Embed Size (px)
Citation preview
ISO/PC 243 N080
i
Committee Draft: May 12, 2011
Committee Draft (V2) INTERNATIONAL STANDARD ISO/CD 10377
Consumer Product Safety:
Practical Guidance for Suppliers
ISO/PC 243
Secretariat: CC/CSA
ISO CD 10377
i
Contents 1 Foreword ............................................................................................................................................................. 1 2 Introduction ........................................................................................................................................................ 2 3 Note to the Reader ............................................................................................................................................. 3 4 1. Scope...................................................................................................................................................... 4 5 2. Normative references ........................................................................................................................... 4 6 3. Terms and Definitions .......................................................................................................................... 5 7 4. Basic Principles for Addressing Consumer Product Safety ............................................................ 9 8
4.1. General ........................................................................................................................................ 9 9 4.1.1 Promoting a Product Safety Culture within the Supplier Organization ........................................ 9 10 4.1.2. Promoting a Product Safety Culture outside the Supplier’s Organization ................................... 9 11 4.1.3. Committing to Providing Safe Products....................................................................................... 9 12 4.1.4. Ensuring Continuous Improvement ........................................................................................... 10 13
5. General Requirements ........................................................................................................................ 10 14 5.1. General ...................................................................................................................................... 10 15 5.2. Commitment to Providing Safe Products .................................................................................. 11 16
5.2.1. Competency and Training 11 17 5.2.2. Adequate resource allocation 11 18 5.2.3. Records Management and Document Control 12 19
5.3. Continuous Improvement ................................................................................................................ 13 20 5.4. Applicable Laws, Regulation and Standards ............................................................................. 14 21 5.5. Product Identification and Traceability ...................................................................................... 14 22 5.6 Understanding the Role of Consumers ..................................................................................... 15 23
5.6.1. General 15 24 5.6.2. Pre-Purchase 16 25 5.6.3. Pre-Use 16 26 5.6.4. Use 16 27 5.6.5. Post-Use 16 28 5.6.6. Vulnerable Consumers 16 29
6. Safety in Product Design ................................................................................................................... 17 30 6.1. General ...................................................................................................................................... 17 31 6.2 Design specification................................................................................................................... 17 32 6.3 Safety Considerations in Design ............................................................................................... 18 33
6.3.1 Predictable Use 18 34 6.3.2. Predictable Misuse 18 35 6.3.3 Unpredictable Misuse 18 36 6.3.4 Exposure analysis 18 37 6.3.5 Hazard identification 19 38 6.3.6 Risk Evaluation 19 39 6.3.7 Risk Treatment 22 40 6.3.8 Risk Communication 23 41
6.4 Documenting the Design Specification Process ...................................................................... 24 42 7. Safety in Production ................................................................................................................................. 24 43
7.1. Basic Principles during Production ............................................................................................ 24 44 7.1.1. Developing a Culture of Product Safety in the Production Facility 24 45 7.1.2 Minimize or Reduce Product Defects 25 46 7.1.3. Commitment to Product Safety 25 47 7.1.4. Best Manufacturing Practices 25 48
7.2. Production Planning .................................................................................................................. 25 49 7.2.1. Design validation 26 50 7.2.2. Production Readiness 26 51
7.3. Production Runs ........................................................................................................................ 27 52 7.3.1. Raw Materials, Components, and Subassemblies 27 53
ISO CD 10377
ii
7.3.2. Production 28 54 7.4. Post Production ......................................................................................................................... 28 55 7.5. Production Support .................................................................................................................... 29 56
7.5.1. Audits 29 57 7.5.2. Regulations and Laws 29 58 7.5.3. Risk-based testing 29 59 7.5.4. Documentation 29 60
8. Safety in the Marketplace ................................................................................................................... 29 61 8.1. General ...................................................................................................................................... 29 62 8.2. Pre-Purchase Assessment ........................................................................................................ 29 63 8.3 Proactive Data Collection and Analysis..................................................................................... 30 64 8.4 Ongoing Assessment of Product Conformance ........................................................................ 31 65 8.5. Warranty and Servicing ............................................................................................................. 31 66 8.6. Product Incident Investigation ................................................................................................... 31 67
Annex A (Informative): Information and Guidance for Small Businesses ................................................ 32 68 A.1. General ...................................................................................................................................... 32 69 A.2. Questions for suppliers to consider when designing, producing or supplying consumer 70
products. .................................................................................................................................... 32 71 A.2.1. General Questions 32 72 A.2.3. Questions Related to Production 33 73 A.2.4. Questions Related to the Marketplace 33 74
A.4. Example of Risk Level Evaluation: ............................................................................................ 35 75 A.5. Product Incident Investigation ................................................................................................... 35 76
Annex B: Informative - List of Some Common Hazards ............................................................................ 37 77 Annex C: Informative, Sources of Information ............................................................................................ 41 78
C.1. Laws and Regulations ............................................................................................................... 41 79 C.2. Standards .................................................................................................................................. 41 80 C.3. Accredited Laboratories ............................................................................................................ 42 81 C.4. Consumer Product Recalls ........................................................................................................ 42 82 C.5. Injury Data ................................................................................................................................. 42 83 C.6. Risk Assessment Methodologies .............................................................................................. 42 84 C. 7. Safe Design ............................................................................................................................... 43 85
86
ISO CD 10377
1
Foreword 87
ISO (the International Organization for Standardization) is a worldwide federation of 88 national standards bodies (ISO member bodies). The work of preparing International 89 Standards is normally carried out through ISO technical committees. Each member 90 body interested in a subject for which a technical committee has been established has 91 the right to be represented on that committee. International organizations, 92 governmental and non-governmental, in liaison with ISO, also take part in the work. 93 ISO collaborates closely with the International Electrotechnical Commission (IEC) on all 94 matters of electro technical standardization. 95 96 International Standards are drafted in accordance with the rules given in the ISO/IEC 97 Directives, Part 2. 98 99 The main task of technical committees is to prepare International Standards. Draft 100 International Standards adopted by the technical committees are circulated to the 101 member bodies for voting. Publication as an International Standard requires approval 102 by at least 75 % of the member bodies casting a vote. 103 104 Attention is drawn to the possibility that some of the elements of this document may be 105 the subject of patent rights. ISO shall not be held responsible for identifying any or all 106 such patent rights. 107 108 ISO 10377 was prepared by Project Committee ISO/PC 243, Consumer Product 109 Safety: Practical Guidance for Suppliers. 110
111
ISO CD 10377
2
Introduction 112 113
A number of governments have established or are establishing laws or requirements for 114 suppliers to only place safe products on the market. In this way, they are trying to deal 115 more broadly with dangers associated with consumer products rather than developing 116 standards or regulations for every single product. 117 118 To supply safe consumer products and to comply with this broader type of legislation 119 and regulation, suppliers must be able: 120
• to identify the hazards; 121 • to assess the risks; and 122 • to manage any risks present. 123
124 Yet many suppliers have limited experience, few available resources, or practical 125 reference documents to guide them through this process. 126 127 This International Standard provides practical guidance for suppliers to assist them in 128 assessing and managing the safety of the consumer products they supply – from the 129 design of the product, to the input of raw materials, to production, to distribution, to 130 retail and to the ultimate product end-user and disposal. This guidance standard should 131 be particularly valuable to small and medium sized enterprises and suppliers who do 132 not design or produce products but are responsible for their safety in many jurisdictions. 133 134 The supply chain for consumer products is made up of a number of players often in 135 different parts of the world where products or product components are being designed 136 in one country, produced in another and sold in yet another. Therefore, it is important 137 that the guidance provided is aligned with international best practice, easy to 138 understand and applied consistently across jurisdictions. By following internationally 139 consistent guidance, it is anticipated that there will be fewer product safety incidents, 140 deaths and injuries, product recalls, problems for suppliers with dissatisfied customers 141 and/or enforcement authorities and reduced costs for those who supply consumer 142 products to many countries. It should also assist governments by improving consumer 143 product safety for its citizens, lead to increased consumer confidence in the safety of 144 consumer products and provide consumers with the information they need to make 145 informed choices with respect to the safe use and disposal of consumer products. 146 147 This standard is not intended to be used for the purpose of certification. Nor does it 148 cover issues such as worker safety, protection of the environment, or social and ethical 149 issues which are covered extensively by other standards such as ISO 26000: Social 150 Responsibility and the ISO 14000 family of standards on Environmental Management. 151 This standard instead focuses on consumer products and helping to ensure that they 152 do not harm consumers and users. It was developed as one component of a wider 153 package of inter-connected standards. The other standards are: 154 155
• ISO 10393: Guidance standard on Consumer product recall and corrective 156 action: Code of good practice; 157
• ISO 12931: Anti-counterfeiting Tools; and 158 • ISO 20245: Standard for Cross-Border Trade of Second-Hand Goods. 159
160 The relationship between these standards is illustrated in Figure 1. 161
162 163
164 165
ISO CD 10377
3
166 167
Figure 1: Package of Standards Related to Consumer Product Safety 168 169 It is the responsibility of all those supplying consumer products to maintain an 170 awareness of and comply with the legislation and regulations of the countries in which 171 the products are manufactured, sold, or distributed. 172 173 ISO/IEC Guide 51 has been taken into account as far as practicable at the time of 174 drafting of this International Standard. 175 176 Note to the Reader 177 The standard is presented and written as practical guidance supplemented with 178 application normative references in Clause 2. Clauses 4 and 5 provide principles and 179 general requirements that apply to all members of the supply chain, while Clauses 6, 7 180 and 8 are targeted to specific sectors of the supply chain. Useful information for 181 business, a list of common hazards and sources of information are provided in Annexes 182 A, B and C, respectively. 183
184
ISO CD 10377
4
Consumer Product Safety: Practical Guidance for Suppliers 185 186 1. Scope 187 188 This International Standard provides practical guidance to suppliers on decisions to be 189 made about the safety of consumer products and the type of documentation required to 190 verify that the assessment and management of risks was carried out and will assist 191 organizations to meet applicable regulatory requirements. More specifically, it describes 192 how to: 193
• identify, assess, reduce and eliminate hazards; 194 • manage risks by reducing them to a tolerable level; and. 195 • provide consumers with warnings about hazards and instructions essential to the 196
safe use and disposal of consumer products. 197 198 This standard complements ISO/IEC Guides 50, 51 and 71. Examples of the types of 199 hazards in consumer products to which the standard applies include but are not limited 200 to biological, chemical, electrical, explosion, fire, physical and mechanical, thermal, fire, 201 and radiation. 202 203 This Guidance Standard was drafted for consumer products but may be useful for 204 decisions of the safety of other product sectors. 205 206 2. Normative references 207 208 The following referenced documents are indispensable for the application of this 209 document. For dated references, only the edition cited applies. For undated references, 210 the latest edition of the referenced document (including any amendments) applies. 211 Other documents that could assist suppliers are referenced in Annex C: Sources of 212 Information. 213 214 ISO/IEC Guide 14, 2003 - Purchase information on goods and services intended for 215 consumers 216 217 ISO/IEC Guide 37:1995 - Instructions for use of products of consumer interest. 218 219 ISO/IEC Guide 41:2003 - Standards for packaging — Consumer requirements. 220 221 ISO/IEC Guide 50:2002 - Safety aspects - Guidelines for child safety. 222 223 ISO/IEC Guide 51:1999 - Safety aspects - Guidelines for their inclusion in standards1. 224 225 ISO/IEC Guide 71:2001 - Guidelines for standards developers to address the needs of 226 older persons and persons with disabilities. 227 228 ISO/IEC Guide 73:2009 - Risk management — Vocabulary — Guidelines for use 229 in standards 230 231 ISO/IEC Guide 74: 2004 - Graphical symbols — Technical guidelines for the 232 consideration of consumers' need 233 234 ISO 3864: 1, 2002 - Graphical Symbols - Safety Colours and Safety Signs Package 235
1 ISO/IEC Guide 51 has been identified for revision
ISO CD 10377
5
ISO 2859-10: 2006 - Sampling procedures for inspection by attributes -- Part 10: 236 Introduction to the ISO 2859 series of standards for sampling for inspection by 237 attributes 238 239 ISO/TR 8550-3: 2007 - Guidance on the selection and usage of acceptance sampling 240 systems for inspection of discrete items in lots -- Part 3: Sampling by variables 241 242 ISO 9000 2005 - Quality management systems -- Fundamentals and vocabulary 243 244 ISO 10002: 2004 - Quality Management Customer satisfaction Guidelines for complaint 245 handling in organizations 246 247 ISO 10393 - Guidance standard on Consumer product recall and corrective action: 248 Code of good practice 249 250 ISO/FDIS 12100: 2010 -Safety of Machinery- General principles for design – Risk 251 assessment and risk reduction 252 253 ISO 31000: 2009 - Risk management — Principles and guidelines 254 255 3. Terms and Definitions 256 257
For the purpose of this document, the following terms and definitions apply. 258 259 3.1. consumer 260
261 individual member of the general public purchasing or using property, products or 262 services for private purposes. (ISO 26000, Guidance on Social Responsibility (MOD) 263 264 3.2. consumer product 265 266 product designed and produced primarily for, but not limited to, personal use, including 267 its components, parts, accessories, instructions and packaging. 268 NOTE: Individual countries may establish different specific definitions in law. 269 270 3.3. competent 271 272 suitably trained or qualified by knowledge and practical experience to enable the 273 required task or tasks to be carried out properly 274 275 3.4. corrective action (definition from ISO 10393) 276 any action to remove potential for harm and reduce risk. 277 278 Note 2: In addition some corrective action can include public notification 279 280 3.5. intended use 281 282 use of a product in accordance with information provided by the supplier 283 284 NOTE: Adapted from ISO/IEC Guide 51, 1999 285 286 3.6. harm 287
288 physical injury or damage to the health of people, or damage to property or the 289 environment 290
ISO CD 10377
6
ISO/IEC Guide 51, 1999 291 292 3.7. harmful event 293 294 occurrence in which a hazardous situation results in harm 295 296 ISO/IEC Guide 51, 1999 297 298 3.8. hazard 299
300 potential source of harm 301 302 NOTE: The term hazard can be qualified in order to define its origin or the nature of 303 the expected harm (e.g. electric shock hazard, biological hazard, crushing hazard, 304 cutting hazard, toxic hazard, fire hazard, drowning hazard). 305 306 ISO/IEC Guide 51, 1999 307 308 3.9 hazardous situation 309 310 circumstance in which people, property or the environment are exposed to one or more 311 hazards 312 313 ISO/IEC Guide 51, 1999 314 315 3.10 organization 316 317 a person or group of people that has its own functions with responsible authorities and 318 relationships to achieve its objectives. 319 320 3.11 predictable use 321 322 use of a product that is capable of being known or anticipated in advance based on a 323 supplier’s actual knowledge about the product. 324 325 3.12. predictable misuse 326 327 improper or incorrect use of a product that is capable of being known or anticipated in 328 advance based on a supplier’s actual knowledge about the product and human 329 behaviour (e.g. children, elderly). 330 331 332 3.13. product recall 333 334 any corrective action taken post production to address consumer health and safety 335 issues associated with a product 336 337 ISO 10393 under development 338 339 3.14. protective measure 340 341 means used to reduce risk 342 343
ISO CD 10377
7
NOTE Protective measures include risk reduction by inherently safe design, protective 344 devices, personal protective equipment, information for use and installation, and 345 training. 346 347 ISO/IEC Guide 51, 1999 348 349 3.15 residual risk 350 351 risk remaining after protective measures have been taken 352 353 ISO/IEC Guide 51, 1999 354 355 3.16. risk 356 357 combination of the probability of occurrence of harm and the severity of that harm 358 359 ISO/IEC Guide 51, 1999 360 361 3.17. risk analysis 362 363 systematic use of available information to identify hazards and to estimate the risk 364 365 ISO/IEC Guide 51, 1999 366 367 3.18 risk assessment 368 369 overall process comprising a risk analysis and a risk evaluation 370 371 ISO/IEC Guide 51, 1999 372 373 3.19 risk communication 374 375 exchange or sharing of information about risk between the decision maker and other 376 stakeholders 377 378 ISO/IEC Guide 73, 2009 379 380 3.20 risk control 381 382 actions implementing risk management decisions 383 384 ISO/IEC Guide 73, 2009 385 386 3.21. risk evaluation 387 388 procedure based on the risk analysis to determine whether the tolerable risk has 389 been achieved 390 391 ISO/IEC Guide 51, 1999 392 393 3.22 risk management 394 395 coordinated activities to direct and control an organization with regard to risk 73, 2009) 396 397
ISO CD 10377
8
NOTE Risk management includes risk assessment, risk treatment, risk acceptance and 398 risk communication. 399 400 ISO/IEC Guide 73, 2009 401 402 3.23. risk treatment 403 404 process of selection and implementation of measures to modify risk 405 406 NOTE 1 The term “risk treatment” is sometimes used for the measures themselves. 407 408 NOTE 2 Risk treatment measures can include avoiding, optimizing, transferring or 409 retaining risk. 410 411 ISO/IEC Guide 73, 2009 412 413 3.24. safety 414 415 freedom from unacceptable risk 416 417 ISO/IEC Guide 51, 1999 418 419 3.25. supplier 420 421 organization or person that provides a product 422 423 Examples: Designer, producer/manufacturer, importer, distributor, retailer or vendor of 424 a product 425 426 Note 1. A supplier can be internal or external to the organization 427 428 Note 2: In a contractual situation, a supplier is sometimes called "contractor". 429 430 ISO 9000 (MOD) 431 432 3.26. supply chain 433 434 the network that designs, manufacturers, imports, distributes and sells a product. 435 436 3.27. tolerable risk 437 438 risk which is acceptable for a specific user group based on the current values of 439 society. 440 441 ISO/IEC Guide 51, 1999 (MOD) 442 443 3.28 traceability 444 445 the process of maintaining records of all materials, components and products from 446 purchasing to finished goods where a unique number identifies a part, batch, or finished 447 product. Traceability also provides the ability to identify and track a product or 448 component to its point of origin. 449 450 451 452
ISO CD 10377
9
3.29. unpredictable misuse 453 454 improper or incorrect use of a product in a manner that a supplier cannot know or 455 anticipate. 456 457 3.30. user 458 459 person who interacts with the product, service or environment 460 461 ISO/IEC Guide 71: Guidelines for standards developers to address the needs of older 462 persons and persons with disabilities. 463 464 4. Basic Principles for Addressing Consumer Product Safety 465
466 4.1. General 467 468 Adherence to the following basic principles will assist members of the supply chain to 469 develop and maintain a shared commitment to consumer product safety. This includes 470 a commitment to the prompt implementation of corrective action when hazards are 471 identified as a result of incorrect design, deficiencies in the production process and 472 problems during distribution or storage. 473
474 4.1.1 Promoting a Product Safety Culture within the Supplier Organization 475 476
Consumer product safety should be a key consideration in a supplier’s 477 organizational and governance structure by means of a consumer product safety 478 compliance management program implemented and endorsed by the governing 479 body and top management. The supplier should understand and comply with the 480 laws, regulations and standards that cover the product produced and the legal and 481 regulatory requirements of the marketplace in which the product is manufactured or 482 sold. Responsibility for compliance should be clearly stated and assigned with 483 appropriate resources allocated to develop, maintain, monitor and continually 484 improve the product safety compliance program. 485 486
4.1.2. Promoting a Product Safety Culture outside the Supplier’s 487 Organization 488
489 A supplier should exercise its influence to promote consumer product safety in the 490 supply chain. Methods of exercising influence may include setting contractual 491 provisions or incentives, promoting good industry-wide practices, and forming 492 partnerships with sector organizations and others and providing consumers with the 493 information they need to assembly, use, maintain and dispose of a product safely. 494 (Reference ISO 26000 – Social Responsibility) 495 496
4.1.3. Committing to Providing Safe Products 497 498
Product safety issues should be addressed at the design stage to reduce the risk 499 from hazards and to avoid the need to expend resources to deal with the recall of 500 unsafe products. Management is accountable for assigning responsibilities for 501 implementing the principles and guidance set out in this standard, including 502 providing appropriate resources for training, records management, and product 503 traceability. 504 505
506 507
ISO CD 10377
10
4.1.4. Ensuring Continuous Improvement 508 509
A structured approach for continuous improvement that defines objectives for the 510 improvement of products and processes through the analysis of data should be 511 applied to safety in product design, production and the marketplace. Continuous 512 improvement activities and their outcomes should be documented and regularly 513 reviewed by management to ensure continuous improvement objectives are being 514 met. 515 516
5. General Requirements 517 518 5.1. General 519 520 The key issues for all members in the supply chain including designers, manufacturers, 521 importers, distributors and retailers are: 522
• to design safety into the consumer product; to identify the hazards associated 523 with their products; 524
• to determine or estimate exposure to the hazard; 525 • to assess the risks to consumer health and safety; 526 • to manage these risks by eliminating or reducing them to a tolerable level; and 527 • to provide consumers with warnings about hazards and instructions essential to 528
the safe use and disposal of the products. 529 530
The functions carried out by members of the supply chain are outlined below and, 531 identified in Figure 2. 532 533
• Design – the development of the requirements and specifications to make a 534 product, taking into consideration the product’s intended use and predictable 535 misuse. 536
• Material Manufacture – the production of materials to be used in the 537 manufacturing process. 538
• Component Manufacture – the production of component products to be used in 539 the manufacture of another product. 540
• Assembly – the production of a product by assembling components that may be 541 used to manufacture another product, or may be a final product. 542
• Manufacture – the production of a product to be supplied to a purchaser 543 • Transport – the movement of products from one location to another. 544 • Storage – the temporary storage of products, intended for distribution. 545 • Import/Export – the movement of products into and out of a jurisdiction. 546 • Distribute – the logistics function to store and move products, which may employ 547
transport and import/export functions. 548 • Retail – the marketing and sales of products to consumers, which may employ 549
transport, import/export, distribute and storage functions, in getting the product to 550 its final destination. 551
552 553 554 555 556 557 558 559
560
ISO CD 10377
11
Figure 2: The Supply Chain 561 562
563
564
5.2. Commitment to Providing Safe Products 565 566
5.2.1. Competency and Training 567 568
The Organization should ensure that those involved, in product safety, whether they 569 are internal or external to the Organization, have the necessary education, training, 570 technical knowledge and experience for carrying out their responsibilities. 571 572 The Organization should establish and maintain a procedure(s) to: 573
• define the competency requirements for those responsible for product safety; 574 • ensure competency to carry out duties and responsibilities for product safety 575
including product safety specifications; and 576 • inform those involved in the safety of products about the potential 577
consequences of providing unsafe products. 578 579
Training activities maybe provided either within the Organization or by external 580 sources and should include elements that are: 581
• based on the competency requirements and the duties and responsibilities for 582 ensuring product safety; 583
• conducted by competent persons; 584 • updated as required to ensure that information remains current; 585 • evaluated and modified as necessary to ensure relevance and effectiveness; 586
and 587 • recorded appropriately and kept by the organization. 588
589 5.2.2. Adequate resource allocation 590
591 An Organization should ensure that appropriate technical, financial and human 592 resources are allocated to safety in design, production and/or the marketplace such 593 as: 594
ISO CD 10377
12
• financial and human resources; 595 • access to expertise and relevant reference documents on consumer product 596
safety; 597 • training of staff on consumer product safety issues; 598 • records management and document control; and 599 • verification and testing production continues to meet relevant safety 600
requirements. 601 602
5.2.3. Records Management and Document Control 603 604
The Organization should establish and maintain procedures to record, control, 605 retain, and retrieve all principal documents and data that reflect safety in design, 606 production, and the marketplace. These items should include: 607
• records arising from the implementation of this standard; 608 • documents created during management of Safety in Design, such as: 609
o Hazard Analysis and Hazard Reduction Plan; 610 o significant design choices and safety decisions; 611 o drawings, product specifications, and bill of materials; 612 o product quality tests and approved product samples; 613 o validation of the design; 614 o warnings and instructions and language(s) in which they are produced; 615 o design testing and inspection; 616 o cost-benefit analysis of corrective action options; 617 o compliance with regulatory requirements and product specific industry 618
standards; and 619 o third-party testing and conformity assessment, as required; 620
• documents created during management of Safety in Production, such as: 621 o good manufacturing practices; 622 o quality assurance records; 623 o purchase orders and instructions to the supply chain; 624 o testing and inspection at the factory; 625 o production plan, design validation, and creation of the product prototype; 626 o change requests and subcontracting; 627 o contamination incidents; and 628 o production readiness, including supply chain management, tooling, 629
commissioning the factory, training, and product specifications; 630 • documents created during management of Safety in Marketplace, such as: 631
o consumer complaints and product safety incidents; 632 o records from the sale and distribution of products throughout the supply 633
chain; 634 o product literature, including advertising, marketing, and packaging; 635 o communications with customers and end users, including product 636
registration, post-sale warnings, market surveys, and feedback from buyers; 637 o reasons for returned products and service records; and 638 o corrective actions. 639
640 Documents created during Safety in Design, Safety in Production, and Safety in 641 Marketplace should reflect information and documents retained from the original 642 design and production and that were generated as a response to potential issues, 643 complaints, reviews about the Organization’s products. In addition, records about 644 the expiry date of a product and its useful life should be recorded. Organizations 645 should “Close the Loop” by responding in writing to all hazards or safety concerns 646 raised during product design, production, or those received from the marketplace. 647 All written responses should be placed in the Organization’s own product files to 648
ISO CD 10377
13
record that the Organization considered all available information about the product, 649 its hazards, and its risks. Documents created during Safety in Design, Safety in 650 Production, and Safety in the Marketplace should be retained by the Organization 651 for the reasonable useful life of the product and should be consulted before the next 652 production cycle of the product as part of the Organization’s continuous 653 improvement process. 654
655 5.3. Continuous Improvement 656
657 The Organization should ensure that continuous improvement becomes established as 658 a part of the organizational culture of product safety. These activities can range from 659 minor to major improvements in the Organization and/or its supply chain. 660 661 Fundamental to effective and efficient improvement is making informed decisions on 662 the basis of data analyses and the incorporation of lessons learned. The Organization 663 should define objectives for the improvement of its products and processes through the 664 analysis of data. 665 666 In particular continuous improvement should apply to safety in product design, 667 production and the marketplace such as improvement activities in: 668
• design might include using small groups to anticipate the product’s use in 669 different situations and determining how the product performs or is viewed by 670 different groups; 671
• production might include obtaining feedback from staff or testing of the product 672 post production; and 673
• marketplace might include but not be limited to customer or consumer comments 674 or complaints and gathering a small team to propose design or production 675 changes or other corrective actions. 676
677 All continuous improvement activities and their outcomes should be documented and 678 reviewed by management regularly to ensure continuous improvement is occurring and 679 that changes do not inadvertently cause another safety problem. 680 681 The Organization should follow a structured approach for continuous improvement as 682 outlined in its quality management plan, many models exist, and information sources 683 are listed in Annex C: Informative - Sources of Information. 684
ISO CD 10377
14
685 Figure 3: Continuous Improvement 686 687
5.4. Applicable Laws, Regulation and Standards 688 689 The Organization should identify, monitor, understand and comply with applicable 690 legislative, regulatory or standard requirements by: 691
• identifying applicable laws, regulations and standards of the marketplace where 692 the product will be sold and/or manufactured; 693
• assigning a resource to identify and access the laws, regulations and standards 694 that apply to the product; and 695
• attending training sessions, conferences or monitoring the regulatory and 696 standards environment. 697 698
Note: see Annex C: Informative Sources of Information on Laws, Regulations and 699 Standards. 700 701
5.5. Product Identification and Traceability 702 703 Suppliers should be able to trace back to the direct supplier of the product (or 704 component) and be able to identify the direct recipient of the product (or component). 705 706 Note: the supplier may want to have traceability down to the consumer level if 707 appropriate or required by law taking into consideration privacy laws. 708 709 Suppliers should use unique product identification and product traceability 710
• to fulfill business needs such as: 711
ISO CD 10377
15
o supporting product safety; 712 o ensuring compliance with various regulatory requirements for product 713
identification, traceability, recall and the establishment and maintenance of 714 records; 715
o reducing business risks above and beyond legal compliance; 716 o recalling or withdrawing products - notably to achieve a greater degree of 717
precision, 718 719
• to demonstrate control, increase efficiency and reduce the 720 cost of product recall or withdrawal for; 721 o compliance with specifications; 722 o efficient supply chain management; 723 o effective quality management; 724 o providing information to consumers and business 725
stakeholders; 726 o verifying the presence or absence of product attributes 727
(e.g., organic, child safe); 728 o protecting brands; and 729 o establishing product authentication and anti-counterfeit 730
policies; 731 732
The suppliers in the supply chain should put in place processes 733 to globally and uniquely identified products. The supporting 734 traceability processes should: 735
• utilize a unique global identifier (part number) allocated to 736 the item and labeled, marked, or tagged at the source of 737 the traceable item; 738
• provide the product with a Serial, Batch or Lot Number to 739 comply with legal requirements that relates the item back 740 to a specific manufacturer, facility location, date of 741 production and quality control records; 742
• maintain information that links inputs (e.g. materials, 743 components, etc) with the output (e.g. product or 744 component); 745
• maintain information and records relating to consumer 746 level product identification including identification of 747 components and sub-assemblies, contractual agreements, technical 748 specifications and test data; and 749
• product identification should remain on the traceable item or attached to it until 750 the traceable item is consumed, returned or destroyed. 751
752 5.6 Understanding the Role of Consumers 753 754
5.6.1. General 755 756
Suppliers should obtain information from consumers and should provide information to 757 them so that they have a better understanding of their role in consumer product safety. 758 This occurs in two ways. First, suppliers should understand the decisions and actions 759 taken by consumers during purchasing, assembling, using, storing, and maintaining a 760 consumer product because these consumer actions may have a significant impact on 761 whether or not the product causes harm. Second, suppliers should provide product 762 information to consumers that will enable them to make good decisions during the 763 purchase, use, assembly, maintenance, and disposal of the product. 764 765
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?
ISO CD 10377
16
5.6.2. Pre-Purchase 766 767
Suppliers should provide sufficient information to consumers that will allow them to 768 make informed purchasing decisions based on the safety features of the product. This 769 may include labeling or advertising that addresses product use. Examples of topics 770 addressed in labeling or advertising are age-appropriate use, potential choking, noise, 771 suffocation, product contents, or other product hazards. Also, suppliers should identify 772 their name and address on the product packaging. Suppliers should be aware of laws 773 and regulations that require particular labeling or advertising in the jurisdiction where 774 their product will be sold. 775 776 5.6.3. Pre-Use 777 778
Consumers should examine their products prior to use to ensure obvious safety hazards 779 are not present. Suppliers should provide consumers with information along with the 780 product that warns and instructs consumers about predictable use and predictable 781 misuse. 782 783
5.6.4. Use 784 785
Consumers should follow instructions for assembly, use, maintenance, storage, and 786 disposal. Consumers also should heed warnings about the product and use the 787 product as intended by the supplier. Consumers also should comply with the limits 788 on the length of time that a consumer product can be used. Suppliers can assist 789 consumers in these actions by ensuring that instructions are clear and complete and 790 by providing special instructions, where necessary. Suppliers should ensure the 791 durability and availability of this information by: 792
• printing it on the product and on the package as space allows; 793 • including package inserts or other materials distributed with the product; and 794 • providing information through a website or through a telephone contact centre. 795
796 5.6.5. Post-Use 797 798
Suppliers should obtain information from consumers about their use of the product. 799 Examples where this information may be obtained include consumer feedback during 800 marketing, consumer complaints to the supplier, consumer information provided during 801 claims and lawsuits, and consumer reports made to regulatory bodies. Suppliers should 802 catalog this consumer information for use during the Continuous Improvement of the 803 product. (See 5.3) Consumers should be proactive in reporting consumer product 804 safety hazards and safety incidents and in participating in product recall procedures. 805 Suppliers may assist consumers in providing information about product use by providing 806 clear instructions on how to report incidents to the supplier and how to detect potential 807 safety hazards. For example, suppliers should encourage consumers to fill out warranty 808 cards and provide information about national and international product recall and data 809 base websites. 810
811 5.6.6. Vulnerable Consumers 812 813
Certain consumer groups may not be able to fulfill their responsibilities and 814 participate in consumer product safety initiatives or provide feedback about their 815 product use. For example, consumers experiencing low levels of literacy, children or 816 the elderly may be unable to understand written instructions, warnings, and symbols. 817 Low income or isolated consumers may not have access to internet or 818 telecommunication that would connect them with government or supplier product 819 safety initiatives. Suppliers should work with government officials and civil society 820
ISO CD 10377
17
groups to help these vulnerable consumers understand and participate in providing 821 feedback about their product use. 822
823 6. Safety in Product Design 824
825 6.1. General 826 827 Safety should be a primary concern at every step in the supply chain, especially at the 828 beginning of the process where consumer product design specifications are developed. 829 Lack of consumer product safety considerations at the design state leads to many 830 product safety failures. It is the responsibility of the Organization to ensure safety in 831 product design, recognizing that design defects are highly preventable. 832 833 6.2 Design specification 834 835 The design specification is a critical element to ensure the safety of products and is 836 comprised of the following items, including but not limited to: 837
• drawings; 838 • description of product; 839 • a bill of materials; 840 • components and parts listing; 841 • raw material selection and sourcing; 842 • model name/ number and additional traceability information; 843 • features, functions, or characteristics of the product 844 • product instructions and warnings; and 845 • compliance with mandatory safety requirements. 846
847 The entire life cycle of the product leading to design specification should take into 848 account the following: 849
• product life expectancy; 850 • environmental factors such as climatic conditions; 851 • packaging; 852 • transportation to market and storage; 853 • post-use disposal; and 854 • end of life failure in a safe manner. 855
856 The safety-related considerations that contribute to the design specification should 857 include, but are not limited to the following activities: 858
• description of product; 859 • intended use; 860 • predictable user behaviour; 861 • exposure analysis; 862 • hazards identification and characterization; 863 • risk assessment evaluation; 864 • risk reduction ; and 865 • risk communication. 866 867
For the purpose of accurate and confident decision making, the organization should 868 undertake market intelligence, gathering and analyzing information to identify the 869 markets to be targeted for its product, the potential users, and the sources and 870 suppliers of raw materials, components and parts. 871 872
873
ISO CD 10377
18
6.3 Safety Considerations in Design 874 875 6.3.1 Predictable Use 876 877 The supplier should predict the intended use of a product based on the supplier’s 878 actual knowledge. Actual knowledge of intended use held by the supplier is derived 879 from the following sources, such as: 880
• use of a product consistent with its function and design, including its technical 881 data on the function and design of the product; 882
• use of a product based on factual human behaviour, (e.g., a young child 883 placing all toys in his/her mouth) or measurements of the human body (; e.g., a 884 child’s head is trapped between the bars of a crib because of the size of the 885 child’s head); 886
• use of a product based on feedback from consumers, including their claims, 887 returns warranties, repairs, lawsuits, etc; 888
• use of a product based on the institutional knowledge of the supplier (e.g. 889 actual knowledge held by the supplier and accumulated over many years); 890
• use of the product that is consistent with the laws and regulations in the 891 location where the product will be used; and 892
• use of a product that is consistent with industry knowledge for that particular 893 product. 894
895 6.3.2. Predictable Misuse 896 897 A supplier should predict the misuse of a product based on the supplier’s actual 898 knowledge. Actual knowledge of misuse that is held by the supplier is derived from 899 the following sources, such as: 900
• use of a product based on factual human behaviour or measurements of the 901 human body (e.g. children, elderly); 902
• use of a product based on feedback from consumers, including their claims, 903 returns, warranties, repairs, lawsuits, etc. and 904
• demographics information from marketing and consumer trends; 905 • use of a product based on the institutional knowledge of the supplier; and 906 • use of a product that is consistent with industry knowledge for that particular 907
product. 908 909 6.3.3 Unpredictable Misuse 910 911
A supplier cannot predict the use of a product that is not known by the supplier, 912 however, suppliers should ensure feedback from the field and this feedback should 913 be monitored and tabulated to ensure there are no repeatable patterns. 914 915 6.3.4 Exposure analysis 916
917 The Organization should conduct an exposure analysis 918 to determine the likely user population and their exposure to the product taking into 919 account the following: 920
• Who are the possible users of the product, and who could come into contact 921 with it – intended users, potential users, unintended users, vulnerable users? 922
• What are the physical capabilities and psychological characteristics of the 923 users such as strength, motor skills, experience, and physical dimensions? 924
• What is the duration that users may be in contact with or exposed to the 925 product? 926
ISO CD 10377
19
• What is the critical path to injury by taking a step-by-step approach to identify 927 all possible scenarios that may lead to incidents or adverse effects? 928
• How likely is each product hazard to actually happen? 929 • How obvious is the hazard to the user? For example, the blade on a sharp 930
knife or a sharp metal edge inside a child’s toy. 931 • Are there cumulative, long term risks such as those that may be associated 932
with chemical products or additives? 933 934
NOTE: When determining the needs, physical and psychological characteristics of 935 vulnerable users. Reference should be made to the following documents. 936 937 ISO/IEC Guide 50 50:2002 - Safety aspects - Guidelines for child safety 938 939 ISO/IEC Guide 71:2001 - Guidelines for standards developers to address the needs 940 of older persons and persons with disabilities 941 942
6.3.5 Hazard identification 943 944
Hazard identification aims at gaining insight about the product regarding potential 945 hazards that may result in injury. 946 947 Hazard identification refers to the identification of all potential hazards associated 948 with the product, its components and packaging. This can be assessed through 949 various types of analysis such as Scenario Analysis, Fault Tree Analysis (FTA), 950 Failure Mode and Effects Analysis (FMEA), Failure Mode, Effects and Criticality 951 Analysis (FMECA), or Event Tree Analysis (ETA). Sources of information on the 952 different types of analysis can be found in Annex C. 953
954 Data and information for hazard identification may come from various sources such 955 as: 956
• consumer complaints and returns from similar products; 957 • incident reports, and injury data, and analysis of data bases; 958 • recall data from various government and independent sources; 959 • requirements in regulations and international, national and industry standards; 960 • product or raw material test reports or certificates, as appropriate; 961 • independent industrial, expert and scientific advice; 962 • relevant ergonomic principles; and 963 • other sources of information related to the product and similar products. 964
965 A list of potential hazards is presented in Annex B: Informative List of Common 966 Hazards. 967 968 When identifying the potential sources of machinery-related hazards (e.g. power 969 tools, lawn mowers), reference can be made to the following international standard: 970 ISO/FDIS 12100: 12000 Safety of machinery – General Principles for design – Risk 971 Assessment and risk reduction 972
973 6.3.6 Risk Evaluation 974
975 This standard refers to risk evaluation in many places. It should not intimate users 976 as risk evaluation is just a logical evaluation of any hazards that a product may pose, 977 determining how likely a consumer or user will be exposed to them, and how severe 978 any harm that may result will be. In some instances but not all, it may require 979 research or obtaining knowledge and expertise to help with the evaluation. 980
ISO CD 10377
20
The Organization should use the exposure analysis and hazard identification during 981 the process to evaluate the potential risk level. In evaluating the elements 982 associated with risk, the following should be considered: 983
• the type of hazard; 984 • the severity of harm caused by the hazard; and 985 • probability of exposure including number of and/or vulnerability of those 986
exposed as well as technical and/or human ability to avoid or limit the harm. 987 988
The Organization should establish a process for conducting risk evaluation when it is 989 determined that there is a hazard posed which has the potential to cause harm as 990 described in 6.3.5. The risk evaluation process will generally include the following 991 steps: 992
• evaluate the type of injury that may occur and the corresponding severity, level 993 such as, fatal vs. non-fatal, serious vs. minor injury; 994
• estimate the probability of the harm occurring taking in to consideration 995 consumer behaviour and the frequency and duration of use of the product; 996
• estimate the risk to each of the identified user groups from the hazards 997 identified; 998
• conduct a sensitivity analysis to see if the level of risk is impacted by changes 999 in assumptions or probabilities; 1000
• document the risk evaluation; 1001 • have experts in the field check the application of the risk evaluation method 1002
and conclusions reached; and 1003 • if the risk is not tolerable, then continue with risk reduction by redesigning the 1004
product or by providing protective measures against the hazard. 1005 1006
Figure 5 below illustrates the risk evaluation process while in Annex B a list of 1007 potential common hazards is presented and Annex C provides sources of 1008 information for methods that provide guidance on quantifying the severity of injuries. 1009 1010
ISO CD 10377
21
1011 1012
1013
Figure 4. Schematic Flow of Risk Evaluation by the Organization (Based on EU Risk 1014 Assessment Guidelines for non-food Consumer Products 1015
1016
1017
ISO CD 10377
22
6.3.7 Risk Treatment 1018 1019
The ultimate goal of carrying out a risk evaluation is to enable 1020 the Organization to determine how best to reduce the risk and 1021 what action needs to be taken. The Organization should 1022 compare the risk evaluation results against what is determined 1023 to be tolerable risk with consideration of social and public 1024 benefit. If a tolerable risk is not achieved, it may be necessary 1025 to take further steps to reduce the risk to a tolerable level. If the 1026 risk cannot be reduced to a tolerable or acceptable level, the 1027 product should not be permitted to reach the marketplace. The 1028 options to reduce or eliminate the risk may include: 1029
• examining the risk evaluation (hazard identification and 1030 exposure to determine which aspects of the product are 1031 contributing to the risk; 1032
• evaluating the extent to which the treatment options 1033 will reduce the risk; 1034
• incorporating protective measures into the product at 1035 the design stage e.g. adding a protective cover to a 1036 table saw; 1037
• reducing risk by providing users with safe use 1038 information through the provision of instructions for use, 1039 assembly and maintenance; and warnings and labels; 1040 only if incorporating protective measures into the 1041 product at the design stage cannot eliminate residual 1042 risk; 1043
• weighing the costs and benefits of each option, in order 1044 to select the most appropriate option to implement; and 1045
• the risk reduction action could range from redesigning 1046 the product to preventing it from reaching the market, if 1047 the risk cannot be managed appropriately or reduced to 1048 a tolerable level. 1049
1050 Figure 5: Risk Reduction Process of Organization 1051 1052 1053
1054
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
ISO CD 10377
23
6.3.8 Risk Communication 1055 1056
Warnings are an integral part of managing product risks. Organizations should give 1057 warnings about a product where the risks it presents cannot be reduced or 1058 eliminated and where use of the product based on predictable user behavior will 1059 present risks to the health or safety of consumers. Warnings are brief safety 1060 messages about the existence, nature, form, or severity of product hazard that could 1061 adversely affect health and safety of the user. The content of a warning must 1062 describe the product hazard, the harm presented by the hazard, and the 1063 consequences if the harm is not avoided. Each product hazard should be 1064 presented in a separate warning. Effective warnings attract attention by using signal 1065 words, safety alert symbols, and a font in a type size and color that is suitable to the 1066 product hazard. Warnings should be placed on the product in labels that are 1067 durable, in product manuals, in safety data sheets, and on organization websites. 1068 1069 Instructions also are integral to the safe use of a product. Organizations should 1070 provide product users with instructions about the use, assembly, maintenance, and 1071 disposal of the product. The content of an instruction should give product users the 1072 means to avoid a harm presented by a product hazard that has not been reduced or 1073 eliminated and directions to avoid the misuse of the product. For example, “Do not 1074 use the camping lantern inside a tent.” Instructions may also give direction about 1075 remedial action if the product is misused such as ingesting bleach. Instructions and 1076 warnings with safety messages about product hazards should be written and 1077 presented separately to avoid confusing directions about product use. 1078 1079 Other considerations that may govern the content or presentation of a warning or 1080 instruction include: 1081
• safety messages required by a law or regulation; 1082 • industry standards that give specific guidance about the risk associated with a 1083
product or its use; 1084 • other languages in which the warning or instruction should also be given; 1085 • the ability of vulnerable consumers to read and understand the warnings (e.g. 1086
children and elderly); 1087 • the location where warnings should be placed on the product; 1088 • the prominence of warnings in the product manual; 1089 • symbols that should be used in product warnings; 1090 • obtaining feedback from a focus group about the content of the warning or 1091
instruction; and 1092 • whether the product’s technology (e.g. software) should provide warnings or 1093
instructions to the user. 1094 1095
NOTE: Where there are no identified regulatory requirements for labelling or 1096 instructions refer to labelling standards. 1097
1098 ISO/IEC Guide 14, 2003 - Purchase information on goods and services intended for 1099 consumers 1100 1101 ISO/IEC Guide 37, 1995 - Instructions for use of products of consumer interest 1102 1103 ISO/IEC Guide 74, 2004 - Graphical symbols — Technical guidelines for the 1104 consideration of consumers' need 1105
1106 ISO 3864, 2002 - Graphical Symbols - Safety Colours and Safety Signs Package 1107
ISO CD 10377
24
6.4 Documenting the Design Specification Process 1108 1109 Documentation of the design specification process is important to demonstrate both 1110 that it was done and how it was done. It is important to document the history of the 1111 product design and development, including evolution of the product design, the history 1112 of other similar products and history of incidents or problems with the product or similar 1113 products. By creating, maintaining and updating these documents the Organization can 1114 ensure that information is available to be used during subsequent risk evaluation 1115 activities and for traceability, product redesign, and legal and regulatory compliance. 1116 1117 Thus, the Organization should establish and maintain procedures to record, control, 1118 retain, and retrieve all principal documents and data related to safety in design, 1119 production, and the marketplace. These should include: 1120
• records arising from the implementation of this standard; 1121 • documents created during Safety in Design, such as; 1122
o risk assessment including data and information used, 1123 o significant design choices and safety decisions, 1124 o drawings, specifications, and Bill of Materials, 1125 o product quality and safety tests and approved product samples, 1126 o validation of the design, 1127 o warnings and instructions, 1128 o design testing and inspection, 1129 o cost-benefit analysis of corrective action options, 1130 o compliance with regulatory requirements and product specific industry 1131
standards, and 1132 o third-party testing and conformity assessment , as required; and 1133
• the options considered and actions taken to reduce or eliminate any risk. 1134 1135
7. Safety in Production 1136 1137 7.1. Basic Principles during Production 1138 1139 The identification and reduction of product safety risks during production will reduce 1140 total cost, improve efficiency, and advance the overall safety and quality of the final 1141 products. Safety should be a major concern during all aspects of production, including 1142 Production Planning, Production Runs, Post-Production, and Production Support. This 1143 section provides guidance about integrating steps into these phases of production and 1144 establishing a culture of product safety resulting in reduced risks to consumers. 1145 1146
1147 1148
7.1.1. Developing a Culture of Product Safety in the Production Facility 1149 1150
Developing a product safety culture in a multi-constituent supply chain will improve 1151 product safety. A product safety culture requires organizations to go beyond 1152
ISO CD 10377
25
traditional concepts in the design, prototyping, testing, inspection and training 1153 approaches to one where rapidly identifying, managing and mitigating risks in 1154 product safety are of paramount importance. The developing of a product safety 1155 culture should be a priority within the organization and the following practices give 1156 evidence of this: 1157
• know the risks associated with the products they handle and how those should 1158 be managed; 1159
• dedicate resources to evaluate supplier practices; 1160 • stay up-to-date on emerging product safety issues; 1161 • foster a value system within the organization that focuses on avoiding any 1162
possible injuries or harm as a result of using the company’s products; 1163 • communicate compelling and relevant messages about risk reduction 1164
activities, and empower others to put them into practice; 1165 • promote effective product safety systems before an incident occurs; 1166 • don't blame customers, including commercial buyers and consumers, when 1167
illnesses are linked to their products; and 1168 • involvement in standardization work in matters related with consumer product 1169
safety (e.g.: at level of technical committees and national mirror committees) 1170 1171
7.1.2 Minimize or Reduce Product Defects 1172 1173 Defects and the introduction of hazards that affect the safety of products may occur 1174 during production and are preventable. The Organisation should ensure that actions 1175 necessary to reduce or eliminate product defects are incorporated into every step of 1176 production. Examples of actions that could be taken include identifying and 1177 controlling the critical steps in the production process such as annealing temperature 1178 of glass, torque of screws, or the hygiene standards in the facility. 1179 1180 7.1.3. Commitment to Product Safety 1181
1182 The Organization should ensure that all necessary facets of product safety, including 1183 training, exist during and for all phases of its production process. Equally important, 1184 the Organization should ensure that its supply chain providers of raw materials, 1185 components, and subassemblies have incorporated all necessary facets of product 1186 safety into their individual production practices. 1187 1188 7.1.4. Best Manufacturing Practices 1189 1190 The Organization should follow industry’s Best Manufacturing Practices (BMP) 1191 during production of consumer products. These are practices that provide continual 1192 measures of safety and quality that can uncover problems due to inconsistency and 1193 fluctuations in the production process as they occur and before the product is 1194 shipped. Thus, BMPs are a more immediate and consistent way to ensure that they 1195 meet the design specifications. 1196 1197
7.2. Production Planning 1198 1199 Planning before production begins will remove product defects during production. A 1200 production facility should plan its production before the start of manufacturing by 1201 validating the final design and preparing for actual production. These steps should be 1202 performed regardless whether the product is being produced for the first time or has 1203 had prior production runs at the production facility. 1204 1205 1206
ISO CD 10377
26
7.2.1. Design validation 1207 1208
The final design and the safety of the product should be confirmed before production 1209 begins. The production facility should prepare a prototype, confirm the final design, 1210 confirm the product’s specifications, and confirm the items provided by the 1211 production facility’s supply chain. The production facility should confirm that the 1212 product can be produced on a mass scale. Depending on these confirmations, 1213 further modification of the final design may be necessary before production begins. 1214
1215 7.2.1.1. Prototype for production 1216 1217 The production facility may wish to produce a prototype to test the ability of the 1218 production facility to manufacture the final product. This prototype is useful to test 1219 the assumptions made about the product, its safe design, its final assembly, and 1220 the production facility’s ability to produce it. The prototype should be validated by 1221 the customer, if possible. 1222 1223 7.2.1.2. Validate with Customer 1224
1225 The production facility should validate the design that will be used in the 1226 production run with the customer. Evaluation may result in the identification of a 1227 safety problem that may generate a change order to deal with a safety problem. If 1228 possible validate the prototype with customers. 1229
1230 7.2.1.3. Specifications 1231
1232 The production facility should have the product’s specifications, which would 1233 include the final design, performance criteria, the material requirements for 1234 production, the raw materials, the components, the subassemblies (if any), the bill 1235 of materials (if any), assembly requirements, final testing, packaging, and 1236 labelling. 1237
1238 7.2.1.4. Supply Chain 1239
1240 The availability of approved raw materials, components, and subassemblies is 1241 critical. Organisations should validate that the items provided by its supply chain 1242 match the product specifications. Further, the Organisation should confirm that 1243 raw materials, components, or subassemblies meet the design specifications and 1244 are not at their end-of-life or are unapproved replacements before production 1245 begins. Finally, it is critical that the product produced accurately reflects the 1246 tested and approved prototype in all aspects including its component parts. 1247
1248 7.2.2. Production Readiness 1249
1250 7.2.2.1. Supply Chain Management 1251
1252 The Organisation should determine the final choice of approved raw materials, 1253 components, or subassemblies to be used in the product. The production facility 1254 should ensure that the raw material, component, or subassembly suppliers 1255 understand that unapproved raw materials or components or any changes are 1256 unacceptable unless approved by the Organization. Also, the production facility 1257 should ensure the supply chain can provide a consistent and uninterrupted supply 1258 of the raw materials and components required to produce the product. 1259
1260 1261
ISO CD 10377
27
7.2.2.2. Tooling 1262 1263
Depending on the product being produced, the production facility will need to 1264 ensure they have the adequate tools necessary for production, including the 1265 physical setup within the production facility, specialized machinery, specialized 1266 equipment, moulds, fabricators, and specialized skills among its staff. It should 1267 define and monitor essential aspects that can affect the safety of the products 1268 produced such as the critical tolerances, wear on tools, operator actions. 1269
1270 7.2.2.3. Processes, Controls, and Measures 1271
1272 Production facilities should establish processes, controls, and measures during 1273 production that are consistent for the production of safe products. It is important 1274 that these be recorded in its documents to demonstrate that the production facility 1275 meets the agreed to safety requirements. Facilities should ensure that 1276 employees are aware of the processes, controls, and measures. 1277
1278 7.2.2.4. Commissioning the Production Facility 1279
1280 The size, ability, process, controls and measures being in place allow a 1281 production facility to be ready for production of a safe product. 1282
1283 7.2.2.5. Training 1284 1285 Production facilities should ensure employees are trained on existing processes, 1286 controls and measures to ensure products are being produced consistently to 1287 meet the product safety culture. Training may require documentation of 1288 processes, staff certification, and staff training. 1289
1290 7.2.2.6. Product Specifications 1291 1292 The production facility should have in its possession the final product 1293 specifications identified in 7.2.1.3. 1294 1295
7.3. Production Runs 1296 1297
Safety in the final product also occurs during the production run. This occurs by the 1298 production facility controlling all parts of the product during actual production including 1299 the raw materials, components, subassemblies, accessories, packaging, warnings, 1300 instructions, and manuals. 1301
1302 7.3.1. Raw Materials, Components, and Subassemblies 1303
1304 Upon receipt by the production facility, every batch of incoming raw materials, 1305 components, and subassemblies should be validated to comply with the product’s 1306 design specifications. Raw materials, components, and subassemblies accepted by 1307 the production facility should be introduced into its production facility inventory, 1308 managed, and traced to identify their source, batch, lot, and date. Raw materials, 1309 components and subassemblies not meeting the specifications should be 1310 segregated to ensure that they are not mixed with acceptable material. 1311 1312 1313 1314 1315
ISO CD 10377
28
7.3.2. Production 1316 1317
7.3.2.1. Production Scheduling 1318 1319
The scheduling of production provides efficiency, cost savings, and planning to 1320 produce a final safe product. 1321
1322 7.3.2.2. Production Consistency. 1323 1324 A production facility must produce final products that are consistent from a safety 1325 and quality perspective across one or multiple production runs. 1326
1327 7.3.2.3. Production Quality Monitoring 1328
1329 Monitoring of production quality assures safety has been integrated into the final 1330 product based on the design, materials, and production planning. Production 1331 monitoring may be included as part of the responsibility of the facility’s production 1332 staff, but the production monitoring processes and execution should be the 1333 responsibility of quality staff assigned to the production floor. Production 1334 monitoring staff should have established the sampling rate for each production 1335 run, and document the monitoring. Production monitoring staff should have the 1336 ability to stop production if an unacceptable number of failures have been 1337 identified. Production monitoring includes inspections and product testing and 1338 should also include the sampling of the product, the manuals and packaging. 1339
1340 7.3.2.4. Finished Product Testing 1341 1342 Finished product (or batch) testing is integral to assuring the safety of the final 1343 product. It includes the complete testing of the finished product and validation of 1344 its manual, labels and packaging to the product specifications. Conformity 1345 Assessment bodies and test laboratories can assist production facilities in 1346 demonstrating that all reasonable steps have been taken to produce a complying 1347 product. 1348
1349 7.4. Post Production 1350 1351 The production facility should consider the logistics of getting the product from their 1352 facilities to their customers. If not carried out properly, it could result in damage or the 1353 introduction of hazards (everything from shipment damage as a result of suboptimal 1354 packaging, packing, transporting, storing, to hazards in the form of biological (moulds) 1355 and chemical). Consideration should be given to these items, such as: 1356
• master carton and shipment ready packaging; 1357 • reviewing customer logistics requirements including security, product integrity, 1358
etc.; and 1359 • developing a logistics plan. 1360
1361 The production facility and the customer should have a shared understanding of the 1362 logistics plan to transfer the product from the facility to the end consumer without being 1363 damaged. With this understanding, the facility and customer should monitor the 1364 transfer to ensure any changes from the plan do not introduce new problems or safety 1365 risks into the product. 1366 1367 1368 1369
1370
ISO CD 10377
29
7.5. Production Support 1371 1372
The production support function in a production facility is part of the administration arm 1373 of the facility’s production floor. 1374
1375 7.5.1. Audits 1376
1377 The production facility could be audited by various stakeholders (conformity 1378 assessment bodies, customers, etc.). Production support would facilitate these 1379 audits, capturing any input for the continuous improvement of the product and 1380 processes. 1381
1382 7.5.2. Regulations and Laws 1383
1384 Production support ensures the production facility knows the standards, laws, and 1385 regulations required for the jurisdictions where the products will be manufactured or 1386 sold. They should ensure that the final products meet those standards, laws, and 1387 regulations. 1388
1389 7.5.3. Risk-based testing 1390
1391 Testing conducted by the production facility, conformity assessment bodies and 1392 customers identify opportunities for continuous improvement of products. 1393 Production support should ensure that risk reduction or corrective actions arising 1394 from product testing are executed and fed back to the organization and through the 1395 supply chain. 1396
1397 7.5.4. Documentation 1398
1399 Documentation and record keeping is important to the integrity of the production 1400 facility and its processes to ensure consistency, as described in 5.2.3. 1401
1402 8. Safety in the Marketplace 1403
1404 8.1. General 1405
1406 To improve consumer product safety, suppliers should conduct pre-purchase 1407 confirmation, proactive data collection and ongoing product assessment. 1408 1409 8.2. Pre-Purchase Assessment 1410
1411 Prior to acceptance, suppliers should confirm that the product ordered meets their 1412 requirements in terms of: 1413
• safety for targeted consumers, vulnerable consumers (e.g. children and elderly) 1414 and those who may be exposed; 1415
• quality attributes that relate to safety; 1416 • compliance with regulations and standards; and 1417 • suitability for the environment, targeted users and marketplace. 1418 1419
The right to verify the product meets requirements should be included in the contract 1420 that was reached prior to the Production stage. In addition, product specifications 1421 should be communicated and agreed to during the design stage. Product specifications 1422 should include elements such as: 1423
• in which marketplace the product will be sold; 1424
ISO CD 10377
30
• the environment, such as an office, nursery, and residential home, where the 1425 product would be used; and 1426
• who the users of the product will be such as age range and capability. 1427 1428
Compliance can be verified by such means as follows: 1429 • obtaining data from the supplier that the product meets specifications, the 1430
applicable laws and standards and how the compliance was determined. 1431 Confirmation can take the form of test criteria and test results generated by 1432 internal facilities or third party independent laboratories, and where required, 1433 certification results from third party certification bodies. 1434
• writing specific contracts that include the safety, quality and the applicable 1435 regulatory compliance requirements for where the products are intended to be 1436 manufactured, sold and used. Contracts should also give the supplier the right to 1437 verify, require proof of compliance, and hold the other members of the supply 1438 chain accountable for correction of non-compliant products. 1439
• reviewing the compliance history of the supplier of the product and the product’s 1440 history of reported incidents, recalls, lawsuits and consumer complaints. 1441 evaluating through sampling and testing. Testing should be done to the test 1442 criteria agreed to during the Safety in Design stage and in accordance with 1443 applicable regulatory requirements. 1444
• evaluating through Inspection. An alternative or complement to product testing is 1445 product inspection, where the product is visually inspected to ensure the 1446 requirements are being met, and necessary safety certification has been 1447 completed. and 1448
• auditing of documentation provided by the supplier of the product can be used as 1449 a complement to or as an alternative to testing or inspecting. The documentation 1450 supplied should present evidence that demonstrates conformance of the product 1451 to the requirements. This would include test reports, inspection reports and 1452 certification documentation. 1453
1454 8.3 Proactive Data Collection and Analysis 1455
1456 Data collection and analysis provides a supplier with the information necessary to 1457 identify trends in product safety, from information such as defects, return rates, repairs, 1458 product incidents, customer complaints and lawsuits. Proactive data collection and 1459 analysis is also valuable as feedback for the risk reduction and continuous 1460 improvement processes. Data collection and analysis may also be required by some 1461 government regulations. 1462 1463 The supplier should establish processes for data collection and analysis by means such 1464 as: 1465
• establishing, communicating and promoting a consumer complaint system which 1466 is a systematic way of obtaining information on how consumers use products, 1467 failure modes and defects, and opportunities to improve the product; 1468
1469 NOTE: See ISO 10002, 2004: Quality Management Customer satisfaction 1470 Guidelines for complaint handling in organizations. 1471 1472 • products and service records which involves reviewing and analyzing the reason 1473
for products being returned and serviced; and 1474 • new data should be used to constantly update the understanding of risks inherent 1475
in a product and how to reduce them. 1476 1477
ISO CD 10377
31
In accordance with ISO 10393: Guidance standard on Consumer product recall and 1478 corrective action: Code of good practice, suppliers should establish a process for 1479 documenting and investigating incidents and defects involving the product. 1480
1481 8.4 Ongoing Assessment of Product Conformance 1482
1483 Suppliers should verify conformance on an ongoing basis. Ongoing assessment helps 1484 to reduce the risks to the health and safety of consumers from variations introduced 1485 during multiple productions runs, from the use of multiple production lines and from 1486 using multiple factories. 1487
1488 Suppliers can assess the product after it enters the marketplace by means such as 1489 those outlined below. 1490
1491 • Obtaining products from the marketplace. Collecting samples for ongoing 1492
assessment as close as possible to or directly from the source where a 1493 consumer would purchase the product helps to identify and reduce any risks that 1494 may have been introduced through the supply chain during transportation, 1495 storage and handling. 1496
1497 • Verifying compliance of the samples with specifications. As part of auditing 1498
documentation, compliance with requirements can be verified by assessing 1499 product samples against the product specifications utilized by the manufacturer. 1500
1501 • Conducting customer satisfaction surveys. 1502 1503 • Analyzing consumer data from various sources including product returns, 1504
websites, call centres, in-store feedback, and social media. 1505 1506 • Establishing a feedback loop through the Organization and the supply chain that 1507
data relevant to the products compliance is captured such production line and 1508 quality control audits. 1509
1510 • Conducting factory surveillance at a frequency determined by product risk and 1511
compliance history of the factory. 1512 1513
8.5. Warranty and Servicing 1514 1515
Products require continued support after being sold to the end user, including warranty, 1516 servicing, parts, responding to customer service claims, and liability claims. 1517 1518 8.6. Product Incident Investigation 1519 1520 Establish a process for documenting and investigating incidents and defects involving 1521 the product. Reference should be made to ISO 10393: Guidance standard on 1522 Consumer Product Recall and Corrective Action: Code of Good Practice and Annex A, 1523 Clause A.4 on product incident investigation. 1524
1525 1526
ISO CD 10377
32
Annex A (Informative): Information and Guidance for Small Businesses 1527 1528
A.1. General 1529 1530
This International Standard is intended for organizations of all sizes. However it is 1531 recognized that many small organizations will have limited experience or resources: 1532
• to identify hazards and the cause of the hazards in products; 1533 • to evaluate risks; and 1534 • to establish the procedures and policies that will assist them in meeting 1535
mandatory legal requirements and best practices to supply safe consumer 1536 products. 1537 1538
The purpose of this Annex is to provide such information and examples to assist 1539 suppliers in implementing the guidance outlined in this standard. 1540 1541 A.2. Questions for suppliers to consider when designing, producing or 1542
supplying consumer products. 1543 1544
A.2.1. General Questions 1545 1546 • Do my staff or external contractors have the necessary education, training, 1547
technical knowledge and experience for carrying out their responsibilities related 1548 to consumer product safety? 1549
• Have I allocated enough financial and human resources to design, produce or 1550 supply safe consumer products? 1551
• Does my company have a system in place to record retain, retrieve and analyze 1552 information received from incidents, complaints, service records, and test reports, 1553 complaints and incidents? 1554
• Does my company know and understand the laws, regulations and standards 1555 with which my product(s) must comply in the country where the product will be 1556 manufactured or sold? 1557
• Does my company know the traceability regulations or standards of the countries 1558 to which my products will be distributed? 1559
• Does my company know the traceability requirements of the other members of 1560 the supply chain involved with my product? 1561
• Are all the product components or products distributed by the supplier, which 1562 need to be traced, identified with a globally unique identification and a 1563 description? 1564 1565
A.2.2. Questions Related to Design 1566 1567 • Do my staff or external contractors have the necessary education, training, 1568
technical knowledge and experience to identify the potential hazards in a product 1569 design, to evaluate the potential risks and to determine what changes need to be 1570 made to the design to remove the risk? 1571
• Who are the possible users of the product, and who could come into contact with 1572 it – intended users, potential users, unintended users, vulnerable users? 1573
• What are the physical capabilities and psychological characteristics of the users 1574 such as strength, motor skills, experience, and physical dimensions? 1575
• What potential hazards may be associated with the product? (In other words, try 1576 to anticipate everything about your product that could go wrong or be dangerous 1577 to the eventual user – its hazards.) 1578
• Will the user actually be exposed to the hazard? E.g. a sharp edge in a product 1579 may not be accessible to the user. 1580
ISO CD 10377
33
• What is the duration that users may be in contact with or exposed to the hazard 1581 associated with the product? 1582
• What possible injuries may be caused by each of the hazards identified? 1583 • How serious could the injuries or harm be for each of the hazards identified? 1584 • How likely is each product hazard to actually happen? 1585 • Does my company have in place the staff and a process to evaluate the risk 1586
associated with the hazards? 1587 • If the risk is not acceptable, can it be reduced by changing the design of the 1588
product to eliminate the cause of the hazard? 1589 • If the design cannot be changed to reduce the risk, can the risk be reduced by 1590
adding protective devices such as a guard on a power saw? 1591 • Can any risk that remains be addressed through information or warnings to the 1592
consumer or user? 1593 1594 A.2.3. Questions Related to Production 1595 1596 • Is the product design specification faulty and result in an unsafe or illegal 1597
product? 1598 • Did the product designer carry out and provide a copy of a risk assessment? 1599 • Is it possible for the production facility to mass produce the product as designed? 1600 • Does my facility have the tools, processes, and trained employees needed to 1601
produce the product? 1602 • Does my facility have the tools and trained staff to maintain and calibrate the 1603
production equipment? 1604 • Do we have processes in place to prevent contamination of the product by 1605
chemical or biological agents? 1606 • Have the steps in the process that are critical to producing a safe product been 1607
identified? 1608 • Can suppliers provide a consistent and uninterrupted supply of the raw materials, 1609
components or subassemblies that are required to produce the product? 1610 • Do we have procedures in place to verify that the raw materials, components and 1611
subassemblies meet specifications? 1612 • Has a plan for testing of the product during production been established and 1613
implemented? 1614 • Will corrective actions arising from testing during production being executed? 1615 1616 A.2.4. Questions Related to the Marketplace 1617 1618 • Does the product ordered meet my company’s requirements for safety, quality, 1619
compliance with regulations, and suitability for consumers and the marketplace 1620 where I intend to distribute and/or sell the product? 1621
• Do I have confidence in the company who is producing and supplying the 1622 product? 1623
• Does my company have the right to verify that the product meets its 1624 requirements? 1625
• Has my company established processes to collect data from complaints, returns, 1626 service records and monitoring products in the marketplace? 1627
• Does my company have the ability to analyze the data collected? 1628 • Does my company know and understand the requirements for reporting of 1629
incidents and actions to correct defects that exist where I plan to distribute the 1630 product? 1631 1632 1633
ISO CD 10377
34
A.3. Hazard and Risk Evaluation 1634 1635 This standard refers to risk evaluation in many places. This should not intimidate users 1636 of the standard as risk evaluation is just the logical identification and evaluation of any 1637 hazards that a product may pose and determining how likely a consumer or user will be 1638 exposed to them. Once the potential hazards and their cause have been identified, it is 1639 then possible to determine the risk posed and if required redesign the product, or add 1640 protective devices before the product is produced or reaches the consumer. In some 1641 instances, but not all, it may require research or obtaining knowledge and expertise to 1642 help with the evaluation. 1643 1644 Illustrated below are a number of examples to illustrate how hazards such as those 1645 identified in Annex B are identified and are evaluated. 1646 1647
Hazard Scenario Evaluate Hazard injury Type Mechanical Hazard – sharp edges that are accessible to the body or part of the body
Child reaches through a small hole or guard with a hand or finger
Measure hole and compare against data on the size of children’s fingers at various ages. (anthroprometic data) to make sure a child’s finger will not fit in the hole
Cut, amputation,
Entrapment between moving parts, parts of structure or an opening
A child’s head is caught between crib slates of a crib. Fingers trapped between supports of a folding chair.
Data on size of children’s heads at different ages (Anthropometric data) Computer simulations
Crushing, strangulation, amputation
Stability Hazard – a product such as a clothes cabinet tips
The cabinet hits a person causing injury
The cabinet hits an electrical product which breaks and live electrical parts become exposed.
Stability test where drawers in the cabinet are loaded and opened
Bruising, fracture, concussion
Electrical shock, burn
Thermal – Hot surfaces
A child or person touches the surface and sustains a burn
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
ISO CD 10377
35
A.4. Example of Risk Level Evaluation: 1648 1649 Example of Risk Level from Probability of Damage and Severity of Injury (from EU 1650 Risk Assessment Guidelines for Non-food Products, Jan. 2010) 1651
1652
1653 A.5. Product Incident Investigation 1654 Establish a process for documenting and investigating reports of incidents and defects 1655 involving the product reference should be made to ISO 10393: Guidance standard on 1656 Consumer Product Recall and Corrective Action: Code of Good Practice. 1657
1658 • The Organization should make it easy for users of the product to file product 1659
incident reports. 1660 • Document the product incident or defect details, the investigation, the findings 1661
and the actions taken. 1662 • Assign competent staff to investigate the incident or defect, and check for trends. 1663
Determine if the incident or defect report is valid and if possible, acquire the 1664 product involved in actual incident for review. 1665
, 1666 1667 NOTE: Harm can be created directly or indirectly if the product does not 1668 function as intended e.g. Smoke alarm which fails to detect smoke. 1669 1670
• Provide regulators or competent authorities, certification bodies and other 1671 stakeholders with product incident and defect reports, the investigation findings 1672 and the actions taken at the frequency and level of detail required by legal and 1673 contractual requirements. 1674
• Perform a risk assessment if the evaluation identifies a harm or potential harm. 1675 • If the risk assessment concludes that corrective action is required, identify means 1676
to reduce the potential harm. Corrective actions include repair or rebuilding the 1677 product, removing the product from the marketplace, scrapping the product or 1678 conducting a product recall. 1679
• Identify the root cause for the defect that created the potential harm. 1680 • Identify and implement corrective actions to eliminate or reduce the reoccurrence 1681
of the defect. For example, depending on the level of risk, this can be 1682
ISO CD 10377
36
accomplished by redesign of the product to remove the potential harm, guarding 1683 against the potential harm or by informing the users of the potential harm. 1684
• Determine if the defect is common to other products and therefore, require that 1685 similar corrective actions be implemented. 1686
• Check to make sure that the corrective actions achieve the desired goal in 1687 reducing the potential for the defect to reoccur. 1688 1689
NOTE that the steps in the process should be carried out in parallel as much as 1690 possible rather than sequentially to reduce the time needed to reach a decision on 1691 the product’s potential to create harm and implement corrective actions. 1692
1693
ISO CD 10377
37
Annex B: Informative - List of Some Common Hazards 2 1694
1695 Biological Disease or other malady caused by living
microorganism. Contamination by insects, animals, plants.
Chemical 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.
Magnet 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.
1696
Physical/Mechanical
Abrasion Penetration injury of the skin caused by contact with a rough surface.
Adhesion Traumatic removal of skin that is attached to a product by an adhesive.
Avulsion Removal of tissue (example: teeth, nails, etc) by tearing.
Drowning Anoxia caused by obstructing the passage of air by submersion of mouth and nose in a fluid.
Entrapment 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.
Ergonomic strain Poor body mechanics during tasks can cause strains and fatigue in muscles, joints and tendons.
Explosion - chemical A release of chemical energy in a sudden and often violent manner, usually with the generation of high temperature and release of gases.
Explosion - mechanical A release of mechanical energy in a sudden and often violent manner.
Fall Injury caused by dropping down freely under the influence of gravity.
Foreign object insertion (non Objects lodged in ears or other non airway body
2 Provided by Xiao Chen and Gene Rider of Intertek on behalf of ANSI.
ISO CD 10377
38
airway) cavities.
Impact - Stationary Object (any injury involving stationary object other than fall)
The force or impetus transmitted to the body by a collision with an immobile object. May result in fracture or bruising.
Impact - Moving Object The force or impetus transmitted to the body by a collision from a moving object. May result in fracture or bruising.
Internal Airway Obstruction/Aspiration
Inhalation of a small object(s) into the airway. Injury may be acute (anoxia) or chronic (infection).
Internal Airway Obstruction/Choking
Objects lodged in the mouth or oral airway. May cause anoxia.
Internal Airway Obstruction/Ingestion Objects lodged in the esophagus. May cause anoxia.
Internal Airway Obstruction/Insertion
Objects lodged in the nasal passages. May lead to infection or aspiration.
Joint overextension (strain sprain etc.)
Damage to connective tissues caused by exceeding movement limitations of joints
Laceration Penetration injury of the skin caused by contact with a sharp edge.
Positional Asphyxia Anoxia caused by obstructing the passage of air through posture or chest compression.
Puncture Penetration injury of the skin caused by contact with a sharp point.
Repetitive Motion Frequently repeated tasks can cause strains and fatigue in muscles, joints and tendons.
Strangulation (neck) Anoxia caused by external pressure obstructing the passage of air through the airway or by preventing the flow of oxygenated blood to the brain.
Suffocation Anoxia caused by obstructing the passage of air by sealing the mouth and nose with an external object (example: plastic films, containers).
Vibration 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.
ISO CD 10377
39
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.
Interference with safe activity
Sensory distraction or masking leading to the creation of a hazard condition.
NIHL (Noise induced hearing loss)
Permanent or temporary complete or partial loss of hearing caused by exposure to noise.
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.
Radiation
Cell phone Radiation emitted by cell phones.
Direct (tissue damage) Damage to ocular tissue caused by intense visible light.
Indirect (glare, afterimage, flash blindness) Visible light that creates a hazard condition.
Infrared Electromagnetic radiation with wavelength between about 780 nm and 1 mm. Capable of damaging tissue through a thermal mechanism (burn).
Ionizing Radiation Electromagnetic radiation with wavelength shorter than ultraviolet (x rays, gamma rays), alpha particles, and beta particles capable of ejecting electrons from biological molecules.
Microwave Electromagnetic radiation with wavelength between about 1 mm and 1 meter. Capable of damaging tissue through heating or of interfering with implanted medical devices.
Photoepilepsy Seizure induced by flashing light.
Ultraviolet Electromagnetic radiation between about 100 nm and 400 nm. capable of causing tissue damage by photochemical effect.
Visible Light Light that people can see, between about 380 nm and 780 nm.
Wireless Radiation emitted by wireless networking equipment.
Other radiation Only radio waves are left. radiation with wavelength longer than about 1 meter.
ISO CD 10377
40
Thermal
Burns - Chemical Burn caused by a caustic or corrosive chemical contacting the skin.
Burns - Cold Burn caused by contact with a cold solid, liquid, or gas.
Burns - Thermal 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.
Flammability Easily ignited and capable of burning.
Smoke Inhalation Breathing of toxic smoke from burning materials or pulmonary injury resulting from breathing such smoke.
1697
1698
ISO CD 10377
41
Annex C: Informative, Sources of Information 1699 1700
C.1. Laws and Regulations 1701
• World Trade Organization Enquiry Points – 1702 www.wto.org/english/tratop_e/tbt_enquiry_points_e.htm#u 1703
• Australian Consumer Law, www.consumerlaw.gov.au 1704 • Commonwealth of Australia, Compliance and enforcement: How regulators 1705
enforce the Australian Consumer Law, 2010, 1706 • Canadian Consumer Product Safety Act, www.laws.justice.gc.ca/ 1707 • Canadian Packaging and Labeling Act, www.laws.justice.gc.ca/pdf/statute/C/C-1708
38.pdf 1709 • California Proposition 65 (Cal Prop 65), Health & Safety Code Sec. 25249.5; 22 1710
Cal. Code Regs § 25102 (June 2008). 1711 • European General Product Safety Directive (GPSD), 2001/95/EC, 1712
http://ec.europa.eu/consumers/safety/prod_legis/index_en.htm 1713 • European Parliament and Council, Directive 2009/48/EC of the European 1714
Parliament and of the Council of 18 June 2009 on the safety of toys, 1715 http://ec.europa.eu/enterprise/sectors/toys/documents/directives/index_en.htm 1716
• European Parliament and Council, Directive 2006/95/EC of the European 1717 Parliament and of the Council of 12 December 2006 on the harmonisation of the 1718 laws of Member States relating to electrical equipment designed for use within 1719 certain voltage limits. http://ec.europa.eu/enterprise/sectors/electrical/lvd 1720
• European Waste Electrical and Electronic Equipment (WEEE), 2002/96/E6. 1721 • European Registration, Evaluation, Authorization, and Restriction of Chemicals 1722
(REACH), EC 1907/2006, 1723 http://ec.europa.eu/environment/chemicals/reach/reach-intro.htm 1724
• European Machinery Safety Directive (MSD), 95/16/EC, and Guide to application 1725 of the Machinery Directive 2006/42/EC, 2nd Edition (June 2010), 1726 http://eu.europa.er/enterprise/sectors/mechanical/machinery/ 1727
• European Classification, Labeling, and Packaging of substances and mixtures 1728 (CLP), Regulation (EC) No. 1272/2008 (10 August 2009), and Guidance in the 1729 Application of the CLP criteria, European Chemicals Agency (2009). 1730
• European Commission, Health and Consumer Protection, Directorate – General. 1731 Notifications of Dangerous Products by Producers and Distributors, October 1732 2006. 1733 http://ec.europa.eu/consumers/cons_safe/prod_safe/gpsd/guidelines_en.htm 1734
• Japanese Consumer Product Safety Law, www.japaneselawtranslation.go.jp 1735 • Japanese Electrical Appliance and Material Safety Law, 1736
www.meti.go.jp/english/policy/economy/consumer/pse/index.html 1737 • Korean Framework Act on Product Safety Law (No. 10028), www.glin.gov 1738 • U.S. Consumer Product Safety Act, 15. U.S.C. §§ 2051-2089. www.cpsc.gov 1739 • U.S. Federal Hazardous Substances Act, 15 U.S.C. §§ 1261-1278. 1740
www.cpsc.gov 1741 • U.S. Poison Prevention Packaging Act, 15 U.S.C. §§ 1471-1477. www.cpsc.gov 1742 • U.S. Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. §§ 121, 136; 1743
U.S. Environmental Protection Agency, Pesticides, 1744 www.epa.gov/pesticides/index.htm 1745
1746 C.2. Standards 1747 1748
• American National Standards Institute, Z535.1-Z535.6 (2006), Product Safety 1749 Information in Product Manuals, Instructions, and Other Collateral Materials. 1750
ISO CD 10377
42
• European Committee for Standardization (CEN) – www.cen.eu 1751 • European Committee for Electrotechnical Standardization (CENELEC) – 1752
www.cenelec.eu 1753 • EC Enterprise and Industry, European Standards, List of References of 1754
Harmonized Standards. http://ec.europa.eu/enterprise/policies/european-1755 standards/documents/harmonised-standards-legislation/list-references 1756
• Instituto Argentino de Normalización y Certificación (IRAM), www.iram.org.ar 1757 • Instituto Nacional de Normalización, Chile, www.inn.cl 1758 • International Organization of Standardization (ISO) – www.iso.org/iso/home.html 1759 • International Electrotechnical Commission (IEC) – www.iec.ch 1760 • Japanese Standards Association (JSA) - www.jsa.or.jp 1761 • Korean Agency for Technology and Standards www.kats.go.kr 1762 • Standards Australia (SA) - www.standards.org.au 1763 • Standards Council of Canada (SCC) – www.scc.ca 1764 • Standardization Administration of China (SAC) , www.new.sac,gov.cn 1765 1766
C.3. Accredited Laboratories 1767
• International Laboratory Accreditation Cooperation (ILAC) – www.ilac.org 1768 • Standards Council of Canada Accredited Laboratories, www.scc.ca 1769
1770 C.4. Consumer Product Recalls 1771
• Baltic Sea Market Surveillance, http://www.hamburg.de/baltic-sea-network/ 1772 • Collective U.S. Recall Authorities, www.recalls.gov 1773 • Consumer Product Safety Commission (CPSC) - 1774
www.cpsc.gov/cpscpub/prerel/prerel.html 1775 • EU Market Surveillance (EMARS), http://www.emars.eu/ 1776 • European RAPEX data base – 1777
http://ec.europa.eu/consumers/safety/rapex/index_en.htm 1778 • Health Canada Consumer Product Recalls – http://cpsr-rspc.hc-sc.gc.ca/PR-1779
RP/home-accueil-eng.jsp 1780 • Product Recall Handbook of Japan (2010) 1781 • Recalls Australia – www.recalls.gov.au 1782 • Recall handbook, Consumer Product Safety Commission, May 1999, 1783
www.cpsc.gov/BUSINFO/8002.html 1784 1785
C.5. Injury Data 1786 1787
• CHIRPP - Canadian Hospitals Injury Reporting and Prevention Program ... 1788 www.phac-aspc.gc.ca › Home › Injury Prevention 1789
• CPSC, National Electronic Injury Surveillance System (NEISS) On-line – 1790 www.cpsc.gov/library/neiss.html 1791 Centers for Disease Control and Prevention, Injury Prevention & Control: Data 1792 & Statistics, www.cdc.gov/injury/ 1793
• NCAA Injury Surveillance Systems, 1794 http://www1.ncaa.org/membership/ed_outreach/health-safety/iss/index.html 1795
• U.S. National Library of Medicine, Household Products Database, 1796 http://householdproducts.nlm.nih.gov 1797
• World Health Organization, www.who.int/ 1798 1799 C.6. Risk Assessment Methodologies 1800 1801
• Applying the R-Map Method to Product Safety and Risk Management, Japan. 1802
ISO CD 10377
43
• Best Practice Techniques in Market Surveillance – EMARS a Prosafe Project 1803 sponsored by the European Commission DG SANCO. Available from 1804 http://www.emars.eu/ 1805
• European Commission, Commission Decision of January 26, 2010 Risk 1806 Assessment Guidelines for non-food Consumer Products, 1807 http://europa.eu/sanco/rag/help/Journal.pdf 1808
• EC Risk Assessment Guidelines for Consumer Products contained in 1809 Commission Decision of 16 December 2009 EC 2010/15/EU: Laying down 1810 guidelines for the management of Community Rapid Information System 1811 ‘Rapex’ established under Article 12 and of the notification procedure 1812 established under Article 11 of Directive 2001/95/EC (the General Product 1813 Safety Directive) 1814
• EC, Establishing a Comparative Inventory of Approaches and Methods Used by 1815 Enforcement Authorities for the Assessment of the Safety of Consumer 1816 Products Covered by Directive 2001/95/EC on General Product Safety and 1817 Identification of Best Practices, February 2006. 1818
• ISO/IEC Guide 51:1999 - Safety aspects - Guidelines for their inclusion in 1819 standards 1820
• IEC’s Advisory Committee on Safety – Development of a standard for safety 1821 related risk assessment in the area of low voltage. 1822
• Product Safety in Europe: A Guide to Corrective Action Including Recalls 1823 ec.europa.eu/consumers/cons_safe/action_guide_en.pdf 1824
• Recall handbook, Consumer Product Safety Commission, May 1999, 1825 www.cpsc.gov/BUSINFO/8002.html 1826
1827 C. 7. Safe Design 1828 1829
• Norris B and John Wilson, Making ergonomics evaluation a part of the design 1830 process, University of Nottingham, October 1997. 1831
1832
