GMP Food Manufacturing Audit Checklist

• Client / Site

• Location
  Address

• Conducted on

  Date

• Prepared by

Current Good Manufacturing Practice

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

  Yes

  No

  N/A

• Yes

  No

  N/A

• Yes

  No

  N/A

• Yes

  No

  N/A

• Has the food been prepared, packed, or held under sanitary conditions whereby it may not have become contaminated with filth, or whereby it may not have been rendered injurious to health?

  Yes

  No

  N/A

Facility and Grounds

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

  Compliant

  Non-Compliant

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Are there adequate, reasonably accessible toilet facilities?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Do toilet facilities have self closing doors?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Is there adequate screening or other protection against pests?

  Yes

  No

  N/A

• Are pests excluded from all areas of the food plant?

  Yes

  No

  N/A

• Are effective measures taken to exclude pests from processing areas?

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

Personnel

• Does management take all reasonable measures and precautions to ensure disease control through medical exam, observation, exclusion, and reporting?

  Yes

  No

  N/A

• Are employees instructed to report health conditions that might contaminate food, food product surfaces or food packaging materials to their supervisor?

  Yes

  No

  N/A

• Does management take all reasonable measures and precautions to ensure cleanliness through hygienic practices?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Are employees trained to maintain adequate personal cleanliness?

  Yes

  No

  N/A

• Are employees trained to wash hands thoroughly before work and after each absence from their work station?

  Yes

  No

  N/A

• Are employees trained to remove unsecured jewelry and other objects that might fall into food?

  Yes

  No

  N/A

• Are gloves used for food handling made of an impermeable material and maintained in a clean sanitary condition?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Are employees trained to confine eating, drinking, gum chewing, and use of tobacco to areas where food is not exposed or equipment and utensils are not washed?

  Yes

  No

  N/A

• Are employees trained to protect against contamination of food, food contact surfaces, or food packaging materials from microorganisms or other foreign substances?

  Yes

  No

  N/A

• Do personnel responsible for identifying plant sanitation failures or food contamination have the combination of education and experience to produce clean, safe food?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Is the responsibility for assuring compliance by all personnel with the requirements & of the GMP regulation clearly assigned to competent supervisory personnel?

  Yes

  No

  N/A

Equipment

• Are all plant equipment and utensils designed to be adequately cleanable and properly maintained?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Are all equipment and utensils properly maintained?

  Yes

  No

  N/A

• Are holding, conveying and manufacturing systems designed in a way to be §110.40(d) maintained in a sanitary condition?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Is equipment taken apart for thorough cleaning as necessary?

  Yes

  No

  N/A

• Are the non-food contact surfaces of equipment in the food handling are constructed that it can be kept in a clean condition?

  Yes

  No

  N/A

• Are non-food-contact surfaces cleaned as often as necessary to protect against the contamination of food?

  Yes

  No

  N/A

• Are freezers and cold storage compartments fitted with appropriate temperature measuring and/or recording devices to accurately show the compartment temperature?

  Yes

  No

  N/A

• Are freezers and cold storage compartments fitted with automatic controls for regulating temperature or, in the case of manual operations, with an automatic alarm system to indicate a significant temperature change?

  Yes

  No

  N/A

• Are instruments and controls for measuring, regulating, or recording temperature, pH, water activity, acidity, etc. accurate (i.e. calibrated)?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Are cleaning and sanitizing of utensils and equipment performed in a manner to protect against contamination?

  Yes

  No

  N/A

• Are cleaning compounds and sanitizing agents free from microorganisms and safe for use?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Are food contact surfaces including utensils and equipment surfaces cleaned frequently to protect against contamination?

  Yes

  No

  N/A

• Are food contact surfaces used for manufacturing or holding low-moisture food dry and in a sanitary condition at the time of use?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Are sanitizing agents safe and adequate under conditions of use?

  Yes

  No

  N/A

• Are cleaned and sanitized portable equipment with food contact surfaces and utensils stored in a manner that protects them from contamination?

  Yes

  No

  N/A

• Are fans and other air blowing equipment located in a manner to prevent contamination of food, food contact surfaces and food packaging materials?

  Yes

  No

  N/A

• Is there adequate ventilation or control equipment to minimize odors and vapors?

  Yes

  No

  N/A

Processes and Controls

• Are operations conducted in accordance with adequate sanitation principles?

  Yes

  No

  N/A

• Is there an appropriate quality control operation employed to ensure that food is suitable for human consumption and that food packaging material is safe and suitable?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Do raw materials or other ingredients contain levels of microorganisms that may produce food poisoning or other disease?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Is appropriate chemical, microbial, or extraneous material testing conducted to identify sanitation failures or possible food contamination?

  Yes

  No

  N/A

• Are containers inspected to ensure they do not contribute to contamination?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Are raw materials and other ingredients, including rework, held in bulk or in containers designed to protect against contamination?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Are raw materials scheduled for rework identified as such?

  Yes

  No

  N/A

• Are frozen raw materials and other ingredients kept frozen?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Are refrigerated foods kept at 45°F (7.2°C) or below as appropriate?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Are acid or acidified foods held in hermitically sealed containers at ambient temperatures heat treated?

  Yes

  No

  N/A

• Are measures such as sterilizing, irradiating, pasteurizing, freezing, refrigerating, control of pH or water activity adequate to prevent the growth of undesirable microorganisms?

  Yes

  No

  N/A

• Is work in progress handled in a manner that protects against contamination?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Are equipment, containers, and utensils used to process food constructed, handled, and maintained in a manner that protects against food contamination?

  Yes

  No

  N/A

• Are liquid or dry materials and other ingredients received and stored in bulk held in a manner to protect against contamination?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Are food, raw materials and other ingredients that are adulterated disposed of in a manner to protect other food from contamination?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Are mechanical manufacturing steps performed so as to protect food from contamination?

  Yes

  No

  N/A

• Is heat blanching, when required, performed in an effective manner and washed, when required, with water of safe and adequate sanitary quality?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Are critical control points identified and controlled for filling, assembling, and packaging operations?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Are human food manufacturing 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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Have Good Manufacturing Practices been followed in producing the food?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

Completion

• Recommendation

• Full Name and Signature of Inspector

  Sign