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  • 7/27/2019 Br c Standard Issue 5

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    ". ._'.'_..

    TAl LIt U .1 .:r E l\ 1 _ s o A T ]

    The Global Standard for Food Safety will be available from late

    February 2008 in the above languages. The translated editions

    will be available in print as well as PDFformat. Order your printed

    copy now by calling +44 (0) 870 243 0123 stating the ISBNbelow

    and code EAB.

    German 9780117037984 Dutch 9780117037960

    French 9780117037977 Chinese 9780117038202

    N

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    LO LFOR FOOD SAFETY

    January 2008

    British Retail Consortium

    London: T50

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    ~TSO

    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 BTI4GD

    02890238451 F a x 028 9023 5401

    71 Lothian Road, Edinburg EH3 9Al

    0870 606 5566 Fax 0870 606 5588

    Liability

    BRC publish information and express opinions in good faith, but accept no l iabil ity for any error or omission in any such

    information or opinion including any information or opinion contained in this document.

    Whi lst the BRC have endeavoured to ensure that the information in this publication is accurate, they shal l not be l iable for any

    damages ( including without l imitation damages for pure economic loss or loss of business or loss of profi ts 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 publ ication or any information contained in it , or from any action or decision

    taken as a result of reading this publication or any such information.

    Al l warranties, conditions and other terms impl ied by statute or common law are, to the fullest extent permitted by law,

    excluded.

    Nothing excludes or l imits the liability of BRC for death or personal injury caused by their negligence, for fraud orfraudulent

    misrepresentation or for any matter which i t would be il legal for them to exclude or attempt to exclude l iabil ity for.

    Copyright

    British Retail Consortium 2007

    Al l 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 wri tten 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.

    Warning: Any unauthorised act in relation to a copyright work may result in both a civil c laim for damages and criminal

    prosecution.

    British Re tail Consortium

    Second Floor

    21 Dartmouth Street

    London

    SW1H9BP

    Tel: +44 (0) 20 78548900

    Fax: +44 (0) 20 7854 8901

    email: [email protected]

    website: www.brcglobalstandards.com

    http://www.brcbookshop.com/mailto:[email protected]:[email protected]://www.brcglobalstandards.com/http://www.brcglobalstandards.com/mailto:[email protected]:[email protected]://www.brcbookshop.com/
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    The Standard consis ts of the following sections:

    S ec t i on I Provides a background to, and details the format of, the Standard.

    S ec t i on I I Details the requirements of the Standard with which a company must comply in order to gain

    certification.

    S ec t i on 1 \ 1 Provides information on the selection of a certification body, and details of the process for gaining a

    certificate.

    S ec t i on I V Describes the BRC Global Standards Directory, the information contained within it and the parties to

    whom this is accessible.

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    1 Introduction

    1.1 Background

    1.2 The Scope of the Global Standard for Food Safety

    1.3 Food Safety Legislation

    1.4 Benefits of the Global Standard for Food Safety

    1.5 The Certification Process

    1.6 Technical Governance of the Global Standard for Food Safety

    1.7 BRC Logos and Plaques

    1.8 Effective Date of Issue 5

    1.9 Acknowledgments: 'A Thank You' from the BRC

    2 The Food Safety Management System

    2.1 Principles of the Global Standard for Food Safety

    2.2 The Format of the Global Standard for Food Safety

    How to Gain Certification

    Introduction

    2 Self Assessment of Compliance with the Standard

    3 Selection of a Certification Body

    4 Company/Certification Body Contractual Arrangements

    4.1 Scope of Audit

    4.2 Extension to Scope

    4.3 Auditor Selection

    5 Audit Preparation by the Company

    6 Duration of the Audit

    7 The On-site Audit

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    8.2 Procedures for Handling Non-conformities and Corrective Action

    Further Action

    Grading of the Audit

    10.1 Certification

    10.2 Appeals

    Audit Reporting

    Ongoing Audit Frequency and Certification

    12.1 Certificate Expiry - Justifiable Circumstances

    12.2 Seasonal Products

    Optional Unannounced Audits

    Communication with Certification Bodies

    Certification Body Performance Monitoring

    15.1 Feedback

    15.2 Complaints

    The BRC Global Standards Directory

    Introduction

    Benefits of the Directory to Companies

    Directory Functionality

    App end ic es

    Appendix 1 The Global Standard for Food Safety and its

    Relationship with Other BRCGlobal Standards

    Qualifications, Training and Experience Requirements

    for Auditors

    Product Categories

    Summary of Grading Criteria, Action Required and

    Audit Frequency

    Certificate Template

    Certificate Validity, Audit Frequency and Planning

    Glossary

    Acknowledgements

    Appendix 3

    Appendix 4

    Appendix 5

    Appendix 6

    Appendix 7

    Appendix 8

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    1 Introduc ti on

    Welcome to the fifth issue of the Global Standard for Food Safety. Originally published by the British

    Retail Consortium (BRC) in 1998 for food producers supplying Own Brand goods into the UK Retail

    Market, the Standard has been updated at regular intervals to reflect the latest thinking in food safety,

    and hasnow attained usageworldwide as a framework for any businessto assistthe production of safe

    food. In response to demand the Global Standard for Food Safety has been translated into many

    languages to facilitate implementation by food businessesacrossthe world. The fifth issue has been

    developed with advice and input from international stakeholders.

    The Global Standard for Food Safety has been developed to specify the safety, quality and operational

    criteria required to be in place within a food manufacturing organisation to fulfil obligations with regardto legal compliance and protection of the consumer. Theformat and content of the Standard isdesigned

    to allow an assessment of a company's premises, operational systems and procedures by a competent

    third party - the certification body - against the requirements of the Standard.

    1.2 The Scope of the Global Standard for Food Safety

    The Global Standard for Food Safety sets out the requirements for the manufacture of processedfoods

    and the preparation of primary products supplied as retailer branded products, branded food products

    and food or ingredients for useby food servicecompanies, catering companies and food manufacturers.

    Certification will apply to products that have been manufactured or prepared at the site where the audit

    hastaken place and will include storage facilities that are under the direct control of the production-site

    management.

    Companies whose primary operation isthe processingof product or the preparation of primary products

    may have factored goods (refer to glossary) included in the scope of the certification, where they can

    demonstrate that appropriate controls a re in place and the scope specifically excludes the processing or

    preparation of these products. Certificates shall clearly identify that these factored goods are included.

    The Standard shall not a pply to activities relating to wholesale, importation, distribution or storage outside

    the direct control of the company. The BRChas developed a range of Global Standardswhich set out the

    requirements for the wide range of activities undertaken in the production, packaging, storage and

    distribution of food. Appendix 1 provides further detail of the scopes of, and relationship between, the

    current Global Standards.

    1.3 Food Safety Legislation

    Legislation covering food safety differs in detail worldwide, but generally requiresfood businesses:

    to ensure the presence of a detailed specification which is lawful and consistent with compositional

    and safety standards and good manufacturing practice

    to ensure they satisfy themselves that their suppliers are competent to produce the specified

    product, comply with legal requirements and operate appropriate systems of processcontrol

    from time to time to make visits, where practical, to verify the competence of their suppliers or

    receive the result of any other audit of the supplier's sy~temfor that purpose

    to establish and maintain a risk-assessedprogramme for product examination, testing or analysis

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    The Global Standard for Feod Safety has been. developed to assist businesses to meet these

    requirements, and !herefore a ssistcompan ies to comply with relevant food safety legislation.

    There are a number of benefits to food businessesarising from the adoption of the Standard. The

    Standard:

    provides a single standard and protocol that allows an accredited audit by third party certification

    bodies

    provides a single audit commissioned by the company, in line with an agreed audit frequency, that

    will allow the company to report upon their statusto customers and other organisations asagreed,

    and can reduce time and costs

    provides a measure by which food manufacturers and suppliers can demonstrate to potential'

    customers a level of competence in food safety and quality systems

    iscomprehensive in scope, covering areasof quality, hygiene and product safety

    addressespart of the legislative requirements of the food manufacturer/supplier, packer/filler,

    retailer and other customers. Companies may alsousethis Standard to ensure their suppliers are

    following good food safety management practices

    requires ongoing surveillance and confirmation of the follow up of corrective actions on non-

    conformity to the Standard thus ensuring that a self-improving quality and product safety systemis

    established.

    The Global Standard for Food Safety isa processand product certification scheme. In this scheme,food

    businesses are certificated upon completion of a satisfactory audit by an auditor employed by an

    independent third party - the certification body. Thecertification body in turn shall have been assessed

    and judged as competent by a national accreditation body. The process of certification and accreditation

    isoutlined in Figure 1.

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

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

    requirements that a certification body must satisfy in order to gain approval.

    As a minimum, the certification body must be accredited to ISO Guide 65/EN45011 by a national

    accreditation body affiliated to the International Accreditation Forum. Further details are available in

    Requirements for Organisations Offering Certif ication Against the Criter ia of the BRC Global Standards -

    available from the BRC.

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    F i g u r e 1

    International

    Accreditation

    Forum & Regional

    Accreditation

    Forums

    National

    Accreditation Body

    Support ingDocu mentat ion

    ;';! 1

    ISO/lEG 17011 f , lGeneral requirements ~1for accredition bodies ~ J

    IAF Guidel ine on the );~

    Application of

    ISO/lEG Guide 65:1966

    EN 45011

    BRG Guidelines for I. !Accreditation Bodies ~

    Assessing Gertification : , ~ . > . , i

    Bodies for BRG Global,.

    Standards f ~

    ISO/lEG Guide 65:1996

    EN 45011

    Requirements for

    Organisations Offering

    Certification Against the

    Criteria of the 8RC Global

    Standards

    BRG Global StandardsWebsite

    www.brcgloba ls tandards .com

    BRG Directory

    www.brcdirectort com

    http://www.brcglobalstandards.com/http://www.brcglobalstandards.com/
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    Tile BR C recognises that in certain circumstances, such as certification bodies wishing to com mence

    auditing against the Giobal Standard Tor Food Safety,the certification body must be able to conduct

    audits aspar: of achieving accreditation. Thiswill be permitted where the organisation can demonstrate:

    II an active application for accreditation against ISOGuide 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 in this document.

    A list of certification bodies approved by the BRC is available on the BRC Global Standards Directory:

    www.brcdirectory.com .

    1.6 Technical Governance of the Global Standard for Food Safety

    The BRC is committed to reviewing the Global Standard for Food Safety at a minimum frequency of at

    least every three years. Issue 5 of the Standard has been developed after extensive consultation with

    technical experts. These have included representativesof the key stakeholders in the Standard including

    producers, retailers, trade assoc iations, certification bod ies and accreditation bodies.

    The technical content and operation of the G lobal Standard for Food Safety is governed by the BRC

    Governance and Strategy Committee consisting of senior technical representatives of international food

    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

    Achieving BRC certification is something of which to be proud. Companies that achieve

    certification following audit are qualified to use the BRClogo on company stationery and

    other marketing materia ls. The BRC has also introduced a high-quali ty p laque that

    cert if icated companies can purchase to display in their offices to help celebrate their

    success.Information relating to the BRClogo is available at www.brcglobalstandards.com.

    As with all revisions of the Global Standards, there must be recognition that a transition period is in place

    between publication and full implementation. Therefore, certification against Issue 5 will commencefrom 1 July 2008. There wil l be no recognit ion of certi ficates that are issued as a result of audits

    performed against Issue4 after 30 June 2008. All certificates issued against audits carried out prior to 1

    July 200S will be against Issue4 and be valid for the period specified on the certificate. In order to ensure

    that the infrastructure is in place to support successfulaudits, audits against Issue 5 will not comm ence

    until 1 July 200S. Certificates issued before this date against Issue 5 will not be recognised.

    1.9 Acknowledgements: 'A Thank You' from the BRC

    The BRCwishes to acknowledge all those food industryexpert; who have contributed to the preparation of

    the Global Standa~dfor Food Safety Issue5. A list of those who have contributed in this review is detailed in

    AppendixS.

    http://www.brcdirectory.com/http://www.brcglobalstandards.com./http://www.brcglobalstandards.com./http://www.brcdirectory.com/
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    2 Th e F o od Safety Man ag em ent System

    2.1 Principles of the Global Standard for Food Safety

    A food business must have a fu ll understanding of the products produced, manufactured anddistributed and have systemsin place to identify and control hazardssignificant to the safety of food. The

    Global Standard for Food Safety is based on two key components: senior management commitment

    and HACCP (Hazard Analysis Critical Control Point - a step-by-step approach to managing food safety

    risks).

    2.1.1 Senior Management Commitment

    Within a food business, food safety must be seen as a cross-functional responsibility, including activities

    that draw on many departments using different skills and levels of management expertise in the

    organisation. Effective food safety management extends beyond technical departments and must

    involve commitment from production operations, engineering, distribution management, procurement

    of raw materials, customer feedback and human resourceactivity such astraining.

    The starting point for an effective food safety plan is the commitment of senior management to the

    development of an all-encompassing policy as a meansto guide the activities that collectively assurefood

    safety.The Global Standard for Food Safety placesa high priority on clearevidence of senior management

    commitment.

    2.1.2 A HACCP-based System

    The Global Standard for Food Safety requires the development of a food safety plan based on HACCP.

    The development of the plan requires the input of all relevant departments and must be supported by

    senior management.

    2.2 The Format of the Global Standard for Food Safety

    The Global Standard for Food Safety requires the development of and compliance with:

    Senior Management commitment - the resourcesrequired for demonstration of commitment to

    achieving the requirements of the Standard are detailed in SectionII, Part 1

    a HACCP plan - this provides a focus on the significant product and processfood safety hazards

    that require specific control to assurethe safety of individual food products or lines as detailed in

    Section II, Part 2

    a Quality M anagement System - details of the organisational and management policies and

    procedures that provide a framework by which the organisation will achieve the requirements in

    this Standard as given in Section II,Part 3

    Prerequisite Programmes - the basic environmental and operational conditions in a food business

    that are necessaryfor the production of safe food. These control generic hazards covering Good

    Manufacturing and Good Hygienic Practiceas detailed in SectionII, Parts4-7.

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    Eachdause ofthe Globat Standard for Food Safety begins with a highlighted paragraph

    in bold text, the 'statement of intent', thataU companies must comply with in order to

    gain certification.

    Below this 'statement of intent' are requirements in atabular 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

    hav e been des ignated as ' fundamenta l' requirements, which are marked with the word

    'FUNDAMENTAL' immediately after the section heading and denoted with the following symbol O.

    These'fundamental' requirements relate to systemsthat are crucial to the establishment and operation

    of an effective food quality and safety operation. The clauses deemed to be 'fundamental' are:

    Traceability, Clause 3.9

    Layout, Product Flow and Segregation, Clause4.3.1

    Housekeeping and Hygiene, Clause4.9

    Handling Requirements for Specific Materials - M aterials Containing Allergens and Identity

    PreservedMaterials, Clause 5.2

    Control of Operations, Clause 6.1

    Training, Clause 7.1.

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

    initial audit or withdrawal of certification at subsequent audits. This will require a further full audit toestablish demonstrable evidence of compliance.

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    SECTION \I

    REQUIREMENTS

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    Section II

    Requirements

    1 Senior Management Commitment and Continual Improvement 10

    2 The Food Safety Plan - HACCP 11

    3 Food Safety and Quality Management System 18

    3 . 1 Food Safety and Quality Policy 1 8

    3 . 2 Food Safety and Quality Manual 1 8

    3 . 3 Organisational Structure, Responsibilities and Management Authority 1 9

    3 . 4 Contract Review and Customer Focus 1 9

    3 . 5 Internal Audit 2 0

    3 . 6 Purchasing - Supplier Approval and Performance Monitoring 2 0

    3 . 7 General Documentation Requirements 2 1

    3 . 8 Corrective and Preventive Action 2 3

    3 . 9 Traceability 2 3

    3. 10 Complaint Handling 2 4

    3. 11 Management of Incidents, Product Withdrawal and Product Recall 2 5

    4 Site Standards 26

    4 . 1 External Standards 2 6

    4 . 2 Security 2 6

    4 . 3 Internal Site Standards 27

    4 . 4 Utilities 3 0

    4 . 5 Equipment 3 0

    4 . 6 Maintenance 3 1

    4 . 7 Staff Facilities 3 2

    4 . 8 Chemical and Physical Product Contamination Control 3 3

    4 . 9 Housekeeping and Hygiene 3 6

    4. 10 Waste/INaste Disposal 3 7

    4. 11 Pest Control 3 8

    4 . 1 2 Storage and Transport 3 9

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    5 Product Control 40

    5 . 1 Product Design/Development 4 0

    5 . 2 Handling Requirements for Specific Materials -

    Materials Containing Allergens and Identity Preserved Materials 4 1

    5 . 3 Foreign Body Detection 4 25 . 4 Product Packaging 4 3

    5 . 5 Product Inspection and Laboratory Testing 4 3

    5 . 6 Control of Non-conforming Product 4 5

    5 . 7 Product Release 4 5

    6 Process Control 46

    6 . 1 Control of Operations 4 6

    6 . 2 Quantity - Weight. Volume and Number Control 4 6

    6 . 3 Calibration and Control of Measuring and Monitoring Devices 4 7

    7 Personnel 48

    7 . 1 Training 4 8

    7 . 2 Access and Movement of Personnel 49

    7 . 3 Personal Hygiene 4 9

    7 . 4 Medical Screening 5 0

    7 . 5 Protective Clothing 5 1

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    o

    1 . 8

    1 . 9

    1 . 1 0

    1 . 1 1

    1 . 1 2{}i

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    SE NI OR MA N A G EM E NT C O MM IT ME N T A N D C O N TI NU A L I MPROV EM E NT

    FUNDAMENTAL

    The company's sen ior.ma nagell1entsha Iideln!?hs~r.ate,theyar~. fully committ~c1t(jthehnpJernentationpfthereq uirements of the GJobaISta nda rd fa r

    Food Safety. ]"his~hiJ UiHch,ldeprovi~ion oti:l.d equiJtere sourcs, effective cOlllwul1icatiol1,sysferns of review and actions taken to effect tontin ualimprovement.O PP()rtulliti~s.forimprovement shall.l:!eipentifiedii mple'1i~l'ltedpnd fpllydoculilented.

    The company's senior management shall provide the human and financial resources required to implement and improve the processes of the quality management system and the food

    safety plan.

    There shall be clear communication and reporting channels to senior management for departments responsible for monitoring compliance with the Global Standard for Food Safety. Thedepartments shall report regularly on effective compliance.

    The company's senior management shall ensure that food safety and quality objectives are established, documented, monitored and reviewed.

    The company's senior management shall ensure that there is a process to identify and address any safety or legality issue at a strategic level.

    The company's senior management shall take responsibility for the review process.

    The review process shall be undertaken at appropriate planned intervals, as a minimum annually, to ensure critical evaluation of the food safety plan and the HACCP system's suitabilitY,

    adequacy and effectiveness.

    The review process shall include the evaluation of:

    in ternal , second par ty and th i rd party audi ts

    previous management review documents , ac t ion p lans and time f rames

    cus tomer per fo rmance indica tors , complaints and f eedback

    inciuents. corrective actions, out-of-specification results and non-conforming materials

    process per fo rmance anu devia tion f rom def ined parameters

    reviews o f the HACCP-based sys tem

    developments in sc ient if ic info rmat ion associa teu wi th the products in scope

    resource requi rements.Records of management reviews shall be comprehensively documented and retained.

    The decisions and actions agreed within the review process shall be effectively communicated to appropriate staff , and actions implemented within agreed time scales. The records shall

    be up dat ed to sho w wh en act ion s ha ve bee n com ple ted .

    The company shall have the current issue of the Global Standard for Food Safety available.

    The company shall maintain certif ication to the Global Standard for Food Safety by effective timescale planning to ensure that certif ication does not expire (refer to Section III,paragraph 12).

    The most senior production or operations manager on site shall attend the opening and closing meetings of the audit for Global Standard for Food Safety certif ication.

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

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    4.3.1

    0Layout, Product Flow and Segregation

    FUNDAMENTAL

    Premi~es~nd plantshaflbedesigned;~on!itructecf j; 'UidNai!1~aitWd~Proc;edures !ih~lIbeinpl~~etoc;ontrol!he r i s k o f p r oduc t cor i t am i na ti on and tocom ply vvithallr~Je"iihflEi9islatjon . .c_c ~~c< -->",~._,; _ . -.. ;:--< .

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

    Physical barriers or demonstrably effective procedures shall be in place to minimise the risk of the contamination of raw materials, intermediate/semi-processed products, packaging and

    finished products with particular consideration given to handling requirements for specific materials (refer to clause 5.2).

    Segregation shall take into account the flow of product, nature of materials, equipment. personnel, waste, airflow, air quality and util it ies provision.

    Based on risk assessment, the cleaning of production utensils shall be carried out in segregated areas or at specific t ime periods separated from the production process.

    Premises shall a llow suffic ient working space and storage capacity to enable all operations to be carried out properly under safe hygienic conditions.

    Cleaning and inspection of areas and equipment shall be aided by the avoidance of obstructions and where appropriate the provision of adequate space.

    Temporary structures constructed during building work or refurbishment etc., shall be designed and located to avoid pest harbourage and potential contamination of products.

    The location of all transfer points shall not compromise high-risk and low-risk segregation and practices shall be in place to minimise risk of product contamination, e.g. disinfection.

    Where h i g h - ri s k p r o d u c t s (refer to glossary) are manufactured, there shall be physical segregation between processing and fin ished product handling areas. This high risk area shall be

    fabricated and designed to a high standard of hygiene, and practices shall be in place to control ingredients, equipment, packaging, environment and personnel to prevent product

    contamination.

    4 .3.1 .1 0 In h ig h-car e a r eas (refer to glossary) where there is a significant r isk of contamination of chilled ready to eat/heat products by pathogenic micro-organisms, the processing or handling of

    food in these areas shall be appropriate to mini mise product contamination by such micro-organisms.

    4.3.1.1

    4.3.1.2

    4.3.1.3

    4.3.1.4

    4.3.1.5

    4.3.1.6

    4.3.1.7

    4.3.1.8

    4.3.1.9

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    " ...-' .

    Requirements,'-'"

    4.3.2.4.1 Where there i s a r i sk to product, windows and roo f g lazing which are des igned to be opened fo r vent i la t ion purposes sha ll be adequate ly screened to prevent the ingress o f pests .

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

    4.3.2.5.1 Where external doo rs to raw m ateria l handl ing, prepara t ion, process ing, packing and s to rage areas are opened, sui table precaut ions sha ll be taken to prevent pes t ingress . Doors and

    dock levellers in these areas shall be close f itting or adequately proofed.

    4.3.2.5.2 Doors shall be in good condition and easy to clean, where required.

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

    4.3.2.6.2 Where they constitute a risk to product, bulbs and strip lights, including those on electric f ly-killer devices, shall be adequately protected. Where full protection cannot be provided,

    a l te rnative management such as wire mesh screens o r m oni to r ing procedures sha ll be in p lace.

    4.3.2.7.1 Adequate ventilation and extraction shall be provided in product storage and processing environments to prevent condensation or excessive dust.

    4.3.2.7.2 Where the process requires screened or f il tered air, the equipment used for this purpose shall be easily accessible and adequately maintained.

    4.3.2,7.3 Where appropriate, positive air-pressure systems shall be in place.

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    All water used as a raw material in the manufacture of processed food, the preparation of product, or for equipment or plant cleaning shall be supplied in suffic ient quantity, be potable or

    pose no risk of contamination according to applicable legislation, either being drawn from mains supply or suitably treated according to its source.

    Based on risk assessment, the microbiological and chemical quality of water, steam, ice, air, compressed air or other gases that does not constitute an ingredient but comes in direct

    contact with food or packaging shall be regularly monitored. It shall present no risk to product safety or quality and comply with relevant legal regulations .

    ....Eqllipmerit~hal' b~JiM~llily:~~i!9n~q1()rfh~.in1~hiJ~~pufp'a~e, " .s :-."_ '--." =-'''.F,i '''-'';:;''~-'''''- - -- -." ,,-u:.-,,,"'.-

    All equipment shall be properly specified before purchase, constructed of appropriate materials, be of a suitable design to ensure it can be effec t ively cleaned, and shall be tested and

    commissioned prior to use.

    Equipment shall be positioned to give acce~s under, inside and around it for ease of cleaning, inspection and servicing, or where permanently sited shall be properly secured and sealed to

    the floor.

    Certif icates of conformity or other evidence shall be available for equipment in direct contact with food to confirm its suitability for use, e.g. conveyor belts.

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    A documented system()fpl~nned !n~intenanc;eshal!bejnCpl~c~,c:ovfingallitems(lfequiplller1farld plantwhic:hare critical to product safety,legality andCfu~lity. . cc'. .

    4.6.1

    "4.6.2

    4.6.3

    4.6.4

    4.6.6

    4.6.7

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

    When commissioning new equipment and plant. a maintenance programme shall be established and put into place based on risk assessment.

    The company shall ensure that the safety or legality of product is not jeopardised during maintenance and cleaning operations.

    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 insrected at

    predetermined intervals, insrection results documented and appropriate action taken.

    Where temporary repairs are made, these shall be controlled to ensure the safety or legality of product is not jeopardised. These temporary measures shall be permanently reraired as

    soon as practicable and within a defined timescale.

    Contractors involved in maintenance or repair activit ies shall be under the supervision of a nominated person.

    Maintenance work shall be followed by a documented hygiene clearance procedure, which records that product contamination hazards have been removed from machinery and

    equipment. On completion of any maintenance work, machinery and equipment shall be clean and free from contamination hazards.

    Materials used for equipment and plant maintenance and that pose a risk by direct or indirect contact with raw materials, intermediate and finished products, such as lubricating oil and

    paints, shall be suitable for the intended use.

    Engineering workshops shall be controlled to prevent contamination risks to the product, e.g. provision of swarf mats where workshops open directly into production areas.

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    S t a f f faciliti~5shalllje s u f f i c i e n t to accOh\m O,datatha requirednumtler.Qfpersorinel,~hd sha"be~'esighecl and operaiedto minimise th e risk o f productcontam inat ion.'Suchfac i l i t i esshal l b E i m aintainf ; !q in 9 Q o d a nd ~Ieanc o n d i t i o n .: . , > . .: . . .._..< .. ,

    c - . _ c . ," . - . - ' - _ . , . : ' ; . ' . . - . - " ' : : , , " , c o - : . - ' ,' - - ; ', ' 0 " , .- . . " ' , , :' _ . '~ " c.: ' , :: _._', :. :'_, :," :.>," :"._ :. . ' :_, , :~: :; ';" :'- ':_:' __.~.:._:. . : ;;" .- ;:' . , . : ._ . : _ : i>

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    4.8 Chemical and Physical Product Contamination Control

    Raw Mater ia l Handl ing, Preparat ion, Processing, Packing and Storage Areas

    Based on r isk assessment, the company shall identify, control and manage any potential r isks from chemical, physical or taint contamination. This may include r isks associated wit h the

    following, although this is not an exhaustive l ist:

    s to ra ge

    pr oduct ion operat ion or pr ocesses or machiner y

    any maintenance or bu ild ing w or k carr ied out

    hyg iene and c lean ing oper ations.

    These shall be verif ied through regular site audits carr ied out at a frequency determined by r isk assessment.

    4 .8 .2 .1 A chemica l cont r ol pr ocedure sha ll be in place w hich manages the use, storage and handling o f non- food chemica ls. Th is sha ll inc lude as a min imum:

    a p pr ov e d p u rc h as e

    availabil i ty of material safety data sheets and specif ications

    w here appropr ia te , confi r med su i tab i li t y for food use

    avo idance o f s t rong scented pr oducts

    ident if ica t ion o f chemica ls a t a l l t imes

    segregated and secur e storage w i th r estr icted access to author ised per sonnel

    use by t r ained personnel on ly .

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    There shall be a documented policy for the control of the use of sharp metal implements including' knives, cutting blades on equipment, needles and w ires. This shall include suitable

    controls both into and out of the factory, and safe disposal.

    Snap-off blade knives shall not be used.

    No n-p rod uc tio n bla de s, eq uip me nt an d too ls sha ll no t be lef t in a po sit ion tha t allo ws the m to co nta mi na te the pro duc t.Where staples or other items are used w hich are likely to cause contamination in packaging, appropriate precautions shall be taken to mini mise the risk of product contamination.

    4.8.3.2

    4.8.3.34.8.3.4

    4.8.4.1 In areas where a risk assessment has identif ied a potential for product contamination from glass, the presence of glass shall be excluded. Where this cannot be avoided, but the risk is

    managed, glass shall be protected against breakage.

    4.8.4.2 Documented procedures for handling glass, brittle or hard plastic, ceramic or other similar materials shall be in place and implemented to ensure that necessary precautions are taken.

    Procedures shall include the following as a minimum:

    l i st o f items deta il ing locat ion, number, type and condi tion

    recorded checks o f condi t ion o f i tems car ried out a t a specif ied f requency based on r i sk assessment

    de tai l s on c leaning o r replac ing i temslo minimise po tent ia l f o r product contamination.

    4.8.4.3 Based on risk assessment, documented procedures detailing the action to be taken in case of breakage of glass, brittle or hard plastic, which includes glass packaging and similar material,

    shall be implemented and include the following:

    quarant in ing the products and product ion area tha t were po tent ial ly a f f ected

    c leaning the product ion area

    inspecting the production area and autho r is ing to cont inue product ion

    changing o f workwear and inspection o f foo twear

    specifying those s ta f f autho r ised to car ry out the above po ints

    recording the breakage inc ident .

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    Re q ui re m e n t s >

    In ar eas w here a r isk assessment has ident if ied the potent ia l fo r pr oduct contaminat ion f r om w ood, the use o f w ood sha ll be excluded. Wher e the use o f w ood cannot be avo ided, and

    the r isk is managed, the condition of wood shall be regular ly checked to ensure it is in good condit ion and clean.

    4.8.6.1

    4.8.6.2

    Filters, sieves and magnets used for foreign body control shall be regularly inspected and properly maintained. Such activit ies shall be recorded and investigated.

    Based on r isk assessment, procedures shall be implemented to minimise foreign body contamination of packaging during f i l ling operations, e.g. covered conveyors, container inversion

    and foreign body removal through r insing or air jets.

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    5.2.1.2

    5.2.1.3

    The company shall carry out r isk assessment of raw materials to establish the presence and likelihood of contamination by allergens (refer to glossary). This shall include approval of raw

    material specifications. The company shall implement systems to specify the integrity of the raw material and compliance with specification throughout the purchasing and supply chain ..

    The company shall identify and list a llergen-containing materials handled on site. This shall include raw materials, intermediate and fin ished products.

    Risk assessment shall be carried out to identify routes of contamination and establish documented polic ies and procedures for handling raw materials, intermediate and fin ished products

    to ensure cross contamination is avoided. This shall include as appropriate:

    physical or t ime segregation whilst a llergen-containing materials are being stored, processed or packed

    use of identif ied, dedicated equipment for processing or cleaning

    a policy for all food brought onto site including that by staff.

    Where rework is used, or reworking operations carried out, procedures shall be implemented to minimise cross contamination from allergen-containing materials and ensure the safety,

    legality and quality of the fin ished product.

    Where a claim is made regarding the suitability of a food for allergy or food sensitiv ity sufferers, the company shall ensure that the production process is fully validated to meet the stated

    claim. This shall be documented.

    Based on risk assessment, documented equipment or area cleaning procedures shall be undertaken to remove or reduce to acceptable levels any potential cross contamination in

    compliance with fin ished product specifications. This shall include validation of cleaning methods and appropriate waste handling and spillage controls.

    All relevant personnel, including temporary staff and contractors, shall be appropriately trained in handling procedures for allergen-containing materials prior to commencing work and

    shall be adequately supervised throughout the working period.

    Any non-conformities relating to allergen control shall be included in the management review process (refer to clause 1.7) and may include, as appropriate, internal or external incidents

    and customer complaints such as labelling or cross-packing errors. The review process shall a lso consider updates or changes in allergen legislation or scientific information.

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    5.2.2.1 Where an identity preseNed claim is made, e.g. that a product isorganic, or where products brought onto site may contain materials which require segregation, e.g. Genetically M odif ied Organisms,

    the company shall carry out a r isk assessment of raw materials to specify the integrity of the raw material and compliance with specification throughout the purchasing and supply chain.

    5.2.2.2 Risk assessment shall be carr ied out to identify routes of contamination and establish documented policies and procedures for handling raw materials, intermediate and f inished products

    to ensure cross contamination is avoided and that controls are in place to maintain identity preseNed status.

    5.3 Foreign Body Detection

    '..The companysllaifllaye ap pro pri aie f9 H ~ ig fll)q H V 'C l~ tect i( jn .eq q ipM e~ 't rr i ,pl~ c~ }nd ehsure i t seff~ctive~op~f;jti9i1,c,;.'....

    Foreign body detection equipment shall be in place unless it can be justif ied as not necessary. This justification shall be documented. Detection equipment shall be situated to maximise

    foreign body detection within the finished product.

    The sensit ivity of detection shall be specified and best practice applied with regard to the nature of the food, the location of the detector and any other factors inf luencing the sensit ivity

    of the detector.

    The metal or foreign body detector shall incorporate the following based on best practice:

    an a lar m on a be lt s top system

    an automat ic r e jection device w hich sha ll e i ther d ivert contaminated pr oduct out o f the pr oduct f low or to a secure un i t accessib le on ly to authorised personnel

    in -l ine detector s w hich ident ify the locat ion o f the contaminant and e f fectively segregate the a f fected pr oduct.

    There shall be documented procedures specifying corrective and investigative action to be taken in the event of the detection of metal or a foreign body.

    The company shall establish and implement procedures for the operation, routine monitoring, testing and calibration of the metal or other foreign body detectors. This shall include as a minimum:

    f r equency and sensi t iv i ty o f checks

    authorisat ion o f t r ained personnel to car ry out speci fied tasks

    d o cu m en ta ti on o f c he c ks .

    The company shall establish and implement corrective action and report ing procedures in the event of the monitor ing and testing procedure identifying any fai lure of the metal or foreign hody

    detector. Action shall include a combination of isolation, quarantining and re- inspection of al l product produced since the last acceptance test of the metal or other foreign body detector.

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    5.5.2.1

    5.5.2.2

    ...Requir~mehtsi

    Pathogen testing shall be subcontracted to an external laboratory or, where conducted internally, the laboratory facil ity shall be remote from the manufacturing site.

    Where routine testing laboratories are present on a manufacturing site, they shall be located, designed and operated to eliminate potential r isks 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

    mo v eme n t o f la bo rato ry p e rs o nn e l

    p rote ct ive c lo th ing a r ra ng e men ts

    p roc e ss e s fo r o b ta inin g p rod u ct s a mple s

    d isp o sa l o f la bo rato ry wa s te .

    Where the company undertakes or subcontracts analyses which are crit ical to product safety or legality, the laboratory, or subcontractors shall have gained recognised laboratory

    accreditation or operate in accordance with the requirements and principles of ISO 17025. Documented justif ication shall be available where accredited methods are not undertaken.

    Procedures shall be in place to ensure reliability of laboratory results, other than those specified in 5.5.2.3. These shall include:

    u s e o f rec o gn ise d te s t meth od s , wh e re a v ai lab le

    d o cu me nte d te s tin g p roc e du res

    ensuring staff are suitably qualif ied and/or trained and competent to carry out the analysis required

    use of a system to verify the accuracy of test results, e.g. r ing or profic iency testing

    use of appropriately calibrated and maintained equipment.

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    Prod lIet paekagi n9shal l b~ appropriate forthe'hi tel ldecl ll sean(f !ihallb~ 's ( o r e r id f i d e r 'c p - r i d i t i ()"s t6rninilTl isecofl tam inat ion ~ncldeterio rat i0n.

    5.4.1

    5-4.2

    5.4.3

    5.4.4

    5.4.5

    Certif icates of conformity or other evidence shall be available for product packaging to confirm its suitability for use.

    Where appropriate, packaging shall be stored away from raw materials and finished product.

    Any part-used packaging materials suitable for use shall be effectively protected before being returned to an appropriate storage area.

    Product contact l iners (or raw materiallwork-in-progress contact l iners) shall be appropriately coloured and of sufficient gauge to prevent accidental contamination where appropriate.Where packaging materials pose a product safety risk, special handling procedures shall be in place to prevent product contamination.

    Product Inspect ion and laboratory Test ing

    Th e compatiyshaifu~dertaCk~or~ubcon-trattins'p~ti!Qnand anafys~$\ivliichir~-trrH,~'to cQ.,firm produ

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    Product packaging, 's l1al l b~ appropriatefqr tIleintel1d~d ~ls~anashallhe~stOreaui1derc9I1aitiOnst

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    5.6 Control of Non-conforming Product

    T he com p an ysha ll e n s lI r e al l olit-of -~pecificMionproduct .isclearlY. Hf~nt i f ied, labe lled. ,u1dqlJa ranti lled,

    .Req\Jir~rhents .

    Procedures for the control of non-conforming material, including rejection, acceptance by concession, or regrading for an a ltern a t ive use, shall be in place and understood by all relevant

    staff. Decisions shall be approved by authorised staff.

    Corrective actions shall be implemented to avoid recurrence of non-conformance. Details of the non-conformance and action taken shall be documented.

    All non-conforming material shall be clearly identified and quarantined as appropriate, and handled or disposed of according to the nature of the problem and/or the specific

    requirements of the customer.

    5.6.2

    5.6.3

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    IIThe company shall be able to.demonstrat~effe(ti~etontrol of aIl6per

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    6.3 Calibration and Control of Measuring and Monitoring Devices

    ..rIJ1easuringequiPrnent[J5~rJtomonit()rCriticaIControlpbjhts .~n~prpduqsafelyaHdre"g~ity.shall be identified.The identified measuring equipment shall be

    calibrated tOClref:o~misedll~tional or iriternatiori~15ta!l~~rd, Where alrace!'lb!e calibratign is not possibl~,theccHTlPcmyshall demonstrate the basis by whichstandardisationis~aitil;!dolJt{, .. . ... .. " ,.> ', . . . . . . . , . .'. . :

    The company shall identify measuring equipment used to monitor CCPs and product safety and legality.

    This shall include as a minimum:

    a d o cu me nte d l ist o f e q uip me n t equipment identif ied and marked in accordance with requirements (e.g. numbered. calibration due date).

    All identified measuring devices shall be checked and where necessary adjusted:

    at a predetermined frequency, based on risk assessment

    b y t ra in ed s ta ff

    to a defined method tra 'ceable to a recognised national or international standard where possible.

    Results shall be documented.

    6 .3.3 T h e p res c rib ed me a su r in g a n d mo ni tor in g d e vic es s h al l b e :

    p rev e nte d f rom a d jus tmen t b y u n au tho r is e d s taf f

    p rote cte d f ro m d ama g e, d e ter iora tio n o r mis us e .

    6.3.4 Procedures shall be in place to record actions taken when the prescribed measuring and monitoring devices are found not to be operating within specified limits.

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    II

    oTraining

    Raw Materia l Handl ing, Preparat ion, Processing, Packing and Storage Areas

    FU N D A M EN TA L

    Th e cQinpanysh~U ei'!surethaf per~(;klh~!perfprOiingWprJ(ttfataffectsprpd~c;tsaf~ty,l~gali!yimcJ qyal i ty are demonstrably competent tocarry out,thejractivify~thf'gughfrainirJg.work:exp~rj~~f~~()rqlf~lifi5~tiOn.:,:" '. : C ,,"c:> . , C , " " " " . . " " ' , , ' , . ' . . : , , _ , , _ C '

    7.1.1

    7.1.2

    7.1.3

    All relevant personnel, including temporary staff and contractors, shall be appropriately trained prior to commencing work and adequately supervised throughout the working period.

    Where personnel are engaged in activ it ies relating to Critical Control Points, relevant training and documented monitoring procedures shall be in place.

    The company shall put in place documented programmes covering the training needs of relevant personnel. These shall include as a minimum:

    identifying the necessary competencies for specific roles

    providing training or other action to ensure staff have the necessary competencies

    reviewing and auditing the implementation and effectiveness of training and competency of the trainer

    consideration of the delivery of training in the appropriate language of trainees.

    Records of all training shall be available. This shall include as a minimum:

    n a me o f t ra ine e a n d c o nf i rma t io n o f at ten d an c e

    d a te an d d u ra t io n o f t rain in g

    tit le or course contents as appropriat~

    t rain in g pro vid er .

    The company shall routinely review the competencies of staff and provide relevant training as appropriate. This may be in the form of training, refresher training, coaching, mentoring or

    on-the-job experience.

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    . The c o m p an y sh al l e n sU r e th a ta c ce $ sa n d m O V m e n f( )f p ers h h n el ,v isit o r~ C 1 rid c :(U l tra c to r$ $ h ~ lln o tcO/TIpromise pr()duct safety_

    7.2.1

    7.2.2

    7.2.3

    7.2.4

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

    If it is necessary to allow access through production areas, designated walkways shall be provided that ensure there is adequate segregation from materials.

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

    Contractors and visitors, including drivers, shall be made aw are of all procedures for access to premises and the requirements of the areas they are visiting, with special reference to

    hazards and potential product contamination.

    Personal Hygiene

    Raw Mater ia l Handl ing, Preparat ion, Processing, Packing and Storage Areas

    T h ~ . to /T IP C ln y 'sR ers q i1 ~ I.I1 Y 9 i~ I'I~ ~ 1 :an aa fd s$ lja lrH ~ # Q flj h l~ h tetlC l n ~ 'C id 9 p te~ ';l jy ~ llirl ~ r{~ n 'rl~ J; jn ~ !M h ,g (:o n tH j~ tQ f $ C 1 lldV js it o f st o t hep f od u c ti on fac i lity.T h ~ se sta rid ~ fti~ :s h an l:> '~ ;Jp rH fU l~ te a; w H H 'q 4 ~ r~ g ~ t~ ,1 :9 'ti~ k P tp r9 ~ ~ ~ r~ p n f~ H W n ~ 'i9 If/;/'/;c.:;;:"' ;':. ,:.';;c;. ,'0 ".' .,'; ,

    7.3.1

    7.3.2

    7.3.3

    7.3.4

    7.3.5

    7.3.6

    7.3.7

    7.3.8

    7.3.9

    7.3.10

    The requirements fo r personal hygiene shall be documented and communicated to a l l personnel . Compl iance wi th the requi rements sha ll be checked regular ly.

    Based on risk assessment, the company shall document its jewellery policy.

    Watches sha ll no t be worn. Jewel lery sha l l no t be worn, w i th the except ion o f a p la in wedding r ing, a wedding wr is tband and s leeper ear rings (cont inuous loop). Rings and s tuds in

    e xp o se d p ar ts o f t he b od y , s uc h a s n o se s, t on gu es an d e ye br ow s , s ha ll n ot b e w o rn .

    Hand cleaning shall be performed at a frequency that is appropriate, based on risk assessment.

    Fingernails shall be kept short, clean and unvarnished. False f ingernails shall not be permitted. Where visitors cannot comply, suitable control procedures shall be in place, e.g. non-

    handling of product, use of gloves.

    Excessive perfume or aftershave shall not be worn.

    Smoking (where permi t ted under l aw) , eat ing and dr inking shall only be permit ted in des ignated areas segregated f rom food-handl ing and s to rage areas.

    Allcuts and grazes on exposed skin shall be covered by an appropriately coloured plaster different from the product colour (preferably blue) and containing a metal detectable strip where

    metal detectionIX-ray equipment is in use. These shall be company issued and m onitored. Where appropriate, in addition to the plaster, a f inger stall shall be worn.

    A sample from each batch of plasters shall be successfully tested through a metal detector and records shall be kept.

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

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    ' T he .c o m p ; m y s h al l e n s u re t h at mediCals,i'~e'ning procedure~are In place for~"employees(tontraCt()rs ofVisitqrswh()wil l be working in or v isi t ing areaswhere pr()ductsaf~tycould~e'~orriprpplis~d.:" ",,'--.;';":', " ' / " _,':, ";

    7.4.1 The company sha ll have a pr ocedur e for the not if ica tion by employees, including tempor ar y employees, o f any r e levant in fections, d isease or condit ion w i th w hich they may have been in

    contact or be suffering from.

    7.4.2 Where there may be r isk to product safety, visitors and contractors shall be required to complete a health questionnaire pr ior to entering the raw material, preparation, processing,

    packing and storage areas. Where appropriate, these persons shall undergo medical screening before permission is granted.

    7.4.3 There shall be documented procedures which are communicated to employees, including temporary employees, contractors and visitors, on action to be taken in the case of infectious disease from

    which they may be suffering or have been in contact. Part icular consideration should be given where product safety may be compromised. Expert medical advice shall be sought where required.

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    7.5 Pr otect ive Clothing

    Employees or Vis i tors to Product ion Areas

    Suit~ble(ompany issued prQtee:tivedQtl1ing~haUbeVIJ()rriby e m plqyees/ (on tractors or visitoisworkiriginoielltering production areas.

    Based on risk assessment, the company shall document and communicate to all employees, contractors or visitors the rules regarding the wearing and changing of protective clothing in

    specified w ork areas, e.g. high-risk and low-risk areas. This shall a lso include policies for wearing of protective clothing away from the production environment, e.g. removal before.

    entering toilets, use of canteen and smoking areas.

    Protective clothing shall be available that is:

    p rov ide d in s u ff icie nt n u mbe rs fo r e a ch e mplo ye e

    of suitable design to prevent contamination of the product (as a minimum contain no external pockets or sewn on buttons).

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

    laundering of protective clothing shall take place in-house using defined and verif ied criteria to validate the effectiveness of the laundering process, or by an approved contracted and

    audited laundry. The effectiveness of cleaning shall be monitored. Washing of workwear by the employee is exceptional but shall be deemed acceptable where, based on a detailed risk

    assessment, it can be confirmed there is no risk to product safety. Detailed procedures shall be in place to ensure the effectiveness of the laundering process.

    Where there is the risk of contamination, smoking and eating while wearing protective clothing shall not be permitted.

    All scalp hair shall be fully contained to prevent product contamination.

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

    Suitable footwear shall be worn within the production environment.

    If g loves are used, they shall be replaced regularly. Where appropriate, gloves shall be suitable for food use;.of a disposable type; of a distinctive colour (blue where possible); be intact and

    not shed loose fibres.

    For operations involving high-risk products (refer to glossary) all v is ibly distinctive protective clothing ( including footwear) shall be applied when entering, and removed when leaving,

    the high risk area and stored in a designated changing area.

    7.5.3

    7.5.4

    7.5.5

    7.5.6

    7..5.7

    7.5.8

    7.5.9

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    SECTION III

    HOWTO GAIN CERTIFICATION

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    How to Gain Cert i f icat ion

    The processby which a company gains and maintains certification issummarised in Figure 2.

    Everyeffort has been made to ensure that the content of this audit protocol is accurate at the time of

    printing. However, it may be subject to minor change, and reference should be made to the BRCGlobal

    Standards website www.brcglobalstandards.com. where changes will be published.

    Conformance by the company to the requirements of the Global Standard for Food Safety and its

    suitability for the awarding of a certificate will be assessedby an independent audit company - the

    certification body. Certification will be graded according to the number and type of non-conformities

    which shall also influence the frequency of ongoing audits. This section describes the process to be

    followed by a company seeking certification.

    2 Self Assessment of Compliance with the Standard

    It is essential that the company is assessedagainst the current issue of the Global Standard for Food

    Safety and that this is available throughout the certification.process. The current issue of the Standard in

    the required language isavailablefrom www.brcglobalstandards.com.

    The Standard should be read and understood and a preliminary self assessmentshould be conducted by

    the company against the Standard. Any areasof non-conformity should be addressed by the company.

    Further information and guidance to ensure compliance with the Standard, including training courses

    and guideline booklets, are available.

    An optional on-site pre-assessment may be carried out by the selected certification body in preparation

    for the audit to provide guidance to the company on the process of certification.

    3 Selection of a Certif ication Body

    Once a self assessmenthas been completed and non-conformities addressed,the company must select

    a certification body. The BRCcannot advise on the selection of a specific certification body, but the BRC

    Global Standards Directory listsBR C-approved certification bodies. Visit www.brcdirectory.com.

    In selecting a certification body, the company should consider:

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

    certification bodies

    the scope of accreditation of the certification body. It isessential that the certification body isaccredited to assesscompanies 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 BRCa nd documented in Appendix 2.

    http://www.brcglobalstandards.com./http://www.brcglobalstandards.com./http://www.brcdirectory.com./http://www.brcdirectory.com./http://www.brcglobalstandards.com./http://www.brcglobalstandards.com./
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    INITIAL AUDIT

    Corrective Action

    Submitted or Revistt

    Wilhin 90 Calendar Days

    EVidence Assessed

    Inadequate

    No Certificate

    IssuedReport Issued

    Specifying Status

    Process!

    Certification

    Suspended

    lCorrective Action

    SUbmitted or Revistt

    Vvlthin 28 CaIendar

    Days

    Additional

    Clarification

    Provided

    Evidence

    Assessed

    Inadequate

    Certificate Details and Audtt Report

    listed on BRC Global Standards

    Directory www.brcdirectory.com

    No Corrective Action

    Submitted Vvlthin 28 Days

    Vidence Assessed

    CompliantNo Certificate Issued

    Report Issued

    Specifying Status

    Processl Certification

    Suspended

    Certification Decision

    made by Certification

    Decision Manager

    Certificate Details and Audit Report

    issued to company and sent to BRC

    Critical or Major

    (Fundamental)

    Non-conformity

    Identified

    Certification

    Suspended

    Audit

    In Accordance' With

    Required Frequency

    http://www.brcdirectory.com/http://www.brcdirectory.com/
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    4 Company/Certification Body Contractual Arrangements

    A contract shall exist between the company and the certification body, detailing the scOpeof the audit

    and the reporting requirements. Thiscontract will be form'ulated by the certification body.

    The BRCwill require an administration fee to be collected bythe certification body from the com pany for

    every audit undertaken. 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.

    4.1 Scop eo f A ud it

    The scope of the audit must be agreed between the company and the certification body.

    The audit, report and certificate shall be 'product' and 'site' specific. Eachsite shall be audited and the

    certificate granted accordingly.

    The scope of the audit and subsequent certificate shall cover the agreed produ cts or product categories

    where certain products may be excluded - exclusionsthat apply must be clearly stated on the certificate.

    The certification of products must include audit of the entire process from raw material to end product

    dispatch. Forfactored goods this must be clearly stated on the certificate.

    Certification relates to the audit of all processeswithin the manufacture of a 'product' and this may in

    some casesinvolve the audit at one or more premisesby the certification body for a specific product, e.g.

    production and maturation of cheese.In the event that one or more premises are audited under one

    product certification, the report and the certificate shallcl~arly indicate this information.

    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 aspectsof the

    required extension to scope. The current certificate will be superseded by any new certificate issued

    using the same expiry date asdetailed on the original certificate.

    It isthe responsibility of the company to ensure that adequate and accurate information isgiven to the

    certification body detailing the products it manufactures and the processtechnologies it usesto enable

    the certification body to selectan auditor with the required skillsto undertake the audit. Auditors must

    be skilled to audit in the relevant product category aslisted in Appendix 3.

    The certification body, auditors and the company m ust 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 u ndertake audits on more than three consecutiv'eoccasionsto the

    same site. Exceptions to this should be justified on the audit report - such asa requirement for audit 'Inspecialist areasand remote regions.

    Forthe 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. Forsubsequent audits, the

    mutually agreed date must allow sufficient time to ensure the company does not go outside of the

    certification time frame as detailed in paragraph 12 'Ongoing Audit Frequency and Certification' and

    referenced in Appendix 6.

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

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    documentation for the au'ditor to assessand to have appropriate staff available at all times during the

    on-site audit.

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

    the intended 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 hasbeen assessed.

    The company shall provide the certification body with any information such as HACCP documentation,

    recent quality issues, withdrawals or customer complaints and other relevant performance data that

    would assistthe auditor in conducting an effective audit.

    The company will make the previous year's audit report available to the auditor and the certification

    body.

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

    the duration and the cost of audit. Thisshould include details of manufacturing schedulesto allow auditsto 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 assessall 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 shallbe 1~ man days.Additionally up to one man day istypically required

    for the completion of a comprehensive audit report.

    However, certain factors can necessitate an increase or decreasein 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.

    Factorswhich may influence the duration of the audit are:

    company staff numbers and functions

    numbers of locations, with separate offices, manufacturing or storage sites

    complexity of the manufacturing process

    number of product lines

    sizeand age of site and impact on material flow

    labour-intensity of processes

    communication difficulties, e.g. language

    the number of non-conformities recorded in the previous audit

    difficulties experienced during the audit requiring further investigation

    the quality of company preparation, e.g. documentation, HACCP,QMS.

    For an audit of typically 1~ days' duration, 30-50% of time should be spent on examination of HACCP-

    based systems and audit of its practical implementation by an inspection of the production facility. This

    will vary according to the complexity of th~ operation. Time taken shall be detailed on the.audit report.

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    the opening meeting - to confirm the scope and processof the audit

    document review - a review of the documented HACCPand Quality Management Systems

    production facility inspection - to review practical implementation of the systemsand 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 bythe certification body management.

    The company will fully assistthe 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 appr~priate

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

    senior operations manager on site or their nominated deputy shall be available at the audit and attendthe opening and closing meetings.

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

    conformities against the Standard and these will be usedasthe basisfor the audit report. The auditor will

    assessthe nature and severity of any non-conformity .

    At the closing meeting, the auditor shall present his/her findings, and discussall 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 processand timescales for the company to provide evidenceto

    the au ditor 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.

    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 levelof non-conformity assigned by an auditor against a requirement of the Standard isan objective

    jud gem ent with resp ect to sev erit y an d risk a nd is bas ed on evid enc e col lected and obs erva tion s made

    during the audit. This isverified by the certification body management.

    C ri ti ca l

    - where there is a critical failure to comply with a food safety or legal issue

    Maj or

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

    of the Standard

    - a situation is identified which would, on the basisof aVailableobjective evidence, raisesignificant

    doubt asto the conformity of the product being supplied

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    - 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 theproduct is not in doubt.

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

    conformity against the Global Standard for Food Safety. 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

    clauseand recording this asa single minor non-conformity isnot permitted.

    8.2 Procedures for Handling Non-conformities and Corrective Action

    The criteria for grading and means of confirming corrective action are summarised in Appendix 4. The

    decision to aw ard a certificate, and the grade of the certificate, A, 8 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 a nd type of non-conformities exceedsa certain level, a

    grade 0 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 by the company to the certification body prior to a certification

    decision being made.

    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 a major.

    C r it ic al o r M ajo r N o n -c o n f o r m i t ie s Rais e d a g ain s t 'F u n d am e n t al ' C lau s e s

    Where a critical or ma jor 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 isfound at a subsequent audit, certification must be immediately suspended.

    In either of the above cases,this results in the awarding of a grade 0 and there shall be a further full on-

    site audit carried out to verify a ppropriate 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

    customers and make them fully aware of the circumstances.Information on the corrective actions to be

    taken in order to achieve certification status will alsobe provided to customers.

    Major Non-conformit ies

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

    corrected.

    It isnormally expected that major non-conformities will be correctedwithin 28 calendar daysof the audit

    taking place, either permanently or temporarily (providing the solution isacceptable to the certification

    body) and the certification body can verify that corrective action hastaken place.

    This can be achieved either by objective evidence being submitted to the certification body such as

    updated procedures, records, photographs or invoicesfor work undertaken etc., or by.the certification

    body unde-rtaking a furttJer on-site visit.

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    For initial audits only, if there is no'temporary solution or if there is a justifiable delay to implementing a

    permanent solution, e.g. lead time for capital expenditure, then provided that an acceptablestatement

    . of explanation is received by the certification bodywithin'28 calendar days, the company may remain in

    the certification programme for up to 90 calendar days,but will remain uncertificated and will only be

    certificated following verification of the corrective action being implemented. If the major non-

    conformity cannot be closed out within the 90-day period, the process of certification will commence

    again, i.e. a full audit.

    If there is no formal commitment to implement correctiveaction received by the certification body within

    the 28 calendar day post-audit period, or if there is a failure to meet the timescale proposed in the non-

    conformity summary sheet without justification, the company does not remain in the certification

    programme. The company will then require a further full audit in order to be considered for certification.

    Certification will only be awarded where minor non-conformities have been addressed,the corrective

    action taken and evidence (e.g. photos, invoices) for work completed has been provided to the

    certification body, within 28 calendar days following the audit. The certification body may undertake

    further site visitsto verify that action hasbeen 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 raisedand

    may be elevated to a major non-conformity.

    For certificated companies, where deemed appropriate, the certification body m ay carry out further

    audits or question activitiesto validate continued certification at any time. Thesevisitsmay take the form

    of announced or unannounced visitsto 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 are deemed inappropriate, certification shallbe 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 alsobe provided to customers.

    10 Grading of the Audit

    The purpose of the certification grading system isto indicate to the user of the report the commitment of

    the company to continual compliance and will dictate the future audit frequency (full detailsavailable inAppendix 4).

    The grade is dependent on the number and severityof the non-conformities identified at the audit and

    verification by a technical review by the certification body management where the number and severity

    of non-conformities may change.

    The certification body will review objective evidenceof corrective action completed prior to awarding a

    certificate, but this will n ot improve the grade awarded.

    After a successfulre.'iiewof the a udit report and documentary evidence provided in relation to t~e non-

    conformities identified, a certification decision shall be made by the designated independentcertification manager and a certificate issuedby the ceitifi~ation body typically within 42 calendardays

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    of the audit. The certi ficate shall conform to the format shown in Appendix S,using BRC and

    accreditation body logo usage rules.

    11 All dates specified on the certificate shallbe the format of: day, month, year,e.g. 11 November 2007,

    The certificate will detail the scope of the audit as agreed in paragraph 4.1.

    Where the on-site audit has been undertaken by an auditor trained by the BRCwho has been issuedwith a BRCThird Party Auditor Certificate for this Standard, the BRCTrained Auditor Logo may be

    added to the certificate.

    The date of audit specified on the initial certificate shall be the date of the audit relating to the

    granting of that certificate (the date of the initial audit) irrespective of whether further audits were

    made to verify corrective action arising from the initial audit.

    The usersof certificates area dvised that they should verify that the scopeof the certificate isclearlystated

    and that this information is consistent with their own requirements. Whilst the certificate is issuedto the

    company, it remainsthe property of the certification body who control its ownership, use and display.

    The company has the right to appeal the certification decision made by the certification body and any

    appeal should be made in writing within sevencalendar daysof 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..shallbe 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 responsewill be given after the completion of a full and thorough

    investigation into the appeal.

    In the event of an unsuccessfulappeal, the certification body hasthe rightto charge costsfor conducting

    the appeal.

    11 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 user needs.

    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 must assistthe reader to:

    gain greater understanding of individual clauseseither for conformity or for non-conformity

    be informed of corrective action taken

    be informed of improvements made sincethe last audit

    be informed of 'best practice' systems,procedures, equipment or fabrication in place

    be informed of any additional pertinent comments the auditor made.

    The report shallaccuratelyreflect the findings of the auditor during the audit. Reportsshallbe preparedand

    dispatched to the company within a period typically no longer than 42 calendardays after the audit date.

    Audit reports shall remain the property of the company commissioning the audit and shall not be

    released, in whole or part, to a third party unlessthe company hasgiven prior consent (unlessotherwise

    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 th~ certification body. The certification body will retain a copy of

    the audit report. The audit report and associated documentation shallbe stored safely a~d securelyfor a

    period of five years by the'certification body.

    A copy of the audit report shall be sent bythe certification body in the required format to the BRC.

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    12 Ongoing Audit Frequency and Certification

    The ongoing audit schedule will be agreed between the company and the certification body. The

    minimum fre