Presented by Steven P. Feltman

Food Safety and Quality Specialist

QUASI Inspection ProgramApproved by NEBWA Board of

DirectorsThird Party InspectionFDA Guidelines GMPsPrerequisite ProgramsHACCP

Section 1-Source ManagementProcess flow diagram of sourcePermits up to dateCurrent analysis including

microbiologicalSource protected from environmental

riskHydro geological reportDocumentation and recordsSecurity

Section 2-Water ExtractionWell heads and housingPermitsDesign specifications and

documentationBorehole protectionEnvironmental contaminationSurface water intrusionSecurity

Section 3-Source to PlantDocumented systemTanker filling/off-loadingFood grade pipingSanitary proceduresHygienic practicesCross contaminationMaintenanceRecords

Section 4-Water StorageIncluded in plot and process flow

diagramsFood grade materialSanitary conditionSanitation recordsVented and protectedHygienic practices

Section 5-Treatment SystemsDistillation, RO, filters, ozone, MIDocumented on flow diagramManuals easily availableSanitary & good working conditionSanitary gauges, glasses, meters &

probesCalibrationFood grade piping, storage & backflowMonitoring & records

Section 6-Product Water ManagementStorage tank ozone resistant and food

gradeDedicated line to filler, cross

contamination, backflow preventionTank, lines and filler sanitized prior to

startOzone resistant seals, gaskets, valves,

tanksOzonated final bottle rinse prior to

filling

Section 6-continuedProduct Water ManagementFiller/capper in clean room with

HEPA filter and positive airFill room construction: walls,

lighting, drains and self closing doorsConveyors or airveyors protected

from airborne contaminantsFill volume check and taste test prior

to start

Section 7-PackagingEmpty bottle storage, handling,

conveyanceCap storage, handling, applicationLabel storage, application, integrityCase storage, specificationsConveyor lubricant, cover, product

integrityQuarterly closure and bottle rinse testsBottle washer detergent and operationFull bottle inspection, handling, storage

Section 7-Packaging continuedWater coolers sanitized with approved

chemicals before dispatchedWater coolers are protected from

physical, chemical or biological contaminants until delivered

Cleaning and sanitizing program at customer

Cooler temperatures are operating at proper levels

Section 8-Laboratory DocumentationProcedures documented and approved for

laboratory operationDocument and record retention programReview of procedures at regular intervalsLogbooks, worksheets, calibration records

traceableSOPs reviewed regularly and personnel

notified of changes and trained accordingly

Sections 9-18: Lab EquipmentThese sections review incubators, sterilizing ovens, autoclaves, colony counters, pH meters, balances, pipettes, water baths, and refrigerators as to calibration, temperature control and operating conditions.

Section 19-Laboratory FacilitiesThis section looks at size, design, construction and environment of the laboratory facilities.

Section 20-Quality Control SystemsInternal system to monitor routine work

and ensure reliability of test resultsSystem to evaluate personnel

performanceSafety program implemented,

documented and employees trainedEffective consumer complaint programReturned or suspect product hold areaTrace and recall programSupplier incoming materials program

Section 21-Quality Control Procedures, Logs and MethodsThis section addresses if procedures are documented and whether samples are labeled, controlled and maintained In addition, how is testing information used and does it permit identifying trends to forecast potential issues.

Section 22-HACCPHazard Analysis Critical Control

Point (HACCP) is the basis for all food safety plans in every food industry, whether the industry is regulated by the FDA or USDA.

This section reviews the company HACCP plan and prerequisite programs required by FDA.

Section 23-Manufacturing Facility Construction and LayoutThis section deals with observing

the general condition of the manufacturing facility. Walls, ceilings, floors, ventilation systems, lighting, drainage etc. are looked at to identify conditions that are taken to prevent possible contamination.

Section 24-Regulatory ComplianceThis section deals with requirements for

federal, state, local and possibly, trade association compliance.

Source approvalSource and product analysis

requirementsGMPsLabeling/standards of

identity/nutritionalRecord keeping

Section 24-Regulatory Compliance

FDA Food Facility Registration

Section 25-Personnel HygieneThis section deals with observation

of people and how they conduct themselves and their responsibilities in the duty of producing a safe product.

Documented evidence of ongoing personnel training in GMPs, Food Hygiene and Safety.

Section 26-Model CodeThis section is only applicable if a company is subject to requirements of additional institutions or trade associations.

Questions?

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