north american br global food standard
TRANSCRIPT
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Issue
FOR FOOD SAFETY - NORTH AMERICAN VERSION
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Tick all the right boxes with the BRCs
Global Standards and Guidelines
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January 2008
British Retail Consortium
London: TSO
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BRC publish information and express opinions in good faith, but accept no liability for any error or omission in any such information
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Whilst the BRC have endeavoured to ensure that the information in this publication is accurate, they shall not be liable for any
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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
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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
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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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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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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 companys 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
suppliers 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/IEC17011General requirementsfor accredition bodies
IAF Guideline on theApplication of
ISO/IECGuide 65:1996EN 45011
NationalAccreditation Body
Certification Body
Company Company Company
ACCREDITATION
Supporting
Documentation
CERTIFICATION
BRCGuidelines forAccreditation Bodies
Assessing CertificationBodies for BRCGlobal
Standards
ISO/IECGuide 65:1996
EN 45011
Requirements forOrganisations OfferingCertification Against theCriteriaof the BRCGlobal
Standards
BRCGlobal Standards
Websitewww.brcglobalstandards.com
BRCDirectorywww.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 47.
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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 companys 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 companys 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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2.10 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 companys 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 companys 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 companys 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 companys 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 companys 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 companys 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 companys 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 companys 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 companys 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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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
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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
28Days
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 Major Non-conformityagainst Fundamental
RequirementNo Certification
Certificate Details and AuditReport listed on BRCGlobal
Standard Directorywww.brcdirectory.com
Current Certificated sitesCertification Withdrawn
No Non-conformitiesIdentified
Corrective ActionSubmitted or Revisit with
28Calendar 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 contract will be formulated by the certification body.
The BRC will require an administration fee to be collected by the certification body from the company 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 Scope of Audit
The scope of the audit must be agreed between the company and the certification body.
The audit, report and certificate shall be product and facility specific. Each facility shall be audited and the
certificate granted accordingly.
The scope of the audit and subsequent certificate shall cover the agreed products or product categories
where certain products may be excluded exclusions that 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 shipment.
For manufactured goods this must be clearly stated on the certificate.
Certification relates to the audit of all processes within the manufacturing of a product and this may in some
cases involve the audit at one or more premises by the certification body for a specific product, e.g.
production and maturation of cheese. In the event that one or more premises are audited under one product
certification, the report and the certificate shall clearly indicate this information.
4.2 Extension to Scope
Once certification has been granted, any additional significant products manufactured or processes
undertaken by the site, which are required to be included in the scope of certification, must be
communicated to the certification body who will then conduct a site visit to examine the aspects of the
required extension to scope. The current certificate will be superseded by any new certificate issued using the
same expiration date as detailed on the original certificate.
4.3 Auditor Selection
It is the responsibility of the company to ensure that adequate and accurate information is given to the
certification body detailing the products it manufactures and the process technologies it uses to enable the
certification body to select an auditor with the required skills to undertake the audit. Auditors must be skilled
to audit in the relevant product category as listed in Appendix 3.
The certification body, auditors and the company must be aware of the need to avoid conflict of interest
when arranging an auditor for the site visit. The company may request or decline the services of a particular
auditor offered by the certification body. However, as guidance, the certification body should ensure that the
same auditor does not undertake audits on more than three consecutive occasions to the same site.Exceptions to this should be justified on the audit report such as a requirement for audit in specialist areas
and remote regions.
5 Audit Preparation by the Company
For the initial audit, the company shall agree a mutually convenient date, with due consideration given to the
amount of work required to meet the requirements of the Standard. For subsequent audits, the mutually
agreed date must allow sufficient time to ensure the company does not go outside of the certification time
frame as detailed in paragraph 12 Ongoing Audit Frequency and Certification and referenced in Appendix 6.
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There is a requirement on the company to plan carefully for the audit, to have appropriate documentation for
the auditor to assess and to have appropriate staff available at all times during the on-site audit.
The company shall ensure that the production schedule at the time of the audit covers products for the
intended scope of the certification. Where possible, the widest range of these products shall be in production
for the auditor to assess. Where the product range is large or diverse, the auditor has the discretion to
continue the audit until sufficiently satisfied that the intended scope of the certification has been assessed.
The company shall provide the certification body with any information such as HACCP documentation,
recent quality issues, withdrawals or customer complaints and other relevant performance data that would
assist the auditor in conducting an effective audit.
The company will make the previous years audit report available to the auditor and the certification body.
6 Duration of the Audit
The company shall provide the certification body with appropriate information to allow them to assess the
duration and the cost of audit. This should include details of manufacturing schedules to allow audits to
cover relevant processes, for example night time manufacturing if necessary. Requested information may
also include, for example, a map of the facility, number of employees and number of production lines. Thetime to assess all documentation is included in the duration of the audit.
Before the audit takes place, the certification body shall indicate the approximate duration of the audit. The