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    Issue4

    BRC/IOP

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    February 2011

    British Retail Consortium

    ISSUE 4

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    BRC Global Standards Liabilityand 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 Safetyand the terms of the disclaimer set out above shall be construed in accordance with English law and

    shall be subject to the non-exclusive jurisdiction of the English Courts.

    Copyright

    British Retail Consortium 2011

    All rights reserved. No part of this publication may be transmitted or reproduced in any form (including photocopying or storage in any

    medium by electronic means) without the written permission of the copyright owner. Application for permission should be addressed to

    the Commercial Director of Global Standards at the British Retail Consortium, contact details below. Full acknowledgement of author and

    source must be given.

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

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

    For more information about BRC, contact

    British Retail Consortium

    Second Floor

    21 Dartmouth Street

    London

    SW1H 9BP

    Tel: +44 (0) 20 7854 8900

    Fax: +44 (0) 20 7854 8901

    email: [email protected]

    website: www.brcglobalstandards.com

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    BRC Global Standard for Packaging & Packaging Materials

    BRC/IOP iii

    Further information available at www.brcglobalstandards.com

    Contents

    Section I Introduction 1

    1 Background 3

    2 The Scope of the Standard (Issue 4) 3

    3 Principles of the Standard 4

    3.1 Senior management commitment 4

    3.2 A risk-based system 4

    3.3 Quality management system and suitable operating conditions 4

    4 Benefits of the Standard 4

    5 The Certification Process 5

    6 The British Retail Consortium/The Packaging Society 5

    7 Acknowledgements: A Thank You from the BRC and IOP 5

    Section II Preparation and Planning for Success 7

    1 Preparation Time 9

    1.1 For specifiers 9

    1.2 For packaging manufacturers 9

    2 Product Categories 11

    Section III Requirements 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

    10.1 Suspension or withdrawal of certification 76

    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

    16.1 Directory functionality 80

    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 100

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    1

    Section I IntroductionFurther information available at www.brcglobalstandards.com

    BRC/IOP

    SECTION I

    INTRODUCTION

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    Section I IntroductionFurther information available at www.brcglobalstandards.com

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    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.

    2 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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    3 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 undersuitable hygienic conditions.

    4 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 customerrequirements 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 IntroductionFurther information available at www.brcglobalstandards.com

    BRC/IOP

    5 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 .

    6 The British Retail Consortium/The Packaging Society

    The BRC is the trade association representing retailers in the UK. The Packaging Society (a division ofthe 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.

    7 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 havecontributed is detailed in Appendix 7.

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

    BRC/IOP

    SECTION II

    PREPARATION AND PLANNING

    FOR SUCCESS

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    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 1Learn

    Stage 3Preparation

    Stage 5Audit and

    certification

    Stage 2Plan

    Stage 4Pre-assessment*

    Stage 6Maintenance

    Visit the BRC website www.brcglobalstandards.com

    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 assistunderstanding of the requirements

    Establish the audit category for certification

    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)

    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)

    Select suitable CB

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

    Implement any identified corrective actions

    Arrange an audit visit with an appropriate CB

    Ensure adequate preparations have been made and that senior

    management staff are available

    Audit is conducted

    CB presents audit report

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

    Achieve certification and gain entry onto the BRC directory

    Continue to meet requirements

    Arrange audit visit before certificate expiry

    Continuous improvement

    Figure 1 Steps towards certification

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    2 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. fordirect 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 hygiene-

    sensitive products where there is no absolute barrier in place.

    Low hygiene riskPackaging 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 theircustomer. 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 [email protected].

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    Figure 2 Decision tree for determining packaging category

    Is the packaging

    intended for a food

    product or hygiene-

    sensitive product, e.g.

    cosmetic product?

    Is the packaging

    intended for direct

    contact with a food

    or hygiene-sensitive

    product?

    Is the product already

    in packaging that

    provides an absolute

    barrier?

    No High hygiene risk

    Low hygiene risk

    No

    Yes Yes High hygiene risk

    Category

    Yes

    Review the use of

    the packaging, or

    packaging product

    group

    No

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

    BRC/IOP

    SECTION III

    REQUIREMENTS

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    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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    BRC/IOP 17

    Further information available at www.brcglobalstandards.com 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*). Thisincludes 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 andContinual Improvement

    1.1 Product safety and quality management policy

    The companys senior management shall develop and document a product safety andquality policy, which is authorised, reviewed, signed and dated by an appropriatesenior 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 Senior management commitment

    FUNDAMENTAL

    The companys senior management shall demonstrate that they are fullycommitted to the implementation of requirements of the Global Standard

    for Packaging & Packaging Materials. This shall include provision of adequateresources, effective communication and systems of management reviewto effect continual improvement. Opportunities for improvement shall beidentified, 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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    Further information available at www.brcglobalstandards.com Section III Requirements

    1.3 Organisational structure, responsibilities andmanagement 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 isundertaken to ensure that the product safety and quality programme is fullyimplemented, 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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    2

    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 andmanage 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 appropriatecontrols 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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    Further information available at www.brcglobalstandards.com 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. Thehazards 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 finalproduct 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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    Further information available at www.brcglobalstandards.com Section III Requirements

    3

    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 theStandard are met. These requirements shall be fully implemented, reviewed atappropriate 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 reviewThe companys senior management shall ensure that processes are in place todetermine customer needs and expectations with regard to quality and safety andensure 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 appropriatedocumented 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 Internal audits

    FUNDAMENTAL

    The company shall audit those systems and procedures which cover therequirements 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 non-

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

    3.5 Subcontracting of production

    Where production processes are subcontracted this shall be with the agreement ofcustomers. Procedures shall be in place for the effective control of subcontractors andthe 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 andrecording forms critical to the management of product safety, legality and quality arein 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 forraw materials, intermediate and finished products, and any product or

    service which could affect the integrity of the finished product andcustomer 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 productsafety, 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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    Further information available at www.brcglobalstandards.com Section III Requirements

    3.9 Traceability

    FUNDAMENTAL

    The company shall have a system in place to identify product batches andto trace and follow all raw materials through processing to the distribution

    of the finished product to the customer. Records shall be retrievable in atimely 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 managementof 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 withdrawalsand 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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    BRC/IOP 29

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

    4

    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 andshall be designed, constructed, maintained and monitored to effectively control therisk 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 ofproduct 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 productsand 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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    Further information available at www.brcglobalstandards.com Section III Requirements

    4.5 Layout and product flow

    Premises and plant shall be logically designed, constructed and maintained. Proceduresshall be in place to control the risk of product contamination and to comply with allrelevant 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 bemaintained 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 ofequipment 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 workand 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 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. Suchfacilities 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 indesignated 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 Housekeeping and cleaning

    FUNDAMENTAL

    Housekeeping and cleaning systems shall be in place, which ensurethat 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 andother 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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    4.11 Pest control

    The company shall be responsible for minimising the risk of pest infestation onthe 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 productsshall be undertaken in a manner to minimise the risk of contamination ormalicious 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 hygiene-

    checking 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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    5

    Product and Process Control

    5.1 Product design and development

    Product design and development processes shall be in place to ensure the productionof 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 Packaging print control

    Where packaging is printed with allergen/safety/legal information, procedures shallbe in place to ensure that the information is fully legible and correctly printed to thecustomers 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 stan