brc global standard for consumer products issue 3 uk free pdf

Issue 3

GLO

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BRC/RILA

ISSUE 3

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February 2010

British Retail Consortium

FOR CONSUMER PRODUCTS ISSUE 3

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BRC Global Standards Liability and Copyright Statements

Liability

BRC publish information and express opinions in good faith, but accept no liability for any error or omission in any such information or opinion including any information or opinion contained in this document.

Whilst the BRC have endeavoured to ensure that the information in this publication is accurate, they shall not be liable for any damages (including without limitation damages for pure economic loss or loss of business or loss of profits or depletion of goodwill or otherwise in each case, whether direct, indirect or consequential, or any claims for consequential compensation whatsoever (howsoever caused) arising in contract, tort (including negligence or breach of statutory duty), misrepresentation, restitution or otherwise, in connection with this publication or any information contained in it, or from any action or decision taken as a result of reading this publication or any such information.

All warranties, conditions and other terms implied by statute or common law are, to the fullest extent permitted by law, excluded.

Nothing excludes or limits the liability of BRC for death or personal injury caused by their negligence, for fraud or fraudulent misrepresentation or for any matter which it would be illegal for them to exclude or attempt to exclude liability for.

The Global Standard for Food Safety and the terms of the disclaimer set out above shall be construed in accordance with English law and shall be subject to the non-exclusive jurisdiction of the English Courts.

Copyright

© British Retail Consortium 2011

All rights reserved. No part of this publication may be transmitted or reproduced in any form (including photocopying or storage in any medium by electronic means) without the written permission of the copyright owner. Application for permission should be addressed to the Commercial Director of Global Standards at the British Retail Consortium, contact details below. Full acknowledgement of author and source must be given.

No part of this publication may be translated without the written permission of the copyright owner.

Warning: Any unauthorised act in relation to a copyright work may result in both a civil claim for damages and criminal prosecution.

For more information about BRC, contact

British Retail Consortium Second Floor 21 Dartmouth Street London SW1H 9BP Tel: +44 (0) 20 7854 8900 Fax: +44 (0) 20 7854 8901 email: [email protected] website: www.brcglobalstandards.com

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BRC Global Standard for Consumer Products

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Further information available at www.brcglobalstandards.com

How this publication is organised

The Global Standard for Consumer Products sets out requirements that a factory should adhere to in order

to be able to consistently produce safe, legal consumer products to the quality required by its customers. It

consists of the following sections:

Section I Overview

Provides a background to the Standard and an overview of the Standard scheme.

Section II Preparation and Planning

Explains the preparation and planning stages including the format of the Standard, how to establish the scope

of products for certification and how to assign the product group for the certification.

Section III Requirements

Details the requirements of the Standard with which a company must comply in order to gain certification.

Section IV Auditing and Certification

Provides information on the certification and auditing process, including selection of a certification body and

a description of the BRC Global Standards Directory.

Section V Operation and Governance of the Scheme

Describes the management and governance systems in place for the Standard and includes some

administrative information.

Appendices

Appendices 1–9 provide additional useful information, including details of other BRC Global Standards,

registration requirements for auditors, a certificate template, and a glossary of terms used throughout

this book.

Note: Frequently used words such as ‘shall’, ‘audit’, ‘auditor’, ‘quality’, ‘safety’, ‘legality’ and ‘risk’ are defined

in the glossary (Appendix 7). All glossary terms are italicised on first mention in each of the sections (Sections

I–V).

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BRC Global Standard for Consumer Products Further information available at www.brcglobalstandards.com

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Contents

Section 1 Overview 1

1 The Scope of the Standard (Issue 3) 3

2 Principles of the Standard 4

2.1 Senior management commitment 4

2.2 A risk-based system 4

2.3 Quality management system and suitable operating conditions 5

3 Regulatory Framework for Safe Consumer Products 5

3.1 Product safety legislation 5

3.2 Chemicals 6

3.3 Product standards 6

4 The Certification and Audit Process 6

Section II Preparation and Planning 7

1 Preparation – the Key to Success 9

1.1 Preparation time 9

1.2 For retailers 9

1.3 For manufacturers and packers 9

2 Scope of the Certification 9

2.1 Extension to scope 11

3 Product Groups 11

3.1 Assigning product groups 12

3.2 Audit level 12

3.3 Who determines the product group? 13

3.4 Guidelines for the use of the product group decision tree

for the manufacture of consumer products 13

Section III Requirements 17

1 Senior Management Commitment and Continual Improvement 20

2 Risk Management 21

2.1 Product scope and group determination 21

2.2 Legislative and safety requirements 21

2.3 Risk assessment – prior to production 22

2.4 Verification of the product risk assessment 23

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3 Management System 24

3.1 Policy statement 24

3.2 General documentation requirements 24

3.3 Organisational structure, responsibility and management authority 26

3.4 Internal audit 26

3.5 Purchasing, supplier approval and performance monitoring 27

3.6 Customer-supplied property 27

3.7 Corrective and preventive action 28

3.8 Traceability 29

3.9 Management of product withdrawal and product recall 30

3.10 Management of incidents and business continuity 30

3.11 Contract review and customer focus 31

3.12 Complaint handling 31

4 Site Standards 32

4.1 Location, perimeter and grounds 32

4.2 Internal site: factory layout, product flow and segregation 33

4.3 Building interiors 34

4.4 Staff facilities 35

4.5 Cleaning procedures 36

4.6 Waste/waste disposal 37

4.7 Pest control 38

4.8 Product transport, storage and distribution 39

4.9 Site security 39

5 Product Control 40

5.1 Pre-production reference samples 40

5.2 Chemical formulation control 40

5.3 Product packaging materials 41

5.4 Control of non-conforming materials 41

5.5 Handling requirements for specific materials 42

5.6 Stock control and product release 42

6 Product Conformity Assessment 43

6.1 Product analysis/testing 43

6.2 Inspections 45

6.3 Product claims 46

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7 Process Control 47

7.1 Control of operations 47

7.2 Control of incoming components and raw materials 47

7.3 Equipment and equipment maintenance 48

7.4 Foreign-body detection and control 49

7.5 Calibration and control of measuring and monitoring devices 50

7.6 Retained production samples 50

7.7 Final product packing and control 51

8 Personnel 52

8.1 Training and competency 52

8.2 Protective clothing 52

8.3 Hygiene practices 53

Section IV Auditing and Certification 55

1 Introduction 57

2 Getting Started 57

3 Self-assessment of Compliance with the Standard 58

4 Selection of a Certification Body 58

5 Company/Certification Body Contractual Arrangements 60

5.1 Administration fee 60

5.2 Auditor selection 60

6 Relationship with Other Certification Standards 60

7 Guidelines 60

7.1 Codes of practice/specific guidelines 60

7.2 Status of guidelines 61

8 Audit Preparation by the Company 61

8.1 Preparation prior to the initial audit 61

8.2 Duration of the audit 62

9 The On-site Audit 62

10 Non-conformities and Corrective Action 64

10.1 Non-conformities 65

10.2 Procedures for handling non-conformities and corrective action 65

11 Further Action by Certification Bodies 66

12 Grading of the Audit 67

12.1 Certification 67

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13 Audit Reporting 67

14 Ongoing Audit Frequency and Certification 68

14.1 Certificate expiry – justifiable circumstances 69

14.2 Seasonal or intermittent production 69

15 BRC Logos and Plaques 69

16 Communication with Certification Bodies 69

16.1 Certification body performance monitoring 70

16.2 Feedback 70

16.3 Complaints 70

17 Appeals 70

18 The BRC Global Standards Directory 70

18.1 Introduction 70

18.2 Directory functionality 70

Section V Operation and Governance of the Scheme 73

1 Accreditation of and Requirements for Certification Bodies 75

2 Technical Governance of the Global Standard for Consumer Products 77

2.1 The Governance and Strategy Committee 77

2.2 Technical advisory committees 77

2.3 The certification body cooperation groups 77

3 Effective Date of Issue 3 78

4 Acknowledgements 78

Appendices 79

Appendix 1 The Standard and its Relationship with Other BRC Global Standards 80

Appendix 2 Registration, Qualifications, Training 81 and Experience Requirements for Auditors

Appendix 3 Product Fields and Categories 83

Appendix 4 Grading Criteria, Action Required and Audit Frequency 85

Appendix 5 Certificate Template 86

Appendix 6 Explanation of Cycles for Certificate Validity, 87 Audit Frequency and Planning

Appendix 7 Glossary of Terms 92

Appendix 8 Acknowledgements 96

Appendix 9 Cross-reference Tables with ISO 9001: 2008 97

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Further information available at www.brcglobalstandards.com Section I Overview

SECTION I

OVERVIEW

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Section I

Overview

Welcome to the third issue of the Global Standard for Consumer Products (henceforward referred to as

the Standard).

The purpose of the Standard is to help manufacturing or contract-packing sites to reliably produce safe,

legal products to the quality levels specified by their customers or demanded by consumers. It defines the

management systems and working practices which, if followed, will assist companies to meet this goal. The

Standard forms the basis for an auditing and certification programme by which companies can demonstrate

their compliance with its requirements and be listed on a secure database of certificated suppliers.

This issue of the Standard has been extensively revised and updated to reflect the latest thinking in the

production of safe and legal consumer products for the global marketplace and is available in a number of

translations. It has been developed with advice and input from international stakeholders and in particular

British Retail Consortium (BRC) members in the UK in association with Retail Industry Leaders Association

(RILA) members in the USA.

The BRC and RILA are trade organisations representing the interests of their membership which comprise the

major retailers in the UK and USA. The Standard supports their commitment to offer safe, legal and high-

quality products to the consumer, but the use of the Standard is not limited to BRC/RILA members and may

be specified or used by other specifiers, purchasers, packers or manufacturers of consumer products.

1 The Scope of the Standard (Issue 3)The Standard sets out the requirements for the production and supply of safe and legal consumer products of

consistent quality. The products may be retailer-branded (private label) or branded, or be unbranded products

for use by other organisations.

The Standard focuses on the safety, legality and quality of the product to the consumer. It does not

encompass other important requirements applicable to manufacturing sites such as workplace health and

safety, environmental concerns, sustainability, security or ethical trading issues.

Compliance with the requirements of the Standard provides assurance that the factory processes take account

of safety, legality and quality and requires that the products produced have met any legal or customer-

required conformity assessment measures. The Standard does not result in a product safety mark being placed

onto products and does not replace or conflict with established technical product standards.

The Standard applies to manufacturing sites but does not apply to activities relating to wholesale,

importation, distribution or storage outside the direct control of the site. It does include the activities of

contract or assembly packers of consumer products. The Standard does not apply directly to importers and

cannot be used to assess importers’ operations. Importers may find it useful to request their manufacturers to

meet the Standard, as this will help them to meet their responsibilities to import safe and legal products.

The scope of the Standard is for non-food, manufactured products placed on the consumer market – i.e. sold

or given to consumers. It may also be used by companies producing components for consumer products,

provided that the items are also consumer products themselves. Examples of such products include pencils,

light bulbs, buttons and batteries. The Standard is not applicable to raw-material producers.

Specific exclusions from the scope of the Standard are:

■ products or activities covered by the current issues of other BRC Global Standards in the series:

● Global Standard for Food Safety (which includes pet food)

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● BRC/IoP Global Standard for Packaging and Packaging Materials. Note that companies producing

packaging materials solely for sale to the consumer may use the Global Standard for Consumer

Products. Packaging used in other circumstances or for dual consumer/trade use is covered by the

Global Standard for Packaging and Packaging Materials

● Global Standard for Storage and Distribution. This covers distribution or storage outside the direct

control of the production premises.

■ motor vehicles except those intended for use as toys or sports equipment and not used on the

public highway

■ fuels dispensed in bulk, or sold in refillable containers

■ pharmaceuticals which are supplied only by prescription from a medical practitioner

■ vitamins, minerals and herbal supplements

■ horticultural growing practice covering live plants, flowers and seeds or the cultivation of plants and

flowers and the media to grow them

■ live animals and pets.

The Standard shall be applied at the points of manufacture and subsequent storage and distribution which are

under the control of the manufacturer, prior to delivery to the retailer or customer.

A technical audit of a manufacturing site, such as to this Standard, forms only one part of the quality and

safety measures necessary to supply consumer products, and the decision to request a company to supply a

product rests with the individual retailer or customer.

2 Principles of the StandardA business must have a full understanding of the products produced, manufactured and distributed and have

systems in place to identify and control hazards significant to the safety and legality of the products. The

Standard is based on key components: senior management commitment, risk assessment of the product and

the process, and a systematic approach to managing identified risks.

2.1 Senior management commitment

Within a business, the safety, legality and quality of the products produced must be seen as a cross-functional

responsibility, involving many departments using different skills and expertise in the organisation. Effective

consumer products management extends beyond technical departments and must involve commitment from

production operations, engineering, distribution, management, procurement of raw materials, customer

feedback and human resource activity such as training.

The starting point for effective implementation of the Standard is the commitment of senior management to

the development of an all-encompassing policy as a means to guide the activities that collectively assure the

production of safe and legal consumer products.

2.2 A risk-based system

The Standard requires an evaluation of the risks that the products could present to the consumer when

the product is used in an intended or reasonably foreseeable way, taking account of the user types and

interactions with other products. The development of this risk assessment system requires the input of all

relevant departments and must be supported by senior management.

In cases where manufacturers are producing goods to a specification set by the customer, steps must still be

taken to ensure that safe and legal products are produced.

Note that, in the context of the Standard, risks relating to failure to meet legal or quality requirements must

be considered, as well as those directly related to the safety of the consumer.

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2.3 Quality management system and suitable operating conditions

The Standard requires the framework of management policies and procedures by which the organisation

will achieve the requirements in this Standard to be documented. It also expects the basic environmental

and operational conditions in a business that are necessary for the production of safe, legal products to be

put in place.

3 Regulatory Framework for Safe Consumer Products

3.1 Product safety legislation

The Standard is not intended to replace the requirements of any specific legal statutes regarding product

safety or quality which exist for an industry sector or product type. Demonstrating up-to-date knowledge of

and compliance with these requirements forms part of the audit to the Standard. Neither does the Standard

replace any need for compliance with individual product safety standards.

The complexity of legislation related to product safety is increasing with regard to both general safety

requirements and product or material-specific requirements. It is essential that companies have a means

of identifying, understanding and keeping up to date with legal statutes relevant to their products in the

countries or regions of intended sale.

Retailers in most countries are obliged to supply safe and legal products to their consumers and must take

all reasonable precautions to ensure this happens. They also need to be able to demonstrate that they have

taken adequate steps to meet such requirements. This obligation is usually shared to some extent with the

manufacturer, importer or brand owner but, in the context of retailer-branded products, the retailer will carry

the main responsibility.

This involves a number of activities, one of which is the verification of the technical competence of the

product’s suppliers. For many years, retailers either undertook this activity themselves, verifying competence

and performance against their own individual, internally developed standards, or they used third-party

auditing and inspection bodies. To improve efficiency and consistency, the BRC/RILA brought together

stakeholder groups to establish the basis for an updated technical standard for consumer products which

could be independently audited and would serve retailers around the world.

Companies producing products must be aware of the following types of legislation and research and keep

up to date with the specific requirements for the products being manufactured. Companies should also

ensure that any new legislation pertaining to safety or quality which is introduced between audit visits shall

be introduced and complied with in a timely manner. The BRC produces a number of sector-specific product

guidelines to accompany the Standard and provide assistance in this respect.

■ General requirements to supply ‘safe’ products.

■ Product liability laws to provide product which is ‘fit for purpose’ and does not cause injury or harm.

■ Product-specific laws defining detailed safety, quality or other legal requirements. This also includes any

obligations concerning declarations of conformity, traceability of products and any particular labelling

and warning requirements.

■ Any requirements to manufacture under specific conditions such as Good Manufacturing Practice (GMP)

or a formal quality management system.

■ Laws concerned with materials or chemicals used in production, or likely to be present as contamination

of the products.

■ The need for product ‘technical files’ and any requirements regarding mandatory reporting or recalling

of unsafe goods.

■ Any licensing or approvals systems needed to manufacture, import or sell products

■ Laws concerned with the packaging provided for the products.

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3.2 Chemicals

Many countries are developing legislation regarding chemicals in order to protect the safety of consumers and

the wider environment (for example, legislation governing the registration, evaluation and authorisation of

chemicals (REACH) and restriction of hazardous substances (ROHS) in Europe, and California Proposition 65

in the USA). Such legislation typically requires companies to be aware of the chemical nature and composition

of the materials used in their products, as well as the quantities. It may additionally contain registration or

authorisation procedures for some chemicals. Product-specific legislation (covering items such as toys, textiles

and electrical goods) increasingly includes limitations on the use of specific chemicals.

It can be difficult to evaluate such chemicals, since although the chemicals themselves may be toxic, the

exposure to a consumer from a single item may be such that the item does not itself pose a serious risk of

harm. It is also often the case that, provided the correct materials are chosen for manufacture, the subsequent

processes of manufacture have little effect on any chemical risks to the consumer. The Standard allows for

these issues by the choice of product group (see Section II) and the requirements for chemical control in

Section III.

3.3 Product standards

For many product types, voluntary or mandatory product standards exist. Some of these standards relate

to manufacturing specifications, whilst others are concerned with testing methods. Some standards have

been made mandatory by government agencies and must be respected but others are voluntary. It is

generally advisable to follow national, regional or international standards when these are available, even

if they are voluntary, since it is a straightforward way of demonstrating that products meet industry best

practice for the aspects covered. If companies choose not to adopt voluntary standards, they should have

alternative means of confirming that their products are safe and legal. In some countries there is a tradition of

using such voluntary consensus standards supported by product certification schemes as the main method of

meeting safety requirements.

4 The Certification and Audit ProcessWhen a site meets the requirements specified in the Standard, it may choose to be audited against the

requirements and become a ‘certificated site’. The audits and certificates are site specific so companies with a

number of manufacturing sites would need separate certification for each location. The Standard is a process

and product certification programme in which businesses are certificated upon completion of a satisfactory

audit by an auditor employed by an independent third party – the certification body.

In order for a business to receive a valid certificate on completion of a satisfactory audit, the organisation

must select a certification body approved by the BRC. The BRC lays down detailed requirements that a

certification body must satisfy in order to gain approval, as well as specific requirements for auditors with

regard to both auditing expertise and product-sector knowledge.

More information about the certification process and certification bodies is given in Sections IV and V of

the Standard.

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Further information available at www.brcglobalstandards.com Section II Preparation and Planning

SECTION II

PREPARATION AND PLANNING

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Section II

Preparation and Planning

1 Preparation – the Key to Success

1.1 Preparation time

In order for everyone to gain the most value from certification to the Global Standard for Consumer Products,

retailers and other specifiers should have a clear understanding of the demands it places on their suppliers

and the benefits that ensue. Equally, manufacturers need to plan carefully to achieve certification.

Both specifiers and companies seeking certification should understand that considerable effort may be

needed to work towards certification, especially for companies that have no previous experience of third-party

certification schemes or quality management systems certification.

It is important to set realistic timescales in which to gain certification and have a clear project plan to ensure

that all the necessary actions are completed before the certification audit visit.

After the audit visit, there is a short timescale allowed to correct any failures in order to meet the

requirements of the Standard, identified by the audit report as non-conformities. This is 60 days for a first

audit and 28 days for subsequent audits. For certification to be awarded, there is a limit to the number

of non-conformities allowed (see Appendix 4 for details). If the number of non-conformities exceeds that

allowed, or the non-conformities are not corrected within the allowed timeframe, a complete re-audit will

be needed before certification can be obtained. It is therefore not advisable to attempt an audit without

adequate preparation.

1.2 For retailers

Retailers and others contemplating specifying the use of the Standard by their suppliers are advised to inform

their suppliers and the certification bodies well in advance of the implementation requirement. This will ensure

that the companies have time for adequate planning and the certification bodies have suitable infrastructure,

such as auditor capacity, in place in the countries of demand and for the correct industry sectors. Retailers

may want to organise internal training to ensure that there is a good understanding of the Standard, and

it may be helpful to arrange supplier briefings or other training events to explain the requirements of the

scheme and other steps to implementation. Assistance with such matters is available from the BRC.

1.3 For manufacturers and packers

Figure 1 indicates the advisable steps for a manufacturer or assembly packer company seeking certification.

A more detailed explanation of the process is given in Section IV. Companies already certificated to previous

versions of this Standard should work through the ‘steps to certification’ but may find that many aspects have

already been addressed.

2 Scope of the CertificationThe scope of the certification must be agreed between the company and the certification body before an

audit takes place. In practice, a site should be clear about which products they wish to have included within

their certification from an early stage in their planning. Sites shall also identify the geographical locations

where the products may be placed on the market. Auditors are only allowed to audit sites that are within

the scope of their technical competence, so it is important that the certification body is fully aware of the

products to be included before they select an auditor for the visit.

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Stage 1 Learn

Stage 3 Preparation

Stage 5 Audit and

certifi cation

Stage 2 Plan

Stage 4 Pre-assessment*

Stage 6 Maintenance

• Visit the BRC website www.brcglobalstandards.com

• Obtain a copy of the Standard and study it

• Translations are available in a number of languages

• Obtain the interpretation guideline and any appropriate sector guidelines to assist understanding of the requirements

• Attend an introductory awareness training course (available from the BRC)

• What needs to be done? Carry out a gap analysis to identify the parts of the Standard which are not adequately covered

• Assemble and train a team of people to participate in risk assessment and other safety and quality matters

• Identify the product scope to be included in BRC certifi cation

• Obtain consultancy if required

• Establish the appropriate product group(s)

• Carry out or obtain risk assessments and ensure that control points in the process have been established

• Prepare procedures

• Check if the site is capable of meeting the requirements of the Standard

• Undertake internal audits

• Contact certifi cation bodies (CB)

• Select suitable CB

• Arrange a pre-assessment visit (*optional but recommended)

• Implement any identifi ed corrective actions

• Arrange an audit visit with an appropriate CB

• Ensure adequate preparations have been made and that senior management staff are available

• Audit is conducted

• CB presents audit report

• Carry out corrective actions within the allowed timescale (if necessary)

• Achieve certifi cation and gain entry onto the BRC directory

• Continue to meet requirements

• Arrange audit visit before certifi cate expiry

• Continuous improvement

Figure 1 Steps to certifi cation

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The audit, report and certificate shall be ‘product’ and ‘site’ specific. Each site shall be audited and the

certificate granted accordingly.

Sites should give careful consideration to selecting the scope of their certification. If the scope is too vague,

they may be exposed to more stringent than necessary auditing since the auditor will have to establish that

the systems and manufacturing processes would be appropriate for any product that could come within

scope. Alternatively, a very narrow product scope may mean that frequent extensions to scope or re-audits

are necessary for new products. Particular care should be given in the consideration of geographical areas,

especially when some regions have more onerous requirements than those pertaining to the country or

region overall.

The scope of the audit shall cover the agreed products or product categories. All products within a certain

area of the site and using the same production processes would normally be included in the audit. Different

types of products made on the same site or products clearly intended for different geographical regions may

be excluded from the scope. Other exclusions would need to be justified and should be confirmed prior to an

audit visit. The scope and any exclusions that apply to it must be clearly stated on the certificate.

The certification audit shall include an assessment of the entire process from raw material to end-product

dispatch and include all the requirements of the Standard. In rare circumstances a clause (or clauses) may

not be applicable to the operation. In this case, the justification must be detailed on the audit report and the

exclusion listed in the scope of certification.

Certification relates to the audit of all processes within the manufacture of a ‘product’, so in some cases the

certification body may carry out an audit at one or more premises for a specific product (e.g. when a product

is transferred to a different location for a finishing process). In the event that one or more premises are

audited under one product certification, the report and the certificate shall clearly indicate this information.

2.1 Extension to scope

Once certification has been granted, any additional significant products manufactured or processes

undertaken that are included in the scope of certification must be communicated to the certification body,

who will then conduct a site visit to examine the aspects of the required extension to scope. The current

certificate will be superseded by any new certificate issued, using the same expiry date as detailed on the

original certificate.

3 Product GroupsThe consumer products industry includes an extremely wide variety of products, involving a wide range of

materials and manufacturing processes. It is essential that the audit against the Standard is appropriate for

the nature of the product produced and its intended or foreseeable use. Some requirements may be essential

for some types of product but not particularly important for others. In order to make the requirements of the

Standard appropriate and to avoid unnecessary rigour when product safety, legality and quality are not at risk,

products have been divided into three product groups with regard to the level of legal requirements and likely

levels of risk to the consumer.

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The Standard divides products into three product groups:

Group 1 Products that have product-specific safety legislation and are required to be manufactured under hygienic conditions either by law or to prevent microbiological or other contamination that has the potential to cause serious injury or death during normal or foreseeable use of the product

Group 2 Products that have product-specific safety legislation or mandatory/harmonised product standards

and/or

Products that have the potential to cause serious injury or death if they fail during normal or foreseeable use

Group 3 Products that have no product-specific safety legislation or products where the only specific legislation is concerned with the toxicity resulting from consumer exposure to chemicals in articles, thus requiring the use of appropriate raw materials

The Standard contains decision trees (see Figures 2 and 3) which identify to which of the three product

groups a product belongs.

3.1 Assigning product groups

The company must first determine whether it is a manufacturer, contract or assembly packer by referring to

the definitions in the glossary (Appendix 7) prior to using the decision tree to determine the product group.

The chosen group needs to be verified and agreed by the certification body that will carry out the audit.

In the case of a novel product type or one on which there has been disagreement between parties, the

certification body or retailer should refer the item to the BRC who will present it to the Technical Advisory

Committee (see Section V for details about the committee) for adjudication concerning the appropriate

product group. Once agreed, the outcome will be published on the website. In urgent cases BRC technical

staff will determine the product group to be used for a specific audit and then refer to the Technical Advisory

Committee for a definitive decision, which must be followed in subsequent audits and for other products of

the same type.

3.2 Audit level

It is not acceptable, in any circumstances, for a company to be audited to a lower product group than that

into which the product falls when the assessment has been carried out. For example, a company cannot

choose to have a Group 1 product audited to Group 3 requirements.

Sometimes a specific product can be demonstrated (by means of a risk assessment and following the decision

tree) to be in a lower group than that which would usually be expected. In such a case, the reason for this

decision should be recorded on the certificate.

There are occasions when companies may decide to be audited to the requirements of a higher product group

than the one defined using the decision tree. This is acceptable, although not encouraged. If this approach is

taken, then the certificate must show both the level to which the factory was audited and the product group

resulting from the decision tree. This enables the product group assigned via the decision tree to be listed on

the BRC directory in order to help maintain consistency.

For further guidance, consult the decision trees (see Figures 2 and 3) and the BRC Global Standards website.

It is recognised that many manufacturers may produce products that fall into more than one group. In these

circumstances they may either choose to use the highest group for the entire site or ensure that suitable

segregation methods are in place to separate different products by areas. It is not acceptable for more than

one product group to be applied to the same area.

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Where there is any doubt, the category for higher risk products as expressed above should be adopted.

3.3 Who determines the product group?

The company shall follow the decision tree and determine the product group for the products being

manufactured and supplied. This product group shall be validated by the certification body, which will confirm

or reject the manufacturer’s decision. If the product group is determined by the certification body as being

higher than the manufacturer’s determined product group, the certification body can seek the manufacturer’s

agreement to be evaluated as the higher-risk product group. If agreement cannot be reached after consulting

the BRC Global Standards website www.brcglobalstandards.com for any guidance or position statements

that may be available, the matter can be referred by either party to the BRC Technical Advisory Committee for

adjudication by contacting the BRC technical services team via email at [email protected].

The company may also be required to provide the certification body with background information on the site

concerned, through the completion of either a pre-audit questionnaire or pro-forma information sheet.

3.4 Guidelines for the use of the product group decision tree for the

manufacture of consumer products

The purpose of the decision tree is to enable the user to determine the product group of any product in the

scope of the Standard. It is important to note that the product group is based on the risk to the consumer

for whom the finished product is intended or by whom it is likely to be used. When using the decision tree,

sources of contamination or other factors that could be introduced during the production and distribution

process, and which could potentially affect the safety, legality and quality of the finished product, shall also

be considered.

When evaluating the risk, the primary effect should be considered. For example, if a product can produce a

small abrasion then the injury is slight. The possibility that such injury could subsequently become infected

should not be taken into account unless the product itself is likely to cause the infection or it is specifically

intended for a user group with reduced immunity.

When evaluating the possibility of serious injury or death, the approach should generally be to consider the

individual product/products received by a consumer. For example, although the presence of trace carcinogenic

materials in a product may contribute to long-term illness, the individual product received by the consumer

will not itself cause serious injury or death. The control or avoidance of the toxic substance would still be an

essential part of the risk assessment and the use of such materials may be illegal.

For each product manufactured or assembled, each question is answered sequentially from the beginning,

until a ‘yes’ answer is reached. The first ‘yes’ determines the product group. Questions should be answered

based upon the risks and the legislation in the market where the finished product is intended to be sold to the

consumer. In the case where a product intended for multiple markets falls into different product groups, the

higher group shall be used.

The decision trees are detailed in Figures 2 and 3.

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Is this product defi ned as a pharmaceutical or a cosmetic, or is it

used invasively?

Does the product have product-specifi c legislation requiring hygienic

manufacture (e.g. GMP)?

Is there potential for contamination of the product which could cause

major injury or harm?

Does the product have any product-specifi c legal requirements

concerning safety or any harmonised or mandatory standards?

Does the product require risk or safety warning on the product

packaging, labelling or instructions?

Is the product in contact with skin during foreseeable use and/or does the product contain nanomaterials?

Can this product type cause death or major injury if it fails during

foreseeable use?

Is the product designed or clearly intended for vulnerable or very

vulnerable user groups?

Product group 1

Product group 1

Product group 1Biological contamination

or radiation

Is the product subject to mandatory labelling of

ingredients or components?

Product group 2Chemical or physical contamination

Are there signifi cant physical, chemical, electrical,

fl ammability, magnetic, acoustic or radiation risks?

Product group 2

Product group 2

Product group 2

Product group 2

Product group 2

Product group 3

Yes

Yes

Yes

Yes

Yes

No

Yes

Yes

Yes

Yes

Yes

Yes

Yes

No

No

No

No

No

No

No

No

Figure 2 Product group decision tree – manufacturer

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Yes

Yes

Yes

Yes

Figure 3 Product group decision tree – assembly packer

Use the manufacturer’s decision tree

Use the manufacturer’s decision tree

Could the introduced hazard cause injury or harm?

Does the assembly packing operation affect the requirements? (e.g.

warnings, labelling)

Yes

No

No

No

Finished components from manufacturer delivered to

packer

Bulk or unwrapped material for contract packing

Is the fi nished component subject to change?

Can the assembly process introduce more risks?

Does the product have any product-specifi c legislation/harmonised or mandatory

standards?

Product group 3

No

NoNo

Product group 2

Yes

Product group 3

Product group 2

Minor

Major

Yes

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Further information available at www.brcglobalstandards.com Section III Requirements

SECTION III

REQUIREMENTS

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Section III

Requirements

In Section III, each clause of the Standard begins with a highlighted paragraph in bold text, the ‘statement of intent’, which all sites must comply with in order to gain certification.

Below this statement of intent are requirements in a tabular format, which together specify the criteria against

which the audit will be carried out.

Certification depends on continued compliance, and within the Standard certain requirements have

been designated as ‘fundamental’ requirements. A fundamental requirement is marked with the word

‘FUNDAMENTAL’ immediately after the section heading and denoted with the following symbol . These

fundamental requirements relate to systems that are crucial to the establishment of an effective production

operation with regard to quality, safety and legality. The clauses deemed to be fundamental are:

■ Senior management commitment and continual improvement, clause 1

■ Risk management, clause 2

■ Corrective and preventive action, clause 3.7

■ Traceability, clause 3.8

■ Internal site: layout, product flow and segregation, clause 4.2

■ Cleaning procedures, clause 4.5

■ Product analysis/testing, clause 6.1

■ Control of operations, clause 7.1

■ Control of incoming components and raw materials, clause 7.2

■ Training and competency, clause 8.1

Failure to comply with the statement of intent of a fundamental clause leads to non-certification at an

initial audit or certification withdrawal at subsequent audits and will require a further full audit to establish

demonstrable evidence of compliance.

Not all of the clauses apply to all sites. The requirements depend upon the product group of the

products being produced. The clauses listed within each section are shaded to show which clauses apply to

which product groups. Those clauses applying to all product groups are listed first, followed by those only

required for the higher groups. Column 2 of the tables also details to which product group(s) an individual

clause applies.

Words in italics are defined in the glossary in Appendix 7. Glossary terms are italicised on first mention only.

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1 Senior Management Commitment and Continual Improvement

FUNDAMENTALThe company's senior management shall demonstrate that they are fully committed to the implementation of the requirements of the Global Standard for Consumer Products. This shall include provision of adequate resources, effective communication, systems of review and actions taken to identify and effect opportunities for improvement.

Clause Product group Requirements

1.1 AllThe company's senior management shall ensure that product safety and quality objectives are established, documented, monitored and reviewed at least annually.

1.2 All

The review process shall be documented and shall include an evaluation of:

● Internal, customer and external audits

● Previous management review documents, corrective action plans and timeframes

● Customer performance indicators, complaints and feedback

● Incidents, non-conforming materials and corrective actions

● An assessment of process performance

● A review of the product risk assessment system

● A review of the results of monitoring and testing

● Developments in legal requirements or scientific information associated with the products in scope

● Resource requirements.

1.3 All

The decisions and actions agreed shall be effectively communicated to appropriate staff and the actions implemented within the agreed timescales. Records should be updated to show when actions have been completed.

1.4 All

The company's senior management shall provide the human and financial resources required to implement and improve the processes of the quality management system, the product risk assessment plan and to address legal, product safety and product quality matters.

1.5 All

There shall be clear communication and regular reporting of the functioning of, and compliance with, the Standard to senior management by the staff responsible. This shall include suggestions for improvement.

1.6 AllThe company shall have a current, original copy of the Standard available on site.

1.7 1 and 2Where required by legislation, the site shall be registered with or approved by the appropriate government agency and evidence of this shall be available.

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Risk Management

FUNDAMENTALThe company shall have a management process in place to assure product safety, legality and quality, based on risk assessment principles. Sites must be aware of and refer to up-to-date legislation, product standards, codes of practice and developments in science or technology that may impact the risk concerning their products and packaging where these exist in the regions of intended sale.

2.1 Product scope and group determination


2.1.1 AllThe company shall identify the range of products it wishes to include in the scope of certification and the countries/states or regions for which the products are to be made available for sale.

2.1.2 AllThe company shall establish and document the product group(s) assigned to the products in scope, derived from application of the questions indicated in the decision tree (see Section II, 3.4).

2.2 Legislative and safety requirements


2.2.1 All

The company shall have and use a system, which may comprise internal and/or external resources, to demonstrate knowledge of all legislation, product standards, product safety issues, scientific and technical developments, and industry/customer codes of practice in the regions of intended sale relevant to the products in scope.

2.2.2 AllIf the company relies on information concerning product safety, quality and legality provided by their customer or related party, it shall validate the information received and document the validation process.

2.2.3 All

A documented process shall exist for incorporating changes in legislation, standards etc. into the company’s procedures in a timely fashion, which shall be before any official implementation date of the relevant change.

2.2.4 AllCopies of applicable legislation, standards, codes of practice and similar documents shall be available to relevant staff.

2

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2.3 Risk assessment – prior to production


2.3.1 All

A design specification covering each product shall be documented, dated and authorised. This shall include all relevant information.

As a guide, this may include the following, although this is not an exhaustive list:

● composition, size, colour

● bill of materials

● assembly diagrams

● primary packaging

● intended shelf life

● warnings or instructions for use

● use, misuse, usage patterns

● production volumes.

Any changes to the product design shall be documented and dated.

2.3.2 AllThe company shall determine and list the legal statutes and mandatory standards applicable to each product and to the materials from which it is made, relevant in the regions of intended sale.

2.3.3 All

The company shall ensure that a product hazard and risk assessment is available and clearly identifies:

● The hazards, the risk level for each hazard and whether the risk is acceptable

● The person responsible for the assessment

● The date performed and the evidence (for example, sample drawings, computer graphics) from which the assessment was derived.

This risk assessment may be provided by internal or external resources.

If the product requires modification, a new risk assessment shall be completed on the modified design.

2.3.4 AllNo products deemed to present an unacceptable risk by the assessment described in clause 2.3.3 shall be produced.

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2.4 Verification of the product risk assessment


2.4.1 AllThe company shall ensure that risk assessments have been carried out by competent staff (internal or external) and shall document the way in which this is assessed.

2.4.2 All

The risk assessment shall be regularly, and at least annually, reviewed (while the products are still in production) to ensure that the assessment remains up to date, takes account of complaints or incidents with the product or similar products and reflects any changes in legislation.

2.4.3 1 and 2The risk assessment shall be carried out before production begins, and completion shall be verified by a designated responsible person. If customer sign-off is part of the contract of sale, this shall be obtained.

2.4.4 1 and 2

Where there is a legal requirement to do so or when it is necessary to confirm its safety or legality, a representative product should be submitted for testing to a suitably qualified and accredited laboratory (internal or external). The results of the test should form part of the risk assessment.

2.4.5 1 and 2

Aspects of the product design/materials that are critical to safety and which must be maintained in production shall be established with the risk assessment provider and the control limits set on these features or materials.

2.4.6 1 and 2

Where legally required, the identity, qualifications and/or licence of the person producing the safety review or risk assessment shall be documented and verified.

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Management System

3.1 Policy statement


3.1.1 All

The policy shall state the company's intention to produce safe and legal products to the specified quality (and to meet its responsibility to its customers). This shall include the commitment for review and continual improvement.

3.1.2 AllThe company's senior management shall ensure the policy statement is communicated to and understood by all staff involved with activities relating to product safety, legality and quality.

3.2 General documentation requirements

3.2.1 Documentation control

The company's senior management shall ensure that all documents, records and data critical to the management of product safety, legality and quality are in place and effectively controlled.


3.2.1.1 AllAll documents in use shall be the current versions, authorised and dated, and a procedure shall be in place to ensure that obsolete documentation is removed from use.

3.2.1.2 AllDocuments shall be clearly legible, unambiguous, in appropriate languages and sufficiently detailed to enable their correct application by staff. They shall be readily accessible to relevant staff at all times.

3.2.1.3 AllChanges or amendments to documents shall be authorised and dated and the reason for the change recorded.

3.2.2 Record completion and maintenance

The company shall maintain records to demonstrate the effective control and achievement of product safety, legality and quality.


3.2.2.1 All

The records shall be legible, genuine, appropriately authorised and retained in good condition for a period which takes account of the product lifetime and is consistent with the legal requirements in the country of manufacture or sale. Customer-specific requirements relevant to record retention shall be respected.

3.2.2.2 AllThe company's senior management shall ensure that procedures are operated for the collation, review, maintenance, storage and retrieval of all records relating to product safety, legality and quality.

3.2.2.3 AllAny alterations to records shall be visible and authorised, and the justification for alteration shall be recorded.

3

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3.2.3 Specifications and technical information dossiers

The company shall ensure that specifications exist for raw materials, components and bought-in components including packaging, intermediate/semi-processed and finished products and any product or service that could affect the integrity of the finished product. A technical dossier shall be established for each product.


3.2.3.1 AllSpecifications shall be adequate and accurate, and shall ensure compliance with relevant safety, legislative and customer requirements. They shall be accessible to relevant staff.

3.2.3.2 All

Companies shall maintain a technical dossier containing all relevant data (or details of where such data is located) to ensure that products meet the requirements of the Standard. For example:

● detailed product specification (see clause 2.3.1)

● bill of materials

● safety data sheets on all chemicals used where relevant to the safety, legality or quality of the product

● risk assessment(s)

● description of the conformity assessment procedure

● test reports, inspection reports

● list of the legislation, product standards with which the products are manufactured to comply

● production control procedures and charts

● approvals by any government body (if applicable)

● declarations of conformity to legal requirements (if applicable).

3.2.3.3 1 and 2

The company shall seek formal agreement of specifications with relevant parties. Where specifications are not formally agreed, then the company shall be able to demonstrate that they have taken steps to seek formal agreement.

3.2.3.4 1 and 2There shall be a documented procedure for the amendment and approval of specifications for all parts of the process including regular reviews to ensure adequacy and status.

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3.3 Organisational structure, responsibility and management authority

The company shall have a clearly defined and documented organisational structure that ensures the awareness of job function, responsibilities and reporting relationships of key staff.


3.3.1 AllThe company shall have an organisation chart demonstrating the structure of the company.

3.3.2 AllDocumented, clearly defined responsibilities shall exist and be communicated to key staff with responsibility for product safety, legality, product quality, and management systems.

3.3.3 All

A named individual with relevant experience and qualifications shall be responsible for the management of the legal, quality and safety requirements laid out in this Standard. This responsibility should not present a conflict of interest with any other responsibilities.

3.3.4 AllThere shall be appropriate documented arrangements in place to cover for the absence of key staff.

3.3.5 All

The company's senior management shall ensure that a description of general duties or work instructions is in place and communicated to all staff involved with activities relating to product safety, legality and quality.

3.4 Internal audit

The company shall audit the management system to ensure that it is complied with and appropriate.


3.4.1 All

Internal audits shall cover all aspects associated with the Standard. They shall be scheduled and their scope and frequency shall be established commensurate with the risks associated with the activity. Audits of aspects that directly affect safety, legality or quality shall be conducted at least annually. Exceptions resulting in audit intervals of more than one year shall be justified by documented risk assessment.

3.4.2 AllInternal audits shall be carried out by competent auditors, who shall be independent of the area of operation being assessed. Auditors shall not audit their own work.

3.4.3 AllCorrective actions shall be formally agreed by the person responsible for the action and implemented within appropriate and agreed timescales.

3.4.4 All

A record of all programmed internal audits and associated corrective actions shall be maintained with both conformity and non-conformity with the requirements documented. All corrective actions shall be verified to ensure satisfactory completion.

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3.5 Purchasing, supplier approval and performance monitoring

The company shall control all purchasing processes which are critical to product safety, legality and quality to ensure that procured products and services conform to defined requirements. In this context suppliers shall include subcontractors and home workers.


3.5.1 All

The site shall have a documented supplier-approval procedure, including a list of approved suppliers for products, materials and services impacting product safety, legality or quality.

Procedures shall be established which include clear criteria for ongoing assessment and the standards of performance required. Ongoing assessment may take the form of monitoring performance through one or more of the following, although there may be other acceptable methods:

● in-house checks

● certificates of analysis

● certificate of conformity

● supplier audits

● traceability checks.

Records of this monitoring shall be retained for at least the lifetime of the product.

3.5.2 All

The company shall review the performance of new suppliers against defined criteria within a specified 'trial' period and thereafter at a specified frequency to decide the level of ongoing supplier performance monitoring.

3.5.3 All

The procedures shall identify whether the use of unapproved suppliers is acceptable under any emergency or unusual situations. If this is the case, the procedure shall define how exceptions are recorded and how they are handled to maintain safety, legality and quality of the products.

3.6 Customer-supplied property

The company shall exercise care with customer property (including intellectual property) while it is under the company’s control or is being used by the company.


3.6.1 All

The company shall identify, verify, protect and safeguard customer property including software, intellectual property and products. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained.

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3.7 Corrective and preventive action

FUNDAMENTALThe company's senior management shall ensure that procedures exist to record, investigate, analyse and correct the cause of non-conforming products or failure to meet standards, specifications and procedures which are critical to product safety, legality and quality.


3.7.1 All

The company shall operate an effective system for the capture, recording and timely investigation of non-conformities or matters reported as possible non-conformities critical to product safety, legality or quality.

3.7.2 AllCustomer complaints concerning actual or potential product non-conformity shall be included in the system.

3.7.3 AllAn appropriate staff member shall be identified and allocated the responsibility and accountability for each corrective action. This shall be documented.

3.7.4 AllThe company shall ensure that effective corrective actions are taken to prevent recurrence of the problem and shall monitor and record their completion within an appropriate timescale.

3.7.5 AllThe company shall review its processes at least annually, incorporate industry best practice and adopt preventive measures as they become available.

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3.8 Traceability

FUNDAMENTALThe company shall have a system to identify and trace product lots/batches including raw materials, components and packaging materials and follow this from the source of the incoming material through all stages of processing to supply of the product to the primary customer and vice versa in a timely manner.

Materials identified as low risk to the safety, legality or quality of the final product may be exempted from lot

traceability.


3.8.1 AllCompanies shall be able to identify the immediate source of all raw materials, components and packaging materials.

3.8.2 AllThe products that constitute a lot/batch shall be defined and documented. This shall include products made by continuous production methods.

3.8.3 All

Identification of lots/batches of raw materials including packaging, processing aids, intermediate/semi-processed products, part-used materials, finished products and materials pending investigation, shall be adequate to ensure traceability.

3.8.4 AllFinal products shall be suitably marked, at least on their outer packaging to allow adequate identification and traceability.

3.8.5 AllTraceability must, in all cases, be available for each lot/batch from source of raw material to supply to the primary customer.

3.8.6 AllThe traceability system shall be maintained when rework or any reworking operation is performed.

3.8.7 All

The company shall test the traceability system to ensure traceability can be determined from raw-material receipt to finished product and vice versa. This shall occur at a predetermined frequency, at least annually, and results shall be retained. The time taken to complete the exercise shall be measured and recorded.

3.8.8 All

When the same component or material is sourced from more than one supplier, the traceability system shall ensure that the lots/batches from each supplier can be identified if the component/material is identified as critical to safety, quality or legality.

3.8.9 AllChanges in materials, processes or components shall be traceable if they could affect the safety, quality or legality of the product and formally agreed by the customer if contractually required.

3.8.10 AllSubcontracted manufacture of products or components (including home working) must be traceable to a level appropriate to the risk.

3.8.11 1 and 2The need for further traceability through the chain should be established, based on the risk assessment and any legal or specific customer requirements.

3.8.12 1 and 2For continuous production processes, methods of defining traceability levels must be documented and based on the risk assessment.

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3.9 Management of product withdrawal and product recall

The company shall have a plan and system in place to effectively manage product withdrawal and product recall procedures.


3.9.1 All

The company shall have a product recall procedure in place to effectively manage product withdrawals and recalls. Procedures shall exist to ensure that customers are notified immediately on issues of significance to the customer or consumer in terms of product safety, quality or legality.

3.9.2 AllThe company shall have written agreements in place with distributors and other parties in the supply chain where these are necessary to ensure effective withdrawal/recall.

3.9.3 All

In the event of a product recall, the certification body issuing the current certificate and the appropriate enforcement authorities shall be informed in a timely manner. The company shall be aware of and adhere to any legal reporting obligations in the regions of sale.

3.9.4 1 and 2

The product recall and withdrawal procedures shall be documented and regularly tested, at least annually, in a way that ensures their effective operation. Results of the test shall include timings of key activities and shall be retained.

3.9.5 1 and 2The company's senior management shall ensure that results of this test shall be used to implement improvements as necessary.

3.10 Management of incidents and business continuity

The company shall have procedures in place to identify methods of ensuring business continuity in the case of incidents and/or informing their customers when incidents occur.


3.10.1 All

The company shall provide written guidance to relevant staff regarding the type of event that would constitute an incident or emergency situation that impacts product safety, legality or quality, and a documented reporting procedure shall be in place which shall include informing their customers in a timely manner.

3.10.2 1 and 2

The company shall develop contingency planning for business continuity in the event of major incidents such as:

● disruption to key services – e.g. water, energy, staff availability

● events such as flood, fire and natural disaster

● malicious contamination or sabotage.

3.10.3 1 and 2

The procedures shall include as a minimum:

● identification of key staff constituting the incident management team and their key responsibilities

● an up-to-date list of key contacts, with details of agencies providing advice and support.

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3.11 Contract review and customer focus

The company's senior management shall ensure that processes are in place to determine any customer requirements and expectations with regard to product safety and quality, and ensure that these are fulfilled.


3.11.1 AllCustomer requirements shall be documented, reviewed and confirmed on a suitable predetermined frequency. Any resulting changes shall be documented and communicated to relevant departments.

3.11.2 AllIn the case where customers have set particular performance indicators to be monitored, these requirements shall be communicated, adhered to and reviewed at least annually.

3.11.3 1 and 2The company shall clearly identify those individuals responsible for communication with customers and shall have an effective system for communication.

3.11.4 1 and 2Performance indicators relating to customer satisfaction shall be established and communicated to relevant staff, and performance reviewed against these targets.

3.12 Complaint handling

The company shall operate an effective system for the capture, recording and investigation of product complaints.


3.12.1 AllA system shall be in place to capture, record and investigate all complaints relating to product safety, legality and unusual or critical quality defects, and the results of the investigation shall be recorded.

3.12.2 All

Where complaints are investigated externally on behalf of the company, the responsibilities of the parties shall be defined and the process shall be documented. Companies shall seek to obtain the results of any investigations carried out by such parties.

3.12.3 AllActions appropriate to the seriousness and frequency of the problems identified shall be carried out promptly and effectively by trained staff.

3.12.4 1 and 2Complaint data shall be analysed and used to implement ongoing improvements to product safety, legality and quality, and to avoid recurrence. This analysis shall be made available to relevant staff.

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Site Standards

4.1 Location, perimeter and grounds

Sites used for manufacturing, storage or distribution shall be of suitable size, location, construction and design to facilitate maintenance, prevent contamination and enable the production of safe and legal products.


4.1.1 AllThe site to be included in the audit shall be clearly defined, and shall be located and maintained so as to allow the production of safe and legal products.

4.1.2 All

Consideration shall be given to local activities and the site environment, which may have an adverse impact on product integrity.

Measures adopted at the site to protect the product from any potential contaminants shall be regularly reviewed to ensure that they continue to be effective.

4.1.3 All The external areas and surroundings shall be maintained in good order.

4.1.4 AllExternal traffic routes that are under site control shall be maintained in good repair to avoid contamination of the product.

4.1.5 AllThere shall be no evidence of facility damage due to inadequate drainage.

4

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4.2 Internal site: factory layout, product flow and segregation

FUNDAMENTALPremises and plant shall be suitably designed, constructed and maintained so as to control the risk of product contamination and to comply with all relevant legislation.


4.2.1 AllThe building shall be maintained to minimise potential for product contamination.

4.2.2 AllThe machinery and equipment shall be positioned to allow an efficient product flow from incoming to outgoing and shall be arranged to minimise the risk of product contamination and damage.

4.2.3 All A process flow diagram shall be available.

4.2.4 AllPremises shall allow sufficient working space and storage capacity to enable all operations to be carried out under safe and, if necessary, hygienic conditions.

4.2.5 All

There shall be effective segregation to minimise the risk of product cross-contamination taking into account the flow of product, nature of materials, equipment, personnel, waste, airflow, air quality and utilities.

When critical to product safety, legality, quality or customer requirements, controls shall be in place to ensure that raw materials, work in progress, rework, packaging and finished products of different specifications are not inadvertently mixed.

4.2.6 1 and 2The location of facilities and services, including toilets, cleaning and catering facilities, shall not jeopardise the integrity of the product.

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4.3 Building interiors

The internal site, buildings and facilities shall be suitable for the intended purpose. All utilities to and within the production and storage areas shall be designed, constructed, maintained and monitored to effectively control the risk of product contamination.


4.3.1 All

The quality and finish of site buildings and facilities, including drainage when required, shall be suitable for the intended purpose with due regard to the risk of product safety, legality and quality, and shall be maintained to an appropriate standard.

This shall include:

● A clean, tidy and clutter-free factory

● Adequate lighting

● Suitable and sufficient removal of any by-products and contaminants

● Impervious floors, in good repair and able to withstand cleaning procedures.

4.3.2 1 and 2

Potential contamination risk from buildings and overhead structures, including building voids, shall be controlled through regular documented inspections, and corrective action shall be taken to prevent the risk of product contamination.

4.3.3 1 and 2

The site shall be assessed for any particular requirements relevant to the products being produced, such as temperature, humidity and electrostatic discharge. Any identified requirements shall be adopted, documented, monitored and regularly reviewed.

4.3.4 1Walls, floors, ceilings, pipe-work and overhead structures shall be designed, constructed, finished and maintained to reduce condensation and mould growth, and shall have access to facilitate cleaning.

4.3.5 1

All water used as an ingredient of the products or preparation of the products where it may come into direct contact with the product shall be potable (as defined in the region of intended product sale), or suitably treated to prevent contamination, and shall be regularly monitored.

4.3.6 1

Water in the form of water, ice or steam used for cleaning or in connection with any operation in the manufacture of products shall comply with legal requirements in the country of use and present no risk to the safety, legality or quality of the products.

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4.4 Staff facilities

Staff facilities shall be sufficient to accommodate the required number of personnel, and shall be designed and operated to minimise the risk of product contamination. Such facilities shall be maintained in good and clean condition.


4.4.1 AllStaff facilities such as washrooms, canteens and break areas shall be designed and operated so as to minimise the risk of product contamination.

4.4.2 1 and 2

Where smoking is allowed under national law, designated controlled smoking areas shall be isolated from production areas to an extent that ensures smoke cannot reach the product. Adequate arrangements for dealing with smokers' waste shall be provided both internally and externally.

4.4.3 1 and 2Storage facilities of sufficient size to accommodate all reasonable personal items shall be provided for all personnel who work in areas where they are unable to keep possessions with them.

4.4.4 1

Where specific work-wear is required, designated changing facilities shall be provided for all personnel: staff, visitor or contractor. These shall be sited to allow direct access to the production, packing or storage areas without recourse to any external area. Where this is not possible, a risk assessment shall be carried out and procedures implemented accordingly.

4.4.5 1Outdoor clothing and other personal items shall be stored separately from work-wear within the changing facilities.

4.4.6 1

Suitable and sufficient hand-cleaning facilities shall be provided at access to, and at other appropriate points within, production areas.

Information on how to clean hands shall also be provided near hand-cleaning points.

4.4.7 1All food brought into manufacturing premises by staff shall be stored in a clean and hygienic state. No food shall be taken into storage, processing or production areas.

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4.5 Cleaning procedures

FUNDAMENTALHousekeeping and cleaning systems shall be in place which ensure that adequate standards of cleanliness and tidiness are maintained at all times and the risk of contamination is minimised.


4.5.1 AllCleaning practices shall be completed so as to minimise risk of contamination.

4.5.2 AllCleaning and, where necessary, disinfection procedures shall be revalidated following building or maintenance work, changes to equipment or introduction of new product types.

4.5.3 All

Cleaning, pest control and process-aid chemicals shall be suitably identified and controlled to prevent the risk of product contamination. They must be clearly labelled and no chemicals shall be decanted unless into properly labelled and identified containers. Adequate storage facilities shall be provided and sited so as not to compromise the safety, legality and quality of the product.

4.5.4 All

If cleaning services are outsourced, the service providers shall have signed a contract which identifies the scope and frequency of the work, and a log book shall be maintained as a record of work done. A defined company representative shall be responsible for ensuring that the work is carried out satisfactorily.

4.5.5 1 and 2

Documented cleaning procedures shall be in place and maintained for the building, utilities, plant and all equipment. Cleaning procedures shall include the following information as a minimum:

● responsibility for cleaning

● item/area to be cleaned

● frequency of cleaning

● method of cleaning

● cleaning materials to be used

● cleaning records and responsibility for verification.

4.5.6 1 and 2Cleaning and housekeeping shall be carried out by trained personnel in accordance with documented procedures, and records shall be maintained.

4.5.7 1

The effectiveness of cleaning and sanitation shall be verified and documented. Corrective actions shall be documented.

Cleaning procedures shall be revalidated following building work, maintenance, changes to equipment or new product introduction.

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4.6 Waste/waste disposal

There shall be adequate systems for the collection, collation and disposal of waste material.


4.6.1 AllSystems shall be in place to prevent the accumulation of waste in production areas, and to prevent the use of unfit or defective materials.

4.6.2 All

Waste shall be categorised according to legislative requirements based on the intended means of disposal, segregated if necessary and collected in suitably designated waste containers.

Where legally necessary, it shall be removed by identified, licensed contractors, and records of disposal shall be maintained by the company.

4.6.3 All

Products which are to be disposed of on safety grounds, as the result of a recall or withdrawal or as substandard trademarked materials, shall be disposed of securely. This may be delegated to a specialist in secure waste disposal. Records of such material destruction or disposal shall be maintained.

4.6.4 AllWaste materials shall be suitably quarantined and routed to ensure that they are not reintroduced into non-waste production flows.

4.6.5 AllExternal waste collection containers and compactors shall be managed in such a manner as to minimise risk to the product if necessary.

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4.7 Pest control

The company shall be responsible for minimising the risk of pest infestation on the site.


4.7.1 All

The company shall be responsible for identifying and controlling the risk of pest infestation and shall operate pest control procedures. If no pest control is conducted the company shall have a full justification for its absence, including its customers’ acceptance. The justification shall be reviewed at least annually. (Note: If there is a justified absence of pest control then the other clauses in this section are not applicable.)

4.7.2 AllThe company shall either have a clearly defined contract with external contractors which reflects the activities of the site, or have trained staff.

4.7.3 AllWritten procedures and inspection documentation for pest control shall be maintained including a log book of work completed.

4.7.4 All

In the event of infestation, immediate action shall be taken to eliminate the hazard and this shall be documented. Action shall be taken to identify, evaluate and authorise the release of any product potentially affected.

4.7.5 AllFull material safety data sheets (MSDS) for all chemical pest control agents used must be available to relevant staff at all times and kept in a designated place.

4.7.6 AllBait stations shall be robustly constructed, operational and effective in killing the target pests and be positioned to avoid potential contamination of materials and products.

4.7.7 All

When necessary, materials or products shall be fumigated, and records of this process shall be kept. Fumigated goods may not be supplied to customers without full professional safety clearance and correct clearance documentation. All fumigation operations shall be controlled by staff with appropriate professional qualifications.

4.7.8 1 Drains should be fitted with screens and traps to prevent pest entry.

4.7.9 1

Fly-killing devices and/or pheromone traps shall be correctly sited and be operational.

The design and location of flying-insect detectors, killers and traps used shall not cause contamination of products in production.

4.7.10 1 Bait stations shall be tamper resistant.

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4.8 Product transport, storage and distribution

All facilities used for the storage and transportation of product, movement around the site, and dispatch of finished product shall be suitable for the purpose and maintained in good repair.


4.8.1 All

The company shall ensure that the transport and storage of products is within its control, from delivery of raw materials and components to finished product. Dispatch shall be undertaken in such a way as to prevent the risk of contamination and damage.

4.8.2 AllWhere storage is necessary, at any stage, all items shall be securely protected from contamination, deterioration and damage.

4.8.3 AllAll transportation shall be in good repair and in a clean/hygienic condition as necessary depending on the product group.

4.8.4 AllWhere the product transported is susceptible to weather damage, vehicles shall be loaded and unloaded so as to protect the product.

4.8.5 AllWhere the product needs specific environmental requirements to prevent degradation, the appropriate conditions shall be documented, maintained and monitored.

4.8.6 All

When products are susceptible to hazards arising from transport conditions or subject to transport restrictions, the required conditions of transport shall be documented, implemented and subject to regular review. Any necessary product labelling shall be documented and monitored.

4.8.7 All

Where the company employs third-party contractors, there shall be an agreement between the company and the contractor. All the requirements specified in this section shall be clearly defined in the contract.

4.9 Site security

Security shall be maintained to prevent access of unauthorised persons to production and storage areas.


4.9.1 AllAccess to the site by employees, contractors and visitors shall be controlled and a visitor-reporting system shall be in place

4.9.2 All

Contractors involved in maintenance or repair shall be qualified or supervised, and a nominated staff member shall be responsible for their activities with regard to potential effects on the safety, legality or quality of products.

4.9.3 1 and 2Staff shall be trained in site security procedures and encouraged to question or report unidentified or unknown visitors.

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5 Product Control

5.1 Pre-production reference samples

Documented procedures shall be in place for the selection, handling, storage, approval and use of reference samples as well as for component samples and samples of subcontracted work where relevant.


5.1.1 All

The company shall document a process to identify, select and categorise reference samples. If customers have a defined system of sealed samples referring to different stages of sample approval, the customer procedure shall be documented and followed.

5.1.2 All

As a minimum, a sample of the product which has been approved by the customer or, if customer approval is not possible, a sample representative of the agreed specification shall be retained.

Procedures shall be in place to record the selection, use, approval and storage of reference and/or component samples.

5.1.3 AllReference samples shall be held and stored in suitable environmental conditions to maintain their original status.

5.1.4 AllA secure and tamper-evident system shall be in place for the storage of samples. Temporary removal of samples must be documented and authorised by a designated responsible person.

5.1.5 AllRecords shall be maintained of reference samples supplied to other parties, including the date supplied and details of the sample.

5.1.6 AllExceptions to the need to store samples shall be made when such storage is impractical, provided that an alternative means of achieving the same objective is documented, justified and maintained.

5.2 Chemical formulation control

The chemical composition of products and chemicals used in the manufacture or processing of products shall be identified, monitored and recorded as required by legislation in the country of sale and/or manufacture. Where approvals for use need to be obtained, these shall be in place.


5.2.1 All

Where companies use materials or preparations for which the supplier does not wish to divulge confidential formulations, they must have a procedure in place to ensure the safety and legality of such materials (for example, through an independent third-party review) and must assure themselves that any information which may be legally required will be made available to the authorities in a timely fashion.

5.2.2 AllCompanies shall review, document and justify the use of any substances classified as dangerous or of very high concern in the country of sale.

5.2.3 AllWritten (and/or diagrammatic), authorised procedures for the handling of chemicals shall be available at the point of use.

5.2.4 1 and 2 Companies shall identify and document the use of any nanomaterials.

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5.3 Product packaging materials

Product packaging materials shall be suitable for the intended use and stored under conditions to minimise the risk of contamination and deterioration.


5.3.1 All

Product packaging shall conform to an agreed and documented specification and shall meet the legal requirements of the regions of sale with regard to composition, recyclability and minimising excessive use of packaging material.

5.3.2 All

Packaging shall be assessed for fitness for purpose and found suitable with regard to:

● protecting the product from damage

● maintaining the integrity of the product

● protecting the consumer from injury

● preventing contamination.

5.3.3 AllPackaging materials shall be effectively protected before being returned to storage.

5.3.4 AllWhere staples or other metal closures are used for packaging, appropriate precautions shall be taken to prevent the risk of contamination, damage or injury to the product or consumer.

5.3.5 1Where there is a risk of product contamination from transit packaging that could compromise product safety, legality and quality, such packaging shall be removed from production areas.

5.4 Control of non-conforming materials

The company shall ensure that non-conforming materials, components and products are clearly identified, labelled, quarantined, investigated and documented.


5.4.1 All

Clear procedures for the control of non-conforming materials and products, including rejection, segregation, acceptance by concession or regrading for an alternative use, shall be in place and understood by all authorised personnel.

5.4.2 All

The company shall have a procedure in place for the secure disposal of non-conforming products and their packaging according to the nature of the problem and/or the specific requirements of the customer and any legal requirements.

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5.5 Handling requirements for specific materials

Where materials or products require special handling procedures to be in place, these shall be maintained to ensure product safety, quality and legality are not compromised.


5.5.1 All

Materials and products requiring segregation procedures (e.g. materials intended for different geographical regions) shall have control procedures in place to ensure that product integrity is maintained.

5.5.2 1 and 2The company shall determine whether allergenic or sensitising materials are used (or likely to be contaminants of materials used) and shall identify any such materials used on site.

5.5.3 1 and 2

Documented policies shall exist for the handling of allergenic or sensitising materials including:

● physical or time segregation from other products

● use of identified, dedicated equipment if necessary

● adequate labelling of final products.

5.6 Stock control and product release

The company shall ensure that the finished product is not released unless all agreed procedures have been followed and the release is suitably controlled.


5.6.1 All

A procedure shall be in place to ensure that only products conforming to specification are dispatched. If no such control is conducted, the company shall have a full justification for its absence, which shall be reviewed at least annually. Procedures may include, but are not limited to:

● positive final release by authorised staff

● online test methods

● automatic rejection process (which must be validated and monitored).

5.6.2 AllCompanies shall ensure that work carried out by home workers or subcontracted off site shall be included in procedures described in clause 5.6.1.

5.6.3 1 and 2Controls shall be in place to ensure correct stock rotation and that materials and products are used in the correct order and within the allocated shelf or usage life if applicable.

5.6.4 1 and 2Procedures shall be in place for disposal of excess stock or obsolete inventory where such situations routinely occur. If such disposal is an isolated instance, measures taken shall be documented.

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6 Product Conformity Assessment

6.1 Product analysis/testing

FUNDAMENTALA suitable, sufficient and validated testing regime shall be in place to ensure the safe, legal production of products to the required conformance of safety, legality and quality. Results from the programme shall be recorded, reviewed and stored securely.


6.1.1 All

Companies shall adopt a product-testing programme based on information such as:

● the outcome of the risk assessment procedure including any defined control points

● any legal requirements for testing in the regions(s) of intended sale

● customer requirements regarding supply of test reports or other information

● their own requirements for demonstrating the production of safe products

● information needed to confirm composition of materials

● historical data on problems or complaints.

In cases where it is established that no testing is required, this shall be justified, documented and reviewed at least annually. (Note: If there is a justified absence of testing then the other clauses in this section are not applicable.)

6.1.2 AllThe company shall identify the different stages (for example, pre-production, production) at which testing is to be performed.

6.1.3 All

A documented sampling plan, testing programme and test specification, including the pass or fail criteria, shall be produced for each product or product type as required.

Testing procedures carried out as a result of a complaint, product failure or other ad hoc reason shall be clearly documented.

6.1.4 AllTesting shall be undertaken by the company, the subcontractor, a competent third party, a laboratory designated by government authorities or the customer‘s designated testing laboratories, as agreed.

6.1.5 All

For tests which are critical to product safety or legality, the laboratory used shall have gained recognised laboratory accreditation against ISO 17025 for the tests to be carried out. If accredited facilities are not used, the laboratory conducting the tests must be able to provide verifiable evidence that it is complying with the requirements of ISO 17025.

6.1.6 AllProcedures shall be in place to ensure the security of samples and test results.

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6.1.7 All

Where testing is submitted to third parties, the required testing shall be clearly defined including, for example, reference to the number, date and version of the test standard or method to be used. In cases where the company relies on the expertise of third-party testing organisations to determine appropriate test requirements, the company shall ensure that the third party receives a clear written briefing on the purpose of the test and that the testing programme is formally agreed and documented.

6.1.8 All

For tests other than those specified in clause 6.1.5, procedures shall be in place to ensure validity of all test results:

● use of documented, validated test methods

● use of correctly calibrated and maintained test equipment

● incorporation of quality control checks in the tests

● use of systems such as proficiency testing to verify the accuracy of results where available

● use of suitably qualified and/or trained staff, competent to carry out the analyses required.

6.1.9 All

Test results which are outside the defined specification shall be reviewed in a timely manner by the nominated person responsible for safety, legality and quality, and the need for corrective action assessed, documented and carried out as necessary.

6.1.10 1 and 2

Where testing laboratories are present on a manufacturing site, they shall be located, designed and operated to eliminate potential risks to product safety. Controls shall be documented, implemented and shall include consideration of the following:

● design and operation of drainage and ventilation systems

● access and security of the facility

● movement of laboratory personnel

● protective clothing arrangements

● processes for obtaining product samples

● disposal of laboratory waste.

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6.2 Inspections

When product inspections are deemed necessary to assure delivery of a safe, legal product of the required quality, they should be carried out following defined procedures that are documented, reviewed and authorised.


6.2.1 All

Companies shall assess the need for product inspections, which, if required, shall have a defined purpose and operate to a defined list of parameters to be examined, with defects and defect types clearly identified.

In cases where it is established that no inspections are necessary, this shall be justified, documented and reviewed at least annually. (Note: If so, then the other clauses in this section are not applicable.)

6.2.2 All

Sampling procedures shall be defined, documented and justifiable.

The appropriateness must be demonstrable and based on considerations of risk, type of product, inspection frequency, statistical rationale etc.

6.2.3 All

Sampling plans, where required, shall be documented and approved and reviewed when changes in production methods or materials occur.

They shall include as a minimum:

● the sample size to be taken

● the acceptance/rejection criteria

● defined acceptable quality limit (AQL)

● the defect classification

● the actions to be taken in the case of rejection.

6.2.4 AllInspections shall be conducted at a level and/or frequency to assure product quality is at an AQL level that is acceptable to the customer.

6.2.5 All

The company shall have a defined policy and procedure covering the handling of inspected goods; for example:

● policy on returning inspected goods to production

● repacking requirements

● disposal.

6.2.6 AllProcedures shall be in place to ensure inspections are carried out in suitable conditions and with sufficient space and lighting to avoid the introduction of hazards into the products.

6.2.7 AllPersonnel undertaking inspections shall be suitably qualified and/or trained, and shall be competent to carry out the work required.

6.2.8 AllWhen external contractors are used for inspections, they shall be subjected to the usual supplier/subcontractor approval processes.

6.2.9 All Inspection results which are outside the defined acceptance level shall be reviewed in a timely manner by a competent person and the need for corrective action assessed, documented and completed.

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6.3 Product claims

The company shall have procedures in place to validate any declared product information or claims made for the products and monitor compliance with such claims if necessary.


6.3.1 AllWhere necessary the company shall operate a quantity control system which conforms to legal requirements and/or specified customer requirement in the region where the product is available for sale.

6.3.2 AllWhere quantity checking is required, the frequency and methodology used shall meet the minimum requirements of any legislation governing quantity verification.

6.3.3 AllAny claims about a product, e.g. a weight limit for a trampoline or sun protection factor on a cream, shall be fully validated to ensure that products meet the stated claim.

6.3.4 1 and 2

The company shall undertake product-in-use evaluations, testing and/or reliability trials and/or shelf-life evaluations to validate and verify that production of a safe and legal product is maintained, taking account of the category of consumers at risk.

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7 Process Control

7.1 Control of operations

FUNDAMENTALThe company shall be able to demonstrate effective control of all operations undertaken, to ensure product safety, legality and quality and ensure that the processes and equipment employed are capable of producing consistently safe and legal product with the desired quality characteristics.


7.1.1 AllThe company shall conduct a risk assessment of hazards potentially introduced during the production, packaging or storage processes.

7.1.2 All

The company shall establish precise process flow(s) and a control plan which identifies the critical control points (if any), control limits, monitoring points and the records required. The company shall define how changes to the control plan are approved and implemented.

7.1.3 AllPre-production meetings shall be conducted prior to new or substantially changed products being produced, to evaluate and approve the processes.

7.1.4 AllProcess monitoring shall be established and adequately controlled to ensure products are produced within the required process specification.

7.1.5 AllCorrective action shall be taken in the event of deviation of the process from specification. This shall be recorded.

7.1.6 1 and 2The company shall have a fully implemented and maintained process risk assessment system, based on established principles.

7.1.7 1 and 2In circumstances where process parameters are controlled by in-line monitoring devices, these shall be linked to a suitable failure alert system and routinely tested.

7.2 Control of incoming components and raw materials

FUNDAMENTALThe company shall have procedures to specify, validate and approve incoming materials, which shall include any testing, inspection or review of certificates of analysis.


7.2.1 All

Raw materials or components critical to product safety, legality or quality shall have documented approval procedures to assure conformance to agreed specifications and requirements and documented positive batch release.

7.2.2 AllThe requirement for documented approval procedures as described in clause 7.2.1 shall also apply to subcontracted work or work performed outside the site being audited.

7.2.3 AllThe company shall have a documented procedure to ensure that materials or components used by home workers (when used) are approved. (See also home-worker requirements in clause 5.6.2.)

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7.3 Equipment and equipment maintenance

Equipment shall be suitably designed for the intended purpose and shall be maintained and used so as to minimise the risk to product safety, legality and quality.


7.3.1 All

All equipment shall be properly specified before commission, and operating parameters for production equipment and tooling shall be determined, validated and implemented as part of the control plan. Validation records pertinent to safety or legality shall be kept for the lifetime of the equipment.

7.3.2 AllIn the case of equipment failure or deviation of the process from specification, procedures shall be in place to establish the safety status of the product prior to release.

7.3.3 All

A documented system of planned maintenance shall be in place, covering all items of equipment and plant which are critical to product safety, legality and quality. This shall include, but not be limited to, records of:

● periodic maintenance schedules and completion

● preventative maintenance

● required safety checks

● spare-parts listings and replacements

● contingency plans for failure of essential equipment.

7.3.4 All

Materials (for example, lubricating oils and paints) used for equipment and plant maintenance shall be assessed to establish whether they pose a risk by direct or indirect contact with raw materials, intermediate and finished products. If necessary, they shall be suitably identified for the intended use and controlled.

7.3.5 AllEngineering workshops shall be controlled to prevent contamination risks to the product and be organised, clean and tidy to allow safe, efficient and quality work.

7.3.6 AllWhen possible, equipment shall be positioned so as to give access beneath, inside and around it for ease of cleaning and servicing.

7.3.7 1 and 2

In addition to any planned maintenance programme, where there is a risk of product contamination by foreign bodies arising from equipment failure, the equipment shall be inspected at predetermined intervals, inspection results documented and any necessary corrective action taken.

7.3.8 1Certificates of conformity or other evidence to confirm suitability for use shall be available for equipment in direct contact with products, raw materials and work in process.

7.3.9 1On completion of any maintenance work, machinery and equipment shall be clean and free from contamination hazards. A documented hygiene clearance procedure shall exist.

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7.4 Foreign-body detection and control

Where deemed necessary by the documented risk assessment, the company shall have systems for foreign-body detection in place and ensure its effective operation.


7.4.1 All

The company shall ensure that all necessary steps are taken to identify and prevent the risks of foreign-body contamination as identified by risk assessment. This shall include any contamination potentially introduced by the packaging.

7.4.2 All

Tools and other sharp objects used in production shall be controlled. Methods such as, but not limited to, the following may be used:

● snap-off-blade knives prohibited

● tools permanently attached to benches

● items controlled by a listing and registration procedure

● needle policy where all parts of broken needles have to be returned prior to new issue.

7.4.3 All

Where a metal or foreign-body detector is required or specified by the customer, the company shall establish documented procedures specifying its use, location, critical limits for detection and recording of results.

7.4.4 1 and 2

Except when used as part of the product, the presence and location of all glass, ceramic and brittle-plastic material in raw-material handling, preparation, processing, and packing and storage areas shall be listed in a register. Checks of the condition of these materials should be carried out at a specified frequency and the results recorded.

7.4.5 1 and 2

Where they constitute a risk to the product, a management system that shall include written procedures shall be in place for all glass, brittle plastics and ceramics to ensure the necessary precautions are taken. Breakages shall be recorded and records retained.

7.4.6 1

Except when used in the product, the use of wood within raw material handling, preparation, processing, packing and storage areas shall be eliminated except for wooden pallets where any risks should be evaluated and controlled.

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7.5 Calibration and control of measuring and monitoring devices

Measuring equipment used to monitor product safety, quality and legality shall be identified. The identified measuring equipment shall be calibrated to a recognised national or international standard. Where a traceable calibration is not possible, the company shall verify the basis by which calibration is declared.


7.5.1 AllThe company shall identify equipment used to make measurements relevant to product safety, legality and quality.

7.5.2 AllThe equipment used in accept or reject activity shall be calibrated to a specified accuracy and precision at a defined frequency (or before use).

7.5.3 AllThe calibration of identified equipment shall be traceable to a recognised national standard. Where such a standard does not exist, the basis by which calibration is declared shall be verified.

7.5.4 AllRecords of the results of calibration and verification shall be maintained for a suitable period, taking account of the life of the products being produced.

7.5.5 AllIdentified equipment shall be prevented from being adjusted by unauthorised staff and shall be marked to show the calibration status and period of validity.

7.5.6 AllThe company shall define suitable test pieces and operate a defined monitoring and testing procedure to identify any failure of metal/foreign-body detectors (if used).

7.5.7 AllProcedures shall be in place for actions to be taken if equipment is found not to be operating within specified tolerances and/or limits.

7.6 Retained production samples

The company shall ensure the adequate and secure retention of production samples to assist in the investigation of complaints and to verify that production is in conformity with the agreed specification.


7.6.1 All

The company shall retain a fully representative production sample of each product as received by the customer (including the packaging). Exceptions may be made for products that are impractical to store, provided the information usually provided by a production sample can still be identified.

A designated person shall authorise retained production samples and/or component samples (see also requirements in 5.1 ‘Pre-production reference samples’).

7.6.2 AllProcedures shall be in place to determine the retention time of retained samples. This should normally be the foreseeable lifetime of the product unless otherwise justified.

7.6.3 AllRetained samples shall be securely held and stored in suitable conditions to maintain their original status.

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7.7 Final product packing and control

The company shall establish a procedure for the packing of products to ensure that products are supplied which meet relevant safety criteria, taking account of legal requirements and customers’ specific requirements.


7.7.1 All

The company shall define and validate the packing procedure for products taking particular account of customer requirements. This shall include methods of ensuring that the correct product(s) and components are correctly packaged with and placed in the correct outer packaging.

7.7.2 AllQuantity markings on the product or pack should be accurate, verified and in accordance with the legal requirements in the country of sale.

7.7.3 All The company shall verify that information shown on primary (consumer) package labels and outer cartons is correct and meets the regulatory and safety requirements of the region of intended sale.

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8 Personnel

8.1 Training and competency

FUNDAMENTALThe company shall ensure that personnel performing work that affects product safety, legality and quality are demonstrably competent to carry out their activity, through training, work experience or qualification.


8.1.1 All

The company shall ensure that all employees are able to demonstrate competence with regards to their activity.

The company shall:

● identify the need for training

● document training procedures and records to demonstrate that training is effective and regularly reviewed

● ensure that training includes both general information on the company and specific job training.

8.1.2 All

Employees having a direct effect on the safety, quality or legality of products shall be trained to ensure understanding of risk assessment procedures or outcomes as necessary for their activity. Those conducting or participating in risk assessments shall be adequately trained in risk assessment methods.

8.1.3 All

Training records should be stored such that privacy of personnel is protected and legal compliance with data protection laws in the country of operation are respected whilst also allowing auditors access to necessary information. Training shall be traceable to an individual employee.

8.2 Protective clothing

The company's standards shall be documented and adopted by all personnel, including contractors and visitors to the production facility.


8.2.1 AllWhere a need for protective clothing has been identified by the risk assessment, this shall not pose a contamination risk to the product.

8.2.2 1 and 2Based on the assessment of risk to the product, suitable footwear shall be worn within the factory environment if necessary.

8.2.3 1 and 2Protective clothing, where provided, shall be effectively laundered at an appropriate frequency.

8.2.4 1 and 2Disposable protective clothing, if used, shall be subject to adequate control to avoid product contamination.

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8.3 Hygiene practices

Standards of hygiene shall be formulated with due regard to the risk of product contamination.


8.3.1 1 and 2Where metal foreign-body detection is in place, detectable plasters shall be used and shall be regularly tested through the detector.

8.3.2 1 and 2The company shall have a policy to control the wearing of jewellery so that it poses no risk of product contamination.

8.3.3 1 All cuts and grazes on exposed skin shall be covered by a contrasting coloured plaster that is company issued and monitored.

8.3.4 1Hand-cleaning shall be performed at a suitable frequency to maintain hygienic conditions.

8.3.5 1No eating, drinking or smoking shall be permitted within production or packaging areas.

8.3.6 1All head and facial hair shall be fully contained to prevent product contamination.

8.3.7 1

The company shall be vigilant concerning employees, including temporary employees, when they may be suffering from or have been in contact with any relevant infectious disease or condition. The company should have a procedure for the notification by employees where this is legally allowable.

8.3.8 1Where the company becomes aware of a person who has entered the premises suffering from a relevant infectious disease, steps shall be taken to minimise any risk to product safety.

8.3.9 1

Where there may be a risk to product safety, and where legally allowable, visitors and contractors shall be required to complete a health questionnaire prior to entering the raw-material, preparation, processing, packing and storage areas. If necessary, these persons shall undergo medical screening before permission is granted to enter the raw-material, preparation, processing, packing and storage areas.

8.3.10 1Fingernails shall be kept short, clean and unvarnished. False fingernails are not permitted.

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Further information available at www.brcglobalstandards.com Section IV Auditing and Certification

SECTION IV

AUDITING AND CERTIFICATION

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Section IV

Auditing and Certification

1 IntroductionMost companies using the Standard wish to be independently assessed to demonstrate that they meet the

requirements of the Standard and to obtain certification to the BRC Global Standard scheme. This assessment

takes the form of an audit visit which is carried out by an approved certification body. The BRC/RILA do

not carry out any audits directly themselves. The detailed process by which a company gains and maintains

certification is summarised in Figure 1.

For confirmation of the latest certification protocols, reference should be made to the BRC Global Standards

website www.brcglobalstandards.com, where changes or updates will be published.

The company will be assessed by an independent BRC-approved audit company – the certification body.

A list of current BRC-approved certification bodies for consumer products can be found at

www.brcglobalstandards.com. The certification will be graded according to the number and type of non-

conformities found during the audit visit. The grade will also influence the frequency of ongoing audits.

This section describes the process to be followed by a company seeking certification.

2 Getting StartedObtaining BRC certification is often a challenging step for companies, and it is vital that the company is well

prepared for the audit, otherwise substantial unnecessary cost may be incurred and disappointment is likely.

Part 1 of Section II of this Standard (‘Preparation – the Key to Success’) gives guidance on how to prepare

for certification.

Some considerations that should be addressed by companies interested in obtaining certification are:

■ Making an accurate ‘gap analysis’ of their situation versus the requirements of the Standard

■ Choosing an appropriate certification body

■ Ensuring that staff are adequately trained in:

● the Standard

● risk assessment

● obtaining legal and safety information relevant to their products

● relevant product standards or codes of practice

Training courses are available from the BRC and other BRC-approved trainers. For more information visit

the training pages on the BRC website

■ Allowing an adequate timescale for implementing the required measures

■ Using consultants to assist in areas of weakness or limited understanding, if necessary.

Many of the certification bodies offer an optional pre-assessment visit. Certification bodies are not allowed to

act as consultants since this could potentially result in them auditing their own work, but such a visit does help

with a gap analysis and allows factories to obtain a clear understanding of where they need to improve their

processes and procedures. A pre-assessment visit is not a part of the certification process and is not taken into

consideration during the actual certification audit.

Evidence suggests that for many companies this is a very useful exercise, which greatly enhances the chances

of successful certification during the BRC audit.

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If a company is working with a specific retailer or other specifier, it would be advisable to discuss an

implementation programme with the site’s technical team to ensure that the steps being taken are

appropriate with regard to the retailer’s requirements and timescales.

3 Self-assessment of Compliance with the StandardIt is a requirement of BRC certification that the company has an original copy of the current issue of the

Standard. The Standard can be obtained in either electronic or paper format and either format is acceptable.

The Standard is available in a number of language versions from www.brcbookshop.com. The Standard

should be obtained as the first stage of preparation to certification.

The Standard should be read, and understood and a preliminary self-assessment should be conducted by

the company itself against the Standard. Any areas of non-conformity should be addressed by the company.

Further information and guidance to help companies comply with the Standard, including an interpretation

guideline, audit tools and training courses, are available on the website www.brcglobalstandards.com.

4 Selection of a Certification BodyOnce a self-assessment has been completed and non-conformities addressed, the company must

select a certification body. The BRC cannot advise on the selection of a specific certification body,

but the BRC Global Standards Directory lists BRC-approved certification bodies. Visit

www.brcdirectory.com.

In selecting a certification body, the company should consider:

■ the acceptability of the certification body to its customers; certain customers carry lists of their preferred

certification bodies

■ the scope of accreditation of the certification body. It is essential that the certification body is accredited

to assess companies for the categories of products produced. Clarification of the categories of products

against which the certification body can audit should be obtained either by confirmation from the

certification body concerned or from accreditation schedules published by the appropriate national

accreditation body. A list of product categories is provided in Appendix 3

■ confirmation that the auditor proposed by the certification body meets the qualifications, training and

experience requirements specified by the BRC.

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Further information available at www.brcglobalstandards.com Section IV Auditing and Certifi cation

Figure 4 How to gain certifi cation

Select certifi cation bodywww.brcdirectory.com

On-site audit

Certifi cation documentation

collated

Evidence assessed inadequate

Certifi cation decision made by certifi cation

decision manager

Certifi cate details and audit report issued

to the company and posted on the BRC

Directory

Closing meetingConfi rmation of any non-conformities


Evidence assessed Clarifi cation required

No corrective action submitted within 28

days

Additional clarifi cation provided

Evidence assessed compliant

No certifi cate issuedReport issued

specifying statusCertifi cation suspended

On-going compliance


Confi rmation of any non-conformities


Additional clarifi cation provided


specifying statusCertifi cation suspended


Certifi cation documentation

collated

Certifi cation decision made by certifi cation

decision manager

Certifi cate details and audit report issued

to the company and posted on the BRC

Directory

Certifi cation suspended

On-going compliance

Critical non-conformity identifi ed


Critical non-conformity

No non-conformities identifi ed


Corrective action status documented

Audit in accordance with required

frequency



specifying statusCertifi cation

specifying status


Critical non-conformity

Evidence assessed

No non-conformities identifi ed


days


specifying statusCertifi cation


Evidence assessed



Evidence assessed Evidence assessed

INITIAL AUDITCorrective action

submitted or revisit within 60 calendar days

Corrective action submitted or

revisit within 28 calendar days

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5 Company/Certification Body Contractual ArrangementsThe BRC requires there to be a contract between the audited site/company and the certification body,

detailing the scope of the audit and the reporting requirements. This contract will be drafted by the

certification body.

5.1 Administration fee

An administration fee is collected on behalf of the BRC by the certification body from the company for every

audit undertaken. This fee is to support further development of the Standard and to fund the maintenance

of the BRC Directory and the further development of the scheme. The certification body shall not issue

a certificate or report until the administration fee has been received, irrespective of the outcome of the

certification process.

5.2 Auditor selection

It is the responsibility of the company to ensure that adequate and accurate information is given to the

certification body detailing the products it manufactures and the process technologies it uses to enable the

certification body to select an auditor with the required skills to undertake the audit. Auditors must be skilled

to audit in the relevant product category as listed in Appendix 3.

The certification body, auditors and the company must be aware of the need to avoid a conflict of interest

when arranging an auditor for the site visit. The company may request or decline the services of a particular

auditor offered by the certification body. However, as guidance, the certification body should ensure that

the same auditor does not undertake audits on more than three consecutive occasions at the same site.

Exceptions to this (such as a requirement for an audit in specialist product areas and remote geographical

regions) should be justified on the audit report.

6 Relationship with Other Certification StandardsThe Standard will be used by certification bodies as a Standard in its own right, without addition or

amendment to format or content.

The BRC is, however, aware that there is an overlap between some requirements of the Standard and other

standards used by industry; in particular ISO 9001 with regard to the management system requirements. A

cross-reference table is provided (see Appendix 9) showing the relationship between these standards.

Some sector-specific requirements such as those for medical devices or personal protective equipment, as well

as some private-sector schemes such as that developed by the Toy Industry Association of America, are also

similar in concept or contain parts that are similar to the Global Standard for Consumer Products.

The BRC does not restrict or preclude joint audits covering the BRC Standard and other standards or schemes,

provided that the requirements of the BRC Standard are audited in full. Discussions concerning joint audit

visits should be held directly with the chosen certification body.

7 Guidelines

7.1 Codes of practice/specific guidelines

The BRC encourages cooperation between stakeholders to agree industry codes of practice and specific

guidelines for individual product categories as required. The BRC publishes an interpretation guideline to

the Standard and specific sector guidelines for some industries. More information on these topics can be

found on the BRC website. These documents will supplement the Standard as guidance for auditors and for

companies hoping to obtain certification. They augment the general requirements of the Standard and will

help factories with the practical implementation of the Standard.

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Legal requirements and ‘state of the art’ with regard to producing safe products evolve rapidly. Regardless of

the availability of sector guidelines, it is the company’s responsibility to ensure that up-to-date information is

available and the requirements are implemented.

7.2 Status of guidelines

It is not mandatory for companies to be in possession of any such guidelines produced by the BRC. The

guidelines do not directly form part of the audit although companies would be expected to have procedures

and systems similar to those described in the guidelines in place, and audit tools used by the auditors may

be based on the sector guidelines. There may, however, be other means of achieving compliance with the

Standard than those quoted in the guideline documents, so any such documents should be treated as best-

practice guidelines and supplementary information rather than additional requirements.

Auditors will be required to undergo training in any guidelines appropriate to their sectors of expertise. This is

to ensure a minimum level of understanding of sector-specific BRC requirements and to establish a high level

of consistency between auditors.

The BRC also produces some general best-practice guidelines on certain aspects of operation such as pest

control and customer complaints. These documents are also only for guidance, are not mandatory and do not

form part of the audit, but they may assist sites to comply with the Standard and help them gain certification.

8 Audit Preparation by the Company

8.1 Preparation prior to the initial audit

For the initial audit, the company shall agree a mutually convenient date, with due consideration given to

the amount of work required to meet the requirements of the Standard. For subsequent audits, the mutually

agreed date must allow sufficient time to ensure the company certification does not lapse (see Appendix 6

for details).

There is a requirement on the company to plan carefully for the audit, to have the appropriate documentation

ready and to have appropriate staff available at all times during the on-site audit.

The company shall ensure that production at the time of the audit covers products within the

intended scope of the certification. Where possible, the widest range of these products shall be in production

for the auditor to assess. Where the product range is large or diverse, the auditor has the discretion to

continue the audit until sufficiently satisfied that the intended scope of the certification has been assessed.

The company shall provide the certification body with any pertinent information and data that would assist

the auditor in conducting an effective audit.

Companies are free to change certification bodies at any time but it is a requirement that the company shall

make the previous BRC audit report available to the auditor and the certification body.

Sites producing products classified as Group 3 are required to undergo an interim surveillance visit

between certification audits. Companies may not use different certification bodies for surveillance and

certification audits.

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8.2 Duration of the audit

The company shall provide the certification body with appropriate information to allow it to assess the

duration and the cost of the audit. This should include details of manufacturing schedules to allow audits to

cover relevant processes, for example night-time manufacture if necessary. Requested information may also

include, for example, a site plan, number of employees and number of product lines. The time to assess all

documentation is supplementary to the duration of the audit.

Before the audit takes place, the certification body shall indicate the approximate duration of the audit. The

typical duration of an audit is between 1.5 and 3 man days but this could be considerably longer for large,

complex sites. Additionally, up to one man day is typically required for the completion of a comprehensive

audit report.

However, certain factors can influence the duration of the audit. These factors will require careful

consideration both upon confirmation of the expected duration of the audit and during the audit itself.

Deviation from this timeframe must be justified and specified on the audit report.

In the event that the company requires certification audits against other standards, the total time taken for

these audits must be specified on the audit report and fully justified.

Factors which may influence the duration of the audit are:

■ product group level

■ company staff numbers and functions

■ separate office, manufacturing or storage buildings

■ complex manufacturing processes using a number of different technologies

■ products of many different types and complexity

■ size of site, whether it has been purpose built

■ labour intensity of the processes, level of automation

■ first visit by the auditor to the company

■ any time-consuming access procedures

■ audit not carried out in the first language of the auditor or company

■ the number of non-conformities recorded in the previous audit

■ difficulties experienced during the audit and requiring further investigation

■ preparedness of the company

■ coordination of documentation.

For an audit, it is usual that 30–50% of the time will be spent on an inspection of the production facility

and an audit of the practical implementation of the Standard, with the remainder of the time being used

to examine the risk-based systems and documentation. This will vary according to the complexity of the

operation. The time taken shall be detailed on the audit report.

9 The On-site AuditThe on-site audit consists of the following six stages:

■ The opening meeting – to confirm the scope and process of the audit and that the audit process

is confidential

■ Document review – a review of the documented risk assessments, quality management systems, records,

test reports and similar

■ Production facility inspection – to review practical implementation of the systems and

interview personnel

■ Review of production facility inspection – to verify and conduct further documentation checks

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■ Final review of findings by the auditor – preparation for the closing meeting

■ Closing meeting – to review audit findings with the company. Note that non-conformities are subject to

subsequent independent verification by the certification body management.

There is no requirement for the auditor to carry out the audit in the order listed above but the audit must

include all elements.

The company shall fully assist the auditor at all times. It is expected that at the opening and closing

meetings those attending on behalf of the company will be senior managers who have the appropriate

authority to ensure that corrective action can be progressed if non-conformities are found. The most senior

operations manager on site or their nominated deputy shall be available at the audit and attend the opening

and closing meetings.

During the audit, detailed notes shall be made regarding the company’s conformities and non- conformities

against the Standard, and these will be used as the basis for the audit report. The auditor will assess the

nature and severity of any non-conformity.

At the closing meeting, the auditor shall present his/her findings, and discuss all non-conformities that

have been identified during the audit but shall not comment on the likely outcome of the certification

process. Information on the process and timescales for the company to provide evidence to the auditor of

the corrective action to close non-conformities must be given. A written summary of the non-conformities

discussed at the closing meeting will be documented by the auditor and provided to the company, either at

the closing meeting or within one working day after completion of the audit.

The decision to award certification and the grade of the certificate will be determined independently by the

certification body management, following a technical review of the audit report and the closing of non-

conformities. The company will be informed of the certification decision following this review. The auditor

cannot make the final decision about the site; it has to be reviewed by others within the certification body.

All information viewed during the audit is regarded as confidential between the auditor and the site, except

as detailed in the audit report. No brand names or similar identifiers of product will be released in the audit

report or certificate.

Auditors and companies may make use of additional documents and checklists to assist them in the

preparation for and conducting of the audit. Figure 5 shows this concept.

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10 Non-conformities and Corrective ActionThe level of non-conformity assigned by an auditor against a requirement of the Standard is an objective

judgement with respect to severity and risk and is based on evidence collected and observations made during

the audit. This is verifi ed by the certifi cation body management.

General interpretation

guidelines

Corrective actions

PassFail

Yes

No

Sector guidelines

The Standard

Yes

Do

product guidelines

exist for this product type?

Standard audit

Sector audit

Pass

Report/score

Directory

Yes

guidelines

Fail

Figure 5 Audit tools

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10.1 Non-conformities

There are three levels of non-conformity:

Critical

● where there is a critical failure to comply with a product safety or legal compliance issue

and/or

● a major non-conformity against a ‘fundamental’ clause is determined

Major

● where there is a substantial failure to meet the requirements of a statement of intent or any clause of the Standard

and/or

● a situation is identified which would, on the basis of available objective evidence, raise significant doubt as to the conformity of the product being supplied

Minor

● where absolute compliance with the statement of intent has not been met but, on the basis of objective evidence, the conformity of the product is not in doubt

and/or

● a clause has not been fully met but, on the basis of objective evidence, the conformity of the product is not in doubt

The objective of the audit is to provide a true reflection of the operation of the site and the level of conformity

against the Global Standard for Consumer Products. Consideration should therefore be given to awarding a

single major non-conformity where minor non-conformities are repeatedly raised against a particular clause of

the Standard. Clustering of a significant number of minor non-conformities against a clause and recording this

as a single minor non-conformity is not permitted.

10.2 Procedures for handling non-conformities and corrective action

The criteria for grading non-conformities and the means of confirming corrective actions are summarised in

Appendix 4. The decision to award a certificate, and the grade of the certificate, A, B or C, will depend on the

number and severity of non-conformities raised and the completion of effective corrective actions within the

stated time limit by the company. Where the number and type of non-conformities exceed a certain level, a

grade D is assigned and certification will not be granted (refer to Appendix 4).

Following identification of any non-conformity during the audit, the company must develop a corrective

action plan to address the non-conformities identified. Evidence that corrective action has been completed

must be provided to the certification body prior to a certification decision being made. It should be noted

that the grade of the audit reflects the situation viewed on the day of the audit visit and is not changed once

the non-conformities have been corrected. It represents the state of compliance of the factory during the

audit visit.

Any non-conformities from the previous audit should be checked during the current audit to confirm

corrective action has been taken and is operating effectively. Any repetition of these same non- conformities in

the current audit shall be highlighted by an asterisk (*) and consideration should be given to raising the status

of minor non-conformities to major.

10.2.1 Critical non-conformities or major non-conformities raised against ‘fundamental’ clauses

Where a critical or major non-conformity against the statement of intent of a ‘fundamental’ clause has been

established at an initial audit, the company shall not gain certification. Where a critical non- conformity is

found at a subsequent audit, certification must be immediately suspended. This means that fundamental

requirements must be substantially in place at the time of the audit visit and cannot be corrected later without

the need for a complete re-audit.

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In either of the above cases, this results in the awarding of a grade D and there shall be a further full on-site

audit carried out, once the company is satisfied that appropriate corrective action has been effectively taken,

to verify appropriate corrective action has taken place and there is demonstrable evidence of compliance.

In the event that a critical or major non-conformity against the statement of intent of a fundamental clause

has been established by the certification body, the company shall immediately inform its current customers

and make them fully aware of the circumstances. It should also review whether the circumstances of the

non-conformity compromise product safety and warrant the informing of past customers. Information on the

corrective actions to be taken in order to achieve certification status will also be provided to customers.

10.2.2 Major non-conformities

No certificate shall be issued until major non-conformities have been demonstrated as having been corrected.

It is normally expected that major non-conformities will be corrected within 28 calendar days of the audit

taking place. (Note that calendar days are defined in the glossary and do not include public holidays). This can

be either a permanent or temporary measure, providing the solution is acceptable to the certification body

and the certification body is able to verify that corrective action has taken place.

This can be achieved either by objective evidence being submitted to the certification body, such as

updated procedures, records, photographs or invoices for work undertaken etc., or by the certification body

undertaking a further on-site visit. Note that if a company obtains a grade C then a re-visit is required to

confirm that the non-conformities have been successfully addressed.

For initial audits 60 calendar days are allowed for correction of non-conformities. The company may remain in

the certification programme, but will be un-certificated and will only be certificated following verification of

the corrective action being implemented. If non -conformity cannot be closed out within the 60-day period,

the process of certification will commence again, i.e. a full audit.

If there is no formal commitment to implement corrective action received by the certification body within the

28/60 calendar day post-audit period as appropriate for existing or new certifications, or if there is a failure to

meet the timescale proposed in the non- conformity summary sheet without justification, the company does

not remain in the certification programme. The company will then require a further full audit in order to be

considered for certification.

10.2.3 Minor non-conformities

Certification will only be awarded where minor non-conformities have been addressed, the corrective action

taken and evidence (e.g. photos, invoices) for work completed has been provided to the certification body

within 28 calendar days following the audit (60 calendar days for an initial audit). The certification body may

undertake further site visits to verify that action has been taken. Where documentary evidence is provided,

absolute verification may be left until the next audit.

At the subsequent audit, if verification cannot be confirmed, then a non-conformity may be raised and this

may be elevated to a major non-conformity.

11 Further Action by Certification BodiesFor certificated companies, where deemed appropriate, the certification body may carry out further audits or

question activities to validate continued certification at any time. These visits may take the form of announced

or unannounced visits to undertake either a full or partial audit.

Where justifiable, certification suspension or withdrawal may be implemented pending the outcomes of such

further reviews by the certification body. The ultimate decision to suspend or withdraw certification remains

with the certification body.

If there is no intention on behalf of the company to take appropriate corrective actions or the corrective

actions taken are deemed inappropriate, certification shall be withdrawn. In the event that certification is

withdrawn or suspended by the certification body, the company shall immediately inform its customers and

make them fully aware of the circumstances relating to the withdrawal or suspension. Information on the

corrective actions to be taken in order to reinstate certification status will also be provided to customers.

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12 Grading of the AuditThe purpose of the certification grading system is to indicate to the user of the report the commitment of

the company to continual compliance and will dictate the future audit frequency (full details are available in

Appendix 4).

The grade is dependent on the number and severity of the non-conformities identified at the audit as

verified in a subsequent technical review by the certification body management, which might modify the

original result.

The certification body will review objective evidence of corrective action completed prior to awarding a

certificate, but this will not improve the grade awarded.

12.1 Certification

After a successful review of the audit report and documentary evidence provided in relation to the non-

conformities identified, a certification decision shall be made by the designated independent certification

manager and a certificate issued by the certification body, typically within 42 calendar days of the audit (74

calendar days for the initial audit).

The certificate shall conform to the format shown in Appendix 5, using BRC and accreditation body logo

usage rules. All dates specified on the certificate shall be the format of day, month, year. The certificate will

detail the scope of the audit as agreed in Section II of this publication.

■ The report should contain the six-digit BRC registration number of the auditor. This number refers to a

register of qualified auditors kept by the BRC and enables it to cross-check auditor competence against

the audit carried out. This register is not publicly available.

■ Where the on-site audit has been undertaken by an auditor issued with a BRC third-party auditor

certificate for this Standard, the BRC ‘trained auditor’ logo may be added to the certificate.

■ The date of audit specified on the certificate shall be the date of the audit relating to the granting of that

certificate, irrespective of whether further audits were made to verify corrective action arising from the

initial audit.

■ The initial audit date should be included on all subsequent certificates, provided continuous certification

has been maintained.

Certificated companies are advised that they should verify that the scope of the certificate is clearly stated and

that this information is consistent with their stated requirements. Other users of the certificates are advised to

carefully check that the stated scope of products is appropriate for their requirements.

13 Audit ReportingFollowing each audit, a full written report shall be prepared in the agreed format, defined by the BRC. The

report shall be produced in open text format in English or in another language, dependent upon customer

needs. The first section of the report must be available in English. This is to enable the information to be

uploaded onto the BRC Directory database. A checklist of audit questions may also be available and appended

to the report.

The report shall not include any confidential information about the site, such as customer names, proprietary

processes or detailed formulations, in order to maintain client confidentiality. However, it will be necessary to

describe, in general terms, the types of materials and technologies used.

The detailed audit report section shall include comment where criteria have been met, particularly where

improvement or enhancement is evident, and objective evidence to support any non-conformities that have

been identified.

The detailed audit report section should demonstrate clear evidence of auditor competence in the category

concerned. Product and production information should be referenced throughout the report which should

have a clear focus on product-sector issues and must assist the reader to:

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■ gain greater understanding of individual clauses either for conformity or for non-conformity

■ be informed of corrective action taken

■ be informed of improvements made since the last audit

■ be informed of ‘best-practice’ systems, procedures or equipment in place

■ be informed of any additional pertinent comments the auditor made.

The report shall accurately reflect the findings of the auditor during the audit. Reports shall be prepared and

dispatched to the company within a period typically no longer than 42 calendar days (74 calendar days for the

initial audit) after the audit date.

Audit reports shall remain the property of the company commissioning the audit (which is usually the site but

could be an agent, holding company or another entity) and shall not be released, in whole or part, to a third

party unless the company has given prior consent (unless otherwise required by law). This authorisation may

be by a consent form, or may be contained within a contract between the company and user or the company

and the certification body.

The certification body will retain a copy of the audit report. The audit report and associated documentation

shall be stored safely and securely for a period of five years by the certification body.

A copy of the audit report shall be uploaded by the certification body in the required format to the

BRC Directory.

14 Ongoing Audit Frequency and CertificationThe ongoing audit schedule will be agreed between the company and the certification body. If a factory

changes significantly in any way, for example a significant change of senior or technical management,

production of different product types or supply to a new geographical area, then a re-audit will be required as

soon as possible to establish continuing conformity. This may be outside of the usual agreed frequency.

Product groups 1 and 2

The minimum frequency will be 12 months, but this could vary according to the performance of the company

at an audit as reflected by the grade, as stated in Appendix 4.

Product group 3

Certification for companies with Group 3 products will be awarded for 24 months but will require an interim

surveillance audit at 12 months, which will cover only the ‘fundamental’ requirements and confirmation that

any previous non-conformities raised have been satisfactorily addressed.

The certification and grade will be awarded for a period of 24 months but should a major non-conformity be

discovered during the surveillance visit, the company shall correct the non-conformity within 28 days or they

will not remain certificated and will require a new, complete audit to regain certification. The surveillance

visit does not result in a new certificate and does not change the grade of the original certificate. In the case

of a company obtaining a critical non-conformity during a surveillance visit however, the certification will

be immediately suspended. More frequent audits may be required depending on performance as stated in

Appendix 4.

The due date of the subsequent audit shall be calculated from the date of the initial audit, irrespective of

whether further site visits were made to verify corrective action arising from the initial audit, and not from the

certificate issue date.

The subsequent audit shall be scheduled to occur within a 28 calendar day time period prior to the next audit

due date. This allows sufficient time for corrective action to take place in the event of any non- conformities

being raised, without jeopardising continued certification.

Appendix 6 provides worked examples in accordance with the six-, twelve- and twenty-four-month audit

frequencies.

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It is the responsibility of the company to maintain certification. Justifiable circumstances for delays shall be

documented in the audit report.

14.1 Certificate expiry – justifiable circumstances

There will be some circumstances where the certificate cannot be renewed on the six-month and twelve-

month basis due to the inability of the certification body to conduct an audit. These justifiable circumstances

can include when the site is:

■ situated in a specific country or an area within a specific country where there is government advice from

the auditor’s country not to visit and there is no suitable local auditor

■ in an area that has suffered a disaster, natural or otherwise, rendering the site unable to produce.

If the renewal of the certificate is prevented due to these exceptional circumstances, the customer may still

decide to take products from that site for an agreed time, as legal compliance may still be demonstrated

by other means such as risk assessment and complaints records to show that the site is still competent to

continue production until another audit can be arranged.

14.2 Seasonal or intermittent production

Refer to the glossary (see Appendix 7) for definitions of seasonal and intermittent production.

A site that is open for 12 months of the year may process products at different times, but would not be

classed as a seasonal or intermittent production site as it would operate all the year round. If specific seasonal

products are in scope, there may be a case to visit the site more than once a year.

For true seasonal products there may be circumstances where the frequency could be more than 12 months.

The on-site audit date will be dictated by the time of year at which the products are produced. The certificate

expiry dates in these circumstances will be controlled by the actual audit date rather than the anniversary of

the initial audit date. Justification must be included on the audit report.

Certain products are manufactured for only six or fewer months in any annual cycle. The audit must take

place during the production of the product, irrespective of the grade assigned from the previous audit.

Verification of corrective action in relation to critical and major non-conformities must take place within the

period that the product is manufactured.

15 BRC Logos and PlaquesAchieving BRC certification is something of which to be proud. Companies that achieve

certification are qualified to use the BRC logo on company stationery and other marketing

materials. A BRC wall plaque is available for certificated companies to display in their offices to

help celebrate their success. Information and conditions relating to the use of the BRC logo is

available at www.brcglobalstandards.com.

If a company is no longer certificated because of certificate expiry, withdrawal or suspension they shall no

longer use the logo or display any plaque or certificate claiming certification.

The BRC logo is not a product certification mark and shall not be used on products or product packaging.

Any certificated site found to be misusing the mark will be subject to the BRC referral process (see 16.3

‘Complaints’) and may risk suspension or removal of their certification.

16 Communication with Certification BodiesIn the event that the company becomes aware of legal proceedings with respect to product safety or legality,

or in the event of a product recall, the company shall immediately make the certification body aware of

the situation. The certification body in turn shall take appropriate steps to assess the situation and any

implications for the certification, and shall take any appropriate action.

TM

BRCconsumerP RODUC T S

certificated

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16.1 Certification body performance monitoring

The BRC has a compliance programme for certification bodies, which requires certification bodies to meet key

performance indicators. The BRC also conducts a programme of sampling audit reports.

16.2 Feedback

Companies audited against the Standard may wish to provide feedback to the certification body or the

BRC on the performance of the auditor. Such feedback sent to the BRC will be considered in confidence

by the compliance manager and/or the relevant Technical Advisory Committee of the Standard as part of

performance management of the certification body.

16.3 Complaints

The BRC has implemented a formal referral process, which is available to organisations involved with the

Global Standards. A document detailing the Global Standards referral process can be found on the website

www.brcglobalstandards.com together with a ‘Global Standard Referral Notification’ form.

From time to time, failure to apply the principles and criteria of the BRC Global Standards at certificated

sites may be reported to the BRC by, for example, retailers and companies conducting their own audits. In

this event, the BRC will request a documented report of the reasons for the complaint and refer this report,

in confidence, to the certification body conducting the audit. The BRC will require a full investigation of

the issues raised and a report from the certification body submitted to the BRC within 28 calendar days (or

shorter time as specified by the BRC in urgent cases).

17 AppealsThe company has the right to appeal against the grade awarded or the certification decision made by the

certification body and any appeal should be made in writing within seven calendar days of receipt of the

certification decision.

The certification body shall have a documented procedure for the consideration and resolution of appeals

against the certification decision. These investigative procedures shall be independent of the individual

auditor and certification manager. Individual certification bodies’ documented appeals procedures will be

made available to the company on request. Appeals will be finalised within 30 calendar days of receipt. A full

written response will be given after the completion of a full and thorough investigation into the appeal.

In the event of an unsuccessful appeal, the certification body has the right to charge costs for conducting

the appeal.

18 The BRC Global Standards Directory

18.1 Introduction

The Global Standards Directory www.brcdirectory.com is an online searchable directory of companies

certificated to the BRC Global Standards for food safety, packaging, consumer products and storage and

distribution. Each entry includes relevant company details, contact and certification information. The directory

also includes details of certification bodies approved by the BRC.

The Global Standards Directory was developed to publicise the list of certificated companies, provide key

information to retailers and improve the management of the BRC Global Standards programme. It provides a

system of data storage of audit information, both live and archived. Data is centrally managed and controlled

to maintain accuracy and integrity.

18.2 Directory functionality

Information about certificated suppliers is provided to the BRC by certification bodies. The directory provides

the following publicly available facilities:

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■ a searchable list of certificated companies, including contact details, the Standard against which they are

certified, scope and links to their website

■ a searchable list of approved certification bodies, including local offices and contact details.

Note that companies may choose not to appear on the directory if they so wish.

The Global Standards Directory provides additional functionality to key user groups including companies,

retailers and certification bodies. This includes user-specific access to certification information, audit reports

and management reporting, further enhancing the value of obtaining BRC certification.

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Further information available at www.brcglobalstandards.com Section V Operation and Governance of the Scheme

SECTION V

OPERATION AND GOVERNANCE OF THE SCHEME

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Section V

Operation and Governance of the Scheme

1 Accreditation of and Requirements for Certification Bodies The Global Standard for Consumer Products is a process and product certification scheme. In this scheme,

businesses are certificated upon completion of a satisfactory audit by an auditor employed by an independent

third party – the certification body. The certification body in turn shall have been assessed and judged as

competent by a national accreditation body.

An outline of the process of certification and accreditation is presented in diagrammatic form in

Figure 6.

In order for a business to receive a valid certificate on completion of a satisfactory audit, the organisation

must select a certification body approved by the BRC. The BRC lays down detailed requirements that a

certification body must satisfy in order to gain approval.

As a minimum, the certification body must be accredited to ISO/IEC Guide 65 (EN 45011) by a national

accreditation body affiliated to the International Accreditation Forum.

Further details are available in the document Requirements for Organisations Offering Certification against the

Criteria of the BRC Global Standards – available from the BRC on request.

Companies looking to become certificated to the Standard should assure themselves that they are using

a genuine certification body approved by the BRC. A list of all certification bodies approved by the BRC is

available in the BRC Global Standards Directory: www.brcdirectory.com.

The BRC recognises that in certain circumstances, such as for new certification bodies wishing to commence

auditing against the Global Standard for Consumer Products, the certification body must be able to conduct

audits as part of achieving accreditation, so some unaccredited audits will be performed. This will be

permitted where the organisation can demonstrate:

■ an active application for accreditation against ISO/IEC Guide 65 (EN 45011) from an approved national

accreditation body

■ that accreditation will be achieved within 12 months of the date of application and the experience and

qualifications of the auditors in the relevant product category are consistent with those specified by

the BRC.

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Figure 6 Process for accreditation of certifi cation bodies and certifi cation of companies

International accreditation

forum and regional accreditation forums ISO/IEC 17011

General requirements for accreditation bodies

IAF guideline on the application of ISO/IEC Guide 65 (EN 45011)

BRC guidelines for accreditation bodies assessing certifi cation

bodies for BRC Global Standards

ISO/IEC Guide 65 (EN 45011)

Requirements for organisations offering certifi cation against the criteria of the BRC Global

Standards

BRC Global Standards website www.brcglobalstandards.com

BRC Directory www.brcdirectory.com

National accreditation body

Certifi cation body

Company Company Company

Supporting documentation

ACCREDITATION

CERTIFICATION

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2 Technical Governance of the Global Standard for Consumer Products

The Standard is owned by the BRC and is governed through a number of committees each of which works to

a set of defined terms of reference.

2.1 The Governance and Strategy Committee

The technical content and operation of all the BRC Global Standards is overseen and governed by the BRC

Governance and Strategy Committee consisting of senior technical representatives of international retail

businesses. The functions of the Governance and Strategy Committee are:

■ to advise on the development and management of the Standard schemes

■ to ensure measures are in place to monitor compliance by companies, certification bodies and

accreditation bodies

■ to coordinate the review of the Standard at appropriate intervals (at least every three years).

2.2 Technical advisory committees

Each BRC Global Standard is supported by technical advisory committees (TACs) who meet regularly to discuss

technical, operational and interpretational issues related to the Standard. The committees are comprised

of technically expert personnel from a range of stakeholders including retailers, certification bodies, trade

associations and accreditation agencies. The BRC/RILA provides the technical secretariat for these groups.

The Standard is reviewed every three years to assess the need for updating or production of a new issue. This

work is undertaken by the TACs, which are expanded for the purpose to include other available expertise.

Once an initial draft has been agreed, it is circulated for wider consultation before the final draft is agreed by

the TAC and prepared for publication by the BRC.

The TACs also review proposed training materials for the Standard and review ancillary documents such

as guidelines.

2.3 The certification body cooperation groups

The certification bodies participating in the scheme also have cooperation groups to discuss matters arising on

the implementation of the Standard to which the BRC/RILA are invited guests. These groups report regularly

to the BRC on operational issues, implementation and suggested improvements.

The structure of the BRC Global Standards operations is outlined in Figure 7.

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Figure 7 BRC Global Standards technical governance

3 Effective Date of Issue 3 As with all revisions of the Global Standards, a transition period is in place between publication and full

implementation in order to allow for sites to become familiar with the new issue, auditors to be adequately

trained and certifi cation bodies to implement new procedures. Therefore, certifi cation against Issue 3 will

commence from 1 October 2010. There will be no recognition of certifi cates that are issued as a result

of audits performed against Issue 2 or 2A after 30 September 2010. All certifi cates issued against audits

carried out prior to 30 September 2010 will be against Issue 2A and be valid for the period specifi ed on the

certifi cate. In order to ensure that the infrastructure is in place to support successful audits, audits against

Issue 3 will not commence until 1 October 2010. Certifi cates issued before this date against Issue 3 will not be

recognised by the BRC.

4 Acknowledgements

A ‘Thank You’ from the BRC and RILA

The BRC and RILA wish to acknowledge all those committee members and industry experts who have

contributed to the preparation of the Standard Issue 3. A list of those who have contributed to this review is

detailed in Appendix 8.

BRC technical team RILA product safety group

Wider stakeholder network, trainers, technical experts

BRC/RILA technical advisory committees

Certifi cation body cooperation groups

Governance and Strategy CommitteeBRC/RILA members and international representatives defi ne policy and oversee progress

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Further information available at www.brcglobalstandards.com Appendices

APPENDICES

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Appendix 1

The Standard and its Relationship with Other BRC Global Standards

The BRC has developed a range of Global Standards, which set out the requirements for the wide

range of activities undertaken in the production of food, consumer goods and packaging, as well as

storage and distribution.

The Standard is an auditing standard that sets out the requirements for businesses that produce consumer

products or are involved in the preparation of products as components for supply as retailer-branded (own-

label) products or branded products. It can only be used at manufacturing or packing sites. It is not suitable

for importers, sales offices and similar operations. Certification will only apply to products that have been

manufactured or prepared at the site where the audit has taken place and will include storage facilities that

are under the direct control of production site management. Companies whose primary occupation is the

manufacturing of products or preparations may have factored goods (see glossary in Appendix 7) included

in the scope of the certification, where they can demonstrate that appropriate controls are in place and the

scope specifically excludes the processing or manufacture of these products.

The BRC Global Standard for Storage and Distribution is an auditing standard that sets out the requirements

for the storage, distribution, wholesaling and contracted services for pre-packaged and loose products,

packaging materials and food. There are specific modules for each activity undertaken, and the Standard

specifies the requirements for storage, distribution, wholesaling and contracted services. Companies that offer

contracted operations will not be covered by this Standard as these operations are deemed to be processing

activities and are covered by the Global Standard for Consumer Products. Application of this Standard only

commences when the products enter third-party storage premises, third-party vehicles or premises owned

by the manufacturer not covered by the scope of the audit for the Global Standards for consumer products,

packaging or food. The Standard is not applicable to:

■ storage facilities under the direct control of the production site management

■ operations where product processing, handling or packing/repacking of open food occurs.

The Global Standard for Storage and Distribution does not cover:

■ live animals

■ pre-farmgate loose bulk agricultural products

■ non-food products that are listed as excluded in the Global Standard for Consumer Products.

In addition, companies such as trade agencies, brokers and importers that do not have manufacturing,

packing, storage or transport facilities cannot apply for certification under the Standard, but such companies

may request certification from their suppliers who are involved in these activities.

The BRC/IoP Global Standard for Packaging and Packaging Materials is an auditing standard that lays

down the requirements for the manufacturing of packaging materials used for food and consumer

products. Businesses may request certification to this Standard from their suppliers of packaging.

Packaging manufactured for retail sale to consumers is included within the scope of the Global Standard

for Consumer Products.

The BRC Global Standard for Food Safety is an auditing standard which is applicable to food and is the most

mature of the BRC Global Standards used in the food industry worldwide. This standard also applies to

products closely related to food such as pet foods, vitamins, minerals and herbal supplements. These products

fall outside the scope of the BRC Global Standard for Consumer Products.

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Appendix 2

Registration, Qualifications, Training and Experience Requirements for Auditors

1 RegistrationAll auditors conducting audits against the BRC Global Standard for Consumer Products are required to be

registered by the BRC. The registration process identifies that auditors have undergone required training

and identifies the product categories in which they have expertise. Evidence of an auditor’s qualifications,

experience and training has to be submitted to the BRC prior to them carrying out audits. All registered

auditors receive a unique registration number which is included on the audit report and is automatically cross-

checked against their competence before the certification is accepted into the BRC Directory.

The following sections identify the minimum requirements for auditors. The verification of competence to

carry out a specific audit shall be carried out by the certification body.

It is the responsibility of the certification body to ensure processes are in place to monitor and maintain the

competence of the auditor to the level required by the Standard.

2 EducationThe auditor ideally shall have a recognised professional apprenticeship, a degree in a science or

engineering discipline or have successfully completed a higher education qualification in a science- or

engineering-related discipline.

3 Work ExperienceThe auditor shall have a minimum of three years’ work experience directly related to the relevant technology

or industry. This shall involve work in quality assurance, technical management, engineering, product

development or product safety functions within manufacturing, retail technology, or technical audits.

The auditor shall be able to demonstrate an understanding and knowledge of specific categories of product

for which they are approved.

4 QualificationsThe auditor must have:

■ passed a registered quality management system (QMS) lead assessor course (e.g. IEMA, IRCA) and

completed a Global Standard for Consumer Products course – ‘How to interpret the Standard’, delivered

by a BRC-approved trainer – and participated in update courses to ensure that they have been trained to

the current issue of the Standard

or

■ successfully completed a course combining technical and lead assessor skills specifically developed by the

BRC and provided by a BRC-approved trainer and participated in update courses to ensure that they have

been trained to the current issue of the Standard

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and, in addition to the above requirements, have:

■ completed a training course in risk assessment or hazard analysis and critical control point (HACCP) of at

least two days’ duration, or be able to demonstrate competence in the understanding and application of

risk assessment/hazard analysis/HACCP principles. It is essential that the HACCP/risk assessment course is

recognised by the relevant sector industry as being appropriate and relevant

and

■ completed a training course on the BRC sector-specific guidelines for the sectors in which they operate,

where such guidelines exist.

5 Audit ExperienceAuditors must have practical auditing experience of product certification schemes or quality management

systems. The details of the required experience are specified in the document Registration, Qualifications,

Training and Experience Requirements for Auditors available from the BRC on request.

6 General Training Obligations of Certification BodiesCertification bodies must be able to demonstrate that every auditor has appropriate training and experience

for the particular categories for which they are considered competent. Auditor competence shall be recorded

at least at the level of each category as indicated in Appendix 3.

Certification bodies must establish training programmes for each auditor, which will incorporate:

■ a period of initial training covering product safety, risk assessment and prerequisite programmes, and

access to relevant laws and regulations

■ a period of supervised training to cover quality management systems, audit techniques and specific

category knowledge

■ assessment of knowledge and skills for each category

■ documented sign-off after the satisfactory completion of the training programme.

Each auditor’s training programme shall be managed and approved by a senior auditor with experience of

auditing against BRC Global Standards. In situations where the certification body has not previously audited

to the BRC Global Standards, the BRC may be contacted to discuss alternative means of approving the auditor

training programme.

Full detailed training records of the individual shall be maintained by the certification body throughout

the term of employment and retained for a minimum period of five years after the auditor has left the

employment of the certification body.

6.1 Exceptions

Where a certification body employs an auditor who does not fully meet the specific criteria for education

but has been assessed as competent, there shall be a fully documented justification in place to support the

employment of the auditor.

Note: Such exceptions only apply to existing auditors working to BRC Global Standards prior to June 2009;

new auditors will be expected to meet the defined criteria.

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Appendix 3

Product Fields and Categories

The product fields listed below represent the broad groups into which consumer products may be placed. The

product categories are the groups to which auditors are registered and must demonstrate their expertise. The

registration of an auditor for a particular category does not imply that they are competent for all products

in the category. It is the responsibility of the certification body to ensure that auditors are suitable for an

individual audit. For example, an auditor listed under ‘furniture’ may have experience of wooden furniture but

not of upholstered furniture or glass furniture.

It is inevitable that some products will be difficult to categorise and may cross boundaries between product

categories. This list may be amended from time to time and users are advised to check for the most up-to-

date information via the website www.brcglobalstandards.com. Note that auditors may be approved for

multiple categories if their expertise is appropriate. Note that products may fall into more than one product

category (for example, a toy that is also an electrical product).

Field BRC category ExamplesCode

number

Soft lines Textiles and textile productsApparel Household textiles Bandages

1

Soft lines Leather, leather products, footwearBelts Shoes Bags

2

Hard lines Wood, wooden products, cork, straw

Pencils Doors Bamboo steamers Baskets Tablemats

3

Soft lines Paper and paper products

Stationery items Tissues Toilet rolls Disposable tableware

4

Hard lines Printing and recorded media

Books DVDs Magazines Labels

5

Formulated products

Coke, charcoal, refined petroleum products

Barbeque fuel Coal Candles Oil for lamps

6

Formulated products

Chemicals and chemical products

Cosmetics Household detergents Garden chemicals Paints

7

Formulated products

PharmaceuticalsMedicines Tablets Creams

8

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Field BRC category ExamplesCode

number

Hard lines Rubber and plastic products

Gloves Elastic bands Household utensils Giftware

9

Hard lines Glass, clay, ceramic and porcelain products

Tableware Cookware Decorative items Mirrors

10

Hard lines Concrete, cement, lime, plaster Building goods 11

Hard lines Metal products excluding machinery

Handles Tins Razor blades Screws, nails etc.

12

Hard lines Machinery and equipmentLadders Tools Gas appliances

13

ElectricalComputer, electronic, communications and optical

Computers Phones Computer accessories Audio visual

14

Electrical Electrical equipment, batteries

Lighting Household appliances White goods Battery-operated items Batteries

15

Hard lines Transport equipment, cycles, boatsBicycles Canoes Car accessories

16

Hard lines Furniture

Outdoor Upholstered Metal, wood, plastic Inflatable

17

Hard lines Games and toys

Plush toys Plastic toys Chemistry sets Radio-controlled cars Swings

18

Hard lines Jewellery and accessories

Precious jewellery Fashion jewellery Buckles Piercings

19

Can be any field depending on product

Medical devicesDressings Walking aids Contact lens solutions

20

Other

Auditors for this category must be qualified in at least 3 of the listed categories (1 to 20)

This section should be used sparingly to cover goods not easily classified elsewhere, for example gift items made of multiple materials

21

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Appendix 4

Grading Criteria, Action Required and Audit Frequency

Grade Critical

Major non-conformity against the ‘statement of intent’ of a ‘fundamental’ requirement

Major Minor Corrective action

Audit frequency

Product groups 1 and 2

Audit frequency

Product group 3

A 010 or fewer

Objective evidence in 28 calendar days (60 days for initial audit)

12 months24 months Surveillance at 12 months

B 110 or fewer



B 011 to 20



C 220 or fewer

Re-visit required within 28 calendar days (60 days for initial audit)

6 months 12 months

C 0 or 1Up to 30

Re-visit required within 28 calendar days (60 days for initial audit)

6 months 12 months

D1 or more

Certification not granted Re-audit required

D 1 or moreCertification not granted Re-audit required

D3 or more


D 221 or more


D 0 or 131 or more


Certification will not be granted and therefore no grade shall be awarded if corrective action is not completed

or evidence of completion is not received by the certification body within the 28-calendar-day (60 days for

first audit) timescale.

The certification body shall justify a high number (more than 20) of minor non-conformities where there is

either one major non-conformity or no major non-conformities. This shall be detailed on the audit report.

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Appendix 5

Certifi cate Template

Accreditation

body logo

Trained third

party auditor

logo

BRC logoName and full address of certifi cation body

This certifi cate remains the property of (name of certifi cation body)

Auditor number

CERTIFICATION BODY NAME OR LOGO

This is to certify that

COMPANY NAME AUDIT SITE ADDRESS

Has been evaluated by certifi cation body name and accreditation body registration number

and found to meet the requirements of

GLOBAL STANDARD for CONSUMER PRODUCTS ISSUE 3: February 2010

SCOPE

Product categories

Achieved grade

Initial audit date:

Date of audit:

Certifi cate issue:

Re-audit due date:

Certifi cate expiry date:

Authorised by

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Appendix 6

Explanation of Cycles for Certificate Validity, Audit Frequency and Planning

The frequency of audits depends on the product group and the grade awarded in previous audits and the

cycle can be 6, 12 or 24 months. The 24-month period requires a surveillance visit after 12 months (see

Appendix 4 for details).

The timescale in which audits may be carried out and certificates awarded is clearly defined in each case.

There are four important dates to consider, all of which are listed on the certificate.

Audit cycles

Date Description Explanation

Audit date The actual date of the audit visit

Certificate issue date The date of the certification decision

The certification body makes a decision on the success and grade of the audit and issues the certificate once all non-conformities have been closed out. The site has 28 days to provide adequate information (60 days for initial audit) and the certification body is allowed up to 14 days to complete the report and assign the grade, so this date must be a maximum of 42 days after the audit date (74 days for an initial audit).

Re-audit due date Date by which re-audit must be carried out

The re-audit must be conducted by the anniversary of the initial audit date (6/12/24 months). The site is allowed a 28-day period before this date in which it can schedule an audit visit.

Note: For subsequent audit visits, it is always the anniversary of the original audit date that is relevant, not the actual audit visit date of any preceding audit.

Certificate expiry date Date on which the current certificate becomes invalid

The certificate expiry date reflects the audit frequency (6, 12 or 24 months) plus a period of 42 days. This allows a company to correct any non-conformities and for the certification body to issue a new certificate before the previous certificate expires.

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Examples

Note that allowance is made for public-holiday periods but this has not been considered in the following

examples.

Example 1 Product group 1 or 2: company receives a grade C after first audit and grade C after second audit

Audit frequency: 6 months

Event Date Explanation

Audit date 1 February 2010 ----

Certificate issue date 24 March 2010 The company takes 40 days to submit all corrective actions (60 days allowed as initial audit)

The certification body takes 11 days to issue the certificate (14 days allowed)

Re-audit due date 1 August 2010 6 months from the initial visit

Re-audit visit 26 July 2010 Company is allowed a 28-day window before the audit due date

Certificate expiry date 12 September 2010 This is 6 months plus 42 days from the initial audit to allow the company to correct non-conformities from the re-audit without losing its certification

Re-certification date 8 September 2010 Company has corrected non-conformities and certification body issued the certificate within the allowed 42-day window

Next audit due date 1 February 2011 Anniversary of original audit date

Next certificate expiry date

15 April 2011 Anniversary of original audit date plus 42 days

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Example 2Product group 1 or 2: company receives a grade C after first audit and grade A or B after second audit

Audit frequency: 6 months then 12 months





Re-audit due date 1 August 2010 6 months from the initial visit

Re-audit visit 26 July 2010 Company is allowed a 28-day window before the audit due date

Certificate expiry date 12 September 2010 This is 6 months plus 42 days from the initial audit to allow the company to correct non-conformities from the re-audit without losing its certification

Re-certification date 8 September 2010 Company has corrected non-conformities and the certification body issued certificate within the allowed 42-day window

Next audit due date 1 August 2011 Anniversary of original audit date


12 September 2011 Anniversary of original audit date plus 42 days

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Example 3Product group 1 or 2: company receives a grade A or B after first and second audit

Product group 3: receives a grade C after first and second audit

Audit frequency: 12 months





Re-audit due date 1 February 2011 12 months from the initial visit

Re-audit visit 26 January 2011 Company is allowed a 28-day window before the audit due date

Certificate expiry date 15 March 2011 This is 12 months plus 42 days from the initial audit to allow the company to correct non-conformities from the re-audit without losing its certification

Re-certification date 2 March 2011 Company has corrected non-conformities and the certification body issued certificate within the allowed 42-day window



15 March 2012 Anniversary of original audit date plus 42 days

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Example 4Product group 3: receives an A or B grade after first and second audit

Audit frequency: 24 months (surveillance at 12 months)





Surveillance due date 1 February 2011 12 months from the initial visit

Surveillance visit 26 January 2011 Company is allowed a 28-day window before the audit due date

Actions following surveillance

No major non-conformities

If major non-conformities are detected, corrective actions are submitted to the certification body and confirmed as OK within 42 days.

If there are no major non-conformities, no action required

Re-audit due date 1 February 2012 24 months from the initial visit

Re-audit visit 28 January 2012 Company is allowed a 28-day window before the audit due date

Certificate expiry date 15 March 2012 This is 24 months plus 42 days from the initial audit to allow the company to correct non-conformities from the re-audit without losing its certification

Re-certification date 2 March 2012 Company has corrected non-conformities and the certification body issued certificate within the allowed 42-day window



15 March 2014 Anniversary of original audit date plus 42 days

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Appendix 7

Glossary of Terms

In relation to terms used within this document, the following words shall have the following meanings.

Accreditation Procedure by which an authoritative body gives formal recognition of the competence of a certification or testing body to provide certification/testing services against a specified standard.

AQL Acceptable quality limit as defined in ISO 2859 part 1

Assembly packer A business that assembles a collection of two or more market-ready finished consumer products into outer packaging for sale as a single product. These companies do not manufacture any of the component products, which are supplied to them for the assembly into the final pack.

Audit A systematic examination to substantiate whether activities and related results comply with planned arrangements, whether these arrangements are implemented effectively, and whether they are suitable to achieve objectives.

Audit level The product group level agreed between the company and the certification body as the criteria for the audit and certification. This shall not be lower than the product with the highest product group within the scope of the audit.

Auditor A person possessing the appropriate competence and skills to carry out an audit.

Batch A discrete quantity of products made using the same operation and raw materials (alternative term is ‘lot’).

Bill of materials List of the materials used, including component parts in the make-up of a product.

Branded product Products bearing the logo, copyright or address of a company which is not primarily a retailer.

Business continuity

A framework which enables an organisation to plan and respond to incidents of business interruption in order to continue business operations at an acceptable predetermined level.

Calendar day Includes both working days and weekends but excludes periods of legal public holiday of the country in which the site and/or certification body is located.

Calibration Set of operations that establish, under specified conditions, the relationship between values of quantities indicated by measuring instruments or measuring systems, or values represented by a material or reference material, and corresponding values realised by standards.

Certification Procedure by which accredited certification bodies provide written assurance that a company conforms to a Standard’s requirement, based upon an audited assessment of a company’s competence.

Certification body Provider of certification services, accredited to do so by an authoritative body.

Certification suspension

Revocation of certification for a given period, pending remedial action on the part of the company.

Certification withdrawal

Revocation of certification.

Company The business name and the site seeking BRC certification.

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Compliance Meeting the regulatory or customer requirements concerning product safety, legality and quality.

Consumer The end-user of the finished product.

Consumer product management system

All systems related to product hazard and risk processes, which determine and control product safety, legality and quality.

Consumer products

Products normally bought by or supplied to private consumers for personal or household use and included within the scope of the Standard.

Contract packer A company that packages the final product into consumer packaging.

Controlled document

A document which is identifiable and for which revisions and removal from use can be tracked. The document is issued to identified individuals and their receipt of the document is recorded.

Control measure Any action and activity that can be used to prevent or eliminate a safety hazard or reduce it to an acceptable level.

Critical control points (CCPs)

Process steps that can be applied and which are essential to prevent a safety hazard or to reduce it to an acceptable level.

Customer A business or person to whom the product has been supplied or sold, either as a finished product or as a component of a finished product.

Customer focus A structured approach to determining and addressing the needs of an organisation to which the company supplies products and which may be measured by the use of performance indicators.

Dispatch The point at which the product leaves the factory site or is no longer the responsibility of the company.

Factored goods Goods not manufactured or part-processed on site but bought in and sold on.

Fundamental requirement

A requirement of the Standard that relates to a system which must be well established, continuously maintained and monitored by the company, as absence or poor adherence to the system will have serious repercussions on the integrity or safety of the product supplied.

Harmonised standard

A standard listed by the European Commission or member state as suitable for determining compliance with essential safety requirements. The list can be found at www.ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist

Hazard An agent of any type with the potential to cause harm.

Incident An event that has occurred which results in the production or supply of unsafe, illegal or non-conforming products.

Infant A child under 36 months.

Initial audit The first BRC audit at a company/site.

Internal audit General process of audit, for all the activity of the company. Conducted by or on behalf of the company for internal purposes.

Job description A list of the responsibilities for a given position at a company.

Injury: serious (major)

2–15% incapacity. Usually irreversible and requiring hospital treatment (e.g. serious cuts, loss of finger or toe, damage to sight, damage to hearing).

Injury: slight (minor)

< 2% incapacity. Usually reversible and not requiring hospital treatment.

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Injury: (very serious)

> 15% incapacity. Usually irreversible and requiring hospital treatment (e.g. serious injury to internal organs, loss of limbs, loss of sight, loss of hearing, acute poisoning).

Invasive A device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body. For the purposes of this standard ‘invasive’ does not include products entering the mouth or outer ear for periods of less than 30 minutes continuous use.

A surgically invasive device is a device which penetrates inside the body through the surface of the body, with the aid or in the context of a surgical operation.

Key staff Those staff whose activities directly affect the safety, legality and quality of the finished product.

Legality Meeting all relevant legislation in the country (or countries) where the product(s) is/are intended to be supplied or sold.

Lot See definition of ‘batch’.

Mandatory standard

Standard which must be met to demonstrate legal compliance with the law in a country or region.

Manufacturer A company that produces product from raw materials and/or components and packs the product into retail units or supplies product in bulk to a packing company that packs the product into retail units. A packer that packs product into retail units from bulk-supplied material can also be classed as a ‘manufacturer’.

Nanomaterials Materials which have structured components with at least one dimension less than 100 nm.

Nanotechnology Technology using nanomaterials in order to impart specific properties.

Non-conformity The non-fulfilment of specified product quality, legal or safety requirements or specific quality requirements.

Original copy A document, whether in electronic or printed form, that has been legally obtained and does not infringe any copyright.

Outer packaging Packaging which is visible when the product is released from the site. For example, a cardboard box could be considered outer packaging even if wrapped in clear film.

Performance indicators

Summaries of quantified data that provide information on the level of compliance against agreed targets, e.g. customer complaints, product incidents, laboratory data.

Primary customer The first customer who receives the goods on dispatch from the factory.

Procedure Agreed method of carrying out an activity or process which is implemented and documented in the form of detailed instructions or process description (e.g. a flowchart).

Product recall Any measures aimed at achieving the return of an unfit product from final consumers.

Product withdrawal

Any measures aimed at achieving the return of an unfit product from customers but not from final consumers.

Quality Meeting the customer’s specification and expectation.

Quantity control A check on the amount of product in the consumer pack. May be related to weight, volume, number of pieces, size etc.

Quarantine Segregation of materials so that mixing with other items does not occur. This can be by physical separation, visually labelling as scrap/waste or other methods.

Reference sample Agreed product or components for referral by the manufacturer for production.

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Retailer A business selling products to the public by retail.

Retailer-branded product

A product bearing a retailer’s trademark, logo, copyright, address or ingredients which are used to manufacture within a retailer’s premises, or which are products legally regarded as the primary responsibility of the retailer.

Retained production sample

Representative product or components taken from a production run and securely held for future reference.

Risk The likelihood of occurrence of harm from a hazard.

Sampling plan A documented plan defining the number of samples to be selected, the acceptance or rejection criteria and the statistical confidence of the result.

Safety Freedom from unacceptable risk to humans or animals.

Seasonal or intermittent production

A product produced on a site that is opened specifically for the duration of the short-term production (typically 6 months or less) during a 12-month cycle.

Senior management

Those with strategic/high-level operational responsibility for the company and the capability to authorise the financial or human resources necessary for the implementation of the Standard.

Shall Is a requirement to comply with the contents of the clause.

Site A unit of the company.

Skin contact Product in intimate contact with the skin for more than 30 minutes at one use. Examples include face paints and lingerie. Products handled during use such as books, keyboards etc. are not included in this description.

Specific legislation

Product-specific legislative requirements in the country where the product will be sold.

Specification An explicit, detailed description of a material product or service.

Specifier Company or person requesting the product or service. Typically a retailer.

Stakeholders Brand owners, certification bodies, enforcement agencies, consumers, suppliers, manufacturers or others with a bona fide interest in the Standard.

Standard, the Global Standard for Consumer Products.

Supplier The person, firm, company or other entity to whom a company’s purchase order to supply is addressed.

Technical dossier A collection of technical documents which together form the technical specification and product conformity information on a specific product.

Testing A technical operation that consists of the determination of one or more characteristics of a given product, process or service following a specific procedure and against an agreed requirement.

Traceability Ability to trace and follow raw materials, components and products through all stages of receipt, production, processing and distribution and vice versa.

Validation Confirmation through the provision of objective evidence that the requirements for the specific intended use or application have been fulfilled.

Verification Confirmation through the provision of objective evidence that specified requirements exist.

Very vulnerable user group

Children under the age of 36 months; people having very extensive and severe disabilities.

Vulnerable user group

Children aged 36 months to 14 years; people with reduced physical, sensory or mental capabilities (e.g. partially disabled or elderly people with some reduction in their physical and mental capabilities).

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Appendix 8

Acknowledgements

The BRC and RILA are grateful to the following people who supported and assisted in the preparation of this document:

Yvonne Anderson Target

Karen Betts BRC

Chari Bierlein JC Penney

Alan Binks BABT/TUV Product Services (UK)

Paula Boult SGS United Kingdom Ltd

Jerry Burnie British Toy & Hobby Association

Tim Cassidy Best Buy

Malcolm Denniss SGS Testing Services

Bill Dolak Walgreens

Peggy Fowler Wal-Mart

Petrina Fridd Consultant

Beth Gammons Dollar General

Chris Gray The John Lewis Partnership

Kathy Guerra Sears Holdings, Inc

Elizabeth Hausler Bureau Veritas

David Highton BSI

Kyle Holifield Wal-Mart

Lisa Hudson Makro Self-Service Wholesalers Ltd

Mark Huyton Waitrose

Alyn Jones SCA Hygiene Products (UK) Ltd

Kelly Joyce Target

Nick Lengden Intertek UK Ltd

Leona Lewis Best Buy

Jennifer Morgan JC Penney

Heather Morschauser Michaels

Jim Neill RILA

Lucy O'Neill Tesco Stores Ltd

Elizabeth Parry Asda Stores Ltd

Phil Penny The co-operative food

Beth Schommer Wal-Mart

Rob Stephenson Dollar General

Tracy Stewart AHPMA (Absorbent Hygiene Products Manufacturers Association)

Jennifer Thompson Costco

Richard Warbey Sainsbury's Supermarkets Ltd

Chris White Booker

Barbara White Target

Andy Wingerter Intertek

Marissa Zanno RILA

UKAS

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Appendix 9

Cross-reference Tables with ISO 9001: 2008

Note that the cross-reference is to clauses which address similar requirements. The exact contents of the clauses are not interchangeable.

BRC Global Standard vs ISO 9000

Clause BRC Issue 3 Clause ISO 9001–2008

1 Senior management commitment and continual improvement

5.1 Management commitment

1.1 5 Management responsibility

1.2 5.6 Management review

1.3

1.4 6, 6.1 Resource management Provision of resources

1.5 8.5 Improvement

1.6

1.7

2 Risk management 7.1 Planning of product realisation

2.1 Product scope and group determination 1 Scope

2.2 Legislative and safety requirements

2.3 Risk assessment – prior to production 7.3 Design and development

2.4 Verification of the product risk assessment

3 Management system 4 Quality management system

3.1 Policy statement 5.3 Quality policy

3.2 General documentation requirements 4.2 Documentation requirements

3.3 Organisational structure, responsibility and management authority

5.5 Responsibility, authority and communication

3.4 Internal audit

3.5 Purchasing, supplier approval and performance monitoring

7.4 Purchasing

3.6 Customer-supplied property

3.7 Corrective and preventive action

3.8 Traceability

3.9 Management of product withdrawal and product recall

3.10 Management of incidents and business continuity

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Clause BRC Issue 3 Clause ISO 9001–2008

3.11 Contract review and customer focus 5.2 Customer focus

3.12 Complaint handling

4 Site standards 6.3 Infrastructure

4.1 Location, perimeter and grounds

4.2 Internal site: factory layout, product flow and segregation

6.4 Work environment

4.3 Building interiors 6.4 Work environment

4.4 Staff facilities 6.4 Work environment

4.5 Cleaning procedures

4.6 Waste/waste disposal

4.7 Pest control

4.8 Product transport, storage and distribution

4.9 Site security

5 Product control 7 Product realisation

5.1 Pre-production reference samples

5.2 Chemical formulation control

5.3 Product packaging materials

5.4 Control of non-conforming materials 8.3 Control of non-conforming product

5.5 Handling requirements for specific materials

5.6 Stock control and product release

6 Product conformity assessment 8 Measurement, analysis and improvement

6.1 Product analysis/testing 6.2 Monitoring and measurement

6.2 Inspections

6.3 Product claims

7 Process control 7.5 Product and service provision

7.1 Control of operations

7.2 Control of incoming components and raw materials

7.3 Equipment and equipment maintenance

7.4 Foreign-body detection and control

7.5 Calibration and control of measuring and monitoring devices

7.6 Control of monitoring and measuring equipment

7.6 Retained production samples

7.7 Final product packing and control

8 Personnel 6.2 Human resources

8.1 Training and competency

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ISO 9000 vs the BRC Global Standard

Clause ISO 9001–2008 Section/clause BRC Issue 3

1 Scope II 2 III 2.1

Scope of the certification Product scope and group determination

1.1 General II

1.2 Application

2 Normative references

3 Terms and definitions App 7 Glossary

4 Quality management system III 3 Management system

4.1 General requirements III 3

4.2 Documentation requirements III 3.2 General documentation requirements

5 Management responsibility III 1.1

5.1 Management commitment III 1 Senior management commitment and continual improvement

5.2 Customer focus III 3.11 Contract review and customer focus

5.3 Quality policy III 3.1 Policy Statement

5.4 Planning

5.5 Responsibility, authority and communication

III 3.3 Organisational structure, responsibility and management authority

5.6 Management review III 1.2

6 Resource management III 1.4

6.1 Provision of resources III 1.4

6.2 Human resources III 8 Personnel

6.3 Infrastructure III 4 Site standards

6.4 Work environment III 4.2, 4.3 and 4.4

Internal site Building interiors Staff facilities

7 Product realisation III 2 III 5

Risk management Product control

7.1 Planning of product realisation III 2 III 3.2.3

Risk management Specifications

7.2 Customer-related processes

7.3 Design and development III 5 Product control

7.4 Purchasing III 3.5 Purchasing, supplier approval and performance monitoring

7.5 Production and service provision III 7 Process control

7.6 Control of monitoring and measuring equipment

III 7.5 Calibration and control of measuring and monitoring devices

8 Measurement, analysis and improvement

III 6 Product conformity assessment

8.1 General

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Clause ISO 9001–2008 Section/clause BRC Issue 3

8.2 Monitoring and measurement III 6.1 Product analysis/testing

8.3 Control of nonconforming product

III 5.4 Control of non-conforming materials

8.4 Analysis of data III 6.1.8

8.5 Improvement III 1.5

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Issue 3

GLO

BAL STA

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BRC/RILAISSU

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9 781784 901899

ISBN 978-1-78490-189-9

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