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Food Manufacturing GMP Audit Checklist

Food manufacturing requires efficient processes and workers to be trained on proper sanitary procedures when handling raw products or when processing and packing food items. This digital GMP Food Manufacturing Audit was based on 21 CFR Part 110 and can be used as a guide when conducting food manufacturing audits. Perform your food manufacturing audits with this template on the Lumiform mobile app. Securely save your completed reports in the cloud and track overall audit score performance.
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Food Manufacturing GMP Audit Checklist

Current Good Manufacturing Practice

Current Good Manufacturing Practice

Has the food been manufactured under such conditions that it is fit for food?

Facility and Grounds

Facility and Grounds

Are the grounds about your plant under your control kept in a condition that will protect against the contamination of food?

Are areas within the vicinity of the plant kept free from litter and waste with grass and weeds trimmed?

Are roads, yards and parking lots maintained to prevent sources of contamination?

Is there adequate drainage of outside areas that may contribute to contamination?

Are systems for waste treatment and disposal operated in a manner to protect against contamination?

Are steps taken to prevent sources of food contamination from bordering grounds not under the control of the facility?

Is there adequate lighting in all dressing and locker rooms and toilet areas?

Is there adequate lighting in all areas where food is processed, packed, or stored and where utensils and equipment are cleaned?

Are there safety-type light bulbs, fixtures, skylights, or other glass suspended over areas where food is exposed provided to protect against food contamination in case of glass breakage?

Are the plant buildings and structures of suitable size, construction, and design to maintain sanitary operations and to produce safe food?

Does the plant building(s) provide sufficient space for placement of equipment and storage of materials to permit maintenance of sanitary operations and production of safe food?

Does the design of the plant permit the separation of operations in which contamination is likely to occur which may include a separation of operations by location, time, space, partition, air flow, or other effective means?

Are there proper precautions to protect food in outdoor bulk fermentation vessels?

Are floors, walls and ceilings constructed to facilitate adequate cleaning?

Does drip or condensate from fixtures, ducts and pipes cause or potentially cause contamination of food, food contact surfaces or food packaging materials?

Are aisles and working spaces unobstructed and of adequate width to permit employees to perform their jobs and protect against contamination?

Are buildings, physical facilities, fixtures, etc. maintained in a good state of repair?

Is plumbing of adequate size and design to: carry sufficient quantities of water to required locations; properly convey sewage and liquid disposable waste from the plant; provide adequate floor drainage; and prevent backflow or cross connections between piping systems carrying fresh and waste water or sewage?

Is sewage disposal made into an adequate sewage system or disposed of by other adequate means?

Are rubbish and offal conveyed, stored, and disposed of in a proper manner?

Is the facility's water supply sufficient for the intended operations and from an adequate source?

Is water used in processing food or cleaning equipment safe and of adequate sanitary quality? Is running water at suitable temperature and under pressure?

Is reused water maintained to prevent the increase of contamination of food?

Are there adequate, reasonably accessible toilet facilities?

Are toilet facilities maintained in a sanitary condition and in good repair?

Do toilet facilities have self closing doors?

Are doors to the toilet facilities designed not to open into areas where food is exposed to airborne contamination or have double doors or positive airflow systems?

Are hand-washing facilities adequate, convenient, and furnished with running water at a suitable temperature?

Are hand-washing facilities furnished with adequate hand cleaning and sanitizing preparations?

Are hand-washing stations equipped with sanitary towel service or suitable drying service?

Are devices and fixtures in toilet facilities designed to protect against recontamination of clean, sanitized hands?

Are there readily understandable signs directing employees to wash and, where appropriate, sanitize their hands?

Are refuse receptacles constructed and maintained to protect against contamination of food?

Is there adequate screening or other protection against pests?

Are pests excluded from all areas of the food plant?

Are effective measures taken to exclude pests from processing areas?

Are there restrictions and precautions to insure that the use of insecticides and pesticides will not contaminate food, food product surfaces and food packaging material?

Personnel

Personnel

Employees are instructed to inform management about health conditions that might contaminate food, food product surfaces or food packaging materials.

Are employees encouraged to protect against contamination of food by correctly wearing & suitable outer garments, hair nets, beard coverings, etc.?

Management takes all reasonable actions and precautions to assure disease control through a medical test, observation, exclusion, and reporting.

Are employees encouraged to sustain sufficient personal cleanliness?

Are employees instructed to wash hands thoroughly before work and after each absence from their work place?

Are gloves used for food handling made of an impermeable material and kept in a clean and neat hygienic condition?

Does management take all reasonable actions and precautions to assure cleanliness through sanitary practices?

Is the duty for ensuring compliance by all employees with the requirements & of the GMP regulation clearly assigned to competent supervisory employees?

Do food handlers and supervisors have proper training in food handling techniques and food protection principles?

Are employees instructed to displace unsecured jewellery and other things that could fall into food?

Is eating, drinking, gum chewing, and use of tobacco forbidden in areas where food is exposed or equipment and utensils are not washed?

Are employees instructed to store clothing or other personal belongings away from places where food is exposed or where equipment or utensils are washed?

Do employees who are responsible for identifying plant sanitation failures or food contamination have a combination of education and experience to produce clean, safe food?

Are employees instructed to protect food, food-contact surfaces, or food packaging materials from contamination, from microorganisms or other foreign substances?

Equipment

Equipment

Has equipment been installed in a way that facilitates cleaning of equipment and adjacent spaces?

Are food contact surfaces made of corrosion-resistant and non-toxic substances?

Are all factory equipment and utensils designed to be appropriately cleanable and properly secured?

Are all equipment and utensils properly sustained?

Are holding, conveying and producing systems designed in a way to be sustained in a hygienic condition?

Are seams on food contact surfaces smoothly bonded or otherwise persevered to minimize growth of microorganisms or accumulation of dirt, food particles, etc.?

Is special equipment taken for accurate cleaning as necessary?

Is equipment created and constructed to preclude adulteration of food with: lubricants, fuel, metal fragments, and contaminated water?

Are non-food-contact surfaces cleaned as regularly as necessary to preserve the contamination of food?

Are freezers and cold storage sections fitted with appropriate temperature measuring and/or recording devices to explicitly show the temperature of the compartment?

Are instruments and controls for measuring, regulating, or recording temperature, pH, water activity, acidity, etc. accurate?

Are the non-food contact surfaces of equipment in the food handling constructed in a way so that it can be kept in a clean and hygienic condition?

Are compressed air or other gases mechanically launched into food or used to clean food contact surfaces or equipment treated to ensure that food is not contaminated with unlawful food additives?

Are freezers and cold storage compartments provided with automatic controls for regulating temperature or, in the case of hand-operated procedures, with an automatic alarm system to indicate a significant temperature change?

Are cleaning and sanitizing of tools and equipment made in a manner to prevent contamination?

Are cleaning compounds and sanitizing agents free from microorganisms and harmless for usage?

Are toxic cleaning compounds, sanitizing tools, and pesticide chemicals used, identified, held, and stored in a manner to protect against contamination of food, food contact surfaces, and food packaging materials?

Are food contact surfaces including utensils and equipment surfaces cleaned regularly to prevent food contamination?

Are cleaned and sanitized portable equipment with food contact surfaces and utensils deposited in a manner that prevents contamination?

In wet processing, are food contact surfaces cleaned and sanitized before usage and after any break during which contamination could occur?

Are single-service items (paper cups, towels, etc.) deposited, handled, and dispensed in an appropriate manner?

Are sanitizing agents secure and sufficient under conditions of use?

Is there appropriate ventilation or control equipment to minimize odours and vapours?

Are ventilators and other air-blowing devices located in a manner to prevent contamination of food, food contact surfaces and food packaging materials?

Are food contact surfaces used for producing or holding low-moisture food dry and in a hygienic and neat condition at the time of usage?

Processes and Controls

Processes and Controls

Is there an adequate quality control operation employed to guarantee that food is suitable for consumption and that food packaging material is safe and suitable?

Is suitable chemical, microbial, or extraneous material testing conducted to distribute sanitation failures or possible food contamination?

Do raw materials or other ingredients contain levels of microorganisms that may provide food poisoning or other diseases?

Are operations handled in accordance with adequate sanitation principles?

Are ingredients that contain microorganisms that may cause disease pasteurized or otherwise handled?

Are all reasonable precautions taken to assure that production procedures protect from contamination from any source?

Are raw materials inspected, segregated or otherwise handled as required to ascertain that they are clean and ready for use?

Is all adulterated food (within the meaning of the FD&C Act) either expelled or treated/processed to eliminate contamination?

Are raw materials and other ingredients held in bulk or in containers made to prevent contamination?

Are frozen raw materials and other ingredients kept frozen?

Do raw materials and other ingredients comply with FDA regulations, guidelines, & and action levels for poisonous or deleterious substances?

Are raw materials held at temperature and humidity levels that prevent food from being adulterated?

Are containers inspected to guarantee they do not contribute to contamination?

Is there careful monitoring of physical factors such as temperature, humidity, pH, pressure, and is there careful monitoring of manufacturing operations such as freezing, dehydration, heat processing,etc.?

Are raw materials registered for rework identified as such?

Are foods, that can support the rapid growth of microorganisms, held in a manner to prevent adulteration?

Are refrigerated foods kept at 45°F (7.2°C) or below if necessary?

Are hot foods sustained at 140°F (60°C) or above?

Are acid or acidified foods held in hermetically sealed boxes/containers at ambient temperatures heat treated?

Is work in progress handled in a manner that prevents contamination?

Are effective measures taken to protect finished food from contamination by raw materials or other ingredients?

Are fluid or dry materials and other ingredients collected and stored in bulk held in a manner to protect against contamination?

Are traps, sieves, metal detectors, magnets, etc. used to identify the inclusion of metal or other extraneous material?

Are equipment, boxes, and utensils used to treat food constructed, handled, and maintained in a manner that prevents food contamination?

Are measures like sterilizing, irradiating, pasteurizing, freezing, refrigerating, control of pH or water activity sufficient to prevent the growth of undesirable microorganisms?

Are food, raw materials and other contaminated ingredients disposed of in a manner to protect other food from contamination?

When reconditioning of contaminated food is done, is a proven effective method used?

Are mechanical manufacturing steps performed in a way that protects food from contamination?

Is heat blanching, if necessary, performed in an effective manner and washed, if necessary, with water of secure and sufficient sanitary quality?

Are batters, breading, and other similar preparations used or maintained in a manner that protects against contamination?

Is reconditioned food inspected and found free of contamination before being incorporated with other food?

Are filling, assembling, and packaging operations protected against contamination by use of safe and suitable material for food containers and packaging materials?

Are foods that rely on the control of water activity preventing the growth of rejected microorganisms processed and maintained at a safe moisture level?

Are human food production areas or equipment not used for manufacturing nonhuman food-grade animal feed or inedible products unless contamination of the human food is not reasonably possible?

Are foods that rely principally on the control of pH for preventing the growth of undesirable microorganisms controlled and kept at pH 4.6 or below?

Has ice in contact with food been made from water that is of adequate sanitary quality and manufactured in accordance with GMPs?

Have good manufacturing practices been followed in manufacturing the food?

Are critical control points recognised and controlled for filling, assembling, and packaging processes?

Has food containing defects above the current defect action level been mixed with another lot of food?

Is the storage and shipping of finished food under conditions that protect against physical, chemical, or microbial contamination?

Is food containing defects beyond current defect action levels mixed with other lots of food?

Completion

Does the finished product contain natural or unavoidable defects at low, non­ hazardous levels?

Completion

Recommendation

Full Name and Signature of Inspector

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