1、 ISO 2013 Consumer product recall Guidelines for suppliers Rappel de produits de consommation Lignes directrices pour les fournisseurs INTERNATIONAL STANDARD ISO 10393 First edition 2013-04-15 Reference number ISO 10393:2013(E) ISO 10393:2013(E)ii ISO 2013 All rights reserved COPYRIGHT PROTECTED DOC
2、UMENT ISO 2013 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission c
3、an be requested from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ISO 10393:2013(E) ISO 2013 Al
4、l rights reserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 T erms and definitions . 1 3 Purpose and principles 4 4 General requirements . 4 4.1 General . 4 4.2 Policy . 4 4.3 Documentation and record keeping . 5 4.4 Regulatory requirement 5 4.5 Expertise required to manage a recall
5、 5 4.6 Authority for key decision . 6 4.7 Training and recall simulation 6 5 Assessing the need for a product recall 8 5.1 General . 8 5.2 Incident notification . 9 5.3 Incident investigation . 9 5.4 Assess the risk 10 5.5 Traceability .10 5.6 Product recall decision 11 6 Implementing a product reca
6、ll .11 6.1 General 11 6.2 Initiate the recall action .12 6.3 Communication .14 6.4 Implement the recall .16 6.5 Monitor and report .17 6.6 Evaluate effectiveness 18 6.7 Review and adjust recall strategy 19 7 Continual improvement of recall programme 20 7.1 General 20 7.2 Reviewing the recall 20 7.3
7、Corrective actions to prevent reoccurrence21 Annex A (informative) Hazard and risk evaluation22 Annex B (informative) Examples of product recall posters and press releases .27 Annex C (informative) Product recall checklist .31 Annex D (informative) Improving recall effectiveness Examples 32 Bibliogr
8、aphy .38 ISO 10393:2013(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested
9、 in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Comm
10、ission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents
11、should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for iden
12、tifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received. www.iso.org/patents Any trade name used in this document is information given for the convenience
13、of users and does not constitute an endorsement. The committee responsible for this document is Project Committee ISO/PC 240, Product recall.iv ISO 2013 All rights reserved ISO 10393:2013(E) Introduction There is a wide variety of products available to consumers in the global marketplace. Products r
14、outinely travel across borders in order to meet increasing consumer demand as suppliers seek to lower cost and expand markets. While many products are safe and fit for intended use, statistics show that, each year, millions of people suffer injuries or illness, or die from unsafe products. While reg
15、ulations and standards exist in many countries, and industries do all they can to make products safe and fit for intended use, problems related to design flaws, manufacturing defects, inadequate warnings or instructions still result in unsafe products entering the marketplace. In those instances, it
16、 is critical that corrective actions, which include recall, are carried out quickly and effectively. Although many countries have regulatory requirements and guidance for suppliers to conduct product recalls, many do not. Even in countries with well-developed requirements, recalls may be ineffective
17、. As a result, there are inconsistencies in the approaches to product recall and other corrective actions, and products that pose health or safety risks to consumers remain in the marketplace. This International Standard is designed to provide practical guidance in determining whether corrective act
18、ions, including recalls, need to be carried out by the supplier of consumer products. It also provides best practices for conducting a product recall if it is necessary. The guidance provides information and tools that suppliers of all sizes can use to develop a documented and validated product reca
19、ll programme that will help them implement timely and cost-effective recalls, minimize legal and reputation risks, and reduce health or safety risks to consumers. Although this International Standard is intended for suppliers, it might also help government agencies in developing or improving product
20、 recall policies and guidelines. Broad application of this International Standard will lead to a more consistent approach to removing unsafe products from the global marketplace, to improving coordination between government and consumer products organizations in different countries, and to increasin
21、g consumer confidence in the safety of products available in the marketplace. This International Standard has been developed in parallel with ISO 10377, which focuses on product safety. The relationship between this International Standard and ISO 10377 is illustrated in Figure 1. Design Material man
22、ufacture Component manufacture Manufacture Assembly Transport/ Storage Distribute Import/ Export Retail Consumer Design Production Marketplace ISO 10393 Consumer product recall Guidelines for suppliers IS0 10377 Consumer product safety Guidelines for suppliers Figure 1 Relationship between this Inte
23、rnational Standard and ISO 10377 ISO 2013 All rights reserved v Consumer product recall Guidelines for suppliers 1 Scope This International Standard provides practical guidance to suppliers on consumer product recalls and other corrective actions after the product has left the manufacturing facility
24、. Other corrective actions include, but are not limited to, refunds, retrofit, repair, replacement, disposal and public notification. This International Standard is intended to apply to consumer products, but might also be applicable to other sectors. 2 T erms a nd definiti ons For the purposes of t
25、his document, the following terms and definitions apply. 2.1 consumer individual member of the general public purchasing or using property, products or services for private purposes SOURCE: ISO 26000:2010, 2.2 2.2 consumer product product designed and produced primarily for, but not limited to, pers
26、onal use, including its components, parts, accessories, instructions and packaging SOURCE: ISO 10377:2013, 2.2 2.3 competent suitably trained or qualified by knowledge and practical experience to enable the required task or tasks to be carried out SOURCE: ISO 22846-1:2003, 2.6 2.4 corrective action
27、action intended to remove potential for harm and to reduce risk Note 1 to entry: For the purposes of this International Standard, corrective actions are referred to as “recalls” because the public and media more readily recognize and respond to that description. 2.5 foreseeable misuse improper or in
28、correct use of a product that is capable of being known or anticipated in advance, based on a suppliers best knowledge about the product and human behaviour EXAMPLE Improper use by children or the elderly. SOURCE: ISO 10377:2013, 2.5 INTERNATIONAL ST ANDARD ISO 10393:2013(E) ISO 2013 All rights rese
29、rved 1 ISO 10393:2013(E) 2.6 foreseeable use use of a product that is capable of being known or anticipated in advance based on a suppliers best knowledge about the product SOURCE: ISO 10377:2013, 2.6 2.7 harm physical injury or damage to the health of people, or damage to property SOURCE: ISO/IEC G
30、uide 51:1999, 3.3, modified 2.8 hazard potential source of harm Note 1 to entry: The term hazard can be qualified in order to define its origin or the nature of the expected harm (e.g. electric shock hazard, biological hazard, crushing hazard, cutting hazard, toxic hazard, fire hazard, drowning haza
31、rd). SOURCE: ISO/IEC Guide 51:1999, 3.5 2.9 incident event or defect that caused or has the potential to cause death, injury or property damage, with respect to a consumer product Note 1 to entry: “Incident” might be defined differently by law in some countries. 2.10 intended use use of a product in
32、 accordance with information provided by the supplier SOURCE: ISO/IEC Guide 51:1999, 3.13, modified 2.11 organization entity or group of people and facilities with an arrangement of responsibilities, authorities and relationships and identifiable objectives Note 1 to entry: For the purposes of this
33、International Standard, organization does not include government acting in its sovereign role to create and enforce law, exercise judicial authority, carry out its duty to establish policy in the public interest or honour the international obligations of the state. SOURCE: ISO 26000:2010, 2.12, modi
34、fied 2.12 product recall corrective action taken post production to address consumer health or safety issues associated with a product 2.13 risk combination of the probability of occurrence of harm and the severity of that harm SOURCE: ISO/IEC Guide 51:1999, 3.2 2.14 risk analysis systematic use of
35、available information to identify hazards and to estimate the risk SOURCE: ISO/IEC Guide 51:1999, 3.102 ISO 2013 All rights reserved ISO 10393:2013(E) 2.15 risk assessment overall process comprising a harm and a risk evaluation SOURCE: ISO/IEC Guide 51:1999, 3.12 2.16 risk evaluation procedure based
36、 on the risk analysis to determine whether the tolerable risk has been achieved SOURCE: ISO/IEC Guide 51:1999, 3.11 2.17 risk management coordinated activities to direct and control an organization with regard to risk SOURCE: ISO Guide 73:2009, 2.1 2.18 safety freedom from unacceptable risk SOURCE:
37、ISO/IEC Guide 51:1999, 3.1 2.19 supplier organization or person that provides a product or service EXAMPLE Designer, producer/manufacturer, importer, distributor, or retailer of a product. SOURCE: ISO 9000:2005, 3.3.6, modified 2.20 supply chain network that designs, manufacturers, imports, distribu
38、tes and sells a product SOURCE: ISO 10377:2013, 2.25 2.21 tolerable risk risk which is acceptable for a specific user group based on the current values of society Note 1 to entry: For the purposes of this International Standard, the terms “acceptable risk” and “tolerable risk” are considered to be s
39、ynonymous. SOURCE: ISO/IEC Guide 51:1999, 3.7, modified 2.22 traceability ability to track a product or component forward through specified stages of the supply chain to the user, and trace back the history, application or location of that product or component SOURCE: ISO 9000:2005, 3.5.4, modified
40、2.23 user person who interacts with the product or service ISO 2013 All rights reserved 3 ISO 10393:2013(E) 2.24 vulnerable consumer consumer who could be at greater risk of harm from products due to their age, level of literacy, physical condition or limitations, or inability to access product safe
41、ty information SOURCE: ISO 10377:2013, 2.30 3 Purpose and principles The purpose of this International Standard is to help suppliers develop, implement and improve a product recall programme in order to reduce risk caused by unsafe products in the marketplace. A product recall programme is a key ele
42、ment of the suppliers overall product safety programme. Suppliers should demonstrate their commitment to consumer product safety by adhering to the principles documented in this International Standard and in ISO 10377. These principles include the following: developing and maintaining appropriate pr
43、ocesses and systems to prevent product-related incidents that could lead to a recall, including addressing product safety risks at the design stage and allocating appropriate resources for quality management, training, records management and product traceability; a commitment to the prompt and effec
44、tive implementation of a product recall when it is assessed that a product is likely to pose a health or safety risk to consumers; promoting a product safety culture by building awareness of the importance of product safety, ensuring product safety programmes are supported and continually improving
45、its product safety programme; promoting a product safety culture to others within its supply chain; establishing and maintaining compliance with all applicable laws, regulations and standards. 4 General requirements 4.1 General All suppliers should be prepared to conduct a product recall. The suppli
46、er should have in place a product recall plan that includes the following: the recall policy (see 4.2); an outline of the documentation and records that will be created and maintained (see 4.3); an outline of the legal, industry and regulatory requirements (see 4.4); identification and explanation o
47、f the roles and responsibilities of the recall management team (see 4.5); a description of the training and exercise requirements for members of the recall management team (see 4.7); guidance on how product incidents will be investigated and a decision made on whether a recall is necessary (see Clau
48、se 5); identification of the resources required and processes used to implement a recall (see Clause 6); establishing the requirement for continual improvement of the suppliers processes (see Clause 7). 4.2 Policy The supplier should develop and maintain a product recall policy and identify how deci
49、sions will be made to carry out a product recall. The policy should contain a simple, clear and precise commitment 4 ISO 2013 All rights reserved ISO 10393:2013(E) by the supplier to ensure that products which present, or which have the potential to present, risks or hazards to consumers are effectively removed from the marketplace, or that safety or health issues or concerns are corrected. 4.3 Documentation and record keeping Management should establish procedures to con
