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Page 1 of 92 GLOBAL STANDARD FOR CONSUMER PRODUCTS Issue 3 Draft 4.3 13/11/09 xxxx 2009 British Retail Consortium London: TSO

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Page 1 of 92

GLOBAL STANDARD FOR CONSUMER PRODUCTS Issue 3 Draft 4.3 13/11/09

xxxx 2009

British Retail Consortium London: TSO

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Published by TSO (The Stationery Office) and available from: Online www.brcbookshop.com Mail, Telephone, Fax & E-mail TSO PO Box 29, Norwich NR3 1GN Telephone orders/General enquiries: 0870 600 5522 Fax orders: 0870 600 5533 E-mail: [email protected] Textphone 0870 240 3701

TSO Shops 16 Arthur Street, Belfast BTI 4GD 0208 9023 8451 Fax 028 9023 5401 71 Lothian Road, Edinburgh EH3 9AZ 0870 606 5566 Fax 0870 606 5588 TSO@Blackwell and other Accredited Agents

Liability BRC publish information and express opinions in good faith, but accept no liability for any error or omission in any such information or opinion including any information or opinion contained in this document. Whilst the BRC have endeavoured to ensure that the information in this publication is accurate, they shall not be liable for any damages (including without limitation damages for pure economic loss or loss of business or loss of profits or depletion of goodwill or otherwise in each case, whether direct, indirect or consequential, or any claims for consequential compensation whatsoever (howsoever caused) arising in contract, tort (including negligence or breach of statutory duty), misrepresentation, restitution or otherwise, in connection with this publication or any information contained in it, or from any action or decision taken as a result of reading this publication or any such information. All warranties, conditions and other terms implied by statute or common law are, to the fullest extent permitted by law, excluded. Nothing excludes or limits the liability of BRC for death or personal injury caused by their negligence, for fraud or fraudulent misrepresentation or for any matter which it would be illegal for them to exclude or attempt to exclude liability for. The Global Standard for Consumer Products and the terms of the disclaimer set out above shall be construed in accordance with English law and shall be subject to the non- exclusive jurisdiction of the English Courts. Copyright © British Retail Consortium 2009 All rights reserved. No part of this publication may be transmitted or reproduced in any form (including photocopying or storage in any medium by electronic means) without the written permission of the copyright owner. Application for permission should be addressed to the Director of Global Standards at the British Retail Consortium, contact details below. Full acknowledgement of author and source must be given. No part of this publication may be translated without the written permission of the copyright owner. Warning: Any unauthorised act in relation to a copyright work may result in both a civil claim for damages and criminal prosecution. The British Retail Consortium and the Retail Industry Leaders Association The British Retail Consortium (BRC) is the Trade Association representing retailers in the UK. The Retail Industry Leader Association (RILA) is a Trade organisation representing many of the largest retailers in the USA. RILA has joined with the BRC in developing and supporting The Global Standard for Consumer Products Issue 3. Members of RILA have participated in the consultation process for this Standard and members of RILA are part of the North American Technical Advisory Committee for the BRC Global Standard for Consumer Products For more information about BRC or RILA British Retail Consortium Retail Industry Leaders Association Second Floor -------- 700 N. Moore Street, Suite 2250 21 Dartmouth Street Arlington, London, UK VA 22209, USA SW1H 9BP Tel: +44 (0) 20 7854 8900 Direct: +1 703∙600∙2022 Fax: +44 (0) 20 7854 8901 Mobile: +1 202∙412∙8960 ..................... -------- Fax: +1 703∙841∙1184 email: [email protected] Email website: www.brcglobalstandards.com Website www.rila.org

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The Standard sets out requirements that a factory should adhere to in order to be able to consistently produce safe, legal consumer products to the quality required by its customers. It consists of the following sections: Section I ----- Provides a background to The Standard and an overview of the Standard Programme. Section II --- Explains the preparation and planning stages including the format of the Standard, how to establish the scope of products for certification and how to assign the product group for the certification. Section III --- Details the requirements of the Standard with which a company must comply in order to gain certification. Section IV --- Provides information on the certification and auditing process, including how to select a certification body and a description of the BRC Global Standards Directory. Section V --- - Describes the Management and Governance systems in place for the Standard and includes some administrative information NOTE: Appendix 7 contains a glossary of definitions of the italicised terms in the text, as well as for definitions of the frequently used terms: “shall”, “audit”, “auditor” “quality”, “safe”, “legal” and “risk”

The Global Standard for Consumer Products for more information visit www.brcglobalstandards.com

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Section I .................................................................................................................................7 1. Introduction .....................................................................................................................7

1.1 Background ...................................................................................................................7 1.2 The Scope of the Standard (Issue 3) .............................................................................7 1.3 Principles of the Standard .............................................................................................8 1.4 Regulatory Framework for Safe Consumer Products ....................................................9 1.5 The Certification and Audit Process ............................................................................10

Section II ..............................................................................................................................12 1 Preparation and planning for success ...........................................................................12

1.1 Preparation time..........................................................................................................12 1.2 For Retailers ...............................................................................................................12 1.3 For Manufacturers and Packers ..................................................................................12

2 Scope of the Certification ..............................................................................................14 2.1 Extension to Scope .....................................................................................................14

3 Product Groups ............................................................................................................15 3.1 Assigning Product Groups ..........................................................................................15 3.2 Audit level ...................................................................................................................15 3.3 Who determines the Product Group? ..........................................................................16 3.4 Guidelines for the Use of the Product Group Decision Tree for the Manufacture of Consumer Products ..........................................................................................................16 3.5 The Format of the Standard ........................................................................................20

Section III .............................................................................................................................21 Requirements .......................................................................................................................21 1 Senior management commitment and continual improvement ......................................21

1.1 ....................................................................................................................................21 1.2 ....................................................................................................................................21 1.3 ....................................................................................................................................21 1.4 ....................................................................................................................................22 1.5 ....................................................................................................................................22 1.6 ....................................................................................................................................22 1.7 ....................................................................................................................................22

2 Risk Management .........................................................................................................23 2.1 Product Scope and Group Determination ....................................................................23 2.2 Legislative and Safety Requirements ..........................................................................23 2.3 Risk Assessment – prior to production ........................................................................24 2.4 Verification of the Product Risk Assessment ...............................................................24

3 Management System ....................................................................................................26 3.1 Policy Statement .........................................................................................................26 3.2 General Documentation Requirements .......................................................................26 3.3 Organisational Structure, Responsibility and Management Authority ..........................28 3.4 Internal Audit ...............................................................................................................28 3.5 Purchasing, Supplier Approval and Performance Monitoring.......................................29 3.6 Customer-supplied property ........................................................................................29 3.7 Corrective and Preventive Action ................................................................................30 3.8 Traceability .................................................................................................................30 3.9 Management of Product Withdrawal and Product Recall .............................................31 3.10 Management of incidents and business continuity ....................................................32 3.11 Contract Review and Customer Focus ......................................................................32 3.12 Complaint Handling ...................................................................................................33

4 Site Standards ..............................................................................................................34 4.1 Location, Perimeter and Grounds................................................................................34 4.2 Internal Site: Factory Layout, Product Flow and Segregation ......................................34 4.3 Building interiors .........................................................................................................35

The Global Standard for Consumer Products for more information visit www.brcglobalstandards.com

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4.4 Staff Facilities .............................................................................................................35 4.5 Cleaning procedures ...................................................................................................36 4.6 Waste/Waste Disposal ................................................................................................37 4.7 Pest Control ................................................................................................................37 4.8 Product Transport, Storage and Distribution ...............................................................38 4.9 Site Security ................................................................................................................38

5 Product Control .............................................................................................................40 5.1 Preproduction Reference Samples..............................................................................40 5.2 Chemical Formulation Control .....................................................................................40 5.3 Product Packaging Materials.......................................................................................41 5.4 Control of Non-conforming Materials ...........................................................................41 5.5 Handling requirements for specific materials ...............................................................42 5.6 Stock Control and Product release ..............................................................................42

6 Product Conformity Assessment ...................................................................................43 6.1 Product Analysis/Testing .............................................................................................43 6.2 Inspections ..................................................................................................................44 6.3 Product claims ............................................................................................................45

7 Process Control ............................................................................................................46 7.1 Control of Operations ..................................................................................................46 7.2 Control of Incoming Components and Raw Materials ..................................................46 7.3 Equipment & equipment maintenance .........................................................................47 7.4 Foreign Body Detection and Control ...........................................................................48 7.5 Calibration and Control of Measuring and Monitoring Devices ....................................48 7.6 Retained Production Samples .....................................................................................49 7.7 Final Product Packing and Control ..............................................................................49

8 Personnel .....................................................................................................................50 8.1 Training and Competency ...........................................................................................50 8.2 Protective clothing .......................................................................................................50 8.3 Hygiene Practices .......................................................................................................51

Section IV .............................................................................................................................52 1 Introduction ...................................................................................................................52 3 Self Assessment of Compliance with the Standard .......................................................53 4 Selection of a Certification Body ...................................................................................53 5 Company/Certification Body Contractual Arrangements ...............................................55

5.1 Administration fee .......................................................................................................55 5.2 Auditor Selection .........................................................................................................55

6 Relationship with Other Certification Standards ............................................................55 7 Guidelines ....................................................................................................................56

7.1 Codes of Practice/Specific Guidelines .........................................................................56 7.2 Status of Guidelines ....................................................................................................56

8 Audit Preparation by the Company ...............................................................................56 8.1 Preparation prior to the initial audit ..............................................................................56 8.2 Duration of the Audit ...................................................................................................57

9 The On-site Audit ..........................................................................................................58 10 Non-conformities and Corrective Action ....................................................................59

10.1 Non-conformities .......................................................................................................59 10.2 Procedures for Handling Non-conformities and Corrective Action .............................60

11 Further Action ...........................................................................................................62 12 Grading of the Audit ..................................................................................................62

12.1 Certification ...............................................................................................................63 13 Audit Reporting .........................................................................................................63 14 Ongoing Audit Frequency and Certification ...............................................................64

14.1 Certificate Expiry – Justifiable Circumstances ...........................................................65

The Global Standard for Consumer Products for more information visit www.brcglobalstandards.com

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14.2 Seasonal or Intermittent Production ..........................................................................65 15 BRC Logos and Plaques ...........................................................................................66 16 Communication with Certification Bodies ..................................................................66

16.1 Certification Body Performance Monitoring ...............................................................66 16.2 Feedback ..................................................................................................................66 16.3 Complaints ................................................................................................................67

17 Appeals.....................................................................................................................67 18 The BRC Global Standards Directory........................................................................67

18.1 Introduction ...............................................................................................................67 18.2 Benefits of the Directory to Companies .....................................................................68 18.3 Directory Functionality ...............................................................................................68

Section V ..............................................................................................................................69 1 Requirements for Certification Bodies ...........................................................................69 2 Technical Governance of the Global Standard for Consumer Products ........................71 3 Effective Date of Issue 3 ...............................................................................................72 4 Acknowledgements .......................................................................................................72 Appendix 1 ...........................................................................................................................73 The Standard and its Relationship with Other BRC Global Standards ..................................73 Appendix 2 ...........................................................................................................................75 1 Registration, Qualifications, Training and Experience Requirements for Auditors .........75

1.1 Responsibility of the Certification Body .......................................................................75 2 Education .....................................................................................................................75 3 Work Experience ..........................................................................................................75 4 Qualifications ................................................................................................................75 5 Audit Experience...........................................................................................................76 6 General Training Obligations of Certification Bodies .....................................................76

6.1 Exceptions ..................................................................................................................77 Appendix 3 ...........................................................................................................................78 Appendix 4 ...........................................................................................................................80 Appendix 5 ...........................................................................................................................81 Appendix 6 ...........................................................................................................................83 Appendix 7 ...........................................................................................................................85 Appendix 8 ...........................................................................................................................89 Appendix 9 ...........................................................................................................................90

The Global Standard for Consumer Products for more information visit www.brcglobalstandards.com

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Section I

1. Introduction

1.1 Background

Welcome to the 3rd issue of the Global Standard for Consumer Products (henceforward referred to as The Standard). The purpose of the Standard is to help manufacturing or contract packing sites to reliably produce safe, legal products to the quality levels specified by their customers or demanded by the consumers. It defines the management systems and working practices which, if followed, will assist companies to meet this goal. The Standard forms the basis for an auditing and certification programme by which companies can demonstrate their compliance with its requirements and be listed on a secure database of certificated suppliers. This issue of the Standard has been extensively revised and updated to reflect the latest thinking in the production of safe and legal Consumer Products for the global marketplace and is available in a number of translations. It has been developed with advice and input from international stakeholders and in particular British Retail Consortium (BRC) members in association with the Retail Industry Leaders Association (RILA) members in the USA. The BRC and RILA are trade organisations representing the interests of their membership which comprise a very large proportion of the retail trade in the UK and USA. The Standard supports their commitment to offer safe, legal and high quality products to the consumer but the use of the Standard is not limited to BRC/RILA members and may be specified or used by other purchasers of specifiers of consumer products..

1.2 The Scope of the Standard (Issue 3)

The Standard sets out the requirements for the production and supply of safe and legal consumer products of consistent quality. The products may be retailer-branded (private label) or branded, or be unbranded products for use by other organisations. The Standard focuses on the safety, legality and quality of the product to the consumer. It does not encompass other important requirements applicable to manufacturing sites such as workplace health and safety, environmental concerns, sustainability, security or ethical trading issues. The Standard applies to manufacturing sites but does not apply to activities relating to wholesale, importation, distribution or storage outside the direct control of the site. It does include the activities of contract or assembly packers of consumer products The Standard does not apply directly to importers and cannot be used to assess importers operations. Importers may find it useful to request their manufacturers to meet the Standard as one of the ways of meeting their responsibilities to demonstrate the import of safe and legal products. The scope of the Standard is for non food, manufactured products placed on the consumer market – i.e. sold or given to consumers. It may also be used by companies producing

The Global Standard for Consumer Products for more information visit www.brcglobalstandards.com

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components for consumer products provided that the items are also consumer products themselves. Examples of such products include pencils, light bulbs, buttons and batteries. The Standard is not applicable to raw material producers. Specific exclusions from the scope of the Standard are:

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

o Global Standard for Food Safety (which includes pet food) o BRC/IoP Global Standard for Packaging and Packaging Materials. Note that

companies producing packaging materials solely for sale to the consumer may use the Global Standard for Consumer Products. Packaging used in other circumstances or for dual consumer/trade use is covered by the Global Standard for Packaging and Packaging Materials

o Global Standard for Storage and Distribution. This covers distribution or storage outside the direct control of the production premises.

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

• fuels dispensed in bulk, or sold in refillable containers • pharmaceuticals which are supplied only by prescription from a medical practitioner • vitamins, minerals and herbal supplements • horticultural growing practice covering live plants, flowers and seeds or the cultivation

of plants and flowers and the media to grow them • live animals and pets

The Standard shall be applied at the point of manufacture and subsequent storage and distribution which are under the control of the manufacturer, prior to delivery to the retailer or customer. A technical audit of a manufacturing site, such as to this Standard forms only one part of the quality and safety measures necessary to supply consumer products and the decision to have a company supply product rests with the individual retailer or customer.

1.3 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 the products. The Standard is based on key components: senior management commitment, risk assessment of the product and the process and a systematic approach to managing identified risks.

1.3.1 Senior Management Commitment

Within a business, the safety legality and quality of the products produced must be seen as a cross-functional responsibility, including activities of many departments using different skills and expertise in the organisation. Effective Consumer Products management extends beyond technical departments and must involve commitment from production operations, engineering, distribution, management, procurement of raw materials, customer feedback and human resource activity such as training. The starting point for effective implementation of the Standard is the commitment of senior management to the development of an all-encompassing policy as a means to guide the activities that collectively assure the production of safe and legal Consumer Products

The Global Standard for Consumer Products for more information visit www.brcglobalstandards.com

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1.3.2 A Risk-based System

The Standard requires an evaluation of the risks that the products could present to the consumer when the product is used in an intended or reasonably foreseeable way, taking account of the user types and interactions with other products. The development of the plan requires the input of all relevant departments and must be supported by senior management. In cases where manufacturers are producing goods to a specification set by the customer, steps must still be taken to ensure that safe and legal products are produced. Note that, in the context of the Standard, risks relating to failure to meet legal or quality requirements must be considered as well as those directly related to the safety of the consumer.

1.3.3 Quality Management System and suitable operating conditions

The Standard requires that the details of the framework of organisational and management policies and procedures by which the organisation will achieve the requirements in this Standard are detailed and documented. It also expects that the basic environmental and operational conditions in a business that are necessary for the production of safe, legal products are put in place

1.4 Regulatory Framework for Safe Consumer Products

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 to individual product safety standards. The complexity of legislation related to product safety is increasing both with regard to general safety requirements and to product or material specific requirements. It is essential that companies shall have a means of identifying, understanding and keeping up to date with legal statutes relevant to their products in the countries or regions of intended sale. Retailers in most countries are obliged to supply safe and legal products to their consumers and must take all reasonable precautions to ensure this happens. They also need to be able to demonstrate they have taken adequate steps to meet such requirements. This obligation is usually shared to some extent with the manufacturer, importer or brand owner but, in the context of retailer-branded products, the retailer will carry the main responsibility. This involves a number of activities, one of which is the verification of the technical competence of the product’s suppliers. For many years, retailers either undertook this activity themselves, verifying competence and performance against their own individual, internally developed standards, or they used third-party auditing and inspection bodies. To improve efficiency and consistency, the BRC/RILA brought together stakeholder groups to establish the basis for an updated technical standard for consumer products which could be independently audited and would serve retailers around the world. Companies producing products must be aware of the following types of legislation and research and keep up to date with the specific requirements for the products being

The Global Standard for Consumer Products for more information visit www.brcglobalstandards.com

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manufactured. BRC produce a number of Sector Specific Product Guidelines to accompany the Standard and provide assistance in this respect

• General requirements to supply “safe” products • Product Liability laws to provide product which is “fit for purpose” and does not cause

injury or harm • Product specific laws defining detailed safety, quality or other legal requirements.

This also includes any obligations concerning declarations of conformity, traceability of products and any particular labelling and warning requirements

• Any requirements to manufacture under specific conditions such as Good Manufacturing Practice (GMP) or a formal Quality Management System.

• Laws concerned with materials or chemicals used in production, or likely to be present as contamination of the products

• The need for product “technical files” and any requirements regarding mandatory reporting or recalling of unsafe goods

• Any licensing or approvals systems needed to manufacture, import or sell products • Laws concerned with the packaging provided for the products

1.4.1 Chemicals

Many countries are developing legislation regarding chemicals in order to protect the safety of consumers and the wider environment (for example the Registration, evaluation and authorisation of chemicals -REACH and Restriction of hazardous substances -ROHS legislation in Europe or California Proposition 65 in the USA). Such legislation typically requires companies to be aware of the chemical nature and composition of the materials used in their products as well as the quantities. It may additionally contain registration or authorisation procedures for some chemicals. Product specific legislation (such as toys, textiles and electrical goods) increasingly includes limitations on the use of specific chemicals.

It can be difficult to evaluate such chemicals since although the chemicals themselves may be toxic, the exposure to a consumer from a single item may be such that the item does not itself pose a serious risk of harm. It is also often the case that, provided the correct materials are chosen for manufacture, the subsequent processes of manufacture have little affect on any chemical risks to the consumer. The Standard allows for these issues by the choice of Product Group (see Section II) and the requirements for Chemical Control in Section III.

1.4.2 Product Standards

For many product types, voluntary or mandatory product standards exist. Some of these standards relate to manufacturing specifications whilst others are concerned with testing methods. Some standards have been made mandatory by government agencies and must be respected but others are voluntary. It is generally advisable to follow national, regional or international standards when these are available, even if they are voluntary since it is a straightforward way of demonstrating that products meet industry best practice for the aspects covered. If companies choose not to adopt voluntary standards, they should have alternative means of confirming that their products are safe and legal.

1.5 The Certification and Audit Process

When a site meets the requirements specified in the Standard, they may choose to be audited against the requirements and become a “certificated site”.

The Global Standard for Consumer Products for more information visit www.brcglobalstandards.com

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The audits and certificates are site specific and so companies with a number of manufacturing sites would need separate certification for each location. The Standard is a process and product certification programme in which businesses are certificated upon completion of a satisfactory audit by an auditor employed by an independent third party – the certification body In order for a business to receive a valid certificate on completion of a satisfactory audit, the organisation must select a certification body approved by the BRC. The BRC lays down detailed requirements that a certification body must satisfy in order to gain approval as well as specific requirements for auditors with regard to both auditing expertise and product sector knowledge. More information about the certification process and certification bodies is given in Sections IV and V of the Standard.

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Section II

1 Preparation and planning for success

1.1 Preparation time

In order for everyone to gain the most value from certification to the Global Standard for Consumer Products, retailers should have a clear understanding of the demands it places on their suppliers and the benefits that ensue and manufacturers need to plan carefully to achieve certification Both specifiers and companies seeking certification should understand that considerable effort may be needed to work towards certification, especially for companies that have no previous experience of third party certification schemes or quality management systems certification. It is important to set realistic timescales in which to gain certification and have a clear project plan to ensure all the necessary actions are completed before the certification audit visit. After the audit visit, there is a short timescale allowed to correct any failures to meet the requirements of the Standard, identified by the audit report as non conformities. This is 60 days for a first audit and 28 days for subsequent audits. There is a limit to the number of non conformities that are allowed before certification is refused (see Appendix 4 for details). If the number of non conformities exceeds that allowed or the non conformities are not corrected within the allowed time frame, a complete re-audit will be needed before certification can be obtained. It is therefore not advisable to attempt an audit without adequate preparation.

1.2 For Retailers

Retailers and others contemplating specifying the use of the Standard by their suppliers are advised to inform their suppliers and the certification bodies well in advance of the implementation requirement. This will ensure that the companies have time for adequate planning and the certification bodies have suitable infrastructure in place in the countries of demand and for the correct industry sectors. Retailers may want to organise internal training to ensure that there is a good understanding of the Standard and it may be helpful to arrange supplier briefings or other training events to explain the requirements of the scheme and other steps to implementation. Assistance with such matters is available from BRC.

1.3 For Manufacturers and Packers

The following diagram indicates the advisable steps for a manufacturer or assembly packer company seeking certification, prior to applying to a certification body for certification. A more detailed explanation of the process is given in Section IV. Companies already certificated to previous versions of the Standard should work through the “steps to certification” but may find that many aspects are already addressed.

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Figure 1 : Steps to Certification

Stage 1 Learn

•Obtain a copy of the Standard and study it.

•Translations are available in a number of languages

•Visit the BRC website www.brcglobalstandards.com

•Go on an introductory awareness training course (available from BRC)

•Obtain the Interpretation Guideline and any appropriate sector guidelines to assist understanding of the requirements

Stage 3 Preparation

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

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

•Identify the product scope to be included in BRC certification

•Obtain Consultancy if needed

Stage 2 Plan

•Establish the appropriate Product Group(s)

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

•Prepare procedures

•Check site is capable of meeting BRC requirements

•Undertake internal audits

•Contact Certification Bodies (CB)

•Select suitable CB

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

•Implement any identified corrective actions

Stage 4 Pre-

assessment*

Stage 5 Audit &

certification

•Arrange an audit visit with an appropriate CB

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

•Audit is conducted

•CB presents audit report

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

•Certification and entry onto BRC directory

Stage 6 Maintenance

•Continue to meet requirements

•Arrange audit visit before certificate expiry

•Continuous improvement

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2 Scope of the Certification The scope of the certification must be agreed between the company and the certification body before an audit takes place. In practice a site should be clear about which products they wish to have included within their certification from an early stage in their planning. Sites shall also identify the geographical locations where the products may be placed on the market. Auditors are only allowed to audit sites that are within the scope of their technical competence and so it is important that the certification body is fully aware of the products to be included before they select an auditor for the visit. The audit, report and certificate shall be ‘product’ and ‘site’ specific. Each site shall be audited and the certificate granted accordingly. Sites should give careful consideration to selecting the scope. If the scope is too vague, they may be exposed to harsher than necessary auditing since the auditor will have to establish that the systems and manufacturing processes would be appropriate for anything that could come within scope, whereas a very narrow product scope may mean that frequent extensions to scope or re-audits are necessary for new products. Particular care should be given in the consideration of geographical areas, especially when some regions have more onerous requirements than those pertaining to the country or region overall. The scope of the audit shall cover the agreed products or product categories. All products within a certain area of the site and using the same production processes would normally be included in the audit. Different types of products made on the same site or products clearly intended for different geographical regions may be excluded from the scope. Other exclusions would require to be justified and should be confirmed prior to an audit visit. The scope and any exclusions that apply must be clearly stated on the certificate. The certification audit shall include an assessment of the entire process from raw material to end product dispatch and include all the requirements of the Standard. In rare circumstances a clause(s) may not be applicable to the operation. In this case, the justification must be detailed on the audit report and the exclusion listed in the scope of certification. Certification relates to the audit of all processes within the manufacture of a ‘product’ and this may in some cases involve the audit at one or more premises by the certification body for a specific product, e.g. when a product is transferred to a different location for a finishing process. In the event that one or more premises are audited under one product certification, the report and the certificate shall clearly indicate this information.

2.1 Extension to Scope

Once certification has been granted, any additional significant products manufactured or processes undertaken by the site, which are required to be included in the scope of certification, must be communicated to the certification body who will then conduct a site visit to examine the aspects of the required extension to scope. The current certificate will be superseded by any new certificate issued using the same expiry date as detailed on the original certificate.

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3 Product Groups The consumer products industry includes an extremely wide variety of products, involving a wide range of materials and manufacturing processes. It is essential that the audit against the Standard is appropriate for the nature of the product produced and its intended or foreseeable use. Some requirements may be essential for some types of product but not particularly important for others. In order to make the requirements of the Standard appropriate and to avoid unnecessary rigour when product safety, legality and quality are not at risk, products have been divided into three product groups with regard to the level of legal requirements and likely levels of risk to the consumer. The Standard divides products into three product groups

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

Group 2 Products that have product specific safety legislation or mandatory / harmonised product Standards. Products that have the potential to cause serious injury or death if they fail during normal or foreseeable use.

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

The Standard contains Decision Trees (Figures 3 and 4) which identify to which of the three product groups a product belongs

3.1 Assigning Product Groups

The company must first determine whether it is a manufacturer, contract or assembly packer by referring to the definitions in the glossary (Appendix 7) prior to using the decision tree to determine the product group. The chosen group needs to be verified and agreed by the certification body that will carry out the audit. In the case of a novel product type or one on which there has been disagreement between parties, the Certification Body or retailer should refer the item to the BRC who will present it to the Technical Advisory Committee (see section V for details about the committee) for adjudication concerning the appropriate product group. Once agreed, the outcome will be published on the website. In urgent cases BRC technical staff will determine the product group to be used for a specific audit and then refer to the Technical Advisory Committee for a definitive decision which must be followed in subsequent audits and for other products of the same type.

3.2 Audit level

It is not acceptable, in any circumstances, for a Company to be audited to a lower Product Group than that into which the product falls when the assessment has been carried out. For

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example, a Company cannot choose to have a Group 1 product audited to Group 3 requirements. Sometimes a specific product can be demonstrated by means of a risk assessment and following the decision tree to be in a lower group than that which would usually be expected. In such a case, the reason for such a decision should be recorded on the certificate. There are occasions when companies may decide to be audited to the requirements of a higher product group than the one defined using the decision tree. This is acceptable, although not encouraged. If this approach is taken then the certificate must show both the level to which the factory was audited and the product group resulting from the decision tree. This enables the product group assigned via the decision tree to be listed on the BRC Directory in order to help maintain consistency. For further guidance, consult the decision tree (Figures 2 and 3) and the BRC Global Standards website It is recognised that many manufacturers may produce products that fall into more than one group. In these circumstances they may either choose to use the highest group for the entire site or ensure that suitable segregation methods are in place to separate them by areas. It is not acceptable that more than one product group would apply within the same area. Where there is any doubt, the category for higher risk products as expressed above should be adopted.

3.3 Who determines the Product Group?

The company shall follow the decision tree and determine the product group for the products being manufactured and supplied. This product group shall be validated by the certification body, which will confirm or reject the manufacturer’s decision. If the product group is determined by the certification body as being higher than the manufacturer’s determined product group, it can seek the manufacturer’s agreement to be evaluated at the higher-risk product group. If agreement can’t be reached after consulting the BRC Global Standards website www.brcglobalstandards.com for any guidance or position statements that may be available, the matter can be referred by either party to the BRC Technical Advisory Committee for adjudication by contacting the BRC technical services team via email at [email protected]. The company may also be required to provide the certification body with background information on the site concerned, through the completion of either a pre-audit questionnaire or pro-forma information sheet.

3.4 Guidelines for the Use of the Product Group Decision Tree for the Manufacture of Consumer Products

The purpose of the decision tree is to enable the user to determine the product group of any product in the scope of the Standard. It is important to note that the product group is based on the risk to the consumer for whom the finished product is intended or by whom it is likely to be used. When using the decision tree, sources of contamination or other factors that could be introduced during the production and distribution process, and which could potentially affect the safety, legality and quality of the finished product, shall also be considered.

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When evaluating the risk, the primary effect should be considered. For example if a product can produce a small abrasion then the injury is slight. The possibility that such injury could subsequently become infected should not be taken into account unless the product itself is likely to cause the infection or it is specifically intended for a user group with reduced immunity. When evaluating the possibility of serious injury or death, the approach should generally be to consider the individual product/ products received by a consumer. For example, although the presence of trace carcinogenic materials in a product may contribute to long term illness, the individual product received by the consumer will not itself cause serious injury or death. The control or avoidance of the toxic substance would still be an essential part of the risk assessment and their use may be illegal. For each product manufactured or assembled, each question is answered sequentially from the beginning, until a ‘yes’ answer is reached. The first ‘yes’ determines the product group. Questions should be answered for risks and the legislation in the market where the finished product is intended to be sold to the consumer. In the case where a product intended for multiple markets falls into different product groups, the higher group shall be used. The decision trees are detailed on the following pages in Figures 2 and 3.

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Figure 2

Is this product defined as apharmaceutical or cosmetic. Is it

used invasively?

Does the product have productspecific legislation requiring hygienic

manufacture (e.g. GMP)?

Is there potential for contaminationof the product which could cause

major injury or harm?

Does the product have any productspecific legal requirements

concerning safety or harmonised ormandatory standards?

Does the product require risk orsafety warning on the product

packaging, labeling or instructions?

Is the product in contact with skinduring foreseeable use?Does the product contain

nanomaterials?

Can this product type cause death ormajor injury if it fails during

foreseeable use?

Is the product designed or clearlyintended for vulnerable or very

vulnerable user groups?

Product Group 1

Product Group 1

Product Group 1

Product Group 2

BiologicalRadiation

ChemicalPhysical

Product Group 2

Product Group 2

Is the productsubject to

mandatory labellingof ingredients or

components

Product Group 2

Product Group 2

Product Group 2

Product Group 3

Physical, Chemical,Electrical,

Flammability,Magnetism,

Acoustics, Radiation

Product Group Decision Tree - Manufacturer

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Figure 3

Finished components frommanufacturer delivered to

packer

Is the finished componentsubject to change?

Can the assembly processintroduce more risks?

Does the product have anyproduct specific legislation/harmonised or mandatory

standards?

Use the manufacturer’sdecision tree

Could the introducedhazard cause injury or

harm?

Does the assemblypacking operation affectthe requirements? (e.g.

warnings, labeling)

Major

Minor

ProductGroup 2

ProductGroup 3

Product Group2

Product Group3

Yes

YesYes

YesYes

No

No No

NoNo

Bulk or unwrapped materialfor contract packing

Use the manufacturer’sdecision tree

Yes

Yes

No

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3.5 The Format of the Standard

In Section III Requirements, each clause of the Standard begins with a highlighted paragraph in bold text, the ‘statement of intent’, that all sites must comply with in order to gain certification. Below this ‘statement of intent’ are requirements in a tabular format, which together specify the criteria against which the audit will be carried out. Product certification depends on continued compliance and within the Standard certain requirements have been designated as ‘fundamental’ requirements, which are marked with the word ‘FUNDAMENTAL’ immediately after the section heading and denoted with the following symbol¶. These ‘fundamental’ requirements relate to systems that are crucial to the establishment and operation of an effective operation with regard to quality, safety and legality. The clauses deemed to be ‘fundamental’ are

• Senior Management Commitment and Continual Improvement, Clause 1 • Risk Management Clause 2 • Corrective and Preventive Action, Clause 3.7 • Traceability, Clause 3.8 • Internal site: Layout, Product Flow and Segregation, Clause 4.2 • Cleaning Procedures Clause 4.5 • Product Analysis / Testing Clause 6.1 • Control of Operations, Clause 7.1 • Control of incoming Components and Raw Materials Clause 7.2 • Training, Clause 8.1

Failure to comply with the statement of intent of a ‘fundamental’ clause leads to non-certification at an initial audit or withdrawal of certification at subsequent audits and will require a further full audit to establish demonstrable evidence of compliance.

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Section III

Requirements The clauses listed within each section are shaded to show which clauses apply to which product groups. Those clauses applying to all product groups are listed first, followed by those only required for the higher groups. Column 2 of the tables also details to which product group (s) an individual clause applies. Words in italics are defined in the glossary in Appendix 7. The glossary also contains definitions of “shall”, “quality” “risk” and “safety” which have not been italicised because of the frequency of use.

1 Senior management commitment and continual improvement

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

Clause Product Group

Requirements

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

1.2 All

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

• Internal, customer and external audits • Previous management review documents, corrective

action plans and time frames • Customer performance indicators, complaints and

feedback • Incidents, non conforming materials and corrective actions • An assessment of process performance. • Review of the product risk assessment system • Review of the results of monitoring and testing • Developments in legal requirements or scientific

information associated with the products in scope • Resource requirements

1.3 All

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

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1.4 All

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

1.5 All

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

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

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

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

2.1 Product Scope and Group Determination

2.2 Legislative and Safety Requirements

Clause. Product Group

Requirements

2.1.1 All

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

2.1.2 All The company shall establish and document the product group(s) assigned to the products in scope, derived from application of the questions indicated in the Decision Tree.

Clause Product Group

Requirements

2.2.1 All

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

2.2.2 All

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

2.2.3 All

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

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

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2.3 Risk Assessment – prior to production

.

Clause Product Group

Requirements

2.3.1 All

A design specification covering each product shall be documented, dated and authorised. This shall include all relevant information. As a guide, this may include the following, although this is not an exhaustive list:

• composition, size, colour • bill of materials • assembly diagrams • packaging system • intended shelf life • warnings or instructions for use • use, misuse, usage patterns • production volumes

Any changes to the product design shall be documented and dated

2.3.2 All

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

2.3.3 All

The company shall ensure that a product hazard and risk assessment is available and clearly identifies • the hazards, the risk level for each hazard and whether the

risk is acceptable • The person responsible for the assessment • The date performed and the evidence ( for example sample,

drawings, computer graphics) from which the assessment was derived

This risk assessment may be provided by internal or external resources. If the product requires modification, a new risk assessment shall be completed on the modified design.

2.3.4 All No products deemed to present an unacceptable risk by the assessment described in 2.3.3 shall be produced.

2.4 Verification of the Product Risk Assessment

Clause Product Group

Requirements

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

2.4.2 All

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

2.4.3 1 & 2 The risk assessment shall be carried out before production

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begins and completion shall be verified by a designated responsible person. If customer sign off is part of the contract of sale, this shall be obtained

2.4.4 1 & 2

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

2.4.5 1 & 2 Critical design features that must be maintained in production, shall be established with the risk assessment provider and the control limits set on these features or materials

2.4.6 1 & 2

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

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3 Management System Requirements

3.1 Policy Statement

The company's senior management shall develop, document and implement a policy statement which is authorised, regularly reviewed, signed and dated by an appropriate senior manager.

Clause Product Group

Requirements

3.1.1 All

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

3.1.2 All

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

3.2 General Documentation Requirements

3.2.1 Documentation Control

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

Clause Product Group

Requirements

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

3.2.1.2 All

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

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

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

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Clause Product Group

Requirements

3.2.2.1 All

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

3.2.2.2 All

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

3.2.2.3 All Any alterations to records shall be visible, authorised and justification for alteration shall be recorded.

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

Clause Product Group

Requirements

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

3.2.3.2 All

Companies shall maintain a technical dossier containing all relevant data (or detail of where such data is located) to ensure that products meet the requirements of the Standard, for example

• a detailed product specification ( see clause 2.3.4) • bill of materials • safety data sheets on all chemicals used where relevant

to the safety, legality or quality of the product • the risk assessment(s) • a description of the conformity assessment procedure; • test reports, inspection reports • a list of the legislation, product standards with which the

products are manufactured to comply • production control procedures and charts • approvals by any government body (if applicable) • declarations of conformity to legal requirements (if

applicable)

3.2.3.3 1 & 2

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

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

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3.3 Organisational Structure, Responsibility and Management Authority

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

Clause Product Group

Requirements

3.3.1 All

The company shall have an organisation chart demonstrating the structure of the company.

3.3.2 All

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

3.3.3 All

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

3.3.4 All

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

3.3.5

All

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

3.4 Internal Audit

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

Clause Product Group

Requirements

3.4.1 All

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

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

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

3.4.4 All

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

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3.5 Purchasing, Supplier Approval and Performance Monitoring

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

Clause Product Group

Requirements

3.5.1 All

The site shall have a documented supplier approval procedure, including a list of approved suppliers. Procedures shall be established which include clear criteria for ongoing assessment and the standards of performance required. Ongoing assessment may take the form of monitoring performance through one or more of the following, although there may be other acceptable methods:

• in-house checks • certificates of analysis • supplier audits • traceability checks

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

3.5.2 All

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

3.5.3 All

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

3.6 Customer-supplied property

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

Clause Product Group

Requirements

3.6.1 All

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

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3.7 Corrective and Preventive Action

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

Clause . Product Group

Requirements

3.7.1 All

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

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

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

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

3.7.5 All The company shall review their processes at least annually, incorporate industry best practice and adopt preventative measures as they become available

3.8 Traceability

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

Clause. Product Group

Requirements

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

3.8.2 All

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

3.8.3 All Final products shall be suitably marked, at least on their outer packaging to allow adequate identification, handling and traceability.

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

3.8.5 All The traceability system shall be maintained when rework or any

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reworking operation is performed.

3.8.6 All

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

3.8.7 All

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

3.8.8 All

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

3.8.9 All Sub-contracted manufacture of products or components (including home working) must be traceable to a level appropriate to the risk

3.8.10 1 & 2 The need for further traceability through the chain should be established, based on the risk assessment and any legal or specific customer requirements

3.8.11 1 & 2 For continuous production processes, methods of defining traceability levels must be documented and based on the risk assessment

3.9 Management of Product Withdrawal and Product Recall

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

Clause Product Group

Requirements

3.9.1 All

The company shall have a product recall procedure in place to effectively manage product withdrawals and recalls. It shall ensure that customers are notified immediately if a situation arises that could result in, or has resulted in, customers receiving non-conforming product.

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

3.9.3 All

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

3.9.4 1 & 2

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

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

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3.10 Management of incidents and business continuity

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

Clause Product Group

Requirements

3.10.1 All

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

3.10.2 1 & 2

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

• Disruption to key services –e.g. water, energy, staff availability

• Events such as flood, fire and natural disaster • Malicious contamination or sabotage

3.10.3 1 & 2

The procedures shall include as a minimum • Identification of key staff constituting the incident

management team and their key responsibilities • An up to date list of key contacts • Details of agencies providing advice and support

3.11 Contract Review and Customer Focus

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

Clause ProductGroup

Requirements

3.11.1 All

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

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

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

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

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3.12 Complaint Handling

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

Clause. Product Group

Requirements

3.12.1 All A system shall be in place to capture, record and investigate as fully as possible all complaints and the results of the investigation recorded. .

3.12.2 All

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

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

3.12.4 1 & 2

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

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4 Site Standards

4.1 Location, Perimeter and Grounds

The site shall be of suitable size, location, construction and design to facilitate maintenance, prevent contamination and enable the production of safe and legal finished products

Clause Product Group

Requirements

4.1.1 All 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.

4.1.2 All

Consideration shall be given to local activities and the site environment, which may have an adverse impact on finished product integrity, and, if necessary, measures shall be taken to prevent contamination

4.1.3 All Measures adopted to protect the site from any potential contaminants, shall be regularly reviewed to ensure they continue to be effective

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

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

4.1.6 All There shall be no evidence of facility damage due to inadequate drainage.

4.2 Internal Site: Factory Layout, Product Flow and Segregation

FUNDAMENTAL ¶ Premises and plant shall be designed, constructed and maintained so as to control the risk of product contamination and to comply with all relevant legislation

Clause Product Group

Requirements

4.2.1 All The building shall be maintained to minimise potential for product contamination

4.2.2 All The machinery and equipment shall be sited to allow an efficient product flow from incoming to outgoing shall be arranged to minimise the risk of product contamination and damage

4.2.3 All A process flow diagram shall be available

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

4.2.5 All

There shall be effective segregation to minimise the risk of product cross-contamination taking into account the flow of product, nature of materials, equipment, personnel, waste, airflow, air quality and utilities When critical to product safety, legality, quality or customer requirements, controls shall be in place to ensure that raw materials, work in progress, rework, packaging and finished products of different specifications are not inadvertently mixed

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

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4.3 Building interiors

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

Clause Product Group

Requirements

4.3.1 All

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

• The factory shall be clean, tidy and free from clutter • Adequate lighting • Suitable and sufficient removal of any by-products and

contaminants • Floors to be impervious, in good repair and able to withstand

cleaning procedures

4.3.2 1 & 2

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

4.3.3 1 & 2

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

4.3.4 1

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

4.3.5 1

All water supplies, in the form of water, ice or steam used for cleaning or in connection with any operation in the manufacture of products shall be potable (as defined in the region of intended product sale), or suitably treated to prevent contamination, and shall be regularly monitored

4.4 Staff Facilities

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

Clause Product Group

Requirements

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

4.4.2 1 & 2

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

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4.4.3 1 & 2 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

4.4.4 1

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

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

4.4.6 1

Suitable and sufficient hand-cleaning facilities shall be provided at access to, and at other appropriate points within, production areas. Information on how to clean hands shall also be provided near hand cleaning points.

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

4.5 Cleaning procedures

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

Clause Product Group

Requirements

4.5.1 All Cleaning practices shall be completed so as to minimise risk of contamination

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

4.5.3 All

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

4.5.4 1 & 2

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

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

4.5.5 1 & 2 Cleaning and housekeeping shall be carried out by trained personnel in accordance with documented procedures and records shall be maintained

4.5.6 1 The effectiveness of cleaning and sanitation shall be verified and documented. Corrective actions shall be documented

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4.6 Waste/Waste Disposal

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

Clause Product Group

Requirements

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

4.6.2 All

Waste shall be categorised according to legislative requirements based on the intended means of disposal, segregated if necessary and collected in suitably designated waste containers. Where legally necessary, it shall be removed by identified, licensed contractors and records of disposal shall be maintained by the company

4.6.3 All

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

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

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

4.7 Pest Control

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

Clause Product Group

Requirements

4.7.1 All

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

4.7.2 All The company shall either have a clearly defined contract with external contractors which reflect the activities of the site. or shall have trained staff

4.7.3 All Written procedures and inspection documentation for pest control shall be maintained.

4.7.4 All

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

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

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

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4.7.7 All

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

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

4.7.9 1

Fly-killing devices and/or pheromone traps shall be correctly sited and be operational. The design and location of flying insect detectors, killers and traps used shall not cause contamination of products in production.

4.8 Product Transport, Storage and Distribution

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

Clause Product Group

Requirements

4.8.1 All

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

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

4.8.3 All All transportation shall be in good repair and in a clean / hygienic condition as defined by the risk assessment.

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

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

4.8.6 All

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

4.8.7 All

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

4.9 Site Security

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

Clause Product Group

Requirements

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

4.9.2 All Contractors involved in maintenance or repair activities shall be under the supervision of a nominated person

4.9.3 1 & 2 Staff shall be trained in site security procedures and encouraged to

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question or report unidentified or unknown visitors

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5 Product Control Requirements

5.1 Preproduction Reference Samples

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

5.1.1 All

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

5.1.2 All

As a minimum, a sample of the product which has been approved by the customer or, if customer approval is not possible, a sample representative of the agreed specification, shall be retained. Procedures shall be in place to record the selection, use, approval and storage of reference and/or component samples.

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

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

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

5.1.6 All

Exceptions to the need to store samples shall be made for products that are physically very large or represent a very high cost, provided the information usually provided by a reference sample can still be identified. Examples meeting this requirement could be

• A reference sample of one complete product with samples of variants of the product – such as a sofa with swatches of fabric used for alternative coverings, or a sample of a camera with different outer body casings

• Reference samples of disassembled components with detailed assembly instructions such as for an item of playground equipment

5.2 Chemical Formulation Control

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

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Clause Product Group

Requirements

5.2.1 All

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

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

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

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

5.3 Product Packaging Materials

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

Clause Product Group

Requirements

5.3.1 All

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

5.3.2 All

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

• Protecting the product from damage • Maintaining the integrity of the product • Protecting the consumer from injury • Preventing contamination

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

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

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

5.4 ---- Control of Non-conforming Materials

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

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Clause. Product Group

Requirements

5.4.1 All

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

5.4.2 All

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

5.5 ---- Handling requirements for specific materials

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

Clause Product Group

Requirements

5.5.1 All

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

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

5.5.3 1 & 2

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

• Physical or time segregation from other products • Use of identified, dedicated equipment if necessary • Adequate labelling of final products

5.6 Stock Control and Product release

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

Clause Product Group

Requirements

5.6.1 All

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

• Positive final release by authorised staff • Online test methods • Automatic rejection process (which must be validated and

monitored)

5.6.2 All Companies shall ensure that work carried out by home-workers or subcontracted off site shall be included in procedures described in 5.6.1

5.6.3 1 & 2 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 if applicable.

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

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6 Product Conformity Assessment Requirements

6.1 Product Analysis/Testing

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

Clause Product Group

Requirements

6.1.1 All

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

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

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

• customer requirements regarding supply of test reports or other information

• their own requirements for demonstrating the production of safe products

• information needed to confirm materials composition • historical data on problems or complaints

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

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

6.1.3 All

A documented sampling plan, testing programme and test specification, including the pass or fail criteria shall be produced for each product or product type as required. Testing procedures carried out as a result of a complaint, product failure or other ad hoc reason shall be clearly documented

6.1.4 All

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

6.1.5 All

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

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

6.1.7 All Where testing is submitted to third parties, the required testing shall

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

6.1.8 All

For tests other than those specified in 6.1.4, procedures shall be in place to ensure validity of all test results.

• Use of documented , validated test methods • Use of correctly calibrated and maintained test equipment • Incorporation of quality control checks in the tests • Use of systems such as proficiency testing to verify the

accuracy of results where available • Use of suitably qualified and/or trained staff, competent to

carry out the analyses required

6.1.9 All

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

6.1.10 1 & 2

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

• design and operation of drainage and ventilation systems • access and security of the facility • movement of laboratory personnel • protective clothing arrangements • processes for obtaining product samples • disposal of laboratory waste

6.2 Inspections

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

Clause. Product Group

Requirements

6.2.1 All

Companies shall assess the need for product inspections, which, if required, shall have a defined purpose and operate to a defined list of parameters to be examined, with defects and defect types clearly identified. In cases where it is established that no inspections are necessary, this shall be justified, documented and reviewed at least annually (NOTE: If so then the other clauses in this section are not applicable)

6.2.2 All

Sampling procedures shall be defined, documented and justifiable. The appropriateness must be demonstrable and based on considerations of risk, type of product, inspection frequency, statistical rationale etc.

6.2.3 All Sampling plans, where required, shall be documented and approved and reviewed when changes in production methods or

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materials occur. They shall include as a minimum

• the sample size to be taken • the acceptance / rejection criteria • defined AQL • the defect classification • the actions to be taken in the case of rejection.

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

6.2.5 All

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

• Policy on returning inspected goods to production • Repacking requirements • Disposal

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

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

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

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

6.3 Product claims

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

Clause. Product Group

Requirements

6.3.1 All

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

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

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

6.3.4 1 &2

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

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7 Process Control

7.1 Control of Operations

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

Clause Product Group

Requirements

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

7.1.2 All

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

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

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

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

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

7.1.7 1 & 2 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.

7.2 Control of Incoming Components and Raw Materials

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

Clause Product Group

Requirements

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

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documented positive batch release

7.2.2 All The procedures described in 7.2.1 shall also apply to work subcontracted or performed outside the site being audited

7.2.3 All The company shall have a documented procedure to ensure that materials or components used by home-workers (when used) are approved. (see also home-worker requirements in 5.6.1)

7.3 Equipment & equipment maintenance

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

Clause Product Group

Requirements

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

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

7.3.3 All

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

• Periodic maintenance schedules & completion • Preventative maintenance • Required safety checks • Spare parts listings and replacements • Contingency plans for failure of essential equipment

7.3.4 All

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

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

7.3.6 All

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

7.3.7

1 & 2

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

7.3.8 1

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

7.3.9 1

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

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7.4 Foreign Body Detection and Control

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

Clause Product Group

Requirements

7.4.1 All

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

7.4.2 All

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

• Snap-off-blade knives prohibited • Tools permanently attached to benches • Items controlled by a listing & registration procedure • Needle policy where all parts of broken needles have to be

returned prior to new issue.

7.4.3 All

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

7.4.4 1 & 2

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

7.4.5 1 & 2

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

7.4.6 1

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

7.5 Calibration and Control of Measuring and Monitoring Devices

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

Group Requirements

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

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

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

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7.5.4 All 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.

7.5.5 All Identified equipment shall be prevented from adjustment by unauthorised staff and shall be marked to show the calibration status and period of validity.

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

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

7.6 Retained Production Samples

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

Group Requirements

7.6.1 All

The company shall retain a fully representative production sample of each product as received by the customer (including the packaging). Exceptions may be made for products that are physically very large or represent a very high cost, provided the information usually provided by a production sample can still be identified. A designated person shall authorise retained production samples and/or component samples. (see also requirements in clause 5.1)

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

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

7.7 Final Product Packing and Control

The company shall establish a final product packing procedure to ensure that products are supplied meeting relevant safety criteria, taking account of legal requirements and customers’ specific requirements Clause Product

Group Requirements

7.7.1 All

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

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

7.7.3 All

The company shall verify that information shown on primary (consumer) package labels and outer cartons are correct and meet the regulatory and safety requirements of the region of intended sale

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8 Personnel

8.1 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. Product Group

Requirements

8.1.1 All

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

• identify the need for training • document training procedures and records to demonstrate

that training is effective and regularly reviewed • ensure that training includes both general information on the

company and specific job training

8.1.2 All

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

8.1.3 All

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

8.2 Protective clothing

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

Group Requirements

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

8.2.2 1 & 2 Based on the assessment of risk to the products, suitable footwear shall be worn within the factory environment.

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

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

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8.3 Hygiene Practices

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

Group Requirements

8.3.1 1 & 2 All cuts and grazes on exposed skin shall be covered by a contrasting coloured plaster that is company issued and monitored.

8.3.2 1 & 2 Where metal foreign body detection is in place, a detectable strip plaster shall be used and shall be regularly tested through the detector.

8.3.3 1 & 2 The company shall have a policy to control the wearing of jewellery so that it poses no risk to product contamination.

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

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

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

8.3.7 1

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

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

8.3.9 1

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

8.3.10 1 Perfume or aftershave shall not be worn where there is a risk to product contamination.

8.3.11 1 Fingernails shall be kept short, clean and unvarnished. False fingernails are not permitted.

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Section IV

Auditing and Certification

1 Introduction Most companies using the Standard wish to be independently assessed to demonstrate that they meet the Requirements of the Standard and to obtain certification to the BRC Global Standard Scheme. This assessment takes the form of an audit visit which is carried out by an approved Certification Body. BRC/ RILA do not carry out any audits directly themselves. The detailed process by which a company gains and maintains certification is summarised in Figure 2. For confirmation of the latest certification protocols reference should be made to the BRC Global Standards website www.brcglobalstandards.com, where changes or updates will be published. The company will be assessed by an independent BRC approved audit company – the Certification Body. A list of current BRC approved certification bodies for Consumer Products can be found at www.brcglobalstandards.com. The Certification will be graded according to the number and type of non-conformities found during the audit visit. The grade will also influence the frequency of ongoing audits. This section describes the process to be followed by a company seeking certification.

2 Getting started Obtaining BRC certification is often a challenging step for companies and it is vital that the company is well prepared for the audit, otherwise substantial unnecessary cost may be incurred and disappointment is likely. The section “Planning for Success” in Section I of this Standard gives guidance on how to prepare for certification. Some considerations that should be addressed by companies interested in obtaining certification are:

• Making an accurate “gap analysis” of their situation versus the requirements of the standard

• Choosing an appropriate Certification Body • Ensuring staff are adequately trained

o About the Standard o About risk assessment o About obtaining legal and safety information relevant to their products o About relevant product standards or codes of practice

Training courses are available from BRC. For more information visit the training pages on the BRC website

• Allowing an adequate time scale for implementing the required measures • Using consultants to assist in areas of weakness or limited understanding if

necessary Many of the Certification Bodies offer an optional pre-assessment visit. Certification Bodies are not allowed to act as consultants since this could potentially result in them auditing their own work, but such a visit does help with a gap analysis and allow factories to get a clear understanding of where they need to improve their processes and procedures. A pre-

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assessment visit is not a part of the certification process and has no effect on the results obtained during the actual certification audit visit. Evidence suggests that for many companies this is a very useful exercise that greatly enhances the chances of successful certification during the BRC audit. If a company is working with a specific retailer or other specifier, it would be advisable to discuss an implementation programme with the site’s technical team to ensure that the steps being taken are appropriate with regard to the retailer’s requirements and timescales.

3 Self Assessment of Compliance with the Standard It is a requirement of BRC certification that the company has an original copy of the current issue of the Standard. The Standard can be obtained in either electronic or paper format and either format is acceptable. The Standard is available in a number of language versions from www.brcbookshop.com. The Standard should be obtained as the first stage of preparation to certification. The Standard should be read and understood and a preliminary self assessment should be conducted by the company itself against the Standard. Any areas of non-conformity should be addressed by the company. Further information and guidance to help companies comply with the Standard, including an interpretation guideline, audit tools and training courses are available on the website www.brcglobalstandards.com. .

4 Selection of a Certification 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 lists BRC-approved certification bodies. Visit www.brcdirectory.com. In selecting a certification body, the company should consider:

• acceptability of the certification body to their customers; certain customers carry lists of their preferred certification bodies

• the scope of accreditation of the certification body. It is essential that the certification body is accredited to assess companies for the categories of products produced. Clarification of the categories of products against which the certification body can audit should be obtained either by confirmation from the certification body concerned or from accreditation schedules published by the appropriate national accreditation body. A list of product categories is provided in Appendix 3

• confirmation that the auditor proposed by the certification body meets the qualifications, training and experience requirements specified by the BRC.

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Figure 4 : How to Gain Certification

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5 Company/Certification Body Contractual Arrangements The BRC requires there to be a contract between the company and the certification body, detailing the scope of the audit and the reporting requirements. This contract will be formulated by the certification body.

5.1 Administration fee

An administration fee is collected on behalf of the BRC by the certification body from the company for every audit undertaken. This fee is to support further development of the Standard and to fund the maintenance of the BRC Directory and the Technical Services Team. The certification body shall not issue a certificate or report until the administration fee has been received, irrespective of the outcome of the certification process.

5.2 Auditor Selection

It is the responsibility of the company to ensure that adequate and accurate information is given to the certification body detailing the products it manufactures and the process technologies it uses to enable the certification body to select an auditor with the required skills to undertake the audit. Auditors must be skilled to audit in the relevant product category as listed in Appendix 3. The certification body, auditors and the company must be aware of the need to avoid conflict of interest when arranging an auditor for the site visit. The company may request or decline the services of a particular auditor offered by the certification body. However, as guidance, the certification body should ensure that the same auditor does not undertake audits on more than three consecutive occasions to the same site. Exceptions to this should be justified on the audit report – such as a requirement for audit in specialist areas and remote regions.

6 Relationship with Other Certification Standards The Standard will be used by Certification Bodies as a Standard in its own right, without addition or amendment to format or content. The BRC is, however, aware that there is overlap between the some requirements of the Standard and other Standards used by industry; in particular ISO 9001 with regard to the Management System requirements. A cross reference table is provided (appendix 9) showing the relationship between the Standards. Some sector specific requirements such as those for medical devices or personal protective equipment, as well as some private sector schemes such as that developed by the Toys Industries of America are also similar in concept or contain parts that are similar to the Global Standard for Consumer Products. BRC does not restrict or preclude the delivery of joint audits covering the BRC Standard and other schemes provided that the requirements of the BRC Standard are audited in full. Discussions concerning joint audit visits should be held directly with the chosen Certification Body

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7 Guidelines

7.1 Codes of Practice/Specific Guidelines

The BRC encourages cooperation between stakeholders to agree industry codes of practice and specific guidelines for individual product categories as required. BRC publishes an interpretation guideline to the Standard and specific sector guidelines for some industries. More information on these topics can be found on the BRC website. These documents will supplement the Standard as guidance for both auditors and companies hoping to obtain certification. They augment the general requirements of the Standard and will help factories with the practical implementation of the Standard. The legal requirements and “state of the art” with regard to producing safe products evolve rapidly. Regardless of the availability of sector guidelines, it is the company’s responsibility to ensure that up to date information is available and the requirements implemented

7.2 Status of Guidelines

It is not mandatory for companies to be in possession of any such Guidelines produced by the BRC. The Guidelines do not directly form part of the audit although companies would be expected to have measures similar to those described in the Guidelines in place and audit tools used by the auditors may be based on the sector guidelines. There may, however, be other means to achieve compliance with the Standard than those quoted in the guideline documents and so any such documents should be treated as best practice guidelines and supplementary information, and do not form additional requirements. Auditors will be required to undergo training in any guidelines appropriate to their sectors of expertise. This is to ensure a minimum level of understanding of sector specific BRC requirements and to establish a level of consistency between auditors. BRC also produce some general “ best practice” guidelines on certain aspects of operation such as “Pest Control” or “Customer Complaints”, these documents are also only for guidance, are not mandatory and do not form part of the audit.

8 Audit Preparation by the Company

8.1 Preparation prior to the initial audit

For the initial audit, the company shall agree a mutually convenient date, with due consideration given to the amount of work required to meet the requirements of the Standard. For subsequent audits, the mutually agreed date must allow sufficient time to ensure the company certification does not lapse (see Appendix 6 for details).

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There is a requirement on the company to plan carefully for the audit, to have the appropriate documentation ready and to have appropriate staff available at all times during the on-site audit. The company shall ensure that production at the time of the audit covers products within the intended scope of the certification. Where possible, the widest range of these products shall be in production for the auditor to assess. Where the product range is large or diverse, the auditor has the discretion to continue the audit until sufficiently satisfied that the intended scope of the certification has been assessed. The company shall provide the certification body with any pertinent information and data that would assist the auditor in conducting an effective audit. Companies are free to change certification bodies at any time but it is a requirement that the company shall make the previous year’s BRC audit report available to the auditor and the certification body. Companies may not use different certification bodies for surveillance and certification audits.

8.2 Duration of the Audit

The company shall provide the certification body with appropriate information to allow them to assess the duration and the cost of audit. This should include details of manufacturing schedules to allow audits to cover relevant processes, for example night time manufacture if necessary. Requested information may also include, for example, a site plan, number of employees and number of product lines. The time to assess all documentation is supplementary to the duration of the audit. Before the audit takes place, the certification body shall indicate the approximate duration of the audit. The typical duration of an audit is between 1.5 and 3 man days but this could be considerably longer for large, complex sites. Additionally up to one man day is typically required for the completion of a comprehensive audit report. However, certain factors can influence the duration of the audit. These factors will require careful consideration both upon confirmation of the expected duration of the audit and during the audit itself. Deviation from this time frame must be justified and specified on the audit report. In the event that the company requires certification audits against other Standards, the total time taken for these audits must be specified on the audit report and fully justified. Factors which may influence the duration of the audit are:

• product group level • company staff numbers and functions • separate office, manufacturing or storage buildings • complex manufacturing processes using a number of different technologies • products of many different types and complexity • size of site, whether it has been purpose built • labour-intensity of the processes, level of automation • first visit by the auditor to the company • any time-consuming access procedures

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• audit not carried out in the first language of the auditor or company • the number of non-conformities recorded in the previous audit • difficulties experienced during the audit and requiring further investigation • preparedness of the company • co-ordination of documentation.

For an audit, it is usual that 30–50% of time will be spent on an inspection of the production facility and audit of the practical implementation of the Standard with the remainder of the time being used to examine the risk based systems and documentation. This will vary according to the complexity of the operation. The time taken shall be detailed on the audit report.

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

• the opening meeting – to confirm the scope and process of the audit • document review – a review of the documented risk assessments, Quality

Management Systems, records, test reports and similar. • production facility inspection – to review practical implementation of the systems and

interview personnel • review of production facility inspection – to verify and conduct further documentation

checks • final review of findings by the auditor – preparation for the closing meeting • closing meeting – to review audit findings with the company. Note that non-

conformities are subject to subsequent independent verification by the certification body management.

There is no requirement for the auditor to carry out the audit in the order listed above but the audit must include all elements. The company shall fully assist the auditor at all times. It is expected that at the opening and closing meetings those attending on behalf of the company will be senior managers who have the appropriate authority to ensure that corrective action can be progressed if non-conformities are found. The most senior operations manager on site or their nominated deputy shall be available at the audit and attend the opening and closing meetings. During the audit, detailed notes shall be made regarding the company’s conformities and nonconformities against the Standard and these will be used as the basis for the audit report. The auditor will assess the nature and severity of any non-conformity. At the closing meeting, the auditor shall present his/her findings, and discuss all non-conformities that have been identified during the audit, but shall not make comment on the likely outcome of the certification process. Information on the process and timescales for the company to provide evidence to the auditor of the corrective action to close non-conformities must be given. A written summary of the non-conformities discussed at the closing meeting will be documented by the auditor either at the closing meeting or within one working day after completion of the audit.

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The decision to award certification and the grade of the certificate will be determined independently by the certification body management, following a technical review of the audit report and the closing of non-conformities. The company will be informed of the certification decision following this review. The auditor cannot make the final decision about the site; it has to be reviewed by others within the certification body. All information viewed during the audit is regarded as confidential between the auditor and the site, except as detailed in the audit report. No brand names or similar identifiers of product will be released in the audit report or certificate Auditors and companies may make use of audit tools to assist them in the preparation of and during the audit. The following diagram shows this concept Figure 4 : Audit tools

General Interpretation

Guidelines

The Standard

Standard Audit

Do ProductGuidelines exist

for this product type?

Sector Audit

Report/Score

Directory

Sector Guidelines

Yes

N

Pass

Corrective actions

Fail

10 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.

10.1 Non-conformities

There are three levels of non-conformity:

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Critical

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

and/or

where a major non conformity with a “fundamental” clause is determined.

Major

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

and/or

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

Minor

where absolute compliance to the ‘statement of intent’ has not been met but on the basis of objective evidence the conformity of the product is not in doubt

and/or

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

The objective of the audit is to provide a true reflection of the operation of the site and the level of conformity against the Global Standard for Consumer Products. Consideration should therefore be given to awarding a single major non-conformity where minor non-conformities are repeatedly raised against a particular clause of the standard. Clustering of a significant number of minor non-conformities against a clause and recording this as a single minor non-conformity is not permitted.

10.2 Procedures for Handling Non-conformities and Corrective Action

The criteria for grading non-conformities and the means of confirming corrective actions are summarised in Appendix 4. The decision to award a certificate, and the grade of the certificate, A, B or C, will depend on the number and severity of non-conformities raised, and the completion of effective corrective actions within the stated time limit by the company. Where the number and type of non-conformities exceed a certain level, a grade D is assigned and certification will not be granted (refer to Appendix 4). Following identification of any non-conformities during the audit, the company must develop a corrective action plan to address the non-conformities identified. Evidence that corrective action has been completed must be provided to the certification body prior to a certification decision being made. It should be noted that the grade of the audit shall be not changed when the non-conformities have been corrected since it represents the state of compliance of the factory during the audit visit. .

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Any non-conformities from the previous audit should be checked during the current audit to confirm corrective action has been taken and is operating effectively. Any repetition of these same non-conformities in the current audit shall be highlighted by an asterisk (*) and consideration should be given to raising the status of minor non-conformities to major.

10.2.1 Critical Non conformities or Major Non-conformities Raised against ‘Fundamental’ Clauses

Where a critical or major non-conformity against the statement of intent of a ‘fundamental’ clause has been established at an initial audit, the company shall not gain certification. Where a critical non-conformity is found at a subsequent audit, certification must be immediately suspended. This means that fundamental requirements must be in place at the time of the audit visit and cannot be corrected later without the need for a complete re-audit. In either of the above cases, this results in the awarding of a grade D and there shall be a further full on-site audit carried out, once the company is satisfied that appropriate corrective action has been effectively taken, to verify appropriate corrective action has taken place and there is demonstrable evidence of compliance. In the event that a critical or major non-conformity against the statement of intent of a ‘fundamental’ clause has been established by the certification body, the company shall immediately inform its current customers and make them fully aware of the circumstances. They should also review whether the circumstances of the non conformity compromise product safety and warrant the inclusion of past customers. Information on the corrective actions to be taken in order to achieve certification status will also be provided to customers.

10.2.2 Major Non-conformities No certificate shall be issued until major non-conformities have been demonstrated as having been corrected. It is normally expected that major non-conformities will be corrected within 28 calendar days of the audit taking place. (Note that calendar days are defined in the glossary and do not include public holidays). This can be either a permanent or temporary solution providing the solution is acceptable to the certification body and the certification body is able to verify that corrective action has taken place This can be achieved either by objective evidence being submitted to the certification body such as updated procedures, records, photographs or invoices for work undertaken etc., or by the certification body undertaking a further on-site visit. Note that if a company obtains a grade C then a re-visit is required to confirm the non conformities have been successfully addressed. For initial audits 60 calendar days are allowed for correction of non conformities. The company may remain in the certification programme, but will be un-certificated and will only be certificated following verification of the corrective action being implemented. If a non-conformity cannot be closed out within the 60-day period, the process of certification will commence again, i.e. a full audit. If there is no formal commitment to implement corrective action received by the certification body within the 28 /60 calendar day post-audit period as appropriate for existing or new certifications, or if there is a failure to meet the timescale proposed in the nonconformity

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summary sheet without justification, the company does not remain in the certification programme. The company will then require a further full audit in order to be considered for certification.

10.2.3 Minor Non-conformities Certification will only be awarded where minor non-conformities have been addressed, the corrective action taken and evidence (e.g. photos, invoices) for work completed has been provided to the certification body, within 28 calendar days following the audit (60 calendar days for an initial audit). The certification body may undertake further site visits to verify that action has been taken. Where documentary evidence is provided, absolute verification may be left until the next audit. At the subsequent audit, if verification cannot be confirmed, then a non-conformity may be raised and this may be elevated to a major non-conformity.

11 Further Action For certificated companies, where deemed appropriate, the certification body may carry out further audits or question activities to validate continued certification at any time. These visits may take the form of announced or unannounced visits to undertake either a full or part audit. Where justifiable, suspension or withdrawal of certification may be implemented pending the outcomes of such further reviews by the certification body. The ultimate decision to suspend or withdraw certification remains with the certification body. If there is no intention on behalf of the company to take appropriate corrective actions or the corrective actions taken are deemed inappropriate, certification shall be withdrawn. In the event that certification is withdrawn or suspended by the certification body, the company shall immediately inform its customers and make them fully aware of the circumstances relating to the withdrawal or suspension. Information on the corrective actions to be taken in order to reinstate certification status will also be provided to customers.

12 Grading of the Audit The purpose of the certification grading system is to indicate to the user of the report the commitment of the company to continual compliance and will dictate the future audit frequency (full details available in Appendix 4). The grade is dependent on the number and severity of the non-conformities identified at the audit as verified in a subsequent technical review by the certification body management which might modify the original result. The certification body will review objective evidence of corrective action completed prior to awarding a certificate, but this will not improve the grade awarded.

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12.1 Certification

After a successful review of the audit report and documentary evidence provided in relation to the non-conformities identified, a certification decision shall be made by the designated independent certification manager and a certificate issued by the certification body typically within 42 calendar days of the audit (74 calendar days for the initial audit). The certificate shall conform to the format shown in Appendix 5, using BRC and accreditation body logo usage rules. All dates specified on the certificate shall be the format of: day, month, year. The certificate will detail the scope of the audit as agreed in Section II

• The report should contain the 6 digit BRC registration number of the auditor. This number refers to a register of qualified auditors kept by the BRC and enables them to cross check auditor competence against the audit carried out. This register is not publically available

• Where the on-site audit has been undertaken by an auditor issued with a BRC Third Party Auditor Certificate for this Standard, the BRC Trained Auditor Logo may be added to the certificate.

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

• The initial audit date should be included on all subsequent certificates provided continuous certification has been maintained.

Certificated companies are advised that they should verify that the scope of the certificate is clearly stated and that this information is consistent with their stated requirements. Other users of the certificates are advised to carefully check the stated scope of products is appropriate for their requirements.

13 Audit Reporting Following each audit, a full written report shall be prepared in the agreed format. The report shall be produced in open text format in English or in another language dependent upon customer needs. The first section of the report must be available in English. A checklist of audit questions may also be available and appended to the report. The detailed audit report section shall include both comment where criteria have been met, particularly where improvement or enhancement is evident, and objective evidence to support any non- conformities that have been identified. The detailed audit report section should demonstrate clear evidence of auditor competence in the category concerned. Product and production information should be referenced throughout the report which should have a clear focus on product sector issues and must assist the reader to:

• gain greater understanding of individual clauses either for conformity or for non-conformity

• be informed of corrective action taken • be informed of improvements made since the last audit

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• be informed of ‘best practice’ systems, procedures, equipment or fabrication in place • be informed of any additional pertinent comments the auditor made.

The report shall accurately reflect the findings of the auditor during the audit. Reports shall be prepared and dispatched to the company within a period typically no longer than 42 calendar days (74 calendar days for the initial audit) after the audit date. Audit reports shall remain the property of the company commissioning the audit (which is usually the site) and shall not be released, in whole or part, to a third party unless the company has given prior consent (unless otherwise required by law). This may be by a consent form, or may be contained within a contract between the company and user or the company and the certification body. The certification body will retain a copy of the audit report. The audit report and associated documentation shall be stored safely and securely for a period of five years by the certification body. A copy of the audit report shall be uploaded by the certification body in the required format to the BRC Directory.

14 Ongoing Audit Frequency and Certification The ongoing audit schedule will be agreed between the company and the certification body. If a factory changes significantly in any way, for example a significant change of senior or technical management, production of different product types or supply to a new geographical area then a re-audit will be required as soon as possible to establish continuing conformity. This may be outside of the usual agreed frequency. Product Groups 1 and 2 The minimum frequency will be 12 months, but this could vary according to the performance of the company at an audit as reflected by the grade, as stated in Appendix 4. Product Group 3 Certification for companies with Group 3 products will be awarded for 24 months but will require an interim, surveillance audit at 12 months which will cover only the “fundamental” requirements and confirmation that any previous non conformities raised have been satisfactorily addressed. The certification and grade will be awarded for a period of 24 months but, should a major non-conformity be discovered during the surveillance visit, the company shall correct the non-conformity within 28 days or they will not remain certificated and will require a new, complete audit to regain certification. The surveillance visit does not result in a new certificate and does not change the grade of the original certificate. In the case of a company obtaining a critical non conformity during a surveillance visit however, the certification will be immediately suspended. More frequent audits may be required depending on performance as stated in Appendix 4 The due date of the subsequent audit shall be calculated from the date of the initial audit, irrespective of whether further site visits were made to verify corrective action arising from the initial audit, and not from the certificate issue date.

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The subsequent audit shall be scheduled to occur within a 28 calendar day time period prior to the next audit due date. This allows sufficient time for corrective action to take place in the event of any nonconformities being raised, without jeopardising continued certification. Appendix 6 provides worked examples in accordance with the six , twelve and twenty four month audit frequencies. It is the responsibility of the company to maintain certification. Justifiable circumstances for delays shall be documented in the audit report.

14.1 Certificate Expiry – Justifiable Circumstances

There will be some circumstances where the certificate cannot be renewed on the six month and twelve month basis due to the inability of the certification body to conduct an audit. These justifiable circumstances can include when the site is:

• situated in a specific country or an area within a specific country where there is government advice from the auditor’s country not visit and there is no suitable local auditor

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

If the renewal of the certificate is prevented due to these exceptional circumstances, the customer may still decide to take products from that site for an agreed time, as they 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.

14.2 Seasonal or Intermittent Production

Refer to glossary for definition of seasonal and intermittent production. A site that is open for 12 months of the year may process products at different times, but would not be classed as a seasonal or intermittent production site as it would operate all the year round. If specific seasonal products are in scope there may be a case to visit the site more than once a year. For true seasonal products there may be circumstances where the frequency could be more than 12 months. The on-site audit date will be dictated by product the time of year at which the products are produced. The certificate expiry dates in these circumstances will be controlled by the actual audit date rather than the anniversary of the initial audit date. Justification needs to be included on the audit report. Certain products are manufactured for only six or fewer months in any annual cycle. The audit must take place during the production of the product, irrespective of grade assigned from the previous audit. Verification of corrective action in relation to critical and major non-conformities must take place within the period that the product is manufactured.

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15 BRC Logos and Plaques

Achieving BRC certification is something of which to be proud. Companies that achieve certification are qualified to use the BRC logo on company stationery and other marketing materials. A BRC wall plaque is available for certificated companies to display in their offices to help celebrate their success. Information relating to the use of the BRC logo is available at www.brcglobalstandards.com. If a company is no longer certificated because of certificate expiry, withdrawal or suspension they shall no longer use the logo or display any plaque or certificate claiming certification.

16 Communication with Certification Bodies In the event that the company becomes aware of legal proceedings with respect to product safety or legality, or in the event of a product recall, the company shall immediately make the certification body aware of the situation. The certification body in turn shall take appropriate steps to assess the situation and any implications for the certification, and shall take any appropriate action.

16.1 Certification Body Performance Monitoring

BRC has a compliance programme for certification bodies which requires certification bodies to meet key performance indicators. The BRC also conducts a programme of sampling of audit reports.

16.2 Feedback

Companies audited against the Standard may wish to provide feedback to the certification body or the BRC on the performance of the auditor. Such feedback sent to the BRC will be considered in confidence by the Compliance Manager and/or the relevant Technical Advisory Committee of the Global Standard as part of performance management of the certification body.

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16.3 Complaints

The BRC has implemented a formal referral process which is available to organisations involved with the Global Standards. A document detailing the Global Standards referral process can be found on the website www.brcglobalstandards.com together with a ”Global Standard Referral Notification” form. From time to time failure to apply the principles and criteria of the BRC Global Standards at certificated sites may be reported to the BRC by, for example, retailers and companies conducting their own audits. In this event, the BRC will request a documented report of the reasons for the complaint, and refer this report, in confidence, to the certification body conducting the audit. The BRC will require a full investigation of the issues raised and a report from the certification body submitted to the BRC within 28 calendar days or shorter time as specified by the BRC in urgent cases.

17 Appeals The company has the right to appeal against the grade awarded or the certification decision made by the certification body and any appeal should be made in writing within seven calendar days of receipt of the certification decision. The certification body shall have a documented procedure for the consideration and resolution of appeals against the certification decision. These investigative procedures shall be independent of the individual auditor and certification manager. Individual certification bodies’ documented appeals procedures will be made available to the company on request. Appeals will be finalised within 30 calendar days of receipt. A full written response will be given after the completion of a full and thorough investigation into the appeal. In the event of an unsuccessful appeal, the certification body has the right to charge costs for conducting the appeal.

18 The BRC Global Standards Directory

18.1 Introduction

The Global Standards Directory www.brcdirectory.com is an online searchable directory of companies certificated to the BRC Global Standards for Food Safety, Packaging, Consumer Products and Storage and Distribution. Each entry includes relevant company details, contact and certification information. The Directory also includes details of certification bodies approved by the BRC. The Global Standards Directory was developed to provide an audience for certificated companies, key information to retailers and to improve the management of the BRC Global Standards programme. It provides a system of data storage of audit information, both live and archived. Data is centrally managed and controlled to maintain accuracy and integrity.

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18.2 Benefits of the Directory to Companies

Inclusion on the BRC Directory provides:

• increased awareness and visibility of the company’s products and services to customers

• use of the BRC Global Standards logo, which can be used on all of the company’s communications, including stationery, brochures and websites

• access to BRC training courses • a quarterly electronic newsletter • pre-release notification and special offers on BRC publications, conferences and

events.

18.3 Directory Functionality

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

• a searchable list of certificated companies including contact details, the Standard against which they are certified, scope and links to their web site

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

Note that companies may choose not to appear on the Directory if they so wish. The Global Standards Directory provides additional functionality to key user groups including companies, retailers and certification bodies. This includes user specific access to certification information, audit reports and management reporting, further enhancing the value of obtaining BRC certification.

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Section V

Operation and Governance of the Scheme

1 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 5 In order for a business to receive a valid certificate on completion of a satisfactory audit, the organisation must select a certification body approved by the BRC. The BRC lays down detailed requirements that a certification body must satisfy in order to gain approval. As a minimum, the certification body must be accredited to ISO/IEC Guide 65/EN45011 by a national accreditation body affiliated to the International Accreditation Forum. Further details are available in the document “Requirements for Organisations Offering Certification against the Criteria of the BRC Global Standards” – available from the BRC on request. Companies looking to become certificated to the Standard should assure themselves that they are using a genuine certification body approved by the BRC. A list of all certification bodies approved by the BRC is available 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 Global Standard for Consumer Products, the certification body must be able to conduct audits as part of achieving accreditation and so some unaccredited audits will be performed. This will be permitted where the organisation can demonstrate:

• an active application for accreditation against ISO/IEC Guide 65/EN45011 from an approved national accreditation body

• that accreditation will be achieved within 12 months of the date of application and the experience and qualifications of the auditors in the relevant product category are consistent with those specified by the BRC.

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Figure 5: Process for Accreditation of Certification Bodies and Certification of Companies

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2 Technical Governance of the Global Standard for Consumer Products

The technical content and operation of the Standard is governed by the BRC Governance and Strategy Committee consisting of senior technical representatives of international retail businesses. The functions of the Governance and Strategy Committee are:

• to advise on the development and management of the Standard • to ensure measures are in place to monitor compliance by companies, certification

bodies and accreditation bodies • to coordinate the review of the Standard at appropriate intervals

For each BRC Global Standard, Technical Advisory Committees (TAC) meet regularly to discuss technical, operational and interpretational issues related to the Standard. The BRC/RILA provides the technical secretariat for these groups. The Standard is reviewed every three years to assess the need for updating or production of a new issue.

The certification bodies participating in the scheme also have co-operation groups to discuss matters arising on the implementation of the Standard and these groups report regularly to BRC. The structure of the BRC Global Standards operations is outlined in Figure 6 below

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Figure 6 : BRC Global Standards Technical Governance

3 Effective Date of Issue 3 As with all revisions of the Global Standards, a transition period is in place between publication and full implementation. Therefore, certification against Issue 3 will commence from 1 October 2010. There will be no recognition of certificates that are issued as a result of audits performed against Issue 2 or 2A after 30 September 2010. All certificates issued against audits carried out prior to 30 September 2010 will be against Issue 2A and be valid for the period specified on the certificate. In order to ensure that the infrastructure is in place to support successful audits, audits against Issue 3 will not commence until 1 October 2010. Certificates issued before this date against Issue 3 will not be recognised by BRC.

4 Acknowledgements

A ‘Thank You’ from the BRC and RILA

The BRC and RILA wish to acknowledge all those industry experts who have contributed to the preparation of the Standard Issue 3. A list of those who have contributed to this review is detailed in Appendix 8.

Governance & Strategy Committee BRC /RILA members and international representatives

Define policy & oversee progress

BRC / RILA Technical Advisory Committees

• Comprised of retailers and other stakeholders

• Contributes to the production & review of Standards and Guidelines

• Advises on interpretation issues

• Reviews training materials

Certification Body Co-operation groups Liaison between CBs and BRC on technical issues & progressing implementation

BRC Technical team RILA Product Safety Group

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Appendix 1

The Standard and its Relationship with Other BRC Global Standards The BRC has developed a range of Global Standards which set out the requirements for the wide range of activities undertaken in the production of food, consumer goods and, packaging, as well as storage and distribution . The Standard is an auditing Standard that sets out the requirements for businesses that produce consumer products or are involved in the preparation of products as components for supply as retailer branded products or branded products. It can only be used at manufacturing or packing sites. It is not suitable for importers, sales offices and similar operations. Certification will only apply to products that have been manufactured or prepared at the site where the audit has taken place, and will include storage facilities that are under the direct control of production site management. Companies whose primary occupation is the manufacturing of products or preparations may have factored goods (refer to glossary) included in the scope of the certification, where they can demonstrate that appropriate controls are in place and the scope specifically excludes the processing or manufacture of these products. The BRC Global Standard for Storage and Distribution is an auditing Standard that sets out the requirements for the storage, distribution and wholesaling and contracted services for pre-packaged and loose products, packaging materials and food. There are specific modules for each activity undertaken and the Standard specifies the requirements for storage, distribution, wholesaling and contracted services. Companies that offer contracted operations will not be covered by this Standard as these operations are deemed to be processing activities and are covered by the Global Standard for Consumer Products. Application of this Standard only commences when the products enters third party storage premises, third party vehicle or premises owned by the manufacturer not covered by the scope of the audit for the Global Standards for Consumer Products, Packaging or Food. The Standard is not applicable to:

• storage facilities under the direct control of the production site management • operations where product processing, handling or packing/repacking of open food

occurs. The Global Standard for Storage and Distribution does not cover: • live animals • pre-farm-gate loose bulk agricultural products • Non food products that are listed as excluded in the Global Standard for Consumer

Products. In addition companies such as trade agencies, brokers and importers that do not have manufacturing, packing, storage or transport facilities cannot apply for certification under the Standard but such companies may request certification from their suppliers involved in these activities. The BRC/IoP Global Standard for Packaging and Packaging Materials is an auditing Standard that lays down the requirements for the manufacturing of packaging materials used for food and consumer products. Businesses may request certification to this Standard from their suppliers of packaging. Packaging manufactured for retail sale to consumers is included within the scope of the Global Standard for Consumer Products.

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The BRC Global Standard for Food Safety is an auditing standard which is applicable to food and is the most mature of the BRC Global Standards widely used in the food industry worldwide. This Standard also applies to products closely related to food such as pet foods, vitamins, minerals and herbal supplements. These products fall out with the scope of the BRC Global Standard for Consumer Products.

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Appendix 2

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 by the BRC. The registration process identifies that auditors have undergone required training and identifies the product categories in which they have expertise. Evidence of an auditor’s qualifications, experience and training has to be submitted to the BRC prior to them carrying out audits. All registered auditors receive a unique registration number which is included on the audit report and is automatically cross checked against their competence before the certification is accepted onto the BRC Directory. The following sections identify the minimum requirements for auditors. The verification of competence to carry out a specific audit shall be carried out by the certification body .

1.1 Responsibility of the Certification Body

It is the responsibility of the certification body to ensure processes are in place to monitor and maintain the competence of the auditor to the level required by the Standard.

2 Education The auditor ideally shall have a recognised professional apprenticeship, a degree in a science or engineering discipline or, as a minimum, have successfully completed a higher education in a science or engineering related discipline.

3 Work Experience The auditor shall have a minimum of three years work experience directly related to the relevant technology or industry. This shall involve work in quality assurance, technical management, engineering, product development or product safety functions within manufacturing, retail technology, or technical audits. The auditor shall be able to demonstrate an understanding and knowledge of specific categories of product for which they are approved.

4 Qualifications The auditor must have:

• Passed a registered QMS Lead Assessor course (e.g. IEMA, IRCA) and

• Completed a Global Standard for Consumer Products “How to interpret the Standard” delivered by a BRC Approved Trainer and participated in update courses to ensure that they have been trained to the current issue of the Standard

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or • successfully completed a course combining technical and lead assessor skills

specifically developed by the BRC and provided by a BRC Approved Trainer and participated in update courses to ensure that they have been trained to the current issue of the Standard

And

• �completed a training course in Risk Assessment or HACCP, of at least two days duration, or be able to demonstrate competence in the understanding and application of Risk Assessment/Hazard Analysis/HACCP Principles. It is essential that the HACCP/Risk Assessment Course is recognised by the relevant sector industry as being appropriate and relevant.

�. • Completed a training course on the BRC sector specific guidelines for the sectors in which they operate, where such guidelines exist.

5 Audit Experience Auditors must have practical auditing experience of Product Certification Schemes or Quality Management Systems. The details of the required experience are specified in the document “Registration, Qualifications, Training and Experience Requirements for Auditors” available from BRC on request.

6 General Training Obligations of Certification Bodies Certification bodies must be able to demonstrate that every auditor has appropriate training and experience for the particular categories for which they are considered competent. Auditor competence shall be recorded at least at the level of each category as indicated in Appendix 3. Certification bodies must establish training programmes for each auditor, which will incorporate:

• a period of initial training covering product safety, risk assessment and prerequisite programmes, and access to relevant laws and regulations

• a period of supervised training to cover quality management systems, audit techniques and specific category knowledge

• assessment of knowledge and skills for each category • documented sign off after the satisfactory completion of the training programme

Each auditor’s training programme shall be managed and approved by a technically competent person within the certification body who can demonstrate technical competence in the categories in which training is given. Full detailed training records of the individual shall be maintained by the certification body throughout the term of employment, and retained for a minimum period of five years after leaving the employment of the certification body.

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6.1 Exceptions

Where a certification body employs an auditor who does not fully meet the specific criteria for education but has been assessed as competent, there shall be a fully documented justification in place to support the employment of the auditor. Note – such exceptions only apply to existing auditors prior to June 2009 new auditors will be expected to meet the defined criteria.

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Appendix 3

Product Fields and Categories

The product fields listed below represent the broad groups into which consumer products may be placed. The product categories are the groups to which auditors are registered and must demonstrate their expertise.

It is inevitable that some products will be difficult to categorise and may cross boundaries between product categories. This list may be amended from time to time and users are advised to check for the most up to date information via the website www.brcglobalstandards.comNote that auditors may be approved for multiple categories if their expertise is appropriate. Note that products may fall into more than one product category. (for example a toy that is also an electrical product)

BRC Consumer Products : Auditor Category Codes

Field BRC Category Examples Code

number

Soft Lines Textiles and textile products Apparel Household textiles Bandages

1

Soft Lines Leather, leather products, footwear Belts Shoes Bags

2

Hard Lines Wood, wooden products, cork, straw

Pencils Doors Bamboo steamers Baskets Tablemats

3

Soft Lines Paper & paper products

Stationery items Tissues Toilet rolls Disposable table ware

4

Hard Lines Printing & recorded media

Books DVDs Magazines Labels

5

Formulated products

Coke, charcoal, refined petroleum products

Barbeque fuel Coal Candles Oil for lamps

6

Formulated products

Chemicals & chemical products

Cosmetics Household detergents Garden chemicals Paints

7

Formulated products

Pharmaceuticals Medicines Tablets Creams

8

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Hard Lines Rubber & plastic products

Gloves Elastic bands Household utensils Giftware

9

Hard Lines Glass, clay, ceramic & porcelain products

Tableware Cookware Decorative items Mirrors

10

Hard Lines Concrete, cement, lime, plaster Building goods 11

Hard Lines Metal products excluding machinery

Handles Tins Razor blades Screws, nails etc

12

Hard Lines Machinery & equipment Ladders Tools Gas appliances

13

Electrical Computer, electronic, communications & optical

Computers Phones Computer accessories Audio visual

14

Electrical Electrical equipment, batteries

Lighting Household appliances White goods Battery operated items Batteries

15

Hard Lines Transport equipment, cycles, boats Bicycles Canoes Car accessories

16

Hard Lines Furniture

Outdoor Upholstered Metal, wood, plastic Inflatable

17

Hard Lines Games & toys

Plush toys Plastic toys Chemistry sets Radio controlled cars Swings

18

Hard Lines Jewellery and accessories

Precious jewellery Fashion jewellery Buckles Piercings

19

Can be any field depending on product

Medical devices

Dressings Walking aids Contact lens solutions

20

Other ( qualified in at least 3 of the above categories)

This section should be used sparingly to cover goods not easily classified elsewhere, for example gift items made of multiple materials

21

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Appendix 4 Summary of Grading Criteria, Action Required and Audit Frequency

Grade Critical

Major non-conformity against the ‘statement of intent’ of a ‘fundamental’ requirement

Major Minor Corrective action

Audit frequency Product Groups 1 and 2

Audit frequency Product Group 3

A 0 10 or fewer

Objective evidence in 28 calendar days (60 days for initial audit)

12 months

24 months Surveillance at12 months

B 1 10 or fewer

Objective evidence in 28 calendar days (60 days for initial audit)

12 months

24 months Surveillance at 12 months

B 0 11 to 20 Objective evidence in 28 calendar days (60 days for initial audit)

12 months

24 months Surveillance at 12 months

C 2 20 or fewer

Re-visit required within 28 calendar days (60 days for initial audit)

6 months 12 months

C 0 or 1 Up to 30

Re-visit required within 28 calendar days (60 days for initial audit)

6 months 12 months

D 1 or more

Certification not granted. Re-audit required

D 1 or more Certification not granted. Re-audit required

D 3 or more

Certification not granted. Re-audit required

D 2 21 or more

Certification not granted. Re-audit required

D 0 or 1 31 or more

Certification not granted. Re-audit required

Certification will not be granted and therefore no grade shall be awarded if corrective action is not completed or evidence of completion is not received by the certification body within the 28 calendar-day (60 days for first audit) timescale. The certification body shall justify a high number (more than 20) of minor non-conformities where there is either one major non-conformity or no major non-conformities. This shall be detailed on the audit report.

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Appendix 5

Certificate Template

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Trained third party auditor logo

Auditor Number -- CERTIFICATION BODY NAME OR LOGO

This is to certify that

COMPANY NAME AUDIT SITE ADDRESS

Has been evaluated by Certification Body name and

accreditation body registration number and found to meet the

requirements of

GLOBAL STANDARD for CONSUMER PRODUCTS ISSUE 3: APRIL 2010

SCOPE

Product Categories

Achieved Grade

Initial audit date

Date of audit:

Certificate issue

Re-Audit due date:

Certificate expiry

date:

..........

Authorised by

Accreditation Body Logo

Name and full address of Certification Body

This certificate remains the property of (name of Certification Body)

BRC logo

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Appendix 6

Certificate Validity, Audit Frequency and Planning

1, 2, 3, 4, 5 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 22, 23, 24 Months

Initial audit

. Latest date to award cert 74 days from audit

Year 1. Certificate validity = 12 months + 42 days from audit visit

Example of a Typical 12 Month Certification Cycle

Latest date for re- certification 6m and 42 days from initial audit

Audit window = 28 days

Audit 12 months max from initial audit

Re audit 24 months max from initial audit

Audit window = 28 days

Actual audit date

Audit 1/2/08 Certificate 20/3/08 Cert expiry 15/3/09 Re-audit 29/01/09

Year 2. Certificate validity = 12 months

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 Months

Initial audit

. Latest date to award cert 74 days from audit

Year 1. Certificate validity = 6 months + 42 days from audit visit

Example of a Typical 6 Month Certification Cycle

Latest date for re- certification 6m and 42 days from initial audit

Audit window = 28 days

Audit 6 months max from initial audit

Re audit 12 or 18 months max from initial audit depending on grade

Audit window = 28 days

Audit window = 28 days

Actual audit date

Audit 1/2/08 Certificate 20/3/08 Cert expiry 15/9/08 Re-audit 30/8/09

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1, 2, 3, 4 10 ,11,12 ,13 21, 22, 23, 24, 25, 26 35, 36, 37 46, 47, 48 Months

Initial audit

. Latest date to award cert 74 days from audit

Year 1. Certificate validity = 24 months + 42 days from audit visit

Example of a Typical 24 Month Certification Cycle

Year 3. Certificate validity = 48 months from initial audit

. Latest date for re- certification 2yrs and 42 days from initial audit

Audit window = 28 days

Surveillance 12 months max from audit

Re audit 24 months max from audit

Re audit 48 months max from initial audit

Surveillance window = 28 days

Surveillance window = 28 days

Audit window = 28 days

Actual audit date

Audit 1/2/08 Certificate 20/3/08 Surveillance 28/1/09 Cert expiry 15/3/10 Re-audit 30/1/10

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Appendix 7

Glossary of Terms

In relation to terms used within this document, the following words shall have the following meanings: Accreditation Procedure by which an authoritative body gives formal recognition

of the competence of a certification or testing body to provide certification / testing services against a specified standard.

AQL Acceptable Quality Limit as defined in ISO 2859 part 1 Assembly packer A business that assembles a collection of two or more market-

ready finished consumer products into outer packaging for sale as single product. These companies do not manufacture any of the component products, which are supplied to them for the assembly into the final pack.

Audit A systematic examination to substantiate whether activities and related results comply with planned arrangements, whether these arrangements are implemented effectively, and whether they are suitable to achieve objectives.

Audit level The product group level agreed between the company and the certification body as the criteria for the audit and certification. This shall not be lower than the product with the highest product group within the scope of audit.

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

Batch A discrete quantity of products made using the same operation and raw materials ( alternative term lot)

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

Branded product Products bearing the logo, copyright or address of a company which is not primarily a retailer.

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

Calendar day Includes both working days and weekends but excludes periods of legal public holiday of the country in which the site and / or Certification Body is located

Calibration Set of operations that establish, under specified conditions, the relationship between values of quantities indicated by measuring instruments or measuring systems, or values represented by a material or reference material, and corresponding values realised by standards.

Certification Procedure by which accredited certification bodies. based upon an audited assessment of a Company’s competence provide written assurance that a company conforms to a Standard’s requirement.

Certification Body Provider of certification services, accredited to do so by an authoritative body.

Certification suspension

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

Certification withdrawal Where certification is revoked.

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company, the The business name and the site seeking BRC certification. Compliance Meeting the regulatory or customer requirements concerning

product safety, legality and quality Consumer The end-user of the finished product. Consumer Product Management System

All systems related to product hazard and risk processes, and which determine and control product safety, legality and quality.

Consumer products Products normally bought or supplied to private consumers for personal or household use and included within the scope of the Standard.

Contract packer A Company that packages final product into consumer packaging Controlled document A document which is identifiable and for which revisions and

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

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

Critical Control Points (CCPs)

Process steps that can be applied and which are essential to prevent a safety hazard or to reduce it to an acceptable level.

Customer A business or person to whom the product has been supplied or sold, either as a finished product or as a component of a finished product.

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

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

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

Fundamental requirement

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

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

Hazard An agent of any type with the potential to cause harm. Incident An event that has occurred which results in the production or

supply of unsafe, illegal or non-conforming products. Infants Children under 36 months. Initial audit The first BRC audit at a company/site. Internal audit General process of audit, for all the activity of the company.

Conducted by or on behalf of the company for internal purposes. Job description A list of the responsibilities for a given position at a company. Injury: serious (major) 2–15% incapacity.

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

Injury: slight (minor) < 2% incapacity. Usually reversible and not requiring hospital treatment.

Injury: major > 15% incapacity. Usually irreversible and requiring hospital treatment (e.g. serious

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injury to internal organs, loss of limbs, loss of sight, loss of hearing, acute poisoning).

Invasive A device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body. For the purposes of this standard “invasive” does not include products entering the mouth or outer ear for periods of less than 30minutes continuous use A surgically invasive device is a device which penetrates inside the body through the surface of the body, with the aid or in the context of a surgical operation.

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

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

Lot See definition of batch Mandatory Standard Standards which must be met to demonstrate legal compliance

with the law in a country or region. Manufacturer A company that produces product from raw materials and/or

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

Nanomaterials

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

Nanotechnology Technology using nanomaterials in order to impart specific properties

Non-conformity The non-fulfilment of specified product quality, legal or safety requirements or specific quality requirements.

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

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

Performance indicators

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

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

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

Product recall Any measures aimed at achieving the return of an unfit product from final consumers.

Product withdrawal Any measures aimed at achieving the return of an unfit product from customers but not from final consumers.

Quality Meeting the customer’s specification and expectation. Quantity Control Check on amount of product in the consumer pack. May be

related to weight, volume, number of pieces, size etc Reference sample Agreed product or components for referral by the manufacturer for

production. Retailer A business selling products to the public by retail. Retailer-branded A product bearing a retailer’s trademark, logo, copyright, address

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product or ingredients which are used to manufacture within a retailer’s premises, or which are products legally regarded as the primary responsibility of the retailer.

Retained production sample

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

Risk The likelihood of occurrence of harm from a hazard. Sampling plan A documented plan defining the number of samples to be

selected, the acceptance or rejection criteria and the statistical confidence of the result

Safety Freedom from unacceptable risk to humans or animals. Seasonal or intermittent production

A product produced on a site that is opened specifically for the duration of the short term production (typically 6 months or less) during a 12-month cycle.

Senior management Those with strategic/high-level operational responsibility for the company and the capability to authorise the financial or human resources necessary for the implementation of the Standard.

Shall Is a requirement to comply with the contents of the clause. Site A unit of the company. Skin contact Product in intimate contact with the skin for more than 30 minutes

at one use. Examples include face paints and lingerie, Products handled during use such as books, keyboards etc are not included in this description

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

Specification An explicit, detailed description of a material product or service. Specifier Company or person requesting the product or service. Typically a

retailer Stakeholders Brand owners, certification bodies, enforcement agencies,

consumers, suppliers, manufacturers or others with a bona fide interest in the Standard.

Standard, the Global Standard for Consumer Products. Supplier The person, firm, company or other entity to whom a company’s

purchase order to supply is addressed. Technical dossier A collection of technical documents which together form the

technical specification and product conformity information on a specific product.

Testing A technical operation that consists of the determination of one or more characteristics of a given product, process or service following a specific procedure and against an agreed requirement.

Traceability Ability to trace and follow raw materials, components and products, through all stages of receipt, production, processing and distribution and vice versa.

Validation Confirmation through the provision of objective evidence that the requirements for the specific intended use or application have been fulfilled.

Verification Confirmation through the provision of objective evidence that specified requirements exist.

Very vulnerable user group

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

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

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Appendix 8

Acknowledgements

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Appendix 9

Cross reference tables with ISO 9001: 2008

Note that the cross reference is to clauses which address similar requirements. The exact contents of the clauses are not interchangeable.

BRC Global Standard v ISO 9000

Clause BRC Issue 3 Clause ISO 9001 - 2008 1 Senior management commitment and

continual improvement 5.1 Management commitment

1.1 5 Management responsibility

1.2 5.6 Management review 1.3 1.4 6, 6.1 Resource management

Provision of resources 1.5 8.5 Improvement 1.6 1.7 2 Risk Management 7.1 Planning of product realization 2.1 Product Scope and Group

Determination ------ 1 Scope

2.2 Legislative and Safety Requirements 2.3 Risk Assessment – prior to production 7.3 Design & development 2.4 Verification of the Product Risk

Assessment

3 Management System 4 Quality Management System 3.1 Policy Statement -- 5.3 Quality policy 3.2 General Documentation Requirements 4.2 Documentation requirements

3.3 Organisational Structure, Responsibility and Management Authority

5.5 Responsibility, authority & communication

3.4 Internal Audit ------ 3.5 Purchasing, Supplier Approval and

Performance Monitoring 7.4 Purchasing

3.6 Customer-supplied property 3.7 Corrective and Preventive Action 3.8 Traceability . 3.9 Management of Product Withdrawal

and Product Recall

3.10 Management of incidents and business continuity

3.11 Contract Review and Customer Focus 5,2 Customer focus 3.12 Complaint Handling 4 Site Standards ----- 6.3 Infrastructure 4.1 Location, Perimeter and Grounds 4.2 Internal Site: Factory Layout, Product

Flow and Segregation 6.4 Work environment

4.3 Building interiors -- 6.4 Work environment 4.4 Staff Facilities ------ 6.4 Work environment 4.5 Cleaning procedures 4.6 Waste/Waste Disposal 4.7 Pest Control

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4.8 Product Transport, Storage and Distribution .

4.9 Site Security 5 Product Control ---- 7 Product realization 5.1 Preproduction Reference Samples 5.2 Chemical Formulation Control 5.3 Product Packaging Materials 5.4 Control of Non-conforming Materials 8.3 Control of non conforming product 5.5 Handling requirements for specific

materials .....

5.6 Stock Control and Product release 6 Product Conformity Assessment 8 Measurement, analysis &

improvement 6.1 Product Analysis/Testing 6.2 Monitoring & measurement 6.2 Inspections . 6.3 Product claims ----- 7 Process Control --- 7.5 Product and service provision 7.1 Control of Operations 7.2 Control of Incoming Components and

Raw Materials ------

7.3 Equipment & equipment maintenance 7.4 Foreign Body Detection and Control 7.5 Calibration and Control of Measuring

and Monitoring Devices 7.6 Control of monitoring & measuring

equipment 7.6 Retained Production Samples 7.7 Final Product Packing and Control 8 Personnel ... 6.2 Human resources 8.1 Training and Competency

ISO 9000 v the BRC Global Standard

Clause ISO 9001 - 2008 Section/Clause

BRC Issue 3

1 Scope II 3 III 2.1

Scope of the certification Product scope & group determination

1.1 General II 1.2 Application 2 Normative references 3 Terms and definitions Ap 7 Glossary 4 Quality management system III 3 Management system 4.1 General requirements III 3 4.2 Documentation requirements III 3.2 General Documentation requirements 5 Management responsibility III 1.1 5.1 Management commitment III 1 Senior management commitment &

continual improvement 5.2 Customer focus III 3.11 Contract review & customer focus 5.3 Quality policy III 3.1 Policy Statement 5.4 Planning 5.5 Responsibility, authority and

communication III 3.3 Organisational structure,

responsibility & management authority

5.6 Management review III 1.2 6 Resource management III 1.4 6.1 Provision of resources III 1.4

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6.2 Human resources III 8 Personnel 6.3 Infrastructure III 4 Site Standards 6.4 Work environment III 4.2, 4.3 &

4.4 Internal site Building interiors Staff facilities

7 Product realization III 2 III 5

Risk management Product control

7.1 Planning of product realization III 2 III 3.2.3

Risk management Specifications

7.2 Customer-related processes 7.3 Design and development III 5 Product control 7.4 Purchasing III 3.5 Purchasing, supplier approval &

performance monitoring 7.5 Production and service provision III 7 Process control 7.6 Control of monitoring and

measuring equipment III 7.5 Calibration & control of measuring &

monitoring devices 8 Measurement, analysis and

improvement III 6 Product conformity assessment

8.1 General 8.2 Monitoring and measurement III 6.1 Product analysis/ testing 8.3 Control of nonconforming

product III 5.4 Control of non conforming materials

8.4 Analysis of data III 6.1.8 8.5 Improvement III 1.5