SIST ISO 10393:2018
Consumer product recall - Guidelines for suppliers
Consumer product recall - Guidelines for suppliers
This International Standard provides practical guidance to suppliers on consumer product recalls and
other corrective actions after the product has left the manufacturing facility. 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.
Rappel de produits de consommation - Lignes directrices pour les fournisseurs
Odpoklic potrošniškega izdelka - Smernice za dobavitelje
Ta mednarodni standard podaja praktične smernice za dobavitelje glede odpoklica potrošniških izdelkov in drugih korektivnih ukrepov po odpremi izdelka iz proizvodnega obrata. Drugi korektivni ukrepi med drugim vključujejo vračila, rekonstrukcijo, popravilo, zamenjavo, odstranjevanje in javno obveščanje.
Ta mednarodni standard se uporablja za potrošniške izdelke, lahko pa se uporablja tudi za druge sektorje.
General Information
Buy Standard
Standards Content (Sample)
SLOVENSKI STANDARD
SIST ISO 10393:2018
01-november-2018
Odpoklic potrošniškega izdelka - Smernice za dobavitelje
Consumer product recall - Guidelines for suppliers
Rappel de produits de consommation - Lignes directrices pour les fournisseurs
Ta slovenski standard je istoveten z: ISO 10393:2013
ICS:
03.080.30 Storitve za potrošnike Services for consumers
13.120 Varnost na domu Domestic safety
SIST ISO 10393:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST ISO 10393:2018
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SIST ISO 10393:2018
INTERNATIONAL ISO
STANDARD 10393
First edition
2013-04-15
Consumer product recall — Guidelines
for suppliers
Rappel de produits de consommation — Lignes directrices pour les
fournisseurs
Reference number
ISO 10393:2013(E)
©
ISO 2013
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ISO 10393:2013(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2013
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Terms 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
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 recall .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 Corrective actions to prevent reoccurrence.21
Annex A (informative) Hazard and risk evaluation.22
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
Bibliography
.38
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Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
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 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 identifying 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 of users and does not
constitute an endorsement.
The committee responsible for this document is Project Committee ISO/PC 240, Product recall.
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Introduction
There is a wide variety of products available to consumers in the global marketplace. Products routinely
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 regulations 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
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. 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
actions, 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 recall 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 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 increasing 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 Production Marketplace
IS0 10377 — Consumer product safety — Guidelines for suppliers
Design
Material Component
manufacture manufacture
ISO 10393 — Consumer product recall —
Manufacture Assembly
Guidelines for suppliers
Transport/ Import/
Storage Export
Distribute Retail
Consumer
Figure 1 — Relationship between this International Standard and ISO 10377
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SIST ISO 10393:2018
INTERNATIONAL STANDARD ISO 10393:2013(E)
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. 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 Terms and definitions
For the purposes of this 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, personal 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
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 incorrect use of a product that is capable of being known or anticipated in advance, based
on a supplier’s best knowledge about the product and human behaviour
EXAMPLE Improper use by children or the elderly.
[SOURCE: ISO 10377:2013, 2.5]
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2.6
foreseeable use
use of a product that is capable of being known or anticipated in advance based on a supplier’s 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 Guide 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 hazard).
[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 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 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, modified]
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 available information to identify hazards and to estimate the risk
[SOURCE: ISO/IEC Guide 51:1999, 3.10]
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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 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: 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, distributes 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 synonymous.
[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]
2.23
user
person who interacts with the product or service
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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 safety 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 element of the supplier’s 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 processes 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 effective 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 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 supplier 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 of 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 Clause 5);
— identification of the resources required and processes used to implement a recall (see Clause 6);
— establishing the requirement for continual improvement of the supplier’s processes (see Clause 7).
4.2 Policy
The supplier should develop and maintain a product recall policy and identify how decisions will be
made to carry out a product recall. The policy should contain a simple, clear and precise commitment
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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 control and maintain all documents and record data
relating to the recall programme for continual improvement, data analysis and facilitation of incident
investigation, product identification and traceability, such as the following:
— a copy of the recall policy and procedures;
— records of training and assessment of employee competency;
— records of consumer complaints and product safety incidents;
— records of risk assessment, which may include test reports, and risk analysis;
— records of the recall decision;
— records of communication, including the communication plan, materials, methods used and dates;
— evidence of the effectiveness of the recall, including return rates, effectiveness per method of
communication and evidence to show that the recall is working;
— financial records;
— records of repair, refurbishment or disposal.
4.4 Regulatory requirement
The supplier should identify, monitor, understand and comply with applicable legislative, regulatory and
standard requirements for recalls, in all markets where a consumer product is produced or sold.
4.5 Expertise required to manage a recall
The supplier should ensure that it has the expertise to investigate the incident, to assess the risk, to make
the recall decision and to carry out the recall. In larger suppliers, this may require the establishment of
a recall management team made up of staff from a range of functional areas.
Regardless of size, suppliers may need outside assistance from advisors and consultants. Arrangements
should be made with advisors and consultants so that they can develop an understanding of its recall
programme before an incident occurs.
The objectives of the people responsible for managing the recall are as follows:
— assess all available information and determine the actions necessary to do the following:
— protect the health or safety of consumers;
— maintain relationships with consumers and stakeholders;
— protect the reputation of the supplier;
— fulfil all relevant legal obligations (e.g. mandatory reporting) in all countries of distribution;
— liaise with relevant government and industry authorities;
— ensure that key stakeholders are kept informed of the supplier’s decisions and actions, including
forthcoming media communications;
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— ensure that decisions and recall actions are implemented effectively with least disruption to the
normal operation of the supplier’s day-to-day business.
Table 1 lists the typical expertise required for a product recall.
4.6 Authority for key decision
The supplier should identify the person or people who have the authority to make the decision to
recall the product.
The key decisions that may need to be made are as follows:
— make a product recall decision and determine the scope of that recall, as discussed in 5.1;
— stop production and place product on hold during a product recall investigation, as discussed in 5.3;
— stop the sale of a product at any point in the supply chain, as discussed in 5.6;
— notify the regulator(s) about a product recall incident, comply with applicable regulatory
requirements, and report the progress of the recall to regulator(s), as discussed in 6.3.3;
— notify the supply chain about a product recall incident, as discussed in 6.3.4;
— communicate to consumers about actions that should be taken during a product recall, as
discussed in 6.3.5;
— execute the logistical requirements of the product recall, as discussed in 6.4;
— assess the effectiveness of the recall to make recommendations about its progress, as discussed in 6.6;
— bring an end to the monitoring phases of the product recall by the regulator and cease active recall
operations, as discussed in 6.7.2.
4.7 Training and recall simulation
The staff responsible for the recall should be familiar with the supplier’s product recall plan and have
the capabilities and personal attributes needed to implement the recall.
Planning, training and conducting recall simulations will help to better prepare people for a recall
and also increase the likelihood that agreed processes are implemented quickly and effectively under
conditions that can be stressful. In addition, these activities may be required to meet contractual, legal
and insurance requirements.
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Table 1 — Typical expertise required for product recall
Expertise required Activities or responsibilities
Recall coordination and First point of contact for incidents
leadership
Initial sorting and escalation of the incident
Ensure notifications are made to appropriate people
Gather people with the appropriate expertise
Facilitate meetings and ensure required actions are carried out
Ensure information needed is collected in a timely manner and appropriate people
are updated regularly
Ensure timely decisions are made
Ensure all communications are consistent and controlled
Ensure appropriate external notifications and briefings are performed
Ensure all required reports are prepared and distributed
Facilitate continual improvement process and ensure follow up responsibilities are
delegated
Technical/Engineering Lead the investigation of the recall incident
Review internal records, quality systems and traceability of the affected product
Establish contact with laboratories and testing authorities and other experts per-
forming the risk analysis or risk assessment
Lead the risk analysis or risk assessment process
Act as a liaison with suppliers
Provide technical advice about the product to the team
Participate in the recall decision
Operations Gather distribution records, ensure they are accurate and create distribution reg-
ister
Manage collection, retrieval, replacement, repair and disposal of product
Ensure accurate records are kept to measure recall effectiveness
Manage the logistical requirements necessary to remove product from the mar-
ketplace, to repair or replace product in the marketplace and to destroy defective
product that was the subject of the recall
Sales and marketing/ Establish and maintain liaison with affected consumers
Accounts
Ensure consumer enquiries and concerns are addressed in a timely manner
Establish consumer needs for replacement products and arranges credits, refunds,
or replacements for the subject product
Participate in the recall decision
Finance/ Estimate costs of proposed actions, sources of funding and potential impact on
Risk management business
Notify insurer where required
Establish budget and monitor costs
Keep records for claims
Work with sales & marketing/accounts to arrange credits and refunds
Participate in the recall decision
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Table 1 (continued)
Expertise required Activities or responsibilities
Legal counsel Ensure compliance with regulators’ requirements
Ensure compliance with contractual requirements with buyers and licensors
Provide advice to minimize organization’s liabilities arising from recall decision
and from day-to-day execution of recall plan
Participate
...
МЕЖДУНАРОДНЫЙ ISO
СТАНДАРТ 10393
Первое издание
2013-04-15
Отзыв потребительских товаров.
Руководство для поставщиков
Consumer product recall – Guidelines for suppliers
Ответственность за подготовку русской версии несёт GOST R
(Российская Федерация) в соответствии со статьёй 18.1 Устава ISO
Ссылочный номер
ISO 10393:2013(R)
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ISO 2013
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ISO 10393:2013(R)
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ISO 10393:2013(R)
Содержание Страница
Предисловие . iv
Введение . v
1 Область применения . 1
2 Термины и определения . 1
3 Цель и принципы. 4
4 Общие требования . 5
4.1 Общие положения. 5
4.2 Политика . 5
4.3 Документация и хранение записей. 5
4.4 Регулирующее требование . 6
4.5 Специальные знания, необходимые для управления отзывом. 6
4.6 Полномочия для принятия ключевого решения. 7
4.7 Обучение и моделирование отзыва продукции . 7
5 Оценка необходимости отзыва продукции. 10
5.1 Общие положения. 10
5.2 Уведомление об инциденте . 10
5.3 Расследование инцидента. 10
5.4 Оценка риска . 11
5.5 Прослеживаемость . 12
5.6 Решение об отзыве продукции . 12
6 Осуществление отзыва продукции. 13
6.1 Общие положения. 13
6.2 Инициирование отзыва . 13
6.3 Обмен информацией . 16
6.4 Осуществление отзыва продукции. 18
6.5 Мониторинг и отчетность . 19
6.6 Оценка эффективности . 20
6.7 Анализ и корректировка стратегии отзыва продукции . 21
7 Совершенствование программы отзыва продукции . 22
7.1 Общие положения. 22
7.2 Анализ отзыва продукции . 23
7.3 Корректирующие действия по предотвращению возникновения повторного
инцидента .23
Приложение А (информативное) Опасность и оценка риска. 24
Приложение В (информативное) Примеры объявлений и пресс-релизов об отзыве
продукции . 29
Приложение С (информативное) Карта контроля по отзыву продукции. 33
Приложение D (информативное) Повышение эффективности отзыва продукции. Примеры. 34
Библиография. 40
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ISO 10393:2013(R)
Предисловие
Международная организация по стандартизации (ISO) представляет собой всемирную федерацию,
состоящую из национальных органов по стандартизации (комитеты-члены ISO). Работа по разработке
международных стандартов обычно ведется техническими комитетами ISO. Каждый комитет-член,
заинтересованный в теме, для решения которой образован данный технический комитет, имеет право
быть представленным в этом комитете. Международные организации, правительственные и
неправительственные, поддерживающие связь с ISO, также принимают участие в работе. ISO тесно
сотрудничает с Международной электротехнической комиссией (IEC) по всем вопросам
стандартизации в области электротехники.
Процедуры, использованные для разработки данного документа, и процедуры его дальнейшей
актуализации описаны в Директивах ISO/IEC Directives, Часть 1. В частности, следует отметить
различные критерии утверждения, необходимые для различных типов документов ISO. Настоящий
документ был разработан в соответствии с редакционными правилами Директив ISO/IEC Directives,
Часть 2. www.iso.org/directives
Следует обратить внимание на тот факт, что отдельные элементы данного документа могут являться
объектами патентного права. ISO не несет ответственность за идентификацию любых или всех
подобных патентных прав. Сведения о всех патентных правах, идентифицированных при разработке
данного документа, содержатся в разделе Введение и /или в перечне ISO полученных патентных
деклараций. www.iso.org/patents
Любой торговый знак, использованный в данном документе, является информацией, приводимой для
удобства пользователей, и не является свидетельством в пользу того или иного товара.
Комитетом, несущим ответственность за данный документ, является Проектный комитет ISO/PC 240,
Отзыв продукции.
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ISO 10393:2013(R)
Введение
На мировом рынке потребителю доступен широкий ассортимент товаров. Ежедневно продукция
пересекает границы, чтобы удовлетворить растущий потребительский спрос, а поставщики стремятся к
сокращению расходов и расширению рынков. В то время как большинство товаров безопасно и
соответствуют своему предполагаемому назначению, статистические данные показывают, что каждый
год миллионы людей получают травмы, страдают от заболеваний или умирают в результате
использования опасной продукции.
Тогда как во многих странах существуют регламенты и стандарты, и промышленность делает все
возможное для производства безопасной продукции, соответствующей своему предназначению,
проблемы, связанные с ошибками проектирования, производственными дефектами, неадекватными
предупреждениями или инструкциями, по-прежнему приводят к появлению на рынке небезопасных
товаров. В этих случаях важно, чтобы корректирующие действия, включающие отзыв продукции,
осуществлялись оперативно и эффективно. Хотя во многих странах действуют регулирующие
требования и руководящие указания для поставщиков по отзыву продукции, в ряде стран они
отсутствуют. Даже в странах с четко сформированными требованиями, отзывы продукции могут
оказаться неэффективными. В результате возникают противоречия в подходах к отзыву продукции и
другим корректирующим действиям, и продукция, представляющая риск для здоровья и безопасности
потребителей, остается на рынке.
Настоящий международный стандарт предназначен для предоставления практических рекомендаций
относительно необходимости проведения поставщиком потребительских товаров, корректирующих
действий, включая отзыв продукции. В этом стандарте также представлена наилучшая практика
осуществления отзыва продукции, когда в этом есть необходимость. Данное руководство
предоставляет информацию и инструменты, которые поставщики любых масштабов могут
использовать для разработки документированной и обоснованной программы отзыва продукции,
которая поможет им провести своевременные и экономически эффективные отзывы, минимизировать
правовые и репутационные риски, и снизить риски для здоровья и безопасности потребителей.
Хотя данный международный стандарт предназначен для поставщиков, он также может помочь
государственным органам в разработке и совершенствовании политики и руководящих принципов
отзыва продукции.
Широкое применение настоящего стандарта приведет к более последовательному подходу устранения
небезопасной продукции с мирового рынка, к совершенствованию координации между правительством
и производителями товаров народного потребления в разных странах и к повышению доверия
потребителей к безопасности товаров, находящихся в обращении на рынке.
Данный международный стандарт разработан параллельно с ISO 10377, который направлен на
безопасность товаров. Взаимосвязь между данным международным стандартом и ISO 10377 показана
на Рисунке 1.
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ISO 10393:2013(R)
Рисунок 1 — Взаимосвязь между данным международным стандартом и ISO 10377
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МЕЖДУНАРОДНЫЙ СТАНДАРТ ISO 10393:2013(R)
Отзыв потребительских товаров. Руководство для
поставщиков
1 Область применения
Настоящий международный стандарт содержит практическое руководство для поставщиков относительно
отзыва потребительских товаров и другим корректирующим действиям после того, как продукция покидает
завод-изготовитель. Другие корректирующие действия помимо всего прочего, включают возмещение,
модернизацию, ремонт, замену, утилизацию и уведомление общественности.
Настоящий международный стандарт предназначен для потребительской продукции, но может быть
использован и в других секторах.
2 Термины и определения
В данном документе используются следующие термины и определения.
2.1
потребитель
consumer
отдельный член общества, приобретающий или использующий имущество, продукцию или услуги в личных
целях
[ИСТОЧНИК: ISO 26000:2010, 2.2]
2.2
потребительская продукция
consumer product
продукция, разрабатываемая и выпускаемая, в первую очередь, для персонального пользования (не
ограничиваясь этим), включая ее комплектующие, детали, аксессуары, инструкции и упаковку
[ИСТОЧНИК: ISO 10377:2013, 2.2]
2.3
компетентный
competent
подготовленный должным образом или квалифицированный в отношении знаний и практического опыта для
выполнения требуемого задания или заданий
[ИСТОЧНИК: ISO 22846-1:2003, 2.6]
2.4
корректирующее действие
corrective action
действие, направленное на устранение потенциального вреда и снижение риска
ПРИМЕЧАНИЕ 1 к статье: Применительно к данному международному стандарту корректирующие действия
подразумевают “отзыв продукции”, поскольку общество и СМИ с большей готовностью признает и реагирует на такую
формулировку.
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ISO 10393:2013(R)
2.5
прогнозируемое неправильное использование
foreseeable misuse
ненадлежащее или неправильное использование продукции, известное или предполагаемое заранее на
основании имеющейся у поставщика информации об этой продукции и поведении человека
ПРИМЕР Ненадлежащее использование детьми или людьми пожилого возраста.
[ИСТОЧНИК: ISO 10377:2013, 2.5]
2.6
прогнозируемое использование
foreseeable use
использование продукции, известное или предполагаемое заранее на основании имеющейся у поставщика
информации об этой продукции
[ИСТОЧНИК: ISO 10377:2013, 2.6]
2.7
вред
harm
физическое повреждение или вред здоровью людей или имуществу
[ИСТОЧНИК: ISO/IEC Guide 51:1999, 3.3, с изменениями]
2.8
опасность
hazard
потенциальный источник возникновения вреда
ПРИМЕЧАНИЕ 1 к статье: Термин “опасность” может быть конкретизирован, чтобы определить происхождение опасности
и природу ожидаемого вреда (например, опасность поражения электрическим током, биологическая опасность, опасность
разрушения, опасность пореза, опасность отравления, пожароопасность, опасность затопления).
[ИСТОЧНИК: ISO/IEC Guide 51:1999, 3.5]
2.9
инцидент
incident
событие или дефект, имеющие отношение к потребительскому товару, которые вызвали или потенциально
могли привести к смерти, травме или повреждению имущества,
ПРИМЕЧАНИЕ 1 к статье:Регулирующими документами некоторых стран термин “инцидент” может быть определен по-
другому.
2.10
целевое назначение
intended use
использование продукции в соответствии с информацией, предоставленной поставщиком
[ИСТОЧНИК: ISO/IEC Guide 51:1999, 3.13, с измененениями]
2.11
организация
organization
юридическое лицо или группа людей и объектов с определенной структурой обязательств, руководства и
взаимоотношений и идентифицируемыми целями
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ISO 10393:2013(R)
ПРИМЕЧАНИЕ 1 к статье: Применительно к данному международному стандарту организация не включает
государственные органы, играющие независимую роль в создании и приведении в действие правовых норм,
осуществляющие судебную власть, выполняющие свои обязанности по формированию политики в интересах
общественности или соблюдению международных обязательств государства.
[ИСТОЧНИК: ISO 26000:2010, 2.12, с изменениями]
2.12
отзыв продукции
product recall
корректирующее действие, предпринятое после производства, с целью защиты здоровья и безопасности
потребителей в связи с использованием какой-либо продукции
2.13
риск
risk
сочетание вероятности причинения вреда и тяжести этого вреда
[ИСТОЧНИК: ISO/IEC Guide 51:1999, 3.2]
2.14
анализ риска
risk analysis
систематическое использование имеющейся информации для выявления опасностей и оценки риска
[ИСТОЧНИК: ISO/IEC Guide 51:1999, 3.10]
2.15
оценка степени риска
risk assessment
полный процесс, включающий оценку вреда и риска
[ИСТОЧНИК: ISO/IEC Guide 51:1999, 3.12]
2.16
оценка риска
risk evaluation
основанная на анализе риска процедура проверки в отношении превышения допустимого риска
[ИСТОЧНИК: ISO/IEC Guide 51:1999, 3.11]
2.17
менеджмент риска
risk management
скоординированные действия для управления и контроля организации в отношении риска
[ИСТОЧНИК: ISO Guide 73:2009, 2.1]
2.18
безопасность
safety
отсутствие недопустимого риска
[ИСТОЧНИК: ISO/IEC Guide 51:1999, 3.1]
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ISO 10393:2013(R)
2.19
поставщик
supplier
организация или лицо, предоставляющее продукцию или услугу
ПРИМЕРЫ Проектировщик, производитель/изготовитель, импортер, дистрибьютор, розничный продавец товара.
[ИСТОЧНИК: ISO 9000:2005, 3.3.6, с изменениями]
2.20
цепь поставок
supply chain
сеть, в которой продукция разрабатывается, изготавливается, импортируется, распределяется и продается
[ИСТОЧНИК: ISO 10377:2013, 2.25]
2.21
допустимый риск
tolerable risk
риск, который приемлем для конкретной группы пользователей при существующих общественных ценностях
ПРИМЕЧАНИЕ 1 к статье: Применительно к данному международному стандарту термины “приемлемый риск” и
“допустимый риск” считаются синонимами.
[ИСТОЧНИК: ISO/IEC Guide 51:1999, 3.7, с изменениями]
2.22
прослеживаемость
traceability
возможность проследить продукцию или компонент в перспективе на установленных стадиях цепи поставок
до пользователя, и обратно, а также проследить историю, применение или местонахождение этой продукции
или компонента
[ИСТОЧНИК: ISO 9000:2005, 3.5.4, с изменениями]
2.23
пользователь
user
лицо, взаимодействующее с продукцией или услугой
2.24
уязвимый потребитель
vulnerable consumer
потребитель, который может оказаться в большей степени подверженным риску или вреду от продукции в
силу своего возраста, образованности, физического состояния или ограниченных возможностей, или
неспособности оценить информацию о безопасности продукции
[ИСТОЧНИК: ISO 10377:2013, 2.30]
3 Цель и принципы
Цель настоящего международного стандарта заключается в оказании помощи поставщикам в разработке,
внедрении и совершенствовании программы отзыва продукции для снижения риска, создаваемого
небезопасной продукцией на рынке.
Программа отзыва продукции является ключевым элементом программы общей безопасности продукции
поставщика. Поставщикам следует продемонстрировать свое обязательство в отношении безопасности
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ISO 10393:2013(R)
потребительской продукции путем следования принципам, изложенным в данном международном стандарте
и в ISO 10377. Эти принципы включают следующее:
— разработку и ведение соответствующих процессов и систем для предотвращения инцидентов, связанных
с продукцией, которые могут привести к отзыву, включая анализ рисков безопасности продукции на
стадии проектирования и выделение соответствующих ресурсов на менеджмент качества, обучение,
управление документами и прослеживаемость продукции;
— готовность оперативно и эффективно осуществить отзыв продукции, если эта продукция может
представлять риск для здоровья и безопасности потребителей;
— пропаганду культуры безопасности продукции посредством широкого информирования о важности
безопасности продукции, гарантируя поддержку программам безопасности продукции и постоянно
совершенствуя свою программу обеспечения безопасности продукции;
— пропаганду культуры безопасности продукции среди других секторов цепи поставок;
— обеспечение соответствия всем действующим законам, регламентам и стандартам.
4 Общие требования
4.1 Общие положения
Все поставщики должны быть готовы к проведению отзыва продукции. Поставщику следует иметь в наличии
план отзыва продукции, который включает следующее:
— политику отзыва продукции (см. 4.2);
— общие сведения о документации и записях, которые будут формироваться и вестись (см. 4.3);
— краткое описание законодательных, отраслевых и регулирующих требований (см. 4.4);
— идентификацию и разъяснение функций и обязанностей группы управления отзывом продукции (см. 4.5);
— описание требований к подготовке и практике членов группы управления отзывом продукции (см. 4.7);
— руководящие указания по расследованию инцидентов, связанных с продукцией, и по принятию решения о
необходимости отзыва продукции (см. Раздел 5);
— идентификацию требующихся ресурсов и процессов, используемых для осуществления отзыва
продукции (см. Раздел 6);
— установление требований к постоянному совершенствованию процессов, осуществляемых поставщиком (см.
Раздел 7).
4.2 Политика
Поставщик должен разработать политику по проведению отзыва продукции, а также определить, каким
образом будут приниматься решения об отзыве продукции. Политика должна содержать простое, четкое и
конкретное обязательство со стороны поставщика по обеспечению реального изъятия из обращения
продукции, которая представляет или может представлять угрозу или опасность для потребителей, и что
проблемы или опасения, связанные с безопасностью и здоровьем потребителей, будут скорректированы.
4.3 Документация и хранение записей
Руководству необходимо разработать процедуры контроля и ведения всех документов и отчетов,
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ISO 10393:2013(R)
касающихся программы отзыва продукции для постоянного улучшения, анализа данных и упрощения
расследования причин инцидентов, идентификации и прослеживаемости продукции, в частности:
— экземпляр политики и процедур отзыва продукции;
— записи о подготовке и оценке компетентности персонала;
— записи жалоб потребителей и инцидентов, связанных с безопасностью продукции;
— записи об оценке риска, которые могут включать протоколы испытаний и анализ риска;
— записи о решении об отзыве продукции;
— записи об обмене информацией, включая коммуникационный план, материалы, использованные методы
и даты;
— подтверждение эффективности отзыва продукции, включая скорость ответной реакции, эффективность
используемых коммуникаций и доказательств того, что отзыв работает;
— финансовая отчетность;
— записи о ремонте, реконструкции или утилизации.
4.4 Регулирующее требование
Поставщику следует идентифицировать, отслеживать, понимать и выполнять все действующие
законодательные, регулирующие и стандартные требования к отзыву продукции и соответствовать им на
всех рынках, где производится или продается потребительская продукция.
4.5 Специальные знания, необходимые для управления отзывом
Поставщик должен гарантировать обладание специальными знаниями для расследования инцидента, оценки
риска, принятия решения об отзыве продукции и осуществления этого отзыва. Для более крупных
поставщиков это может потребовать формирования группы управления отзывом продукции, включающей
персонал из различных функциональных областей.
Независимо от размера организации, поставщикам может потребоваться помощь советников и консультантов
извне. Следует обговорить с советниками и консультантами возможность разработки программы отзыва
продукции до возникновения инцидента.
В задачи персонала, ответственного за управление отзывом продукции, входит следующее:
— анализ всей имеющейся информации и определение действий, необходимых для того, чтобы:
— защитить здоровье и безопасность потребителей;
— поддерживать взаимосвязь с потребителями и причастными (заинтересованными) сторонами;
— защитить репутацию поставщика;
— выполнять соответствующие правовые обязательства (например, обязательная отчетность) во
всех странах, где реализуется продукция;
— установление контактов с соответствующими государственными и промышленными властями;
— обеспечение информирования основных причастных сторон о решениях и действиях, принимаемых
поставщиком, включая будущее взаимодействие с СМИ;
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ISO 10393:2013(R)
— обеспечение эффективного выполнения решений и действий по отзыву продукции при минимальном
нарушении обычного режима повседневной деятельности поставщика.
В Таблице 1 приведены обычные требуемые профессиональные знания и опыт для выполнения отзыва
продукции.
4.6 Полномочия для принятия ключевого решения
Поставщик должен идентифицировать лицо или лиц, полномочных принимать решение об отзыве продукции.
К ключевым решениям, которые требуется принять, относятся следующие:
— решение об отзыве продукции и определение объема этого отзыва, в соответствии с 5.1;
— приостановление производства продукции в период расследования инцидента, в соответствии с 5.3;
— прекращение реализации продукции в любой точке цепи поставок, в соответствии с 5.6;
— уведомление органов надзора об инциденте, вызвавшем отзыв продукции, выполнение применяемых
регулирующих требований, и предоставление отчета о проведении мероприятий по отзыву продукции
органу надзора, в соответствии с 6.3.3;
— уведомление всех секторов цепи поставок об инциденте, приведшем к отзыву продукции, в
соответствии с 6.3.4;
— информирование потребителей о действиях, которые им следует выполнять в процессе отзыва
продукции, в соответствии с 6.3.5;
— выполнение логистических требований к проведению отзыва продукции, в соответствии с 6.4;
— оценка эффективности отзыва для внесения рекомендаций относительно порядка и процедур его
проведения, в соответствии с 6.6;
— завершение этапа мониторинга отзыва продукции органом надзора и прекращение активных действий,
в соответствии с 6.7.2.
4.7 Обучение и моделирование отзыва продукции
Персонал, несущий ответственность за проведение отзыва, должен быть ознакомлен с планом отзыва
продукции поставщика и обладать способностями и личными качествами, необходимыми для осуществления
отзыва продукции.
Планирование, обучение персонала и моделирование отзыва продукции поможет лучше подготовить
персонал к осуществлению отзыва, а также повысит вероятность того, что согласованные процессы будут
выполняться оперативно и эффективно в стрессовых условиях. Кроме того, может потребоваться, чтобы эта
деятельность осуществлялась в соответствии с требованиями контрактов, законов и страхования.
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ISO 10393:2013(R)
Таблица 1 – Обычные профессиональные знания и опыт, необходимые для отзыва продукции
Профессиональные Действия или обязанности
знания и опыт
Координация и Первое контактное лицо по инцидентам
руководство отзывом
Первоначальная сортировка и эскалация инцидента
продукции
Обеспечение уведомления соответствующих лиц
Подбор специалистов с соответствующим опытом
Проведение совещаний и обеспечение необходимых действий
Обеспечение своевременного сбора необходимой информации и регулярного
информирования соответствующих лиц
Обеспечение принятия своевременных решений
Обеспечение последовательного и управляемого обмена информацией
Обеспечение соответствующих внешних уведомлений и проведения брифингов
Обеспечение подготовки и распространения всех требующихся отчетов
Обеспечение процесса постоянного совершенствования и распределения
обязанностей
Технические/инженерные Проведение расследования инцидента, приведшего к отзыву продукции
Обзор внутренних записей, анализ систем качества и прослеживаемости отзываемой
продукции
Установление контактов с лабораториями, испытательными центрами и другими
экспертами, проводящими анализ или оценку риска
Обеспечение руководства процессом анализа или оценки риска
Обеспечение связи с поставщиками
Предоставление группе по отзыву продукции консультаций по техническим вопросам,
связанным с продукцией,
Участие в принятии решения об отзыве продукции
Оперативные Сбор записей по распространению продукции, обеспечение их точности и создание
реестра распространения продукции
Организация сбора, возврата, замены, ремонта и утилизации продукции
Обеспечение сохранения точных записей для определения эффективности отзыва
Управление логистическими требованиями, необходимыми для изъятия продукции из
обращения, ремонта, замены продукции на рынке, уничтожения дефектной
продукции, которая стала предметом отзыва
Реализация и маркетинг/ Установление и поддержание связи с пострадавшими потребителями
Отчетная документация
Обеспечение своевременной обработки запросов и ответов на вопросы
потребителей
Формирование запросов потребителей о замене продукции и организация кредитов,
компенсаций или замен пр
...
INTERNATIONAL ISO
STANDARD 10393
First edition
2013-04-15
Consumer product recall — Guidelines
for suppliers
Rappel de produits de consommation — Lignes directrices pour les
fournisseurs
Reference number
ISO 10393:2013(E)
©
ISO 2013
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ISO 10393:2013(E)
COPYRIGHT PROTECTED DOCUMENT
© 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 can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
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Published in Switzerland
ii © ISO 2013 – All rights reserved
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ISO 10393:2013(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Terms 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
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 recall .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 Corrective actions to prevent reoccurrence.21
Annex A (informative) Hazard and risk evaluation.22
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
Bibliography
.38
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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 in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
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 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 identifying 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 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
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ISO 10393:2013(E)
Introduction
There is a wide variety of products available to consumers in the global marketplace. Products routinely
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 regulations 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
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. 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
actions, 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 recall 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 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 increasing 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 Production Marketplace
IS0 10377 — Consumer product safety — Guidelines for suppliers
Design
Material Component
manufacture manufacture
ISO 10393 — Consumer product recall —
Manufacture Assembly
Guidelines for suppliers
Transport/ Import/
Storage Export
Distribute Retail
Consumer
Figure 1 — Relationship between this International Standard and ISO 10377
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INTERNATIONAL STANDARD ISO 10393:2013(E)
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. 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 Terms and definitions
For the purposes of this 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, personal 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
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 incorrect use of a product that is capable of being known or anticipated in advance, based
on a supplier’s best knowledge about the product and human behaviour
EXAMPLE Improper use by children or the elderly.
[SOURCE: ISO 10377:2013, 2.5]
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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 supplier’s 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 Guide 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 hazard).
[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 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 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, modified]
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 available information to identify hazards and to estimate the risk
[SOURCE: ISO/IEC Guide 51:1999, 3.10]
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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 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: 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, distributes 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 synonymous.
[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]
2.23
user
person who interacts with the product or service
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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 safety 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 element of the supplier’s 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 processes 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 effective 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 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 supplier 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 of 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 Clause 5);
— identification of the resources required and processes used to implement a recall (see Clause 6);
— establishing the requirement for continual improvement of the supplier’s processes (see Clause 7).
4.2 Policy
The supplier should develop and maintain a product recall policy and identify how decisions will be
made to carry out a product recall. The policy should contain a simple, clear and precise commitment
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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 control and maintain all documents and record data
relating to the recall programme for continual improvement, data analysis and facilitation of incident
investigation, product identification and traceability, such as the following:
— a copy of the recall policy and procedures;
— records of training and assessment of employee competency;
— records of consumer complaints and product safety incidents;
— records of risk assessment, which may include test reports, and risk analysis;
— records of the recall decision;
— records of communication, including the communication plan, materials, methods used and dates;
— evidence of the effectiveness of the recall, including return rates, effectiveness per method of
communication and evidence to show that the recall is working;
— financial records;
— records of repair, refurbishment or disposal.
4.4 Regulatory requirement
The supplier should identify, monitor, understand and comply with applicable legislative, regulatory and
standard requirements for recalls, in all markets where a consumer product is produced or sold.
4.5 Expertise required to manage a recall
The supplier should ensure that it has the expertise to investigate the incident, to assess the risk, to make
the recall decision and to carry out the recall. In larger suppliers, this may require the establishment of
a recall management team made up of staff from a range of functional areas.
Regardless of size, suppliers may need outside assistance from advisors and consultants. Arrangements
should be made with advisors and consultants so that they can develop an understanding of its recall
programme before an incident occurs.
The objectives of the people responsible for managing the recall are as follows:
— assess all available information and determine the actions necessary to do the following:
— protect the health or safety of consumers;
— maintain relationships with consumers and stakeholders;
— protect the reputation of the supplier;
— fulfil all relevant legal obligations (e.g. mandatory reporting) in all countries of distribution;
— liaise with relevant government and industry authorities;
— ensure that key stakeholders are kept informed of the supplier’s decisions and actions, including
forthcoming media communications;
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ISO 10393:2013(E)
— ensure that decisions and recall actions are implemented effectively with least disruption to the
normal operation of the supplier’s day-to-day business.
Table 1 lists the typical expertise required for a product recall.
4.6 Authority for key decision
The supplier should identify the person or people who have the authority to make the decision to
recall the product.
The key decisions that may need to be made are as follows:
— make a product recall decision and determine the scope of that recall, as discussed in 5.1;
— stop production and place product on hold during a product recall investigation, as discussed in 5.3;
— stop the sale of a product at any point in the supply chain, as discussed in 5.6;
— notify the regulator(s) about a product recall incident, comply with applicable regulatory
requirements, and report the progress of the recall to regulator(s), as discussed in 6.3.3;
— notify the supply chain about a product recall incident, as discussed in 6.3.4;
— communicate to consumers about actions that should be taken during a product recall, as
discussed in 6.3.5;
— execute the logistical requirements of the product recall, as discussed in 6.4;
— assess the effectiveness of the recall to make recommendations about its progress, as discussed in 6.6;
— bring an end to the monitoring phases of the product recall by the regulator and cease active recall
operations, as discussed in 6.7.2.
4.7 Training and recall simulation
The staff responsible for the recall should be familiar with the supplier’s product recall plan and have
the capabilities and personal attributes needed to implement the recall.
Planning, training and conducting recall simulations will help to better prepare people for a recall
and also increase the likelihood that agreed processes are implemented quickly and effectively under
conditions that can be stressful. In addition, these activities may be required to meet contractual, legal
and insurance requirements.
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ISO 10393:2013(E)
Table 1 — Typical expertise required for product recall
Expertise required Activities or responsibilities
Recall coordination and First point of contact for incidents
leadership
Initial sorting and escalation of the incident
Ensure notifications are made to appropriate people
Gather people with the appropriate expertise
Facilitate meetings and ensure required actions are carried out
Ensure information needed is collected in a timely manner and appropriate people
are updated regularly
Ensure timely decisions are made
Ensure all communications are consistent and controlled
Ensure appropriate external notifications and briefings are performed
Ensure all required reports are prepared and distributed
Facilitate continual improvement process and ensure follow up responsibilities are
delegated
Technical/Engineering Lead the investigation of the recall incident
Review internal records, quality systems and traceability of the affected product
Establish contact with laboratories and testing authorities and other experts per-
forming the risk analysis or risk assessment
Lead the risk analysis or risk assessment process
Act as a liaison with suppliers
Provide technical advice about the product to the team
Participate in the recall decision
Operations Gather distribution records, ensure they are accurate and create distribution reg-
ister
Manage collection, retrieval, replacement, repair and disposal of product
Ensure accurate records are kept to measure recall effectiveness
Manage the logistical requirements necessary to remove product from the mar-
ketplace, to repair or replace product in the marketplace and to destroy defective
product that was the subject of the recall
Sales and marketing/ Establish and maintain liaison with affected consumers
Accounts
Ensure consumer enquiries and concerns are addressed in a timely manner
Establish consumer needs for replacement products and arranges credits, refunds,
or replacements for the subject product
Participate in the recall decision
Finance/ Estimate costs of proposed actions, sources of funding and potential impact on
Risk management business
Notify insurer where required
Establish budget and monitor costs
Keep records for claims
Work with sales & marketing/accounts to arrange credits and refunds
Participate in the recall decision
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ISO 10393:2013(E)
Table 1 (continued)
Expertise required Activities or responsibilities
Legal counsel Ensure compliance with regulators’ requirements
Ensure compliance with contractual requirements with buyers and licensors
Provide advice to minimize organization’s liabilities arising from recall decision
and from day-to-day execution of recall plan
Participate in the recall decision
Communications Identify key audiences, with special focus in vulnerable groups
Assist in the development of the communication strategy and key messages
Establish and manage resources to handle enquiries (call centre, product recall
consultant)
Prepare communications and gain approval for release
Monitor clarity and usefulness of communications and recommend any changes
necessary to improve effectiveness.
A supplier should do the following:
— identify the people and organizations that may be needed to carry out recall activities, provide them
with the recall plan and make them aware of their responsibilities and authority to act during a recall;
— train people so that they understand their responsibilities and have the skills to carry out those
responsibilities during a product recall,
— practise the implementation of the recall plan through a simulated recall, in order to verify that the
recall plan is likely to be useful in a real recall situation;
— document and implement what has been le
...
SLOVENSKI STANDARD
oSIST ISO 10393:2018
01-september-2018
Odpoklic potrošniškega izdelka - Smernice za dobavitelje
Consumer product recall - Guidelines for suppliers
Rappel de produits de consommation - Lignes directrices pour les fournisseurs
Ta slovenski standard je istoveten z: ISO 10393:2013
ICS:
03.080.30 Storitve za potrošnike Services for consumers
13.120 Varnost na domu Domestic safety
oSIST ISO 10393:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST ISO 10393:2018
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oSIST ISO 10393:2018
INTERNATIONAL ISO
STANDARD 10393
First edition
2013-04-15
Consumer product recall — Guidelines
for suppliers
Rappel de produits de consommation — Lignes directrices pour les
fournisseurs
Reference number
ISO 10393:2013(E)
©
ISO 2013
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oSIST ISO 10393:2018
ISO 10393:2013(E)
COPYRIGHT PROTECTED DOCUMENT
© 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 can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
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Published in Switzerland
ii © ISO 2013 – All rights reserved
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oSIST ISO 10393:2018
ISO 10393:2013(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Terms 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
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 recall .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 Corrective actions to prevent reoccurrence.21
Annex A (informative) Hazard and risk evaluation.22
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
Bibliography
.38
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Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
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 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 identifying 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 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
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Introduction
There is a wide variety of products available to consumers in the global marketplace. Products routinely
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 regulations 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
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. 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
actions, 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 recall 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 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 increasing 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 Production Marketplace
IS0 10377 — Consumer product safety — Guidelines for suppliers
Design
Material Component
manufacture manufacture
ISO 10393 — Consumer product recall —
Manufacture Assembly
Guidelines for suppliers
Transport/ Import/
Storage Export
Distribute Retail
Consumer
Figure 1 — Relationship between this International Standard and ISO 10377
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oSIST ISO 10393:2018
INTERNATIONAL STANDARD ISO 10393:2013(E)
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. 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 Terms and definitions
For the purposes of this 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, personal 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
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 incorrect use of a product that is capable of being known or anticipated in advance, based
on a supplier’s best knowledge about the product and human behaviour
EXAMPLE Improper use by children or the elderly.
[SOURCE: ISO 10377:2013, 2.5]
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2.6
foreseeable use
use of a product that is capable of being known or anticipated in advance based on a supplier’s 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 Guide 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 hazard).
[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 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 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, modified]
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 available information to identify hazards and to estimate the risk
[SOURCE: ISO/IEC Guide 51:1999, 3.10]
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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 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: 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, distributes 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 synonymous.
[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]
2.23
user
person who interacts with the product or service
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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 safety 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 element of the supplier’s 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 processes 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 effective 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 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 supplier 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 of 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 Clause 5);
— identification of the resources required and processes used to implement a recall (see Clause 6);
— establishing the requirement for continual improvement of the supplier’s processes (see Clause 7).
4.2 Policy
The supplier should develop and maintain a product recall policy and identify how decisions will be
made to carry out a product recall. The policy should contain a simple, clear and precise commitment
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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 control and maintain all documents and record data
relating to the recall programme for continual improvement, data analysis and facilitation of incident
investigation, product identification and traceability, such as the following:
— a copy of the recall policy and procedures;
— records of training and assessment of employee competency;
— records of consumer complaints and product safety incidents;
— records of risk assessment, which may include test reports, and risk analysis;
— records of the recall decision;
— records of communication, including the communication plan, materials, methods used and dates;
— evidence of the effectiveness of the recall, including return rates, effectiveness per method of
communication and evidence to show that the recall is working;
— financial records;
— records of repair, refurbishment or disposal.
4.4 Regulatory requirement
The supplier should identify, monitor, understand and comply with applicable legislative, regulatory and
standard requirements for recalls, in all markets where a consumer product is produced or sold.
4.5 Expertise required to manage a recall
The supplier should ensure that it has the expertise to investigate the incident, to assess the risk, to make
the recall decision and to carry out the recall. In larger suppliers, this may require the establishment of
a recall management team made up of staff from a range of functional areas.
Regardless of size, suppliers may need outside assistance from advisors and consultants. Arrangements
should be made with advisors and consultants so that they can develop an understanding of its recall
programme before an incident occurs.
The objectives of the people responsible for managing the recall are as follows:
— assess all available information and determine the actions necessary to do the following:
— protect the health or safety of consumers;
— maintain relationships with consumers and stakeholders;
— protect the reputation of the supplier;
— fulfil all relevant legal obligations (e.g. mandatory reporting) in all countries of distribution;
— liaise with relevant government and industry authorities;
— ensure that key stakeholders are kept informed of the supplier’s decisions and actions, including
forthcoming media communications;
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— ensure that decisions and recall actions are implemented effectively with least disruption to the
normal operation of the supplier’s day-to-day business.
Table 1 lists the typical expertise required for a product recall.
4.6 Authority for key decision
The supplier should identify the person or people who have the authority to make the decision to
recall the product.
The key decisions that may need to be made are as follows:
— make a product recall decision and determine the scope of that recall, as discussed in 5.1;
— stop production and place product on hold during a product recall investigation, as discussed in 5.3;
— stop the sale of a product at any point in the supply chain, as discussed in 5.6;
— notify the regulator(s) about a product recall incident, comply with applicable regulatory
requirements, and report the progress of the recall to regulator(s), as discussed in 6.3.3;
— notify the supply chain about a product recall incident, as discussed in 6.3.4;
— communicate to consumers about actions that should be taken during a product recall, as
discussed in 6.3.5;
— execute the logistical requirements of the product recall, as discussed in 6.4;
— assess the effectiveness of the recall to make recommendations about its progress, as discussed in 6.6;
— bring an end to the monitoring phases of the product recall by the regulator and cease active recall
operations, as discussed in 6.7.2.
4.7 Training and recall simulation
The staff responsible for the recall should be familiar with the supplier’s product recall plan and have
the capabilities and personal attributes needed to implement the recall.
Planning, training and conducting recall simulations will help to better prepare people for a recall
and also increase the likelihood that agreed processes are implemented quickly and effectively under
conditions that can be stressful. In addition, these activities may be required to meet contractual, legal
and insurance requirements.
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Table 1 — Typical expertise required for product recall
Expertise required Activities or responsibilities
Recall coordination and First point of contact for incidents
leadership
Initial sorting and escalation of the incident
Ensure notifications are made to appropriate people
Gather people with the appropriate expertise
Facilitate meetings and ensure required actions are carried out
Ensure information needed is collected in a timely manner and appropriate people
are updated regularly
Ensure timely decisions are made
Ensure all communications are consistent and controlled
Ensure appropriate external notifications and briefings are performed
Ensure all required reports are prepared and distributed
Facilitate continual improvement process and ensure follow up responsibilities are
delegated
Technical/Engineering Lead the investigation of the recall incident
Review internal records, quality systems and traceability of the affected product
Establish contact with laboratories and testing authorities and other experts per-
forming the risk analysis or risk assessment
Lead the risk analysis or risk assessment process
Act as a liaison with suppliers
Provide technical advice about the product to the team
Participate in the recall decision
Operations Gather distribution records, ensure they are accurate and create distribution reg-
ister
Manage collection, retrieval, replacement, repair and disposal of product
Ensure accurate records are kept to measure recall effectiveness
Manage the logistical requirements necessary to remove product from the mar-
ketplace, to repair or replace product in the marketplace and to destroy defective
product that was the subject of the recall
Sales and marketing/ Establish and maintain liaison with affected consumers
Accounts
Ensure consumer enquiries and concerns are addressed in a timely manner
Establish consumer needs for replacement products and arranges credits, refunds,
or replacements for the subject product
Participate in the recall decision
Finance/ Estimate costs of proposed actions, sources of funding and potential impact on
Risk management business
Notify insurer where required
Establish budget and monitor costs
Keep records for claims
Work with sales & marketing/accounts to arrange credits and refunds
Participate in the recall decision
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Table 1 (continued)
Expertise required Activities or responsibilities
Legal counsel Ensure compliance with regulators’ requirements
Ensure compliance with contractual requirements with buyers and licensors
Provide advice to minimize organization’s liabilities arising from recall decision
and from day-to-day execution of recall plan
Participate in the recal
...
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