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Production and Process Controls

Process control is a statistical and engineering discipline that deals with the design and mechanisms for maintaining the output of a specific process within a desired range. These activities are involved in ensuring a process is predictable, stable, and consistently operating at the target level of performance with only normal variation. Process control enables mass production of continuous process as well a level of automation by which a small staff may operate a complex process from a central control room.

Processes and Controls

 All operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of food shall be conducted in accordance with adequate sanitation principles. Appropriate quality control operations shall be employed to ensure that food is suitable for human consumption and that food-packaging materials are safe and suitable. Overall sanitation of the plant shall be under the supervision of one or more competent individuals assigned responsibility for this function. All reasonable precautions shall be taken to ensure that production procedures do not contribute contamination from any source. Chemical, microbial, or extraneous-material testing procedures shall be used where necessary to identify sanitation failures or possible food contamination. All food that has become contaminated to the extent that it is adulterated within the meaning of the act shall be rejected, or if permissible, treated or processed to eliminate the contamination.

§  (a) Raw materials and other ingredients.

  1.  Raw materials and other ingredients shall be inspected and segregated or otherwise handled as necessary to ascertain that they are clean and suitable for processing into food and shall be stored under conditions that will protect against contamination and minimize deterioration. Raw materials shall be washed or cleaned as necessary to remove soil or other contamination. Water used for washing, rinsing, or conveying food shall be safe and of adequate sanitary quality. Water may be reused for washing, rinsing, or conveying food if it does not increase the level of contamination of the food. Containers and carriers of raw materials should be inspected on receipt to ensure that their condition has not contributed to the contamination or deterioration of food.
  2.  Raw materials and other ingredients shall either not contain levels of microorganisms that may produce food poisoning or other disease in humans, or they shall be pasteurized or otherwise treated during manufacturing operations so that they no longer contain levels that would cause the product to be adulterated within the meaning of the act. Compliance with this requirement may be verified by any effective means, including purchasing raw materials and other ingredients under a supplier's guarantee or certification.
  3. Raw materials and other ingredients susceptible to contamination with aflatoxin or other natural toxins shall comply with current Food and Drug Administration regulations and action levels for poisonous or deleterious substances before these materials or ingredients are incorporated into finished food. Compliance with this requirement may be accomplished by purchasing raw materials and other ingredients under a supplier's guarantee or certification, or may be verified by analyzing these materials and ingredients for aflatoxins and other natural toxins.
  4.  Raw materials, other ingredients, and rework susceptible to contamination with pests, undesirable microorganisms, or extraneous material shall comply with applicable Food and Drug Administration regulations and defect action levels for natural or unavoidable defects if a manufacturer wishes to use the materials in manufacturing food. Compliance with this requirement may be verified by any effective means, including purchasing the materials under a supplier's guarantee or certification, or examination of these materials for contamination.
  5.  Raw materials, other ingredients, and rework shall be held in bulk, or in containers designed and constructed so as to protect against contamination and shall be held at such temperature and relative humidity and in such a manner as to prevent the food from becoming adulterated within the meaning of the act. Material scheduled for rework shall be identified as such.
  6.  Frozen raw materials and other ingredients shall be kept frozen. If thawing is required prior to use, it shall be done in a manner that prevents the raw materials and other ingredients from becoming adulterated within the meaning of the act.
  7. Liquid or dry raw materials and other ingredients received and stored in bulk form shall be held in a manner that protects against contamination.

§  (b) Manufacturing operations. 

  1.  Equipment and utensils and finished food containers shall be maintained in an acceptable condition through appropriate cleaning and  sanitizing, as necessary. Insofar as necessary, equipment shall be taken apart for thorough cleaning.

 2. All food manufacturing, including packaging and storage, shall be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, or for the contamination of food. One way to comply with this requirement is careful monitoring of physical factors such as time, temperature, humidity, aw, pH, pressure, flow rate, and manufacturing operations such as freezing, dehydration, heat processing, acidification, and refrigeration to ensure that mechanical breakdowns, time delays, temperature fluctuations, and other factors do not contribute to the decomposition or contamination of food.

3. Food that can support the rapid growth of undesirable microorganisms, particularly those of public health significance, shall be held in a manner that prevents the food from becoming adulterated within the meaning of the act. Compliance with this requirement may be accomplished by any effective means, including:
 (i) Maintaining refrigerated foods at 45 °F (7.2 °C) or below as appropriate for the particular food involved.
(ii) Maintaining frozen foods in a frozen state
 (iii) Maintaining hot foods at 140 °F (60 °C) or above
 (iv) Heat treating acid or acidified foods to destroy mesophilic microorganisms when those foods are to be held in hermetically sealed containers at ambient temperatures.

4. Measures such as sterilizing, irradiating, pasteurizing, freezing, refrigerating, controlling pH or controlling aw that are taken to destroy or prevent the growth of undesirable microorganisms, particularly those of public health significance, shall be adequate under the conditions of manufacture, handling, and distribution to prevent food from being adulterated within the meaning of the act.

5. Work-in-process shall be handled in a manner that protects against contamination.

6. Effective measures shall be taken to protect finished food from contamination by raw materials, other ingredients, or refuse. When raw materials, other ingredients, or refuse are unprotected, they shall not be handled simultaneously in a receiving, loading, or shipping area if that handling could result in contaminated food. Food transported by conveyor shall be protected against contamination as necessary.

7. Equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or food shall be constructed, handled, and maintained during manufacturing or storage in a manner that protects against contamination.

8. Effective measures shall be taken to protect against the inclusion of metal or other extraneous material in food. Compliance with this requirement may be accomplished by using sieves, traps, magnets, electronic metal detectors, or other suitable effective means.

9. Food, raw materials, and other ingredients that are adulterated within the meaning of the act shall be disposed of in a manner that protects against the contamination of other food. If the adulterated food is capable of being reconditioned, it shall be reconditioned using a method that has been proven to be effective or it shall be reexamined and found not to be adulterated within the meaning of the act before being incorporated into other food.

10. Mechanical manufacturing steps such as washing, peeling, trimming, cutting, sorting and inspecting, mashing, dewatering, cooling, shredding, extruding, drying, whipping, defatting, and forming shall be performed so as to protect food against contamination. Compliance with this requirement may be accomplished by providing adequate physical protection of food from contaminants that may drip, drain, or be drawn into the food. Protection may be provided by adequate cleaning and sanitizing of all food-contact surfaces, and by using time and temperature controls at and between each manufacturing step.

11. Heat blanching, when required in the preparation of food, should be effected by heating the food to the required temperature, holding it at this temperature for the required time, and then either rapidly cooling the food or passing it to subsequent manufacturing without delay. Thermophilic growth and contamination in blanchers should be minimized by the use of adequate operating temperatures and by periodic cleaning. Where the blanched food is washed prior to filling, water used shall be safe and of adequate sanitary quality.

12. Batters, breading, sauces, gravies, dressings, and other similar preparations shall be treated or maintained in such a manner that they are protected against contamination. Compliance with this requirement may be accomplished by any effective means, including one or more of the following:
(i) Using ingredients free of contamination.
(ii) Employing adequate heat processes where applicable.
(iii) Using adequate time and temperature controls
(iv) Providing adequate physical protection of components from contaminants that may drip, drain, or be drawn into them.
(v) Cooling to an adequate temperature during manufacturing.
 (vi) Disposing of batters at appropriate intervals to protect against the growth of microorganisms.

13. Filling, assembling, packaging, and other operations shall be performed in such a way that the food is protected against contamination. Compliance with this requirement may be accomplished by any effective means, including:
(i) Use of a quality control operation in which the critical control points are identified and controlled during manufacturing.
 (ii) Adequate cleaning and sanitizing of all food-contact surfaces and food containers
 (iii) Using materials for food containers and food- packaging materials that are safe and suitable
 (iv) Providing physical protection from contamination, particularly airborne contamination.
 (v) Using sanitary handling procedures.

14. Food such as, but not limited to, dry mixes, nuts, intermediate moisture food, and dehydrated food, that relies on the control of aw for preventing the growth of undesirable microorganisms shall be processed to and maintained at a safe moisture level. Compliance with this requirement may be accomplished by any effective means, including employment of one or more of the following practices:
 (i) Monitoring the aw (water activity) of food.
 (ii) Controlling the soluble solids-water ratio in finished food.
​(iii) Protecting finished food from moisture pickup, by use of a moisture barrier or by other means, so that the aw of the food does not increase to an unsafe level.

15. Food such as, but not limited to, acid and acidified food, that relies principally on the control of pH for preventing the growth of undesirable microorganisms shall be monitored and maintained at a pH of 4.6 or below. Compliance with this requirement may be accomplished by any effective means, including employment of one or more of the following practices:
 (i) Monitoring the pH of raw materials, food in process, and finished food.
(ii) Controlling the amount of acid or acidified food added to low-acid food.

16. When ice is used in contact with food, it shall be made from water that is safe and of adequate sanitary quality, and shall be used only if it has been manufactured in accordance with current good manufacturing practice as outlined in this part.

17. Food-manufacturing areas and equipment used for manufacturing human food should not be used to manufacture nonhuman food-grade animal feed or inedible products, unless there is no reasonable possibility for the contamination of the human food.

21 CFR 110.80 e [51 FR 22475, June 19, 1986, as amended at 65 FR 56479, Sept. 19, 2000]

Warehousing and Distribution

Stock Arrangement

  • All stock shall be stored 18 inches from the wall and 5 inches off the floor.
  • All stock shall be stored in a clean and dry environment.
  • Finished goods, raw materials and quarantined damaged goods shall be stored separately.
  • All stock shall be stored in an orderly manner and properly stacked to prevent damage.
  • All partially used ingredient or packaging containers shall be properly resealed or covered to preclude contamination.
  •  All pallets, racks and shelving shall be clean and in good repair.
  • All damaged finished product shall be disposed of in a timely manner.
  • All stock shall be rotated on a first-in, first-out (FIFO) basis.
  • Finished product, packaging material, equipment or ingredients will not be stored in close proximity to any chemicals, cleaning compounds, pesticides or odorous materials.

Product Protection

  • All ingredients, packaging material and finished products shall be handled, stored or processed in such a manner as to assure a safe, wholesome and unadulterated product.
  • All pesticides shall be stored in a locked area and separated from all ingredients, cleaning material, equipment/utensils and sanitizers.
  • All sanitizers, cleaning compounds, and chemicals shall be stored separately from all ingredients, packaging material and finished product in such a manner as to prevent any contamination.
  • There will be no flaking or peeling paint, static product, soil buildup, or rust on or above product zones.
  • All product or product containers shall be adequately protected to preclude contamination.
  •  There will be no condensation above product zones.
  • All conveyor belts in direct product contact shall be constructed of a non-toxic and non-absorbent material and shall be clean and in good repair.
  • Lights shall be provided with adequate shielding to protect from breakage.
  • Wood, cardboard or other absorbent materials shall not be used for product contact surfaces.
  • Air used for conveying product or packaged materials shall be filtered, clean and oil-free.
  • Glass will not be used in, above or near processing or ingredient areas.
  • All gasket material will be non-toxic, non-absorbent and will be in good condition (not torn, frayed or deteriorated).
  • Pressure cleaning/sanitizing shall not be conducted near, on or above product zones during processing or packaging.
  • All tanks, vats and blenders shall be covered.
  • No objectionable odors or abnormal odors shall be present.
  •  Rotten or spoiled food should be removed from all areas as they often result in objectionable odors and other food safety hazards.
  • All strong chemical odors which could contaminate food shall be prevented.

    Production Controls

  • All operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of food shall be conducted in accordance with adequate sanitation principles.
  • All reasonable precautions shall be taken to ensure that production procedures do not contribute contamination from any source.
  • Chemical, microbial, or extraneous material testing procedures shall be used where necessary to identify failures or possible food contamination.
  • All food that has become contaminated to the extent that it is adulterated within the meaning of the act shall be rejected, or if permissible, treated or processed to eliminate contamination.
  • Appropriate quality control operations shall be employed to ensure that food is suitable for human consumption and that food packaging materials are safe and suitable.
  • Overall sanitation of the plant shall be under the supervision of one or more competent individuals assigned responsibility for this function.
  • Effective measures shall be taken to protect finished food from contamination by raw materials, other ingredients, or refuse.
    • When raw materials, other ingredients, or refuse are unprotected, they shall not be handled simultaneously in a receiving, loading, or shipping area if that handling could result in contaminated food.
  • Food transported by conveyor shall be protected against contamination as necessary.
  • Equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or food shall be constructed, handled, and maintained during manufacturing and/or storage in a manner that protects against contamination.
  • Mechanical manufacturing steps such as washing, peeling, trimming, cutting, sorting, inspecting, mashing, dewatering, cooling, shredding, extruding, drying, whipping, defatting, and forming shall be performed so as to protect against food contamination.
    • Compliance with this requirement may be accomplished by providing adequate physical protection of food from contaminants that may drip, drain, or be drawn into the food.
    • Protection may be provided by adequate cleaning and sanitizing of food contact surfaces, and by using time and temperature controls at and between each manufacturing step.
  • Filling, assembling, packaging, and other operations shall be performed in a way that food is protected from contamination.
  • Food manufacturing areas and equipment used for manufacturing human food should not be used to manufacture nonhuman food-grade animal feed or inedible products, unless there is no reasonable possibility for contamination of the human food.