BRC Global Standard for Consumer Products General Merchandise Issue 4 UK Free PDF

July 23, 2017 | Author: Raluca Dudescu | Category: Audit, Tort, Safety, Quality Management System, Damages
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BRC Global Standard for Consumer Products General Merchandise Issue 4 UK Free PDF...

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GLOBAL STANDARD

CONSUMER PRODUCTS GENERAL MERCHANDISE

ISSUE 4

GLOBAL STANDARD

CONSUMER PRODUCTS

GENERAL MERCHANDISE

BRC TRADING LIMITEDNOVEMBER 2016

ISSUE 4

LIABILITY BRC Trading Limited publishes information and expresses opinions in good faith, but accepts no liability for any error or omission in any such information or opinion, including any information or opinion contained in this publication. Whilst BRC Trading Limited has endeavoured to ensure that the information in this publication is accurate, it 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 permied by law, excluded. Nothing excludes or limits the liability of BRC Trading Limited for death or personal injury caused by its negligence, for fraud or fraudulent misrepresentation or for any maer which it would be illegal for it to exclude or aempt to exclude liability for. The Global Standard for Consumer Products Issue 4 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 © BRC Trading Limited 2016 All rights reserved. No part of this publication may be transmied or reproduced in any form (including photocopying or storage in any medium by electronic means) without the wrien permission of the copyright owner. Application for permission should be addressed to the Operations Director of Global Standards at BRC Trading Limited (contact details below). Full acknowledgement of the author and source must be given. The contents of this publication cannot be reproduced for the purposes of training or any other commercial activity. No part of this publication may be translated without the wrien 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: BRC Trading Limited 2 London Bridge London SE1 9RA Tel: +44 (0) 20 7854 8900 Fax: +44 (0) 20 7854 8901 Email: [email protected] Website: www.brcglobalstandards.com

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CONTENTS

How this publication is organised

iv

PART I INTRODUCTION PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS How the requirements are set out Fundamental requirements 1 Senior management commitment 2 Product risk management 3 Product safety and quality management 4 Site standards 5 Product inspection and testing 6 Process control 7 Personnel

9 9 10 12 14 21 26 28 34

PART III AUDIT PROTOCOL Introduction 1 General protocol – audit preparation 2 General protocol – foundation and higher levels 3 General protocol – post audit

38 40 42 49

PART IV MANAGEMENT AND GOVERNANCE Requirements for certification bodies Technical governance of the Standard Achieving consistency – compliance

54 54 56

APPENDICES Appendix 1 Registration, qualifications, training and experience requirements for auditors Appendix 2 Product categories Appendix 3 Multiple sites audit protocol Appendix 4 Certificate template Appendix 5 Other BRC Global Standards Appendix 6 Glossary Appendix 7 Acknowledgements

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60 62 66 69 70 71 80

III

HOW THIS PUBLICATION IS ORGANISED

This publication sets out the requirements for the auditing and certification of manufacturers of consumer products in order for them to achieve certification for the BRC Global Standard Consumer Products Issue 4. The document consists of the following parts:

PART 1 INTRODUCTION Provides an introduction and background to the development and benefits of the scheme. It also defines the scope and the types of product and operations which may be certificated against the Standard.

PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS Details the requirements of the Standard with which a company and site must comply in order to gain certification.

PART III AUDIT PROTOCOL Provides information on the audit process and rules for the awarding of certificates. It details the different certification programmes available within the Standard as well as information on logos and the BRC Global Standards Directory.

PART IV MANAGEMENT AND GOVERNANCE Describes the management and governance systems in place for the Standard and for the management of certification bodies registered to operate the scheme.

APPENDICES The appendices provide other useful information, including auditor competency requirements, product categories and a glossary of terms.

IV

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PART I INTRODUCTION BENEFITS OF THE NEW ISSUE 2

Additional voluntary modules

THE SCOPE OF THE STANDARD 3 3 3

Scope of operations Scope of products Exemptions on the basis of risk

PRINCIPLES OF THE STANDARD 4 4 4

Senior management commitment Product risk management Product and quality management system

A REGULATORY FRAMEWORK FOR SAFE CONSUMER PRODUCTS 4

Product safety legislation

THE CERTIFICATION AND AUDIT PROCESS

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PART I INTRODUCTION

Welcome to the fourth issue of the Consumer Products Standard. This Standard was first published in 2003 and since then it has undergone extensive changes to support the needs of the wide-reaching consumer products industry. Along the way it has developed into a robust Standard based on the principles of risk assessment and good manufacturing practice (GMP) to deliver safe, legal products of specified quality to the end-consumer. Issue 4 brings a marked change in structure in the requirements, to reflect the needs of the market. It is composed of two new Standards: Personal Care and Household, and General Merchandise. Each Standard is composed of requirements that can be certificated at two levels: foundation and higher. Personal Care and Household covers formulated and fabricated products which typically have higher hygiene requirements due to the nature and usage of products. Examples include cosmetics, medical devices, nappies, food wrap and household cleaners. General Merchandise covers a wide range of mainly fabricated products where management of the production process to ensure the safety and quality of the products is the primary concern. Examples include electrical equipment, toys, furniture, textiles and jewellery.

BENEFITS OF THE NEW ISSUE The benefits of Issue 4 include: ○ ○ ○ ○ ○ ○ ○ ○

a simplified process and approach introduction of a more risk-based approach to the requirements assurance that the Standard meets the actual buying expectations of specifiers whilst encouraging continual improvement introduction of two levels of certification – foundation and higher – to recognise manufacturers with compliant production systems and to allow continual improvement introduction of interim reporting to speed up information transfer to potential customers a widening of the scope from manufacturers and assembly packers to include raw material and component suppliers and products not for direct retail sale (e.g. wholesale) a revised auditor selection programme to further enhance competency and consistency provision for additional voluntary modules to reduce multiple audits.

ADDITIONAL VOLUNTARY MODULES Issue 4 has been developed to enable the incorporation of additional voluntary modules which sites can elect to include with the audit. The BRC will continue to develop such modules and make these available on its website in response to market needs. It is expected that this flexibility will enable sites to meet regional or specific customer expectations and reduce the number of site audits and site visits.

THE SCOPE OF THE STANDARD The Standard sets out the requirements for the production and supply of safe and legal consumer products of consistent quality. The products may be retailer-branded (private label), branded or unbranded for use by other organisations. The Standard is a product safety and quality management standard. It does not encompass other important requirements applicable to manufacturing sites such as workplace health and safety, environmental concerns, sustainability, security or ethical trading issues.

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PART I INTRODUCTION

Compliance with the requirements of the Standard provides assurance that the factory processes take account of safety, legality and quality and that the products produced have met any legal or customer-required conformity assessment measures. The Standard does not result in a product safety mark being placed onto products and does not replace or conflict with established technical product standards. SCOPE OF OPERATIONS The Standard applies to manufacturing sites of raw materials (excluding packaging) and of finished products for business to business or for retail sale to consumers. It includes the activities of contract or assembly packers of consumer products. It does not apply to activities relating to wholesale, importation, distribution or storage outside the direct control of the site. The Standard does not apply directly to importers and cannot be used to assess importers’ operations. Importers may find it useful to request that their manufacturers should meet the requirements of the Standard, as this will help the importers to meet their responsibilities to import safe and legal products. SCOPE OF PRODUCTS The scope of the Standard is for non-food, manufactured products placed on the consumer market – in other words, sold or given to consumers. It may also be used by companies producing raw materials and components for consumer products. The General Merchandise Standard is designed to include products such as apparel, hair accessories, furniture, flooring, electrical appliances, DIY goods, toys and cookware. For a more extensive list of examples, see Appendix 2. Specific exclusions from the scope of the Standard are: ○ pharmaceuticals ○ vitamins, minerals and herbal supplements. The Standard shall be applied at the points of manufacture and subsequent storage and distribution which are under the control of the manufacturer, prior to delivery to the retailer or customer. The BRC has developed a series of Global Standards seing out the requirements for the wide range of activities undertaken in the production, packaging, storage and distribution of food or consumer products. Appendix 5 provides further details on the scope of, and relationships between, the current Global Standards. A company that meets the requirements of a satisfactory quality management system – for example, one conforming to that specified in ISO 9001 or ISO 22716 GMP Guidelines – may already meet many of the requirements of the Standard. It is in the interest of the company to bring these points to the aention of the certification body. The auditor will verify that the procedures are adequate for the purpose of compliance with this Standard. EXEMPTIONS ON THE BASIS OF RISK The requirements have been wrien to reflect expectations typical of the particular product categories across a range of process technologies (e.g. luggage, stationery). There may be occasions where a requirement is not appropriate in a particular operation. Some requirements may be excluded on the basis of risk; however, in each case a documented risk assessment must be provided for the auditor to evaluate. The final audit report will include comments on any clauses deemed to be not applicable or excluded on the basis of risk analysis. A technical audit of a manufacturing site, such as compliance with this Standard, forms only one part of the quality and safety measures necessary to supply consumer products, and the decision to request a company to supply a product rests with the individual specifier.

PRINCIPLES OF THE STANDARD A business must have a full understanding of the products produced, manufactured and distributed and have systems in place to identify and control hazards significant to the safety and legality of these products. The Standard is based on key components: senior management commitment, risk assessment of the product and the process, a systematic approach to managing identified risks, and the implementation of a quality management system with suitable operating conditions.

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SENIOR MANAGEMENT COMMITMENT Within a business, the safety, legality and quality of the products it produces must be seen as a cross-functional responsibility, involving many departments using different skills and expertise within the organisation. Effective management and control extends beyond technical departments and must involve commitment from production operations, engineering, distribution, management, procurement of raw materials, customer feedback and human resource activity such as training. The starting point for effective implementation of the Standard is the commitment of senior management to the development of an all-encompassing policy as a means to guide the activities that collectively ensure the production of safe and legal consumer products. PRODUCT RISK MANAGEMENT The Standard requires an evaluation of the risks that a product could present to the consumer when the product is used in an intended or reasonably foreseeable way, taking account of the potential users and interactions with other products. It also relies on the use of risk assessment principles to identify, manage and control potential risks in the manufacturing process. Note that, in the context of the Standard, risks relating to failure to meet legal or quality requirements must be considered, as well as those directly related to the safety of the consumer. PRODUCT AND QUALITY MANAGEMENT SYSTEM Documentation of the framework of management policies and procedures by which the organisation will achieve the requirements in this Standard (i.e. the quality management system) is essential. The organisation must also put in place the basic environmental and operational conditions necessary for the production of safe, legal products (i.e. suitable operating conditions).

A REGULATORY FRAMEWORK FOR SAFE CONSUMER PRODUCTS PRODUCT SAFETY LEGISLATION The Standard is not intended to replace the requirements of any specific legal statutes regarding product safety or quality which exist for an industry sector or product type. Demonstrating up-to-date knowledge of and compliance with these requirements forms part of the audit to the Standard. Neither does the Standard replace any need for compliance with individual product safety standards. The complexity of legislation related to product safety is increasing with regard both to general safety requirements and to product or material-specific requirements. It is essential that companies have a means of identifying, understanding and keeping up to date with legal statutes relevant to their products in the countries or regions of intended sale. Retailers in most countries are obliged to supply safe and legal products to their consumers and must take all reasonable precautions to ensure this. They also need to be able to demonstrate that they have taken adequate steps to meet such requirements. This obligation is usually shared to some extent with the manufacturer, importer or brand owner but, in the context of retailer-branded products, the retailer will carry the main responsibility. Ensuring that products are safe and legal involves a number of activities, one of which is verifying the technical competence of the product’s suppliers. For many years, retailers either undertook this activity themselves, verifying competence and performance against their own individual, internally developed standards, or they used third-party auditing and inspection bodies. To improve efficiency and consistency, the BRC brought together stakeholder groups to establish the basis for an updated technical standard for consumer products which could be independently audited and would serve retailers around the world. Companies must be aware of the following types of legislation and research and must keep up to date with the specific requirements for the products they manufacture. Companies should also ensure that any new legislation pertaining to safety or quality which is introduced between audit visits shall be introduced and complied with in a timely manner. Companies must be aware of: ○ general requirements to supply ‘safe’ products ○ product liability laws to provide product which is ‘fit for purpose’ and does not cause injury or harm ○ product-specific laws defining detailed safety, quality or other legal requirements; this also includes any obligations concerning declarations of conformity, traceability of products and any particular labelling and warning requirements ○ any requirements to manufacture under specific conditions such as good manufacturing practice (GMP) or a formal quality management system ○ laws concerned with materials or chemicals used in production, or likely to be present as contaminants of the products ○ the need for product data retention and any requirements regarding mandatory reporting or recall of unsafe goods

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There are voluntary or mandatory standards for many product types. Some of these standards relate to manufacturing specifications, whilst others are concerned with testing methods. Some standards have been made mandatory by government agencies and must be respected, but others are voluntary. It is generally advisable to follow national, regional or international standards when these are available, even if they are voluntary, since this is a straightforward way of demonstrating that products meet industry best practice for the aspects covered. If companies choose not to adopt voluntary standards, they should have alternative means of confirming that their products are safe and legal. In some countries there is a tradition of using such voluntary consensus standards supported by product certification schemes as the main method of meeting safety requirements.

THE CERTIFICATION AND AUDIT PROCESS When a site meets the requirements specified in the Standard, it may choose to be audited against the requirements and become a ‘certificated site’. The audits and certificates are site-specific, so companies with a number of manufacturing sites will need separate certification for each location. The Standard is a process and product certification programme in which businesses are certificated upon completion of a satisfactory audit by an auditor employed by an independent third party – the certification body. In order for a business to receive a valid certificate on completion of a satisfactory audit, it must first select a certification body approved by the BRC. The BRC lays down detailed requirements that a certification body must satisfy in order to gain approval, as well as specific requirements for auditors with regard to both auditing expertise and product sector knowledge. More information about the certification process and certification bodies is given in Parts III and IV of this Standard.

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PART I INTRODUCTION

○ any licensing or approvals systems needed to manufacture, import or sell products ○ laws concerned with the packaging provided for the products ○ voluntary codes of practice and standards.

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PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS HOW THE REQUIREMENTS ARE SET OUT 1 SENIOR MANAGEMENT COMMITMENT 1.1

Senior management commitment and continual improvement 1.2 Organisational structure, responsibilities and management authority

10 11

2 PRODUCT RISK MANAGEMENT 2.1 2.2 2.3 2.4

Legislation and safety requirements Product risk assessment Product labelling and claims Packaging materials

12 12 13 13

3 PRODUCT SAFETY AND QUALITY MANAGEMENT 3.1 Product safety and quality management system 3.2 Documentation control 3.3 Record completion and maintenance 3.4 Internal audit 3.5 Supplier approval and performance monitoring 3.6 Specifications and technical files 3.7 Corrective and preventive action 3.8 Control of non-conforming materials 3.9 Traceability 3.10 Complaint handling 3.11 Management of incidents, product withdrawal and product recall

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14 14 14 15 15 17 18 18 18 19 19

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4 SITE STANDARDS 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9

External standards Security Layout, product flow and segregation Building interiors Staff facilities Housekeeping and hygiene Waste and waste disposal Pest control Product storage, dispatch and transport

21 21 21 22 23 23 24 25 25

5 PRODUCT INSPECTION AND TESTING 5.1 Product inspection and laboratory testing 26 5.2 Quantity control 27 5.3 Product sample control 27

6 PROCESS CONTROL 6.1 6.2 6.3 6.4

Control of operations Equipment and equipment maintenance Product contamination control Calibration and control of measuring and monitoring devices 6.5 Final product packing and control 6.6 Stock control and product release

28 29 30 32 33 33

7 PERSONNEL 7.1 Training and competency 7.2 Protective clothing 7.3 Hygiene practices

8

34 34 35

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HOW THE REQUIREMENTS ARE SET OUT The requirements to be met for certification differ between the foundation level and higher level. Here, the requirements for the two levels are presented side by side. Each main section or subsection of the requirements in the Standard begins with a statement of intent. This sets out the expected outcome of compliance with the requirements of that section. This forms part of the audit and all sites must comply with the statements of intent. Below the statements of intent in the tables are more specific and detailed requirements (clauses) that, if applied appropriately, will help to achieve the stated objective of the requirement. All of the requirements shall form part of the audit for the applicable level, and must be complied with in order to achieve certification. Statement of intent (expected outcome of compliance with the requirements)

CLAUSE

FOUNDATION

HIGHER

1.1.1

Applicable only at foundation level

Applicable only at higher level

1.1.2

Applicable at both foundation and higher levels

FUNDAMENTAL REQUIREMENTS

FUNDAMENTAL Within the Standard certain requirements have been designated as ‘fundamental’ requirements. These are marked with the word ‘FUNDAMENTAL’ and denoted with the symbol pictured left. These requirements relate to systems that are crucial to the establishment and effective implementation of the Standard. The requirements deemed to be fundamental are: ○ ○ ○ ○ ○ ○ ○ ○ ○ ○

senior management commitment and continual improvement (1.1) product risk management (2) control and acceptance of incoming raw materials, components and packaging materials (3.5.2) corrective and preventive action (3.7) traceability (3.9) layout, product flow and segregation (4.3) housekeeping and hygiene (4.6) product inspection and laboratory testing (5.1) control of operations (6.1) training and competency (7.1).

Failure to comply with the statement of intent of a fundamental requirement (i.e. a major non-conformity) may lead to noncertification at an initial audit or withdrawal of certification at subsequent audits. A further full audit will be required to establish demonstrable evidence of compliance.

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PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

1 SENIOR MANAGEMENT COMMITMENT 1.1 SENIOR MANAGEMENT COMMITMENT AND CONTINUAL IMPROVEMENT FUNDAMENTAL The site’s senior management shall demonstrate they are fully commied to the implementation of the requirements of the Global Standard for Consumer Products and to processes which facilitate continual improvement of product safety and quality management.

CLAUSE

FOUNDATION

HIGHER

1.1.1

The site shall have an implemented policy which demonstrates the site’s intention to meet its obligation to produce safe and legal products to the specified quality and its responsibility to its customers. This shall be:

The site shall have a documented policy which states the site’s intention to meet its obligation to produce safe and legal products to the specified quality and its responsibility to its customers. This shall be:

○ authorised by the person with overall responsibility for the site ○ communicated to all staff.

○ authorised and signed by the person with overall responsibility for the site ○ communicated to all staff.

1.1.2

The site’s senior management shall ensure that clear objectives are defined to maintain safety and legality and improve the quality of products manufactured, in accordance with the site’s product safety and quality policy and commitment to implementing the requirements of this Standard. These objectives shall be clearly communicated to relevant staff and monitored, and results reported at least annually to site senior management.

1.1.3

The site shall have a programme of management meetings which enable product safety, legality or quality issues to be brought to the aention of senior management for resolution. Records of the minutes from these meetings shall be maintained.

Management review meetings aended by the site’s senior management shall be undertaken at appropriate planned intervals, at least annually, to review the site’s performance against the Standard and objectives set in clause 1.1.2. The review process shall include the evaluation of: ○ previous management review action plans and timeframes ○ results of internal, second-party and/or third-party audits (relevant to the scope of this Standard) ○ customer complaints and results of any customer feedback ○ product safety and quality incidents, corrective actions, out-of-specification results and non-conforming materials ○ output of review of the management of the systems for product risk assessment, changes in legal requirements and process performance ○ resource requirements. Records of the meeting shall be documented and used to revise the objectives. The decisions and actions agreed within the review process shall be effectively communicated to appropriate staff and actions implemented within agreed timescales.

1.1.4

The site’s senior management shall provide sufficient human and financial resources required to produce and improve products safely and in compliance with the requirements of this Standard.

1.1.5

Where the site is certificated to the Standard, it shall ensure that announced recertification audits occur on or before the audit due date indicated on the certificate.

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FOUNDATION

HIGHER

1.1.6

The site shall have a genuine hard copy or electronic version of the current Standard available with a position statement and be aware of any changes to the Standard or protocol that are published on the BRC website.

1.1.7

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

1.1.8

A system shall be in place to close out nonconformities raised with consideration of the root cause.

The site’s senior management shall ensure that the root causes of non-conformities identified at the previous audit against the Standard have been effectively addressed to prevent recurrence. A system shall be in place to close out nonconformities raised at internal, second-party and third-party audits, with consideration of the root cause.

1.2 ORGANISATIONAL STRUCTURE, RESPONSIBILITIES AND MANAGEMENT AUTHORITY The site shall have a clear organisational structure and lines of communication to enable effective management of product safety, legality and quality.

CLAUSE

FOUNDATION

HIGHER

1.2.1

The responsibilities for the management of activities which ensure product safety, legality and quality shall be clearly allocated and understood by the managers responsible.

The site shall have an up-to-date organisation chart for key staff demonstrating the management structure of the company. The responsibilities for the management of activities which ensure product safety, legality and quality shall be clearly allocated and understood by the managers responsible. There shall be clear evidence of who deputises in the absence of the responsible person.

1.2.2

The site’s senior management shall ensure that all employees are aware of their responsibilities. Where documented work instructions exist for activities undertaken, the relevant employees shall have access to these and be able to demonstrate that work is carried out in accordance with the instructions. A senior member of staff should be identified with responsibility and authority to stop production, if required.

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PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

CLAUSE

2 PRODUCT RISK MANAGEMENT FUNDAMENTAL The site shall have a management process in place to ensure that a risk assessment is completed on each product group to ensure safety, legality and quality in the regions of intended sale, where known.

2.1 LEGISLATION AND SAFETY REQUIREMENTS CLAUSE

FOUNDATION

HIGHER

2.1.1

The site shall have a system to demonstrate knowledge of all applicable legislation, product standards and product safety issues in the place of production and regions of intended sale of each product. This may be within the company or by use of external expertise.

2.1.2

If the site relies on information concerning product safety, quality and legality provided by their customer or a third party, it shall have a process in place to validate the credibility of the provider of the information and retain evidence of this validation.

2.1.3

The company’s senior management shall have a system in place to ensure that the site is kept informed of and reviews: ○ ○ ○ ○

changes in legislation scientific and technical developments industry codes of practice new risks to raw materials, components, packaging and finished product.

Any changes shall be implemented in a timely and controlled manner or as defined by legal requirements. Copies of applicable legislation, standards, codes of practice and similar documents shall be available to relevant staff.

2.1.4

2.2 PRODUCT RISK ASSESSMENT CLAUSE

FOUNDATION

HIGHER

2.2.1

A full assessment of the safety and legality of each product or product group shall be completed and be appropriate for the intended market. Records shall be available to demonstrate the safety and legality of each product.

The company shall ensure that a product hazard and risk assessment is undertaken for each product or product group. The assessment shall be documented and include:

Where the assessment has been completed by a service provider or by the customer, confirmation of the safety and legality of the product shall be available.

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○ a description of the product assessed (for example, approved samples or mock-ups, sample drawings, computer graphics, photographs, specification) ○ the intended use of the product and foreseeable abuse conditions ○ the hazards, the risk level for each hazard and whether the risk is acceptable ○ the date performed, name of the person responsible and the evidence from which the assessment was derived.

FOUNDATION

HIGHER If the assessment indicates that a product may present an unacceptable risk to consumers, that product shall not be produced by the site. If the product requires modification, a new risk assessment shall be completed on the modified design.

2.2.2

The assessment shall be undertaken by suitably trained and competent internal or external resources. Evidence of this shall be available unless the assessment is provided by the customer.

2.2.3

The site shall determine and maintain up-to-date information about the legislation and mandatory standards applicable to each product and to the materials from which it is made, relevant in the regions of intended sale. The risk assessment shall be reviewed, at least annually, to ensure that the assessment remains up to date, takes account of complaints or incidents with the product or similar products and reflects any changes in specification, manufacturing process and legislation.

2.2.4

The assessment shall be reviewed whenever changes occur to specification, legislative requirements or in response to significant changes in production methods, complaints or incidents with the product or similar products.

2.2.5

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

2.2.6

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

2.3 PRODUCT LABELLING AND CLAIMS CLAUSE

FOUNDATION

HIGHER

2.3.1

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

2.3.2

The site shall have a process in place to ensure that any claims made about a product shall be fully validated to ensure that products meet the stated claim.

2.3.3

Where applicable, the site shall ensure that product-in-use evaluation (internal or external), reliability trials and shelf-life tests are validated. It shall be verified that the production of a safe and legal product is maintained, taking account of the category of consumers at risk.

2.4 PACKAGING MATERIALS CLAUSE

FOUNDATION

2.4.1

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

HIGHER

protecting the product from damage maintaining product integrity protecting the consumer from injury preventing contamination.

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PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

CLAUSE

3 PRODUCT SAFETY AND QUALITY MANAGEMENT 3.1 PRODUCT SAFETY AND QUALITY MANAGEMENT SYSTEM The site’s processes and procedures to meet the requirements of this Standard shall allow consistent application, facilitate training, and support due diligence in the production of a safe and legal product to agreed quality.

CLAUSE

FOUNDATION

HIGHER

3.1.1

The site shall have an established quality management system (QMS) in place which is appropriate to the size of business and risk associated with the products. The QMS shall be fully implemented, collated in a navigable and readily accessible way, and translated into appropriate languages if necessary.

3.2 DOCUMENTATION CONTROL The site shall operate an effective document control system to ensure that only the correct approved versions of documents, including recording forms, are available and in use.

CLAUSE

FOUNDATION

HIGHER

3.2.1

The site shall be able to demonstrate that key documents which form part of the product safety and quality system are identified with a version number and issue date.

The site shall have a document control procedure to ensure that all key documents which form part of the product safety and quality system are effectively managed.

This shall include a list of controlled documents indicating the last version number.

This shall include: ○ a list of all controlled documents indicating the latest version number ○ the method for the identification and authorisation of controlled documents ○ a record of the reason for any changes or amendments to documents ○ the system for replacement of existing documents when these are updated. Documents which are in electronic form shall be suitably protected to prevent loss or malicious intervention.

3.3 RECORD COMPLETION AND MAINTENANCE The site shall maintain original, accurate, timely and legible records to demonstrate the effective control of product safety, legality and quality.

CLAUSE

FOUNDATION

3.3.1

Records shall be maintained in good condition and retrievable. Any alterations to records shall be authorised and justification for alteration shall be recorded. Where records are in electronic form these shall be suitably backed up to prevent loss.

3.3.2

Records shall be retained for a defined minimum period with consideration given to: ○ legal requirements ○ the shelf life of the product ○ customer requirements.

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HIGHER

The company shall be able to demonstrate that it verifies the effectiveness of the product safety and quality requirements implemented from the Global Standard for Consumer Products.

CLAUSE

FOUNDATION

HIGHER

3.4.1

The internal audit shall consist of a scheduled programme of recorded inspections by trained staff to ensure that the factory environment and processing equipment is maintained in a suitable condition for production of safe and legal product against GMP guidelines.

There shall be a scheduled programme of internal audits throughout the year with a scope which covers the implementation of the process risk assessment, GMP and documented procedures to achieve this standard. The scope and frequency of the audits shall be established in relation to the risks associated with the activity and previous audit performance. Internal audits shall be carried out by appropriately trained, competent auditors. Auditors shall be independent (i.e. not audit their own work).

3.4.2

3.4.3

The inspection programme shall be fully implemented, and the results shall be reported to a suitable person. Records of any nonconformities and corrective actions shall be available within agreed timescales and completion verified.

The internal audit programme shall be fully implemented and tracked. Internal audit reports shall identify conformity as well as non-conformity and the results shall be reported to the personnel responsible for the activity audited. Corrective actions and timescales for their implementation shall be agreed and completion of the actions verified.

3.5 SUPPLIER APPROVAL AND PERFORMANCE MONITORING 3.5.1 MANAGEMENT OF SUPPLIERS OF RAW MATERIALS, COMPONENTS AND PACKAGING The site shall have an effective supplier approval and monitoring system to ensure that any potential risks from raw materials, components or packaging to the safety, legality and quality of the final product are understood and managed.

CLAUSE

FOUNDATION

HIGHER

3.5.1.1

The site shall have a defined and implemented process for supplier approval, including a list of approved suppliers of raw materials, components and packaging impacting product safety, legality or quality.

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

The approval of these suppliers shall be based on at least one or a combination of the following: ○ ○ ○ ○

supplier questionnaire certificate of analysis supplier audits supplier certification with a scope covering the products supplied ○ historical evidence of good supply.

The approval of these suppliers shall be based on at least one or a combination of the following: ○ ○ ○ ○

supplier questionnaire certificate of analysis supplier audits supplier certification with a scope covering the products supplied.

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PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

3.4 INTERNAL AUDIT

CLAUSE

FOUNDATION

HIGHER Documented procedures shall be established which include clear criteria for ongoing assessment of the standards of performance required. Ongoing assessment may employ one or more of the following or other acceptable methods:

3.5.1.2

○ ○ ○ ○

in-house checks certificate of conformity supplier audits traceability checks.

Records of this monitoring shall be retained with consideration given to legal requirements, product shelf life and customer requirements. Documented procedures shall define how exceptions are handled; for example, the use of products where audit or monitoring has not been undertaken.

3.5.1.3

Based on a batch or delivery basis, the procedure may involve the assessment of certificates of analysis. 3.5.2 CONTROL AND ACCEPTANCE OF INCOMING RAW MATERIALS, COMPONENTS AND PACKAGING MATERIALS

FUNDAMENTAL The company shall have an effective process to ensure that incoming raw materials, components and packaging materials are suitable for use and do not adversely affect the safety, legality or quality of the finished product.

CLAUSE

FOUNDATION

HIGHER

3.5.2.1

Raw materials, components and packaging shall be checked on arrival to ensure they conform to agreed specifications and any agreed acceptance criteria, e.g. certificates of analysis.

Raw materials, components and packaging shall have documented approval procedures to ensure they conform to agreed specifications and requirements, and documented positive batch release. Incoming goods, including materials returned to site from subcontractors (and home workers), shall be subject to a documented positive batch release procedure.

3.5.2.2

The company shall have a process to ensure that raw materials, components and packaging used by home workers (when used and if authorised by the customer) are approved.

The company shall have a documented procedure to ensure that raw materials, components and packaging used by home workers (when used and if authorised by the customer) are approved.

3.5.2.3

The company shall have in place a process to ensure the authenticity of raw materials, components and packaging to prevent fraud.

The company shall have in place a documented procedure to ensure the authenticity of raw materials, components, packaging and documentation to prevent fraud.

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A system shall be in place to manage specifications and technical data for raw materials, components and packaging materials.

CLAUSE

FOUNDATION

HIGHER

3.6.1

Suitably detailed and accurate specifications shall be held for all raw materials, components, packaging materials and finished products to ensure compliance with relevant safety, legislative, quality and customer requirements. The specifications shall be accessible to relevant staff and the company shall seek formal agreement of specifications with relevant parties.

3.6.2

A specification shall be available for each finished product and shall have been verified to ensure it is fit for purpose, meets customer requirements and is compliant with relevant safety and legislative requirements in the regions of intended sale. As a minimum, the specification may include the following, although this is not an exhaustive list: ○ ○ ○ ○ ○ ○ ○ ○ ○

3.6.3

product name and description composition physical and/or chemical parameters assembly diagrams packaging labelling intended shelf life warnings instructions for use.

Companies shall maintain the data in a technical file that is accessible to relevant staff containing all relevant data (or details of where such data is located) to ensure that products meet the requirements of the specification and legislative and customer requirements. Relevant data may include: ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○

bill of materials safety data sheets on all chemicals used where relevant to the safety, legality or quality of the product risk assessment(s) description of the conformity assessment procedure test reports inspection reports list of the legislation and product standards with which the products are manufactured to comply production control procedures and charts approvals by any government body (if applicable) declarations of conformity to legal requirements (if applicable) self-inspection reports corrective actions.

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PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

3.6 SPECIFICATIONS AND TECHNICAL FILES

3.7 CORRECTIVE AND PREVENTIVE ACTION FUNDAMENTAL The site shall be able to demonstrate that it uses the information from identified failures in the product safety and quality management system to make necessary corrections and prevent recurrence.

CLAUSE

FOUNDATION

HIGHER

3.7.1

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

The company shall operate an effective documented process for the capture, recording and timely investigation of non-conformities or maers reported as possible non-conformities critical to product safety, legality or quality. An appropriate staff member shall be identified and assigned the responsibility and accountability for each corrective action. This shall be documented.

3.7.2

The company shall ensure that corrective actions prevent recurrence of the problem and shall monitor and record their completion.

3.7.3

The company shall ensure that effective corrective actions are taken to prevent recurrence of the problem and shall monitor and record their completion within an appropriate timescale. The company shall review its processes at least annually and adopt preventive measures as they become available.

3.7.4

3.8 CONTROL OF NON-CONFORMING MATERIALS The company shall ensure that non-conforming raw materials, packaging, components and products are clearly identified, labelled, quarantined, investigated and documented.

CLAUSE

FOUNDATION

HIGHER

3.8.1

Clear procedures for the control of non-conforming materials and products, including customer returns, shall be in place and understood by all relevant, authorised personnel. These shall include effective identification and quarantining before a decision has been made on the final disposition of the nonconforming product by rejection, acceptance by concession or regrading for an alternative use.

3.9 TRACEABILITY FUNDAMENTAL The site shall be able to trace all raw materials, components and packaging from its suppliers through all stages of processing and dispatch to its primary customers, and from the customer back to the supplier.

CLAUSE

FOUNDATION

HIGHER

3.9.1

The site shall have a system in place to enable all raw materials, components and packaging materials critical to safety or where legally required to be traced to the supplier and the batch or order number.

The site shall have a system in place to enable all raw materials, components and packaging materials to be traced to the supplier and the batch or order number.

3.9.2

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

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FOUNDATION

HIGHER

3.9.3

Finished product shall be identified with a unique code such as a batch code applied to the product or packaging where legally required or specified by the customer.

Finished product shall be identified with a unique code such as a batch code applied to the product or packaging.

Systems must be in place to trace a finished product back to the batch of raw materials or packaging used.

Documented procedures must be in place to trace a finished product back to the batch of raw materials or packaging used.

3.9.4

Subcontracted manufacture of products or components shall have prior customer approval and shall be traceable to a level appropriate to the risk.

3.9.5

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

3.9.6

The need for extended traceability through the chain should be established on the basis of risk and any legal or specific customer requirements. Where required, extended traceability shall be implemented.

3.10 COMPLAINT HANDLING The company shall operate an effective system for the capture, recording and investigation of product complaints at all levels of severity.

CLAUSE

FOUNDATION

HIGHER

3.10.1

All complaints shall be recorded, investigated using root analysis and the results of the investigation recorded where sufficient information is provided. Actions appropriate to the seriousness and frequency of the problems identified shall be carried out to reduce the likelihood of recurrence.

3.10.2

The company shall have a process in place to respond in a timely manner to consumers and customers regarding complaints. Complaint data shall be analysed for significant trends. This analysis shall be made available to relevant staff.

3.10.3

3.11 MANAGEMENT OF INCIDENTS, PRODUCT WITHDRAWAL AND PRODUCT RECALL The company shall have a plan and system in place to manage incidents effectively and enable the withdrawal and recall of products should this be required.

CLAUSE

FOUNDATION

HIGHER

3.11.1

The site shall have a system in place to monitor issues which could result in the need to withdraw or recall products including consumer complaints, product rejections and feedback from customers. There should be a process in place to notify senior management of an incident or emergency that may affect the legality, safety and quality of a product.

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

3.11.2

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

3.11.3

The documented product withdrawal and recall procedures shall include as a minimum: ○ identification of key staff constituting the incident management team and their key responsibilities ○ an up-to-date list of key contacts, with details of agencies providing advice and support ○ a list of persons who can initiate a recall.

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PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

CLAUSE

CLAUSE

FOUNDATION

HIGHER The site shall have wrien technical and quality agreements in place with agents and distributors and other parties in the supply chain where these are necessary to ensure effective withdrawal/ recall.

3.11.4

3.11.5

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

3.11.6

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

3.11.7

The product recall and withdrawal procedures shall be tested at least annually.

The product recall and withdrawal procedures shall be regularly tested, at least annually, in a way that ensures their effective operation. Results of the test shall include timings of key activities and shall be retained. The company’s senior management shall ensure that results of this test shall be used to implement improvements as necessary.

3.11.8

The company shall develop contingency planning for business continuity in the event of major incidents such as: ○ disruption to key services (e.g. water, energy, staff availability) ○ events such as flood, fire and natural disaster ○ malicious contamination or sabotage.

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

CLAUSE

FOUNDATION

HIGHER

4.1.1

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

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

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

The external areas and surroundings shall be maintained in good order. A site plan shall be retained and readily available. Consideration shall be given to local activities and the site environment and measures shall be taken to prevent contamination.

4.1.2

Where measures have been put into place to protect the site (from potential contaminants, flooding, etc.), they shall be regularly reviewed in response to any changes.

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

CLAUSE

FOUNDATION

HIGHER

4.2.1

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

4.2.2

Contractors involved in maintenance or repair shall be qualified or supervised and a member of staff shall oversee their activities.

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

4.3 LAYOUT, PRODUCT FLOW AND SEGREGATION FUNDAMENTAL The factory layout, flow of processes and movement of personnel shall be adequate to prevent the risk of product contamination and mix-ups and to comply with relevant legislation.

CLAUSE

FOUNDATION

4.3.1

The layout process flow of machinery and equipment shall be arranged to minimise the risk of product contamination and damage.

4.3.2

Premises shall allow sufficient working space and storage capacity to enable all operations to be carried out and, if necessary, in hygienic conditions. The necessary level of hygiene shall be maintained for each product.

4.3.3

HIGHER

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

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PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

4 SITE STANDARDS

CLAUSE

FOUNDATION

HIGHER

4.3.4

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

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

4.3.5

Documented control procedures shall be in place.

Where materials or products require special handling procedures to be in place, these shall be maintained to ensure product safety, quality and legality are not compromised. The company shall determine whether allergenic or sensitising materials are used and, if so, documented policies shall exist for the handling of such materials including:

4.3.6

○ physical or time segregation from other products ○ use of identified, dedicated equipment if necessary ○ adequate labelling of final products.

4.3.7

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

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

4.4 BUILDING INTERIORS The interior of the site, buildings and facilities shall be suitable for the intended purpose.

CLAUSE

FOUNDATION

4.4.1

The site shall be maintained to minimise potential for product contamination. The quality and finish of site buildings and facilities, including any pipework and drainage, shall be suitable for the intended purpose with due regard to the risk to product safety, legality and quality, and shall be maintained to an appropriate standard. This shall include, as defined by the risk assessment: ○ ○ ○ ○ ○

HIGHER

a clean, tidy and organised factory adequate lighting adequate ventilation walls, floors, windows, doors and ceilings maintained in a good condition to prevent foreign body risks suitable and sufficient removal of any by-products and contaminants.

4.4.2

Suitable and sufficient lighting shall be provided for correct operation of processes, inspection of products, and effective cleaning.

4.4.3

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

4.4.4

Where water quality presents a risk to the final product it shall comply with the required specification (as defined in the region of intended product sale), suitably treated to prevent contamination and regularly monitored.

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

CLAUSE

FOUNDATION

HIGHER

4.5.1

Staff facilities such as washrooms and break areas must be provided and maintained in a clean condition and segregated from production areas to prevent product contamination. Where a site provides food service the food preparation areas must be clean and fit for purpose and adequately segregated from production areas.

4.5.2

Where smoking or use of electronic cigarees is allowed under national law, designated controlled smoking areas shall be provided and isolated from production and storage areas to an extent that ensures smoke cannot reach the product. Adequate arrangements for dealing with smokers’ waste shall also be provided at smoking facilities, both inside buildings and at external locations.

4.5.3

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

4.5.4

Based on risk assessment, the site shall determine and provide workwear as required and make provisions for changing areas for all personnel: staff, visitors and contractors.

4.5.5

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

The site shall use risk assessment to determine where a change to workwear in different areas is required. Any required changing facilities shall be provided for all personnel: staff, visitors and contractors. Changing areas should be sited to allow direct access to the production, packing or storage areas without exposure to any external area. Where this is not possible, the site shall use the risk assessment to help determine the activities required to mitigate any risk. This procedure shall be documented.

4.6 HOUSEKEEPING AND HYGIENE FUNDAMENTAL Housekeeping and cleaning systems shall be in place which ensure appropriate standards of hygiene are maintained at all times and the risk of product contamination is minimised.

CLAUSE

FOUNDATION

HIGHER

4.6.1

Equipment, production and storage areas shall be maintained in a state of cleanliness appropriate to the operations undertaken. Cleaning practices shall be completed so as to minimise risk of contamination and records kept.

4.6.2

Suitable cleaning chemicals shall be identified, clearly labelled and controlled to prevent the risk of product contamination. Chemicals shall not be decanted unless into properly labelled and identified containers. Adequate storage facilities shall be provided and sited so as not to compromise the safety, legality and quality of the product.

4.6.3

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

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PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

4.5 STAFF FACILITIES

CLAUSE

FOUNDATION

HIGHER Documented cleaning procedures shall be in place, validated and maintained for the building, utilities, plant and all equipment. Where more than basic cleaning is required, cleaning procedures shall include the following information as a minimum:

4.6.4

○ ○ ○ ○ ○ ○

responsibility for cleaning item/area to be cleaned frequency of cleaning method of cleaning cleaning materials to be used cleaning records and responsibility for verification.

Cleaning and housekeeping shall be carried out by trained personnel in accordance with documented procedures, and records shall be maintained. The standard of cleaning shall be appropriate to the product being manufactured and shall be verified and documented and, where relevant, agreed with the customer. Corrective actions shall be documented.

4.6.5

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

4.7 WASTE AND WASTE DISPOSAL Waste disposal shall be managed in accordance with legal requirements and to prevent accumulation, mix-up, risk of contamination and the araction of pests.

CLAUSE

FOUNDATION

HIGHER

4.7.1

Waste disposal shall be managed in accordance with legal requirements and to prevent accumulation, mix-up, risk of contamination and the araction of pests.

4.7.2

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

4.7.3

Waste materials shall be controlled, clearly labelled and where necessary quarantined to ensure that they are not reintroduced into nonwaste production flows.

4.7.4

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

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The whole site shall have an effective preventive pest control programme in place to minimise the risk of pests. Sufficient resources shall be available to respond rapidly to any issues that occur, in order to prevent risk to products.

CLAUSE

FOUNDATION

HIGHER

4.8.1

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

4.8.2

The company shall either have a clearly defined contract with external contractors which reflects the activities of the site, or have trained staff. During each visit activity/action reports shall be completed. These should include observations of pests or evidence of pest activity and recommendations for action by the site.

4.8.3

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

4.8.4

Full material safety data sheets for all chemical pest control agents used shall be controlled, available to relevant staff at all times and kept in a designated place.

4.9 PRODUCT STORAGE, DISPATCH AND TRANSPORT Facilities for the storage and transportation of products shall be suitable for purpose and minimise the risk of product contamination, damage and malicious intervention.

CLAUSE

FOUNDATION

HIGHER

4.9.1

All materials, work in progress and product shall be properly identified and protected during storage by appropriate packaging to protect the product from contamination.

4.9.2

Where storage of raw materials, components, packaging, intermediate or finished product is necessary it shall be maintained in good condition and be securely protected from contamination, deterioration and damage. All handling operations during storage shall be managed to prevent product damage.

4.9.3

Vehicles or containers used for transportation and dispatch of product shall be inspected prior to loading to ensure that they are fit for purpose. Records of inspection shall be maintained.

4.9.4

Documented procedures to maintain product safety and quality during loading and transportation shall be developed and implemented.

4.9.5

Where product is vulnerable to weather damage, vehicles and containers for transportation shall be loaded and unloaded so as to protect the product.

4.9.6

Where a third-party haulage contractor is used, all the requirements shall be defined within a contract and effectively managed.

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PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

4.8 PEST CONTROL

5 PRODUCT INSPECTION AND TESTING 5.1 PRODUCT INSPECTION AND LABORATORY TESTING FUNDAMENTAL The company shall have a programme for product inspection and testing to control products during and aer production to ensure that products are safe, legal and meet the quality specification.

CLAUSE

FOUNDATION

HIGHER

5.1.1

There shall be a scheduled product-testing programme according to risk for each product or product group as defined in the specifications. This shall be based on information such as: ○ the outcome of the product and process risk assessments ○ any legal requirements for testing in the regions(s) of intended sale ○ the site’s requirements for demonstrating the production of safe products. The methods, frequency and specified limits of testing shall be clearly defined.

5.1.2

The testing programme shall be implemented and records kept of all test results. Results which are outside the defined specification shall be reviewed promptly by an authorised competent person. The need for corrective action shall be assessed and documented, and any action carried out as necessary.

5.1.3

Where the company undertakes or subcontracts analyses which are 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/IEC 17025. Documented justification shall be available where accredited methods are not undertaken.

5.1.4

Procedures shall be in place to ensure reliability of test results, other than those critical to safety and legality. These shall include: ○ ○ ○ ○ ○

5.1.5

use of recognised test methods and reference standards, where available documented testing procedures ensuring staff are suitably qualified and/or trained and competent to carry out the analysis required use of a system to verify the accuracy of test results (e.g. ring or proficiency testing) use of appropriately calibrated and maintained equipment.

Test and inspection results shall be reviewed regularly to identify trends. The significance of external laboratory results must be understood and acted upon accordingly. Appropriate actions shall be implemented promptly to address any unsatisfactory trends. Where testing is submied to third parties, the required testing shall be clearly defined, including reference to the number, date and version of the test standard or method to be used.

5.1.6

In cases where the company relies on the expertise of third-party testing organisations to determine appropriate test requirements, the company shall ensure that the third party receives a clear wrien briefing on the purpose of the test and that the testing programme is formally agreed and documented.

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The company shall operate a quantity control system which conforms to the legal requirements in the country where the product is sold and any additional customer requirements.

CLAUSE

FOUNDATION

HIGHER

5.2.1

Where necessary the company shall operate a quantity control system which conforms to legal requirements and/or specified customer requirements in the region where the product is available for sale. Documentary evidence shall be available on site to substantiate claims.

5.2.2

Where quantity checking is required, the frequency and methodology used based on valid sampling plans shall meet the minimum requirements of any legislation governing quantity verification.

5.3 PRODUCT SAMPLE CONTROL The site shall ensure that procedures are in place for the selection, handling, storage, approval and use of reference samples taken from pre-production, subcontracted and finished production in accordance with customer requirements.

CLAUSE

FOUNDATION

HIGHER

5.3.1

Where legally required or specified by a customer, a reference sample of the product which has been approved by the customer or a representative of the agreed specification shall be retained.

Where legally required or specified by a customer, a sample of the product which has been approved by the customer or a representative of the agreed specification shall be retained. The company shall document a process to identify, select and categorise reference samples. If customers have a defined system of sealed samples referring to different stages of sample approval, the customer’s procedure shall be documented and followed.

5.3.2

Reference samples shall be stored and recorded in suitable environmental conditions to maintain their original status for a specified period.

5.3.3

A secure and tamper-evident system shall be in place for the storage of samples. A sampletracking process shall be in place and temporary removal of samples shall be managed.

5.3.4

A secure and tamper-evident system shall be in place for the storage and tracking of samples, with access by authorised personnel. The removal and return of samples to storage shall be documented and authorised by a designated responsible person. Documented procedures shall be in place to determine the retention time for samples. This should normally be the foreseeable lifetime of the product unless otherwise justified.

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PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

5.2 QUANTITY CONTROL

6 PROCESS CONTROL 6.1 CONTROL OF OPERATIONS FUNDAMENTAL The site’s programme of process and quality controls to ensure the production of safe and legal products of consistent quality shall be based on a risk assessment of the production process and the potential for product contamination. 6.1.1 PROCESS RISK ASSESSMENT

CLAUSE

FOUNDATION

HIGHER

6.1.1.1

There shall be a suitably experienced designated manager with overall responsibility for the assessment of process controls to ensure the safety and quality of products.

A hazard and risk analysis shall be carried out by a multi-disciplinary team or demonstrably competent manager. In the event of the company not having appropriate in-house knowledge, external expertise may be sought but the day-today management of the system shall remain the responsibility of the site. Where the hazard and risk analysis study has been undertaken centrally by the head office, accurate flow diagrams shall be available on site.

6.1.1.2

It must be possible to demonstrate that a central hazard and risk analysis has been verified to meet the specific activities of the local operation. Verification activities include internal audits and complaints review or analysis. The site shall establish precise process flow diagrams identifying each step in the production of the products.

6.1.1.3

6.1.1.4

The site shall consider the potential product safety and quality issues which could occur at each process stage.

The site shall consider the potential product safety and quality issues which could occur at each process stage. This should include:

Each potential issue shall be assessed to determine the level of risk and suitable controls established to reduce or eliminate the risk.

○ physical or chemical product contamination ○ microbiological contamination ○ product quality or safety issues as appropriate to the products manufactured. The results of this assessment shall be documented.

6.1.1.5

A record shall be maintained of in-process checks and of any actions taken where checks identify any failure to meet the control limits.

Each potential issue shall be assessed to determine the level of risk and appropriate controls to reduce or eliminate the risk. Where an issue is considered to present a significant risk to the safety, legality or quality of the products produced a documented control plan shall be developed and implemented.

6.1.1.6

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

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Where any significant product safety or quality issues are controlled by process monitoring the process parameters shall be defined and records retained of checks of the process.

FOUNDATION

HIGHER If there are identified critical control points (CCPs) where product safety and legality require control measures to be in place, then for each CCP the site shall:

6.1.1.7

○ establish and validate critical limits ○ establish a system to monitor control of the CCPs ○ establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control ○ establish procedures of validation and verification to confirm that the system is working effectively, including auditing of the system ○ establish appropriate documentation concerning all procedures and records. Corrective action shall be taken in the event of deviation of the process from specification. This shall be recorded.

6.1.1.8

6.1.1.9

The programme of controls for product safety and quality shall be reviewed whenever new product types are manufactured or significant changes are made to production methods.

The hazard and risk analysis shall be reviewed whenever new product types are manufactured or significant changes are made to production methods.

6.1.2 LINE CLEARANCE AND IN-PROCESS CHECKS

CLAUSE

FOUNDATION

HIGHER

6.1.2.1

Before the start of any manufacturing operation and following changes of product, checks shall be made to ensure that the production line has been cleared and made ready for use.

Before the start of any manufacturing operation, documented checks shall be carried out to ensure that the production line and the relevant areas around it have been cleared and, where necessary, cleaned, to avoid mixing with materials from the previous operations.

All work instructions, raw materials, components and packaging with the necessary equipment shall be available for use.

All documentation, raw materials, components and packaging with the necessary equipment shall be available for use. It shall be possible to identify the production line with its name or identifying code as determined by the risk assessment.

6.2 EQUIPMENT AND EQUIPMENT MAINTENANCE Equipment shall be suitable for the intended purpose and shall be used in such a way as to minimise the risk of contamination of product.

CLAUSE

FOUNDATION

HIGHER

6.2.1

All equipment shall be fit for purpose and constructed of appropriate materials. The design and placement of equipment shall ensure it can be effectively cleaned and maintained.

6.2.2

In the case of equipment failure, procedures shall be in place to establish the safety and legal status of the product prior to release.

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PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

CLAUSE

CLAUSE

FOUNDATION

HIGHER

6.2.3

An implemented maintenance programme covering all items of equipment and plant which are critical to product safety, legality and quality shall be in place.

A documented planned preventive maintenance programme based on risk assessment and covering all items of equipment and plant which are critical to product safety, legality and quality shall be in place.

6.2.4

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

6.2.5

Repairs or servicing of equipment shall be completed by competent maintenance personnel.

6.2.6

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

6.3 PRODUCT CONTAMINATION CONTROL Appropriate facilities and procedures shall be in place to control the risk of foreign body, chemical or biological contamination. 6.3.1 IDENTIFICATION AND PREVENTION OF RISK OF PRODUCT CONTAMINATION

CLAUSE

FOUNDATION

HIGHER

6.3.1.1

The site shall ensure that all necessary steps are taken to identify and prevent the risks of foreign body, chemical and biological contamination as identified by risk assessment. This shall include any contamination potentially introduced by raw materials, components or packaging.

6.3.2 CHEMICAL AND BIOLOGICAL CONTROL

CLAUSE

FOUNDATION

6.3.2.1

Processes shall be in place to manage the use, storage and handling of non-production chemicals and biological materials to prevent contamination. These shall include as a minimum: ○ ○ ○ ○

HIGHER

a list of approved chemicals for purchase availability of material safety data sheets the labelling and/or identification of containers of chemicals and biological materials at all times a designated storage area with access restricted to authorised personnel.

6.3.3 METAL CONTROL

CLAUSE

FOUNDATION

HIGHER

6.3.3.1

Tools and other sharp metal implements including knives, cuing blades, needles, perforation blades and wires used in production shall be controlled where there is a risk of product contamination. Methods such as, but not limited to, the following may be used: ○ tools permanently aached to equipment to prevent loss ○ items controlled by an issue listing and registration procedure ○ recovery of all parts of broken needles before the issue of a replacement needle. Snap-off-blade knives shall be prohibited.

6.3.3.2

Staples, paper clips and drawing pins shall not be used in open product areas. Where staples or other items are present as packaging materials or closures, appropriate precautions shall be taken to minimise the risk of product contamination.

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CLAUSE

FOUNDATION

6.3.4.1

Glass or other brile materials shall be excluded or protected against breakage in areas where there is a risk of product contamination.

6.3.4.2

Where there is a potential risk to product all glass, ceramic, wood and brile-plastic items in production areas (except where the item is part of the product) shall be included in the risk assessment and listed in a register. Documented procedures for handling these materials shall include: ○ ○ ○ ○

HIGHER

regular checks of the condition of these materials carried out at specified intervals and recorded recording of all breakages in an incident report segregation of contaminated product recording details of cleaning or replacement to minimise potential for product contamination.

6.3.5 FOREIGN BODY DETECTION AND REMOVAL EQUIPMENT The risk assessment shall identify the potential use of equipment to detect or remove foreign body contamination. 6.3.5.1 Filters and sieves

CLAUSE

FOUNDATION

HIGHER

6.3.5.1.1

Filters and sieves used for foreign body control shall be of a specified mesh size or gauge and designed to provide the maximum protection that is practical for the product. Material retained or removed by the system shall be examined and recorded to identify risks.

6.3.5.1.2

Filters and sieves shall be regularly inspected and tested for damage. Defective sieves and filters shall be segregated and appropriate action taken to replace them. Records shall be maintained.

Filters and sieves shall be regularly inspected and tested for damage at a documented frequency determined by the risk assessment. Defective sieves and filters shall be segregated and appropriate action taken to replace them. Records shall be maintained.

6.3.5.2 Metal detectors and X-ray equipment

CLAUSE

FOUNDATION

HIGHER

6.3.5.2.1

Where a metal or other foreign body detector is required based on risk assessment, the company shall establish documented procedures specifying the methods and frequency of testing, critical limits for detection, and recording of test results.

6.3.5.2.2

The metal detector or X-ray equipment shall incorporate one of the following: ○ an automatic rejection device ○ a belt stop system with an alarm where the product cannot be automatically rejected (e.g. for very large packs) ○ in-line detectors which identify the location of the contaminant to allow effective segregation of the affected product.

6.3.5.2.3

Systems shall be in place to segregate product rejected by the metal detector to prevent accidental reintroduction and allow investigation of the source of the metal contaminant.

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PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

6.3.4 GLASS, BRITTLE PLASTIC, CERAMICS, WOOD AND SIMILAR MATERIALS CONTROL

CLAUSE

FOUNDATION

HIGHER

6.3.5.2.4

The company shall examine product rejected by the metal detector and retain any metal contaminant.

There shall be a documented procedure to examine product rejected by the metal detector and to retain any metal contaminant.

The source of the contamination shall be investigated and appropriate corrective action taken to minimise the risk of further contamination.

The source of the contamination shall be investigated and appropriate corrective action taken to minimise the risk of further contamination.

Records shall be maintained.

Records shall be maintained.

CLAUSE

FOUNDATION

HIGHER

6.3.5.3.1

The type, location and strength of magnets shall be recorded in a register.

6.3.5.3 Magnets

Documented procedures shall be in place for inspection, cleaning, strength testing and integrity checks. Records of all checks shall be maintained.

6.4 CALIBRATION AND CONTROL OF MEASURING AND MONITORING DEVICES Measuring equipment used to monitor product safety, quality and legality shall be calibrated and of suitable accuracy for its intended purpose.

CLAUSE

FOUNDATION

HIGHER

6.4.1

The site shall have a list of equipment used to make measurements relevant to product safety, legality and quality.

6.4.2

The equipment used to accept or reject a product shall be calibrated to a specified accuracy and precision at a defined frequency (or before use).

6.4.3

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

6.4.4

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

6.4.5

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Adjustment of identified equipment by unauthorised staff shall be prevented and the equipment shall be marked to show its calibration status and period of validity.

Adjustment of listed equipment by unauthorised staff shall be prevented and the equipment shall be marked to show its calibration status and period of validity.

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

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

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The company shall ensure that products are packed in accordance with customer-specified requirements and any relevant safety criteria, quality and legal requirements.

CLAUSE

FOUNDATION

HIGHER

6.5.1

Before the start of the packaging operation and following changes of product, checks shall be carried out to ensure that the packing line has been cleared and made ready for packing.

Before the start of the packaging operation, documented checks shall be carried out to ensure that the packing line and the relevant areas around it have been cleared, and where necessary cleaned, to avoid mixing with materials from the previous operations.

All work instructions and packaging materials shall be available for use.

All documentation and packaging materials shall be available for use. The packing line shall be identifiable by its name or identifying code as determined by the risk assessment.

6.5.2

The company shall ensure that product packing is effectively managed to ensure that it meets customer-specified packing requirements for the product. This shall include methods of ensuring that the correct product(s) and components are correctly packaged and placed in the correct outer packaging.

6.5.3

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

The quantity of product should match the quantity markings, which should be accurate, verified and in accordance with the legal requirements in the country of sale.

6.6 STOCK CONTROL AND PRODUCT RELEASE The company shall ensure that stock and finished product are not released unless all agreed procedures have been followed and the release is suitably controlled.

CLAUSE

FOUNDATION

HIGHER

6.6.1

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

6.6.2

The company shall ensure that product brought in from off-site subcontractors shall be included in the product release procedure.

6.6.3

Only products conforming to specification and agreed quality requirements are to be released for dispatch. If no such control is conducted, the company shall have a full justification for its absence documented in the customer agreement, which shall be reviewed at least annually.

A documented procedure shall be in place to ensure that only products conforming to specification are released for dispatch. Procedures may include, but are not limited to: ○ positive final release by authorised staff ○ online test methods ○ automatic rejection process (which shall be validated and monitored). If a risk assessment determines that no such control is required, the company shall have a full justification for its absence, which is documented in the customer agreement and shall be reviewed at least annually.

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PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

6.5 FINAL PRODUCT PACKING AND CONTROL

7 PERSONNEL 7.1 TRAINING AND COMPETENCY FUNDAMENTAL The company shall ensure that personnel performing work that affects product safety, legality and quality are demonstrably competent to carry out their activity, through training, work experience or qualification.

CLAUSE

FOUNDATION

HIGHER

7.1.1

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

The company shall ensure that all employees are able to demonstrate competence with regard to their activity. The company shall: ○ identify the need for training ○ document training procedures and records to demonstrate that training is effective and regularly reviewed ○ ensure that training includes both general information on the company and specific job training ○ retain all training records.

Records shall be available of the training provided to employees, including:

7.1.2

○ general training provided at induction ○ training provided relevant to the job role.

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

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

CLAUSE

FOUNDATION

HIGHER

7.2.1

The company shall use risk assessment to determine the need for protective clothing. Where a need for protective clothing has been identified by the risk assessment, this shall not pose a contamination risk to the product.

7.2.2

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

7.2.3

Protective clothing, where provided, shall be effectively laundered at an appropriate frequency. Disposable protective clothing, if used, shall be subject to adequate control to avoid product contamination.

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

CLAUSE

FOUNDATION

HIGHER

7.3.1

Where the risk has been identified, the company shall have a policy to control the wearing of jewellery so that it poses no risk of product contamination.

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

7.3.2

All cuts and grazes on exposed skin shall be covered by a contrasting coloured plaster that is issued and monitored by the site, to avoid contamination of product.

7.3.3

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

7.3.4

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

7.3.5

Eating, drinking or smoking shall only be permied within designated areas and where there is no risk of contamination of products.

7.3.6

Where there may be a risk to product safety and legality, the site should have a procedure for the notification by personnel, including temporary personnel, visitors and contractors of any relevant infectious diseases or conditions which they may have been in contact with or be suffering from.

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PART II REQUIREMENTS FOR FOUNDATION AND HIGHER LEVELS

7.3 HYGIENE PRACTICES

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PART III AUDIT PROTOCOL INTRODUCTION 1 GENERAL PROTOCOL – AUDIT PREPARATION 40

1.1 Selection of an audit option 1.2 Self-assessment of compliance with the Standard 1.3 Selection of a certification body 1.4 Company/certification body contractual arrangements 1.5 Registration fee 1.6 Scope of audit

40 41 41 41 41

2 GENERAL PROTOCOL – FOUNDATION AND HIGHER LEVELS 2.1 2.2 2.3 2.4 2.5 2.6 2.7

42 43 44 46 47 47

Audit planning The on-site audit Non-conformities and corrective action Grading of the audit Audit reporting Certification Ongoing audit frequency and recertification

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3 GENERAL PROTOCOL – POST AUDIT 3.1 3.2 3.3 3.4 3.5 3.6 3.7

Communication with certification bodies Extension to scope Certification withdrawal Appeals Surveillance of certificated companies BRC logos The BRC Global Standards Directory

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PART III AUDIT PROTOCOL

INTRODUCTION The general audit protocol describes the requirements for auditing and certification which are applicable to all of the audit programmes for both levels of certification. This should be read and fully understood before proceeding with the certification process. An independent audit company – the certification body – will assess the company’s conformance to the requirements of the Global Standard for Consumer Products: General Merchandise and its suitability for certification. This assessment takes the form of an audit visit which is carried out by an approved certification body. The BRC does not carry out any audits directly itself. The detailed process by which a company gains and maintains certification is summarised in Figure 1. Certification will be graded according to the audit option selected and the number and type of non-conformities. This part of the Standard describes the process to be followed by a company seeking certification. For confirmation of the latest certification protocols, reference should be made to the BRC Global Standards website (www.brcglobalstandards.com), where changes or updates will be published.

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O O

O

Audit O

preparation

O O

O

Audit planning

O O

O O

On-site audit

O O O O O

O

Non-conformities and corrective action

O O

O O

Post audit

O O O

PART III AUDIT PROTOCOL

Learn

Visit www.brcglobalstandards.com Review any appropriate guidelines

Select appropriate Standard (Personal Care and Household, or General Merchandise) Self-assessment of compliance with the Standard Selection of a certification body Define scope of the audit

Ensure information and appropriate personnel are available for the audit even in the event of an unannounced audit Provide information to certification body for audit preparation Define audit date and agree duration based on audit duration calculator

Opening meeting Production facility inspection Document review Traceability challenge Review of production facility inspection Final review of findings by auditor Closing meeting – review audit findings and confirm any non-conformities

Corrective action provided for any non-conformities identified within 28 days or revisit depending on number and nature Certification body reviews evidence in 14 days If corrective action deemed satisfactory, certificate, audit report and corresponding grade issued

Ongoing maintenance of the Standard and continual improvement Get login details for the BRC Global Standards Directory and share audit report with any required customers Use of BRC logos Ongoing communication with certification body Schedule re-audit date before re-audit due date

FIGURE 1 AUDIT PROTOCOL – HOW TO GAIN CERTIFICATION WWW.BRCGLOBALSTANDARDS.COM

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1 GENERAL PROTOCOL – AUDIT PREPARATION Obtaining BRC certification is oen a challenging step for a company. It is vital that the company is well prepared for the audit, otherwise it may incur substantial unnecessary cost and is likely to be disappointed with the outcome. A company that is interested in obtaining certification should address the following considerations: ○ making an accurate gap analysis of their situation versus the requirements of the Standard, using the self-assessment tool ○ choosing an appropriate certification body ○ ensuring that staff are adequately trained in: – the Standard – risk assessment – obtaining legal and safety information relevant to their products – relevant product standards or codes of practice ○ allowing an adequate timescale for implementing the required measures ○ using consultants to assist in areas of weakness or limited understanding, if necessary. Many of the certification bodies offer an optional pre-assessment visit. Certification bodies are not allowed to act as consultants since this could potentially result in them auditing their own work, but a pre-assessment visit helps with the gap analysis and allows companies to obtain a clear understanding of where they need to improve their processes and procedures. Evidence suggests that for many companies this is a very useful exercise, which greatly enhances the chances of successful certification during the BRC Global Standards audit. 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 company is working with a specific retailer or other specifier, it is advisable to discuss an implementation programme with the site’s technical team to ensure that the steps being taken are appropriate with regard to the retailer’s requirements and timescales. Training courses are available from the BRC and other BRC-approved trainers. For more information, visit the training pages on the BRC Global Standards website. 1.1 SELECTION OF AN AUDIT OPTION In order to meet the different expectations of specifiers, the Standard can be set at foundation level or higher level. All legal requirements and the objectives of all statements of intent apply at both levels. 1.1.1 Foundation level The site must be able to demonstrate compliance with all of the requirements in the column headed ‘Foundation’. All legal, safety and critical quality checks must be in place. Product must comply with legislation in the intended place of sale. This is oen the responsibility of a third party on behalf of the customer. 1.1.2 Higher level The site must comply with all of the requirements in the column headed ‘Higher’. This includes documented procedures for risk assessments to define product and process controls and for practical application of all requirements. 1.2 SELF-ASSESSMENT OF COMPLIANCE WITH THE STANDARD It is a requirement of certification that the company has an original copy of the current issue of the Standard, in either electronic or paper format. If the company has a central head office and multiple sites, the Standard should be held centrally, with easy access provided to the individual sites. The Standard is available in a number of language versions from www.brcglobalstandards.com. Obtaining an original copy of the Standard is the first step in preparing for certification. The second step is to read and understand the Standard. The third step is for the company to conduct a preliminary self-assessment against the Standard and address any areas of non-conformity. Further information and guidance to help companies comply with the Standard, including audit tools and training courses, are available on the BRC Global Standards website (www.brcglobalstandards.com).

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In selecting a certification body, the company should consider the following points: ○ Is the certification body acceptable to the company’s customers? Certain customers have lists of their preferred certification bodies. ○ Is the certification body accredited to assess the company for the categories of products it produces? Clarification of the scope of accreditation of the certification body and confirmation of categories of products against which it can audit should be obtained either from the certification body concerned or from accreditation schedules published by the appropriate national accreditation body. A list of categories and product examples is provided in Appendix 2. ○ Does the auditor proposed by the certification body meet the qualifications, training and experience requirements specified by the Standard? 1.4 COMPANY/CERTIFICATION BODY CONTRACTUAL ARRANGEMENTS There shall be a contract between the company and the certification body that is in accordance with the requirements of ISO/IEC 17065, detailing the scope of the audit and the reporting requirements. The contract shall also contain clauses which allow the effective management of the scheme by the BRC and accreditation of the certification body by their accreditation body. These clauses are essential to ensure confidence in the way in which the scheme is managed and consistency achieved, which benefits all certificated sites. In particular, it is a condition of certification to the scheme that: ○ A copy of the audit report and any subsequent certificate or audit result shall be supplied to the BRC and may be supplied to the accreditation body in the agreed format for the BRC Global Standard used. Other documents in relation to the audit shall be made available to the BRC upon request. All documents submied to the BRC shall be copies of original documents. Documents provided to the BRC will be treated as confidential. ○ The auditor(s) may be accompanied by other personnel for training, assessment or calibration purposes. This activity may include: – training of new auditors by the certification body – routine certification body shadow audit programmes – witness audits by accreditation bodies – witness audits by the BRC. The BRC reserves the right to conduct its own audit or visit to a site once certificated in response to complaints or as part of the routine BRC compliance activity to ensure the integrity of the scheme. Such visits may be announced or unannounced. The BRC may contact the site directly in relation to its certification status or for feedback on certification body performance, or investigation into reported issues. This publication sets out the requirements for sites that want to apply to be audited against the Standard and for sites issued with a certificate. Contracts between the certification body and the site shall include a clause acknowledging these obligations. This contract will be formulated by the certification body. Non-compliance with any of these contractual obligations may affect the status of certification of the site. 1.5 REGISTRATION FEE The BRC will require a registration fee to be collected by the certification body from the company for every audit undertaken. The certificate and audit report shall not be valid until the registration fee and the certification body’s audit fees have been received, irrespective of the outcome of the certification process. 1.6 SCOPE OF AUDIT 1.6.1 Defining the audit scope The scope of the audit – products produced and manufacturing processes – shall be agreed between the site and the certification body in advance of the audit, to ensure the allocation of auditor(s) with the correct category and product knowledge. The audit shall include all applicable requirements within the Standard and all production processes undertaken for the products included within the scope at the site seeking certification.

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1.3 SELECTION OF A CERTIFICATION BODY Once a self-assessment has been completed and non-conformities addressed, the company must select a certification body. The BRC cannot advise on the selection of a specific certification body, but the BRC Global Standards Directory (www.brcdirectory.com) lists BRC-approved certification bodies.

The audit scope and any permied exclusions shall be clearly defined both on the audit report and on any certificate issued. The wording of the scope will be verified by the auditor during the site audit. The wording of the scope, of the product groups and, where applicable, the packaging format, shall enable a recipient of the report or certificate to clearly identify whether the products supplied have been included within the scope. This shall include a description of processing activities undertaken at the site that fall within the scope of this Standard, where this adds clarity for the user of the report or certificate (e.g. plastic moulding and assembly of electronic toys). 1.6.2 Exclusions from scope The fulfilment of the certification criteria relies on clear commitment from the site management to adopt the best-practice principles outlined within the Standard. It follows therefore that the exclusion of products from the scope of certification shall only be permied by exception. The BRC logo can only be used by sites that have no exclusions. The exclusion of products produced at a site will only be acceptable where: ○ the excluded products can be clearly differentiated from products within scope and ○ the products are produced in a physically segregated area of the factory. Where exclusions are requested these shall be agreed with the certification body in advance of the audit. Exclusions shall be clearly stated on the audit report and certificate and the justification recorded on the audit report. The certification of products must include audit of the entire process from raw material to end-product dispatch. It is not possible to exclude either parts of the process undertaken at the site or parts of the Standard. Where exclusions are accepted, the auditor(s) shall assess any hazards presented by excluded areas or products (e.g. the introduction of pests or foreign body risks) and non-conformities may be raised relating to the excluded area where this poses a risk to the products within the audit scope. The auditor retains the right to refuse the exclusion request where the criteria are not adequately met.

2 GENERAL PROTOCOL – FOUNDATION AND HIGHER LEVELS 2.1 AUDIT PLANNING 2.1.1 Preparation by the company For initial audits the site shall agree a mutually convenient date, with due consideration given to the amount of work required to meet the requirements of the Standard. There is a requirement on the site to be prepared for the audit, to have appropriate documentation for the auditor(s) to assess and to have appropriate staff available at all times during the on-site audit. The site shall ensure that the production schedule at the time of the audit covers products for the intended scope of the certification. Where possible, the widest range of these products shall be in production for the auditor(s) to assess. Where the product range is large or diverse, the auditor(s) has the discretion to continue the audit until sufficiently satisfied that the intended scope of the certification has been assessed. Where a significant production process is undertaken only during a different period of the year from the audit, a separate audit may be required to assess that production method. The need for an additional audit will depend on the nature of the additional process and products and how they vary from the process and products in the audit scope. 2.1.2 Information to be provided to the certification body for audit preparation The site shall supply the certification body with background information prior to the audit day to ensure the auditor(s) is fully prepared and to provide the best opportunity for the audit to be completed efficiently. The information will be requested by the certification body and may include but is not limited to: ○ ○ ○ ○ ○ ○ ○

the process flow diagram a simple site plan the management organisational chart the list of products or product groups included within the audit scope typical shi paerns production schedules, to allow audits to cover relevant processes any requested exclusions from the scope of the audit.

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2.1.3 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 will vary from 1 to 1.5 days (8 hours per day at the site) at foundation level and 2 to 3 days at higher level. A calculator has been developed to assess the expected time required to undertake the audit of any particular site to ensure consistency and this shall be used as the basis for calculating the total audit duration. Full details can be found on the BRC Global Standards website (www.brcglobalstandards.com). The calculation for the audit duration is based on: ○ the number of employees (as full-time equivalent employees) per main shi, including seasonal workers ○ the size of the manufacturing facility (including storage facilities on site) ○ the number of manufacturing processes at the site. It is recognised that other factors may also influence the calculation, but they are considered to be less significant and therefore shall not influence the audit duration by more than 30% from the total calculated audit time. These factors include: ○ ○ ○ ○ ○ ○ ○ ○

the complexity of the manufacturing process the number of product lines the age of the site and its impact on material flow the labour intensity of processes audit not carried out in the first language of the auditor or the site personnel the number of non-conformities recorded in the previous audit difficulties experienced during the audit requiring further investigation the quality of site preparation (e.g. documentation, risk assessment, quality management systems).

If additional storage facilities, locations or head office assessments are included within the audit process then additional time shall be allocated for this over and above that indicated in the audit calculator. In the event that the audit against this Standard includes voluntary BRC modules or is intended to be combined with other audit standards, the total audit time will need to be appropriately extended. Details of combined audits shall be specified on the audit report. The calculation for audit duration shall determine the amount of time to be expected to undertake the audit at the site. Additional time will be required for the review of any documentary evidence provided and completion of the final audit report. Deviation from the calculated audit timeframe must be justified and specified on the audit report. 2.2 THE ON-SITE AUDIT The on-site audit consists of the following seven stages: ○ Opening meeting – to confirm the scope and process of the audit. ○ Production facility inspection – to review practical implementation of the systems, including observing product changeover procedures, and interview of personnel. ○ Document review – a review of the documented product and process risk assessments and quality management systems. ○ Traceability challenge – including a review of all relevant records of production (e.g. raw material intake, production records, finished product checks and specifications). This is a vertical audit, as specified within the BRC Global Standards guidance document on audit techniques. ○ Review of production facility inspection – to verify and conduct further documentation checks. ○ Final review of findings by the auditor(s) – preparation for the closing meeting. ○ Closing meeting – to review audit findings with the site. (Note that non-conformities are subject to subsequent independent verification by the certification body management.) There is no requirement for the auditor to carry out the audit in the order listed, apart from the opening and closing meetings, but the audit must include all seven elements.

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The site shall make the previous year’s audit report and certificate available to the certification body, where this is a contract with a new certification body.

The site shall fully assist the auditor(s) at all times. It is expected that at the opening and closing meetings those aending on behalf of the site 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 at the time of the audit, or their nominated deputy, shall be available at the audit and aend the opening and closing meetings. The audit process gives emphasis to the practical implementation of product safety and quality management procedures and general good manufacturing practices. It is expected that at least 50% of the audit duration will be spent auditing production and site facilities, interviewing staff, observing processes and reviewing documentation in production areas with the relevant staff. During the audit, detailed notes shall be made by the auditor regarding the site’s conformities and non-conformities against the Standard and these will be used as the basis for the audit report. The auditor(s) shall assess the nature and severity of any non-conformity and shall discuss this with the accompanying site representative at the time. At the closing meeting, the auditor(s) shall present their findings and reconfirm 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 site to provide evidence to the auditor(s) of the corrective action to close non-conformities must be given. A wrien summary of the non-conformities discussed at the closing meeting will be documented by the auditor(s) either at the closing meeting or within one working day aer completion of the audit. At the closing meeting the auditor(s) shall provide the site with an explanation of the BRC Global Standards Directory, which allows secure access to audit data to both the client and their nominated customers, together with the feedback systems available to communicate with the certification body and with the BRC. The decision to award certification and the grade of the certificate will be determined independently by the certification body management following a technical review of the audit report and the closing of non-conformities in the appropriate timeframe. The company will be informed of the certification decision following this review. 2.3 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 on evidence collected and observations made during the audit. This is verified by the certification body management. 2.3.1 Non-conformities There are three levels of non-conformity: ○ Critical Where there is a critical failure to comply with a product safety or other legal requirement. ○ Major Where there is a substantial failure to comply with the statement of intent of a clause or any requirement of the Standard, or where a situation is identified which would, on the basis of available objective evidence, raise significant doubt as to the conformity of the product being manufactured. ○ Minor Where a requirement 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 standard of the operation and level of conformity with the Standard. Consideration should therefore be given to awarding a single major non-conformity where minor non-conformities are repeatedly raised against a particular clause of the Standard. Clustering of a significant number of minor non-conformities against a clause and recording this as a single minor non-conformity is not permied. The certification body shall justify a high number (more than 20) of minor non-conformities where no more than one major non-conformity is given. This shall be detailed on the audit report. Any non-conformities from the previous audit shall 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 noted and consideration shall be given to raising the status of repeated minor non-conformities to a major non-conformity. 2.3.2 Procedures for handling non-conformities and corrective action Following identification of any non-conformities during the audit, the site must undertake corrective action to remedy the immediate issue (correction) and undertake an analysis of the underlying cause of the non-conformity (root cause) to develop a preventive action plan addressing the root cause and preventing recurrence.

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Critical non-conformities or non-conformities resulting in non-certification In some circumstances the number or severity of non-conformities raised at the audit prevents the site from being certificated at either foundation or higher level following that audit. This will be the case where: ○ a critical non-conformity is raised, and/or ○ a major non-conformity against the statement of intent of a fundamental clause is raised, and/or ○ the number or type of non-conformities exceeds the limits for certification, as per Table 1. The grading of non-conformities will be reviewed by the independent certification process of the certification body as soon as possible aer the audit. Where the review confirms that a certificate cannot be awarded, the site will be required to undertake another full audit before assessment for certification. Where this occurs at a certificated site, certification must be withdrawn immediately. Re-audit shall not take place any earlier than 28 days from the audit date, as it is unlikely that non-conformities can be addressed and fully effective improvements implemented and established within that time – although there may be some exceptions. It is a requirement of some customers that they shall be informed when their suppliers have a critical non-conformity identified or where they fail to gain certification. In such circumstances the company shall immediately inform its customers and make them fully aware of the circumstances. Information on the corrective actions to be taken in order to address the non-conformities will also be provided to customers where required.

Major and minor non-conformities No certificate shall be issued until major and minor non-conformities have been demonstrated as having been corrected, either permanently or via a temporary solution that is acceptable to the certification body. For each non-conformity raised, the site shall, in addition to undertaking the necessary immediate corrective action, undertake a review of the root cause of the non-conformity. The root cause shall be identified and an action plan to correct this, including timescale, provided to the certification body. The proposed preventive action shall be included in the audit report. Close-out of non-conformities can be achieved either by objective evidence being submied to the certification body, such as updated procedures, records, photographs or invoices for work undertaken, or by the certification body undertaking a further on-site visit. Where the number and level of non-conformities identified at a higher-level audit would result in a grade of D being awarded (foundation-level audits are not graded), the closure of non-conformities shall be by means of a further site visit to review the action taken. This visit shall be within 28 calendar days of the audit if a certificate is to be issued. For initial audits only, up to 90 calendar days are allowed to provide objective evidence of the correction of any non-conformities identified at the audit. The site will, however, remain uncertificated and will only be certificated following verification of the corrective action being implemented. For all minor non-conformities and major non-conformities raised at recertification audits, if satisfactory evidence is not provided within the 28 calendar-day period allowed for submission following the audit, certification will not be granted. In both instances, if the site cannot close out the non-conformity within the time period, the site will require a further full audit in order to be considered for certification. Non-conformities from the audit shall also be checked during the next site audit to verify effective close-out of the nonconformities and their root cause. Where the correction has been ineffective then a non-conformity shall be raised. The certification body will review objective evidence of corrective action completed prior to awarding a certificate.

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The process for ‘closing out’ non-conformities depends upon the level of non-conformity and the number of non-conformities identified.

2.4 GRADING OF THE AUDIT The purpose of the certification grading system is to indicate to the user of the report the commitment of the site to continual compliance and will dictate the future audit frequency. The grade is dependent on the number and severity of the nonconformities identified at the time of the audit. Non-conformities are verified by a technical review process by the certification body management. If the review results in a change in the number and/or severity of non-conformities, the site shall be notified. Foundation-level audits are not graded but operate on a pass or fail system. In order to obtain certification a site must comply with all the relevant clauses and all non-conformities identified shall have been closed out as indicated in section 2.3.2. Table 1 indicates the number and level of non-conformities which would result in noncertification. Higher-level audits are graded as shown in Table 1.

TABLE 1 SUMMARY OF GRADING CRITERIA, ACTION REQUIRED AND AUDIT FREQUENCY GRADE

CRITICAL

MINOR

CORRECTIVE ACTION

AUDIT FREQUENCY

AA

5 or fewer

Objective evidence within 28 calendar days (90 days for initial audit)

12 months

A

6–10

Objective evidence within 28 calendar days (90 days for initial audit)

12 months

B

11–16

Objective evidence within 28 calendar days (90 days for initial audit)

12 months

10 or fewer

Objective evidence within 28 calendar days (90 days for initial audit)

12 months

17–24

Objective evidence within 28 calendar days (90 days for initial audit)

12 months

B

MAJOR

1

C C

1

11–16

Objective evidence within 28 calendar days (90 days for initial audit)

12 months

C

2

10 or fewer

Objective evidence within 28 calendar days (90 days for initial audit)

12 months

25–30

Revisit required within 28 calendar days (90 days for initial audit)

12 months

D D

1

17–24

Revisit required within 28 calendar days (90 days for initial audit)

12 months

D

2

11–16

Revisit required within 28 calendar days (90 days for initial audit)

12 months

Not certificated

1 or more

Certificate not granted. Re-audit required

Not certificated

31 or more

Certificate not granted. Re-audit required

Not certificated

1

25 or more

Certificate not granted. Re-audit required

Not certificated

2

17 or more

Certificate not granted. Re-audit required

Not certificated

3 or more

Note that shaded cells indicate zero non-conformities.

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Certificate not granted. Re-audit required

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2.5 AUDIT REPORTING Following each audit, a full wrien report shall be prepared in the agreed format. The report shall be produced in English or in another language, dependent upon user needs. Where the report is produced in a language other than English, the audit summary sections shall, in addition, always be reported in English. The audit report shall provide the company and customers or prospective customers with a profile of the company and an accurate summary of the performance of the site against the requirements of the Standard. The audit report must assist the reader to be informed of: ○ the product safety controls in place and improvements since the last audit ○ ‘best practice’ systems, procedures, equipment or fabrication in place ○ non-conformities, the corrective action taken and plans to correct the root cause (preventive actions). The report shall accurately reflect the findings of the auditor during the audit. Reports shall be prepared and dispatched to the company within 42 calendar days of the completion of the full audit (104 calendar days for an initial audit). The audit report shall be uploaded to the BRC Global Standards Directory in a timely manner irrespective of whether a certificate is issued. The owner of the audit report may allocate access to the audit report to customers or other parties in the directory. The audit report and associated documentation including auditor’s notes shall be stored safely and securely for a period of 5 years by the certification body. 2.5.1 Interim report Some customers may require notification of the outcome of the audit before the review and certification process is completed. In such circumstances an interim report indicating the level of audit and non-conformities raised will be produced and uploaded onto the BRC Directory within 10 calendar days of the audit. The site may share this interim report with its customers. 2.6 CERTIFICATION Aer a review of the audit report and documentary evidence provided in relation to the non-conformities identified, a certification decision shall be made by the designated independent certification manager. Where a certificate is granted this shall be issued by the certification body within 42 calendar days of the audit (104 calendar days for an initial audit). The certificate shall conform to the format shown in Appendix 4. Logos used on certificates (e.g. BRC and accreditation body logos) shall comply with their respective usage rules. The certificate will detail: ○ the scope of the audit and any accepted exclusions from scope ○ the audit option chosen (i.e. foundation or higher) or whether the certificate is a reissue for an extension to scope ○ the six-digit auditor registration number of the lead auditor. The date(s) of audit specified on the certificate shall be the date of the audit relating to the granting of that certificate irrespective of whether later visits were made to verify corrective action arising from the audit. While the certificate is issued to the site, it remains the property of the certification body, and that body controls its ownership, use and display. 2.7 ONGOING AUDIT FREQUENCY AND RECERTIFICATION 2.7.1 Scheduling re-audit dates The ongoing audit schedule and choice of audit programme will be agreed between the site and the certification body. The frequency of announced audits will be 12 months. The due date of the subsequent audit shall be calculated from the date of the initial audit, irrespective of whether further site visits were made to verify corrective action arising from the initial audit, and not from the certificate issue date. The subsequent announced audit shall be scheduled to occur within a 28-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, without jeopardising continued certification.

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It is the responsibility of the site to maintain certification. Where an audit is delayed beyond the due date, except in justifiable circumstances, this shall result in a major non-conformity being awarded at the next audit. Justifiable circumstances shall be documented in the audit report. 2.7.2 Certificate expiry – justifiable circumstances There will be some circumstances where the certificate cannot be renewed on the 12-month basis due to the inability of the certification body to conduct an audit. These justifiable circumstances, which would not result in the assigning of a major non-conformity (clause 1.1.5), can be included when 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 ○ within a statutory exclusion zone that could compromise product safety ○ in an area that has suffered a natural or unnatural disaster, rendering the site unable to produce or the auditor unable to visit ○ affected by conditions that do not allow access to the site or restrict travel (e.g. heavy snow) ○ producing seasonal products where production is delayed by a late start to the season (e.g. due to weather or product availability). Moving the audit date to a more ‘acceptable’ later date for reasons of combining audits, lack of personnel or undertaking building work is not an acceptable reason for missing the due date. It is not justifiable to delay an audit just because the site is not in full production; however, audits must be undertaken while there are products being manufactured. If the renewal of the certificate is prevented due to these exceptional circumstances, the customer may still decide to take products from that site for an agreed time, as customers may still demonstrate legal compliance by other means, such as risk assessment and complaints records, to show that the site is still competent to continue production until another audit can be arranged. 2.7.3 Audits undertaken prior to due dates The due date of renewal audits occurs within a 28-day window prior to the 12-month anniversary of the initial audit. In some circumstances it is possible to undertake the audit earlier than these due dates, for example to reset the audit dates to allow combined audits with another scheme, or to include a product produced at a different season. Where an audit date is brought forward the following rules shall apply: ○ ○ ○ ○

The audit report will detail the reasons why an audit has been brought forward. The audit due date will be ‘reset’ to be 12 months from this audit date. The certificate should be issued with an expiry date of 12 months + 42 days from the ‘new’ audit date. Under no circumstances should a certificate have a validity of more than 12 months.

2.7.4 Seasonal production sites Refer to the glossary for the definition of ‘seasonal production sites’. A site that is open for 12 months of the year may process products in different seasons, but would not be classed as a seasonal production site as it would operate all the year round. If specific seasonal products are in scope, there may be a case to visit the site more than once a year. For true seasonal production sites there may be circumstances where the frequency of audits could be more than 12 months. The on-site audit date will be dictated by seasonal demands driven by key festivals and events. The certificate expiry dates in these circumstances will be controlled by the actual audit date rather than the anniversary of the initial audit date. Justification needs to be included on the audit report.

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3 GENERAL PROTOCOL – POST AUDIT 3.1 COMMUNICATION WITH CERTIFICATION BODIES In the event that any circumstances change within the site that may affect the validity of continuing certification, the site must immediately notify the certification body. This may include: ○ ○ ○ ○ ○

legal proceedings with respect to product safety or legality product recall significant damage to the site (e.g. natural disaster such as flood, or damage by fire) change of ownership significant change to the operation or scope.

The certification body in turn shall take appropriate steps to assess the situation and any implications for the certification, and shall take any appropriate action. Information shall be provided to the certification body by the site on request so that an assessment can be made as to the effect on the validity of the current certificate. The certification body may as appropriate: ○ ○ ○ ○ ○ ○

confirm the validity of certification suspend certification pending further investigation require further details of corrective action taken by the site undertake a site visit to verify the control of processes and confirm continued certification withdraw certification issue a new certificate with the new owner’s details.

Changes to the certification status of a site shall be recorded in the BRC Global Standards Directory. 3.2 EXTENSION TO SCOPE Once certification has been granted, any additional significant products manufactured or processes undertaken by the site, which are required to be included in the scope of certification, must be communicated to the certification body. The certification body shall assess the significance of the new products or processes and decide whether to conduct a site visit to examine the aspects of the required extension to scope. A revisit is required before granting a scope extension in the following circumstances: ○ inclusion of manufacturing facilities not taken into account in the original audit ○ inclusion of a new processing technology (e.g. introduction of electronic toys where these were not previously manufactured) ○ inclusion of new products which introduce a significant new risk to the facility. A revisit is less likely, for example, where: ○ new products are added to the existing ranges produced on existing equipment (e.g. a new fabric is introduced into a plush toy factory but the process does not change) ○ a simple additional process is included in the activities of the site. Where an extension to scope is required shortly before the certificate is due to expire, it may be more appropriate to undertake a full audit and issue a new certificate. This option should be agreed between the certification body and their client prior to undertaking the extension-to-scope audit. When a revisit is considered necessary, the duration of this visit will vary depending on the aspects to be examined for the required extension to scope. The site visit should be conducted along the same principles as the original audit (i.e. including an opening meeting, inspection of the operation of the process, documentation trails and closing meeting). The revisit should be announced. Identified non-conformities should be documented and actioned within the normal protocol of the Standard (i.e. the company has 28 days to provide appropriate evidence of close-out and the certification body should review the information and confirm the certification decision in the normal manner). The additional non-conformities raised at the site visit will affect neither the current certificated grade nor continued certification. However, if practices are seen that give the certification body cause to doubt

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continued certification (e.g. the identification of a critical non-conformity) then the certification body shall arrange a full re-audit of the site. In these circumstances the current certificate shall be withdrawn. A visit report should be documented, but shall not be in the format of a standard BRC audit report. A short explanation of the nature of the visit, what was audited and the conclusions shall be given. The visit report should document what controls are in place and confirm the effectiveness of these controls. It should be clear in the report what aspects were looked at and what was excluded. The site’s current certificate will be superseded by any new certificate issued. The certificate must use the same expiry date as detailed on the original certificate. The due date of the next full audit will therefore remain the same and this should be made clear to the supplier by the certification body when arranging extension-to-scope visits. The grade shall also remain the same. The certificate should include identification that it was a scope extension and the date of the visit. 3.3 CERTIFICATION WITHDRAWAL The certificate may be withdrawn by the certification body in a number of circumstances where the site may no longer comply with the requirements of the BRC certification scheme and ISO/IEC 17065 requirement. Examples of these instances are: ○ evidence that the site no longer complies with the requirements of the Standard, raising significant doubt of the conformity of the products produced ○ failure to implement adequate corrective action plans within appropriate timescales ○ evidence of falsification of records. 3.4 APPEALS The company has the right to appeal the certification decision made by the certification body and any appeal should be made in writing to the certification body within 7 calendar days of receipt of the certification decision. The certification body shall have a documented procedure for the consideration and resolution of appeals against the certification decision. These investigative procedures shall be independent of the individual auditor and certification manager. Individual certification bodies’ documented appeals procedures will be made available to the site on request. Appeals will be finalised within 30 calendar days of receipt. A full wrien response will be given aer 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. 3.5 SURVEILLANCE OF CERTIFICATED COMPANIES For certificated companies, where appropriate, the certification body or the BRC Global Standards team may carry out further audits or question activities to validate continued certification at any time. These visits may take the form of announced or unannounced visits to undertake either a full or a partial audit. Refusal of access to the site may affect certification status. Any non-conformities identified at a visit must be corrected and closed out within the normal protocol (i.e. within 28 days of the visit), and reviewed and accepted by the certification body. If there is no intention on behalf of the site to take appropriate corrective actions, or the corrective actions are deemed inappropriate, certification shall be withdrawn. The ultimate decision to suspend or withdraw certification remains with the certification body. Any change in certification status shall be notified to the BRC by the certification body and the status in the BRC Global Standards Directory amended accordingly. In the event that certification is withdrawn or suspended by the certification body, the company shall immediately inform its customers and make them fully aware of the circumstances relating to the withdrawal or suspension. Information on the corrective actions to be taken in order to reinstate certification status should also be provided to customers. 3.6 BRC LOGOS Achieving BRC certification is something of which to be proud. Companies that achieve certification and have no exclusions from their scope are qualified to use the BRC logo on site stationery and other marketing materials. Information and conditions relating to the use of the BRC logo are available at www.brcglobalstandards.com. If a site is no longer certificated because of certificate expiry, withdrawal or suspension it shall no longer use the logo or certificate claiming certification.

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The BRC logo may not be used by companies that do not include all products within the audit scope. 3.7 THE BRC GLOBAL STANDARDS DIRECTORY The BRC Global Standards Directory (www.brcglobalstandards.com) is the database of all audits conducted against a BRC Global Standard, all certification bodies, all auditors and their recognised audit categories. The directory holds full copies of all audit reports in read-only PDF. This includes archived audit documents from 2008 onwards. Certification bodies are responsible for maintaining site name, address, audit content and certificate status. All certification bodies are assessed and graded by the BRC on how quickly and accurately they update audit data. Audit reports can only be accessed following secure sign-in. The directory also features a publicly accessible search function which displays certification data only. The public directory lists only currently certificated sites, not those expired or withdrawn. Sites wishing to be excluded from public listing should contact their certification body. 3.7.1 Site code Each audited site is allocated a unique seven-digit reference number known as a site code. This can be used to authenticate the validity of any certificate. A site code is created when a site is audited for the first time and remains unchanged regardless of subsequent auditing certification bodies or audit status. Site codes are located on the top right-hand corner of the first page of the audit report and on the corresponding certificate. The listing for any certificated site can be located in the public directory by adding the site code to the ‘Site Code’ search field. If no results are returned for a search, contact the BRC to confirm certification authenticity. 3.7.2 Audit-sharing The directory allows audit owners to share their audit reports with customers, including retailers, manufacturers, suppliers and other specifiers. When audit sharing is set up, customers can access full current, archived and future audit documents as they become available without any further administration. An audit owner can cancel sharing at any time. All sharing changes take immediate effect. Audit documents shared in the directory cannot be edited or doctored by the audit owner. As such, audits obtained via the directory can be considered as complete and authenticated. 3.7.3 Notification emails The directory notifies audit owners, and anybody who has shared access to the audit, if a site’s certification is suspended, withdrawn or expires without replacement. Notifications are via automated email and can be turned off if not required. For further information on the directory or audit sharing, contact the BRC Directory Services team via [email protected]

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The BRC logo is not a product certification mark and shall not be used on products or product packaging. Any certificated site found to be misusing the mark will be subject to the BRC complaints/referral process (see Part IV) and may risk suspension or removal of its certification.

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PART IV MANAGEMENT AND GOVERNANCE REQUIREMENTS FOR CERTIFICATION BODIES TECHNICAL GOVERNANCE OF THE STANDARD 54 56 56

International advisory boards Technical advisory committee The certification body co-operation groups

ACHIEVING CONSISTENCY – COMPLIANCE 57 57 57

Calibrating auditors Feedback Complaints

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PART IV MANAGEMENT AND GOVERNANCE REQUIREMENTS FOR CERTIFICATION BODIES The Global Standard for Consumer Products is a process and product certification scheme. In this scheme, businesses are certificated upon completion of a satisfactory audit by an auditor employed by an independent third party – the certification body. The certification body in turn shall have been assessed and judged as competent by a national accreditation body. The process of certification and accreditation is outlined in Figure 2. In order for a business to receive a valid certificate on completion of a satisfactory audit, the organisation must select a certification body approved by the BRC. The BRC lays down detailed requirements that a certification body must satisfy in order to gain approval. As a minimum, the certification body must be accredited to ISO/IEC 17065 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’, which is 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 which 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 the process of achieving accreditation and so some unaccredited audits will be performed. This will be permied where the organisation can demonstrate: ○ an active application for accreditation against ISO/IEC 17065 from an approved national accreditation body ○ that accreditation will be achieved within 12 months of the date of application and that the experience and qualifications of the auditors in the relevant product and process technology are consistent with those specified by the BRC ○ 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.

TECHNICAL GOVERNANCE OF THE STANDARD The Standard and associated scheme is managed by the BRC with governance and technical advice provided through a number of stakeholder groups (see Figure 3), each of which works to a set of defined terms of reference. INTERNATIONAL ADVISORY BOARDS The technical management and operation of the Standard is governed by the BRC International Advisory Boards. These consist of senior technical representatives of international retail and manufacturing businesses in Europe, America and Asia. The functions of the advisory boards are to provide strategic advice on the development and management of the BRC Global Standards and the activities to ensure the effective management of the certification bodies and audit process.

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PART IV MANAGEMENT AND GOVERNANCE

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 17065

National accreditation body

ACCREDITATION ISO/IEC 17065

Requirements for certification bodies offering certification against the criteria of the BRC Global Standards

Certification body

CERTIFICATION

Site

Site

Site

BRC Global Standards website www.brcglobalstandards.com

BRC Global Standards Directory www.brcdirectory.com

FIGURE 2 PROCESS FOR ACCREDITATION OF CERTIFICATION BODIES WWW.BRCGLOBALSTANDARDS.COM

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TECHNICAL ADVISORY COMMITTEE Each BRC Global Standard is supported by at least one technical advisory commiee (TAC), which meets regularly to discuss technical, operational and interpretational issues relating to the Standard. The BRC provides the technical secretariat for these groups. The TAC for the Global Standard for Consumer Products is made up of senior technical managers representing the users of the Standard and includes representatives of retailers, manufacturers, trade associations for each sector, certification bodies, accreditation agencies and independent technical experts. The Standard is reviewed every 3 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. THE CERTIFICATION BODY CO-OPERATION GROUPS The BRC encourages and facilitates meetings of the certification bodies participating in the scheme (co-operation groups) to discuss maers 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 co-operation groups aend the TAC meetings.

International advisory boards

BRC executive

Technical advisory committee

Certification body co-operation groups

FIGURE 3 GOVERNANCE OF THE BRC SCHEMES

ACHIEVING CONSISTENCY – COMPLIANCE The maintenance of a high and consistent standard of audit and certification, and the ability of the certificated sites to maintain the standards achieved at the audit, are essential to confidence in the scheme and to the value of certification. The BRC therefore has an active compliance programme to supplement the work of accreditation bodies and ensure high standards are maintained. The BRC scheme may only be certificated by certification bodies registered and approved by the BRC and accredited by a BRC-recognised accreditation body. All auditors undertaking audits against the Standard must meet the BRC auditor competency requirements and shall be registered with the BRC. The qualifications, training and experience requirements for auditors who conduct audits against the BRC Global Standard for Consumer Products are detailed in Appendix 1. All audits undertaken against the Standard shall be uploaded to the BRC Global Standards Directory, which provides the BRC with an oversight of the activity of the certification bodies and the opportunity to review the quality of the reports produced. To support the Standard, the BRC operates a compliance programme which reviews the performance of the certification bodies, samples the quality of audit reports, assesses 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 (KPI) programme.

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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 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. 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. COMPLAINTS The BRC has implemented a formal complaint process, which is available to organisations involved with the Global Standards. This is available on the website (www.brcglobalstandards.com). 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 conduct an investigation as appropriate and may undertake announced or unannounced visits to a certificated site.

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PART IV MANAGEMENT AND GOVERNANCE

As part of the compliance programme the BRC audits the offices of certification bodies and accompanies auditors on audits at sites to observe the performance of auditors. The BRC may also undertake independent visits to certificated sites to ensure standards of product safety, quality and legality are being maintained in line with its certification status and ensure that the audit and reporting process is to the expected standard.

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APPENDICES APPENDIX 1 Registration, qualifications, training and experience requirements for auditors

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APPENDIX 2 62

Product categories

APPENDIX 3 66

Multiple sites audit protocol

APPENDIX 4 69

Certificate template

APPENDIX 5 70

Other BRC Global Standards

APPENDIX 6 71

Glossary

APPENDIX 7 80

Acknowledgements

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APPENDIX 1 REGISTRATION, QUALIFICATIONS, TRAINING AND EXPERIENCE REQUIREMENTS FOR AUDITORS All auditors conducting audits against the BRC Global Standard for Consumer Products are required to be registered with the BRC. The registration process identifies that auditors have undergone the required training and identifies the process technologies in which they have expertise. Evidence of an auditor’s qualifications, experience and training has to be submied to the BRC before they carry 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. Competence to carry out a specific audit shall be verified 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 TAC. The following outlines the requirements of auditors who may be registered to audit against the Standard.

EDUCATION The auditor ideally shall have a recognised professional apprenticeship, a degree in a science or engineering discipline or have successfully completed a higher education qualification in a science- or engineering-related discipline.

WORK EXPERIENCE The auditor shall have a minimum of 3 years’ post-qualification experience related to their main qualification discipline or to the relevant technology or industry. 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 process technologies for which they are approved. The verification to carry out work within specific process technologies will be carried out by the certification body.

PROFESSIONAL QUALIFICATIONS The auditor must have: ○ passed a registered management system lead assessor course (e.g. IRCA) or the BRC third-party auditor course delivered by a BRC-approved trainer ○ completed a training course in hazard analysis and risk assessment of at least 2 days’ duration. It is essential that the hazard analysis and risk assessment 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 process technologies for which they are considered competent. Auditor competence shall be recorded at the level of each field of audit as indicated in Appendix 2.

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Certification bodies must establish a training programme for new auditors, which will incorporate: ○ a Global Standard for Consumer Products awareness course delivered by a BRC-approved trainer ○ a period of initial training covering product safety, hazard and risk management, good manufacturing practice and management of factory environment standards that will include access to relevant laws and regulations ○ a period of supervised training to cover management systems, audit techniques and specific process technologies of audit knowledge ○ assessment of knowledge and skills for each process technology ○ documented sign-off on the satisfactory completion of the training programme. Each auditor’s training programme shall be managed and approved by an assessor who can demonstrate that they are technically competent in the process technologies in which training is given. Full, detailed training records of the individual must be maintained by the certification body throughout their term of employment, and retained for a minimum period of 5 years aer leaving the employment of the certification body.

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APPENDIX 2 PRODUCT CATEGORIES

In order to help customers search for suppliers in the BRC Directory, the BRC Global Standards team have defined 21 product categories. The appropriate Standard, category and examples of typical products are detailed in the table below.

STANDARD

BRC CODE

BRC CATEGORY

PRODUCT EXAMPLES

General Merchandise

1

Textiles and textile products

Apparel, hair accessories

Personal Care and Household

General Merchandise

1

Textile furnishings, bed linen, towels

1

Carpets

1

Coon wool

1

Coon wipes

2

General Merchandise

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Belts, pet accessories

2

Footwear

2

Bags, luggage

3

Personal Care and Household

Leather, leather products

Wood, wood mix, cork, straw

Pencils

3

Doors, flooring

3

Bamboo steamers

3

Baskets, mats

3

Tablemats

4

Paper and paper-mix products

Stationery items

4

Disposable tissues

4

Toilet roll, kitchen towels

4

Disposable table and party ware (food contact)

4

Food wrap, bags

4

Coffee filters

4

Foil and film

4

Wet wipes

4

Personal hygiene sanitary, nappies

5

Printing and recorded media

DVDs

5

Magazines, books

5

Labels

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Personal Care and Household

BRC CODE

BRC CATEGORY

PRODUCT EXAMPLES

6

Coke, charcoal, refined petroleum products

Barbecue fuel

6

Coal

6

Oil for lamps

6

Candles

7

Chemicals and chemical products

7 General Merchandise

Personal Care and Household

Household chemicals

7

Chemicals and chemical products

Paints

8

Gardening products

Garden chemicals

8

Compost, peat

8

Gardening tools

8

Barbecues

9

Plastic and rubber products

9 General Merchandise

9

Personal Care and Household

General Merchandise

Cosmetics

Gloves Nursery accessories

Plastic and rubber products

Stationery items

9

Pet accessories

9

Household utensils, water filters

9

Personal protective equipment, outer wear

9

Footwear, hair accessories

9

Flooring

9

Luggage

9

Disposable table and party ware (food contact)

9

Food wrap, film, bags

9

Bin liners

10

Glass, ceramic and nonmetallic mineral products

Tableware

10

Cookware

10

Decorative items, vases, pictures

10

Mirrors

10

Cat lier

11

Building goods

Concrete, lime, cement, plaster

12

Metal products excluding machinery

Handles

12

Tins (storage), trays

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APPENDICES

STANDARD

PRODUCT CATEGORIES continued STANDARD

BRC CODE

Personal Care and Household

General Merchandise

PRODUCT EXAMPLES

12

Cookware, cutlery

12

Razor blades

12

Foil

12

Stationery items

12

Screws, nails

13

Machinery and equipment

Ladders

13

Sports and camping

13

Tools

13

Gas appliances

13

Lawn mowers

13

DIY accessories

14

Computers, electronic communications

Computers

14

Phones

14

Computer accessories

14

Audiovisual

15

Electrical equipment

Lighting

15

Household appliances, plug-in air fresheners, hair straighteners

15

White goods

15

Baery-powered items

15

Baeries

16

Transport equipment, cycles, boats

Bicycles

16

Canoes

16

Car accessories

17

Furniture

Outdoor

17

Upholstered

17

Metal, wood, plastic, glass

17

Inflatables (excluding toys)

18

Games and toys

Plush toys

18

Plastic toys

18

Wooden toys

18

Chemistry sets

18

Radio-controlled toys

18

Playground equipment

19 19

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Jewellery

Gemstones Precious jewellery

BRC CODE

Personal Care and Household

General Merchandise

BRC CATEGORY

PRODUCT EXAMPLES

19

Fashion jewellery, hair accessories

19

Buckles

19

Piercings

20

Medical devices

Dressings (non-medicated)

20

Walking aids

20

Contact lens solutions (non-medicated)

20

Thermometers, healthmonitoring equipment

21 21

Party and leisure

Dressing-up costumes (excluding toys) Fireworks, party crackers, poppers

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APPENDICES

STANDARD

APPENDIX 3 MULTIPLE SITES AUDIT PROTOCOL SCOPE OF AUDIT The scope of a BRC audit needs to be agreed between the site and the certification body prior to the audit. The audit, report and certificate shall be site-specific. However, in some exceptional circumstances more than one site may be included under a single certification. Audits may cover multiple site addresses where all of the following rules apply: ○ ○ ○ ○ ○

all sites are owned by the same organisation all sites are operated against the same documented quality management systems the sites manufacture product which is part of the same manufacturing process the sites solely supply other sites included in the certification, with no additional customers the sites are no more than 30 miles/50 km apart.

AUDIT PLANNING All sites must be visited as part of the same audit schedule (i.e. within the same timeframe). The certification body’s audit plan needs to clearly show the sites that are to be audited. It must be clearly stated on the report and certificate that the audit has consisted of visits to more than one site address.

AUDITING OF ACTIVITIES WHERE THE HEAD OFFICE IS LOCATED SEPARATELY When undertaking audits of sites which are part of a larger manufacturing group, it is not uncommon to find that some of the requirements within the scope of the Standard are undertaken by a central or head office. Typically, this may apply to activities such as purchasing, supplier approval, product development or product recall. Occasionally, there is a group-shared quality management system for document control and procedures. All requirements within the scope of the Standard must be assessed as satisfactory before a certificate can be issued. This requires that any centrally managed systems are included within the audit process. There are two approaches to auditing the requirements which are managed at a central office: ○ Request and review information while at the manufacturing site as part of the site audit – standard audit. ○ Undertake a separate audit of the centrally managed processes at the group/head office location – two-stage audit. APPROACH 1: REQUESTING AND REVIEWING INFORMATION AT THE MANUFACTURING SITE This is recommended only where: ○ satisfactory links can be established with the central office (telephone or video conferencing links to allow interview of relevant personnel; fax or email links to allow documents to be requested and viewed), and arrangements in place to ensure availability of relevant personnel ○ the amount and type of information can be effectively reviewed and challenged remotely. Where a site elects for the information to be assessed during the manufacturing site audit and satisfactory information cannot be provided during the audit, unsubstantiated requirements shall be recorded as non-conformities on the site audit report.

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Non-conformities Non-conformities raised against a centrally operated requirement shall be recorded on the audit report and included within the count of non-conformities contributing to the site grade. Corrective action shall be assessed in the same way as for non-conformities raised at the manufacturing site and must be satisfactorily corrected before a certificate can be issued to the site. Subsequent manufacturing site audits The central system requirements shall be challenged and evidence of compliance provided at each manufacturing site audit. APPROACH 2: TWO-STAGE AUDITS – CENTRAL SYSTEM AND SEPARATE MANUFACTURING SITE AUDITS This approach is recommended where it is not practical to effectively assess requirements from the manufacturing site. For example, where: ○ practical arrangements to allow assessment cannot be provided ○ there are too many centrally managed requirements to be effectively reviewed remotely. This shall be offered to the site being audited and undertaken when requested by the site. Stage 1 – Central system audit The audit of the central system shall be completed before undertaking the manufacturing site audit. The audit shall assess both how the central system complies with the relevant requirement of the Standard and how this links to the manufacturing site operation.

Reports for the central system audit The certification body may produce a report of the central system audit for the benefit of the company. However, as this audit will only include some of the requirements of the BRC Standard: ○ no grade may be allocated ○ no certificate may be issued ○ the report must be in a format which is clearly different from the full BRC audit report. The central system report shall not be uploaded to the BRC Global Standards Directory but the findings of the central system audit shall be incorporated into the final audit report of each of the associated manufacturing sites.

Recording non-conformities identified at the central system audit All non-conformities identified at the central office audit shall be recorded on the audit report of the first manufacturing site audited following the central systems audit – irrespective of whether these have been closed out before that audit or not. However, only those non-conformities raised at the central office audit which have not been closed out to the satisfaction of the certification body at the time of the manufacturing site audit shall be counted when calculating the grade for the manufacturing site. Any non-conformities identified at the head office audit which are still outstanding at the time of further manufacturing site audits (second, third, etc.) shall be included on that manufacturing site report and be included when calculating the grade for the site.

Closure of central system’s corrective actions Corrective actions required following the central office audit shall be assessed in the same way as corrective actions raised at the manufacturing site and must be satisfactorily corrected before a certificate can be issued to the manufacturing sites. This may be by documentary evidence or a revisit, as appropriate.

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APPENDICES

Reporting The audit report shall make it clear where a requirement is managed by a central office together with a comment on how the company complies with the requirement.

Stage 2 – Manufacturing site(s) audit Information from the central office audit, including any evidence of corrective actions taken, shall be made available to the auditors of the associated manufacturing sites by the certification body. The auditor shall establish that the central systems components assessed are the same as those operating at the manufacturing site. The auditor shall verify any corrective actions already taken following the central systems audit.

Audit duration It may be possible to reduce the duration of the manufacturing site audit to take account of systems already audited at a central office.

BRC audit report The final audit report shall be applicable to the manufacturing site. The central office audit shall be commented upon in the Company Profile; for example: ‘An audit was carried out at the central office at ……………. on the ……… to assess requirements as indicated in the report’. The key personnel may include the names of key staff present at the central office audit. The manufacturing site(s) audit report shall include information about how both the site and the central system comply with the requirements of the Standard. The report shall indicate where a requirement is managed by a central office and provide an explanation of how that requirement is satisfied.

Corrective action The time limit allowed for evidence of corrective action to be provided starts from the date of the manufacturing site audit. It is the responsibility of the site to ensure that central office corrective actions have been provided to the certification body in order to allow the site to become certificated. This will require effective communication with the central systems office. Where central systems corrective actions have been accepted prior to the first manufacturing site audit, this shall be indicated on the first manufacturing site audit report and the date of acceptance of the action indicated in the ‘action taken’ section of the non-conformity report.

Certificate The certificate, where awarded, is issued to the manufacturing site. The re-audit date for the manufacturing site shall be 12 months from the initial audit date. The central office audits shall be carried out every 12 months and shall occur before the anniversary of the audit of the first manufacturing site.

Audits of other manufacturing sites associated with the central system Usually there will be several manufacturing sites associated with a central system. The information from the annual central system audit shall be used for each subsequent manufacturing site audit. Non-conformities originally raised at the central office and effectively corrected before the audit of that manufacturing site shall not be recorded as non-conformities on the site audit report. Any outstanding non-conformities at the time of the manufacturing site audit shall, however, be included within that site’s report and calculation for grading purposes. The BRC shall be contacted by the certification body for advice before carrying out audit programmes for more complex arrangements of sites and centralised systems.

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APPENDIX 4 CERTIFICATE TEMPLATE CERTIFICATION BODY NAME OR LOGO

Auditor number

[Certification body name, certification body number] certifies that, having conducted an audit For the scope of activities: Exclusions from scope: Product categories: At COMPANY NAME SITE CODE AUDIT SITE ADDRESS Meets the requirements set out in the

BRC GLOBAL STANDARD for CONSUMER PRODUCTS ISSUE 4: NOVEMBER 2016 GENERAL MERCHANDISE

Level: FOUNDATION / HIGHER LEVEL (as applicable) Has achieved Grade: (Higher level only)

Date(s) of audit: If an extension to scope, include original audit date and visit date] Certificate issue date: Re-audit due date: from

to

Certificate expiry date:

Accreditation body logo

Authorised by

BRC logo

Name and full address of certification body Certificate traceability reference This certificate remains the property of [name of certification body] If you would like to feedback comments on the BRC Global Standard or the audit process directly to BRC, please contact [email protected] or call the Tell BRC Hot line +44 (0)20 7717 5959.

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APPENDIX 5 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 other BRC Standards complement the Global Standard for Consumer Products and provide a resource for the auditing and certification of suppliers. The BRC Global Standard for Food Safety is an auditing Standard that sets out the requirements for the manufacture of processed foods and the preparation of primary products supplied as retailer-branded products, branded food products, and food or ingredients for use by food service companies, catering companies and food manufacturers. The BRC Global Standard for Packaging and Packaging Materials is an auditing standard that lays down the requirements for the manufacturing of packaging materials used for food and consumer products. The Standard applies wherever processes are undertaken with packaging materials – even simple processes such as cut and crease. The BRC Global Standard for Storage and Distribution is an auditing standard that sets out the requirements for the storage, distribution, wholesaling and contracted services for 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 (e.g. the BRC Global Standard for Food Safety). The Global Standard for Storage and Distribution applies only where no processing activities occur. The BRC Global Standard for Agents and Brokers is an auditing standard which enables companies to be audited and certificated where they buy and sell products or provide services to other parties but are unable to gain certification to the production or storage and distribution standards because there is no product present to be audited. The BRC Global Standard for Retail is an auditing standard applicable to businesses in the food retail industry that buy and sell products and provide services for the sourcing, purchase, importation, distribution, preparation and retailing of products. The companies may also have their own processing, storage or distribution facilities but these facilities are certificated to the relevant production or storage and distribution standards.

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APPENDIX 6 GLOSSARY

Acceptable quality limit (AQL)

Acceptable quality limit as defined in ISO 2859 part 1.

Accreditation

The procedure by which an authoritative body gives formal recognition of the competence of a certification body to provide certification services against a specified Standard.

Agent/non-manufacturing service provider

A company that facilitates trade between a manufacturer or broker and their customer through the provision of services, but does not at any point own or take title to the goods.

Allergen

A known component which causes physiological reactions due to an immunological response, e.g. fragrances, preservatives, nuts and others identified in legislation relevant to the country of production or sale.

Announced audit

An audit where the company agrees the scheduled audit day in advance with the certification body.

Assembly packer

A business that assembles a collection of two or more market-ready finished consumer products into outer packaging to be sold as a single product. An assembly packer does not manufacture any of the component products which are supplied for the assembly into the final pack.

Assembly packing

A process that assembles a collection of two or more market-ready finished products into outer packaging to be sold as single product. Companies undertaking this process do not manufacture any of the component products, but are supplied with them for assembly into the final pack.

Assured status

Products produced in accordance with a recognised product certification scheme, the status of which needs to be preserved through the BRC certified production facility (e.g. GlobalGAP).

ATP bioluminescence techniques

A rapid test for cleanliness of surfaces based on ATP (adenosine triphosphate) – a substance used in energy transfer in cells and therefore present in biological material.

Audit

A systematic examination to measure compliance of practices with a predetermined system, and whether the system is implemented effectively and is suitable to achieve objectives, carried out by certified bodies.

Audit level

The level (foundation or higher) agreed between the company and the certification body as the criterion for the audit and certification.

Auditor

A person possessing the appropriate competence and skills to carry out an audit.

Back-haul

To collect a load following the delivery of products for return to the distribution depot or warehouse.

Batch

A discrete quantity of products made using the same operation and raw materials (alternative term is ‘lot’).

Bill of materials

List of the materials used, including component parts, in the make-up of a product.

Brand owner

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

Branded product

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

Broker

A company which purchases or ‘takes title to’ products for resale to businesses (e.g. manufacturers, retailers or food service companies) but not to the ultimate consumer.

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Business continuity

A framework that enables an organisation to plan and respond to incidents of business interruption in order to continue business operations at an acceptable predetermined level.

Calendar day

Includes both working days and weekends but excludes periods of legal public holiday for the country in which the site and/or certification body is located.

Calibration

A set of operations that establish, under specified conditions, the relationship between values of quantities indicated by a measuring instrument or measuring system, or values represented by a material measure or reference material, and the corresponding values realised by standards.

Certificate suspension

Revocation of certification for a given period, pending remedial action on the part of the company.

Certificate withdrawal

Where certification is revoked. Certification may only be regained following successful completion of the full audit process.

Certification

The procedure by which an accredited certification body, based on an audit and assessment of a company’s competence, provides wrien assurance that a company conforms to a standard’s requirements.

Certification body

Provider of certification services, accredited to do so by an authoritative body and registered with the BRC.

Clause

A specific requirement or statement of intent that a site must comply with in order to achieve certification.

Cleaning in place (CIP)

The process of cleaning and sanitising food-processing equipment in its assembled position without the need for dismantling and cleaning the individual parts.

Codex Alimentarius Commission

A body responsible for establishing internationally recognised standards, codes of practice and guidelines, of which HACCP (Hazard Analysis and Critical Control Points) is one standard.

Company

The entity with legal ownership of the site which is being audited against the BRC Global Standard.

Competence

Demonstrable ability to apply skill, knowledge and understanding of a task or subject to achieve intended results.

Compliance

Meeting the regulatory or customer requirements concerning product safety, legality and quality.

Consumer

The end-user of the finished product, commodity or service.

Consumer product management system

Any system related to product hazard and risk processes, which determine and control product safety, legality and quality.

Consumer products

Non-food products normally bought by or supplied to wholesale and private consumers for personal, business or household use, and included within the scope of the BRC Consumer Products Standard.

Contamination

Introduction or occurrence of an unwanted organism, taint or substance to packaging, food or the food environment. Contamination includes physical, chemical, biological and allergen contamination.

Contract packer

A company that packages the final product into consumer packaging.

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.

Control measure

Any action or activity that can be used to prevent or eliminate a product safety hazard or reduce it to an acceptable level.

Controlled document

A document which is identifiable and for which revisions and removal from use can be tracked. The document is issued to identified individuals and their receipt of the document is recorded.

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Cook

A thermal process designed to heat a food item to a minimum of 70°C for 2 minutes or an equivalent thereof.

Corrective action

Action to eliminate the cause of a detected non-conformity.

Critical control point (CCP)

A step at which control can be applied and is essential to prevent or eliminate a food or product safety hazard or reduce it to an acceptable level.

Cross-docking

Material is unloaded at distribution premises, and handled, but not formally put away into storage. This may be a staging area where inbound materials are sorted, consolidated and temporarily stored until the outbound shipment is complete and ready to ship.

Customer

A business or person to whom a service or product has been provided, either as a finished product or as a component part of the finished product.

Customer focus

A structured approach to determining and addressing the needs of an organisation to which the company supplies products and which may be measured by the use of performance indicators.

Day

See calendar day.

Despatch/dispatch

The point at which the product leaves the factory site or is no longer the responsibility of the company.

Distribution

The transportation of goods within any container (goods on the move) by road, rail, air or ship.

End-consumer

The ultimate consumer of a foodstuff, who will not use the food as part of any food-business operation or activity.

Enrolment scheme

A scheme whereby registration is followed by an audit giving a scored result. This result can be used as part of a continual development plan by a company.

Environmental aspect

Element of an organisation’s activities or products that can interact with the environment.

Environmental impact

Any change to the environment, whether adverse or beneficial, wholly or partially resulting from an organisation’s activities, goods or services.

Exemption

A requirement that may not be applicable to a product or product sector, and is verified by hazard and risk analysis.

Exporter

A company facilitating the movement of products out of a country, across an international border.

Factored goods

Goods not manufactured or part-processed on site but bought in and sold on.

Final manufacturer

The site where the last processing act is undertaken on a product before it is supplied to the agent or broker.

Flow diagram

A systematic representation of the sequence of steps or operations used in the production or manufacture of a particular item.

Food

Products as defined by the EU Food Hygiene Regulations 178/2002.

Food handler

Anyone who handles or prepares food, whether open (unwrapped) or packaged.

Food safety

Assurance that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use.

Fundamental requirement

A requirement of the Standard that relates to a system which must be well established, continuously maintained and monitored by the company as absence or poor adherence to the system will have serious repercussions on the integrity or safety of the product supplied.

Genetically modified organism (GMO)

An organism whose genetic material has been altered by the techniques of genetic modification so that its DNA contains genes not normally found there.

Global Food Safety Initiative (GFSI)

Managed by the Consumer Goods Forum, a project to harmonise and benchmark international food safety standards (www.mygfsi.com).

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.

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Good manufacturing practice (GMP)

Implemented procedures and practices undertaken using best practice principles.

Harmonised standard

A standard listed by the European Commission or member state as suitable for determining compliance with essential safety requirements. The list can be found at: www.ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist

Hazard

An agent of any type with the potential to cause harm (usually biological, chemical, physical or radiological).

Hazard Analysis and Critical Control Points (HACCP)

A system that identifies, evaluates and controls hazards which are significant for food safety.

Hazard and risk analysis (HARA)

A system that identifies, evaluates and controls hazards which are significant for product safety, quality and legality.

High-care area

An area designed to a high standard where practices relating to personnel, ingredients, equipment, packaging and environment aim to minimise product contamination by pathogenic micro-organisms.

High-care product

A product that requires chilling or freezing during storage, is vulnerable to the growth of pathogens, has received a process to reduce the microbiological contamination to safe levels (typically 1–2 log reduction) and is ready to eat or heat.

High-risk area

A physically segregated area, designed to a high standard of hygiene, where practices relating to personnel, ingredients, equipment, packaging and environment aim to prevent product contamination by pathogenic micro-organisms.

High-risk product

A chilled ready-to-eat/ready-to-heat product or food where there is a high risk of growth of pathogenic micro-organisms.

Hub depot

A storage and distribution site receiving products from external companies and supplying products to other depots within the company’s own distribution network. See satellite depot.

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.

Identity preserved

A product which has a defined origin or purity characteristic which needs to be retained throughout the food chain (e.g. through traceability and protection from contamination).

Importer

A company facilitating the movement of products across an international border. Usually the first recipient of the products in that country.

Incident

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

Infant

A child under 36 months.

Initial audit

The BRC audit at a company/site which is not in possession of a valid BRC certificate. This may be the first audit at a site or a subsequent audit of a site whose certification has lapsed.

Injury: serious (major)

2–15% incapacity. Usually irreversible and requiring hospital treatment (e.g. serious cuts, loss of finger or toe, damage to sight, damage to hearing).

Injury: slight (minor)

15% incapacity. Usually irreversible and requiring hospital treatment (e.g. serious injury to internal organs, loss of limbs, loss of sight, loss of hearing, acute poisoning).

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.

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Used to describe a device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body. For the purposes of this Standard, ‘invasive’ does not include products entering the mouth or outer ear for periods of less than 30 minutes. A surgically invasive device is a device which penetrates inside the body through the surface of the body, with the aid or in the context of a surgical operation.

Job description

A list of the responsibilities for a given position at a company.

Key staff

Those staff whose activities affect the safety, legality and quality of the finished product.

Legality

In compliance with the law in the place of production and in the countries where the product(s) is/are intended to be sold.

Location

The geographical area within which individual premises reside in order to be classed as a single site for auditing purposes (i.e. a radius of 50 km from the usual place of work of the management team).

Loose/open food

Food ingredients or finished products that are unwrapped or not stored in packaging that is designed to protect the product when it is sold to the consumer (e.g. trays of fresh produce, meat carcasses).

Lot

See batch.

Low-risk area

An area where the processing or handling of foods presents minimum risk of product contamination or growth of micro-organisms, or where the subsequent processing or preparation of the product by the consumer will ensure product safety.

Mandatory standard

Standard which must be met to demonstrate legal compliance in a country or region.

Manufacturer

A company that produces product from raw materials and/or components and packs the product into retail units or supplies product in bulk to a packing company that packs the product into retail units. A packer that packs product into retail units from bulk-supplied material can also be classed as a ‘manufacturer’.

May

Indicates a requirement or text which provides guidance but is not mandatory for compliance to the Standard.

Nanomaterials

Materials that have structured components with at least one dimension less than 100 nm.

Nanotechnology

Technology using nanomaterials in order to impart specific properties.

Non-conformity

The non-fulfilment of a specified product safety, legal or quality requirement or a specified system requirement.

Office

For the purposes of this Standard, an office is a dedicated workplace where two or more people work, that has accessibility to company files, and is a registered postal address for the company.

Original copy

A document, whether in electronic or printed form, that has been legally obtained and does not infringe any copyright.

Outer packaging

Packaging which is visible when the product is released from the site. For example, a cardboard box could be considered outer packaging even if wrapped in clear film.

Performance indicators

Summaries of quantified data that provide information on the level of compliance against agreed targets (e.g. customer complaints, product incidents, laboratory data).

Positive release

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

Post-consumer recyclate (PCR)

Material generated by households or by commercial, industrial and institutional facilities in their role as end-users of the goods or services which can no longer be used for its intended purpose. This includes returns of material from the distribution chain.

Post-consumer waste (PCW)

Waste collected aer the consumer has used and disposed of it.

Post-industrial waste (PIW)

Waste collected aer processing but before it has reached the supply chain.

Potable water

Water being safe to drink, free from pollutants and harmful organisms and conforming to local legal requirements.

Premises

A physical building or place owned by the company and audited as part of a site.

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APPENDICES

Invasive

Pre-packaged products

Products in their final packaging that is designed for sale to the consumer.

Prepared primary product

A food product which has undergone a washing, trimming, size-grading or quality-grading process and is pre-packed.

Prerequisite

The basic environmental and operational conditions in a food business that are necessary for the production of safe food. These control generic hazards covering good manufacturing practice and good hygienic practice and shall be considered within the HACCP study.

Primary customer

The first customer who receives the goods on dispatch from the factory.

Primary packaging

That packaging which constitutes the unit of sale, used and disposed of by the consumer (e.g. bole, closure and label).

Procedure

Agreed method of carrying out an activity or process which is implemented and documented in the form of detailed instructions or process description (e.g. a flowchart).

Processed food

A food product which has undergone any of the following processes: aseptic filling, baking, baering, blending, boling, breading, brewing, canning, coating, cooking, curing, cuing, dicing, distillation, drying, extrusion, fermentation, freeze drying, freezing, frying, hot filling, irradiation, microfiltration, microwaving, milling, mixing, being packed in modified atmosphere, being packed in vacuum packing, packing, pasteurisation, pickling, roasting, slicing, smoking, steaming or sterilisation.

Processing aid

Any substance not consumed as a food by itself, intentionally used in the processing of raw materials, foods or their ingredients to fulfil a certain technological purpose during treatment or processing, and which may result in the unintentional but technically unavoidable presence of the residues of the substance or its derivatives in the final product – provided that these residues do not present any health risk and do not have any technological effect on the finished product.

Product integrity

The undamaged and sound condition of the product, aided by the ability of the packaging material to provide an effective protective barrier.

Product recall

Any measures aimed at achieving the return of an unfit product from customers and final consumers.

Product withdrawal

Any measures aimed at achieving the return of out-of-specification or unfit products from customers, but not from final consumers.

Protective clothing

Clothing designed to protect the product from potential contamination by the wearer.

Provenance

The origin or the source of raw materials.

Quality

Meeting the customer’s specification and expectation.

Quantity check/mass balance

A reconciliation of the amount of incoming raw material against the amount used in the resulting finished products, also taking into account process waste and rework.

Quantity control

Check on amount of product in the consumer pack. May be related to weight, volume, number of pieces, size etc.

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.

Ready-to-cook food

Food designed by the manufacturer as requiring cooking or other processing effective to eliminate or reduce to an acceptable level micro-organisms of concern.

Ready-to-eat food

Food intended by the manufacturer for direct human consumption without the need for cooking or other processing, effective to eliminate or reduce to an acceptable level microorganisms of concern.

Ready-to-heat food

Food designed by the manufacturer as suitable for direct human consumption without the need for cooking. The heating of the product is intended to make the product more palatable.

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APPENDICES

Recognised laboratory accreditation

Laboratory accreditation schemes that have gained national and international acceptance, awarded by a competent body and recognised by government bodies or users of the Standard (e.g. ISO/IEC 17025 or equivalents).

Recycled material

Material that has been reprocessed from recovered (reclaimed) material by means of a manufacturing process and made into a final product or into a component for incorporation into goods or services.

Reference sample

Agreed product or components for referral by the manufacturer for production.

Requirement

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

Retail brand

A trademark, logo, copyright or address of a retailer.

Retailer

A business selling products to the public by retail.

Retailer-branded products

Products bearing a retailer’s logo, copyright, address or ingredients used to manufacture within retailer’s premises. These are products that are legally regarded as the responsibility of the retailer.

Retained production sample

Representative product or components taken from a production run and securely held for future reference.

Re-use

Cleaning and/or refurbishing an old product to be used again.

Risk

The likelihood of occurrence of harm from a hazard.

Risk analysis

A process consisting of three components: risk assessment, risk management and risk communication.

Risk assessment

The identification, evaluation and estimation of the levels of risk involved in a process to determine an appropriate control process.

Root cause

The underlying cause of a problem, which, if adequately addressed, will prevent a recurrence of that problem.

Safety

Freedom from unacceptable risk or harm.

Sampling plan

A documented plan defining the number of samples to be selected, the acceptance or rejection criteria and the statistical confidence of the result.

Satellite depot

A warehouse/distribution site receiving products only from another site within the same company.

Schedule

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

Seasonal or intermient production

Short-term (typically 6 months or less) production of a product during a 12-month cycle at the site.

Seasonal production site

A product harvested and processed on a site that is opened specifically for the duration of the short term of that harvest (typically 12 weeks or less) during a 12-month cycle.

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 and the capability to authorise the financial or human resources necessary for the implementation of the Standard.

Shall

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

Should

Signifies that compliance with the contents of the clause is expected or desired.

Site

A unit of a company; the entity which is audited and which is the subject of the audit report and certificate. A site may be made up of more than one premises within a location. For distribution this will be the address from which vehicles operate.

Skin contact

Product in intimate contact with the skin for more than 30 minutes at one use. Examples include face paints and lingerie. Products such as books, keyboards etc. are not included in this description.

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Specific legislation

Product-specific legislative requirements in the country where the product will be sold.

Specification

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

Specifier

Company or person requesting the product or service.

Stakeholders

Brand owners, certification bodies, enforcement agencies, consumers, suppliers, manufacturers or others with a bona fide interest in the Standard.

Stock reconciliation

The process by which the location and quantity of raw material and intermediate and finished products are identified and matched to product schedules and quantities.

Subcontractor

A firm, company or individual carrying out a process on products on behalf of the site being certificated to this Standard.

Supplier

The person, firm, company or other entity to which a site’s purchase order to supply is addressed.

Suspension

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

Technical dossier

A collection of technical documents which together form the technical specification and product conformity information on a specific product.

Tertiary packaging

Also known as transport packaging, this is 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 following a specific procedure and against an agreed requirement.

Traceability

Ability to trace and follow raw materials, components and products, through all stages of receipt, production, processing and distribution both forwards and backwards.

Trans-shipment

A direct transfer of goods from one vehicle or container to another.

Trend

An identified paern of results.

Unannounced audit

An audit undertaken on a date unknown to the company in advance.

User

The person or organisation who requests information from the company regarding certification.

Utilities

Commodities or services, such as electricity or water, that are provided by a public body.

Validation

Obtaining evidence through the provision of objective evidence that a control or measure, if properly implemented, is capable of delivering the specified outcome.

Vehicle

Any device used for the conveyance of product that is capable of being moved upon highways, waterways or airways. Vehicles can be motorised (e.g. a lorry), or non-motorised (e.g. container or rail truck).

Verification

Confirmation through the provision of objective evidence that specified requirements have been fulfilled.

Very vulnerable user group

Children under the age of 36 months; people having very extensive and severe disabilities.

Vulnerable user group

Children aged 36 months to 14 years; people with reduced physical, sensory or mental capabilities (e.g. partially disabled or elderly people with some reduction in their physical and mental capabilities).

Waste recovery

Where any type of waste is recovered, typically to be processed to provide energy.

Where appropriate

In relation to a requirement of the Standard, the company will assess the need for the requirement and, where applicable, put in place systems, processes, procedures or equipment to meet the requirement. The company shall be mindful of legal requirements, best-practice standards, good manufacturing practice and industry guidance, and any other information relating to the manufacture of safe and legal product.

Wholesaler

A distributor or business-to-business company who purchases products to sell mainly to retailers, institutions or other companies rather than to consumers.

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Wholesaler exclusive products

Products not bearing the wholesaler’s logo but produced with a brand exclusively for sale and distribution by the wholesaler.

Wholesaler own brand

Products bearing a wholesaler’s logo, copyright and/or address that are legally regarded as the responsibility of the wholesaler.

Work in progress/work in process

Partially manufactured products, intermediates or materials waiting for completion of the manufacturing process.

Workwear

Company-issued or authorised clothing worn in the work place usually to provide protection to the wearer or the wearer’s own clothing.

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APPENDIX 7 ACKNOWLEDGEMENTS

The BRC is grateful to the members of the working groups and steering commiee who helped to develop Issue 4 of the BRC Global Standard for Consumer Products. Their names are listed alphabetically below. Grace Abamba

BRC Global Standards

Pam Beha

UKAS

Alex Boryslawsky

Morrisons plc

David Brackston

BRC Global Standards

Peter Brownhill

B&Q UK and Ireland Ltd (Kingfisher)

Jerry Burnie

British Toy and Hobby Association

David Chapman

ASDA

David Daley

Walmart

Melanie Fuller

Wilko Retail Ltd

Chris Gray

John Lewis Partnership

Alex Gifford

Unilever

Steven Goss

Aldi

Michael Harris

Sainsbury’s Supermarkets Ltd

David Hempson

F4SS

Dean Hill

Sainsbury’s Supermarkets Ltd

Mahew Hinchen

Sainsbury’s Supermarkets Ltd

Simon Hollidge

ASDA

Amanda Isom

Cosmetic Toiletry & Perfumery Association

Keith Javes

ASDA

Nick Lengden

Nick Lengden Ltd

Neil Lewis

Proctor & Gamble

Rosemary Macdonald

Aldi

Romulo P. Martin II

Walmart

Colin McCoy

Jeyes Group

Jon Mellor

Waitrose Ltd

Neil Milvain

SGS

Leon Mol

Royal Ahold

Clare Norman

Waitrose Ltd

Margaret Palmer

Robert McBride

Jo Pybus

SCA

Dawn Rusling

Home Retail Group

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Toiletry Sales

John Stafford

Sainsbury’s Supermarkets Ltd

Emma West

Intertek

Marie Whatmough

The Co-operative Group

Brian Winter

Sainsbury’s Supermarkets Ltd

Chiu P. Wong

ASDA

Nina Zhelyaznik

Metro

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APPENDICES

Amanda Spedding

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BRC Trading Limited 2 London Bridge London SE1 9RA Tel: +44 (0) 20 7854 8900 Fax: +44 (0) 20 7854 8901 Email: [email protected]

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