Presented by Steven P. Feltman Food Safety and Quality Specialist

QUASI Inspection Program Approved by NEBWA Board of Directors Third Party Inspection FDA Guidelines GMPs Prerequisite Programs HACCP

Section 1-Source Management Process flow diagram of source Permits up to date Current analysis including microbiological Source protected from environmental risk Hydro geological report Documentation and records Security

Section 2-Water Extraction Well heads and housing Permits Design specifications and documentation Borehole protection Environmental contamination Surface water intrusion Security

Section 3-Source to Plant Documented system Tanker filling/off-loading Food grade piping Sanitary procedures Hygienic practices Cross contamination Maintenance Records

Section 4-Water Storage Included in plot and process flow diagrams Food grade material Sanitary condition Sanitation records Vented and protected Hygienic practices

Section 5-Treatment Systems Distillation, RO, filters, ozone, MI Documented on flow diagram Manuals easily available Sanitary & good working condition Sanitary gauges, glasses, meters & probes Calibration Food grade piping, storage & backflow Monitoring & records

Section 6- Product Water Management Storage tank ozone resistant and food grade Dedicated line to filler, cross contamination, backflow prevention Tank, lines and filler sanitized prior to start Ozone resistant seals, gaskets, valves, tanks Ozonated final bottle rinse prior to filling

Section 6-continued Product Water Management Filler/capper in clean room with HEPA filter and positive air Fill room construction: walls, lighting, drains and self closing doors Conveyors or airveyors protected from airborne contaminants Fill volume check and taste test prior to start

Section 7-Packaging Empty bottle storage, handling, conveyance Cap storage, handling, application Label storage, application, integrity Case storage, specifications Conveyor lubricant, cover, product integrity Quarterly closure and bottle rinse tests Bottle washer detergent and operation Full bottle inspection, handling, storage

Section 7-Packaging continued Water coolers sanitized with approved chemicals before dispatched Water 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 Documentation Procedures documented and approved for laboratory operation Document and record retention program Review of procedures at regular intervals Logbooks, worksheets, calibration records traceable SOPs reviewed regularly and personnel notified of changes and trained accordingly

Sections 9-18: Lab Equipment These 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 Facilities This section looks at size, design, construction and environment of the laboratory facilities.

Section 20-Quality Control Systems Internal system to monitor routine work and ensure reliability of test results System to evaluate personnel performance Safety program implemented, documented and employees trained Effective consumer complaint program Returned or suspect product hold area Trace and recall program Supplier incoming materials program

Section 21-Quality Control Procedures, Logs and Methods This 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-HACCP Hazard 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 Layout This 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 Compliance This section deals with requirements for federal, state, local and possibly, trade association compliance. Source approval Source and product analysis requirements GMPs Labeling/standards of identity/nutritional Record keeping

Section 24-Regulatory Compliance FDA Food Facility Registration

Section 25-Personnel Hygiene This 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 Code This section is only applicable if a company is subject to requirements of additional institutions or trade associations.

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