GMP Checklist - Agriculture Department USDA

Use the GMP Checklist from USDA Agriculture Department to ensure safety and adherence to Good Manufacturing Practices for agricultural products.

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GMP Checklist - Agriculture Department USDA

General

Training

1. Have adequate precautions been taken to ensure that production procedures do not contribute to allergen cross-contact and contamination from any source? If color coding is used to identify equipment for various purposes, is the system effectively implemented?

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Raw Ingredients

3. Is water used for washing, rinsing, or conveying food safe and of adequate sanitary quality? Is recirculated or reused water used in a way that prevents allergen cross-contact or an increase in the level of contamination of the food? Is water treatment monitored to verify adequate pH, temperature, and/or chemical control?

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5. Have raw materials and/or ingredients that are susceptible to contamination with aflatoxin or other natural toxins been identified? Have steps been implemented to ensure compliance with FDA regulations for poisonous or deleterious substances? Are control measures documented?

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6. Have raw materials and/or ingredients that pose a risk for contamination with pests, undesirable microorganisms, or extraneous material been identified? Have steps been implemented to ensure compliance with FDA regulations for natural or unavoidable defects? Are control measures documented?

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7. Are raw materials, other ingredients, and rework held in bulk or in containers designed and constructed to protect against allergen cross-contact and contamination? Are they held at appropriate temperature and relative humidity to prevent food from becoming adulterated? Are materials identified for rework if scheduled for this purpose?

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8. Are frozen raw materials and other ingredients kept frozen? Is the temperature of the freezer(s) maintained appropriately? If the product is thawed prior to use, is it done in a manner that prevents raw materials and other ingredients from becoming adulterated?

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Allergens

7. Have measures such as sterilizing, irradiating, pasteurizing, cooking, freezing, refrigerating, controlling pH, or controlling Aw, necessary to destroy or prevent the growth of undesirable microorganisms, been identified, implemented, and documented?

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8. Are the identified measures effectively implemented to protect against comingling, allergen cross-contact, contamination, and growth of undesirable microorganisms in the facility’s product flow and work areas for work-in-process (WIP) and rework?

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9. Are effective measures taken to protect finished food from allergen cross-contact and contamination by raw materials, other ingredients, or refuse? Are raw materials, other ingredients, or refuse that are unprotected handled simultaneously in a receiving, loading, or shipping area if that handling could result in allergen cross‐contact or contaminated food? Is food transported by the conveyor protected against allergen cross‐contact and against contamination as necessary?

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10. Are equipment, containers, and utensils used to convey, hold, or store raw materials and other ingredients, work-in-process, rework, or other food constructed, handled, and maintained during manufacturing, processing, packing, and holding in a manner that protects against allergen cross-contact and contamination?

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12. If the facility identifies food, raw materials, and other ingredients as adulterated, do they dispose of the material in a manner that protects against the contamination of other food? Or if appropriate, do they recondition the material so that it meets process and regulatory requirements?

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13. Are steps such as washing, peeling, trimming, cutting, sorting and inspecting, mashing, dewatering, cooling, shredding, extruding, drying, whipping, defatting, and forming performed so as to protect food against allergen cross-contact and contamination? Is food protected from contaminants that may drip, drain, or be drawn into the food?

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15. If batters, breading, sauces, gravies, dressings, dipping solutions, and other similar preparations are held and used repeatedly over time, are they treated or maintained in such a manner that they are protected against allergen cross-contact and contamination, and to minimize the potential for the growth of undesirable microorganisms?

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17. For dry mixes, nuts, intermediate moisture food, and dehydrated food that rely principally on the control of water activity (Aw) for preventing the growth of undesirable microorganisms, are they processed to, and maintained at a safe Aw level? Are controls documented?

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Defect Action

Equipment And Utensils (Design, Materials, And Maintenance)

General

Plumbing

Toilet Facilities

11. Do the hand-washing facilities in the breakroom and production area include running water at a suitable temperature, soap, and either single-use towels or forced air hand dryers? Are signs posted indicating the importance of hand washing (multilingual if appropriate)?

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Maintenance And Sanitation

3. Is cleaning and sanitizing of utensils and equipment conducted in a manner that protects against allergen cross-contact and contamination of food, food contact surfaces, or food packaging materials? Is the procedure documented, and are there records to show completion?

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Sanitation Chemicals And Supplies

Pest Control

Sanitation Of Food-Contact Surfaces

1. Are all food-contact surfaces, including utensils and food-contact surfaces of equipment, cleaned as frequently as necessary to protect against allergen cross-contact and contamination of food? Is the procedure documented, and are records maintained to show completion? Is cleaning and sanitation oversight assigned to at least one competent staff person?

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2. For processing, packing, or holding low-moisture food, are food contact surfaces cleaned and dry before use? If wet-cleaned, are the surfaces sanitized and thoroughly dried before use? Is the procedure documented, and are there records to show completion?

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3. In wet processing operations, are all food contact surfaces cleaned and sanitized before use and after any interruption during which the food contact surfaces may have become contaminated? Are utensils and food-contact surfaces of equipment cleaned and sanitized as necessary in continuous production operations? Is the procedure documented, and are there records to show completion?

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5. Are non-food contact surfaces of equipment used in the operation of a food plant cleaned in a manner and as frequently as necessary to protect against allergen cross-contact and contamination of food, food-contact surfaces, and food-packaging materials?

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Warehousing And Distribution

1. Is the storage and transportation of food carried out to protect against allergen cross-contact and contamination from biological, chemical (including radiological), and physical sources, as well as against deterioration of the food and its container?

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Food By-Products For Animal Food

Facility And Grounds

Regulatory

Food Safety Plan

4. Does the facility document, implement, and record daily, weekly, and/or monthly site inspections as necessary to verify the implementation of its food safety plan controls and policies associated with housekeeping, cleaning, sanitation, and maintenance?

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Personnel Qualifications And Training

4. Do supervisory personnel have the responsibility for ensuring personnel compliance with food safety and food hygiene policies and procedures? Do they have the necessary education, training, or experience (or a combination thereof) to supervise the production of clean and safe food?

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Personnel Hygiene

Supply Chain

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GMP Checklist - Agriculture Department USDA

Use the GMP Checklist from USDA Agriculture Department to ensure safety and adherence to Good Manufacturing Practices for agricultural products.

1. Are all facility operations conducted in accordance with adequate sanitation principles?

2. Have quality control measures been established and implemented to ensure food and food-packaging materials are safe and suitable for intended use?

3. Is sanitation of the plant under the supervision of one or more competent individuals assigned responsibility for this function?

1. Have adequate precautions been taken to ensure that production procedures do not contribute to allergen cross-contact and contamination from any source? If color coding is used to identify equipment for various purposes, is the system effectively implemented?

2. Are documented testing procedures used where necessary to identify sanitation failures or possible allergen cross-contact and food contamination?

3. Is food that has become contaminated to the extent that it is adulterated rejected, or if appropriate, treated or processed to eliminate the contamination?

1. Is there a system in place for the proper inspection, handling, segregation, and storage of raw materials?

2. Are raw materials washed or cleaned as necessary to remove soil or other contamination?

4. Have raw materials and/or ingredients that need pasteurization or other treatment prior to processing to prevent possible contamination from pathogenic microorganisms been identified? Have necessary treatments been implemented and documented?

5. Have raw materials and/or ingredients that are susceptible to contamination with aflatoxin or other natural toxins been identified? Have steps been implemented to ensure compliance with FDA regulations for poisonous or deleterious substances? Are control measures documented?

6. Have raw materials and/or ingredients that pose a risk for contamination with pests, undesirable microorganisms, or extraneous material been identified? Have steps been implemented to ensure compliance with FDA regulations for natural or unavoidable defects? Are control measures documented?

8. Are frozen raw materials and other ingredients kept frozen? Is the temperature of the freezer(s) maintained appropriately? If the product is thawed prior to use, is it done in a manner that prevents raw materials and other ingredients from becoming adulterated?

1. Are there documented procedures in place for management to identify all allergenic materials and food chemical sensitivities present in the facility?

2. Have types of allergens/chemicals been identified?

3. Are raw materials and other ingredients that are food allergens, and rework that contains food allergens, identified and held in a manner that prevents allergen cross-contact?

4. Are equipment, utensils, and food containers maintained in adequate condition through appropriate cleaning and sanitizing, as necessary? Is equipment taken apart for a thorough cleaning, if necessary?

5. Is manufacturing, processing, packing, and holding conducted to minimize the potential for the growth of microorganisms, allergen cross-contact, contamination of food, and deterioration of food?

6. Is food that can support the rapid growth of undesirable microorganisms held at temperatures that prevent it from becoming adulterated during manufacturing, processing, packing, and holding?

7. Have measures such as sterilizing, irradiating, pasteurizing, cooking, freezing, refrigerating, controlling pH, or controlling Aw, necessary to destroy or prevent the growth of undesirable microorganisms, been identified, implemented, and documented?

8. Are the identified measures effectively implemented to protect against comingling, allergen cross-contact, contamination, and growth of undesirable microorganisms in the facility’s product flow and work areas for work-in-process (WIP) and rework?

11. Does the facility take adequate measures to protect against the inclusion of metal or other extraneous material in food?

12. If the facility identifies food, raw materials, and other ingredients as adulterated, do they dispose of the material in a manner that protects against the contamination of other food? Or if appropriate, do they recondition the material so that it meets process and regulatory requirements?

14. If heat blanching is utilized in the preparation of food capable of supporting microbial growth, is the process documented and implemented? Is the blanching equipment periodically cleaned and sanitized as necessary?

16. Are filling, assembling, packaging, and other operations performed in such a way that the food is protected against allergen cross-contact, contamination, and growth of undesirable microorganisms?

17. For dry mixes, nuts, intermediate moisture food, and dehydrated food that rely principally on the control of water activity (Aw) for preventing the growth of undesirable microorganisms, are they processed to, and maintained at a safe Aw level? Are controls documented?

18. Are acid and acidified foods monitored and maintained at a pH of 4.6 or below?

19. Is ice that is used (internally produced or externally supplied) in contact with food made from water that is safe and of adequate sanitary quality and manufactured in accordance with current good manufacturing practices?

1. Has the facility determined if defect action levels are established for the food handled or manufactured by the facility? Are controls documented?

2. Have defect action levels been identified for the quality control operations to reduce natural or unavoidable defects to the lowest level currently feasible? Are these policies documented, with records of implementation?

3. Does the facility avoid mixing foods containing defects at levels that render the food adulterated with other lots of food?

1. Are all plant equipment and utensils used in manufacturing, processing, packing, or holding food designed of such material and workmanship as to be adequately cleanable and adequately maintained?

2. Are equipment and utensils designed, constructed, and used appropriately to avoid the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants?

3. Are equipment constructed and located so that they are accessible for cleaning, maintenance, and inspection?

4. Are food-contact surfaces corrosion-resistant, made of non-toxic materials, and designed to withstand the environment of their intended use and the cleaning process?

5. Are food-contact surfaces maintained to protect food from allergen cross-contact and contamination?

6. Are seams on food-contact surfaces sanitary welds, smoothly bonded and maintained to minimize accumulation of food particles, dirt, and organic matter, thus minimizing the opportunity for microorganism growth and allergen cross-contact?

7. Is non-food contact equipment located in the processing and packing areas constructed so that it can be maintained, and is it in good condition and able to be cleaned?

8. Are holding, conveying, and manufacturing systems designed and constructed to enable them to be maintained, and are they in an appropriate clean, and sanitary condition?

9. Are freezer and cold storage compartments fitted with an indicating thermometer, temperature-measuring device, or temperature-recording device?

10. Are instruments and controls used for measuring, regulating, or recording temperatures, pH, water activity, etc., properly maintained, calibrated, and adequate in number for their designated uses?

11. Is compressed air or other gases mechanically introduced into food or used to clean food-contact surfaces or equipment filtered and oil-free?

1. Is the water supply/system adequate for the operations intended and derived from an adequate source? Are private wells inspected annually?

2. Are there testing results showing that water used for processing, cleaning, as an ingredient, or by personnel is potable?

3. Who issued the water test results and what is the date of testing?

4. Is running water of suitable temperature and pressure available in all areas where required for the processing of food, cleaning of equipment, utensils, and food-packaging materials, or for employee sanitary facilities?

1. Is the plumbing of adequate size and design to handle water and waste flow for the facility without creating possible contamination or unsanitary conditions?

2. Do floors, gutters, or drains have sufficient slope and outlets to drain adequately?

3. Are there no cross-connections between treated and untreated water supplies?

4. Are backflow prevention devices installed on all water and steam lines, and are they periodically certified?

5. Who certified them and when was the last certification?

6. Is sewage disposed of into an adequate sewage system or through other adequate means?

1. Are toilet facilities adequate and are there a readily accessible number of units for the facility size/number of employees?

2. Do they have independent outside ventilation?

3. Are they designed so that they do not open directly into food handling areas (processing, repacking, or reconditioning areas)?

4. Do they have self-closing doors or a maze-type entrance?

5. Is there adequate lighting?

6. Are there sufficient and proper waste receptacles?

7. Are signs posted indicating the importance of hand washing (multilingual if appropriate)?

8. Do the hand-washing facilities have running water at a suitable temperature, soap, and either single-use towels or forced air hand dryers?

9. Are the toilet areas clean, dry, properly stocked with toilet paper, and of good general appearance?

10. Are the toilets, sinks, and faucets in good working condition?

11. Do the hand-washing facilities in the breakroom and production area include running water at a suitable temperature, soap, and either single-use towels or forced air hand dryers? Are signs posted indicating the importance of hand washing (multilingual if appropriate)?

12. Is the capacity of the facility’s rubbish/waste storage sufficient for the operation, with dedicated waste containers and timely removal of waste? Has a policy for waste management been documented?

1. Are the buildings, fixtures, and other physical facilities of the plant maintained in a clean and sanitary condition, and kept in repair adequate to prevent food from becoming adulterated?

2. After maintenance repairs of equipment associated with food processing or food contact surfaces, is the equipment cleaned, sanitized, and inspected? Is this policy documented, and are implementation records maintained?

3. Is cleaning and sanitizing of utensils and equipment conducted in a manner that protects against allergen cross-contact and contamination of food, food contact surfaces, or food packaging materials? Is the procedure documented, and are there records to show completion?

1. Are the cleaning compounds and sanitizing agents used in cleaning procedures free from undesirable microorganisms and appropriate for use? Is documentation available for verification?

2. Are the chemicals stored at the facility appropriate for use in a plant where food is processed and exposed? Are food-grade lubricants used in exposed product zones?

3. Is there a locked storage area for chemicals with controlled access, and are chemicals clearly and properly labeled?

1. Has the facility documented and implemented an effective pest control program?

2. Is a pest control station map properly maintained and available?

3. Are routine maintenance and inspection of pest control devices documented?

4. Are the type, number, and placement of pest control/deterrent devices adequate and appropriate to prevent infestation?

5. Is the facility free from pest infestation?

6. Are pesticides used to control pests in the facility applied under precautions and restrictions that protect against contamination of food, food-contact surfaces, and food packaging materials?

2. For processing, packing, or holding low-moisture food, are food contact surfaces cleaned and dry before use? If wet-cleaned, are the surfaces sanitized and thoroughly dried before use? Is the procedure documented, and are there records to show completion?

4. Are single-service articles stored, handled, and disposed of in a manner that protects against allergen cross-contact and contamination of food, food-contact surfaces, or food packaging materials?

5. Are non-food contact surfaces of equipment used in the operation of a food plant cleaned in a manner and as frequently as necessary to protect against allergen cross-contact and contamination of food, food-contact surfaces, and food-packaging materials?