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AWARENESS TRAINING PROGRAMME Technical Standard and Protocol for Companies Supplying Retailer Branded Food Products. presented by David Burns. Retailers Safeway Tesco Asda Sainsbury Iceland Somerfield CWS Boots Waitrose. Who Were Involved ?. Inspection Bodies EFSIS TLC Law Labs

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slide1

AWARENESS TRAINING PROGRAMMETechnical Standard and Protocol for Companies Supplying Retailer Branded Food Products

presented by

David Burns

who were involved
Retailers

Safeway

Tesco

Asda

Sainsbury

Iceland

Somerfield

CWS

Boots

Waitrose

Who Were Involved ?
  • Inspection
  • Bodies
  • EFSIS
  • TLC
  • Law Labs
  • RSSL
  • National Britannia
  • Trade
  • Associations
  • FDF
  • BACFID

Accreditation

Body

  • UKAS
consistency of inspection

FOUNDATION

LEVEL

Consistency of Inspection

HIGHER LEVEL

Additional

Beneficial

Practices

BEST

PRACTICE

RECOMMENDATIONS

UKAS & EN 45004

NEW EN 45011

benefits of the standard
Benefits of the Standard
  • Accepted Standard based on best practice
  • Inspection bodies accredited to EN45004 to achieve maximum consistency in application and interpretation (this is changing to EN 45011, refer to Protocol section)
  • Open and transparent
  • Encourages continuous improvement
  • Cost effective, removes need for multiple inspections
benefits for the retailer
Benefits for the Retailer
  • Removes “burden” of “routine” visits
  • Focus on HACCP development
  • Focus on quality
  • Focus on complaint issues
  • Focus on “hot” issues e.g GMO,allergen
benefits for the manufacturer
Benefits for the Manufacturer
  • Resource benefit as due diligence visits

are reduced

  • Focus on factory issues
  • Focus on development
  • Focus on specific Retailer requirements
  • Cost effective, independent and professional audit
certification
CERTIFICATION
  • Accredited Certification (UKAS):
  • Quality Management
  • Product Certification
types of standards
TYPES OF STANDARDS
  • Food Standards in Europe
  • Voluntary Codes
  • EU Legislated
types of standards1
TYPES OF STANDARDS
  • Voluntary Codes (for example)
  • Animal Feeds
  • Cereals
  • Horticultural Produce
  • Dairy Produce
  • Beef, Lamb, Pork
types of standards2
TYPES OF STANDARDS
  • EU Legislated (for example)
  • Food Labelling
  • Beef Labelling
  • Organic Food Production
  • Egg Production
  • Animal Welfare
  • Environment
haccp
HACCP

Majority of Food Chain Standards incorporate

Hazard Analysis Critical Control Point(HACCP)

brc standard contents
BRC - STANDARD CONTENTS
  • 1. HACCP System
  • 2. Quality Management System
  • 3. Factory Environment Standards
  • 4. Product Control
  • 5. Process Control
  • 6. Personnel
brc technical standard
BRC - TECHNICAL STANDARD
  • The BRC Standard is divided into two levels, as follows:
  • Foundation Level
  • Higher Level
brc haccp
BRC & HACCP

Useful reference documentation as suggested by the BRC Working Group

Title:

Hazard Analysis Critical Control Points (HACCP) system Guidelines for its Application

Published in:

Codex Alimentarius Food Hygiene Texts

Ref. Number:

ISBN 92-5-104021-4

the standard requirements
THE STANDARD REQUIREMENTS
  • 1. HACCP
  • HACCP - Principles
  • Conduct hazard analysis
  • Determine critical control points
  • Establish critical limits programme
  • Monitor against programme
  • Establish corrective action
  • Verification and validation records
  • Establish documentation
the standard requirements1
THE STANDARD REQUIREMENTS
  • HACCP - Risk
  • Assessment of the identified risk
  • Reference to appropriate technical documentation
  • Prioritisation of monitoring programme
  • Monitor recurring trends
  • Underpinned by technical personnel
the standard requirements2
THE STANDARD REQUIREMENTS
  • HACCP - Management
  • HACCP led by Senior Management commitment
  • Reference to product legal and safety obligations
  • Technically competent HACCP team
  • Plotting the CCP through the production process
  • Identification with reference to technical working instructions / methods for CCP
  • Proof of training / awareness for HACCP at all appropriate levels
the standard requirements3
THE STANDARD REQUIREMENTS
  • 2. QUALITY MANAGEMENT SYSTEM
  • 2.1 Quality Management System (QMS)

General Requirements

  • Identify the processes needed for the QMS application
  • Sequence and interaction of processes
  • Determine criteria and methods to ensure operational control(s)
  • Resources management
  • Monitor, measurement and analysis
  • Implementation, planning and improvement
the standard requirements4
THE STANDARD REQUIREMENTS
  • 2. QUALITY MANAGEMENT SYSTEM
  • 2.2 Quality Policy Statement
  • Published statement by the Top Management
  • Commitment to the Standard requirements
  • Appropriate to the purpose of the company
  • Commitment to continuous improvement
  • Establishing and reviewing quality objectives
  • Communicated and understood
  • Reviewed for continuing suitability
  • Authorised and approved by Top Management
the standard requirements5
THE STANDARD REQUIREMENTS
  • 2.3 Quality Manual
  • Development and maintenance of a formal documented management system
  • The manual should be fully implemented and supported by documented evidence (internal systems auditing)
  • Procedures, and where applicable, referring to specification and methods
the standard requirements6
THE STANDARD REQUIREMENTS
  • 2.4 Organisational Structure, Responsibility and Management Authority
  • Authority and communication at appropriate levels
  • Responsibility of the management
  • Including clear responsibility of safety, legal, environmental and quality matters
  • Technical responsibility of product compliance to specification
  • Details of deputy personnel
the standard requirements7
THE STANDARD REQUIREMENTS
  • 2.5 Management Commitment
  • Top management commitment to the QMS
  • Importance of meeting customer, statutory and regulatory requirements
  • establishing the quality policy
  • Ensuring quality and business objectives are established
  • Conducting management reviews
  • Ensuring the availability of resources
the standard requirements8
THE STANDARD REQUIREMENTS
  • 2.6 Customer Focus
  • Top management shall ensure that the customer requirements (and expectations) are determined and are met with the aim of enhancing customer satisfaction
  • Customers may include:
  • The immediate retailer
  • The transporter
  • The wider community, and consumer
the standard requirements9
THE STANDARD REQUIREMENTS
  • 2.7 Management Review
  • Top management shall ensure that the QMS is reviewed at regular intervals, consistent with the management objectives.
  • Agenda (may include):
  • Internal audit
  • Customer complaints
  • Production issues
  • Supplier evaluation of performance
the standard requirements10
THE STANDARD REQUIREMENTS
  • 2.8 Resource Management
  • The company shall determine and provide the resources needed;
  • To implement and maintain the QMS and continually improve its effectiveness, and;
  • to enhance customer satisfaction by meeting customer requirements
  • To provide financial resources required for HACCP study and implementation
the standard requirements11
THE STANDARD REQUIREMENTS
  • 2.9 Internal Auditing
  • Programme of audits in consideration of risk
  • Senior management approval
  • Technical personnel
  • Documented results of audit
  • Review of audit results
  • Corrective and preventive actions
the standard requirements12
THE STANDARD REQUIREMENTS
  • 2.10 Purchasing
  • Purchasing information shall describe the product to be purchased, including requirements;
  • For approval of product, procedures, processing and equipment
  • For qualification of personnel, and
  • Quality management system
the standard requirements13
THE STANDARD REQUIREMENTS
  • 2.10.1 Supplier Performance Monitoring
  • The evaluation and selection of suppliers;
  • Formal evaluation and selection
  • Approved supplier list (product impact)
  • Product receipt inspection
  • Performance monitoring
the standard requirements14
THE STANDARD REQUIREMENTS
  • 2.10.1 Supplier Performance Monitoring
  • Supplier conformance with HACCP
  • Traceability of product supplied
  • Verification of supplier claims / approvals
  • Method and frequency of assessment in consideration of risk
  • Supplier audits (programme)
the standard requirements15
THE STANDARD REQUIREMENTS
  • 2.11 General Documentation Requirements
  • 2.11.1 Document Control
  • 2.11.2 Specifications
  • 2.11.3 Procedures
  • 2.11.4 Record Keeping
the standard requirements16
THE STANDARD REQUIREMENTS
  • 2.11.1 Document Control
  • Policy statement
  • Quality manual
  • Technical procedures and methods
  • Administration procedures
  • Supporting records and archives
  • Reference standards appropriate to the scope
the standard requirements17
THE STANDARD REQUIREMENTS
  • 2.11.2 Specifications
  • Product specification
  • Product name
  • Customer supplied specifications
  • Unique reference / issue number
  • Authorisation
  • Availability at point of use
the standard requirements18
THE STANDARD REQUIREMENTS
  • 2.11.2 Specifications
  • The company shall ensure that appropriate specifications exist for:
  • Raw materials (including packaging)
  • Completed products (including packaging)
  • In-process / part completed (where applicable)
the standard requirements19
THE STANDARD REQUIREMENTS
  • 2.11.3 Procedures
  • Production and administration control
  • Procedure / process name
  • Customer supplied procedures (and methods)
  • Unique reference / issue number
  • Authorisation
  • Availability at point of use
the standard requirements20
THE STANDARD REQUIREMENTS
  • 2.11.3 Procedures
  • Production and administration control
  • Process and performance driven
  • Clear, unambiguous and legible
  • Issued to appropriate personnel
  • Readily accessible at all times
the standard requirements21
THE STANDARD REQUIREMENTS
  • 2.11.4 Record Keeping
  • Information and data generated from the QMS
  • Name of record(s)
  • Location of record(s) and traceability
  • Unique reference / issue number
  • Retention period (legal and/or contract obligation)
  • Disposal of archive records
the standard requirements22
THE STANDARD REQUIREMENTS
  • 2.11.4 Record Keeping
  • (continued summary)
  • In line with procedures
  • Records must be legible and genuine
  • Safe storage, traceable and retrievable
  • Contain appropriate information safety, testing, legality and product quality
  • Computer back-up (as applicable)
the standard requirements23
THE STANDARD REQUIREMENTS
  • 2.11 General Documentation Requirements

(continued summary)

  • Reference standards appropriate to the scope, may include;
  • Food Safety
  • Compositional standards
  • Metrology
  • Additives
  • Lot identification and traceability
  • Labelling and packaging information
the standard requirements24
THE STANDARD REQUIREMENTS
  • 2.11 Documentation Control (continued summary)
  • Approved for adequacy prior to issue
  • Documents shall be authorised
  • Identification and issue status controlled
  • Ensure access to documentation at all appropriate levels
  • Control of customer / supplier documents
  • Obsolete documentation removed from use
  • Completed documents and records controlled
the standard requirements25
THE STANDARD REQUIREMENTS
  • 2.12 Corrective Action
  • Investigation of cause
  • Assessment of risk
  • Corrective actions completed in a timely manner
  • Implementation of corrective actions
  • Review of corrective actions
  • Verification of actions
  • Impact - Refer to HACCP
the standard requirements26
THE STANDARD REQUIREMENTS
  • 2.13 Traceability
  • Raw materials
  • Work in progress
  • Finished goods
  • Product identifiable at all stages of production
the standard requirements27
THE STANDARD REQUIREMENTS
  • 2.13 Traceability (continued summary)
  • Raw materials supply
  • Component supply
  • Packaging supply
  • Product re-call at all stages of production
  • Appropriate reference documentation
  • Reworking operations control
the standard requirements28
THE STANDARD REQUIREMENTS
  • 2.14 Management Of Incidents and

Product Recall

  • Product re-call at all stages of production
  • Appropriate reference documentation
  • Testing of the system(s)
the standard requirements29
THE STANDARD REQUIREMENTS
  • 2.14 Management Of Incidents and

Product Recall

  • Documented incident reporting procedure
  • Customer notification
  • Documented recall procedure
  • Product re-call at all stages of production
  • Control of non conforming products
  • Corrective and preventive actions
  • Verification of recall systems
the standard requirements30
THE STANDARD REQUIREMENTS
  • 2.15 Complaint Handling
  • Documented system for complaints
  • Effective management review
  • Implementation of corrective and preventive actions
  • Complete records of action taken
  • Approval of actions
the standard requirements31
THE STANDARD REQUIREMENTS
  • 3. FACTORY ENVIRONMENT STANDARDS
  • 3.1 Location
  • Location away from “offensive” trades
  • Maintenance of buildings and infrastructures
  • Internal fabric to prevent contamination
  • Boundaries clearly defined
  • Security of site location
  • Authorised movement of personnel
the standard requirements32
THE STANDARD REQUIREMENTS
  • 3.2 Perimeter & Grounds
  • Proper drainage
  • Waste water
  • Contaminated water / effluent
  • Storage protected from contamination
  • Security of the site boundary
  • Regular monitoring (audited)
the standard requirements33
THE STANDARD REQUIREMENTS
  • 3.3 Layout / Product Flow
  • Process flow to prevent contamination
  • Operative working space
  • Cross contamination (biological / chemical)
  • Laboratory facilities (where provided)
  • Environmental controls
  • Washing of equipment
the standard requirements34
THE STANDARD REQUIREMENTS
  • 3.4 Fabrication
  • 3.4.1Walls
  • Should be appropriate design
  • Finished surfaces
  • Removal of dirt, mould, bacteria
  • Consideration when cleaning of corners
the standard requirements35
THE STANDARD REQUIREMENTS
  • 3.4 Fabrication
  • 3.4.2 Floors
  • Water / drainage flow away from “high risk”
  • Clean and well maintained
  • Should be appropriate design
  • Finished surfaces
  • Removal of dirt, mould, bacteria
  • Consideration when cleaning of corners
the standard requirements36
THE STANDARD REQUIREMENTS
  • 3.4 Fabrication
  • 3.4.3 Ceilings / Overheads
  • Clean and well maintained
  • Should be appropriate design
  • Finished surfaces
  • Removal of dirt, mould, bacteria
  • Consideration when cleaning of corners
  • Falling items / dirt
the standard requirements37
THE STANDARD REQUIREMENTS
  • 3.4 Fabrication
  • 3.4.4 Windows
  • Clean and well maintained
  • Should be appropriate design
  • Prevention of ingress of pests
  • Glass should be protected from breakage
  • Use of glass should be avoided
the standard requirements38
THE STANDARD REQUIREMENTS
  • 3.4 Fabrication
  • 3.4.5 Doors
  • Clean and well maintained
  • Should be appropriate design
  • Prevention of ingress of pests
  • Use of glass should be avoided
  • Use of curtains
  • Secure
the standard requirements39
THE STANDARD REQUIREMENTS
  • 3.4 Fabrication
  • 3.4.6 Lighting
  • Should be adequate to carry out the function
  • Should be appropriate design
  • Glass (bulb, strip lights) should be protected
  • EFK tubes should be protected
  • Procedures for replacement of lighting
  • Glass management
the standard requirements40
THE STANDARD REQUIREMENTS
  • 3.4 Fabrication
  • 3.4.7 Air Conditioning / Ventilation
  • Should be appropriate design
  • Adequate ventilation
  • Dust and fume extraction
  • Use of filters
  • Air movement monitoring
the standard requirements41
THE STANDARD REQUIREMENTS
  • 3.4 Fabrication
  • 3.4.8 Services
  • Use of water, ice, and steam supply
  • Cleaning according to source
  • Monitored to prevent risk of contamination
the standard requirements42
THE STANDARD REQUIREMENTS
  • 3.5 Equipment
  • Positioned to give access
  • Ease of cleaning
  • Properly specified and commissioned
  • Planned maintenance programmes
  • Working use and set-up instructions
  • Operate to legal and safety requirements
the standard requirements43
THE STANDARD REQUIREMENTS
  • 3.6 Maintenance
  • Planned maintenance programme
  • Technically competent personnel
  • Outside Contractors
  • Manufacturers instruction (where applicable)
  • Breakdown procedures
the standard requirements44
THE STANDARD REQUIREMENTS
  • 3.7 Staff Facilities
  • Changing facilities
  • Work-wear appropriate to the task for staff and visitors
  • Suitable equipment
  • Hand-washing / shower facilities
  • Toilet, smoking and catering facilities
  • Personal lockers and food controls
the standard requirements45
THE STANDARD REQUIREMENTS
  • 3.8 Physical & Chemical Contamination Risk
  • Appropriate and secure storage areas
  • Handling procedures and personnel training
  • Elimination (where possible) of wood, glass, clear plastics in the raw material process areas
  • Glass and hard plastic register
the standard requirements46
THE STANDARD REQUIREMENTS
  • 3.9 Housekeeping & Hygiene
  • Cleaning schedules
  • Approved cleaning instruction / methods
  • Use of approved cleaning detergents
  • Cleaning practices to minimise the risk of cross contamination
  • Monitoring of effectiveness
the standard requirements47
THE STANDARD REQUIREMENTS
  • 3.10 Waste / Waste Disposal
  • Minimise accumulation of waste in production
  • Disposal must meet legal requirements
  • Use of licensed waste contractors
  • Use of appropriate containers (closed / covered)
  • Aware of waste packaging regulations (obligation towards recovery / recycling initiatives)
the standard requirements48
THE STANDARD REQUIREMENTS
  • 3.11 Pest Control
  • Use of approved contractors for pest control
  • Records and location of pest control baits
  • Correctly sited E.F.K’s
  • Use of screens on drains
  • Minimise waste materials on site
  • Raw materials inspected for pest infestation
  • Baits identified on plan
the standard requirements49
THE STANDARD REQUIREMENTS
  • 3.12 Transport
  • All vehicles must be fit for purpose
  • Good repair and hygienic
  • Part of a cleaning programme
  • Refrigeration controls must be to specification
  • In transit breakdown procedures (product controls: safety, legality and quality)
  • Maintenance programme
the standard requirements50
THE STANDARD REQUIREMENTS
  • 4. PRODUCT CONTROL
  • 4.1 Product Design / Development
  • New products shall under-go production trials
  • Processes reviewed to ensure legally safe
  • Product testing and verification of methods
  • Shelf life cycles to be confirmed / verified
  • Use of storage conditions detailed
  • Plot new processes (HACCP)
the standard requirements51
THE STANDARD REQUIREMENTS
  • 4.2 Product Packaging
  • Minimise risk of contamination from packaging
  • Confirm packaging conforms to specification
  • Food safety legislation
  • Use of metal staples / other items
  • Packaging stored separate from raw materials
the standard requirements52
THE STANDARD REQUIREMENTS
  • 4.3 Product Analysis
  • Confirm product conforms to specification
  • Test results reliable
  • Use of accredited test laboratory
  • Technically qualified personnel
  • Records of results and verification
the standard requirements53
THE STANDARD REQUIREMENTS
  • 4.4 Segregation
  • Prevention of cross-contamination
  • In-process controls:
  • raw meat
  • cooked meat
  • packaging
  • waste materials
the standard requirements54
THE STANDARD REQUIREMENTS
  • 4.5 Stock Rotation
  • Identification of product location
  • Unique stock / item number
  • Details of shelf life
  • Product labelling (supplier traceable)
  • Internal audit programme
the standard requirements55
THE STANDARD REQUIREMENTS
  • 4.6 Metal Detection / Foreign Body Detection
  • Form a part of the HACCP documentation
  • Appropriate to the nature of the product
  • Minimise the risk
  • Procedures for equipment use
  • Maintenance of equipment
  • Isolation and quarantine procedures
  • Form a part of the internal audit programme
the standard requirements56
THE STANDARD REQUIREMENTS
  • 4.7 Product Release
  • Final product inspections / tests
  • Records of all inspections
  • Authorised personnel only (procedures)
  • Use of despatch documentation
the standard requirements57
THE STANDARD REQUIREMENTS
  • 4.8 Control of Non-Conforming Product
  • The company shall deal with non-conformity using one or more of the following methods;
  • Reject, remove and destroy product
  • Authorising product use by concession
  • Taking action to preclude product original use
  • Product correction, verified to specification
the standard requirements58
THE STANDARD REQUIREMENTS
  • 4.8 Control of Non-Conforming Product

(continued summary)

  • Identification of product
  • Segregation of product
  • Total rejection controls
  • Re-working and concessions
  • Product disposal (confirmation)
  • Records for all actions
the standard requirements59
THE STANDARD REQUIREMENTS
  • 4.8 Control of Non-Conforming Product

(continued summary)

  • Final product inspections / tests
  • Records of all inspections
  • Authorised personnel only (procedures)
  • Use of despatch documentation
the standard requirements60
THE STANDARD REQUIREMENTS
  • 5. PROCESS CONTROL
  • 5.1 Temperature / Time Control
  • Where applicable:
  • Control of raw materials
  • Control of work-in-progress
  • Environmental controls
  • Use of alarms in case of temperature failure
  • Procedures for all areas
the standard requirements61
THE STANDARD REQUIREMENTS
  • 5.2 Quantity Control
  • EU (UK) legal requirements
  • Quantity (average / minimum)
  • Measurement / weight (calibration)
  • Importers shall control packaging in line with EU regulations
  • Inspection and testing records
the standard requirements62
THE STANDARD REQUIREMENTS
  • 5.3 Equipment & Process Validation
  • Validation of:
  • Process methods (HACCP)
  • Product formulation (Specification)
  • Use of equipment (calibration and maintenance)
  • Regular review (internal auditing)
  • Control of records
the standard requirements63
THE STANDARD REQUIREMENTS
  • 5.4 Calibration and Control of Measuring and Monitoring Devices
  • Traceable calibration of all test and measurement equipment, including;
  • Scales and weigh bridges
  • Temperature
  • Control of equipment calibration / test records
the standard requirements64
THE STANDARD REQUIREMENTS
  • 5.5 Specific Handling Requirements
  • Prevent cross-contamination (all areas)
  • Example:
  • Meat / vegetarian products
  • Peanuts – anaphylactic shock
  • Use of handling methods / procedures
  • Use of customer specified procedures, as required under contract
the standard requirements65
THE STANDARD REQUIREMENTS
  • 6. PERSONNEL
  • 6.1 Personal Hygiene controls
  • Raw material handling
  • Processing
  • Packing
  • Storage areas
the standard requirements66
THE STANDARD REQUIREMENTS
  • 6.1 Personal Hygiene controls
  • Finger nails
  • Jewellery
  • Exposed skin / cuts
  • Smoking / eating
  • Hand cleaning
  • Perfume / after-shave
the standard requirements67
THE STANDARD REQUIREMENTS
  • 6.2 Medical Screening
  • Induction training / contract
  • Reporting procedures for infections, etc.
  • Visitors / contractors, where appropriate shall be medically screened prior to visiting production process areas
the standard requirements68
THE STANDARD REQUIREMENTS
  • 6.3 Protective Clothing
  • Hair covered to prevent contamination
  • Appropriate footwear used
  • Appropriate clothing (spares)
  • Approved laundry services (contractors)
  • Available for visitors
the standard requirements69
THE STANDARD REQUIREMENTS

6.4 Training

  • Induction training supervision
  • Personnel training at all levels to include contractors and temporary staff
  • Review of training procedures
  • Use of equipment
  • Health and safety
  • Personnel (personal) records
  • Training records
protocol
PROTOCOL
  • Certification Bodies
  • Only Accredited Certification bodies to EN45011* with the appropriate scope, shall carry out evaluations against the BRC Standard, and issue certificates, or;
  • Until 31st May 2003, to include those Certification Bodies actively seeking accreditation to EN45011
  • * The BRC requirement was EN 45004
protocol1
PROTOCOL
  • Before the initial evaluation
  • The Supplier is required to review the BRC Standard
  • Make any necessary amendments or improvements to its operation and systems
  • Provide background information on the site concerned, by completion of a pre-evaluation questionnaire or pro-forma information sheet.
protocol2
PROTOCOL
  • The scope of the evaluation shall be defined between the Supplier and the Certification Body
  • The scope shall be identified in the evaluation report and any certificate of inspection.
  • The Supplier may contract the Certification Body to evaluate matters beyond the scope of the BRC Standard, but no relevant elements of the BRC Standard shall be omitted.
protocol3
PROTOCOL
  • Any additions to evaluation scope may or may not fall within the scope of the Certification Bodies accreditation
  • A supplier may be advised to check with either the Certification Body or UKAS before contracting such additional work
protocol4
PROTOCOL
  • Evaluation Procedures
  • Duration of evaluations will be dependant upon a number of factors but due regard must be given to;
  • size of the site
  • the types of processes to produce and store product
  • number of product lines
protocol5
PROTOCOL
  • Evaluation Procedures (continued)
  • the number of employees related to food

(food safety)

  • size of random sampling
  • the number of non conformance’s as recorded in previous evaluation
protocol6
PROTOCOL
  • At all evaluations there are four elements, which shall be carried out;
  • opening meeting
  • review of quality systems and procedures
  • site inspection
  • closing meeting
protocol7
PROTOCOL
  • Major
  • There is substantial failure to meet the requirements of a statement of intent and any mandatory clause of the Standard.
  • Depending upon the level of certification sought (Foundation or Higher), the mandatory clauses will differ.
  • The mandatory clauses for Foundation Level are all those listed in the Foundation Level column.
  • The mandatory clauses for Higher Level are as for Foundation Level, and in addition, all the clauses in the Higher Level column.
protocol8
PROTOCOL
  • Minor
  • This is where absolute compliance to the statement of intent and a mandatory clause has not been demonstrated, but on the basis of objective evidence the conformity of the product’s safety and legality is not in doubt
protocol9
PROTOCOL
  • Recommendation
  • There is a failure to meet a recommendation of good practice.
protocol10
PROTOCOL
  • The report contains the following sections:
  • evaluation details
  • evaluation summary- overview of performance
  • details of non-conformance and corrective action plan
  • detailed evaluation report