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BRC/IOP

Issue 4

ISSUE 4
February 2011
British Retail Consortium

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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: brcglobalstandards@brc.org.uk
website: www.brcglobalstandards.com

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BRC Global Standard for Packaging & Packaging Materials

Contents

Section I Introduction

1 Background

2 The Scope of the Standard (Issue 4)

3 Principles of the Standard

3.1 Senior management commitment

3.2 A risk-based system

3.3 Quality management system and suitable operating conditions

4 Benefits of the Standard

5 The Certification Process

6 The British Retail Consortium/The Packaging Society

7 Acknowledgements: A Thank You from the BRC and IOP

Section II Preparation and Planning for Success

1 Preparation Time

1.1 For specifiers

1.2 For packaging manufacturers

2 Product Categories

Section III Requirements

11

13

Layout and Use of the Requirements of the Standard

15

Categories

15

The format of the Standard

15

Fundamental requirements

15

Exclusion of Requirements

15

Non-applicable clauses

15

Risk-based exemptions

16

High Hygiene Risk Category

17

1 Senior Management Commitment and Continual Improvement

17

1.1 Product safety and quality management policy

17

1.2 Senior management commitment

18

1.3 Organisational structure, responsibilities and management authority

19

1.4 Management review

19

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2 Hazard and Risk Management System

20

2.1 Hazard and risk management team

20

2.2 Hazard and risk analysis

20

2.3 Exemption of requirements based on risk analysis

22

3 Product Safety and Quality Management System

23

3.1 Product safety and quality manual

23

3.2 Customer focus and contract review

23

3.3 Internal audits

24

3.4 Supplier approval and performance monitoring

24

3.5 Subcontracting of production

25

3.6 Documentation control

25

3.7 Specifications

26

3.8 Record keeping

26

3.9 Traceability

27

3.10 Complaint handling

27

3.11 Management of incidents, product withdrawals and recalls

28

4 Site Standards

29

4.1 External standards

29

4.2 Building fabric and interiors

29

4.3 Utilities

30

4.4 Security

30

4.5 Layout and product flow

31

4.6 Equipment

31

4.7 Maintenance

32

4.8 Staff facilities

33

4.9 Housekeeping and cleaning

34

4.10 Waste and waste disposal

34

4.11 Pest control

35

4.12 Transport, storage and distribution

36

5 Product and Process Control

37

5.1 Product design and development

37

5.2 Packaging print control

38

5.3 Process control

39

5.4 Product inspection and analysis

39

5.5 In-line testing and measuring equipment

40

5.6 Calibration

40

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5.7 Control of non-conforming product

41

5.8 Foreign body contamination control

41

6 Personnel

43

6.1 Training and competence

43

6.2 Access and movement of personnel

43

6.3 Personal hygiene

44

6.4 Medical screening

44

6.5 Protective clothing

45

Low Hygiene Risk Category

46

1 Senior Management Commitment and Continual Improvement

46

1.1 Product safety and quality management policy

46

1.2 Senior management commitment

46

1.3 Organisational structure, responsibilities and management authority

47

1.4 Management review

47

2 Hazard and Risk Management System

48

2.1 Hazard and risk management team

48

2.2 Hazard and risk analysis

48

2.3 Exemption of requirements based on risk analysis

49

3 Product Safety and Quality Management System

50

3.1 Product safety and quality manual

50

3.2 Customer focus and contract review

50

3.3 Internal audits

50

3.4 Supplier approval and performance monitoring

51

3.5 Subcontracting of production

51

3.6 Documentation control

52

3.7 Specifications

52

3.8 Record keeping

52

3.9 Traceability

53

3.10 Complaint handling

53

3.11 Management of incidents, product withdrawals and recalls

53

4 Site Standards

54

4.1 External standards

54

4.2 Building fabric and interiors

54

4.3 Utilities

55

4.4 Security

55

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4.5 Layout and product flow

55

4.6 Equipment

56

4.7 Maintenance

56

4.8 Staff facilities

56

4.9 Housekeeping and cleaning

57

4.10 Waste and waste disposal

57

4.11 Pest control

58

4.12 Transport, storage and distribution

58

5 Product and Process Control

59

5.1 Product design and development

59

5.2 Packaging print control

60

5.3 Process control

61

5.4 Product inspection and analysis

61

5.5 In-line testing and measuring equipment

62

5.6 Calibration

62

5.7 Control of non-conforming product

62

5.8 Foreign body contamination control

63

6 Personnel

64

6.1 Training and competence

64

6.2 Access and movement of personnel

64

6.3 Personal hygiene

64

6.4 Protective clothing

65

Section IV Audit and Certification Process

67

1 Introduction

69

2 Getting Started

69

3 Self-assessment of Compliance with the Standard

69

4 Selection of a Certification Body

70

5 Company/Certification Body Contractual Arrangements

70

5.1 Registration fee

70

5.2 Scope of audit

70

5.3 Extension to scope

70

5.4 Auditor selection

72

6 Audit Preparation by the Company

72

7 Duration of the Audit

72

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8 The On-site Audit

73

9 Non-conformities and Corrective Action

74

9.1 Non-conformities

74

9.2 Procedures for handling non-conformities and corrective action

74

9.3 Revisits

75

10 Further Action by Certification Bodies

75

76

10.1 Suspension or withdrawal of certification

11 Grading of the Audit

76

12 Audit Reporting and Certification

76

12.1 Reporting

76

12.2 Certification

77

12.3 Appeals

78

13 Ongoing Audit Frequency and Certification

78

13.1 Certificate expiry justifiable circumstances

79

13.2 Withdrawal from the scheme

80

14 BRC Logos and Plaques

80

15 Notification of Legal Proceedings

80

16 The BRC Global Standards Directory

80

80

16.1 Directory functionality

Section V Management and Governance of the Scheme

81

1 Requirements for Certification Bodies

83

2 Technical Governance of the Global Standard for Packaging & Packaging Materials 85

2.1 The Governance and Strategy Committee

85

2.2 Technical Advisory Committee

85

2.3 The certification body cooperation groups

86

3 Achieving Consistency Compliance

86

3.1 Calibrating auditors

86

3.2 Complaints and referrals

86

Appendices 87
Appendix 1

The Standard and its Relationship with other BRC Global Standards

89

Appendix 2

Examples of Packaging Categories

90

Appendix 3

Registration, Qualifications, Training and Experience Requirements


for Auditors

92

Appendix 4

Fields of Audit for Packaging and Packaging Materials

94

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Appendix 5

Certificate Template

95

Appendix 6

Examples of Records that should be Kept

96

Appendix 7

Glossary

97

Appendix 8

Acknowledgements

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Section I Introduction

SECTION I
INTRODUCTION

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Section I Introduction

Section I

Introduction
1 Background
Welcome to the fourth issue of the Global Standard for Packaging & Packaging Materials (henceforward
referred to as the Standard). Originally published by the British Retail Consortium (BRC) and Institute of
Packaging in 2001, it was designed to protect the consumer by providing a common basis for the certification
of companies supplying packaging to own-brand food producers.
The Standard has been updated at regular intervals to reflect the latest thinking and the scope expanded
to include packaging for consumer products. The emphasis of the Standard has also changed reflecting
the needs of customers to ensure that not only is the packaging produced in a hygienic environment but
that the quality and performance (functional properties) are effectively managed to meet specifications.
The Standard has now established worldwide usage as a framework for businesses to assist in the
production of safe packaging for use both for food and for consumer products. In response to considerable
demand, the Standard has been translated into many languages to facilitate implementation by businesses
across the world. This fourth issue has been developed with advice and input from a wide range of
international stakeholders.
The Standard specifies the safety, quality and operational criteria required within packaging manufacturing
organisations to fulfil obligations with regard to legal compliance and protection of the consumer. The format
and content of the Standard are designed to allow an assessment of company premises, operational systems
and procedures by a competent third party (the certification body) against the requirements of the Standard.

The Scope of the Standard (Issue 4)

Compliance to the Standard will establish conformity with management procedures and factory standards
used by manufacturers of packaging and packaging materials.
The Standard applies to the manufacture of packaging and packaging materials used in food packaging and
filling operations and to packaging and packaging materials for cosmetics, toiletries and other consumer
products and materials. It is also intended to apply to:

prior operations, e.g. production of packaging materials for conversion or printing

operations that are supplying packaging material from stock where additional product processing or
repacking occurs; this has been demonstrated to require the same level of control as a final/integrated
converting operation

packaging manufacturers who also produce consumer-disposable goods that come into contact with
food; for example, paper plates and disposable plastic drinking cups, aluminium foil, food-grade
parchment paper, cling film and disposable cutlery. These products may also be audited under the BRCs
Global Standard for Consumer Products where the primary operation of the factory is the production of
consumer products and not packaging manufacture

the manufacture and supply of other materials that are unconverted or semi-converted and used or
incorporated, e.g. coatings and adhesives, where this is based on a risk analysis and mutually agreed
between those involved.

Companies that meet the requirements of a satisfactory quality management system for example, one
conforming to that specified in ISO9001:2008 may already meet many of the requirements of the Standard.
It is in the interest of the company to bring these points to the attention of the certification body. The auditor
will verify that the procedures are adequate for the purpose of compliance with this Standard.

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Principles of the Standard

A business must have a full understanding of the processes and products manufactured and have systems in
place to ensure that products are produced within a hygienic environment and consistently meet the quality
and product safety expectations of their customers. The Standard is based on the following key components:
senior management commitment; risk assessment of the product and manufacturing process; and a
systematic approach to managing product quality and safety.

3.1 Senior management commitment


Within a business, the safety, legality and quality of the products produced must be seen as a cross-functional
responsibility, involving and using different skills and expertise in the organisation. Effective adoption
of the principles of this Standard extends beyond the responsibility of a single individual and must be
wholly supported by the full management team. 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 packaging and
packaging materials.

3.2 A risk-based system


The Standard requires an evaluation of the risks to product quality and safety associated with the manufacture
of packaging and packaging materials. The hazard and risk analysis process defined in the Standard should
enable potential risks to be identified and controlled, either through existing prerequisite programmes such as
cleaning, pest control and maintenance, or by the introduction of specific controls. An effective hazard and
risk analysis provides a basis for the management system.

3.3 Quality management system and suitable operating conditions


The Standard requires the organisation to document the framework of management policies and procedures
by which it will achieve the requirements in this Standard. It also expects the business to maintain the basic
environmental and operational conditions that are necessary for the production of safe, legal products under
suitable hygienic conditions.

Benefits of the Standard

There are a number of benefits arising from the adoption of the Standard. These include:

providing a single audit report that is recognised by many customers in place of their own audits saving
time and cost

operating under an accreditation framework that ensures the results of certification have international
credibility and recognition

a comprehensive scope, covering areas of quality, hygiene and product safety, that meets most customer
requirements when assessing and approving suppliers

providing a framework for the development of quality and hygiene management systems in companies
that encourages continuous improvement, reduction in waste and increased efficiency

addressing part of the legislative requirements of the packaging manufacturer/supplier, packer/filler and
retailer. Packaging manufacturers may also use this Standard to ensure their suppliers are following good
manufacturing practices and are fulfilling legal requirements

certificated sites making use of the marketing opportunities provided, through recognition on the public
BRC Global Standards Directory website and use of the BRC logo.

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Section I Introduction

The Certification Process

The Standard is a process and product certification scheme. In this scheme, packaging businesses are
certificated upon completion of a satisfactory audit by an auditor employed by an independent third party
the certification body. Certification bodies in turn will have been assessed and judged as competent by a
national accreditation body.
In order for a packaging 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 Guide 65/EN45011 by a national accreditation body affiliated to the International
Accreditation Forum.
A list of certification bodies approved by the BRC is available on the BRC Global Standards Directory:
www.brcdirectory.com.

The British Retail Consortium/The Packaging Society

The BRC is the trade association representing retailers in the UK. The Packaging Society (a division of
the Institute of Materials, Minerals and Mining) was formerly the Institute of Packaging (IOP) and is the
professional membership body for the packaging industry in the UK. It is referred to throughout this
document as IOP and has joined with the BRC in developing the Standard. It is recognised that the packaging
industry is diverse in its materials, processing and technologies. Trade associations representing the paper
and board, plastic, aluminium, steel and glass packaging industry sectors have all been consulted during the
development of this Standard.

Acknowledgements: A Thank You from the BRC and IOP

The BRC and IOP wish to acknowledge all those packaging industry experts who have contributed to the
preparation of the Global Standard for Packaging & Packaging Materials (Issue 4). A list of those who have
contributed is detailed in Appendix 7.

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Section II Preparation and Planning for Success

SECTION II
PREPARATION AND PLANNING
FOR SUCCESS

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Section II Preparation and Planning for Success

Section II

Preparation and Planning for Success


1

Preparation Time

In order for everyone to gain the most value from certification to the Standard, 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 to meet the requirements of
the Standard, which are identified by the audit report as non-conformities. This is 28 days (extended to 90
days for major non-conformities at initial audits). There is a limit to the number of non-conformities that are
allowed before certification is refused (see Section IV, 11 Grading of the Audit, for details). If the number of
non-conformities exceeds that allowed or the non-conformities are not corrected within the allowed time
frame, a complete re-audit will be needed before certification can be obtained. It is therefore not advisable to
attempt an audit without adequate preparation.

1.1

For specifiers

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 packaging fields. 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.

1.2 For packaging manufacturers


Figure 1 indicates the advisable steps for a packaging manufacturer seeking certification, prior to applying
to a certification body. 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.

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Stage 1
Learn

Obtain a copy of the Standard and study it


Translations are available in a number of languages
Make use of optional support materials including interpretation and best
practice guidelines and training courses (available from BRC) to assist
understanding of the requirements

Establish the audit category for certification

Stage 2
Plan

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 certification
Obtain consultancy if required

Renew prerequisite programmes


Establish the appropriate product group(s)

Stage 3
Preparation

Carry out hazard and risk analysis and ensure that control points in the
process have been established
Prepare procedures
Check the site is capable of meeting BRC requirements
Undertake internal audits

Contact certification bodies (CB)

Stage 4
Pre-assessment*

Select suitable CB
Arrange a pre-assessment visit (*optional but recommended)
Implement any identified corrective actions

Arrange an audit visit with an appropriate CB

Stage 5
Audit and
certification

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 certification and gain entry onto the BRC directory

Stage 6
Maintenance

Continue to meet requirements


Arrange audit visit before certificate expiry
Continuous improvement

Figure 1 Steps towards certification

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Section II Preparation and Planning for Success

Product Categories

The packaging industry produces a wide variety of packaging, involving an extensive range of materials
for use in many diverse industries. Given the scope of this activity, it is essential that the audit against the
Standard is appropriate for the nature of material produced and its intended use. Customers expect that all of
the packaging materials they purchase are safe for their intended use and produced to the quality agreed in
the specification. It is recognised, however, that the production of packaging for some particular uses, e.g. for
direct food contact, necessitates more stringent and demanding hygiene requirements of the manufacturer.
The requirements of the Standard for Issue 4 are divided into two categories depending upon the intended
use of the packaging and consequent standards of hygiene under which the packaging is produced.
The Standard contains a decision tree (Figure 2), which helps to define the appropriate category for any
particular use.
In general, the two categories can be considered as follows:

High hygiene risk

Packaging that comes into direct contact with food products (or other designated
hygiene-sensitive products*). Primary packaging used for food or other hygienesensitive products where there is no absolute barrier in place.

Low hygiene risk

Packaging for consumer products and the secondary and tertiary packaging for
all uses.

*Those products intended for human consumption or which come into contact with the body, such as application to the skin.

For further guidance, consult the decision tree in Figure 2 and Appendix 2, which provides examples of
products for each category.
It is recognised that many manufacturers or suppliers may produce packaging in both categories. In these
circumstances they may either choose to use one category for the entire factory or separate them by areas. It
is not envisaged that more than one category would apply within the same area.
The final packaging category determination is a matter of discussion between the company and their
customer. Examples given in Appendix 2 are not an exhaustive list and are only provided as a guide. Where
there is any doubt, the more demanding hygiene risk category should be adopted.
If there is no clear definition of product category, referral shall be made by the company to the BRC for
clarification at brcglobalstandards@brc.org.uk.

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Review the use of


the packaging, or
packaging product
group

Is the packaging
intended for a food
product or hygienesensitive product, e.g.
cosmetic product?

Category

Yes

Is the packaging
intended for direct
contact with a food
or hygiene-sensitive
product?

Yes

High hygiene risk

No

High hygiene risk

No

No

Is the product already


in packaging that
provides an absolute
barrier?

Yes

Low hygiene risk

Figure 2 decision tree for determining packaging category

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Section III Requirements

SECTION III
REQUIREMENTS

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Section III Requirements

Section III

Requirements
Layout and Use of the Requirements of the Standard
Categories
The requirements to be met for certification differ between the two categories (high hygiene risk and low
hygiene risk) for food and consumer products. The requirements for the two categories are set out separately
within this section. All applicable requirements for that category shall be met in order to achieve certification.

The format of the Standard


Each clause of the Standard begins with a highlighted paragraph in bold text, which is the statement of
intent that all sites must comply with in order to gain certification. It identifies the objective to be met for the
particular clause.
Below this statement of intent, in a tabular format, are requirements, which identify particular points that
must be met as part of achieving the statement of intent.
The audit will assess compliance against both the statement of intent and individual requirements.

Fundamental requirements
In line with the other BRC Global Standards, the concept of fundamental requirements has been introduced
to the Standard to identify particular systems or operations within it that need to be in place at the time of
the audit. The fundamental requirements are marked with the word FUNDAMENTAL immediately after the
section heading and denoted with the star symbol . The clauses deemed to be fundamental are:

Senior management commitment, clause 1.2

Hazard and risk analysis, clause 2.2

Internal audits, clause 3.3

Specifications, clause 3.7

Traceability, clause 3.9

Housekeeping and cleaning, clause 4.9

Process control, clause 5.3

Training and competence, clause 6.1.

Failure to comply with the statement of intent of a fundamental clause leads to non-certification. This will
require a further full audit to demonstrate evidence of compliance.

Exclusion of Requirements
Non-applicable clauses
The majority of the requirements of the Standard will apply to all packaging material manufacturers within the
category. There are however some requirements that would not apply to some industry sectors or operations;
for example, the requirements of clause 5.2 are not applicable where printing of materials is not carried out.
Any such specific requirements may be excluded and will be marked as not applicable (N/A) in the final audit
report. The auditor will assess and decide on the applicability of any requirements that the site believes are
not applicable.
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Risk-based exemptions
The requirements have been written to reflect expectations typical of the particular product category
across a range of packaging formats, e.g. board, glass, metals, etc. There may be occasions where a
requirement may not be appropriate in a particular operation. On the basis of risk some requirements may
be excluded, however, in each case a documented risk assessment must be provided for the auditor to
evaluate (clause 2.3).
The final audit report will include comments on any clauses deemed as not applicable or excluded on the basis
of risk analysis.

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Section III Requirements

High Hygiene Risk Category


The requirements relate to packaging factories producing packaging materials for products that
require the highest hygiene standards during manufacture. They involve packaging that comes
into direct contact with food products (or other designated hygiene-sensitive products*). This
includes primary packaging used for food or other hygiene-sensitive products where there is no
absolute barrier in place.
*Those products intended for human consumption or which come into contact with the body, such as application to the skin.

1 Senior Management Commitment and


Continual Improvement
1.1

Product safety and quality management policy

The companys senior management shall develop and document a product safety and
quality policy, which is authorised, reviewed, signed and dated by an appropriate
senior manager.

Clause

Requirements

1.1.1

The policy shall state the companys intention to meet its obligation to produce safe and
legally compliant products to the specified quality, and its responsibility to its customers.
This shall include a commitment to a process of continuous improvement.

1.1.2

The companys senior management shall ensure the policy is communicated to all staff
involved with activities relating to product safety, legality, regulatory compliance and quality.

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1.2

Further information available at www.brcglobalstandards.com

Senior management commitment


Fundamental
The companys senior management shall demonstrate that they are fully
committed to the implementation of requirements of the Global Standard
for Packaging & Packaging Materials. This shall include provision of adequate
resources, effective communication and systems of management review
to effect continual improvement. Opportunities for improvement shall be
identified, implemented and fully documented.

Clause

Requirements

1.2.1

The companys senior management shall ensure that product safety and quality objectives
are measurable, established, documented, monitored and reviewed.

1.2.2

The companys senior management shall provide the human and financial resources
required to implement the processes of the quality management system and product
safety programme.

1.2.3

Clear communication and reporting channels shall be in place to report on and monitor
compliance with the Standard.

1.2.4

The companys senior management shall have a system in place to ensure that the
company is kept informed of all relevant legislative requirements in the country of
manufacture and, where known, the country in which the packaging material will be
sold. The company shall also be aware of any scientific and technical developments and
industry codes of practice applicable.

1.2.5

The company shall ensure that the materials manufactured comply with the relevant
legislation (including any legislation concerning the use of recycled content) in the country
of manufacture and in which the products are intended to be sold and/or ultimately used,
where known.

1.2.6

The companys senior management shall ensure that non-conformities identified at the
previous audit against the Standard are effectively actioned.

1.2.7

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

1.2.8

Where the company is certificated to the Standard they shall ensure that recertification
audits occur on or before the audit due date indicated on the certificate.

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1.3

Section III Requirements

Organisational structure, responsibilities and


management authority

The company shall have a clear organisational structure and define the responsibilities,
reporting relationships and job functions of those personnel whose activities affect
product safety, legality, regulatory compliance and quality.
Clause

Requirements

1.3.1

The company shall have an up-to-date organisation chart demonstrating the structure of
the company.

1.3.2

Within the management team there shall be a designated competent manager and deputy
with the responsibility for coordinating compliance with the Standard.

1.3.3

Documented, clearly defined responsibilities shall exist and be communicated to key staff
with responsibility for product safety, legality, regulatory compliance and quality systems.

1.3.4

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

1.3.5

The companys senior management shall ensure a description of general duties or work
instructions are in place and communicated to all those members of staff involved with
activities relating to product safety, legality, regulatory compliance and quality.

1.4

Management review

The companys senior management shall ensure that a management review is


undertaken to ensure that the product safety and quality programme is fully
implemented, effective and that opportunities for improvement are identified.
Clause

Requirements

1.4.1

The review process shall be undertaken at appropriate planned intervals; as a


minimum annually.

1.4.2

The review process shall include the evaluation of:


previous management review documents and action plans
internal, second-party and third-party audits
customer performance indicators, complaints and feedback
incidents, corrective actions, out-of-specification results and non-conforming materials
resource requirements.

1.4.3

The review process shall set objectives and continual improvement targets.

1.4.4

Records of management reviews and action plans shall be documented.

1.4.5

The decisions and actions agreed within the review process shall be effectively
communicated to appropriate staff and actions implemented within agreed timescales.

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Hazard and Risk Management System


2.1

Hazard and risk management team

A multidisciplinary hazard and risk management team shall be in place to develop and
manage the hazard and risk analysis system and ensure this is fully implemented.
Clause

Requirements

2.1.1

The hazard and risk management system shall be developed, reviewed and managed by
a multidisciplinary team that includes those responsible for quality/technical, engineering/
maintenance, production operations, and other relevant functions.
In the event that the company does not have the appropriate expertise in-house,
external expertise shall be sought and used to develop and review the hazard and risk
management system. However, the day-to-day management shall remain the responsibility
of the company.

2.1.2

The multidisciplinary team shall have a designated team leader who shall be able to
demonstrate competence and experience of hazard and risk analysis.

2.1.3

The team shall be suitably trained in hazard and risk analysis principles and kept up to date
with factory changes and customer requirements as they occur.

2.2

Hazard and risk analysis


Fundamental
A formal hazard and risk management system shall be in place to ensure that
all hazards to product safety and integrity are identified and appropriate
controls established.

Clause

Requirements

2.2.1

The scope of the hazard and risk analysis shall be clearly defined and shall cover all products
and processes included within the intended scope of certification.

2.2.2

The hazard and risk analysis team shall maintain awareness of and take into account:
historical and known hazards associated with specific processes, raw materials or end use
of the product
relevant codes of practice or recognised guidelines
legislative requirements.

2.2.3

A full description of the product shall be developed, which includes all relevant information
on product safety and integrity. As a guide this may include:
composition, e.g. raw materials, inks, varnishes, coatings and other print chemicals
origin of raw materials including use of recycled materials
intended use of the packaging materials and defined restrictions on use; for instance,
direct food contact, physical or chemical conditions.

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Section III Requirements

Clause

Requirements

2.2.4

A process flow diagram shall be prepared for each product, product group or
process. This shall include each process step from the receipt of raw materials to despatch
to the customer.
The process flow shall as a guide include, as relevant:
receipt and approval of art work
receipt and preparation of raw materials such as additives, inks and adhesives
each manufacturing process step
the use of rework and post-consumer recycled materials
any subcontracted operations
customer returns.
The accuracy of the process flow shall be verified by the hazard and risk analysis team.

2.2.5

The hazard and risk analysis team shall identify and record all potential hazards that are
reasonably expected to occur at each step in relation to the product and process. The
hazards considered shall include, where relevant:
microbiological
foreign objects
chemical contamination (e.g. taint, odour, allergen, component transfer from inks,
varnishes and glues)
potential problems arising from the use of recycled materials
legality
defects critical to consumer safety
hazards that may have an impact on the functional integrity and performance of the final
product in use.

2.2.6

The hazard and risk analysis team shall identify control measures necessary to prevent,
eliminate or reduce each hazard to acceptable levels.
Where control is through a prerequisite programme these shall be reviewed to ensure they
adequately control the risk identified and where necessary improvements implemented.

2.2.7

For each hazard that requires control, other than by an existing prerequisite programme,
the control points shall be reviewed to identify those that are critical. This process shall
include an assessment of the risk level for each hazard based on the likelihood of the
occurrence and the severity of the outcome. Critical control points shall be those control
points that are required to prevent, eliminate or reduce a product safety or integrity hazard
to acceptable levels.
Where controls are not classified as critical and control may be achieved through a
prerequisite programme, a programme shall be developed that is sufficiently specified to
effectively control the identified hazards.

2.2.8

For each critical control point, the appropriate critical limits shall be defined in order to
identify clearly if the process is in or out of control. Critical limits shall be measurable where
possible and the rationale for their establishment clearly documented. Relevant legislation
and codes of practice shall be taken into account when establishing the limits.

2.2.9

For each critical control point a monitoring system shall be defined in order to ensure
compliance with critical limits. Records of the monitoring shall be maintained. Procedures
relating to the monitoring of critical controls shall be included in internal audits against the
Standard (refer to clause 3.3).

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Clause

Requirements

2.2.10

The corrective action that shall be taken when monitored results indicate a failure to meet
the control limit shall be established and documented. This shall include the procedures for
quarantining and evaluating potentially out-of-specification products to ensure they are not
released until their safety can be established.

2.2.11

A review of the hazard and risk management system shall be carried out at least once per
year and following any significant incidents or when any process changes.
The review shall include a verification that the hazard and risk analysis plan is effective and
may include a review of:
complaints
product failures
recalls
product withdrawals
results of internal audits of prerequisite programmes
results from external third-party auditors.

2.3

Exemption of requirements based on risk analysis

Clause

Requirements

2.3.1

The hazard and risk analysis study shall be fully supported by the implementation of the
prerequisites set out in requirements clauses 4 to 6. However, the hazard and risk analysis
may indicate that some of the requirements are not applicable. Exemptions shall be
documented and regarded as proposed exemptions for review at audit. Acceptance or
rejection of the proposed exemptions shall be recorded in the auditors report.

2.3.2

The company shall keep recorded exemptions to the Standard under review and provide
documented evidence of this review at subsequent audit.

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Section III Requirements

Product Safety and Quality Management System


3.1

Product safety and quality manual

The company shall have a manual which describes how the requirements of the
Standard are met. These requirements shall be fully implemented, reviewed at
appropriate planned intervals and improved where necessary.
Clause

Requirements

3.1.1

The product safety and quality manual shall contain an outline of working methods and
practices or references to where such an outline is documented.

3.1.2

The manual or relevant components shall be readily available to key staff.

3.2

Customer focus and contract review

The companys senior management shall ensure that processes are in place to
determine customer needs and expectations with regard to quality and safety and
ensure these are fulfilled.
Clause

Requirements

3.2.1

The company shall clearly identify those job titles responsible for communication with
customers and shall have an effective system for communication.

3.2.2

Customer requirements relating to the design, development, specification, manufacture and


distribution of the product shall have been agreed with the customer and where appropriate
documented and agreed prior to order fulfilment.

3.2.3

Customer needs and requirements shall be reviewed on a suitable predetermined frequency.


Any changes to existing agreements or contracts shall be agreed, documented and
communicated to appropriate departments.

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3.3

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Internal audits
Fundamental
The company shall audit those systems and procedures which cover the
requirements of the Standard to ensure they are in place, appropriate and
complied with.

Clause

Requirements

3.3.1

Internal audits shall be planned and their scope and frequency shall be established in
relation to the risks associated with the activity. Audits shall be scheduled so that all aspects
of the Standard are audited at least annually.

3.3.2

Internal audits shall be carried out by appropriately trained competent personnel who shall
be sufficiently independent from the department being audited to ensure impartiality.

3.3.3

Deficiencies and details of non-conformities shall be notified to appropriate supervisory staff


and corrective action implemented within a specified and appropriate time period.

3.3.4

The completion of corrective action shall be recorded and verified.

3.3.5

Internal audit reports shall be sufficiently detailed to ensure that conformity as well as nonconformity can be clearly identified and verified.

3.4

Supplier approval and performance monitoring

The company shall operate procedures for approval and monitoring of its suppliers.
This shall include suppliers of materials and services to the company and ensure that
materials and services procured conform to defined requirements.
Clause

Requirements

3.4.1

The company shall have a documented supplier approval procedure and continual
assessment programme in place, based upon risk analysis.

3.4.2

The procedures shall include clear criteria for the assessment and approval of new suppliers.
Assessment may take the form of:
supplier audits
supplier certification with a scope covering the products supplied, e.g. against the
appropriate BRC Global Standard
supplier questionnaires.

3.4.3

Records of supplier assessment and necessary actions shall be maintained and reviewed.

3.4.4

The procedures shall define how exceptions are handled, e.g. the use of products or services
where audit or monitoring has not been undertaken. Assessment may take the form (on a
batch or delivery basis) of:
certificate of analysis
declaration of compliance.

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3.5

Section III Requirements

Subcontracting of production

Where production processes are subcontracted this shall be with the agreement of
customers. Procedures shall be in place for the effective control of subcontractors and
the work undertaken.
Clause

Requirements

3.5.1

The use of subcontractors and the status of the subcontractor with respect to the Standard
shall be notified to the brand owner and/or customer.

3.5.2

Suppliers of subcontracted services shall be approved in accordance with the procedures


identified in clause 3.4.

3.5.3

Where any production processes are subcontracted, the risks to the quality and safety of the
product shall form part of the hazard and risk analysis and the companys evaluation of the
system shall be held on record.

3.5.4

Clear specifications shall be agreed for all work outsourced to a subcontractor. Controls shall
be in place for checks on finished work to ensure the safety and quality meets specification.

3.6 Documentation control


The companys senior management shall ensure that documented procedures and
recording forms critical to the management of product safety, legality and quality are
in place and effectively controlled.
Clause

Requirements

3.6.1

All documents in use shall be properly authorised and be the current version.

3.6.2

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

3.6.3

All changes and amendments to documents critical to product safety, legality or quality
system procedures shall be authorised, recorded, and obsolete documentation shall be
removed, archived and replaced with the current version.

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3.7 Specifications
Fundamental
The company shall ensure that appropriate specifications exist for
raw materials, intermediate and finished products, and any product or
service which could affect the integrity of the finished product and
customer requirements.

Clause

Requirements

3.7.1

Specifications shall be suitably detailed, accurate and shall ensure compliance with relevant
product safety and legislative requirements.

3.7.2

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 put an agreement in place.

3.7.3

A declaration of compliance shall be maintained, which enables users of the


packaging materials to ensure compatibility with the product with which the materials
may be in contact.
The declaration of compliance shall contain as a minimum:
the nature of the materials used in the manufacture of the packaging
confirmation that materials meet relevant legal requirements
the inclusion of any post-consumer recycled materials
this shall identify any limitations of use of the declaration of compliance.
Products shall meet at least minimum legal requirements in the country of manufacture and
use, where known.

3.7.4

Trademarks for application on packaging materials shall, where appropriate, be formally


agreed between relevant parties.

3.7.5

The company shall operate a specification review procedure.

3.8

Record keeping

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

Requirements

3.8.1

The records shall be legible, genuine, appropriately authorised and retained in good
condition for an appropriate defined time period.

3.8.2

Any alterations to records shall be authorised and justification for the alteration shall
be recorded.

3.8.3

The companys senior management shall ensure that procedures are operated for the
organisation, review, maintenance, storage and retrieval of all records relating to product
safety, legality, regulatory compliance and quality.

3.8.4

The period of retention for records shall relate to the usable life of the packaging and
products it is designed to contain and shall respect any customer requirements.

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Section III Requirements

3.9 Traceability
Fundamental
The company shall have a system in place to identify product batches and
to trace and follow all raw materials through processing to the distribution
of the finished product to the customer. Records shall be retrievable in a
timely manner.

Clause

Requirements

3.9.1

The company shall have a system which has the ability to trace and follow all raw materials
from the supplier through all stages of processing and distribution of the finished product
and vice versa. Where continuous processes are used or raw materials are in bulk silos,
traceability shall be achieved to the best practical level of accuracy.

3.9.2

An appropriate system shall be in place to ensure the customer can identify a product or
production lot number for the product, for the purposes of traceability.

3.9.3

The system shall be tested to ensure traceability can be determined from raw material to the
finished product and vice versa. This shall take place on a predetermined frequency, at least
on an annual basis, and results retained for inspection.

3.10 Complaint handling


The company shall have a system for the effective capture, recording and management
of product complaints.
Clause

Requirements

3.10.1

All complaints shall be recorded, investigated and the results of the


investigation documented.

3.10.2

Complaint data shall be analysed on a predetermined frequency to identify trends and used
to implement ongoing improvements.

3.10.3

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

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3.11 Management of incidents, product withdrawals


and recalls
The company shall have a plan and systems in place to effectively manage incidents,
product withdrawals and recalls, in order to ensure that all potential risks to the
quality, hygiene and legality of products are controlled.
Clause

Requirements

3.11.1

The company shall provide written guidance and training for relevant staff regarding the
type of event that would constitute an incident. A documented incident reporting procedure
shall be in place.

3.11.2

The company shall determine the activity required to effectively manage an incident, based
on the risk to the product, to prevent the release of product where safety or quality may
have been affected.

3.11.3

A product withdrawal/recall procedure shall be documented, practical to implement and


regularly reviewed. This shall include as a minimum:
identification of the key personnel involved in assessing potential withdrawal/recall
incidents with clear identified responsibilities
a communications plan including methods of informing customers and, where necessary,
regulatory bodies in a timely manner
corrective action and business recovery
review of any withdrawals or recalls to implement appropriate improvements as required.

3.11.4

The product withdrawal/recall procedure shall be tested on at least an annual basis and
used to evaluate the procedure and implement improvement.

3.11.5

The recall procedure shall be capable of being operated at any time and will take into
account notification to the supply chain, stock return, logistics for recovery, storage of
recovered product and disposal.

3.11.6

The designated manager shall be responsible for ensuring that preventive action is taken,
based on a review of incidents, to implement improvements as necessary.

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Section III Requirements

Site Standards

4.1

External standards

All grounds within the site shall be finished and maintained to an appropriate standard.
Clause

Requirements

4.1.1

Consideration shall be given to local activities and the site environment which may have
an adverse impact on the integrity of the finished product or raw materials, and measures
shall be taken to prevent contamination. Where measures have been put in place to protect
the site from any potential contaminants, they shall be regularly reviewed to ensure they
continue to be effective, e.g. flood controls.

4.1.2

The external areas shall be maintained in good order. Grounds shall be regularly tended and
well maintained. Where possible, a clean and unobstructed area shall be provided along the
external walls of the buildings used for production and/or storage.

4.1.3

The building fabric shall be maintained to minimise potential for pest entry, ingress of water
and other contaminants. External silos, pipe work or other access points for the product
and/or raw materials shall be appropriately sealed and secured.

4.1.4

Where natural drainage is inadequate, external drainage shall be installed. Drains shall be
properly protected to prevent entry of pests.

4.1.5

External traffic routes, under site control, shall be suitably surfaced to avoid contamination
of the product.

4.1.6

Where external storage of raw materials is necessary these shall be protected from
contamination.

4.1.7

External storage of refuse shall be in designated areas.

4.2

Building fabric and interiors

Raw material handling, preparation, processing and storage areas


The internal site, buildings and facilities shall be suitable for the intended purpose and
shall be designed, constructed, maintained and monitored to effectively control the
risk of product contamination.
Clause

Requirements

4.2.1

Walls, floors, ceilings and pipe work shall be maintained in good condition and shall
facilitate cleaning.

4.2.2

Where suspended ceilings exist they shall be accessible for inspection and cleaning.

4.2.3

Suitable and sufficient lighting shall be provided for a safe working environment, correct
operation of processes, effective inspection of the product and cleaning.

4.2.4

All internal drain openings shall be suitably protected against the entry of pests and odour.

4.2.5

Where there is a risk to the product, windows and roof glazing that are designed to
be opened for ventilation shall be adequately screened to prevent the ingress of pests.

4.2.6

Where they pose a risk to the product, glass windows shall be protected against breakage.

4.2.7

Suitable and sufficient ventilation shall be provided.

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4.3 Utilities
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.
Clause

Requirements

4.3.1

All water used in the processing of the products or equipment cleaning shall be potable or
suitably treated to prevent contamination.

4.3.2

Based on risk assessment, the microbiological and chemical quality of water, steam, ice, air,
compressed air or other gases, which do not constitute an ingredient but come in direct
contact with packaging, shall be regularly monitored. These shall present no risk to product
safety or quality and comply with relevant legal regulations.

4.4 Security
Security arrangements shall be assessed to ensure the integrity of products
and processes.
Clause

Requirements

4.4.1

Based on risk assessment, a procedure shall be in place to address the security of the site
and products and establish, implement and maintain a system to reduce or eliminate the
identified risk.

4.4.2

Access to the site by employees, contractors and visitors shall be controlled, through
designated entrances, and a visitor reporting system shall be in place. Areas shall be
assessed according to risk; sensitive or restricted areas shall be defined, clearly marked,
monitored and controlled.

4.4.3

Staff shall be trained in site security procedures and encouraged to report or challenge
unidentified or unknown visitors.

4.4.4

All new part- and full-time personnel employed on-site on a temporary or permanent basis
shall be subject to appropriate reference checks.

4.4.5

Contractors involved in maintenance or repair shall be supervised by a qualified person, and


a nominated staff member shall be responsible for their activities.

4.4.6

Access to the site for third-party transport personnel shall be controlled and, where possible,
facilities provided to negate the need to enter storage or production areas.

4.4.7

Site IT systems shall be secure, adequately controlled and backed up.

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4.5

Section III Requirements

Layout and product flow

Premises and plant shall be logically designed, constructed and maintained. Procedures
shall be in place to control the risk of product contamination and to comply with all
relevant legislation.
Clause

Requirements

4.5.1

The process flow from intake to despatch shall be arranged to minimise the risk of
contamination or damage to the product.

4.5.2

Premises shall allow sufficient working space and storage capacity to enable all operations
to be carried out properly under safe and hygienic conditions.

4.5.3

Work in progress shall be clearly identified and adequately protected.

4.5.4

Sorting or other activities involving the direct handling of the product shall take place in
areas that have, as a minimum, the same standards as production areas.

4.5.5

Activities that could produce a contamination risk, such as the removal of outer packaging,
shall be carried out in a designated, segregated area.

4.6 Equipment
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.
Clause

Requirements

4.6.1

Equipment shall be designed for the intended purpose and shall minimise the risk of
contamination to the product.

4.6.2

Newly installed equipment shall be properly specified before purchase. Equipment shall
be constructed of appropriate materials and be of a suitable design to ensure it can be
effectively cleaned and maintained. New equipment shall be tested and commissioned prior
to use and a maintenance programme established.

4.6.3

Notices on equipment shall be cleanable and secure.

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4.7 Maintenance
A documented system of planned maintenance shall be in place, covering all items of
equipment and plant that are critical to product safety, legality and quality.
Clause

Requirements

4.7.1

Equipment, including fixtures and fittings, shall be maintained to minimise the risk of
product contamination.

4.7.2

A condition-based or preventative maintenance programme shall be in place, covering all


items of equipment and plant that are critical to product safety, legality and quality.

4.7.3

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 appropriate
action taken.

4.7.4

Maintenance work shall not place the product at risk. There shall be a procedure in place
and a recording system to ensure that equipment is checked following maintenance work
and cleared to resume production.

4.7.5

Tools and other maintenance equipment shall be cleared away after use and
appropriately stored.

4.7.6

Temporary repairs/modifications using tape, cardboard, etc. shall only be permitted in


emergencies and where product contamination is not at risk. Such modifications shall be
subject to a time limit and shall be recorded and scheduled for correction.

4.7.7

Wooden equipment including desks, chairs, tables, etc. shall be properly sealed to enable
effective cleaning. This equipment shall be kept clean, in good condition and free from
splinters or other sources of physical contamination.

4.7.8

Engineering workshops shall be controlled to prevent contamination risks to the product,


e.g. provision of swarf mats where workshops open directly into production areas.

4.7.9

When commissioning new equipment and plant, a maintenance programme shall be


established and put into place based on risk assessment.

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4.8

Section III Requirements

Staff facilities

Staff facilities shall be sufficient to accommodate the required number of personnel,


and designed and operated to minimise the risk of product contamination. Such
facilities shall be kept in a good and clean condition.
Clause

Requirements

4.8.1

Suitable and sufficient hand-washing facilities shall be available to enable cleaning of hands
before commencing work, after breaks, and as necessary during the course of work. Such
hand-washing facilities shall provide, as a minimum:
sufficient quantity of warm water
unscented liquid soap
single-use towels or suitably designed and located air driers
advisory signs to prompt use (including consideration of appropriate languages).
Where direct food contact or high-risk contact products are handled, hand-washing
facilities shall be sited at the entrance to the production area.

4.8.2

Toilets shall be adequately segregated and shall not open directly into storage, processing or
production areas. Toilets shall be provided with hand-washing facilities comprising:
sufficient quantity of warm water
unscented liquid soap
single-use towels or suitably designed and located air driers
advisory signs to prompt use (including consideration of appropriate languages).

4.8.3

Locker rooms shall be accessed without the need to enter production areas unless
appropriately segregated walkways are in place.

4.8.4

Lockers shall be provided for all personnel who work in raw material handling, processing,
preparation, packing and storage areas. Lockers shall be of sufficient size to accommodate
all reasonable personal items.

4.8.5

Company-issued protective clothing and personal clothing shall not be stored in the same
locker or shall be effectively segregated within the locker.

4.8.6

Eating, drinking and smoking shall not be allowed in locker and changing rooms.

4.8.7

Facilities for visitors and contractors shall enable compliance with the companys
hygiene policy.

4.8.8

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

4.8.9

Where smoking is allowed under national law, any smoking shall only be permitted in
designated controlled smoking areas which shall be isolated from production and storage
areas and fitted with extraction to the exterior of the building. Adequate arrangements
for dealing with smokers waste shall also be provided at smoking facilities, both inside
buildings and at external locations.

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4.9

Further information available at www.brcglobalstandards.com

Housekeeping and cleaning


Fundamental
Housekeeping and cleaning systems shall be in place, which ensure
that appropriate standards of hygiene are maintained and that risk of
contamination to the product is minimised.

Clause

Requirements

4.9.1

Good standards of housekeeping shall be maintained, which shall include a clean as you
go policy.

4.9.2

All internal surfaces of buildings, equipment and vehicles shall be subject to documented
scheduled cleaning. Cleaning schedules shall include the following information:
responsibility for cleaning
item/area to be cleaned
frequency of cleaning
method of cleaning
cleaning materials to be used
cleaning record and responsibility for verification.

4.9.3

Cleaning equipment and materials shall be kept in a secure designated location such as a
locked cupboard.

4.9.4

Cleaning chemicals shall be fit for purpose, suitably labelled, secured in closed containers
and used in accordance with manufacturers instructions.

4.9.5

Chemicals that are strongly scented or could give rise to taint and odour contamination shall
not be used.

4.9.6

Materials and equipment used for cleaning toilets shall be segregated from those used
elsewhere.

4.10 Waste and waste disposal


Suitable facilities shall be provided for the storage and disposal of process and
other waste.
Clause

Requirements

4.10.1

Suitable and sufficient refuse and waste containers shall be provided, which shall be
emptied at appropriate frequencies and maintained in an adequately clean condition.

4.10.2

Where appropriate, waste shall be categorised according to legislative requirements based


on the intended means of disposal, segregated and collected in appropriate designated
waste containers.

4.10.3

Where agreed with the customer, substandard trademarked materials shall be rendered
unusable through a destructive process. All materials disposed of shall be recorded.

4.10.4

If substandard trademarked materials are transferred to a third party for destruction or


disposal, that third party shall be a specialist in appropriate waste disposal and shall provide
records of material destruction.

4.10.5

Waste streams shall be sorted and segregated to facilitate recycling and waste containers
shall be suitably labelled or marked.

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Section III Requirements

4.11 Pest control


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

Requirements

4.11.1

A preventive pest control programme shall be maintained covering all areas of the site under
the companys control.

4.11.2

The company shall either contract the services of a competent pest control organisation or
shall have appropriately trained staff for the regular inspection and treatment of the site to
deter and eradicate infestation. The frequency of inspections shall be determined by risk
assessment and shall be documented. Where the services of a pest control contractor are
employed, the service contract shall be clearly defined and reflect the activities of the site.

4.11.3

Effective precautions shall be in place to prevent pests entering the premises. The building
shall be suitably proofed against the entry of all pests via doors, windows, ducts, and cable
entry points.

4.11.4

In the event of infestation, immediate action shall be taken to eliminate the hazard. Action
shall be taken to identify, evaluate the potential for contamination or damage, and authorise
the release of any product potentially affected.

4.11.5

In the event of an infestation and at appropriate intervals, the company shall request a catch
analysis from flying insect control devices to help identify problem areas.

4.11.6

Written procedures and detailed records of pest activity, pest control inspections and
recommendations shall be maintained. These shall include as a minimum:
an up-to-date, signed and authorised site plan identifying numbered pest control device
locations
identification of the baits and/or monitoring devices on site
clearly defined responsibilities for site management and the contractor
details of pest control products used and instructions for their effective use
detailed records of pest control inspections, recommendations and of any
pest infestation.
It shall be the responsibility of the company to ensure that all the relevant recommendations
made by the contractor or in-house expert are implemented in a timely manner and
monitored for effectiveness.

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4.12 Transport, storage and distribution


The transport, storage and distribution of raw materials and finished products
shall be undertaken in a manner to minimise the risk of contamination or
malicious intervention.
Clause

Requirements

4.12.1

All finished products and materials transferred between premises shall be fully identified and
protected during transit and storage by appropriate external packaging or transported under
conditions to protect the product from contamination. This shall include the risk of taint or
odour and of malicious intervention.

4.12.2

Receipt documents and/or product identification shall facilitate correct stock rotation of
goods in storage and, where appropriate, ensure materials are used in the correct order and
within the prescribed shelf life.

4.12.3

Incoming goods shall be visually checked for packaging integrity and potential
contamination.

4.12.4

All pallets shall be checked. Damaged, contaminated or unacceptable pallets shall be


discarded. Wooden pallets that come into direct contact with finished products or raw
materials shall not be allowed to contaminate the product. Wooden pallets, if used, shall be
sound, dry, clean and free from damage and contamination.

4.12.5

Storage, including off-site storage, shall be controlled to protect the product from
contamination, including taint or odour and malicious intervention. Where off-site storage is
used the same requirements apply as for on-site storage.

4.12.6

In order to prevent contamination, procedures shall be in place to appropriately segregate


raw materials, intermediate and finished products.

4.12.7

Work in progress shall be suitably labelled and covered to ensure proper identification and
prevent damage.

4.12.8

Material intended for recycling shall be appropriately protected against


contamination hazards.

4.12.9

Vehicle drivers shall comply with the site rules relevant to this Standard.

4.12.10

All vehicles used for deliveries shall be kept clean and in a condition to minimise the risk of
product contamination.

4.12.11

All company-owned vehicles used for deliveries shall be included in the documented
cleaning schedules.

4.12.12

All delivery vehicles and shipping containers shall be subject to a documented hygienechecking procedure before loading.

4.12.13

Where the company employs third-party contractors there shall be a contract or


agreed terms and conditions. All the requirements specified in this section shall be clearly
defined in the contract or the company shall be certificated to the Global Standard for
Storage and Distribution.
Where this is not possible, with general carriers, the packaging shall be adequate to protect
the product against damage, contamination hazards, taint and odour.

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Section III Requirements

Product and Process Control


5.1

Product design and development

Product design and development processes shall be in place to ensure the production
of safe and legal products to defined quality parameters.
Clause

Requirements

5.1.1

Customer design requirements shall be defined and agreed prior to undertaking product
design, taking into consideration process requirements and end use, where possible. Any
critical use parameters shall be identified and defined; for example, barrier requirements,
max/min use temperature, machine running, use of recycled materials, etc.
Special attention shall be made to any materials that are required or requested to be
manufactured from recycled materials, to ensure that they are both appropriate and legal.

5.1.2

A product specification shall be prepared and, where possible, agreed with the customer or
brand owner before the production process begins.

5.1.3

A process shall be in place to ensure final product concepts and artwork are formally
accepted by the specifier, where possible.

5.1.4

Production trials, where appropriate, shall be carried out and testing shall validate that
manufacturing processes are capable of producing a safe and legal product and that agreed
product quality/print standards can be consistently achieved.

5.1.5

The company shall ensure that the product design processes, procedures and records of
design together result in the development of specifications for each manufacturing process
step to ensure the production of safe and legal products of the prescribed quality.

5.1.6

Samples as agreed with the specifier shall be retained for future reference.

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5.2

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Packaging print control

Where packaging is printed with allergen/safety/legal information, procedures shall


be in place to ensure that the information is fully legible and correctly printed to the
customers specification.
Clause

Requirements

5.2.1

An assessment shall be carried out of the print process and handling of printed packaging
(product) to identify:
risks of loss of essential information
mixing of printed product.
Controls shall be established and implemented to reduce the risks identified.

5.2.2

Printing plates, other print equipment and reproduction media shall be fully traceable to the
customers approved origination material.

5.2.3

Printing plates shall be appropriately stored.

5.2.4

Each print run shall be approved against the agreed standard (or master sample). This shall
be recorded.

5.2.5

A system shall be in place to detect and identify printing errors during the run, and to sort
these errors from the acceptable printed material.

5.2.6

Where composite print is used (a mixture of different designs are printed together),
a process shall be in place to ensure effective segregation of differing print variants.

5.2.7

Samples of printed packaging shall be retained together with production records for a
period of time to be agreed with the customer/specifier/brand owner.

5.2.8

Any unused printed product shall be accounted for and either disposed of or identified and
appropriately stored.

5.2.9

Personnel carrying out print quality control shall be appropriately trained, aware of the
importance of consumer safety information and adequately supervised.

5.2.10

Lighting in print inspection cabinets and other means of print/colour checking shall be
agreed with the customer or be to accepted industry standards.

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5.3

Section III Requirements

Process control
Fundamental
Procedures shall be in place to ensure effective quality assurance of operations
throughout the process.

Clause

Requirements

5.3.1

The company shall undertake a review of the manufacturing and, where applicable, printing
process to identify critical manufacturing process control points that could affect the quality
of the products produced.

5.3.2

For each critical manufacturing process control point, machine settings or process limits shall
be established and documented the process specification.

5.3.3

Documented process checks shall be undertaken at start up, following adjustments


to equipment, and periodically during production, to ensure products are consistently
produced to the agreed quality specification.

5.3.4

A clearance procedure shall be in place to ensure that at start up, the line is clear of all
previous work and production documents.

5.3.5

Suppliers of incoming materials, as appropriate, shall provide evidence of conformity.

5.3.6

Quality checks shall be carried out to demonstrate that the finished product is within
the tolerances laid down in the agreed product specification and conforms to any critical
technical/legal requirements.

5.3.7

In the event of changes to product composition, processing methods or equipment, the


company shall, where appropriate, re-establish process characteristics and validate product
data to ensure product safety, legality and quality are achieved.

5.4

Product inspection and analysis

The company shall use appropriate procedures and facilities when undertaking or
subcontracting inspection and analyses critical to product safety, legality and quality.
Clause

Requirements

5.4.1

Quality checks shall be carried out at appropriate stages in production to demonstrate that
the product is within the tolerances laid down in the agreed product specification.

5.4.2

Personnel undertaking quality checks and analyses shall be suitably trained and shall be
competent to carry out the work.

5.4.3

Procedures shall be in place to ensure the reliability of test results.

5.4.4

Frequency of checks shall be in accordance with industry-accepted practice or customer


requirements and based on risk analysis.

5.4.5

Where the company undertakes or subcontracts analyses critical to product safety


or legality, the laboratory or subcontractors shall have gained recognised laboratory
accreditation or operate in accordance with the requirements and principles of ISO 17025
(General Requirements for the Competence of Testing and Calibration Laboratories).
Documented justification shall be available where accredited methods are not undertaken.

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5.5

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In-line testing and measuring equipment

The company shall use hazard and risk analysis principles to determine the need for
in-line product testing equipment to ensure the integrity and quality of products.
Clause

Requirements

5.5.1

The accuracy of measurement of in-line equipment shall be specified having due regard to
the product parameter being controlled.

5.5.2

The company shall establish and implement procedures for the operation, routine
monitoring and testing of equipment. This shall include:
frequency and sensitivity of checks
authorisation of trained personnel to carry out specified tasks
documentation of test results.

5.5.3

In-line testing equipment critical to product integrity or safety shall incorporate a system to
identify and, where appropriate, divert a non-conforming product out of the product flow
or identify it for removal.

5.5.4

The company shall establish and implement corrective action and reporting procedures
in the event of the monitoring and testing procedure identifying any failure of the in-line
test equipment. Any such failures shall be subject to an assessment of potential risk and
subsequent action may include a combination of isolation, quarantine and re-inspection of
products produced since the last acceptance test of the equipment.

5.6

Calibration

Measuring equipment used to monitor critical manufacturing process points and


product safety and legality shall be calibrated.
Clause

Requirements

5.6.1

Measuring equipment used to monitor critical manufacturing process points and the
products compliance with relevant legal requirements and specifications shall be identified
and calibrated.

5.6.2

Where possible, calibration shall be traceable to a recognised national standard. Where


a traceable calibration is not possible, the company shall demonstrate the basis by which
standardisation is carried out.

5.6.3

All identified measuring equipment shall be checked and adjusted at a predetermined


frequency, based on risk analysis. This shall be carried out by trained staff to a defined
method to ensure accuracy within defined parameters.

5.6.4

The identified measuring equipment shall be prevented from adjustment by unauthorised


staff and shall be protected from damage, deterioration and misuse.

5.6.5

Results and any actions taken when measuring equipment is found to be operating outside
the specified limits shall be documented.

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5.7

Section III Requirements

Control of non-conforming product

The company shall ensure that out-of-specification product is clearly identified,


labelled and quarantined.
Clause

Requirements

5.7.1

Clear procedures for the control of out-of-specification or non-conforming materials shall be


in place and understood by all authorised personnel. This shall include the effective labelling
or quarantining of materials before a decision has been made on their final disposition.

5.7.2

Non-conforming materials shall be assessed and a decision taken to reject, accept by


concession or authorise to be reworked or for an alternative use. The decision and reasons
shall be documented.

5.7.3

Corrective actions shall be implemented to avoid recurrence of the non-conformance.


Actions taken shall be documented.

5.8

Foreign body contamination control

All practicable steps shall be taken to identify, avoid, eliminate or minimise the risk of
foreign body contamination.

5.8.1

Foreign body control

Clause

Requirements

5.8.1.1

Based on risk assessment, the company shall identify, control and manage potential risks
from physical contamination.

5.8.1.2

There shall be no unnecessary non-production glass or brittle plastic, which may pose a risk
of contamination.

5.8.1.3

Based on the likelihood and risk of glass contamination, all bulbs and strip lights, including
those on flying insect control devices, shall be protected.

5.8.1.4

All glass or brittle plastics other than the product shall be controlled and recorded on a
register and checked for damage at an appropriate frequency. The register shall be kept up
to date as necessary. The frequency of checks will vary according to risk of damage leading
to contamination.

5.8.1.5

Where glass breakage occurs a responsible person shall be placed in charge of the clean-up
operation and shall ensure that no other area is allowed to become contaminated due to the
breakage. Any product that has become contaminated shall be segregated and disposed of.
All breakages shall be recorded in an incident report.

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5.8.2

Further information available at www.brcglobalstandards.com

Sharps control

Clause

Requirements

5.8.2.1

There shall be a documented policy for the control of the use of sharps.

5.8.2.2

Sharp blades, equipment and tools shall not be left in a position that allows them to
contaminate the product.

5.8.2.3

Sharp cutting instruments used in the manufacture of packaging materials shall be


controlled to prevent product contamination. This shall include control into and out of
the factory.

5.8.2.4

Snap-off blade knives shall not be used.

5.8.2.5

Where open notice boards are present in production areas, loose fastenings, such as
drawing pins and staples, shall not be used.

5.8.3

Chemical and biological control

Controls shall be in place to prevent contamination from chemical or


biological hazards.
Clause

Requirements

5.8.3.1

Chemicals including cleaning materials, lubricants and adhesives shall be of the appropriate
grade and be suitably controlled to prevent contamination of the product.

5.8.3.2

Through hazard and risk analysis the company shall identify, control and manage any
potential risks from microbiological contamination.

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Section III Requirements

Personnel

Raw materials handling, preparation, processing, packing and


storage areas

6.1

Training and competence


Fundamental
The company shall ensure that all employees are adequately trained,
instructed and supervised commensurate with their activity and are competent
to undertake their job role.

Clause

Requirements

6.1.1

All personnel, including temporary personnel, shall be appropriately trained prior to


commencing work and adequately supervised throughout the working period. Induction
training shall include the company hygiene rules.

6.1.2

The company shall routinely review the competencies of staff and provide relevant training
as appropriate. This shall cover all packaging quality assurance, potential contamination and
safety hazards, including those specific to established critical process steps.

6.1.3

Records of training shall be kept for all current and recent key employees.

6.1.4

A programme of refresher training shall be in place.

6.1.5

The company shall document training procedures and records to demonstrate that training
is effective and regularly reviewed.

6.2

Access and movement of personnel

The company shall ensure that access and movement of personnel, visitors and
contractors shall not compromise product safety and quality.
Clause

Requirements

6.2.1

There shall be a plan of the site, which defines access points for personnel, travel routes and
staff facilities.

6.2.2

If it is necessary to allow access through production areas, designated walkways shall be


provided that ensure there is adequate segregation from materials.

6.2.3

All facilities shall be designed and positioned, where possible, so that movement of
personnel is by simple, logical routes.

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6.3

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Personal hygiene

The companys personal hygiene standards shall be documented and adopted by


all personnel, including visitors to the production facility. These standards shall be
developed with due regard for risk of product contamination.
Clause

Requirements

6.3.1

The company shall document its jewellery policy.

6.3.2

Jewellery and wrist watches shall not be worn, with the exception of a plain wedding ring, a
wedding wristband and sleeper earrings (continuous loop).

6.3.3

Personal items and belongings including personal mobile telephones shall not be taken into
production areas without the permission of the management.

6.3.4

Procedures shall be in place to control the use of personal medicines to minimise the risk of
contamination of the product.

6.3.5

All personnel, visitors and contractors shall wash their hands after using the toilet, eating,
smoking or drinking (unless drinking only water in accordance with the conditions set out in
clause 6.3.9) and whenever otherwise necessary.

6.3.6

Fingernails shall be kept short and clean. False fingernails and nail varnish/polish shall not
be used. Where visitors can not comply, suitable control procedures shall be in place, e.g.
non-handling of product, use of gloves.

6.3.7

If gloves are used, they shall be replaced regularly. Where appropriate, gloves shall be of a
disposable type, of a distinctive colour, be intact and not shed loose fibres.

6.3.8

Eating (including the eating of confectionery and chewing of gum or tobacco), drinking
and smoking shall not be allowed in the production or storage areas. If it is impractical for
personnel to leave their work area, local controlled facilities (such as a fully walled area with
hand-washing facilities) shall be provided.

6.3.9

Drinking of water from purpose-made dispensers and/or by using disposable conical cups
or spill-proof containers may be allowed, provided it is confined to a designated area away
from equipment.

6.4

Medical screening

Health conditions likely to adversely affect product safety shall be monitored


and controlled.
Clause

Requirements

6.4.1

The company shall have a procedure for the notification by personnel, including temporary
personnel, of any relevant infections, diseases or conditions with which they may have been
in contact or be suffering from. Employees and visitors suffering from any of the above
shall be excluded from work involving contact with high-risk packaging for as long as the
symptoms persist.

6.4.2

Visitors and contractors shall be required to fill in a health questionnaire prior to being
allowed into production areas.

6.4.3

All cuts and grazes on exposed skin shall be covered by an appropriately coloured plaster,
different from the product colour (preferably blue), and containing a metal detectable strip.
These shall be company issued and monitored when involved in work in contact with highrisk materials. Where appropriate, in addition to the plaster, a finger stall shall be worn.

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6.5

Section III Requirements

Protective clothing

Appropriate protective clothing shall be worn in production and storage areas to


minimise the risk of product contamination.
Clause

Requirements

6.5.1

Appropriate clean protective clothing that cannot contaminate the product shall be worn.
Where no need for protective clothing has been established by risk assessment in
a particular area, it shall be fully justified and shall not pose a contamination risk to
the product.

6.5.2

Sufficient sets of clothing shall be provided appropriate to the activities carried out.

6.5.3

Protective clothing worn in production areas shall provide adequate covering of the
upper torso.
Where direct food contact or high-risk contact products are handled, the clothing shall have
no external pockets on the upper body garments or sewn on buttons. Changes of such
clothing shall be available at all times as required.

6.5.4

Based on hazard and risk analysis, a policy shall be documented and implemented to state
where protective clothing can be worn away from the production environment.

6.5.5

Based on the assessment of risk to the product, suitable footwear shall be worn within the
factory environment.

6.5.6

Based on hazard and risk analysis, snoods for beards and moustaches shall be worn to
prevent product contamination.

6.5.7

Based on hazard and risk analysis, all scalp hair shall be fully contained to prevent
product contamination.

6.5.8

Protective clothing shall be kept clean and laundered. Laundering shall be carried out by
one of the following methods: professional laundry service, in-house, controlled laundering
facilities or self-care.

6.5.9

Where self-care laundry is permitted, it shall be ensured that:


employees have received written instructions regarding the laundering process to
be used and these shall be reinforced as part of an induction or other in-house
training programme
employees shall be provided with suitable means to safely transport washed garments
from home to the workplace
there shall be a defined process within the company for monitoring the effectiveness of
the system
there shall be a procedure and system for dealing with any case where employees are
unable to perform self-laundry effectively, either through lack of diligence or facilities.

6.5.10

Clean and dirty clothing shall be segregated and controlled to prevent cross-contamination.

6.5.11

Disposable protective clothing, if used, shall be subject to adequate control to avoid


product contamination.

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Low Hygiene Risk Category


Requirements for the manufacturers producing packaging for consumer products and the
secondary and tertiary packaging for all uses.

1 Senior Management Commitment and


Continual Improvement
1.1

Product safety and quality management policy

The senior management shall commit the company to producing products to the
specified quality and which are safe and legally compliant.
Clause

Requirements

1.1.1

The policy shall state the companys intention to meet its obligation to produce safe and
legally compliant products to the specified quality, and its responsibility to its customers.
This shall include the commitment for review and continuous improvement.

1.1.2

The companys senior management shall ensure the policy is communicated to all staff
involved with activities relating to product safety, legality, regulatory compliance and quality.

1.2

Senior management commitment


Fundamental
The companys senior management shall demonstrate that they are fully
committed to the implementation of requirements of the Global Standard
for Packaging & Packaging Materials. This shall include provision of adequate
resources, effective communication and systems of management review
to effect continual improvement. Opportunities for improvement shall be
identified, implemented and fully documented.

Clause

Requirements

1.2.1

The companys senior management shall ensure that product safety and quality objectives
are measurable, established, documented, monitored and reviewed.

1.2.2

The companys senior management shall have a system in place to ensure that the company
is kept informed of all relevant legislative, scientific and technical developments, and
industry codes of practice applicable in the country of manufacture and, where known, the
country in which the packaging material will be sold.

1.2.3

The company shall ensure that the materials manufactured comply with the relevant
legislation (including any legislation concerning the use of recycled content) in the country
of manufacture and in which the products are intended to be sold and/or ultimately used,
where known.

1.2.4

The companys senior management shall ensure that non-conformities identified at the
previous audit against the Standard are effectively actioned.

1.2.5

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

1.2.6

Where the company is certificated to the Standard they shall ensure that recertification
audits occur on or before the audit due date indicted on the certificate.

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1.3

Section III Requirements

Organisational structure, responsibilities and


management authority

The organisational structure shall be clear, with defined responsibilities, and key staff
shall be aware of their responsibilities with regard to packaging safety and quality.
Clause

Requirements

1.3.1

The company shall have an up-to-date organisation chart demonstrating the structure of
the company.

1.3.2

Within the management team there shall be a designated competent manager and deputy
with the responsibility for coordinating compliance with the Standard.

1.4

Management review

Opportunities for continuous improvement of the product safety and quality


programme shall be identified and effectively implemented through management
reviews of the product safety system and results.
Clause

Requirements

1.4.1

The review process shall be undertaken at appropriate planned intervals, as a


minimum annually.

1.4.2

The review process shall include the evaluation of:


previous management review documents and action plans
internal, second-party and third-party audits
customer performance indicators, complaints and feedback
incidents, corrective actions, out-of-specification results and non-conforming materials
resource requirements.

1.4.3

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Records of management reviews and action plans shall be documented.

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Hazard and Risk Management System


2.1

Hazard and risk management team

The hazard and risk management system shall be managed by a multidisciplinary team
competent in hazard and risk analysis.
Clause

Requirements

2.1.1

The multidisciplinary team shall have a designated team leader who shall be able to
demonstrate competence and experience of hazard and risk analysis.
In the event that the company does not have the appropriate expertise in-house,
external expertise shall be sought and used to develop and review the hazard and risk
management system. However, the day-to-day management shall remain the responsibility
of the company.

2.2

Hazard and risk analysis


Fundamental
The company shall establish the effectiveness of its prerequisite programmes
through a hazard and risk analysis and identify and implement any further
risks to the safety and legality of products.

Clause

Requirements

2.2.1

The scope of the hazard and risk analysis shall be clearly defined and shall cover all products
and processes included within the intended scope of certification.

2.2.2

The hazard and risk analysis team shall maintain awareness of and take into account:
historical and known hazards associated with specific processes, raw materials or end use
of the product
relevant codes of practice or recognised guidelines
legislative requirements.

2.2.3

A full description of the packaging produced by product or product group and its intended
use shall be documented.

2.2.4

A process flow diagram shall be prepared for each product, product group or
process. This shall include each process step from the receipt of raw materials to despatch
to the customer.
The process flow shall as a guide include, as relevant:
receipt and approval of art work
receipt and preparation of raw materials such as additives, inks and adhesives
each manufacturing process step
the use of rework and post-consumer recycled materials
any subcontracted operations
customer returns.
The accuracy of the process flow shall be verified by the hazard and risk analysis team.

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Section III Requirements

Clause

Requirements

2.2.5

The hazard and risk analysis team shall identify and record all potential hazards that are
reasonably expected to occur at each step in relation to the product and process. The
hazards considered shall include, where relevant:
foreign objects
chemical contamination (e.g. taint, odour, allergen, component transfer from inks,
varnishes and glues)
hazards that may have an impact on the functionality of the final product in use.

2.2.6

The hazard and risk analysis team shall identify control measures necessary to prevent,
eliminate or reduce each hazard to acceptable levels.

2.2.7

For each hazard that requires control, the control points shall be reviewed to evaluate if
existing prerequisites are effective in providing control.
Where greater controls are required to the prerequisite programmes, improvements shall be
implemented to ensure control is achieved.

2.2.8

A review of the hazard and risk management system shall be carried out at least once per
year and following any significant incidents or when any process changes.
The review shall include a verification that the hazard and risk analysis plan is effective and
may include a review of:
complaints
product failures
recalls
product withdrawals
results of internal audits of prerequisite programmes
results from external third-party auditors.

2.3

Exemption of requirements based on risk analysis

Clause

Requirements

2.3.1

The hazard and risk analysis study shall be fully supported by the implementation of the
prerequisites set out in requirements clauses 4 to 6. However, the hazard and risk analysis
may indicate that some of the requirements are not applicable. These shall be documented
and regarded as proposed exemptions for review at audit. Acceptance or rejection of the
proposed exemptions shall be recorded in the auditors report.

2.3.2

The company shall keep recorded exemptions to the Standard under review and provide
documented evidence of this review at subsequent audit.

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Product Safety and Quality Management System


3.1

Product safety and quality manual

The company shall have a manual that describes how the requirements of the Standard
are met. These requirements shall be fully implemented, reviewed at appropriate
planned intervals and improved where necessary.
Clause

Requirements

3.1.1

The product safety and quality manual shall contain an outline of the working methods and
practices or references to where such information is documented.

3.1.2

The manual or relevant components shall be readily available to key staff.

3.2

Customer focus and contract review

The company shall ensure that customer needs and expectation with respect to quality
and safety are identified and met, and that communication channels are clear.
Clause

Requirements

3.2.1

Customer requirements relating to the design, development, specification, manufacture and


distribution of the product shall have been agreed with the customer and where appropriate
documented and agreed prior to order fulfilment.

3.3

Internal audits
Fundamental
The company shall establish through a programme of internal audits that the
implementation of the requirements of the Standard are in place, appropriate
and complied with.

Clause

Requirements

3.3.1

Internal audits shall be planned and their scope and frequency shall be established in
relation to the risks associated with the activity. Audits shall be scheduled so that all aspects
of the Standard are audited at least annually.

3.3.2

Audits shall be conducted by personnel who are competent, and sufficiently independent
from the department being audited to ensure impartiality.

3.3.3

Deficiencies and details of non-conformities shall be notified to appropriate supervisory staff


and corrective action implemented within a specified and appropriate time period.

3.3.4

The completion of corrective action shall be recorded and verified.

3.3.5

Conformity as well as non-conformity shall be clearly identified and verified within the
internal audit report.

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3.4

Section III Requirements

Supplier approval and performance monitoring

The company shall ensure that suppliers of goods and services are operating in
a manner that ensures that product quality and safety is not compromised and
specifications can be achieved.
Clause

Requirements

3.4.1

The company shall have a documented supplier approval procedure and continual
assessment programme in place, based upon risk analysis.

3.4.2

The procedures shall include clear criteria for the assessment and approval of new suppliers.
Assessment may take the form of:
supplier audits
supplier certification with a scope covering the products supplied e.g. against the
appropriate BRC Global Standard
supplier questionnaires.

3.4.3

Records of supplier assessment and necessary actions shall be maintained and reviewed.

3.4.4

The company shall define how exceptions are handled, e.g. the use of products or services
where assessment or approval has not been undertaken. Assessment may take the form (on
a batch or delivery basis) of:
certificate of analysis
declaration of compliance.

3.5

Subcontracting of production

Subcontractors shall be effectively managed to prevent any risk of contamination or


damage and ensure product is produced to specification.
Clause

Requirements

3.5.1

The use of subcontractors and the status of the subcontractor with respect to the Standard
shall be notified to the brand owner and/or customer.

3.5.2

Suppliers of subcontracted services shall be approved in accordance with the procedures in


clause 3.4.

3.5.3

Where any production processes are subcontracted, the risks to the quality and safety of
the product shall be assessed. Any risks shall be communicated to relevant personnel and
effectively managed.

3.5.4

Clear specifications shall be agreed for all work outsourced to a subcontractor. Controls shall
be in place for checks on finished work to ensure the safety and quality meets specification.

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3.6 Documentation control


Documentation essential to the management and control of product safety, legality
and quality shall be relevant, controlled and available, as the correct version, to the
appropriate personnel.
Clause

Requirements

3.6.1

Documents shall be sufficiently detailed to enable their correct application by appropriate


personnel. They shall be readily accessible to relevant staff at all times.

3.6.2

All changes and amendments to documents critical to product safety, legality or quality
system procedures shall be authorised, recorded, and obsolete documentation shall be
removed, archived and replaced with the current version.

3.7 Specifications
Fundamental
Appropriate specifications shall exist for raw materials, intermediate and
finished products, and any product or service that could affect the integrity of
the finished product.

Clause

Requirements

3.7.1

Specifications shall be suitably detailed, accurate and shall ensure compliance with relevant
product safety and legislative requirements.

3.7.2

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 put an agreement in place.

3.7.3

Trademarks for application on packaging materials shall, where appropriate, be formally


agreed between relevant parties.

3.8

Record keeping

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

Requirements

3.8.1

The records shall be legible, genuine, appropriately authorised and retained in good
condition for an appropriate defined time period.

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Section III Requirements

3.9 Traceability
Fundamental
The company shall have a system in place to identify product batches and
to trace and follow all raw materials through processing to the distribution
of the finished product to the customer. Records shall be retrievable in a
timely manner.

Clause

Requirements

3.9.1

An appropriate system shall be in place to ensure that the customer can identify a product
or production lot number for the product for the purposes of traceability.

3.9.2

The system shall be tested to ensure traceability can be determined from raw materials to
the finished product and vice versa. This test shall take place at least annually.

3.10 Complaint handling


All complaints made by customers and consumers shall be recorded and investigated.
Corrective actions where required shall be implemented and recorded.
Clause

Requirements

3.10.1

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

3.11 Management of incidents, product withdrawals


and recalls
The company shall have a plan and systems in place to effectively manage incidents
and if required the withdrawal or recall of products, in order to ensure that all
potential risks to the quality and hygiene and legality of products are controlled.
Clause

Requirements

3.11.1

The company shall provide written guidance and training for relevant staff regarding the
type of event that would constitute an incident. A documented incident reporting procedure
shall be in place.

3.11.2

The company shall effectively manage the incident to prevent release of product where
safety or quality may have been affected.

3.11.3

A product withdrawal/recall procedure shall be documented, practical to implement and


regularly reviewed. This shall include as a minimum:
identification of the key personnel involved in assessing potential withdrawal/recall
incidents with clear identified responsibilities
a communications plan including methods of informing customers and, where necessary,
regulatory bodies in a timely manner
corrective action and business recovery
review of any withdrawals or recalls to implement appropriate improvements as required.

3.11.4

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The product withdrawal/recall procedure shall be tested on at least an annual basis and
used to evaluate the procedure and implement improvement.

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Site Standards

4.1

External standards

All grounds within the site shall be finished and maintained to an appropriate standard.
Clause

Requirements

4.1.1

Consideration shall be given to local activities and the site environment which may have
an adverse impact on the integrity of the finished product. Measures shall be taken to
prevent contamination.

4.1.2

The external areas shall be maintained in good order. Grounds shall be regularly tended and
well maintained and potential pest-harbouring areas shall be identified and monitored.

4.1.3

The building fabric shall be maintained to minimise potential for pest entry, ingress of water
and other contaminants. External silos, pipe work or other access points for the product
and/or raw materials shall be appropriately sealed and secured.

4.1.4

Where natural drainage is inadequate, external drainage shall be installed. Drains shall be
properly protected to prevent entry of pests.

4.1.5

External traffic routes, under site control, shall be maintained in good repair to avoid
contamination of the product.

4.1.6

Where external storage of raw materials is necessary these shall be protected from
contamination as required.

4.2

Building fabric and interiors

Raw material handling, preparation, processing and storage areas


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.
Clause

Requirements

4.2.1

Walls, floors, ceilings (including suspended ceilings) and pipe work shall be maintained in
good condition and shall facilitate cleaning.

4.2.2

Suitable and sufficient lighting shall be provided for a safe working environment, correct
operation of processes, effective inspection of the product and cleaning.

4.2.3

Potential sources for the ingress of pests, such as drain openings or windows opened for
ventilation, shall be suitably pest proofed.

4.2.4

Where they pose a risk to the product, glass windows shall be protected against breakage.

4.2.5

Suitable and sufficient ventilation shall be provided.

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4.3

Section III Requirements

Utilities

Product cleanliness and integrity shall not be compromised by the location,


construction and delivery of the utilities to and within the production and
storage areas.
Clause

Requirements

4.3.1

All water used in the processing of the products or equipment cleaning shall be potable or
suitably treated to prevent contamination.

4.3.2

Air, compressed air or other gases that come into direct contact with the packaging shall
present no risk to product safety or quality and comply with any relevant legal regulations.

4.4

Security

Product and process integrity shall be assured through appropriate site


security provision.
Clause

Requirements

4.4.1

Based on risk assessment, a procedure shall be in place to address the security of the site
and products and establish, implement and maintain a system to reduce or eliminate the
identified risk.

4.4.2

Access to the site by employees, contractors and visitors shall be controlled, through
designated entrances, and a visitor reporting system shall be in place.

4.4.3

Staff shall be trained in site security procedures and encouraged to report or challenge
unidentified or unknown visitors.

4.4.4

Contractors involved in maintenance or repair shall be supervised by a qualified person, and


a nominated staff member shall be responsible for their activities.

4.4.5

Access to the site for third-party transport personnel shall be controlled and, where possible,
facilities provided to negate the need to enter storage or production areas.

4.4.6

Site IT systems shall be adequately controlled and backed up.

4.5

Layout and product flow

Premises and plant shall be logically designed, constructed and maintained.


Clause

Requirements

4.5.1

The process flow from intake to despatch shall be arranged to minimise the risk of
contamination or damage to the product.

4.5.2

Premises shall allow sufficient working space and storage capacity to enable all operations
to be carried out properly under hygienic conditions.

4.5.3

Work in progress shall be identified clearly and adequately protected.

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4.6

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Equipment

Product safety, legality and quality shall be ensured through the use of appropriate
equipment that shall be properly designed and maintained.
Clause

Requirements

4.6.1

Newly installed equipment shall be properly specified before purchase. Equipment shall
be constructed of appropriate materials and be of a suitable design to ensure it can be
effectively cleaned and maintained. New equipment shall be tested and commissioned prior
to use, and a maintenance programme established.

4.7

Maintenance

Proper maintenance and monitoring of all equipment critical to product safety, quality
and legality shall ensure consistent high levels of product safety, functionality and
quality.
Clause

Requirements

4.7.1

A condition-based or preventative maintenance programme shall be in place covering all


items of equipment and plant that are critical to product safety, quality and legality.

4.7.2

Maintenance work shall not place the product at risk. After breakdown or maintenance,
machinery shall be thoroughly checked before re-commencing production.

4.7.3

Temporary repairs/modifications using tape, cardboard, etc. shall only be permitted in


emergencies and where product contamination is not at risk. Such modifications shall be
subject to a time limit and shall be recorded and scheduled for correction.

4.7.4

Engineering workshops shall be controlled to prevent contamination risks to the product,


e.g. provision of swarf mats where workshops open directly into production areas.

4.8

Staff facilities

Staff facilities shall be sufficient to accommodate the required number of personnel,


and designed and operated to minimise the risk of product contamination. Such
facilities shall be kept in a good and clean condition.
Clause

Requirements

4.8.1

Suitable and sufficient hand-washing facilities shall be available to enable cleaning of hands
before commencing work and as necessary during the course of work.

4.8.2

Toilets shall be adequately segregated and shall not open directly into storage, processing or
production areas. Toilets shall be provided with hand-washing facilities comprising:
sufficient quantity of warm water
unscented liquid soap
single-use towels or suitably designed and located air driers
advisory signs to prompt use (including consideration of appropriate languages).

4.8.3

Eating, drinking and smoking shall not be allowed in locker and changing rooms.

4.8.4

Facilities for visitors and contractors shall comply with the companys hygiene policy.

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4.9

Section III Requirements

Housekeeping and cleaning


Fundamental
Housekeeping and cleaning systems shall be in place, which ensure that
appropriate standards of cleanliness are maintained and that risk of
contamination to the product is minimised.

Clause

Requirements

4.9.1

Good standards of housekeeping shall be maintained, which shall include a clean as you
go policy.

4.9.2

The cleaning of production equipment and internal surfaces of storage and production
facilities shall be effectively managed using cleaning schedules.

4.9.3

Cleaning chemicals shall be fit for purpose, suitably labelled, secured in closed containers
and used in accordance with manufacturers instructions. Materials and equipment used for
cleaning toilets shall be segregated from those used elsewhere.

4.10 Waste and waste disposal


Suitable facilities shall be in place for the storage and disposal of process and
other waste.
Clause

Requirements

4.10.1

Where appropriate, waste shall be categorised according to legislative requirements based


on the intended means of disposal (such as recycling) and segregated in appropriate
designated waste containers.

4.10.2

Where agreed with the customer, substandard trademarked materials shall be rendered
unusable through a destructive process. If transferred to a third party for destruction or
disposal, that third party shall be a specialist in appropriate waste disposal and shall provide
records of material destruction.

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4.11 Pest control


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

Requirements

4.11.1

A preventive pest control programme shall be maintained covering all areas of the site under
the companys control.

4.11.2

The company shall either contract the services of a competent pest control organisation or
shall have appropriately trained staff for the regular inspection and treatment of the site to
deter and eradicate infestation.

4.11.3

A pest control manual shall be maintained including:


detailed records of pest control inspections, recommendations and of any pest activity
details of pest control products used and instructions for their use
a site plan showing the location of pest control devices.

4.11.4

In the event of infestation, immediate action shall be taken to eliminate the hazard. Action
shall be taken to evaluate the potential for contamination or damage to packaging and
checks instigated before release.

4.12 Transport, storage and distribution


The risk of contamination of raw materials and finished products shall be minimised
whilst in transport, storage or distribution.
Clause

Requirements

4.12.1

All finished products and materials transferred between premises shall be fully identified and
protected during transit and storage.

4.12.2

Receipt documents and/or product identification shall facilitate correct stock rotation of
goods in storage.

4.12.3

Deliveries of incoming goods shall be visually checked for packaging integrity and potential
foreign body contamination.

4.12.4

All pallets shall be checked. Damaged, contaminated or unacceptable pallets shall


be discarded. Wooden pallets, if used, shall be sound, dry, clean and free from damage
and contamination.

4.12.5

Work in progress shall be suitably labelled and covered to ensure proper identification and
prevent damage.

4.12.6

Material intended for recycling shall be appropriately protected against


contamination hazards.

4.12.7

All vehicles used for deliveries shall be in a condition to minimise the risk of
product contamination.

4.12.8

All company-owned vehicles used for deliveries shall be visually checked for cleanliness
before loading. Unsatisfactory lorries shall not be loaded.

4.12.9

Where the company employs third-party contractors there shall be a contract or


agreed terms and conditions. Where this is not possible, with general carriers, the
packaging shall be adequate to protect the product against damage, contamination
hazards, taint and odour.

4.12.10

Storage, including off-site storage, shall be controlled to protect the product


from contamination.

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Section III Requirements

Product and Process Control


5.1

Product design and development

Product design and development processes shall be in place to ensure the production
of safe and legal products to defined quality parameters.
Clause

Requirements

5.1.1

Customer requirements shall be defined and agreed prior to undertaking development,


where possible, taking into consideration process requirements and end use.

5.1.2

A product specification shall be prepared and, where possible, agreed with the customer or
brand owner before the production process begins.

5.1.3

A process shall be in place to ensure final product concepts and artwork are formally
accepted by the specifier, where possible.

5.1.4

Production trials, where appropriate, shall be carried out and testing shall validate that
manufacturing processes are capable of producing a safe and legal product and that agreed
product quality/print standards can be consistently achieved.

5.1.5

The company shall ensure that the product design processes, procedures and records of
design together result in the development of specifications for each manufacturing process
step to ensure the production of safe and legal products of the prescribed quality.

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5.2

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Packaging print control

Processes shall be in place to ensure that print quality meets agreed specifications
and critical print content such as allergen/safety/legal information is fully legible and
correctly printed.
Clause

Requirements

5.2.1

An assessment shall be carried out of the print process and handling of printed packaging
(product) to identify:
risks of loss of essential information
mixing of printed product.
Controls shall be established and implemented to reduce the risks identified.

5.2.2

Printing plates, other print equipment and reproduction media shall be fully traceable to the
customers approved origination material.

5.2.3

Printing plates shall be appropriately stored.

5.2.4

Each print run shall be approved against the agreed standard (or master sample). This shall
be recorded.

5.2.5

A system shall be in place to detect and identify printing errors during the run, and to sort
these errors from the acceptable printed material.

5.2.6

Where composite print is used (where a mixture of different designs are printed together),
a process shall be in place to ensure effective segregation of differing print variants.

5.2.7

Samples of printed packaging shall be retained together with production records for a
period of time to be agreed with the customer/specifier/brand owner.

5.2.8

Any unused printed product shall be accounted for and either disposed of or identified and
appropriately stored.

5.2.9

Personnel carrying out print quality control shall be appropriately trained, aware of the
importance of consumer safety information and adequately supervised.

5.2.10

Lighting in print inspection cabinets and other means of print/colour checking shall be
agreed with the customer or be to accepted industry standards.

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5.3

Section III Requirements

Process control
Fundamental
The production process shall be controlled through effective quality assurance
of operations to ensure packaging materials can be consistently produced to
the quality specified by customers.

Clause

Requirements

5.3.1

The company shall undertake a review of the manufacturing and, where applicable, printing
process to identify critical manufacturing process control points that could affect the quality
of the products produced.

5.3.2

For each critical manufacturing process control point, machine settings or process limits shall
be established and documented the process specification.

5.3.3

Documented process checks shall be undertaken at start up, following adjustments


to equipment, and periodically during production, to ensure products are consistently
produced to the agreed quality specification.

5.3.4

A clearance procedure shall be in place to ensure that at start up, the line is clear of all
previous work and production documents.

5.3.5

In the event of changes to product composition, processing methods or equipment, the


company shall, where appropriate, re-establish process characteristics and validate product
data to ensure product safety, legality and quality are achieved.

5.4

Product inspection and analysis

The company shall use appropriate procedures and facilities when undertaking or
subcontracting inspection and analyses critical to product safety, legality and quality.
Clause

Requirements

5.4.1

Quality checks shall be carried out at appropriate stages in production to demonstrate that
raw materials, work in progress and the finished product are within the tolerances laid down
in the agreed product specification.

5.4.2

Personnel undertaking quality checks and analyses shall be suitably trained and shall be
competent to carry out the work.

5.4.3

Procedures shall be in place to ensure the reliability of test results.

5.4.4

Frequency of checks shall be in accordance with industry-accepted practice or customer


requirements and based on risk analysis.

5.4.5

Where the company undertakes or subcontracts analyses critical to product safety


or legality, the laboratory or subcontractors shall have gained recognised laboratory
accreditation or operate in accordance with the requirements and principles of ISO 17025
(General Requirements for the Competence of Testing and Calibration Laboratories).
Documented justification shall be available where accredited methods are not undertaken.

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5.5

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In-line testing and measuring equipment

In-line measuring or product testing equipment, where used, shall be tested and
maintained to ensure it is effective in ensuring product safety integrity and quality.
Clause

Requirements

5.5.1

The accuracy of in-line equipment shall be specified having due regard to the product
parameter being measured and controlled.

5.5.2

The company shall establish and implement procedures for the operation, routine
monitoring and testing of equipment.

5.6

Calibration

Where specialist measuring is required to assess compliance with product safety and
legality, the devices shall be maintained and calibrated.
Clause

Requirements

5.6.1

Measuring equipment used to monitor critical manufacturing process points and the
products compliance with relevant legal requirements and specifications shall be identified
and calibrated.

5.6.2

Calibration shall be traceable to a recognised national standard. Where such a traceable


calibration is not possible, the company shall demonstrate the basis by which standardisation
is carried out.

5.7

Control of non-conforming product

The company shall ensure that out-of-specification product is clearly identified,


labelled and quarantined.
Clause

Requirements

5.7.1

Clear procedures for the control of out-of-specification or non-conforming materials shall be


in place and understood by all authorised personnel. This shall include the effective labelling
or quarantining of materials before a decision has been made on their final disposition.

5.7.2

Non-conforming materials shall be assessed and a decision taken to reject, accept by


concession or authorise to be reworked or for an alternative use. The decision and reasons
shall be documented.

5.7.3

Corrective actions shall be implemented to avoid recurrence of the non-conformance.


Actions taken shall be documented.

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5.8

Section III Requirements

Foreign body contamination control

The company shall be able to demonstrate that effective controls are in place to
ensure product is protected from contamination during production and storage.

5.8.1

Foreign body control

Clause

Requirements

5.8.1.1

Based on risk assessment, the company shall identify, control and manage potential risks
from physical contamination.

5.8.1.2

Based on the likelihood and risk of glass contamination, all bulbs and strip lights, including
those on flying insect control devices, shall be protected.

5.8.1.3

Where glass breakage occurs a responsible person shall be placed in charge of the clean-up
operation and shall ensure that no other area is allowed to become contaminated due to the
breakage. Any product that has become contaminated shall be segregated and disposed of.
All breakages shall be recorded in an incident report.

5.8.2

Sharps control

Clause

Requirements

5.8.2.1

There shall be a documented policy for the control of the use of sharps.

5.8.2.2

Sharp blades, equipment and tools shall not be left in a position that allows them to
contaminate the product.

5.8.2.3

Snap-off blade knives shall not be used.

5.8.3

Chemical control

Controls shall be in place to prevent contamination from chemical hazards.


Clause

Requirements

5.8.3.1

Chemicals including cleaning materials, lubricants and adhesives shall be of the appropriate
grade and be suitably controlled to prevent contamination of the product.

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Personnel

aw materials handling, preparation, processing, packing and


R
storage areas

6.1

Training and competence


Fundamental
The company shall ensure that all employees are adequately trained,
instructed and supervised commensurate with their activity and are competent
to undertake their job role.

Clause

Requirements

6.1.1

All personnel, including temporary personnel, shall be appropriately trained prior to


commencing work and adequately supervised throughout the working period.

6.1.2

The company shall routinely review the competencies of staff and provide relevant training
as appropriate. Records of training shall be maintained.

6.2

Access and movement of personnel

The company shall ensure that access and movement of personnel, visitors and
contractors shall not compromise product safety and quality.
Clause

Requirements

6.2.1

There shall be a plan of the site, which defines access points for personnel, travel routes and
staff facilities.

6.2.2

If it is necessary to allow access through production areas, designated walkways shall be


provided that ensure there is adequate segregation from materials.

6.3

Personal hygiene

The companys personal hygiene standards shall be documented and adopted by


all personnel, including visitors to the production facility. These standards shall be
developed with due regard for risk of product contamination.
Clause

Requirements

6.3.1

The company shall have a documented jewellery policy.

6.3.2

Personal items and belongings including personal mobile phones shall not be taken into
production areas without the permission of the management.

6.3.3

Eating (including the eating of confectionery and chewing of gum or tobacco), drinking and
smoking shall not be allowed in production or storage areas.

6.3.4

Drinking of water from purpose-made dispensers and/or by using disposable conical cups
or spill-proof containers may be allowed, provided it is confined to a designated area away
from equipment.

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6.4

Section III Requirements

Protective clothing

The risk of product contamination from clothing, hair or personal items shall
be minimised.
Clause

Requirements

6.4.1

Appropriate clean protective clothing that cannot contaminate the product shall be worn.
Where no need for protective clothing has been established by risk assessment, it shall
be fully justified and guidance provided to staff on any limitations to personal clothing to
prevent a contamination risk to the product.

6.4.2

Where protective clothing is used it shall be kept adequately clean. Changes of clothing shall
be available as required.

6.4.3

Where protective clothing is used, clean and dirty clothing shall be segregated and
controlled to prevent cross contamination.

6.4.4

Disposable protective clothing, if used, shall be subject to adequate control to avoid


product contamination.

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Section IV Audit and Certification Process

SECTION IV
AUDIT AND CERTIFICATION PROCESS

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Section IV Audit and Certification Process

Section IV

Audit and Certification Process


1 Introduction
This section provides the specific requirements of auditing and certification to the Standard. It shall be used
by the certification bodies undertaking certification. It also provides the basis for accreditation bodies when
carrying out their own audit and for the surveillance work of certification bodies seeking accreditation to
operate the Standard. The section also provides guidance for companies seeking certification on the audit and
certification process to help them prepare and organise for the audit.
The process by which a company gains and maintains certification is summarised in Figure 3.
Every effort has been made to ensure that the content of this audit protocol is accurate at the time of printing.
However, it may be subject to minor change, and reference should be made to the BRC Global Standards
website (www.brcglobalstandards.com) where changes will be published.

Getting Started

Obtaining 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.
Some considerations that should be addressed by companies interested in obtaining certification are outlined
in this section.
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 can
help and allows sites 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.
If a site is working with a specific customer, it would be advisable to discuss an implementation programme
with the sites technical team to ensure that the steps being taken are appropriate with regard to the
customers requirements and timescales.

Self-assessment of Compliance with the Standard

It is a requirement of BRC certification that the company has an original copy of the current issue of the
Standard, which can be obtained in either electronic or paper format. Either format is acceptable. The current
issue of the Standard in the required language is available from www.brcbookshop.com. The Standard
should be obtained as the first stage of preparation for certification.
The Standard should be read and understood and a preliminary self-assessment should be conducted by the
company against the Standard. Any areas of non-conformity should be addressed by the company. Further
information and guidance to ensure compliance with the Standard, including an interpretation guideline, audit
tools and training courses, are available on the website: www.brcglobalstandards.com.
Companies who meet the requirements of a satisfactory quality management system (for example, one
conforming to that specified in ISO9001:2008) may already meet many of the requirements of the Standard.
It is in the interest of the company to bring these points to the attention of the certification body. The auditor
shall, however, verify that all the procedures are adequate for the purpose of compliance with the Standard.

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Selection of a Certification Body

Once a self-assessment has been completed and any 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 following:

Confirmation that the auditor proposed by the certification body meets the qualification and training
requirements specified by the BRC as documented in Appendix 3.

The scope of accreditation of the certification body. It is essential that the certification body is accredited
to assess companies for the range of products produced. Clarification of the fields of packaging against
which the certification body can audit should be obtained either by confirmation from the certification
body concerned or accreditation schedules published by the national accreditation body. A list of
packaging fields is provided in Appendix 4.

Company/Certification Body Contractual Arrangements

A contract shall exist between the company and the certification body, detailing the scope of the audit and
reporting requirements. This contract will be formulated by the certification body.

5.1 Registration fee


A registration fee is collected on behalf of the BRC by the certification body from the site for every audit
undertaken. This fee is to support further development of the scheme and to fund the maintenance of the
BRC Directory.
The certification body shall not issue a certificate or report to the client until the registration fee has been
received, irrespective of the outcome of the certification process.
It is a requirement of the BRC scheme that a copy of every audit report shall be uploaded by the certification
body onto the BRC Directory irrespective of the audit result. This enables the BRC to oversee the scheme,
monitor the performance of certification bodies and ensure the consistency of application of the scheme
around the world.

5.2 Scope of audit


The scope of the audit must be agreed between the company and the certification body.
The audit, report and certificate shall be site-specific. Each site shall be audited and the certificate
granted accordingly.
A certificate shall not normally be issued which covers more than one site owned by a company.
The scope of the audit and subsequent certificate shall cover the agreed products or product groups, and
shall normally be expected to include all products manufactured at the site within the product category
certificated. Where any products or areas are excluded from the scope, this shall be clear on the report and
certificate. The certification of products must include audit of the entire process from raw materials to endproduct despatch.
The hazard and risk analysis may indicate that some of the requirements of clauses 4 to 6, except fundamental
clauses, may be exempted. Any exemptions shall be documented and regarded as proposed exemptions for
review by the auditor and recorded in the audit report. It would not be expected that any regular process
closely associated with the production of packaging would be excluded.

5.3 Extension to scope


Certificated sites may apply for an extension of scope where significantly different products or processes are
introduced to the packaging site. The certification body shall be contacted and provided with details of the

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Further information available at www.brcglobalstandards.com

Obtain copy of Standard www.brcglobalstandards.com

Self-assessment compliance with Standard

Select certification body www.brcdirectory.com

Pre-assessment (optional)

On-site audit

Closing meeting
Confirmation of any non-conformities

INITIAL AUDIT
Corrective action
submitted or revisit within
90 calendar days

Corrective action
submitted or
revisit within 28
calendar days

Evidence assessed
inadequate

Evidence assessed
Clarification required

Additional clarification
provided

Critical non-conformity
or fundamental

No non-conformities
identified

No corrective action
submitted within 28
days

Evidence assessed
compliant

No certificate issued
Report issued
specifying status
Process/certification
suspended

Corrective action
status documented

Certification
documentation
collated

No certificate issued
Report issued
specifying status
Process/certification
suspended

Evidence assessed
inadequate

Certificate and audit details


listed on BRC Global
Standards Directory
www.brcdirectory.com

Figure 3 The certification process


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Certification and
grading decision
made by certification
decision manager

Certificate details and


audit report issued to
the company and sent
to BRC

On-going compliance

Audit in accordance
with required
frequency
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product/processes to be added to the scope. The certification body will assess the aspects of the required
extension to scope and seek assurances that the management of the new product/process are in compliance
with the Standard. This will often take the form of a site visit. The current certificate will be superseded by any
new certificate issued using the same expiry date detailed on the original certificate.

5.4 Auditor selection


It is the responsibility of the company to ensure 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 packaging fields as listed in Appendix 4.
The certification body, auditors and the company must be aware of the need to avoid conflict of interest
when arranging an auditor for the site visit. The company may decline the services of a particular auditor
offered based on the potential for conflict of interest. However, as guidance, the certification body should
ensure that the same auditor does not undertake audits on more than five consecutive occasions at the
same site.

Audit Preparation by the Company

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 does not go out of the certification time frame
as detailed in Section IV, 13 Ongoing Audit Frequency and Certification, and with reference to Table 2.
There is a requirement on the company to plan carefully for the audit, to have appropriate documentation for
the auditor to assess, and to have appropriate staff available at all times during the on-site audit.
The company shall ensure that the production programme at the time of the audit covers products for the
intended user(s) 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 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 information such as risk analysis documentation,
details of recent quality issues, withdrawals or customer complaints, and other relevant performance data
when requested, to 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.

7 Duration of the Audit


The company shall provide the certification body with appropriate information to allow them to assess the
duration and the cost of the audit. This should include details of manufacturing schedules to allow audits to
cover relevant processes if necessary (for example, night-time manufacture). Requested information may also
include a site plan, the number of employees, and the number of product lines. The time required 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 shall be one-and-a-half man days with further time as appropriate for the
completion of a comprehensive audit report.
However, certain factors can necessitate an increase or decrease in the duration of the audit. These factors
will require careful consideration both on confirmation of the expected duration of the audit and during the
audit itself. Deviation from this time frame must be justified and specified on the audit report.
The audit may not be completed in the time allocated if the company has not agreed the scope with the
certification body before the audit. Factors that may influence the duration of the audit are:

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Section IV Audit and Certification Process

company staff numbers and functions

site layout numbers of buildings, separate offices, manufacturing or storage sites

complexity of the manufacturing process

number of product lines

size and age of site and impact on material flow

labour intensity of processes

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

the number of non-conformities recorded in the previous audit

difficulties experienced during the audit requiring further investigation

quality of company preparation, e.g. documentation, hazard analysis, quality management system.

The On-site Audit

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

the opening meeting to confirm the scope and process of the audit

document review a review of documentation, e.g. hazard and risk analysis

production facility inspection to review practical implementation of the systems and


interview personnel

review of production facilities inspection to verify and conduct further documentation checks

final review of findings by the auditor preparation for the closing meeting

closing meeting to review the findings of the auditor with the company. Note that
non-conformities and consequent grade 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 will 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 companys 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 make 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 summary of any non-conformities discussed at
the closing meeting will be documented by the auditor either at the closing meeting or within one working
day after completion of the audit.
The decision to award certification 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.
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 certificates, although it will be necessary to describe, in general terms, the types of materials and
technologies used.

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9 Non-conformities and Corrective Action


The 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 upon evidence collected and observations made
during the audit. This is verified by the certification body management.

9.1 Non-conformities
There are three levels of non-conformity:
Critical

Where there is a critical failure to comply with a product safety or legality issue.
Where there is a substantial failure to meet the requirements of a statement of intent or
any clause of the Standard

Major

and/or
A situation is identified that would, on the basis of available objective evidence, raise
significant doubt as to the conformity of the product being supplied.
Where absolute compliance to the statement of intent has not been met, but on the
basis of objective evidence the conformity of the product is not in doubt

Minor

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 standards of the operation, and level of
conformity with the Standard. Consideration should therefore be given to awarding a single major nonconformity where minor non-conformities are repeatedly raised against a particular clause of the Standard in
the current or previous audits. Clustering of a significant number of minor non-conformities against a clause
and recording this as a single minor non-conformity is not permitted.
Any non-conformities from the previous audit should be checked during the current audit to confirm that
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 a major.

9.2 Procedures for handling non-conformities and corrective action


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 by the company to the certification body prior to a certification decision being made. All
identified non-conformities must be corrected to the satisfaction of the certification body before a certificate
can be issued.

9.2.1 Critical non-conformities or major non-conformities raised against


fundamental clauses
Fundamental requirements must be substantially in place at the time of the audit visit and cannot be corrected
after without the need for a complete re-audit. Where a critical or major non-conformity against the
statement of intent of a fundamental clause has been established, the company shall not gain certification.
Existing certificated sites shall have their certification suspended.
A further full audit shall be carried out to verify that appropriate corrective action has taken place and that
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 relevant customers
and make them fully aware of the circumstances. Information on the corrective actions to be taken in order to
achieve certification status will also be provided to customers.
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Section IV Audit and Certification Process

9.2.2 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, either permanently or temporarily (providing the solution is acceptable to the certification body)
and the certification body can verify that the 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 revisit is required to
confirm that the non-conformities have been successfully addressed.
For initial audits only, if there is no temporary solution or if there is a justifiable delay to implementing a
permanent solution (e.g. lead time on capital expenditure), then provided that an acceptable statement of
explanation is received by the certification body within 28 calendar days, the company may remain in the
certification programme for up to 90 calendar days. It will, however, remain uncertificated and will only be
certificated following verification of the corrective action being implemented. If the major non-conformity
cannot be closed out within the 90-calendar-day period, the process of certification will commence again, i.e.
a full audit.
If there is no formal commitment to implementation of the corrective action received by the certification body
within the 28-calendar-day post-audit period, the company will not remain in the certification programme
and will require a further full audit in order to be considered for certification.

9.2.3 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. The certification body may undertake further visits to verify that
action has been taken.
At the subsequent audit, if verification cannot be confirmed, then a non-conformity may be raised and may
be elevated to a major non-conformity.

9.3 Revisits
Where revisits are required to review the action taken in response to the non-conformities identified at the
audit, this will be scheduled to be completed within the timescales for certification i.e. 28 calendar days for
certificated sites, and 90 calendar days for initial audits. The visit will primarily review the effectiveness of the
corrective actions taken; however, if new non-conformities are identified during the course of the visit, these
must also be satisfactorily resolved before a certificate can be issued. The action taken to correct the nonconformities will be recorded on the final audit report.

9.3.1 Documentary evidence


Where a revisit is not required, suitable documentary evidence (e.g. updated procedures, records,
photographs, invoices for work completed) shall be provided to the certification body within the timescales
for certification i.e. 28 days for certificated sites, and 90 calendar days for major non-conformities at initial
audits. The evidence provided should clearly demonstrate that adequate corrective actions have been taken
and implemented. If this cannot be effectively demonstrated to the satisfaction of the certification body, then
a revisit may be required before a certificate can be issued.

10 Further Action by Certification Bodies


For 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 either undertake a full or partial audit.
Where justifiable, suspension or withdrawal of certification may be implemented pending the outcomes of

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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 by the company to take appropriate corrective actions or the corrective actions are
deemed inappropriate, certification shall be withdrawn.

10.1 Suspension or withdrawal of certification


In the event that certification is withdrawn or suspended by the certification body, the company shall
immediately inform its customers and the BRC 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.

11 Grading of the Audit


The purpose of the certification grading system is to indicate to the user of the report the commitment of the
company to continual compliance and it will dictate the future audit frequency.
The grade is dependent on the number and severity of the non-conformities identified at the audit and
verification by a technical review by the certification body management where the number and severity of
non-conformities may change.
The criteria for grading and means of confirming corrective action are summarised in Table 1. 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.
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 Audit Reporting and Certification


12.1 Reporting
Following 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 user 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.
The detailed audit report section must assist the reader to gain greater understanding of how sites have
implemented the requirements of the Standard.
The report shall accurately reflect the findings of the auditor during the audit. Reports shall be prepared by
the certification body and despatched to the company within a period typically no longer than 42 calendar
days (104 calendar days for the initial audit where major non-conformities are identified) after the audit date.
Audit reports shall remain the property of the company purchasing the audit 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 may be by 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
company and certification body.
A copy of the audit report shall be uploaded by the certification body in the required format to the
BRC Directory.

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Table 1 Standard grading of packaging

Grade

Critical or
major nonconformity
against the
statement of
intent of a
fundamental
requirement

Critical

Major

Minor

Corrective action

10 or
fewer

Objective evidence in 28
calendar days

12 months

10 or
fewer

Objective evidence in 28
calendar days

12 months

11 to 20

Objective evidence in 28
calendar days

12 months

20 or
fewer

Revisit required within


28 days

6 months

Fewer
than 2

Up to
30

Revisit required within


28 days

6 months

1 or more

Certification not
granted.
Re-audit required

1 or
more

Certification not
granted.
Re-audit required

3 or
more

Certification not
granted.
Re-audit required

21 or
more

Certification not
granted.
Re-audit required

Fewer
than 2

31 or
more

Certification not
granted.
Re-audit required

Audit
frequency

12.2 Certification
After a successful review of the audit report and documentary evidence provided in relation to
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. The certificate shall conform to the format shown in Appendix 5 using BRC and accreditation
body logo usage rules.

The certificate shall 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.

All dates specified on the certificate shall be in the format of day, month, year, e.g. 11 November 2011.

The certificate will detail the scope of the audit as agreed in Section IV, 5.2 above and the hygiene
risk category.

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Where the audit has been undertaken by an auditor trained by the BRC who has been issued with a BRC
third-party auditor certificate, the BRC trained auditor logo may be added to the certificate and shall
comply with the BRC logo usage rules.

The date of audit specified on the initial certificate shall be the date of the audit relating to the granting
of that certificate (i.e. the date of the initial audit) irrespective of whether further audits were made to
verify corrective action arising from the initial audit.

The users of certificates are advised that they should verify that the scope of the certificate is clearly stated
and that this information is consistent with their own requirements.
Whilst the certificate is issued to the company, it remains the property of the certification body, which control
its ownership, use and display.

12.3 Appeals
The company has the right to appeal to the certification body against the certification decision of the
certification body and this should be made in writing within seven calendar days of receipt of the 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. The certification bodys documented appeals procedure will be made available to
suppliers 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.

13 Ongoing Audit Frequency and Certification


The ongoing audit schedule will be agreed between the company and the certification body. 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 Table 2.
If a factory changes significantly in any way (for example, a significant change of senior or technical
management, or production of different product types), then a re-audit will be required as soon as possible to
establish continuing conformity. This may be outside of the usual agreed frequency.
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, or to assess an
increase to audit scope, and not from the certificate issue date.
The subsequent audit shall be scheduled to occur within a 28-calendar-day time period up 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 as a result of internal audits, without jeopardising continued certification.
Table 2 provides worked examples in accordance with the 6- and 12-month audit frequencies.
It is the responsibility of the site to maintain certification. Where an audit is delayed beyond the due date, a
major non-conformity shall be raised in accordance with requirement clause 1.2.8/1.2.6. Where the audit is
delayed, the next audit due date and certificate expiry date shall be based on the initial audit dates and not
the delayed audit date.
Where sites leave the scheme for more than 6 months (for instance, because they no longer have customers
insisting on certification) and then decide to rejoin; the audit will be classed as an initial audit. This will not be
treated as a late audit and no penalty will be applied against requirement clause 1.2.8/1.2.6.

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Section IV Audit and Certification Process

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Table 2 Worked example of an initial audit followed by 6- and 12-month recertification audits
Audit

Event

Date

Initial audit
(audit 1)

Initial audit date

1 February 2012

Certificate issue
date

7 April 2012

Explanation

The company takes 54 days to submit all


corrective actions (90 days allowed as initial
audit)
The certification body takes 11 days to issue
the certificate (14 days allowed)

Recertification
audit (audit 2)

Certificate expiry
date

14 March 2013

Anniversary of the initial audit date plus 42


days

Re-audit due date

1 February 2013

12 months from the initial visit

Actual re-audit
visit

26 January 2013

Company is allowed a 28-day window


before the audit due date

Certificate issue
date

25 February 2013

The company takes 20 days to submit all


corrective actions (28 days allowed)
The certification body takes 10 days to issue
the certificate (14 days allowed)

Certificate expiry
date

14 September
2013
or

This is 6 or 12 months plus 42 days from the


initial audit date. This allows the site to take
the audit up to 28 days early without losing
time from the certificate.

14 March 2014
Recertification
audit due date

1 August 2013
or
1 February 2014

The company has corrected nonconformities and the certification body has
issued the certificate within the 42-day
window.

13.1 Certificate expiry justifiable circumstances


There will be some circumstances where the certificate cannot be renewed at the required frequency due
to the inability of the certification body to conduct an audit within the appropriate time frame. These
circumstances can include:

the site is situated in a specific country or an area within a specific country where there is government
advice to not visit and there is no suitable local auditor

the site is within a statutory exclusion zone

the site is in an area that has suffered a natural or unnatural disaster, rendering the site unable
to produce.

If the renewal of the certificate is prevented due to these exceptional circumstances, a major nonconformance will not be raised against clause 1.2.8/1.2.6. The Standard user may still decide to take products
from that site for an agreed time, as it may still demonstrate legal compliance by other means, such as risk
assessment and complaints records, which show that the site is still competent to continue production until
another audit can be arranged.

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13.2 Withdrawal from the scheme


While it is generally incompatible with the successful implementation of the scheme, it may be necessary
for a site to withdraw from the scheme. Should this occur, then a minimum of 6 months shall pass before a
site can begin the certification process. The site shall be required to undergo an initial audit and the date of
certification shall not be related to any previous certification.

14 BRC Logos and Plaques


Achieving BRC certification is something to be proud of. Companies that achieve certification
following audit are qualified to use the BRC logo on company stationery and other marketing
materials. The BRC has also introduced a high-quality plaque that certificated suppliers can
purchase to display in their offices to help celebrate their success. Information relating to the BRC
logo is available at www.brcdirectory.com.

15 Notification of Legal Proceedings


In 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 take any appropriate action.

16 The BRC Global Standards Directory


www.brcdirectory.com
The Global Standards Directory is an online searchable directory of certificated packaging, food, consumer
products, and storage and distribution companies. 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 provide key information to retailers and to improve the
management of the BRC Global Standards scheme. 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.

16.1 Directory functionality


Information about certificated suppliers is provided to the BRC by certification bodies. The Directory provides
the following publicly available facilities:

a searchable list of certificated companies including contact details, the Standard against which they are
certified, scope and website links

a searchable list of approved certification bodies, including local offices and contact details.

The Global Standards Directory provides additional functionality to key user groups including companies,
customers 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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Section V Management and Governance of the Scheme

SECTION V
MANAGEMENT AND GOVERNANCE OF
THE SCHEME

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Section V Management and Governance of the Scheme

Section V

Management and Governance of


the Scheme
1

Requirements for Certification Bodies

The Global Standard for Packaging & Packaging Materials 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.
The process of certification and accreditation is outlined in Figure 4.
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, which a
certification body must satisfy in order to gain approval.
As a minimum, the certification body must be accredited to ISO/IEC Guide 65/EN45011 by a national
accreditation body affiliated to the International Accreditation Forum and recognised by the BRC.
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 on 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 Standard, accreditation may not yet have been achieved. This is because the accreditation
process itself requires some audits to have been completed that will then be reviewed as part of the
accreditation audit of the certification body. The certification body must be able to conduct audits as part of
achieving accreditation and 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/EN45011 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

that a contract is in place with the BRC and all other contracted requirements have been met.

The acceptability of audit reports generated by certification bodies awaiting accreditation but meeting the
above criteria is at the discretion of individual specifiers.

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Supporting
documentation

International
accreditation
forum and regional
accreditation forums

ISO/IEC 17011
General requirements for
accreditation bodies

IAF guideline on the application of


ISO/IEC Guide 65:1996 (EN45011)

National
accreditation body

BRC guidelines for accreditation


bodies assessing certification
bodies for BRC Global Standards

ACCREDITATION
ISO/IEC Guide 65:1996 (EN45011)

Requirements for organisations


offering certification against
the criteria of the BRC Global
Standards

Certification body

CERTIFICATION

Company

Company

Company

BRC Global Standards website


www.brcglobalstandards.com

BRC Directory
www.brcdirectory.com

Figure 4 Process for accreditation of certification bodies


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Section V Management and Governance of the Scheme

Technical Governance of the Global Standard for Packaging


& Packaging Materials

The BRC/IOP Standard and associated scheme is managed 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 management and operation of the Standard is 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 Global Standards

ensure measures are in place to monitor compliance by companies, certification bodies and
accreditation bodies

oversee the review of the Standard at appropriate intervals.

2.2

Technical Advisory Committee

Each BRC Global Standard is supported by at least one Technical Advisory Committee (TAC) which meets
regularly to discuss technical, operational and interpretational issues related to the Standard. The BRC and The
Packaging Society provide the technical secretariat for these groups.
The TAC is made up of senior technical managers representing the users of the Standard and includes
representatives of retailers, packaging trade associations for each sector, certification bodies and independent
technical experts.
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 TAC, which is expanded for the purpose to include other available expertise.
The TAC also reviews auditor competence requirements, proposed training materials and supplementary
technical documents supporting the Standards.

Governance and Strategy Committee


Advises on policy, developments and scheme governance

BRC executive
Scheme management

Technical Advisory Committee


Multi-stakeholder group providing technical advice on scheme

Certification body cooperation groups


Issues of interpretation and consistency of the
Standard

Figure 5 Governance of the BRC schemes


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2.3 The certification body cooperation groups


The BRC encourages and facilitates meetings of the certification bodies participating in the scheme
(cooperation groups) to discuss matters arising on the implementation of the Standard and discuss issues of
interpretation. These groups report regularly to the BRC on operational issues, implementation and suggested
improvements. Representatives from the cooperation groups attend the TAC meetings.

Achieving Consistency Compliance

The BRC scheme may only be certificated by certification bodies registered and approved by the BRC
and accredited by a BRC-recognised accreditation body. The BRC recognises that the quality of the audits
undertaken, the consistency of assessment of the application of the requirements, and the standards of
performance in the management of the certification process are all essential to the confidence of users of
the scheme.
To support the Standard, the BRC runs a compliance programme which reviews the performance
of the certification bodies, samples the quality of audit reports and levels of understanding of the
scheme requirements, and investigates any issues or complaints. As part of this programme, the BRC
provides feedback on the performance of each certification body through a key performance indicator
programme.
On occasions the BRC may audit the offices of certification bodies and accompany auditors on audits at sites
to observe the performance of auditors.

3.1 Calibrating auditors


A key component of the scheme is the calibration of the auditors to ensure a consistent understanding and
application of the requirements. All certification bodies are required to have processes to calibrate their own
auditors. An essential element of the training and calibration of auditors is the witnessed audit programme.
Auditors are observed during an audit and provided with feedback on the performance of the audit. In order
to ensure consistency between certification bodies and for the purposes of accreditation, an audit may be
witnessed by a BRC/IOP representative or accreditation body auditor. Guidelines apply to these activities to
ensure that sites are not disadvantaged by the presence of two auditors. This process forms an essential part
of the scheme and sites are obliged to permit witnessed audits as part of the conditions for certification.

3.1.1 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. Feedback
provides a valuable input to the BRC monitoring programme for certification body performance.

3.2 Complaints and referrals


The BRC has implemented a formal complaint and 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).

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Appendices

APPENDICES

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Appendices

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 manufacture of
food and consumer products, the packaging used to protect the products, and the storage and distribution of
these products.
The BRCs Global Standard for Packaging & Packaging Materials is an auditing standard that lays down the
requirements for the manufacturing of packaging materials used for food and consumer products. Food and
non-food businesses may request this from their suppliers of packaging.
The Global Standard for Food Safety is an auditing standard that is applicable to the production of food.
This was the first BRC standard and is the most mature of the BRC Global Standards. It is now used in the
food industry worldwide, and is also applied to products closely related to food, such as pet foods, vitamins,
minerals and herbal supplements.
The Global Standard for Consumer Products is an auditing standard applicable to the manufacture and
assembly of consumer products.
The BRCs Global Standard for Storage and Distribution is an auditing standard that sets out the requirements
for the storage, distribution, wholesaling and contracted services for packaged and unpackaged food
products, packaging materials and consumer goods. The standard is not applicable to storage facilities under
the direct control of the production facility management, which is covered by the relevant manufacturing
standard. In the case of packaging materials, these would be covered by this Standard.

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Appendix 2

Examples of Packaging Categories


Further examples may be found on the Global Standards website: www.brcglobalstandards.com.
Users are advised to cross-refer against the decision tree (Figure 2).
It must be stressed that this is not an exhaustive list and only provides examples. The final packaging
category determination should be agreed between the company and their customer and discussed with the
certification body.

High Hygiene Risk


This category applies to packaging manufacturers producing packaging used for products where particularly
high standards of hygiene are required in the production of the packaging material.

Direct contact with products that are consumed or applied to the skin

Plastic film laminate for cooked/uncooked meats

Plastic film for bread

Plastic laminate for toothpaste tube

Lipstick case mechanism

Caps for bottles of mouthwash

Packaging for facial wet wipes

Tube for eyeliner

Tub for baby ointment

Caps for bottles of shampoo

Packaging for sanitary products or baby nappies/diapers

Skincare product containers

Packaging that is in direct contact with a food product that has a natural barrier

Corrugated case used for packing bananas or avocados

Moulded pulp/expanded polystyrene box for eggs

Low Hygiene Risk


This category applies to packaging manufacturers producing packaging for products that are less vulnerable
to hygiene risk.

Packaging that will be used for a product that is already in an impermeable pack

Labels used for any product in plastic/glass jars or metal cans

Corrugated case for film over wrapped biscuits where the case is filled in a different area to the
biscuit wrapping

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Appendices

Packaging for products that are not consumed or applied to the skin

Clothing (coat hangers or shirt bags)

Textiles (sheets, oven gloves or curtains)

Homeware (pots/pans, cutlery or crockery)

Household products (kettles, toasters or china ornaments)

DIY products (chisels, screws, curtain rails or mastic)

Automotive products

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Appendix 3

Registration, Qualifications, Training and


Experience Requirements for Auditors
All auditors conducting audits against the BRC Global Standard for Packaging & Packaging Materials
are required to be registered with the BRC. The registration process identifies that auditors have undergone
the required training and identifies the fields of packaging in which they have expertise. Evidence of an
auditors 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 onto the
BRC Directory.
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 that processes are in place to monitor and maintain
the competence of the auditor to the level required by the Standard.
The BRC publishes a detailed guide to registered certification bodies on auditor competency requirements;
expectations of the initial assessment of auditor competence; ongoing training; and assessment procedures.
This is reviewed and updated periodically by the Technical Advisory Committee. The following outlines the
requirements of auditors who may be registered to audit against the Standard.

1 Education
Auditors will be drawn generally from two distinct disciplines: those with expertise and a qualification in food
or biosciences, and those with expertise and a qualification in packaging technology. This main qualification
will be supported by a minimum secondary qualification in the other disciplines as appropriate. Where
equivalence of qualification is unclear, this shall be referred to the BRC for review.
The auditor shall have:

a degree or diploma in packaging and have successfully completed a food safety/hygiene qualification at
least equivalent to a UK Level 3 qualification (see www.brcglobalstandards.com for information), or

a degree or diploma in a food or bioscience-related discipline and have successfully completed the PIABC
EQIPT examination in packaging.

Work Experience

The auditor shall have a minimum of three years post-qualification experience related to their main
qualification discipline. This shall involve work in quality assurance, technical management or risk
management functions within manufacture, retailing, inspection or enforcement, and the auditor shall be
able to demonstrate an understanding and knowledge of specific fields of packaging for which they are
approved. The verification to carry out work within specific fields of packaging will be carried out by the
certification body.

3 Qualifications
The auditor must have:

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passed a registered management system lead assessor course (e.g. IRCA) or the BRC third-party auditor
course delivered by a BRC-approved trainer

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Appendices

completed a training course in HACCP, based on the principles of Codex Alimentarius, of at least
two days duration, or be able to demonstrate competence in the understanding and application of
HACCP principles. It is essential that the HACCP course is recognised by the industry as being
appropriate and relevant.

Audit Training

Auditors must have successfully completed a period of supervised training in practical assessment including
witnessed assessment of a minimum of three audits at a variety of organisations against the Standard.
Certification bodies must be able to demonstrate that every auditor has appropriate training and experience
for the particular fields, for which they are considered competent. Auditor competence shall be recorded at
the level of each field of audit as indicated in Appendix 4.
Certification bodies must establish a training programme for new auditors, which will incorporate:

a Global Standard for Packaging & Packaging Materials awareness course delivered by a
BRC-approved trainer

a period of initial training covering product safety, hazard and risk management, and prerequisite
programmes that will include access to relevant laws and regulations

a period of supervised training to cover management systems, audit techniques and specific fields of
audit knowledge

assessment of knowledge and skills for each packaging field

documented sign-off on the satisfactory completion of the training programme.

Each auditors training programme shall be managed and approved by an assessor who can demonstrate that
they are technically competent in the packaging fields in which training is given.
Full detailed training records of the individual must be maintained by the certification body throughout the
term of employment, and retained for a minimum period of five years after leaving the employment of the
certification body.

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Appendix 4

Fields of Audit for Packaging and


Packaging Materials
Packaging field

Typical packaging components/materials/articles

Glass

Glass bottles, jars and decanters


Ceramic bottles, jars and decanters

Paper

Paper bags
Paper sacks
Paper labels, tags and neck collars
Board cartons
Board sleeves
Chipboard cartons and layer pads
Corrugated cases and trays
Corrugated fitments

Metals

Cans
Aerosol containers
Tubes
Closures
Aluminium foil
Foil trays

Plastics

Bottles and jars


Caps and closures
Thermoformed trays
Tubs and pots
Adhesives
Buckets and pails
Bulk containers
Plastic film, including vacuum metallised films, and labels
Multi-ply laminates of combinations of paper, plastics and aluminium foil
Flexible intermediate bulk containers

Wood and other materials

Pallets
Boxes and crates
Decorative wooden boxes
Natural cork
Wood for food and cosmetic use
Hessian sacks
Wooden utensils

Composites shall be categorised by the component that contributes the highest percentage composition of
the product.

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Appendices

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Appendix 5

Certificate Template
Trained thirdparty auditor
logo

CERTIFICATIOn BOdY nAME OR LOGO

Auditor number

This is to certify that


COMPAnY nAME
SITE AddRESS
BRC SITE COdE

has been audited by certification body name and accreditation body registration number
and found to meet the requirements of
GLOBAL STAndARd FOR PACKAGInG & PACKAGInG MATERIALS
ISSUE 4: February 2011

And has been found to meet its requirements for category:


GRAdE ACHIEVEd
SCOPE
Exclusions

Date of audit:
Certificate issue date:
Re-audit due date:
Certificate expiry date:

Authorised by

Accreditation
body logo

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Name and full address of certification body

BRC logo

This certificate remains the property of (name of certification body)

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Appendix 6

Examples of Records that should be Kept


Records shall be maintained in order to demonstrate that technical and hygiene procedures have been
followed. Records shall include as a minimum, the following:

hazard and risk management plan and verification

records supporting product compliance and suitability for food/cosmetics/toiletries (including the
presence and extent of recycled content) use

management review

training

internal auditing

traceability

supplier monitoring

results of any product analysis

cleaning schedules and cleaning records

instances of foreign-body contamination

receipt and investigation of customer complaints

pest control reports and records

maintenance and engineering work

control of glass and brittle plastics

control of blades and sharp objects

product recall test and any actual recalls

non-conforming goods

calibration of equipment.

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Appendices

Appendix 7

Glossary
Accreditation

Procedure by which an authoritative body gives formal recognition of the


competence of a certification body to provide certification services against a
specified standard.

Audit

A systematic examination to measure compliance of practices with a predetermined


system, whether the system is implemented effectively and is suitable to achieve
objectives, carried out by certified bodies.

Brand owner

The owner of a brand logo or name who places the said logo or name on to
retail products.

Branded product

Products bearing the logo, copyright or address of a company that is not a retailer.

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.

Certificate
suspension

Where certification is revoked for a given period, pending remedial action on the
part of the company.

Certificate
withdrawal

Where certification is revoked indefinitely.

Certification

Procedure by which accredited certification bodies provide written assurance


that a company conforms to a standards requirement, based upon an audit and
assessment of a companys competence.

Clause

A group of requirements and statement of intent that a site must comply with in
order to achieve certification.

Company

The business name and the site seeking certification against the Global Standard for
Packaging & Packaging Materials.

Consumer

The end user of an item, commodity or service.

Contamination

The action of making impure or hazardous. (Contaminant that which


contaminates, usually physical, chemical or microbiological in nature.)

Contractor or
supplier

A person or organisation providing services or materials.

Control

To manage the conditions of an operation to maintain compliance with established


criteria, and/or the state wherein correct procedures are being followed and criteria
are being met.

Corrective action

Procedure to be followed when a system requirement is not met.

Customer/client

A person or organisation that acquires, or intends to acquire, ownership of


the product.

Exemption

A requirement that may not be applicable to a product, or product sector, and


verified by hazard and risk analysis.

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Good hygiene
practice

The combination of process, personnel and/or service control procedures


intended to ensure that product and/or services consistently achieve appropriate
levels of hygiene.

Good
manufacturing
practice

The combination of manufacturing and quality control procedures aimed at


ensuring that products are consistently manufactured to their specifications.

Hazard

The potential to cause harm; may be a biological, chemical or physical entity.

High-risk product

Those products intended for human consumption or that will come into close
contact with the body, such as application to the skin, or are intended for infants.

Hygiene

All measures necessary to ensure the wholesomeness, quality and safety of an


entity that might otherwise be hazardous.

Hygiene-sensitive
product

Those products intended for human consumption or that will come into close
contact with the body, such as application to the skin, or are intended for infants.

Incident

An event that has occurred that may result in the production or supply of unsafe,
illegal or non-conforming products.

Initial audit

The first Global Standard for Packaging & Packaging Materials audit at a
company/site.

Inspection

A systematic examination involving professional judgement to determine


acceptability against a specified standard.

Internal audit

General process of audit, for all the activity of the company. Conducted by or on
behalf of the company for internal purposes.

Legality

Meeting all relevant legislation in the country (or countries) where the product(s) is/
are intended to be sold.

Non-conformity

The non-fulfilment of specified product quality, legal or safety requirements or a


variation from a procedure, practice or performance standard.

Positive release

Ensuring a product or material is of an acceptable standard prior to release for use.

Primary packaging

That packaging which constitutes the unit of sale, used and disposed of by the
consumer, e.g. bottle, closure.

Product integrity

The ability of the packaging material to provide an effective protective barrier for
the product it is designed to contain.

Product recall

The removal of unsafe, out-of-specification or illegal products from the supply


chain. This includes products in the possession of the consumer.

Product
withdrawal

Any measures aimed at achieving the return of out-of-specification or unfit


products from customers, but not from final consumers.

Quarantine

The status given to any material or product set aside while awaiting confirmation of
its suitability for intended use or sale.

Raw material

Any base material or semi-finished material used by the organisation for the
manufacture of a product.

Requirement

Those statements comprising a clause with which compliance will allow sites to
be certificated.

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Retailer

A business selling products to the public by retail.

Retailer-branded
product

Products bearing a retailers logo, copyright, address, or products that are legally
regarded as the responsibility of the retailer.

Risk

The likelihood of occurrence of harm from a hazard.

Safety

Freedom from unacceptable risk or harm.

Schedule

A tabulated statement giving details of actions and/or timings.

Secondary
packaging

Packaging that is used to collate and transport sales units to the retail environment,
e.g. corrugated case.

Senior
management

Those with strategic/high-level operational responsibility for the company.

Shall

Is a requirement to comply with the contents of the clause.

Site

The area (and its boundaries) containing the activity being audited.

Specification

An explicit or detailed description of a material, product or service.

Specifier

A retailer, food service company, agent, wholesaler or direct customer of the


packaging manufacturer who may specify compliance to this Standard.

Standard, the

Global Standard for Packaging & Packaging Materials, Issue 4.

Subcontractor

A firm, company or individual carrying out a process on products on behalf of the


site being certificated to this Standard.

Tertiary
packaging

Also known as transport packaging, used to facilitate the handling and transport of
products, e.g. pallets and stretchwrap.

Testing

A technical operation that consists of the determination of one or


more characteristics of a given product, process or service according to a
specific procedure.

Traceability

Ability to trace and follow raw material intended, or expected, to be incorporated


into packaging through all stages of production, processing and distribution,
including from the supplier and on to the intended customer.

User

The person or organisation who requests information from the company


regarding certification.

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 have been fulfilled.

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Appendices

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Appendix 8

Acknowledgements
The British Retail Consortium and The Packaging Society are grateful to the members of the BRC/
The Packaging Society Working Group who prepared this document.
John Bentham

Printpack Ltd

David Brackston

BRC Trading Ltd

Alan Campbell

Campden BRI

Adam Chappell

SAI Global Assurance Services Ltd

Phil Davidson

Smurfit Kappa UK

Roy Dixon

The Packaging Society

Henry Emblem

The Packaging Society

Iain Ferguson

The Co-operative

Mark Gallen

The John Lewis Partnership

Duncan Goodwin

NSF-Cmi Ltd

Joanna Griffiths

BRC Trading Ltd

Graham Hardcastle

British Glass

Martin Hodgson

British Glass

Clive Manvell

NSF-Cmi Ltd

Neil Milvain

SGS

Andrew Parkin

Sainsburys Supermarkets Ltd

John Revell

Exova (UK) Ltd

Terry Robins

Robins Packaging Consultants Ltd

Gordon Stewart

The Packaging Society

Christopher Suter

Royal Society for Public Health Certification

Terence Wilde

Tesco

Liz Wilks

Sustainability Eco Limited

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Appendices

The British Retail Consortium and The Packaging Society are also pleased to acknowledge the helpful
contributions provided by individuals and organisations from across the globe.

Bart Baelus

Van Genechten Packaging, Belgium

Hans Bjrck

Korsns, Gvle, Sweden

Paolo Confalonieri

DNV, Italy

Kath Cotterill

Boxes GH Ltd, UK

Christine Floeter

TUV Nord, Germany

Ralph Geyer

Hygenius Consultancy, Germany

DI Alfred Greimel

qualityaustria, Austria

Dr Ahmed Hammad

ISOQAR, Egypt

Vivi Konetes

HJ Heinz

Niek Oosterkamp

IsaCert

Glenn Pike

DS Smith Packaging, Rawcliffe, UK

Txomin Echarri Sucunza

SCA Packaging Bertako, Spain

Adriano Zamarian

Taghleef Industries SpA., Italy

Intertek, UK
Knight International
QA International Certification Ltd, UK
SAI Global
TUV Rheinland, Germany

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ISBN 978-1-78490-169-1

9 781784 901691

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