intro to cgmps: the building blocks for gfsi compliance
TRANSCRIPT
Intro to cGMPs:The Building Blocks for
GFSI ComplianceSonia AkbarzadehFounder & Partner
Food Industry Consulting, Inc.
Rajan GuptaVP Customer SuccessTraceGains
Sonia AkbarzadehFounder & PartnerFood Industry Consulting, Inc.
Introduction to cGMPs
Presented by: Sonia Akbarzadeh Msc, Eng.
Food Safety Consultant
Introduction to GMPsGMPsRoot of any food safety systemContinuous evolving GFSIFSSC 22000, BRC, IFS, SQF, Global Gap FDA food safety modernization Act (FSMA)
Introduction to GMPsInternationally recognized standards:
GMPs in detailMandatory requirements:
Risk assessmentsValidation
Introduction to GMPsSchemes vary in: Scope Structure Standards Certification process PopularitySchemes have in commonComprehensive GMPs & HACCP
Introduction to GMPsGMPs Foundation of HACCP Detailed programs & procedures Control hazards introduced by:
personnel, environment & operations Regulatory requirements countries
products are made & sold in
Introduction to GMPs4 Stages for Successful GMP Programs:
1. Development - write down what you doRisk assessment
2. Implementation - employee training; providerecourses/tools/equipment
3. Validation - Initial, annually, for changes4. Verification - ensure effectiveness
Introduction to GMPsPersonnel hazards: Sneezing Illnesses Cuts Infections Dirty hands Dirty clothes Jewelry and loose objects
Introduction to GMPsEnvironmental hazards Leaking roof Dirty or corroded equipment Non-potable water Pests Poor ventilation Damaged packaging Ingredients received in poor condition
Introduction to GMPs
Documentation & RecordkeepingControlled documents Document register to include:
oDocument numbersoLatest versionoIssued dateoApproveroLocation (folder & plant)
Introduction to GMPsDocumentation & Recordkeeping
Managing document changeReason for changeApproval of the new version Old folderReplacing the plant documents
Introduction to GMPsDocumentation & Recordkeeping
Detailed procedures Verifying recordsRecordkeepingApplicable standardsCustomer requirements Shelf life plus additional one year
Introduction to GMPsPersonnel Practices Each employeeVisitorContractorTraining Frequency:Once they are hiredAnnually as refresherWhen guidelines are changed
Introduction to GMPsPersonnel Practices VerificationObservations Inspections on a regular basisVarious shiftsMonthly GMP Internal audit
Introduction to GMPsPersonnel Practices
Traffic patterns (Employees & Visitors)Site map Hand washing policyUniform policy
Introduction to GMPsSanitationoComprehensive systemoEffectively remove
Food residues Soil Unacceptable chemical residues
Introduction to GMPsSanitation Effective cleaning & sanitizingRoomsUtensils EquipmentAvoid cross contaminating
Introduction to GMPsMaster Sanitation Schedule
To include all the items such as:Overhead & ceilingsWallsVarious equipment AreasRacksLaddersCatwalks & stairsLift trucks
Introduction to GMPsSanitation program Validation frequency:At the design stageAnnually When any elements changed
Verification:Prior to production
Introduction to GMPsWater PotabilityAdequateFrom known clean sourceUsed as:Processing aid CleaningIngredientIce
Introduction to GMPsWater PotabilityWater testing frequency:Minimum annuallyWhen changes in:
SourceDelivery system
Introduction to GMPsWater PotabilityTesting for:
Heavy metals Bacteria pH Turbidity
Introduction to GMPsWater map to indicate: Water distribution flows Water holding tank Water treatment location Water recycle if applicable Water sampling points
oTreatment validationoColor coding non-potable water pipes
Introduction to GMPsPest Control Program
Methods used to control pestsAssigning responsibilityList of pesticides & chemicals-Target pest for each pesticide application Pest elimination method Frequency of inspection. Pest control site map
Introduction to GMPsPest Control Verification:
Service report for completeness & complianceObserving the pest Control Operator Monthly GMP auditsDaily inspection Pest control company quality assurance
Introduction to GMPsPest Control Validation
By reviewing:Annual trend report Customer complaintsIncidentsMonthly GMPAudits
Introduction to GMPsFacility and building design
ConstructionLocationPlant surroundings Prevent contamination
Introduction to GMPsFacility & building design
Approved materials by the local regulationRegular inspection Elimination of possible contaminations Flow of waste water (Darin map)Inspection of the exterior
Introduction to GMPsEquipment and Preventive maintenance
Reduce frequency of regular maintenanceReduce emergency repairsProlonging equipment lifespan Reduce downtimesSave timeSave money
Introduction to GMPsEquipment and Preventive maintenanceAnnual Master PM schedulePreventive maintenance SOPMaintenance checklistWork ordersPost maintenance sanitation procedureDocumenting & investigating equipment failuresControl of temporary repairVerification
Introduction to GMPsNew equipment
Meets the desired functionIs easy to clean & maintainCan be positioned for ease of cleaning &
operationIts type & design suitable for food production
Introduction to GMPsReceiving/Storage/Shipping
Storing:Sanitary conditionProper environmental conditions
(Temperature & humidity) Designated areas
Site map
Introduction to GMPsReceiving/Storage/Shipping Conditions vary depending on : Type Nature Temperature
Such as,• Bulk• Bagged• Refrigerated• Frozen• Packaging materials
Introduction to GMPs
Receiving/Storage/Shipping Approving contract transport
o Freight questionnaire o Audit
Truck designated for only foodNot for metals, chemicals or glass
transportation
Introduction to GMPsReceiving/Storage/Shipping Truck inspection prior to downloading & loadingProduct condition inspectionChecklistsList of approved suppliersCriteria for rejecting incoming materialsTrailer breakdown procedureMonitoring temperature if applicableProduct & ingredient identification & color
codeValidation of transportation temperature
Introduction to GMPsAllergen Control Identification Management Communication Comply with regulation where products made &
sold Such as:Maximum residue limits, food safety, trade weight, packaging, product description, nutrition, additives, allergen labeling, relevant industry codes of practice
Introduction to GMPsEffective allergen program include:Prevention method Identifying ingredients & products Identifying area and equipment Dedicated storage areaDedicated utensils & color codeChange over cleaning procedure Cleaning verification method Logic production scheduleReviewing labels
Introduction to GMPsRecall Lot coding raw materials & products Minimizing risk to consumers’ health Fast & efficient procedures Regain control of unsafe products Mock recall
Introduction to GMPsEffective recall program Recall team Recall coordinator Recall contact list to include:
o Team 24/7o Regulatory authoritieso Standard ownero Certification body o Customers, distributers, supplierso Laboratory, consultants & legal
representative
Introduction to GMPsEffective recall program Recall forms Mock recallReport to include: Team member name Duties Time spent to finish task Areas of opportunities Action plan
Introduction to GMPsTrainingGMPs Specific training Training register:Participant nameSkills description Description of the training providedDate of training completionTrainer or training providerSupervisor’s verification
Introduction to GMPsTraining sign log to include:Subject of the trainingsMaterial usedParticipant names SignaturesDateTrainer name Duration of the training
Automating Supplier
and Quality Management
TraceGains Products
Specification Publishing
Create, maintain, and publish your company’s unique specifications to ensure compliance on incoming ingredients.
Supplier Compliance
Automate lot-by-lot compliance across purchasing, COAs,
receiving, testing, and plant floor.
Finished Goods COAs
Generate finished goods COAs, manage
customer-specific formats, and send to
customers on demand.
Supplier Management
Automatically manage supplier qualification,
documents, and relationships.
Quality Management
Automate HACCP / HARPC and comply with GFSI, FSMA, safety, and quality.
Supplier Analysis& Scorecarding
TraceGains Supplier Management
To-do Lists,Corrective Actions
Access Anywhere,Anytime
Allergens OrganicAudits KosherNutritionSupplier Qualification
FSMA, GFSI, 365 Audit Ready™
C.O.O.L. Specifications
24/7 Monitoring
eNotifications
Labeling(e.g., Genesis)
TraceGains Quality Management
To-do Lists, Alerts,Corrective Actions
Trends & Graphs
Access Anywhere,Anytime
CCPsPre-op Sanitize, Calibrate, etc.
Verify CCPs Automate FSMA, GFSI Audits & Records
GFSI Documents
FSMA, GFSI, 365 Audit Ready™
Pre-ShipmentCheckoff
Staff Training
Automation Solves Many Problems
GFSI
Labeling
FSMA
Audits
