north american brc global food standard - free to view1.pdf

8/17/2019 North American BRC Global Food Standard - FREE to view1.pdf

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Issue

FOR FOOD SAFETY - NORTH AMERICAN VERSION


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Tick all the right boxes with the BRC’s

Global Standards and Guidelines

To order your copies of these new titles or to find out more visit

www.brcbookshop.com or call 0870 243 0123 quoting code DPC.

The British Retail Consortium continues to

lead the market with new editions of its Global

Standards and Guidelines.

Used by suppliers in almost 90 countries across

the world, the BRC’s Global Standards help

manufacturers to meet their customers’ needs

and retailers to purchase with confidence.

The Stationery Office Limited is registered in England No. 3049649 at Clifton House, Worship Street, London, EC2A 2EJ. DPC

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U S ( 2 )

1 2 . 0 8

BRC Global Standards:

Consumer Products Issue 2a

Print: 9780117025967

PDF: 9780117038851

Packaging Issue 3

Print: 9780117037601

PDF: 9780117038110

Storage and Distribution Issue 1

Print: 9780117036741

PDF: 9780117036734

BRC Guidelines:

Category 5 Fresh Produce

(Food Safety) Issue 5

Print: 9780117025790

PDF: 9780117025875

Cookware (Consumer Products)

Print: 9780117025806

PDF: 9780117025882

Interpretation Guideline

(Food Safety)

Print: 9780117025813

PDF: 9780117025899


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January 2008

British Retail Consortium

London: TSO


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Published by TSO (The Stationery Office) and available from:

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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, tort1

(including negligence or breach of statutory duty), misrepresentation, restitution or

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reading this publication or any such information.

All warranties, conditions and other terms implied by statute or common law are, to the fullest extent permitted by law, excluded.

Nothing excludes or limits the liability of BRC for death or personal injury caused by their negligence, for fraud or fraudulent

misrepresentation or for any matter which it would be illegal for them to exclude or attempt to exclude liability for.

The Global Standard for Food Safety and the terms of the disclaimer set out above shall be construed in accordance with English Law

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

Copyright

© British Retail Consortium 2007

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.

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website: www.brcglobalstandards.com

1An action in ‘tort’ is a claim for damages to compensate the claimant for the harm suffered. Such claims arise from cases of personal injury, breach of contract and damage to

personal reputation. As well as damages, remedies include an injunction to prevent harm occurring again.


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BRC Global Standard for Food Safety – North American version

© BRC

Further information available at www.brcglobalstandards.com

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The Standard consists of the following sections:

Section I Provides a background to, and details the format of, the Standard.

Section II Details the requirements of the Standard with which a company must comply in order to gain certification.

Section III Provides information on the selection of a certification body, and details of the process for gaininga certificate.

Section IV Describes the BRC Global Standards Directory, the information contained within it and the parties to whom

this is accessible.


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BRC Global Standard for Food Safety – North American version Further information available at www.brcglobalstandards.com

© BRC

Contents

Section I

1 Introduction 1

1.1 Background 1

1.2 The Scope of the Global Standard for Food Safety 1

1.3 Food Safety Legislation 1

1.4 Benefits of the Global Standard for Food Safety 2

1.5 The Certification Process 2

1.6 Technical Governance of the Global Standard for Food Safety 4

1.7 BRC Logos and Plaques 4

1.8 Effective Date of Issue 5 4

1.9 Acknowledgments: ‘A Thank You’ from the BRC 4

2 The Food Safety Management System 5

2.1 Principles of the Global Standard for Food Safety 5

2.2 The Format of the Global Standard for Food Safety 5

Section II

Requirements 7

Section III

How to Gain Certification 53

1 Introduction 54

2 Self Assessment of Compliance with the Standard 54

3 Selection of a Certification Body 54

4 Company/Certification Body Contractual Arrangements 56

4.1 Scope of Audit 56

4.2 Extension to Scope 56

4.3 Auditor Selection 56

5 Audit Preparation by the Company 56

6 Duration of the Audit 57

7 The On-site Audit 58


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8 Non-conformities and Corrective Action 58

8.1 Non-conformities 58

8.2 Procedures for Handling Non-conformities and Corrective Action 59

9 Further Action 60

10 Grading of the Audit 60

10.1 Certification 60

10.2 Appeals 61

11 Audit Reporting 61

12 Ongoing Audit Frequency and Certification 62

12.1 Certificate Expiration – Justifiable Circumstances 62

12.2 Seasonal Products 62

13 Optional Unannounced Audits 63

14 Communication with Certification Bodies 63

15 Certification Body Performance Monitoring 63

15.1 Feedback 63

15.2 Complaints 63

Section IV

The BRC Global Standards Directory 65

1 Introduction 66

2 Benefits of the Directory to Companies 66

3 Directory Functionality 66

Appendices 67

Appendix 1 The Global Standard for Food Safety and its

Relationship with Other BRC Global Standards 68

Appendix 2 Qualifications, Training and Experience Requirements for Auditors 69

Appendix 3 Product Categories 71

Appendix 4 Summary of Grading Criteria, Action Required and Audit Frequency 74

Appendix 5 Certificate Template 75

Appendix 6 Certificate Validity, Audit Frequency and Planning 76

Appendix 7 Glossary 77

Appendix 8 Acknowledgements 81


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1

Section I

1 Introduction

1.1 Background

Welcome to the fifth issue of the Global Standard for Food Safety. In response to demand the Global

Standard for Food Safety has been translated into many languages to facilitate implementation by food

businesses across the 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 organization to fulfill obligations

with regard to legal and regulatory compliance and protection of the consumer. The format and content of

the Standard is designed 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 processed foods and

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

or ingredients for use by food service companies, catering companies and food manufacturers. Certification

will 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 the production-site management.

Companies whose primary operation is the processing of product or the preparation of primary products may

have products not manufactured or partly processed on site 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 preparation of these products. Certificates shall clearly identify that these products are included.

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

the direct control of the company. The BRC has developed a range of Global Standards which 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 requires food businesses to:

ensure the presence of a detailed specification which is lawful and consistent with industry and safety

standards and good manufacturing practices

ensure that they are confident that their suppliers are competent to produce the specified product,

comply with legal and regulatory requirements, and operate appropriate systems of process control

verify the competence of their suppliers by self-audits or receive the result of any other audit of the

supplier’s system

establish and maintain a risk-assessed program for product examination, testing or analysis

monitor and act upon customer complaints.


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The Global Standard for Food Safety has been developed to assist businesses to meet these requirements,

and therefore assist companies to comply with relevant food safety legislation.

1.4 Benefits of the Global Standard for Food Safety

There are a number of benefits to food businesses arising 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 status to customers and other organizations as agreed, 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

is comprehensive in scope, covering areas of quality, hygiene and product safety

addresses part of the legislative requirements of the food manufacturer/supplier, packer/filler, retailer

and other customers. Companies may also use this Standard to ensure their suppliers are following 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 food safety system is established.

1.5 The Certification Process

The Global Standard for Food Safety is a process and product certification program. In this program, food

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 1.

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

organization 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 Certification Against the Criteria of the BRC Global Standards –

available from the BRC.


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Figure 1

Process for Accreditation of Certification Bodies and Certification of Companies


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International

AccreditationForum & Regional

AccreditationForums

ISO/IEC 17011General requirementsfor accredition bodies

IAF Guideline on theApplication of

ISO/IEC Guide 65:1996EN 45011

NationalAccreditation Body

Certification Body

Company Company Company

ACCREDITATION

Supporting

Documentation

CERTIFICATION

BRC Guidelines forAccreditation Bodies

Assessing CertificationBodies for BRC Global

Standards

ISO/IEC Guide 65:1996

EN 45011

Requirements forOrganisations OfferingCertification Against theCriteria of the BRC Global

Standards

BRC Global Standards

Websitewww.brcglobalstandards.com

BRC Directorywww.brcdirectory.com


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The BRC recognizes that in certain circumstances, such as certification bodies wishing to begin auditing

against the Global Standard for Food Safety, the certification body must be able to conduct audits as part of

achieving accreditation. This will be permitted where the organization can demonstrate:

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

accreditation body

that accreditation will be achieved within 12 months of the date of application and the experienceand 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 representatives of the key stakeholders in the Standard including producers,

retailers, trade associations, certification bodies and accreditation bodies.

The technical content and operation of the Global 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

to coordinate the review of the Standard at appropriate intervals.

1.7 BRC Logos and Plaques

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

certification following audit are qualified to use the BRC logo on company stationery and other

marketing materials. The BRC has also introduced a high-quality plaque that companies

achieving certification can purchase to display in their offices to help celebrate their success.

Information relating to the BRC logo is available at www.brcglobalstandards.com.

1.8 Effective Date of Issue 5

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 commence from 1

July 2008. There will be no recognition of certificates that are issued as a result of audits performed against

Issue 4 after 30 June 2008. All certificates issued against audits carried out prior to 1 July 2008 will be against

Issue 4 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 5 will not commence until 1 July 2008. Certificates

issued before this date against Issue 5 will not be recognized.

1.9 Acknowledgements: ‘A Thank You’ from the BRC

The BRC wishes to acknowledge all those food industry experts who have contributed to the preparation of the

Global Standard for Food Safety Issue 5. A list of those who have contributed in this review is detailed in Appendix 8.


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2 The Food Safety Management System

2.1 Principles of the Global Standard for Food Safety

A food 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 of food. The Global Standard for

Food Safety is based on two key components: senior management commitment and Hazard Analysis Critical

Control Point (HACCP).

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 organization.

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 resource activity such as training.

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 means to guide the activities that collectively assure food

safety. The Global Standard for Food Safety places a high priority on clear evidence 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 SafetyThe Global Standard for Food Safety requires the development of and compliance with:

Senior Management commitment – the resources required for demonstration of commitment to

achieving the requirements of the Standard are detailed in Section II, Part 1

a HACCP plan – this provides a focus on the significant product and process food safety hazards that require

specific control to assure the safety of individual food products or lines as detailed in Section II, Part 2

a Quality Management System – details of the organizational and management policies and procedures

that provide a framework by which the organization will achieve the requirements in this Standard as

given in Section II, Part 3

Prerequisite Programs – the basic environmental and operational conditions in a food business that are

necessary for the production of safe food. These control generic hazards covering Good Manufacturing

and Good Hygienic Practice as detailed in Section II, Parts 4–7.


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Each clause of the Global Standard for Food Safety begins with a highlighted paragraph

in bold text, the ‘statement of intent’, that all companies 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 food quality

and safety operation. The clauses deemed to be ‘fundamental’ are:

Senior Management Commitment and Continual Improvement, Clause 1

The Food Safety Plan – HACCP, Clause 2

Internal Audits, Clause 3.5

Corrective and Preventive Action, Clause 3.8

Traceability, Clause 3.9

Layout, Product Flow and Segregation, Clause 4.3.1

Housekeeping and Hygiene, Clause 4.9

Handling Requirements for Specific Materials – Materials Containing Allergens and Identity Preserved

Materials, 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 leads to non-certification at an initial

audit or withdrawal of certification at subsequent audits. This will require a further full audit to establishdemonstrated evidence of compliance.


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SECTION II

REQUIREMENTS


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Section II

Requirements

Contents

1 Senior Management Commitment and Continuous Improvement 10

2 The Food Safety Plan – HACCP 11

3 Food Safety and Quality Management System 18

3.1 Food Safety and Quality Policy 18

3.2 Food Safety and Quality Manual 18

3.3 Organizational Structure, Responsibilities and Management Authority 19

3.4 Contract Review and Customer Focus 19

3.5 Internal Audit 20

3.6 Purchasing – Supplier Approval and Performance Monitoring 20

3.7 General Documentation Requirements 21

3.8 Corrective and Preventive Action 23

3.9 Traceability 23

3.10 Complaint Handling 24

3.11 Management of Incidents, Product Withdrawal and Product Recall 25

4 Site Standards 26

4.1 External Standards 26

4.2 Security 26

4.3 Internal Site Standards 27

4.4 Utilities 30

4.5 Equipment 30

4.6 Maintenance 31

4.7 Staff Facilities 32

4.8 Chemical and Physical Product Contamination Control 33

4.9 Housekeeping and Hygiene 36

4.10 Waste/Waste Disposal 37


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4.11 Pest Control 38

4.12 Storage and Transport 39

5 Product Control 40

5.1 Product Design/Development 40

5.2 Handling Requirements for Specific Materials – Materials Containing

Allergens and Identity Preserved Materials 41

5.3 Foreign Body Detection 42

5.4 Product Packaging 43

5.5 Product Inspection and Laboratory Testing 43

5.6 Control of Non-conforming Product 45

5.7 Product Release 45

6 Process Control 46

6.1 Control of Operations 46

6.2 Quantity – Weight, Volume and Number Control 46

6.3 Calibration and Control of Measuring and Monitoring Devices 47

7 Personnel 48

7.1 Training 48

7.2 Access and Movement of Personnel 49

7.3 Personal Hygiene 49

7.4 Medical Screening 507.5 Protective Clothing 51


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Requirements

2.1.1 The HACCP plan shall be developed and managed by a multi-disciplinary food safety team that includes those responsible for Quality/

Maintenance and other relevant functions. The team members shall have specific knowledge of HACCP and relevant knowledge of p

2.1.2 The HACCP food safety team shall have a designated and qualified team leader who shall be able to demonstrate competence in HA

2.1.3 Records shall be maintained that demonstrate the HACCP food safety team has the required knowledge and understanding of HACCP.

appropriate in-house knowledge, external expertise may be sought, but day-to-day management of the food safety system shall remai

2.1.4 The company’s senior management shall demonstrate commitment and support of the HACCP food safety team.

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2 THE FOOD SAFETY PLAN – HACCP

FUNDAMENTAL

The company’s Food Safety Plan shall be based on a HACCP system which shall be systematic, comprehensive, thmaintained. Codex Alimentarius HACCP principles shall be used and reference shall be made to relevant legislatio

2.1 The HACCP Food Safety Team – Codex Alimentarius Step 1


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Requirements

2.2.1 The HACCP food safety team will define the specific products and/or processes that are the subject of the HACCP plan.

2.2.2 All relevant information needed to conduct the hazard analysis shall be collected, maintained, documented and updated. The comp

based on comprehensive information sources, which are referenced and available on request. This may include the following, althou

the latest scientific literature

historical and known hazards associated with specific food products

relevant Codes of Practice

recognized guidelines

food safety legislation of products in destination countries

customer requirements.

2.2.3 A full description of the product shall be developed, which includes all relevant information on food safety. As a guide, this may includ

exhaustive list:

origin of all ingredients

physical or chemical properties that impact food safety (e.g. pH, aw)

treatment and processing (e.g. heating, freezing, salting)

packaging system (e.g. modified atmosphere, vacuum)

storage and distribution conditions (e.g. chilled, ambient)

target safe shelf life under prescribed storage and usage conditions

instructions for use (e.g. storage, preparation)

consideration of potential misuse (e.g. storage, preparation).

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2.2 Describe the Product – Codex Alimentarius Step 2


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2.3 Identify Intended Use – Codex Alimentarius Step 3

Requirements

2.3.1 The intended use of the product by the customer shall be described defining the consumer target groups, including the suitability o

the population, e.g. infants, elderly, allergy sufferers.

2.4 Construct a Process Flow Diagram – Codex Alimentarius Step 4

Requirements

2.4.1 A flow diagram shall be prepared to cover each product, product category or process. This shall set out all aspects of the food proce

from raw materials selection through processing, storage and distribution. As a guide, this may include the following, although this

a map of the facility that includes the placement of production equipment.

raw materials including introduction of utilities and other contact materials (e.g. water, packaging)

sequence and interaction of all process steps

outsourced processes and subcontracted work

process parameters

potential for process delay

rework and recycling

low/high risk and clean/dirty area segregation

finished products, intermediate/semi-processed products, by-products and waste.

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2.5 Verify Flow Diagram – Codex Alimentarius Step 5

Requirements

2.5.1 The HACCP food safety team shall verify the accuracy of the flow diagrams by on-site audit and challenge. Daily and seasonal variat

Records of verified flow diagrams shall be maintained.

2.6 List All Potential Hazards Associated with Each Process Step, Conduct a HazaConsider any Measures to Control Identified Hazards – Codex Alimentarius S

Requirements

2.6.1 The HACCP food safety team shall confirm the scope of the HACCP plan and identify and record all the potential hazards that are rea

relation to product, process and facilities which may not be controlled by existing pre-requisite programs. This shall include hazards pr

during the process or surviving the process steps, and allergen risks (refer to clause 5.2). It shall also take account of the preceding and

2.6.2 The HACCP food safety team shall conduct a hazard analysis to identify hazards which need to be prevented, eliminated or reduced

shall be given to the following as a minimum:

likely occurrence of hazard

severity of the effects on consumer safety

vulnerability of those exposed

survival and growth of micro-organisms of concern

presence or production of toxins, chemicals or foreign bodies

contamination of raw materials, intermediate/semi-processed product, or finished product

potential for adulteration and/or deliberate contamination.

2.6.3 The HACCP food safety team shall consider the control measures necessary to prevent, eliminate or reduce the hazard to acceptable

using more than one control measure. Justification for acceptable levels in the finished product for each hazard shall be determined

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2.10 Establish a Corrective Action Plan – Codex Alimentarius Step 10, Principle 5

Requirements

2.10.1 The HACCP food safety team shall specify and document the corrective action to be taken when monitored results indicate a failure

monitored results indicate a trend towards loss of control. This shall include the action to be taken by designated personnel with reg

manufactured during the period when the process was out of control.

2.10.2 Documented procedures shall be established and maintained for the appropriate handling of potentially unsafe products to ensure

confirmed as suitable for release.

2.11 Establish Verification Procedures – Codex Alimentarius Step 11, Principle 6

Requirements

2.11.1 Procedures of verification shall be established to confirm that the HACCP plan is effective. Examples of verification activities are:

internal audits

review of records where acceptable limits have been exceeded

review of complaints and/or non-conformances from customers and/or regulatory agencies.

review of incidents of product withdrawal or recall.

2.11.2 Verification results shall be recorded and communicated to the HACCP food safety team.

2.12 HACCP Documentation and Record Keeping – Codex Alimentarius Step 12, P

Requirements

2.12.1 Documentation and record keeping shall be sufficient to assist the company to verify that the HACCP controls are in place and main

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2.13 Review the HACCP Plan

Requirements

2.13.1 The HACCP food safety team shall ensure that procedures exist to review the HACCP plan prior to any changes which may affect pr

include the following, although this is not an exhaustive list:

change in raw materials or supplier of raw materials

change in ingredients and/or recipe

change in processing conditions or equipment

change in packaging, storage or distribution conditions

change in staff or management responsibilities

change in consumer use

developments in scientific information associated with ingredients, process or product.

Appropriate changes resulting from the review shall be incorporated into the HACCP plan, fully documented and validated.

2.13.2 Irrespective of any of the above changes, the HACCP plan will be reviewed at least annually and records shall be maintained.

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3 FOOD SAFETY AND QUALITY MANAGEMENT SYSTEM

3.1 Food Safety and Quality Policy

The company’s senior management shall develop and document a food safety and quality policy which is authorizeby an appropriate senior manager.

Requirements

3.1.1 The policy shall state the company’s intention to meet its obligation to produce safe and legally compliant products to the specified q

customers. This shall include the commitment for review and continuous improvement. The company’s senior management shall en

staff involved with activities relating to product safety, legality, regulatory compliance and quality.

3.2 Food Safety and Quality Manual

The company shall have a food safety and quality manual which describes how the requirements of the Global StaThese requirements shall be fully implemented, reviewed at appropriate planned intervals and improved where n

Requirements

3.2.1 The food safety and quality manual shall contain an outline of working methods and practices or references to where such an outlin

3.2.2 The food safety and quality manual shall be readily available to key staff.

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3.3 Organizational Structure, Responsibilities and Management Authority

The company shall have a clear organizational structure and define the responsibilities, reporting relationships andwhose activities affect product safety, legality, regulatory compliance and quality.

Requirements

3.3.1 The company shall have an organization chart demonstrating the structure of the company.

3.3.2 Documented, clearly defined responsibilities shall exist and be communicated to key staff with responsibility for product safety, l

quality systems.

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

3.3.4 The company’s senior management shall ensure a description of general duties or work instructions are in place and communicated

relating to product safety, legality, regulatory compliance and quality.

3.3.5 The company’s senior management shall have a system in place to ensure that the company is kept informed of all relevant legislativ

developments, and industry regulations and/or standards applicable in the country of raw material supply, production and, where k

will be sold.

3.4 Contract Review and Customer FocusThe company’s senior management shall ensure that processes are in place to determine any customer requiremento product safety and quality, and ensure these are fulfilled.

Requirements

3.4.1 The company shall clearly identify those individuals responsible for communication with customers and shall have an effective syste

3.4.2 Customer requirements relating to the development, specification, manufacture and distribution of product shall have been agreed

appropriate, documented and agreed prior to order fulfillment (refer to clause 3.7.2.3).

3.4.3 Customer needs and requirements shall be reviewed on a suitable pre-determined frequency. Any changes to existing agreements o

documented and communicated to appropriate departments.

3.4.4 Performance indicators shall be established relating to customer satisfaction. These shall be communicated to appropriate staff and per


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3.5 Internal Audit

FUNDAMENTAL

The company shall audit those systems and procedures which cover the requirements of the Global Standa

they are in place, appropriate and complied with.

Requirements

3.5.1 Internal audits shall be planned and their scope and frequency shall be established in relation to the risks associated with the activity

aspects of the food safety and quality management system are audited at least annually.

3.5.2 Internal audits shall be carried out by appropriately trained competent auditors, who are independent from the audited department

3.5.3 Internal audit reports shall identify and verify conformity as well as non-conformity.

3.5.4 Results of the internal audit shall be reported to the personnel responsible for the activity audited. Corrective actions and timelines for

3.5.5 The completion of corrective action shall be verified.

3.5.6 A record of all programmed internal audits and associated corrective actions shall be maintained.

3.6 Purchasing – Supplier Approval and Performance Monitoring

The company shall control all purchasing processes which are critical to product safety, legality, regulatory compliapurchased products and services conform to defined requirements.

Requirements

3.6.1 The company shall have a documented supplier approval procedure and continual assessment program in place, based on risk asses

3.6.2 These procedures shall include clear criteria for ongoing assessment and standards of performance required. Ongoing assessment mperformance through the following, although this is not an exhaustive list:

in-house checks

certificates of analysis

supplier audit as appropriate.

Records of this monitoring shall be retained.

3.6.3 The procedures shall define how exceptions are handled, e.g. the use of products or services where audit or monitoring has not bee

3.6.4 The company shall review the performance of new suppliers against defined criteria within a specified ‘trial’ period and thereafter alevel of ongoing supplier performance monitoring.


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3.7 General Documentation Requirements

3.7.1 Documentation Control

The company’s senior management shall ensure that all documents, records and data critical to the management of regulatory compliance and quality are in place and effectively controlled.

Requirements

3.7.1.1 All documents in use shall be properly authorized and be the correct version.

3.7.1.2 Documents shall be clearly legible, unambiguous, in appropriate languages and sufficiently detailed to enable their correct applicati

readily accessible to relevant staff at all times.

3.7.1.3 The reason for any changes or amendments to documents critical to product safety, legality, regulatory compliance or quality system

3.7.1.4 A procedure shall be in place to ensure obsolete documentation is removed, and when applicable replaced with a revised version.

3.7.2 Specifications

The company shall ensure that specifications exist for raw materials including packaging, work-in-progress and finapplicable), and any product or service which could affect the integrity of the finished product.

Requirements

3.7.2.1 Specifications shall be adequate and accurate and shall ensure compliance with applicable safety and legislative requirements.

3.7.2.2 Manufacturing instructions shall comply with recipes as detailed in agreed customer specifications and shall be implemented.

3.7.2.3 The company shall seek formal agreement of specifications with applicable parties. Where specifications are not formally agreed to,

demonstrate that they have taken steps to ensure a formal agreement is in place.

3.7.2.4 There shall be a documented procedure for the amendment and approval of specifications for all parts of the process including regula

3.7.2.5 Specifications and/or their contents shall be accessible to the applicable staff.

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3.7.3 Record Completion and Maintenance

The company shall maintain genuine records to demonstrate the effective control of product safety, legality, regula

Requirements

3.7.3.1 The records shall be legible, genuine, appropriately authorized and retained in good condition for an appropriate defined time perio

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

3.7.3.3 The company’s senior management shall ensure that procedures are operated for the organization, review, maintenance, storage a

product safety, legality, regulatory compliance and quality.

3.7.3.4 The period of retention for records shall relate to shelf life of the product and take into account, where it is specified on the label, th

extended by the consumer, e.g. freezing.

3.7.3.5 Any legal and customer specific requirements relevant to record retention shall be taken into account.

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3.10 Complaint Handling

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

Requirements

3.10.1 All complaints shall be recorded, investigated and the results of the investigation recorded.

3.10.2 Actions appropriate to the severity and frequency of the problems identified shall be carried out promptly and effectively by approp

3.10.3 Complaint data shall be analyzed and used to implement ongoing improvements to product safety, legality, regulatory compliance a

analysis shall be made available to relevant staff.

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4.3 Internal Site Standards

4.3.1 Layout, Product Flow and Segregation

FUNDAMENTAL

Premises and plant shall be designed, constructed and maintained. Procedures shall be in place to control thand to comply with all governmental regulations.

Requirements

4.3.1.1 The process flow from receiving of materials to the shipping of finished product shall be arranged to minimize the risk of product co

4.3.1.2 Physical barriers and/or effective procedures shall be in place to minimize the risk of the contamination of raw materials, work-in-pro

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

4.3.1.3 Segregation shall take into account the flow of product, nature of materials, equipment, personnel, waste, airflow, air quality and u

4.3.1.4 Based on risk assessment, the cleaning of production utensils shall be carried out in segregated areas or at specific time periods sepa

4.3.1.5 Premises shall allow sufficient working space and storage capacity to enable all operations to be carried out properly under safe hyg

4.3.1.6 Cleaning and inspection of areas and equipment shall be aided by the lack of obstructions and where appropriate the provision of a

4.3.1.7 Temporary structures erected during building construction or repair projects shall be designed and located to avoid pest harborage an

4.3.1.8 The location of all transfer points shall not compromise high-risk and low-risk segregation and practices shall be in place to minimize

sanitation activities.

4.3.1.9 Where high-risk products (refer to glossary) are manufactured, there shall be physical segregation between processing and finishe

area shall be constructed and designed to a high standard of hygiene, and practices shall be in place to control ingredients, equipme

personnel to prevent product contamination.

4.3.1.10 In high-care areas (refer to glossary) where there is a significant risk of contamination of chilled ready to eat and/or heat products b

processing or handling of food in these areas shall be appropriate to minimize product contamination by such micro-organisms.


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4.3.2 Building ConstructionRaw Material Handling, Preparation, Processing, Packing and Storage Areas

The construction of the site, buildings and facilities shall be suitable for the intended purpose.

4.3.2.1 Walls

Requirements

4.3.2.1.1 Walls shall be designed, constructed, finished and maintained to prevent the accumulation of dirt, minimize condensation and mold

4.3.2.2 Floors

Requirements

4.3.2.2.1 Floors shall be designed to meet the demands of the process, and withstand cleaning materials and methods. They shall be impervio4.3.2.2.2 Drainage, including drains from laboratories, where provided, shall be placed, designed and maintained to minimize risk of product

product safety. Machinery and piping shall be arranged so that, wherever feasible, process waste water goes directly to the drain.

4.3.2.2.3 Where significant amounts of water are used, or direct piping to the drain is not feasible, floors shall have adequate slope to cope with t

suitable drainage.

4.3.2.3 Ceilings/Overheads

Requirements

4.3.2.3.1 Ceilings and overheads shall be designed, constructed, finished and maintained to prevent the accumulation of dirt, minimize cond

facilitate cleaning.

4.3.2.3.2 Where suspended ceilings are used, adequate access to the vacant spaces shall be provided to facilitate cleaning, maintenance of ut


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4.3.2.4 Windows

Requirements

4.3.2.4.1 Where there is a risk to product, windows and ceiling openings which are designed to be opened for ventilation purposes shall be ad

ingress of pests.

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

4.3.2.5 Doors

Requirements

4.3.2.5.1 Where external doors to raw material handling, processing, packing and storage areas are opened, suitable precautions shall be tak

dock levelers in these areas shall be tight fitting or adequately sealed.

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

4.3.2.6 Lighting

Requirements

4.3.2.6.1 Suitable and sufficient lighting shall be provided for a safe working environment, correct operation of processes, inspection of prod

4.3.2.6.2 Where they constitute a risk to product, bulbs and fluorescent lights, including those on flying insect electronic light traps, shall be a

protection cannot be provided, alternative management such as wire mesh screens or monitoring procedures shall be in place.

4.3.2.7 Air Conditioning/Ventilation

Requirements

4.3.2.7.1 Adequate ventilation and air flow shall be provided in product storage and processing environments to prevent condensation or exc

4.3.2.7.2 Where the process requires screened or filtered air, the equipment used for this purpose shall be easily accessible and adequately ma4.3.2.7.3 Where appropriate, positive air-pressure systems shall be in place.


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4.4 Utilities

All utilities to and within the production and storage areas shall be designed, constructed, maintained and monitorof product contamination.

Requirements

4.4.1 All water used as a raw material in the manufacture of processed food, the preparation of product, or for equipment or plant cleani

quantity, be potable or pose no risk of contamination according to governmental regulations, either being drawn from a municipal s

its source.

4.4.2 Based on risk assessment, the microbiological and chemical quality of water, steam, ice, air, compressed air or other gases that does

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

4.5 Equipment

Equipment shall be suitably designed for the intended purpose and shall be used to minimize the risk of contaminat

Requirements

4.5.1 All equipment shall be properly specified before purchase, constructed of appropriate materials, be of a suitable design to ensure it

tested and commissioned prior to use.

4.5.2 Equipment shall be positioned to give access under, inside and around it for ease of cleaning, inspection and servicing, or where per

secured and sealed to the floor.

4.5.3 Certificates of conformity or other evidence shall be available for equipment in direct contact with food to confirm its suitability for


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4.6 Maintenance

A documented system of planned maintenance shall be in place, covering all items of equipment and plant wsafety, legality, regulatory compliance and qual ity.

Requirements

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

4.6.2 When commissioning new equipment and/or plant, a maintenance program shall be established and put into place based on risk as

4.6.3 The company shall ensure that the safety, regulatory compliance or legality of product is not jeopardized during maintenance and cl

4.6.4 In addition to any planned maintenance program, where there is a risk of product contamination by foreign bodies arising from equ

inspected at predetermined intervals, inspection results documented and appropriate action taken.

4.6.5 Where temporary repairs are made, these shall be controlled to ensure the safety, legality and regulatory compliance of product is n

measures shall be permanently repaired as soon as practicable and within a defined time limit.

4.6.6 Contractors involved in maintenance or repair activities shall be under the supervision of a designated person.

4.6.7 Maintenance work shall be followed by a documented sanitary clearance procedure, which records that product contamination haz

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

4.6.8 Materials used for equipment and plant maintenance and that pose a risk by direct or indirect contact with raw materials, intermed

lubricating oil and paints shall be suitable for the intended use.

4.6.9 Maintenance workshops shall be controlled to prevent contamination risks to the product, e.g. provision of mats to retain engineer

where workshops open directly into production areas.


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4.8 Chemical and Physical Product Contamination ControlRaw Material Handling, Preparation, Processing, Packing and Storage Areas

Appropriate facilities and procedures shall be in place to control the risk of chemical or physical contamination of pr

Requirements

4.8.1 Based on risk assessment, the company shall identify, control and manage any potential risks from chemical, physical or biological co

associated with the following, although this is not an exhaustive list:

storage

production operation or processes or machinery

any maintenance or building work carried out

sanitation and cleaning operations.

These shall be verified through regular site audits carried out at a frequency determined by risk assessment.

4.8.2 Chemical Control

Requirements

4.8.2.1 A chemical control procedure shall be in place which manages the use, storage and handling of non-food chemicals. This shall inclu

approved purchase

availability of material safety data sheets and specifications

where appropriate, confirmed suitability for food use

avoidance of strong scented products

identification of chemicals at all times

segregated and secure storage with restricted access to authorized personnel

use by trained personnel only.


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4.8.3 Metal Control

Requirements

4.8.3.1 There shall be a documented policy for the control of the use of sharp metal implements including knives, cutting blades on equipmsuitable controls both into and out of the factory, and safe disposal.

4.8.3.2 Snap-off blade knives shall not be used.

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

4.8.3.4 Where staples or other items are used which are likely to cause contamination in packaging, appropriate precautions shall be taken to mi

4.8.4 Glass, Brittle and Hard Plastic, Ceramics and Similar Materials

Requirements

4.8.4.1 In areas where a risk assessment has identified a potential for product contamination from glass, the presence of glass shall be exclu

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 implement

are taken. Procedures shall include as a minimum:

list of items detailing location, number, type and condition

recorded checks of condition of items carried out at a specified frequency based on risk assessment

details on cleaning or replacing items to minimize potential for 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 plast

similar material, shall be implemented and include the following:

quarantining the products and production area that were potentially affected

cleaning the production area

inspecting the production area and the authorization to continue production

changing of workwear and inspection of footwear

specifying those staff authorized to carry out the above points

recording the breakage incident.


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4.8.5 Wood

Requirements

4.8.5.1 In areas where a risk assessment has identified the potential for product contamination from wood, the use of wood shall be exclud

avoided, and the risk is managed, the condition of wood shall be regularly checked to ensure it is in good condition and clean.

4.8.6 Other

Requirements

4.8.6.1 Filters, sieves and magnets used for foreign body control shall be regularly inspected and properly maintained. Such activities shall b

4.8.6.2 Based on risk assessment, procedures shall be implemented to minimize foreign body contamination of packaging during filling ope

container inversion and foreign body removal through rinsing or air jets.


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4.9 Housekeeping and Hygiene

FUNDAMENTAL

Housekeeping and cleaning systems shall be in place which ensure appropriate standards of hygiene are mrisk of contamination is minimized.

Requirements

4.9.1 Documented cleaning procedures shall be in place and maintained for the building, utilities, plant and all equipment. Cleaning proc

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.

4.9.2 Cleaning-in-place (CIP) facilities shall be monitored and maintained to ensure effective operation. Consideration shall be given to fre

chemical concentration and spray ball location and coverage. CIP systems shall have adequate separation from active product lines.

4.9.3 Cleaning and housekeeping shall be carried out by trained personnel in accordance with documented procedures and records shall

4.9.4 Cleaning chemicals and equipment shall be:

suitable for purpose

suitably identified for intended use, e.g. color coded or labeled

stored in a sanitary manner to prevent contamination.

4.9.5 The effectiveness of the cleaning and sanitation procedures shall be verified and recorded. Corrective actions shall be documented.

4.9.6 Cleaning and sanitation procedures shall be revalidated following building or maintenance work, new product introduction or chan


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4.10 Waste/Waste Disposal

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

Requirements

4.10.1 Systems shall be in place to avoid the accumulation of waste in production areas, and shall prevent the use of unfit materials.

4.10.2 Where appropriate, waste shall be categorized according to governmental regulations based on the intended means of disposal, sedesignated waste containers.

4.10.3 Waste disposal shall meet governmental regulations. Where licensing is in operation for disposal of categorized waste, it shall be rem

records of disposal shall be maintained and available for audit.

4.10.4 External waste collection containers and rooms housing waste facilities shall be managed to minimize risk. These shall be:

clearly identified

designed for ease of use and effective cleaning

maintained to allow cleaning and, where required, sanitation.

emptied at appropriate frequencies

covered or doors kept closed as appropriate.

4.10.5 If substandard trademarked materials are transferred to a third party for destruction or disposal, that third party shall be a specialist

shall provide records of material destruction or disposal.


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4.11 Pest Control

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

Requirements

4.11.1 A preventive pest control program shall be maintained covering all areas of the site to minimize pest infestation.

4.11.2 The company shall either contract the services of a competent pest control organization, or shall have appropriately trained staff, fo

of the site to deter and eradicate infestation. The frequency of inspections shall be determined by risk assessment and shall be docu

control contractor are employed, the service contract shall be clearly defined and reflect the activities of the site.

4.11.3 Written procedures and inspection documentation shall be maintained. This shall include as a minimum:

an up-to-date, signed and authorized site map identifying numbered pest control device locations

identification of the baits and/or monitoring devices on site

clearly defined responsibilities for facility management and the contractor

details of pest control products used and instructions for their effective use.

4.11.4 Bait stations, glue boards and/or sticky traps shall be robust, of tamper resistant construction, secured in place and appropriately located t

4.11.5 Insect light traps and/or pheromone traps shall be correctly placed and operational. If there is a danger of insects being expelled fromcontaminating the product, alternative systems and equipment shall be used.

4.11.6 In the event of infestation, immediate action shall be taken to eliminate the hazard. Action shall be taken to identify, evaluate and a

potentially affected.

4.11.7 Detailed records of pest control inspections, recommendations and actions taken shall be maintained. It shall be the responsibility of

relevant recommendations made by their contractor or in-house expert are carried out and monitored. The completion of corrective

documented evidence.

4.11.8 Results of pest control inspections shall be assessed and analyzed for trends on a regular basis, but as a minimum:

in the event of an infestation

annually.

This shall include a catch analysis from trapping devices to identify problem areas. Any such problems shall be suitably corrected.


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5 PRODUCT CONTROL

5.1 Product Design/Development

Product design and development procedures shall be in place to ensure manufacturing processes are capable of profully compliant with regulatory requirements.

Requirements

5.1.1 A HACCP-based study shall be part of the product design and development process.

5.1.2 Production trials shall be carried out and thorough testing shall validate that product formulation and manufacturing processes are

and legal product against the proposed shelf life.

5.1.3 Shelf-life trials shall be undertaken using documented protocols reflecting conditions during storage and handling throughout shelf

retained and shall confirm compliance with relevant microbiological, chemical and organoleptic criteria.

5.1.4 Where new products are introduced, the company shall ensure control of handling requirements for specific materials (refer to clau

5.1.5 Procedures shall be in place to confirm that product packaging conforms to relevant food safety legislation and specification and is

5.1.6 The company’s senior management shall ensure that a system is in place to confirm that labeling of product or other forms of custom

the designated country of use and in accordance with the appropriate product specification.

5.1.7 Where a product is designed to enable a claim to be made to satisfy a consumer group, e.g. a nutritional claim of reduced sugar, the

formulation and production process is fully validated to meet the stated claim.

5.1.8 The product design/development process shall be documented and effectively communicated throughout the organization, to ensu

adequately assessed for safety, legality and regulatory compliance.


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5.4 Product Packaging

Product packaging shall be appropriate for the intended use and shall be stored under conditions to minimize conta

Requirements

5.4.1 Letters of guarantee or other evidence shall be available for product packaging to confirm its suitability for use.

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

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

5.4.4 Product contact liners (or raw material/work-in-progress contact liners) shall be appropriately colored and of sufficient gauge to prev

appropriate.

5.4.5 Where packaging materials pose a product safety risk, special handling procedures shall be in place to prevent product contaminatio

5.5 Product Inspection and Laboratory Testing

The company shall undertake or subcontract inspection and analyses which are critical to confirm product safety, le

and quality, using appropriate procedures, facilities and standards which prevent risk to product safety.

5.5.1 Product Inspection

Requirements

5.5.1.1 Based on risk assessment, testing and inspection schedules shall be established to ensure specified product requirements are met. In

frequency shall be documented.

5.5.1.2 Test and inspection results shall be recorded and reviewed regularly to identify trends. Appropriate actions shall be implemented pro

the specifications or where trends indicate results outside of the specifications.

5.5.1.3 Where validation of finished product quality attributes is required, organoleptic tests shall be carried out regularly in accordance wit

5.5.1.4 The company shall ensure that a system of ongoing shelf life assessment is in place. This shall be based on risk and shall include micras relevant chemical factors such as pH and aw. Records and results from shelf life tests shall validate the minimum shelf life period in


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5.5.2 Laboratory Testing

Requirements

5.5.2.1 Pathogen testing shall be subcontracted to an external laboratory or, where conducted internally, the laboratory facility shall be rem

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

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.

5.5.2.3 Where the company undertakes or subcontracts analyses which are critical to product safety, regulatory compliance or legality, the l

gained recognized laboratory accreditation or operate in accordance with the requirements and principles of ISO 17025. Document

accredited methods are not undertaken.5.5.2.4 Procedures shall be in place to ensure reliability of laboratory results, other than those specified in 5.5.2.3. These shall include:

use of recognized test methods, where available

documented testing procedures

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

use of a system to verify the accuracy of test results, e.g. comparative or proficiency testing

use of appropriately calibrated and maintained equipment.


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5.6 Control of Non-conforming Product

The company shall ensure all out-of-specification product is clearly identified, labeled and quarantined.

Requirements

5.6.1 Procedures for the control of non-conforming material, including rejection, acceptance by concession, or regrading for an alternativ

by all relevant staff. Decisions shall be approved by authorized staff.5.6.2 Corrective actions shall be implemented to avoid recurrence of non-conformance. Details of the non-conformance and action taken

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

specific requirements of the customer.

5.7 Product Release

The company shall ensure that finished product is not released unless all agreed procedures have been followed.

Requirements

5.7.1 A procedure shall be in place, based on risk assessment, to ensure that only products conforming to specification are dispatched, an

authorized staff.


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6 PROCESS CONTROL

The company shall be able to demonstrate effective control of all operations undertaken.

6.1 Control of Operations

FUNDAMENTALThe company shall operate procedures that verify that the processes and equipment employed are capable oand legal product with the desired quality characteristics, in full compliance with regulatory requirements a

Requirements

6.1.1 A process shall ensure that all Critical Control Points and specified limits identified through HACCP are transferred into day-to-day pro

6.1.2 Process monitoring such as temperature, time, pressure and chemical properties shall be established and adequately controlled to e

the required process specification.

6.1.3 Process monitoring shall be carried out by trained staff and shall be documented.

6.1.4 In circumstances where process parameters are controlled by in-line monitoring devices, these shall be linked to a suitable failure ale

6.1.5 In the case of equipment failure or deviation of the process from specification, procedures shall be in place to establish the safety sta6.1.6 Corrective action shall be taken in the event of deviation of process from specification. This shall be recorded.

6.1.7 Procedures shall be in place to ensure that products are packed into the correct packaging and correctly labeled with due considerat

6.1.8 In the event of changes to product formulation, processing methods, equipment or packaging, monitoring of the specified process

6.2 Quantity – Weight, Volume and Number Control

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

Requirements6.2.1 The frequency and methodology of quantity checking shall meet the requirements of appropriate legislation governing quantity ver

6.2.2 Where the quantity of the product is not governed by legislative requirements (e.g. bulk quantity), the product must conform to cus


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6.3 Calibration and Control of Measuring and Monitoring Devices

Measuring equipment used to monitor Critical Control Points and product safety, regulatory compliance and legalitidentified measuring equipment shall be calibrated to a recognized national or international standard. Where a tracthe company shall demonstrate the basis by which standardization is carried out.

Requirements

6.3.1 The company shall identify measuring equipment used to monitor CCPs and product safety, regulatory compliance and legality.

This shall include as a minimum:

a documented list of equipment

equipment identified and marked in accordance with requirements (e.g. numbered, calibration due date).

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

at a predetermined frequency, based on risk assessment

by trained staff

to a defined method traceable to a recognized national or international standard where possible.

Results shall be documented.

6.3.3 The prescribed measuring and monitoring devices shall be:

prevented from adjustment by unauthorized staff

protected from damage, deterioration or misuse.

6.3.4 Procedures shall be in place to record actions taken when the prescribed measuring and monitoring devices are found not to be ope


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7 PERSONNEL

7.1 TrainingRaw Material Handling, Preparation, Processing, Packing and Storage Areas

FUNDAMENTAL

The company shall ensure that personnel performing work that affects product safety, legality, regulatory cdemonstrably competent to carry out their activity, through training, work experience or qualification.

Requirements

7.1.1 All relevant personnel, including temporary staff and contractors, shall be appropriately trained prior to beginning work and adequa

7.1.2 Where personnel are engaged in activities relating to Critical Control Points, relevant training and documented monitoring procedu

7.1.3 The company shall put in place documented programs covering the training needs of relevant personnel. These shall include as a mi

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.

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

name of trainee and confirmation of attendance

date and duration of training

title or course contents as appropriate

training provider.

7.1.5 The company shall routinely review the competencies of staff and provide relevant training as appropriate. This may be in the form o

mentoring or on-the-job experience.


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7.4 Medical Screening

The company shall ensure that medical screening procedures are in place for all employees, contractors or visitors wareas where product safety could be compromised.

Requirements

7.4.1 The company shall have a procedure for the notification by employees, including temporary employees, of any relevant infections, d

have been in contact or be suffering from.

7.4.2 Where there may be risk to product safety, visitors and contractors shall be required to complete a health questionnaire prior to ente

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

7.4.3 There shall be written and communicated procedures for employees, including temporary employees, contractors and visitors, on a

infectious disease from which they may be suffering or have been in contact. Particular consideration should be given where produc

medical advice shall be sought where required.


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7.5 Protective ClothingEmployees or Visitors to Production Areas

Suitable company issued protective clothing shall be worn by employees, contractors or visitors working in or enter

Requirements

7.5.1 Based on risk assessment, the company shall document and communicate to all employees, contractors or visitors the rules regardinprotective clothing in specified work areas, e.g. high-risk and low-risk areas. This shall also include policies for wearing of protective

environment, e.g. removal before entering rest rooms, use of break room/lunchroom and smoking areas.

7.5.2 Protective clothing shall be available that is:

provided in sufficient numbers for each employee

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

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

7.5.4 Laundering of protective clothing shall take place in-house using defined and verified criteria to validate the effectiveness of the lau

contracted and audited laundry. The effectiveness of cleaning shall be monitored. Washing of workwear by the employee is exceptio

where, based on a detailed risk assessment, it can be confirmed there is no risk to product safety. Detailed procedures shall be in plac

laundering process.

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

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

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

7.5.8 Suitable footwear shall be worn within the production environment.

7.5.9 If gloves are used, they shall be replaced regularly. Where appropriate, gloves shall be suitable for food use; of a disposable type; of a

be intact, and not shed loose fibers.

7.5.10 For operations involving high-risk products (refer to glossary) all visibly distinctive protective clothing (including footwear) shall be

when leaving, the high-risk area and stored in a designated changing area.


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Section III

How to Gain Certification

1 IntroductionThe process by which a company gains and maintains certification is summarized in Figure 2.

Every effort has been made to ensure that the content of this audit protocol is accurate at the time of printing.

However, it may be subject to minor change, and reference should be made to the BRC Global Standards

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

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

for the awarding of a certif icate will be assessed by 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 assessed against 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 is available from www.brcglobalstandards.com.

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

company against the Standard. Any areas of non-conformity should be addressed by the company. Further

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

booklets, are available.

An optional on-site pre-assessment may be carried out by the selected certification body in preparation forthe audit to provide guidance to the company on the process of certification.

3 Selection of a Certification Body

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

certification body. The BRC cannot advise on the selection of a specific certification body, but the BRC Global

Standards Directory lists BRC-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 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 and documented in Appendix 2.


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Figure 2

How to Gain Certification

Obtain Copy Of Standard

www.brcglobalstandards.com

Self Assessment Compliance

With Standard

Selected Certification Body

www.Brcdirectory.com

Selected Certification Body

www.Brcdirectory.com

Pre-assessment (Optional)Pre-assessment (Optional)

On Site Audit

Closing MeetingConfirmation of anyNon Conformities

No Corrective ActionSubmitted Within

28 Days

Certification Decisionmade by Certification

Decision Manager

Certificate Details andAudit Report Issued toCompany and sent to

BRC

On Going Compliance

Audit InAccordance with

Required Frequency

Evidence AssessedCalrification Required

Evidence AssessedCompliant

No Certificate IssuedNumber and type of

Non-conformities Identifiedresult in Grade DNo Certification

Critical or Ma jor Non-conformityagainst Fundamental

RequirementNo Certification

Certificate Details and AuditReport listed on BRC Global

Standard Directorywww.brcdirectory.com

Current Certificated sitesCertification Withdrawn

No Non-conformitiesIdentified

Corrective ActionSubmitted or Revisit with

28 Calendar Days

Evidence AssessedInadequate

Additional

Clairification

Provided

CertificationDocumentation Collated

No Certificate IssuedReport Issued Specifying Status

No Certification


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4 Company/Certification Body Contractual Arrangements

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

the reporting requirements. This cont