Presented by Steven P. Feltman Food Safety and Quality Specialist
Dec 29, 2015
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?
THANK YOU!