Consumer product recall — Guidelines for suppliers

ISO 10393:2013 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. ISO 10393:2013 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

Status
Published
Publication Date
15-Apr-2013
Current Stage
9093 - International Standard confirmed
Start Date
25-Jun-2019
Completion Date
25-Jun-2019

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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
---------------------- Page: 1 ----------------------
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.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2013 – All rights reserved
---------------------- Page: 2 ----------------------
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

© ISO 2013 – All rights reserved iii
---------------------- Page: 3 ----------------------
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
---------------------- Page: 4 ----------------------
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
© ISO 2013 – All rights reserved v
---------------------- Page: 5 ----------------------
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]
© ISO 2013 – All rights reserved 1
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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]
2 © ISO 2013 – All rights reserved
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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
© ISO 2013 – All rights reserved 3
---------------------- Page: 8 ----------------------
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

4 © ISO 2013 – All rights reserved
---------------------- Page: 9 ----------------------
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;
© ISO 2013 – All rights reserved 5
---------------------- Page: 10 ----------------------
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.
6 © ISO 2013 – All rights reserved
---------------------- Page: 11 ----------------------
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
© ISO 2013 – All rights reserved 7
---------------------- Page: 12 ----------------------
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
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.

---------------------- Page: 1 ----------------------
SIST ISO 10393:2018
---------------------- Page: 2 ----------------------
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
---------------------- Page: 3 ----------------------
SIST 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.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2013 – All rights reserved
---------------------- Page: 4 ----------------------
SIST 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

© ISO 2013 – All rights reserved iii
---------------------- Page: 5 ----------------------
SIST ISO 10393:2018
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
---------------------- Page: 6 ----------------------
SIST ISO 10393:2018
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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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
...

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