product is being produced for the first time or has had prior production runs at the production facility.

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7.2.1. Design validation The final design and the safety of the product should be confirmed before production begins. The production facility should prepare a prototype, confirm the final design, confirm the products specifications, and confirm the items provided by the production facilitys supply chain. The production facility should confirm that the product can be produced on a mass scale. Depending on these confirmations, further modification of the final design may be necessary before production begins. 7.2.1.1. Prototype for production The production facility may wish to produce a prototype to test the ability of the production facility to manufacture the final product. This prototype is useful to test the assumptions made about the product, its safe design, its final assembly, and the production facilitys ability to produce it. The prototype should be validated by the customer, if possible. 7.2.1.2. Validate with Customer The production facility should validate the design that will be used in the production run with the customer. Evaluation may result in the identification of a safety problem that may generate a change order to deal with a safety problem. If possible validate the prototype with customers. 7.2.1.3. Specifications The production facility should have the products specifications, which would include the final design, performance criteria, the material requirements for production, the raw materials, the components, the subassemblies (if any), the bill of materials (if any), assembly requirements, final testing, packaging, and labelling. 7.2.1.4. Supply Chain The availability of approved raw materials, components, and subassemblies is critical. Organisations should validate that the items provided by its supply chain match the product specifications. Further, the Organisation should confirm that raw materials, components, or subassemblies meet the design specifications and are not at their end-of-life or are unapproved replacements before production begins. Finally, it is critical that the product produced accurately reflects the tested and approved prototype in all aspects including its component parts. 7.2.2. Production Readiness

7.2.2.1. Supply Chain Management The Organisation should determine the final choice of approved raw materials, components, or subassemblies to be used in the product. The production facility should ensure that the raw material, component, or subassembly suppliers understand that unapproved raw materials or components or any changes are unacceptable unless approved by the Organization. Also, the production facility should ensure the supply chain can provide a consistent and uninterrupted supply of the raw materials and components required to produce the product.

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7.2.2.2. Tooling Depending on the product being produced, the production facility will need to ensure they have the adequate tools necessary for production, including the physical setup within the production facility, specialized machinery, specialized equipment, moulds, fabricators, and specialized skills among its staff. It should define and monitor essential aspects that can affect the safety of the products produced such as the critical tolerances, wear on tools, operator actions. 7.2.2.3. Processes, Controls, and Measures Production facilities should establish processes, controls, and measures during production that are consistent for the production of safe products. It is important that these be recorded in its documents to demonstrate that the production facility meets the agreed to safety requirements. Facilities should ensure that employees are aware of the processes, controls, and measures. 7.2.2.4. Commissioning the Production Facility The size, ability, process, controls and measures being in place allow a production facility to be ready for production of a safe product. 7.2.2.5. Training Production facilities should ensure employees are trained on existing processes, controls and measures to ensure products are being produced consistently to meet the product safety culture. Training may require documentation of processes, staff certification, and staff training. 7.2.2.6. Product Specifications The production facility should have in its possession the final product specifications identified in 7.2.1.3. 7.3. Production Runs Safety in the final product also occurs during the production run. This occurs by the production facility controlling all parts of the product during actual production including the raw materials, components, subassemblies, accessories, packaging, warnings, instructions, and manuals. 7.3.1. Raw Materials, Components, and Subassemblies

Upon receipt by the production facility, every batch of incoming raw materials, components, and subassemblies should be validated to comply with the products design specifications. Raw materials, components, and subassemblies accepted by the production facility should be introduced into its production facility inventory, managed, and traced to identify their source, batch, lot, and date. Raw materials, components and subassemblies not meeting the specifications should be segregated to ensure that they are not mixed with acceptable material.

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7.3.2.

Production

7.3.2.1. Production Scheduling The scheduling of production provides efficiency, cost savings, and planning to produce a final safe product. 7.3.2.2. Production Consistency. A production facility must produce final products that are consistent from a safety and quality perspective across one or multiple production runs. 7.3.2.3. Production Quality Monitoring Monitoring of production quality assures safety has been integrated into the final product based on the design, materials, and production planning. Production monitoring may be included as part of the responsibility of the facilitys production staff, but the production monitoring processes and execution should be the responsibility of quality staff assigned to the production floor. Production monitoring staff should have established the sampling rate for each production run, and document the monitoring. Production monitoring staff should have the ability to stop production if an unacceptable number of failures have been identified. Production monitoring includes inspections and product testing and should also include the sampling of the product, the manuals and packaging. 7.3.2.4. Finished Product Testing Finished product (or batch) testing is integral to assuring the safety of the final product. It includes the complete testing of the finished product and validation of its manual, labels and packaging to the product specifications. Conformity Assessment bodies and test laboratories can assist production facilities in demonstrating that all reasonable steps have been taken to produce a complying product. 7.4. Post Production

The production facility should consider the logistics of getting the product from their facilities to their customers. If not carried out properly, it could result in damage or the introduction of hazards (everything from shipment damage as a result of suboptimal packaging, packing, transporting, storing, to hazards in the form of biological (moulds) and chemical). Consideration should be given to these items, such as: master carton and shipment ready packaging; reviewing customer logistics requirements including security, product integrity, etc.; and developing a logistics plan. The production facility and the customer should have a shared understanding of the logistics plan to transfer the product from the facility to the end consumer without being damaged. With this understanding, the facility and customer should monitor the transfer to ensure any changes from the plan do not introduce new problems or safety risks into the product.

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7.5. Production Support The production support function in a production facility is part of the administration arm of the facilitys production floor. 7.5.1. Audits

The production facility could be audited by various stakeholders (conformity assessment bodies, customers, etc.). Production support would facilitate these audits, capturing any input for the continuous improvement of the product and processes. 7.5.2. Regulations and Laws

Production support ensures the production facility knows the standards, laws, and regulations required for the jurisdictions where the products will be manufactured or sold. They should ensure that the final products meet those standards, laws, and regulations. 7.5.3. Risk-based testing

Testing conducted by the production facility, conformity assessment bodies and customers identify opportunities for continuous improvement of products. Production support should ensure that risk reduction or corrective actions arising from product testing are executed and fed back to the organization and through the supply chain. 7.5.4. Documentation

Documentation and record keeping is important to the integrity of the production facility and its processes to ensure consistency, as described in 5.2.3.

8.

Safety in the Marketplace

8.1. General To improve consumer product safety, suppliers should conduct pre-purchase confirmation, proactive data collection and ongoing product assessment. 8.2. Pre-Purchase Assessment Prior to acceptance, suppliers should confirm that the product ordered meets their requirements in terms of: safety for targeted consumers, vulnerable consumers (e.g. children and elderly) and those who may be exposed; quality attributes that relate to safety; compliance with regulations and standards; and suitability for the environment, targeted users and marketplace. The right to verify the product meets requirements should be included in the contract that was reached prior to the Production stage. In addition, product specifications should be communicated and agreed to during the design stage. Product specifications should include elements such as: in which marketplace the product will be sold;

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the environment, such as an office, nursery, and residential home, where the product would be used; and who the users of the product will be such as age range and capability. Compliance can be verified by such means as follows: obtaining data from the supplier that the product meets specifications, the applicable laws and standards and how the compliance was determined. Confirmation can take the form of test criteria and test results generated by internal facilities or third party independent laboratories, and where required, certification results from third party certification bodies. writing specific contracts that include the safety, quality and the applicable regulatory compliance requirements for where the products are intended to be manufactured, sold and used. Contracts should also give the supplier the right to verify, require proof of compliance, and hold the other members of the supply chain accountable for correction of non-compliant products. reviewing the compliance history of the supplier of the product and the products history of reported incidents, recalls, lawsuits and consumer complaints. evaluating through sampling and testing. Testing should be done to the test criteria agreed to during the Safety in Design stage and in accordance with applicable regulatory requirements. evaluating through Inspection. An alternative or complement to product testing is product inspection, where the product is visually inspected to ensure the requirements are being met, and necessary safety certification has been completed. and auditing of documentation provided by the supplier of the product can be used as a complement to or as an alternative to testing or inspecting. The documentation supplied should present evidence that demonstrates conformance of the product to the requirements. This would include test reports, inspection reports and certification documentation. 8.3 Proactive Data Collection and Analysis

Data collection and analysis provides a supplier with the information necessary to identify trends in product safety, from information such as defects, return rates, repairs, product incidents, customer complaints and lawsuits. Proactive data collection and analysis is also valuable as feedback for the risk reduction and continuous improvement processes. Data collection and analysis may also be required by some government regulations. The supplier should establish processes for data collection and analysis by means such as: establishing, communicating and promoting a consumer complaint system which is a systematic way of obtaining information on how consumers use products, failure modes and defects, and opportunities to improve the product; NOTE: See ISO 10002, 2004: Quality Management Customer satisfaction Guidelines for complaint handling in organizations. products and service records which involves reviewing and analyzing the reason for products being returned and serviced; and new data should be used to constantly update the understanding of risks inherent in a product and how to reduce them.

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In accordance with ISO 10393: Guidance standard on Consumer product recall and corrective action: Code of good practice, suppliers should establish a process for documenting and investigating incidents and defects involving the product. 8.4 Ongoing Assessment of Product Conformance

Suppliers should verify conformance on an ongoing basis. Ongoing assessment helps to reduce the risks to the health and safety of consumers from variations introduced during multiple productions runs, from the use of multiple production lines and from using multiple factories. Suppliers can assess the product after it enters the marketplace by means such as those outlined below. Obtaining products from the marketplace. Collecting samples for ongoing assessment as close as possible to or directly from the source where a consumer would purchase the product helps to identify and reduce any risks that may have been introduced through the supply chain during transportation, storage and handling. Verifying compliance of the samples with specifications. As part of auditing documentation, compliance with requirements can be verified by assessing product samples against the product specifications utilized by the manufacturer. Conducting customer satisfaction surveys. Analyzing consumer data from various sources including product returns, websites, call centres, in-store feedback, and social media.

Establishing a feedback loop through the Organization and the supply chain that data relevant to the products compliance is captured such production line and quality control audits. Conducting factory surveillance at a frequency determined by product risk and compliance history of the factory. 8.5. Warranty and Servicing Products require continued support after being sold to the end user, including warranty, servicing, parts, responding to customer service claims, and liability claims. 8.6. Product Incident Investigation Establish a process for documenting and investigating incidents and defects involving the product. Reference should be made to ISO 10393: Guidance standard on Consumer Product Recall and Corrective Action: Code of Good Practice and Annex A, Clause A.4 on product incident investigation.

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Annex A (Informative): Information and Guidance for Small Businesses

A.1. General This International Standard is intended for organizations of all sizes. However it is recognized that many small organizations will have limited experience or resources: to identify hazards and the cause of the hazards in products; to evaluate risks; and to establish the procedures and policies that will assist them in meeting mandatory legal requirements and best practices to supply safe consumer products. The purpose of this Annex is to provide such information and examples to assist suppliers in implementing the guidance outlined in this standard. A.2. Questions for suppliers to consider when designing, producing or supplying consumer products. A.2.1. General Questions

Do my staff or external contractors have the necessary education, training, technical knowledge and experience for carrying out their responsibilities related to consumer product safety? Have I allocated enough financial and human resources to design, produce or supply safe consumer products? Does my company have a system in place to record retain, retrieve and analyze information received from incidents, complaints, service records, and test reports, complaints and incidents? Does my company know and understand the laws, regulations and standards with which my product(s) must comply in the country where the product will be manufactured or sold? Does my company know the traceability regulations or standards of the countries to which my products will be distributed? Does my company know the traceability requirements of the other members of the supply chain involved with my product? Are all the product components or products distributed by the supplier, which need to be traced, identified with a globally unique identification and a description? A.2.2. Questions Related to Design

Do my staff or external contractors have the necessary education, training, technical knowledge and experience to identify the potential hazards in a product design, to evaluate the potential risks and to determine what changes need to be made to the design to remove the risk? Who are the possible users of the product, and who could come into contact with it intended users, potential users, unintended users, vulnerable users? What are the physical capabilities and psychological characteristics of the users such as strength, motor skills, experience, and physical dimensions? What potential hazards may be associated with the product? (In other words, try to anticipate everything about your product that could go wrong or be dangerous to the eventual user its hazards.) Will the user actually be exposed to the hazard? E.g. a sharp edge in a product may not be accessible to the user.

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1581 1582 1583 1584 1585 1586 1587 1588 1589 1590 1591 1592 1593 1594 1595 1596 1597 1598 1599 1600 1601 1602 1603 1604 1605 1606 1607 1608 1609 1610 1611 1612 1613 1614 1615 1616 1617 1618 1619 1620 1621 1622 1623 1624 1625 1626 1627 1628 1629 1630 1631 1632 1633

What is the duration that users may be in contact with or exposed to the hazard associated with the product? What possible injuries may be caused by each of the hazards identified? How serious could the injuries or harm be for each of the hazards identified? How likely is each product hazard to actually happen? Does my company have in place the staff and a process to evaluate the risk associated with the hazards? If the risk is not acceptable, can it be reduced by changing the design of the product to eliminate the cause of the hazard? If the design cannot be changed to reduce the risk, can the risk be reduced by adding protective devices such as a guard on a power saw? Can any risk that remains be addressed through information or warnings to the consumer or user? A.2.3. Questions Related to Production

Is the product design specification faulty and result in an unsafe or illegal product? Did the product designer carry out and provide a copy of a risk assessment? Is it possible for the production facility to mass produce the product as designed? Does my facility have the tools, processes, and trained employees needed to produce the product? Does my facility have the tools and trained staff to maintain and calibrate the production equipment? Do we have processes in place to prevent contamination of the product by chemical or biological agents? Have the steps in the process that are critical to producing a safe product been identified? Can suppliers provide a consistent and uninterrupted supply of the raw materials, components or subassemblies that are required to produce the product? Do we have procedures in place to verify that the raw materials, components and subassemblies meet specifications? Has a plan for testing of the product during production been established and implemented? Will corrective actions arising from testing during production being executed? A.2.4. Questions Related to the Marketplace

Does the product ordered meet my companys requirements for safety, quality, compliance with regulations, and suitability for consumers and the marketplace where I intend to distribute and/or sell the product? Do I have confidence in the company who is producing and supplying the product? Does my company have the right to verify that the product meets its requirements? Has my company established processes to collect data from complaints, returns, service records and monitoring products in the marketplace? Does my company have the ability to analyze the data collected? Does my company know and understand the requirements for reporting of incidents and actions to correct defects that exist where I plan to distribute the product?

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A.3.

Hazard and Risk Evaluation

This standard refers to risk evaluation in many places. This should not intimidate users of the standard as risk evaluation is just the logical identification and evaluation of any hazards that a product may pose and determining how likely a consumer or user will be exposed to them. Once the potential hazards and their cause have been identified, it is then possible to determine the risk posed and if required redesign the product, or add protective devices before the product is produced or reaches the consumer. In some instances, but not all, it may require research or obtaining knowledge and expertise to help with the evaluation. Illustrated below are a number of examples to illustrate how hazards such as those identified in Annex B are identified and are evaluated. Hazard Mechanical Hazard sharp edges that are accessible to the body or part of the body Entrapment between moving parts, parts of structure or an opening Scenario Child reaches through a small hole or guard with a hand or finger Evaluate Hazard Measure hole and compare against data on the size of childrens fingers at various ages. (anthroprometic data) to make sure a childs finger will not fit in the hole Data on size of childrens heads at different ages (Anthropometric data) Computer simulations Stability test where drawers in the cabinet are loaded and opened injury Type Cut, amputation,

Stability Hazard a product such as a clothes cabinet tips

A childs head is caught between crib slates of a crib. Fingers trapped between supports of a folding chair. The cabinet hits a person causing injury The cabinet hits an electrical product which breaks and live electrical parts become exposed. A child or person touches the surface and sustains a burn

Crushing, strangulation, amputation

Bruising, fracture, concussion Electrical shock, burn

Thermal Hot surfaces

Measure the temperature of the surface Burn data provides information on the time for skin to be burned at various temperatures.

1st to 3rd degree burn depending on duration of contact with hot surface

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A.4. Example of Risk Level Evaluation: Example of Risk Level from Probability of Damage and Severity of Injury (from EU Risk Assessment Guidelines for Non-food Products, Jan. 2010)

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A.5. Product Incident Investigation Establish a process for documenting and investigating reports of incidents and defects involving the product reference should be made to ISO 10393: Guidance standard on Consumer Product Recall and Corrective Action: Code of Good Practice. The Organization should make it easy for users of the product to file product incident reports. Document the product incident or defect details, the investigation, the findings and the actions taken. Assign competent staff to investigate the incident or defect, and check for trends. Determine if the incident or defect report is valid and if possible, acquire the product involved in actual incident for review. , NOTE: Harm can be created directly or indirectly if the product does not function as intended e.g. Smoke alarm which fails to detect smoke. Provide regulators or competent authorities, certification bodies and other stakeholders with product incident and defect reports, the investigation findings and the actions taken at the frequency and level of detail required by legal and contractual requirements. Perform a risk assessment if the evaluation identifies a harm or potential harm. If the risk assessment concludes that corrective action is required, identify means to reduce the potential harm. Corrective actions include repair or rebuilding the product, removing the product from the marketplace, scrapping the product or conducting a product recall. Identify the root cause for the defect that created the potential harm. Identify and implement corrective actions to eliminate or reduce the reoccurrence of the defect. For example, depending on the level of risk, this can be

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accomplished by redesign of the product to remove the potential harm, guarding against the potential harm or by informing the users of the potential harm. Determine if the defect is common to other products and therefore, require that similar corrective actions be implemented. Check to make sure that the corrective actions achieve the desired goal in reducing the potential for the defect to reoccur. NOTE that the steps in the process should be carried out in parallel as much as possible rather than sequentially to reduce the time needed to reach a decision on the products potential to create harm and implement corrective actions.

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Annex B: Informative - List of Some Common Hazards 2

Biological Disease or other malady caused by living microorganism. Contamination by insects, animals, plants. Allergenic/Irritant/Sensitization Poisoning (Acute, Chronic, Carcinogen, etc.) Death, injury or impairment of a bodily function through chemical action Substances that induce an allergy, cause irritation or inflammation, or cause acquired sensitivity to the same or other agents. Magnets or magnetic small parts when ingested in multiple or in conjunction with ferromagnetic objects, it has the potential to stick across to the intestinal wall which can lead to tissue necrosis, fistula, or volvulus.

Chemical

Magnet

1696 Physical/Mechanical Abrasion Adhesion Avulsion Drowning Entrapment Penetration injury of the skin caused by contact with a rough surface. Traumatic removal of skin that is attached to a product by an adhesive. Removal of tissue (example: teeth, nails, etc) by tearing. Anoxia caused by obstructing the passage of air by submersion of mouth and nose in a fluid. Hazardous condition in which a limb or digit enters a space from which it cannot be removed. Loops acting as tourniquets and moving rigid components which may pinch or amputate are included. Poor body mechanics during tasks can cause strains and fatigue in muscles, joints and tendons. A release of chemical energy in a sudden and often violent manner, usually with the generation of high temperature and release of gases. A release of mechanical energy in a sudden and often violent manner. Injury caused by dropping down freely under the influence of gravity. Objects lodged in ears or other non airway body

Ergonomic strain Explosion - chemical

Explosion - mechanical Fall Foreign object insertion (non

Provided by Xiao Chen and Gene Rider of Intertek on behalf of ANSI.

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airway) Impact - Stationary Object (any injury involving stationary object other than fall) Impact - Moving Object

cavities. The force or impetus transmitted to the body by a collision with an immobile object. May result in fracture or bruising. The force or impetus transmitted to the body by a collision from a moving object. May result in fracture or bruising. Inhalation of a small object(s) into the airway. Injury may be acute (anoxia) or chronic (infection). Objects lodged in the mouth or oral airway. May cause anoxia. Objects lodged in the esophagus. May cause anoxia. Objects lodged in the nasal passages. May lead to infection or aspiration. Damage to connective tissues caused by exceeding movement limitations of joints Penetration injury of the skin caused by contact with a sharp edge. Anoxia caused by obstructing the passage of air through posture or chest compression. Penetration injury of the skin caused by contact with a sharp point. Frequently repeated tasks can cause strains and fatigue in muscles, joints and tendons. Anoxia caused by external pressure obstructing the passage of air through the airway or by preventing the flow of oxygenated blood to the brain. Anoxia caused by obstructing the passage of air by sealing the mouth and nose with an external object (example: plastic films, containers). Hand-Arm vibration (HAV) (usually associated with the use of vibrating hand tools), and Whole-Body Vibration (WBV) which is experienced when the operator or driver sits on or in a vibrating machine, usually a vehicle such as a forklift, or one of the numerous kinds of vehicles used in agriculture, transport, materials handling, mining and forestry.

Internal Airway Obstruction/Aspiration Internal Airway Obstruction/Choking Internal Airway Obstruction/Ingestion Internal Airway Obstruction/Insertion Joint overextension (strain sprain etc.) Laceration Positional Asphyxia Puncture Repetitive Motion Strangulation (neck)

Suffocation

Vibration

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Physical/Non Mechanical Electric shock A sudden stimulation of the nerves or convulsion caused by the passage of electric current through any portion of the body. Sensory distraction or masking leading to the creation of a hazard condition. Permanent or temporary complete or partial loss of hearing caused by exposure to noise. Sound of sufficient loudness that it can damage hearing or lead to an accident by masking sound necessary for safe activity or by creating a distraction.

Interference with safe activity NIHL (Noise induced hearing loss) Noise

Radiation Cell phone Direct (tissue damage) Indirect (glare, afterimage, flash blindness) Infrared Radiation emitted by cell phones. Damage to ocular tissue caused by intense visible light. Visible light that creates a hazard condition. Electromagnetic radiation with wavelength between about 780 nm and 1 mm. Capable of damaging tissue through a thermal mechanism (burn). Electromagnetic radiation with wavelength shorter than ultraviolet (x rays, gamma rays), alpha particles, and beta particles capable of ejecting electrons from biological molecules. Electromagnetic radiation with wavelength between about 1 mm and 1 meter. Capable of damaging tissue through heating or of interfering with implanted medical devices. Seizure induced by flashing light. Electromagnetic radiation between about 100 nm and 400 nm. capable of causing tissue damage by photochemical effect. Light that people can see, between about 380 nm and 780 nm. Radiation emitted by wireless networking equipment. Only radio waves are left. radiation with wavelength longer than about 1 meter.

Ionizing Radiation

Microwave

Photoepilepsy Ultraviolet

Visible Light Wireless Other radiation

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Thermal Burns - Chemical Burns - Cold Burns - Thermal Burn caused by a caustic or corrosive chemical contacting the skin. Burn caused by contact with a cold solid, liquid, or gas. Including scald burn caused by contact with a hot liquid or steam, hot surface burn caused by contact with a hot solid, and electrical burn or tissue damage caused by electric current passing through the tissue. Easily ignited and capable of burning. Breathing of toxic smoke from burning materials or pulmonary injury resulting from breathing such smoke.

Flammability Smoke Inhalation

1697 1698

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Annex C: Informative, Sources of Information

C.1. Laws and Regulations World Trade Organization Enquiry Points www.wto.org/english/tratop_e/tbt_enquiry_points_e.htm#u Australian Consumer Law, www.consumerlaw.gov.au Commonwealth of Australia, Compliance and enforcement: How regulators enforce the Australian Consumer Law, 2010, Canadian Consumer Product Safety Act, www.laws.justice.gc.ca/ Canadian Packaging and Labeling Act, www.laws.justice.gc.ca/pdf/statute/C/C38.pdf California Proposition 65 (Cal Prop 65), Health & Safety Code Sec. 25249.5; 22 Cal. Code Regs 25102 (June 2008). European General Product Safety Directive (GPSD), 2001/95/EC, http://ec.europa.eu/consumers/safety/prod_legis/index_en.htm European Parliament and Council, Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys, http://ec.europa.eu/enterprise/sectors/toys/documents/directives/index_en.htm European Parliament and Council, Directive 2006/95/EC of the European Parliament and of the Council of 12 December 2006 on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits. http://ec.europa.eu/enterprise/sectors/electrical/lvd European Waste Electrical and Electronic Equipment (WEEE), 2002/96/E6. European Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH), EC 1907/2006, http://ec.europa.eu/environment/chemicals/reach/reach-intro.htm European Machinery Safety Directive (MSD), 95/16/EC, and Guide to application of the Machinery Directive 2006/42/EC, 2nd Edition (June 2010), http://eu.europa.er/enterprise/sectors/mechanical/machinery/ European Classification, Labeling, and Packaging of substances and mixtures (CLP), Regulation (EC) No. 1272/2008 (10 August 2009), and Guidance in the Application of the CLP criteria, European Chemicals Agency (2009). European Commission, Health and Consumer Protection, Directorate General. Notifications of Dangerous Products by Producers and Distributors, October 2006. http://ec.europa.eu/consumers/cons_safe/prod_safe/gpsd/guidelines_en.htm Japanese Consumer Product Safety Law, www.japaneselawtranslation.go.jp Japanese Electrical Appliance and Material Safety Law, www.meti.go.jp/english/policy/economy/consumer/pse/index.html Korean Framework Act on Product Safety Law (No. 10028), www.glin.gov U.S. Consumer Product Safety Act, 15. U.S.C. 2051-2089. www.cpsc.gov U.S. Federal Hazardous Substances Act, 15 U.S.C. 1261-1278. www.cpsc.gov U.S. Poison Prevention Packaging Act, 15 U.S.C. 1471-1477. www.cpsc.gov U.S. Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 121, 136; U.S. Environmental Protection Agency, Pesticides, www.epa.gov/pesticides/index.htm C.2. Standards American National Standards Institute, Z535.1-Z535.6 (2006), Product Safety Information in Product Manuals, Instructions, and Other Collateral Materials.

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European Committee for Standardization (CEN) www.cen.eu European Committee for Electrotechnical Standardization (CENELEC) www.cenelec.eu EC Enterprise and Industry, European Standards, List of References of Harmonized Standards. http://ec.europa.eu/enterprise/policies/europeanstandards/documents/harmonised-standards-legislation/list-references Instituto Argentino de Normalizacin y Certificacin (IRAM), www.iram.org.ar Instituto Nacional de Normalizacin, Chile, www.inn.cl International Organization of Standardization (ISO) www.iso.org/iso/home.html International Electrotechnical Commission (IEC) www.iec.ch Japanese Standards Association (JSA) - www.jsa.or.jp Korean Agency for Technology and Standards www.kats.go.kr Standards Australia (SA) - www.standards.org.au Standards Council of Canada (SCC) www.scc.ca Standardization Administration of China (SAC) , www.new.sac,gov.cn C.3. Accredited Laboratories International Laboratory Accreditation Cooperation (ILAC) www.ilac.org Standards Council of Canada Accredited Laboratories, www.scc.ca C.4. Consumer Product Recalls Baltic Sea Market Surveillance, http://www.hamburg.de/baltic-sea-network/ Collective U.S. Recall Authorities, www.recalls.gov Consumer Product Safety Commission (CPSC) www.cpsc.gov/cpscpub/prerel/prerel.html EU Market Surveillance (EMARS), http://www.emars.eu/ European RAPEX data base http://ec.europa.eu/consumers/safety/rapex/index_en.htm Health Canada Consumer Product Recalls http://cpsr-rspc.hc-sc.gc.ca/PRRP/home-accueil-eng.jsp Product Recall Handbook of Japan (2010) Recalls Australia www.recalls.gov.au Recall handbook, Consumer Product Safety Commission, May 1999, www.cpsc.gov/BUSINFO/8002.html C.5. Injury Data CHIRPP - Canadian Hospitals Injury Reporting and Prevention Program ... www.phac-aspc.gc.ca Home Injury Prevention CPSC, National Electronic Injury Surveillance System (NEISS) On-line www.cpsc.gov/library/neiss.html Centers for Disease Control and Prevention, Injury Prevention & Control: Data & Statistics, www.cdc.gov/injury/ NCAA Injury Surveillance Systems, http://www1.ncaa.org/membership/ed_outreach/health-safety/iss/index.html U.S. National Library of Medicine, Household Products Database, http://householdproducts.nlm.nih.gov World Health Organization, www.who.int/

C.6. Risk Assessment Methodologies Applying the R-Map Method to Product Safety and Risk Management, Japan.

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Best Practice Techniques in Market Surveillance EMARS a Prosafe Project sponsored by the European Commission DG SANCO. Available from http://www.emars.eu/ European Commission, Commission Decision of January 26, 2010 Risk Assessment Guidelines for non-food Consumer Products, http://europa.eu/sanco/rag/help/Journal.pdf EC Risk Assessment Guidelines for Consumer Products contained in Commission Decision of 16 December 2009 EC 2010/15/EU: Laying down guidelines for the management of Community Rapid Information System Rapex established under Article 12 and of the notification procedure established under Article 11 of Directive 2001/95/EC (the General Product Safety Directive) EC, Establishing a Comparative Inventory of Approaches and Methods Used by Enforcement Authorities for the Assessment of the Safety of Consumer Products Covered by Directive 2001/95/EC on General Product Safety and Identification of Best Practices, February 2006. ISO/IEC Guide 51:1999 - Safety aspects - Guidelines for their inclusion in standards IECs Advisory Committee on Safety Development of a standard for safety related risk assessment in the area of low voltage. Product Safety in Europe: A Guide to Corrective Action Including Recalls ec.europa.eu/consumers/cons_safe/action_guide_en.pdf Recall handbook, Consumer Product Safety Commission, May 1999, www.cpsc.gov/BUSINFO/8002.html

C. 7. Safe Design Norris B and John Wilson, Making ergonomics evaluation a part of the design process, University of Nottingham, October 1997.

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