Title Page
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Conducted on
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Prepared by
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Location
GENERAL
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Floors must be suitably hard wearing to meet the demands of the process, and withstand cleaning materials and methods. They must be impervious and maintained in good repair. They should be free of excessive paint bubbles or loose tiles which can harbor microbiological contamination. They should be visibly clean and free from off-odors or excessive accumulation of biofilms and debris.
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Floor drains are visibly clean and free of off-odors or excessive accumulation of biofilms and debris (use flash light).
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Pest control traps must be properly labeled and placed inside the plant on both sides of all exterior doors. Pheromone traps and electric fly killers (EFK) must be used where applicable. There is no visible evidence of bird, rodent or insect infestation, such as feathers, hair, urine, droppings, insect wings, spider webs, etc.
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Walls and roofs must be constructed, finished and maintained to prevent the accumulation of dirt, minimize condensation and mold growth, and facilitate cleaning. Interior walls must be free of signs of non-repaired prior leaks, moisture ingress or excessive condensation. Interior walls must not have excessive holes, cracks, flaking paint or mold accumulation.
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Suitable and sufficient lighting must be provided for correct operation of processes, inspection of product and effective cleaning. All lights are either shatterproof or fitted with covers, lighting is adequate to provide a safe working environment.
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Production equipment (vessels, valves, pumps, pipes, etc.) exteriors are clean and free from visible build-up of dust, stains, mold and dirt in general.
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Production equipment (vessels, valves, heat exchangers, pumps, pipes, in-line instrumentation, sight-glasses, sample valves etc.) are in good repair and generally free of leaks and other structural or functional defects.
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Production equipment (vessels, valves, pumps, pipes, etc.) are cleaned (CIP) at the required minimum frequency with the proper flow (velocity), time, pressure, temperature and chemical concentration. Cleaning records/proof of cleaning must be maintained for minimum 18 months.
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Non-food contact cleaning equipment (chemicals, brushes, brooms, shovels, etc.) are properly stored in cabinets, shelves or hooks, labeled as non-food contact and kept away from food contact tools.
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Production tools (brushes, brooms, shovels, etc.) used for the cleaning of production vessels are stored in cabinets, shelves or hooks, labeled as food contact and kept away from non-food contact tools. Production tools are in good condition, replaced when defective.
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Glass or other brittle materials must be excluded or protected against breakage in areas where open products are handled or there is a risk of product contamination.
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All production fittings (elbows, reducers, gaskets, etc.) and bends should be cleaned prior to being placed in a sanitizing bath (fully submerged). The bath must be clean and chemically active. Extra Production fittings and/or sampling devices are stored in cabinets, shelves or hooks and properly labeled for 5S. Production fittings are in good condition and kept clean.
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Secondary containers are properly stored and labeled to meet Food Safety requirements. Secondary containers are kept clean and free of residue. All containers used for the measurement and dispensing of adjuncts and processing aids must be properly labeled or color-coded, and washed thoroughly after use before being stored in a clean dry place. Labeled containers must only be used (or contain materials) as indicated on their label.
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Production (Food Contact) Hoses (especially hose ends) are stored off of the floor, capped at both ends, in good conditions, and clean.
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Bulk materials and equipment are stored a minimum distance of 45 cm (18 inches) from walls. Bulk materials are stored off-the-floor, on clean pallets, racks or shelves to facilitate cleaning. Opened containers are closed and properly sealed when not in use.
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Adequate ventilation and extraction must be provided in product storage and processing environments to prevent condensation or excessive dust. Equipment used for air movement must be free of dust build up, oil leaks, have working hinged louvers, be properly screened and fully functioning. Environmental filters must be used as needed and replaced on a regular schedule.
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Where temporary repairs are made, these must be controlled to ensure the safety or legality of product is not jeopardized. These temporary measures must be permanently repaired as soon as practicable and within timescale of two weeks unless otherwise documented and justified.
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Wood should not be used in open product areas except where this is a process requirement (e.g. maturation of products in wood). Where the use of wood cannot be avoided, the condition of wood must be continually monitored to ensure it is in good condition and free from damage or splinters which could contaminate products
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The control of the use of sharp metal implements including knives, cutting blades on equipment, needles and wires is required. Snap-off blade knives must not be used.
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All materials and equipment are stored off-the-floor, on clean pallets, racks or shelves.
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Cleaners, lubricants, or any other potential contaminants/chemicals are stored away from product and open vessels. Any food grade chemicals/lubricants must be segregated from non-food grade chemicals/lubricants. Chemicals and food grade materials/ingredients cannot be stored in the same area/room where cross contamination is possible..
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Doors must be maintained in good condition. External doors must be close fitting or adequately proofed. External doors to open product areas must not be left open when not in immediate use except for emergencies. Where external doors to enclosed product areas are opened, suitable precautions must be taken to prevent pest ingress. Exterior doors and/or air curtains provide an adequate barrier against rodent, bird and insect entry (functional, sealed, in good repair).
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Measurement equipment is properly maintained, clean, calibrated as needed and in working order. Records of calibration are maintained - 3 yrs. minimum.
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All water used within the plant that may contact product or product contact surfaces must be potable.
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Control rooms, work stations, offices, maintenance areas and satellite labs must adhere to 5S, personal items properly stored, be free of food/drinks (unless a risk assessment is performed and hand washing is available). Social distance rules and surface disinfection routines are in place
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The plant has a designated area for the segregation/isolation of non-conforming material/products per the ABI Blocking Policy.
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No repair spare parts are found in the area, e.g.: screws, packing rings, welding rods, etc.
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No excess lubrication is observed for any equipment.
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CIP stations, all dosing points must be clearly labeled with the name of the chemical that must be dosed there. Correct chemical to be connected.
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Containers with chemicals must be labeled clearly by supplier, including the safety icons. The storage place for the container must also be labeled to make sure to separate acid from alkali & oxidizing agents. Oxidizing agents must be stored on plastic pallets, no wood! All chemicals must be stored on secondary containments to avoid contamination or mixture of chemicals in the sewer system or damage to the floor & sewers. Safety instructions, MSDS & compatibility matrix to be published & respected in storage area.
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All incoming material lots are inspected to verify certificate of analysis, free of moisture damage, off-odors and/or pest infestation, and physical damage. FIFO followed for all materials. Expiration dates, if applicable must be visible on the label.
GENERAL PACKAGING
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Conveyors from bottle washer (returnable bottles) / bottler rinser (non-returnable bottles) to filler/crowner are covered to reduce the risk of drop-in contamination and visibly clean. Conveyer covers should be fitted close enough to the package to ensure effectiveness. Reduce the risk of metal contamination by using “locking nuts” to hold the conveyor covers in place.
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Underside of conveyor belts/chains are generally clean, with minimal biofilms or mold development.
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No empty or full containers from previous production runs (different bottle type of brand) can be found along the entire line
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All lubricants used on the conveying lines and seamer must be approved for use in the food industry.
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All overhead motors and hydraulic lines that are positioned directly above line conveyors or equipment are fitted with a protective shield to prevent oil drop-in contamination.
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Lubrication nozzles are turned off when conveyor is not in use to keep packaging areas as dry as possible. Dry-lube is used wherever possible.
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Catwalks, pipes, roof beams, lamps and other overhead devices are generally clean and free of dust and debris accumulation.
Depaletizer
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The depaletizer / decrater area is generally clean, free of excessive dust / debris and broken glass accumulation.
Bottle washer
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Bottle washer critical operation parameters (caustic concentration, temperature, label screen integrity, etc.) are monitored at a pre-established frequency and records of these checks are properly maintained.
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There is no evidence of condensation or liquid dripping off of the washer onto or into clean bottles.
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Washed bottles exiting the bottle washer have a clean appearance, free of any traces of residual caustic or label material.
Bottle rinser
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Bottle rinser critical operation parameters are monitored at a pre-established frequency and records of these checks are properly maintained.
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Bottle rinser nozzles are well-aligned and free of any visible biofilms or mold development (inspect closely).
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EBIs
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Empty Bottle Inspectors (EBIs) are kept very clean and in excellent working order to maximize their reliability. Rejected bottles are segregated effectively to avoid excessive recirculation that might cause their eventual acceptance.
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EBI Cameras are kept clean and dry.
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EBI test bottles are clean, well-labeled and kept in a clean and dry location.
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EBIs are validated at the defined frequency by qualified personnel and any deviations in EBI performance are documented and corrected according to policy.
Filler/Crowner
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Bottle transfer starwheel and conveyor line between the filler and the crowner is shielded to prevent broken glass drop-in contamination from bottle explosions
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Filler and crowner area are generally clean, free of excessive broken glass debris. Filler room walls and ceiling, if any, are free of visible biofilm or mold growth.
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Autoflush nozzles and manifold are clean, with no plugged or misaligned nozzles and free of visible biofilm or mold growth.
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Crowner hopper and transport covered and free of dust or debris.
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Bottle breakage rates are monitored and reaction plans exist to address increases beyond and established maximum level.
Label machine
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Labeler area is generally clean, free of excessive labels on the floor, broken glass debris, glue spills, etc. Tools and cleaning equipment are stored in a designated area which is kept clean and organized.
Packing machine/crater
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Packaging machine / crater area is generally clean, free of excessive dust and debris. Tools and cleaning equipment are stored in a designated area which is kept clean and well organized.
Palletizer
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Palletizer area is generally clean, free of excessive dust and debris. Tools and cleaning equipment are stored in a designated area which is kept clean and well organized.
Employee GMP's
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Employee restroom facilities are clean and fully functional with hand washing signs displayed in all restrooms. Toilets must not open directly into production areas.
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Storage facilities of sufficient size to accommodate personal items must be provided for all personnel who work in raw material handling, preparation, processing, packing and storage areas.
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Hand washing stations (basins), located by personnel access points and in the proximity of processing areas, are maintained, clean, and fully operational. Fully operational is defined as: (1) Potable water supply, preferably warm in cold climates where very cold water may act as a deterrent to employees washing their hands thoroughly. (2) Effective hand-cleaning and sanitizing preparations. (3) Sanitary towel service or suitable drying devices. (4) Readily understandable signs directing employees to wash hands. Risk Assessments should be considered where basins are not immediately located at an access point into a production area.
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Employee locker rooms are clean and well lit. Brewery-issued work clothing/uniforms/PPE must be stored separately from personal clothing.
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"Employees understand and adhere to the plant Personal Protective Equipment (PPE) policies. PPE used by operators is generally clean and in good condition.
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All cuts and grazes on exposed skin must be covered by an appropriately colored plaster that is different from the product color (preferably blue). These must be company issued and monitored. Where appropriate, in addition to the plaster, a glove must be worn
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Employees clothing and personal hygiene (personal health, clean clothing, hand washing, trimmed fingernails, hair covering/restraint, no excessive perfume or aftershave etc.) reflect their professionalism and understanding of GMPs. The jewelry policy is followed.
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Food or drinks, including chewing gum and candy, are never introduced to or consumed in production areas, including control rooms (check trash containers for candy-wrappers, drink cups, etc.). Only water or single consumption electrolyte drinks in clear, covered, labeled, plastic containers are permitted in production areas. Control rooms have been allowed food & drink if hand cleaning station in place with signage.
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Smoking only takes place in designated areas. No cigarette butts or any other evidence of smoking in non-designated areas can be observed. Employees must be directed with signage to wash their hands after smoking. Adequate arrangements for dealing with smokers’ waste must be provided at smoking facilities. No cigarette butts or any other evidence of smoking in non-designated areas can be observed
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Areas assigned to contractors are clearly marked, safe and in good condition (if NOK, issues are also escalated to the project manager). This includes social distancing rules and hand washing stations.
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Containers are not reused for any purpose than their original intended purpose. A risk assessment must be completed to justify a business case to safely reuse containers.
