Some standard content:
The full text of this standard is mandatory.
This standard replaces GB12693-1990 "Hygiene Standards for Dairy Factories". Compared with GB12693-1990, the main changes in this standard are as follows: -The name of the standard is changed to "Good Manufacturing Practice for Dairy Enterprises"; -In accordance with the requirements of good manufacturing practices, the format has been changed and the content has been adjusted accordingly; -Added "equipment", "organization and personnel", "production process management", "quality management" and other contents; GB12693-2003
The original "hygiene management" part of the content is repeated in the "General Hygiene Standards for Food Factories". This standard reduces the length of the "hygiene management" part, and the reduced part is implemented in accordance with the "General Hygiene Standards for Food Factories". From the date of implementation of this standard, GB12693-1990 will be abolished at the same time. This standard is proposed and managed by the Ministry of Health of the People's Republic of China. The responsible drafting unit of this standard: Nutrition and Food Safety Institute of Chinese Center for Disease Control and Prevention. The drafting units of this standard include: Heilongjiang Provincial Health and Epidemic Prevention Station, Hebei Provincial Health and Epidemic Prevention Station, Harbin Municipal Health and Epidemic Prevention Station, Heilongjiang Longdan Dairy Technology Co., Ltd., etc.
The main drafters of this standard include: Shi Gensheng, Bao Dayue, Jin Hongdao, Kang Le, Gao Tiefu, Hao Donghai, Wang Yuejin, Zhang Xudong. 1 Scope
Good Manufacturing Practice for Dairy Enterprises
GB12693--2003
This standard specifies the conditions and requirements that dairy enterprises should meet in the process of raw material procurement, processing, packaging, storage and transportation, regarding the setting of personnel, buildings, facilities, equipment, and hygiene, production and quality management. This standard is applicable to dairy product manufacturers such as milk powder, sterilized milk, sterilized milk, fermented milk, condensed milk, cheese, reconstituted milk, cream, and colored milk. 2 Normative References
The clauses in the following documents become the clauses of this standard through reference in this standard. For dated references, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, parties to agreements based on this standard are encouraged to study whether the latest versions of these documents can be used. For undated references, the latest versions apply to this standard. GB2760 Hygienic Standard for the Use of Food Additives Hygienic Standard for Drinking Water
GB 5749
GB7718 General Standard for Food Labeling
GB8978
Comprehensive Sewage Discharge Standard
Emission Standard for Air Pollutants from Boilers
GB 1327J
GB 13432
Labeling of Special Nutritional Foods
General Hygienic Standard for Food Enterprises
GB 14881
GB/T18204.1 Method for Examination of Air Microorganisms in Public Places Determination of Total Colony Count 3 Terms and Definitions
The following terms and definitions apply to this standard. 3.1
Dairy products
Various products made from cow's milk, goat's milk, etc. as the main raw materials. 3.2
Clean working area
Working areas with high cleanliness requirements such as semi-finished product storage, filling and inner packaging workshops. 3.3
Quasi-clean working area
Working areas in production sites such as fresh milk processing workshops with cleanliness requirements lower than those of clean working areas. 3.4
General working area
Working areas such as milk collection rooms, raw material warehouses, material warehouses, outer packaging workshops and finished product warehouses with cleanliness requirements lower than those of quasi-clean working areas. 3.5
Non-food processing areas
Inspection rooms, offices, hand washing and disinfection rooms, toilets, etc., areas where food is not directly processed. 3.6
Hazard Analysis Critical Control Point (HACCP)
A means of control for producing (processing) safe food: 1
GB 12693-2003
Analyze raw materials, key production processes and human factors that affect product safety; determine the key links in the processing process, establish and improve monitoring procedures and monitoring standards, and take standardized corrective measures. 4 Factory Environment
4.1 The factory should be built in an area with convenient transportation and sufficient water sources. The factory area shall not be located downstream of polluted rivers; there shall be no dust, harmful gases, radioactive substances and other diffuse pollution sources around the factory area; there shall be no potential places for insects to breed in large numbers and other situations that are prone to pollution. 4.2 Any facilities and equipment in the factory area shall be easy to maintain and clean, and shall not become a source of pollution to the surrounding environment; there shall be no leakage of toxic and harmful gases, bad odors, dust and other pollutants that are harmful to hygiene. 4.3 The open space and roads in the factory area and adjacent areas should be paved with concrete, asphalt or other hard materials or greening to prevent dust and water accumulation. 4.4 The factory area should be reasonably laid out, with clear divisions of functional areas and isolation measures. Facilities that are prone to pollution should be located on the upwind side of the lowest frequency wind direction throughout the year; incinerators, boilers, wastewater treatment stations, and sewage treatment sites should be at a certain distance from production workshops, warehouses, and water supply facilities, and protective measures should be taken.
4.5 Animals are prohibited from being raised in the factory area.
4.6 There should be appropriate facilities around the wide area to prevent external pollution sources and harmful animals from invading people. If a fence is set up, the part at least 30cm below the ground should be built with solid and airtight materials. 5 Factory buildings and facilities
5.1 Design
5.1.1 All new, expanded, and renovated engineering projects (dairy factories, workshops, etc.) related to food hygiene should be designed and constructed in accordance with the provisions of this specification and GB14881. 5.1.2 The site selection and other relevant materials (general layout, plan, section, elevation, quality and hygiene standards of raw materials, semi-finished products and finished products, production process, etc.) should be submitted to the local health administrative department for review and filing. 5.2 Workshop setting and layout
5.2.1 The workshop setting should include production workshop and auxiliary workshop. The production workshop includes milk collection room, raw material pretreatment workshop, processing workshop, semi-finished product storage and finished product packaging workshop. Auxiliary workshops should include inspection rooms, raw material warehouses, material warehouses, finished product warehouses, changing rooms and hand washing and disinfection rooms, toilets and other necessary places set up for production services. 5.2.2 The workshop setting should be arranged in an orderly and neat manner according to the production process needs and hygiene requirements. 5.2.3 The changing room and hand washing and disinfection room should be connected to the processing workshop and set at the entrance of the processing workshop for employees. 5.3 Workshop isolation
The workshop isolation should be isolated according to the production process, production operation needs and the cleanliness requirements of the production operation area to prevent mutual contamination.
5.4 Roof
5.4.1 The indoor roof of processing, packaging, storage and other places should be easy to clean, prevent dust accumulation, condensation, mildew or shedding. If the roof of the clean operation area, quasi-clean operation area and other food exposure places (except the milk collection room) is a structure that is easy to hide dirt, a smooth and easy-to-clean ceiling should be added; if it is a reinforced concrete structure, its indoor roof should be flat and seamless, and the top angle should have an appropriate curvature. The roof should be equipped with a drainage channel.
5.4.2 The flat roof or ceiling should be constructed with non-toxic, odorless white or light-colored waterproof materials. If spray paint is used, mildew-proof, non-flaking and easy-to-clean paint should be used.
5.4.3 Steam, water, electricity and other piping shall not be set directly above the food exposure, otherwise facilities should be installed to prevent dust and condensation from falling. 5.5 Walls, doors and windows
5.5.1 The walls of the production workshop should be constructed of non-toxic, odorless, smooth, impermeable, easy-to-clean light-colored anti-corrosion materials. The corners of the walls and columns (between walls, between walls and columns and the ground, between walls and columns and the ceiling) should have a certain degree of arc, and the radius of curvature should be more than 3cm to facilitate cleaning and disinfection.
5.5.2 The doors and windows of the production workshop and storage places should be tightly assembled, and should be equipped with screens and screens that are easy to remove and clean and will not rust; windows should not be equipped with windowsills. If there are windowsills, they should be more than 1m above the ground, and the tabletop should be tilted inward at 45°. GB12693—2003
5.5.3 The entrances and exits of the clean working area and quasi-clean working area should be equipped with doors and (or) air curtains that can be closed automatically. Insect traps should be installed in the production workshop and storage places to prevent or eliminate harmful insects. 5.6 Floor and Drainage
5.6.1 The floor should be constructed of non-toxic, odorless, impermeable materials, and must be flat, non-slip, crack-free and easy to clean and disinfect. 5.6.2 The floor of areas where drainage or wastewater flows to the ground during operations, the working environment is often humid, or the cleaning operation is carried out by washing should be acid-resistant and alkali-resistant, and should have a certain drainage slope (not less than 1.5%) and drainage system. 5.6.3 The drainage system should have a slope, be kept unobstructed, and be easy to clean. The side and bottom joints of the drainage ditch should have a certain curvature, and the radius of curvature should be not less than 3cm.
5.6.4 A floor drain with a water seal should be installed at the entrance of the drainage system to prevent solid waste from flowing in and foul air from escaping. 5.6.5 There shall be no other pipes in and below the drainage system. 5.6.6 The drainage outlet shall be equipped with a device to prevent harmful animals from invading people. 5.6.7 The flow direction of indoor drainage shall be from the high-cleanliness area to the general cleanliness area, and there shall be a design to prevent wastewater from flowing back. 5.6.8 Wastewater shall be discharged to the wastewater treatment system or treated by other appropriate means. 5.7 Water supply facilities
5.7.1 The water quality, pressure, and water volume of the water used in various parts of the factory shall be guaranteed to meet the production needs. 5.7.2 Water storage tanks (towers, tanks), water supply pipes and appliances that are in direct contact with water shall be constructed of non-toxic, odorless, and anti-corrosive materials. 5.7.3 Safety and sanitation facilities shall be added to the exit of water supply facilities to prevent harmful animals and other harmful substances from entering and causing food contamination. 15.7.4 The site selection of self-supplied water sources shall be more than 30m away from the pollution source (septic tanks, garbage storage places), and a sanitary protection zone shall be set up and a dedicated person shall be responsible.
5.7.5 When using self-supplied water sources, water purification facilities (such as sedimentation, filtration, iron removal, manganese removal, fluoride removal, disinfection, etc.) should be added according to the local water quality characteristics to ensure that the water quality meets the requirements of GB5749. 5.7.6 The piping system of non-drinking water (such as cooling water, sewage or wastewater, etc.) that does not contact food and the piping system of water for food manufacturing should be clearly distinguished by color and transported in completely separate pipelines. There should be no backflow or mutual intersection. 5.8 Lighting facilities
5.8.1 There should be sufficient natural lighting or artificial lighting in the factory building. The daylight factor of the workshop should not be lower than the standard IV level. The mixed illumination of the working surface of the quality control site should not be lower than 5401x, the working surface of the processing site should not be lower than 2201x, and other places should not be lower than 1101x. The light source should not change the color of the food.
5.8.2 Lighting facilities should not be installed directly above the exposed food. Otherwise, safe lighting facilities should be used to prevent food contamination when broken. 5.9 Ventilation facilities
5.9.1 Air conditioning facilities should be installed in the clean operation area to prevent excessive indoor temperature, steam condensation and keep the indoor air fresh; general production workshops should be equipped with ventilation facilities to remove damp and dirty air in time. When air conditioning, air intake and exhaust or fans are used in the factory, the air flow should flow from the high clean area to the low clean area to prevent food, production equipment and inner packaging materials from being contaminated. 5.9.2 Where odors and gases (steam and toxic and harmful gases) or dust are generated and may contaminate food, there should be appropriate removal, collection or control devices.
5.9.3 The exhaust port should be equipped with an easy-to-clean, corrosion-resistant mesh cover to prevent harmful animals from invading people; the air inlet must be more than 2m above the ground, away from pollution sources and exhaust ports, and equipped with air filtering equipment. The ventilation and exhaust devices should be easy to disassemble, clean, repair or replace. 5.10 Hand-washing facilities
5.10.1 A sufficient number of hand-washing and hand-drying equipment should be set up in appropriate and convenient locations (such as workshops: main entrances, toilets, and processing areas). An independent hand-washing and disinfection room should be set up at the main entrances and exits of clean work areas and quasi-clean work areas. 5.10.2 A sufficient number of hand-washing and hand-drying equipment should be set up in the hand-washing and disinfection room, and a shoe disinfection pool or a shoe cleaning sole cleaning facility with equivalent functions or other effective cleaning measures should be set up (when setting up a shoe disinfection pool, if a chlorinated disinfectant is used, the remaining chlorine concentration should be kept above 200 mg/kg). Shoe-changing facilities should be set up in clean work areas that need to be kept dry. 3
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5.10.3 The drainage of hand-washing facilities should have devices to prevent backflow, harmful animals from invading people, and odor. Liquid cleaning and disinfecting agents and simple and easy-to-understand hand-washing method signs should be available near the hand-washing facilities. 5.10.4 The hand-washing station should be constructed of impermeable materials such as stainless steel or ceramics. Its design and construction should not easily hide dirt and dirt and be easy to clean and disinfect.
5.10.5 The faucet should be a non-manual switch such as a foot-operated, elbow-operated or inductive switch. There should be a sufficient number of inductive hand-washing facilities nearby.
5.11 Changing room
5.11.1 The changing room should be located at the entrance of the workshop and have independent compartments. The changing room should be separated by men and women and adjacent to the hand-washing and disinfection room. The changing room should have proper lighting and good ventilation.
5.11.2 The changing room should have a space of sufficient size for employees to change clothes. There should be enough lockers, shoe cabinets and full-body changing mirrors according to the number of employees. bzxZ.net
5.12 Toilets
5.12.1 Toilets provided for workshop employees should be connected to the main body of the workshop, and a hand washing and disinfection room should be set up to isolate the toilet from the workshop. The outer door of the toilet should not face the clean working area or quasi-clean working area. 5.12.2 The outer door of the toilet should be able to close automatically (at least a normally closed spring free door should be used), and it should not face the food processing area or storage area, but this does not apply if there are buffer facilities and exhaust facilities (effectively controlling the air flow direction) that can effectively prevent contamination. 5.12.3 The floor, walls, toilet bowl, etc. of the toilet should be constructed of materials that are impermeable, easy to clean, and do not accumulate dirt, and whose surfaces can be cleaned and disinfected. Toilets should be flush-type, and their number should be sufficient for employees to use. 5.12.4 The setting of hand washing facilities in the toilet should comply with the provisions of 5.10 and should be located near its exit. 5.12.5 Toilets should be equipped with effective exhaust (odor) devices and appropriate lighting. Doors and windows should be equipped with stainless steel or other tight, strong, easy-to-clean screen doors and screen windows.
5.12.6 Toilet drainage pipes should be separated from workshop drainage pipes and should have reliable anti-odor water seals. 5.13 Warehouses
5.13.1 Storage places should be set up according to the different properties of raw materials, auxiliary materials, semi-finished products, finished products, etc., and cold (frozen) storage should be set up when necessary. 5.13.2 Raw material warehouses and finished product warehouses should be set up separately. When different items of different properties are stored in the same warehouse, they should be properly isolated (such as classified and stored on shelves).
5.13.3 The warehouse structure should be able to reduce the quality deterioration of raw materials, semi-finished products, and finished products in storage and custody, and have a structure to prevent pollution. It should be built with non-toxic and sturdy materials. Its size should be sufficient to allow operations to proceed smoothly and be easy to maintain cleanliness. It should also have devices to prevent harmful animals from invading (such as rat-proof boards or rat-proof trenches at the door of the warehouse). 5.13.4 The warehouse should be equipped with sufficient number of pallets (storage racks) and the storage items should be at least 20cm away from the wall and the ground to facilitate air circulation and the handling of items.
5.13.5 Cold (frozen) storage should be equipped with thermometers, temperature measuring devices or temperature automatic recorders that can correctly indicate the temperature in the warehouse, and should be equipped with automatic controllers or automatic alarms that can warn of abnormal temperature changes. 6 Equipment
6.1 Design
6.1.1 The design and construction of all mechanical equipment should be conducive to ensuring food hygiene, easy to clean and disinfect, and easy to check. There should be a structure that can prevent lubricating oil, metal debris, sewage or other substances that may cause pollution from mixing with food during use. 6.1.2 The food contact surface should be smooth, without depressions or cracks, to reduce the accumulation of food debris, dirt and organic matter, and minimize the growth of microorganisms.
6.1.3 The design should be simple and easy to drain and keep dry. 6.1.4 The design and manufacture of storage, transportation and processing systems (including gravity, pneumatic, closed and automatic systems) should be easy to maintain in good sanitary conditions.
GB12693—2003
6.1.5 In food processing or handling areas, equipment and utensils that do not come into contact with food should also be constructed so that they can be easily kept clean. 6.1.6 All material storage equipment in the factory, such as milk storage tanks, ingredient tanks, etc., should be equipped with top covers. There should be designated spare parts racks for equipment storage outside the production and raw material packaging material storage areas, and they should be easy to keep clean and dry so that various tools can be returned to designated locations in time after use.
6.1.7 Cleaning and disinfection equipment and milk pipes should adopt a cleaning in place (CIP) system. 6.2 Materials
6.2.1 All equipment and utensils used in food handling areas and those that may come into contact with food shall be made of materials that are non-toxic, free of odor or foreign smell, non-absorbent, corrosion-resistant and able to withstand repeated cleaning and disinfection. At the same time, the use of inappropriate materials that may cause contact corrosion shall be avoided. 6.2.2 Wood materials shall not be used on product contact surfaces. 6.3 Production equipment
6.3.1 The arrangement shall be orderly to ensure smooth production operations and avoid cross contamination, and the capabilities of each equipment shall be able to cooperate with each other. 6.3.2 Measuring instruments and recorders used for measurement, control or recording shall be able to fully perform their functions and must be accurate and calibrated regularly. 6.3.3 Compressed air or other gases used for food, cleaning food contact surfaces or equipment shall be filtered and purified to prevent indirect contamination.
6.3.4 Milk collection and storage equipment should include metering equipment, milk barrels and milk tank trucks and other milk storage equipment, as well as washing and sterilization equipment, filters or milk purifiers, cooling equipment, milk storage tanks with insulation layers, raw milk inspection equipment, refrigeration equipment, etc. 6.3.5 Pretreatment equipment should include mixing and blending equipment (raw material blending tank, standardized blending tank), homogenizer, filter or milk purifier, heat exchanger (sterilizer), etc.
6.3.6 Fresh milk and reconstituted milk processing equipment should include pretreatment equipment, emulsion storage equipment, bottle washing machine and bottling machine (limited to glass bottles) or automatic paper packaging machine or plastic film packaging machine, white date printing (spraying) machine, cleaning equipment, finished product cold storage, etc. 6.3.7 Fermented milk processing equipment should include pretreatment equipment, bacterial culture equipment, agitator (mixer), fermentation liquid storage tank, fermentation liquid dilution tank, bottle washing machine (limited to glass bottles), bottle inspection machine (limited to glass bottles), filling machine, date printing (spraying) machine, culture room, cold storage, etc. 6.3.8 Condensed milk processing equipment should include pretreatment equipment, concentration equipment, empty can cleaning and disinfection equipment, packaging machine, high pressure sterilizer, cooling equipment, crystallization equipment (sweet condensed milk), etc.
6.3.9 Milk powder processing equipment shall include pretreatment equipment, concentration equipment, spray drying system, powder cooling equipment (fluidized bed), powder sifter, milk powder storage tank or powder silo storage equipment, additive mixing equipment, empty can sterilizer, milk powder packaging machine, etc. 6.3.10 Cream processing equipment shall include raw milk storage tank, cream separator, sterilizer, cream storage tank, buttermilk storage tank, cream pump, cream packaging machine and corresponding equipment added according to actual production, such as cream ripening tank, continuous cream processing machine, etc. 6.3.11 Cheese production equipment shall include pretreatment equipment, cheese tank or curd tank, cheese brine tank, filter press tank car, cheese heating and molding machine, fermentation room, melting pot, cutting machine, packaging machine, etc. 6.3.12 CIP equipment shall include cleaning liquid storage tank, spray head, cleaning liquid delivery pump and pipeline and fittings, program control device, etc. 6.3.13 The processing of other dairy products shall have necessary professional production equipment. 6.4 Quality Management Equipment
6.4.1 Appropriate testing instruments and equipment should be configured according to the needs of raw materials, semi-finished products and product testing. 6.4.2 Necessary basic equipment includes analytical balance (accuracy of one ten-thousandth), pH meter for dairy products, milk hydrometer, centrifuge for fat determination (or fat determination instrument), microbiological testing equipment, protein determination equipment, laboratory table and laboratory rack, reagent cabinet, fume hood, water supply and washing equipment, electric heating, constant temperature and sub-drying equipment, impurity plate filter, magnifying glass, microscope, ultraviolet lamp (254nm), etc. 6.4.3 Professional testing equipment should include ashing furnace (condensed milk, milk powder), viscometer (condensed milk), residual oxygen determination device (milk powder), handheld refractometer, spectrophotometer, etc.
6.4.4 The factory should have sufficient air supply equipment to ensure the normal use of air in drying, conveying, cooling and purging processes. Measures should be taken to filter out oil, moisture, dust, microorganisms, tail worms and other debris from compressed air in key processes and in contact with the surface of dairy products. 6.4.5 The factory should have sufficient inspection equipment for routine quality inspection and hygienic quality inspection of raw materials, semi-finished products and finished products. If necessary, it can entrust authoritative research and inspection institutions to inspect items that it cannot detect. 5
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7 Organization and personnel
7.1 Organization and responsibilities
7.1.1 Production management, quality management, sanitation management and other departments or organizations should have responsible persons. The production person in charge is responsible for production-related management work such as raw material handling, processing and finished product packaging. The quality management person in charge is responsible for the formulation, sampling inspection and quality tracking of quality control standards for raw materials, packaging materials, processing and finished products. The sanitation management person in charge is responsible for the formulation and revision of various sanitation management systems, the sanitation of the factory environment and factory facilities, production and cleaning operations, personnel sanitation, and organizing sanitation training and health examinations for employees. 7.1.2 A first-level (directly affiliated to the highest leader of the enterprise) quality management organization should be established to take overall management responsibility for factory supervision. 7.1.3 The quality management department should have sufficient authority to perform quality management duties, and its person in charge should have the power to stop production or shipment. 7.1.4 The quality management department should set up food inspection personnel to be responsible for the inspection and analysis of general food quality and hygienic quality. 7.1.5 A hygienic management organization should be established, consisting of the person in charge of hygienic management and the heads of production, quality management and other departments, responsible for planning, reviewing, supervising and assessing the hygienic matters of the whole factory.
7.1.6 The hygienic management organization should be equipped with professionally trained full-time or part-time food hygienic management personnel; publicize and implement food hygienic laws and regulations and relevant rules and regulations, be responsible for supervising the implementation and keeping relevant records. 7.1.7 The hygienic management organization and the heads of various departments should be loyal to their duties, set an example, and supervise and educate employees to strictly follow the established operating procedures and regulations.
7.1.8 The person in charge of production and the person in charge of quality management shall not hold the positions of each other. 7.2 Personnel and Qualifications
7.2.1 The person in charge of production management, quality management and hygiene management shall have a college degree or above in a related major or a technical secondary school degree in a related major and have more than 4 years of direct or related management experience. 7.2.2 The person in charge of production shall have the corresponding processing technology, experience and hygiene knowledge. 7.2.3 The person in charge of quality management shall have the ability to discover and identify the occurrence of undesirable conditions in each production link and product, and be competent for the job.
7.2.4 Food inspection personnel shall have a college degree or above in a related major, or have graduated from a technical secondary school and have been engaged in food inspection for more than two years, or have obtained relevant professional inspection qualifications after professional training by an authoritative technical department recognized by the administrative department at or above the provincial level (including the provincial level). 7.2.5 The factory shall have enough quality management and inspection personnel to be able to inspect each batch of products. 7.2.6 Full-time hygiene management personnel shall have a college degree or above in hygiene or related majors or an equivalent degree; part-time hygiene management personnel shall have a technical secondary school degree or above in hygiene or related majors or an equivalent degree. 7.3 Education and Training
7.3.1 The factory shall formulate a training plan and organize the heads of various departments and practitioners to participate in various pre-employment and on-the-job training and relevant food GMP and HACCP learning to increase the relevant knowledge and skills of employees. 7.3.2 Health training and education shall be carried out in accordance with the provisions of 8.7.1 and 8.7.2. 8 Health Management
8.1 Health System
8.1.1 The factory shall formulate a health management system and assessment standards as the basis for health management and assessment, and its content shall include the provisions of each article of this chapter.
2 Health management shall be implemented by individuals and the post responsibility system shall be implemented. 8.1.3 A health inspection plan shall be formulated to specify the inspection time, inspection items and assessment standards. Each inspection requires complete inspection records and assessment results records and archives.
8.1.4 Personnel who fail to perform their health duties shall be dealt with in accordance with the health management post responsibility system. 8.2 Environmental sanitation management
GB12693—2003
8.2.1 The roads and courtyards within and adjacent to the factory area should be kept clean. The roads and ground within the factory area should be kept in good condition, without damage, water accumulation, and dust.
8.2.2 The grass and trees within the factory area should be trimmed regularly to keep the environment clean; it is prohibited to pile up sundries and unnecessary equipment to prevent harmful animals from breeding. 8.2.3 The drainage system should be kept unobstructed, and sludge should not be accumulated. Waste should be properly handled. 8.2.4 The generation of harmful (toxic) gases, wastewater, waste, noise, etc. should be avoided to prevent pollution of the surrounding environment. 8.2.5 Temporary waste storage facilities should be set up in appropriate locations away from the dairy processing room, and the waste should be stored according to its characteristics. Perishable waste should be removed at least once a day, and the containers after removal should be cleaned and disinfected in time. 8.2.6 There shall be no bad smell or harmful (toxic) gas overflow in the waste storage area, and harmful animals shall be prevented from breeding, and food, food contact surfaces, water sources and ground shall be prevented from being contaminated. 8.2.7 Toxic substances shall not be stored or placed in dairy production sites; raw materials, inner packaging materials or other irrelevant items that are not about to be used shall not be piled up.
8.2.8 The air in the dairy production workshop shall be kept clean to prevent food contamination. According to the natural sedimentation method in GB/T18204.1, the total number of colonies in the air of each production operation area shall be controlled within the provisions of Table 1: Table 1
Operation area
Clean operation area
Push clean operation area
8.3 Sanitation management of plant facilities
Colony count per square blood/(cfu/blood)
8.3.1 A maintenance system for plant facilities shall be established, and the plant facilities shall be maintained and repaired or inspected in accordance with regulations to keep them in good sanitary conditions.
8.3.2 All facilities in the factory should be kept clean and repaired or updated in time. If there is damage to the roof, ceiling and wall of the factory, it should be repaired immediately. There should be no damage or water accumulation on the ground. 8.3.3 The milking room, raw material pre-treatment workshop, processing workshop, toilets, etc. (including the ground, gutters, walls, etc.) should be cleaned in time before and after each shift, and disinfected if necessary.
8.3.4 The exterior of lamps and pipes should be cleaned or washed regularly. The staff should tidy up their work environment at any time and keep it tidy. 8.3.5 The cold (frozen) storage room should be cleaned frequently to keep it clean, avoid water accumulation on the ground, and disinfect it regularly. The temperature in the cold (frozen) storage room should be measured and recorded regularly or an automatic recording device should be installed. 8.3.6 If harmful animals are found in the factory, their source should be traced and eliminated, but the method of extermination should be based on the principle of not contaminating food, food contact surfaces and packaging materials (such as avoiding the use of pesticides as much as possible). 8.3.7 In places where raw materials are handled, processed, packaged, and food is stored, containers for storing waste that are impermeable, easy to clean and disinfect (except for single-use containers), and can be tightly covered (sealed) should be provided at appropriate locations, and should be moved out of the factory regularly (at least once a day). Containers that are used repeatedly should be cleaned and disinfected immediately after discarding the contents. Equipment for handling waste should be cleaned and disinfected immediately when it stops operating. 8.3.8 Raw materials, inner packaging materials, or other unnecessary items that are not about to be used should not be piled up in processing workplaces, and toxic and hazardous items are strictly prohibited from being stored.
8.4 Sanitary management of mechanical equipment
8.4.1 Equipment, tools, and production pipelines used for processing, packaging, storage, and transportation should be cleaned and disinfected regularly. The CIF method should be used for disinfection. During cleaning and disinfection operations, care should be taken to prevent contamination of food, food contact surfaces, and inner packaging materials. 8.4.2 All food contact surfaces, including the surfaces of utensils and equipment that come into contact with food, should be disinfected as often as possible, and should be thoroughly cleaned after disinfection (except for thermal disinfection) to prevent residual disinfectants from contaminating food. 8.4.3 After the production is completed, the used equipment and utensils shall be thoroughly cleaned and disinfected, and if necessary, cleaned once more before the production starts.
GB12693--2003
8.4.4 The cleaned and disinfected movable equipment and utensils shall be placed in an appropriate place to prevent their food contact surfaces from being contaminated again, and shall be kept in a suitable state.
8.4.5 The water used to clean equipment and utensils in contact with food shall comply with the provisions of GB5749. 8.4.6 The machinery and equipment and places used for processing dairy products shall not be used for other purposes unrelated to dairy product processing. 8.5 Sanitary management of auxiliary facilities
8.5.1 Water supply station
8.5.1.1 It shall be managed by professional personnel with secondary technical school education or above who have passed the training and assessment. 8.5.1.2 Detailed operating procedures and management systems should be formulated, and there should be strict and systematic water quality inspections, system maintenance and maintenance records. Supervisors should conduct regular inspections and assessments, at least once a quarter. 8.5.1.3 All equipment should be regularly maintained and maintained to maintain good sanitary conditions. The tools used must meet sanitary requirements. Disinfectants must be properly stored, strictly registered for use, and the accounts and materials must be consistent. Other sundries not related to water quality treatment must not be placed in the station. 8.5.1.4 The water storage tank (tower, pool) should be cleaned and disinfected regularly (at least once a quarter); and the water quality should be checked at any time to ensure that the water quality of production water meets the requirements of GB5749.
8.5.1.5 No idle personnel are allowed to enter; various inspection ports, doors and windows must be covered and closed at ordinary times. 8.5.2 Boiler room
8.5.2.1 Boiler operators must be trained before taking up their posts and take up their posts after passing the assessment. 8.5.2.2 The boiler must be operated, repaired and maintained in safe manner in strict accordance with the requirements of the labor department. The chemicals used for water treatment in the boiler should be non-toxic and the amount used should be strictly controlled. The sewage should be discharged regularly (with sewage discharge records) to prevent the deterioration of steam quality. 8.5.2.3 The exhaust smoke of the boiler must be monitored and its discharge should comply with the provisions of GB13271. The exhaust pipes should be cleaned regularly to prevent pollution to the factory environment.
8.5.2.4 If the boiler water is deoxidized and de-hardened by chemical methods, attention should be paid to the effects of deoxidizers and descaling agents on the steam quality to prevent food contamination.
8.6 Cleaning and disinfection management
8.6.1 Effective cleaning and disinfection methods and systems should be formulated to ensure that all workshops and places in the factory are clean and hygienic to prevent food contamination. 8.6.2 Air disinfection should be carried out regularly in the clean operation area and quasi-clean operation area. 8.6.3 The cleaning and disinfection methods must be safe and hygienic to prevent human body and food from being contaminated. The disinfectants and cleaning agents used must be approved by the health administration department.
8.6.4 Equipment and utensils used for cleaning, washing and disinfection should be placed in a special place for safekeeping. 8.7 Personnel hygiene management
8.7.1 New and temporary employees should be trained in hygiene knowledge, and they can only start work after obtaining a training certificate. On-the-job employees should be trained regularly (at least once a year) in personal hygiene and dairy processing hygiene. 8.7.2 The "Food Hygiene Law of the People's Republic of China", this specification and other relevant health regulations should be regularly publicized and educated to all factory employees. There should be an education plan and assessment standards. Health education and training should be institutionalized and standardized. 8.7.3 Dairy processing personnel must maintain good personal hygiene, and should frequently get their hair cut, cut their nails, take a bath and change clothes. 8.7.4 Before entering the production workshop, they must wear clean work clothes, work hats, and work shoes and boots. Work clothes should cover outer clothes, and hair should not be exposed outside the hat. Masks should be worn when necessary.
8.7.5 Workers are not allowed to wear work clothes or shoes when entering the toilet or leaving the production and processing site. 8.7.6 Hands should be kept clean during operation. Hands should be washed and disinfected before going to work and frequently during operation. 8.7.7 Hands must be washed and disinfected in the following situations, and the factory should have supervision measures: after going to the toilet; after handling contaminated raw materials and items; after engaging in other activities unrelated to production. 8.7.8 Personnel who have direct contact with dairy products are not allowed to apply nail polish, wear watches and accessories. 8.7.9 Workers with skin incisions or wounds are not allowed to continue to work in direct contact with dairy products. 8.7.10 Smoking, eating food or doing other activities that are harmful to the hygiene of dairy products are not allowed during work. 8
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8.7.11 Personal clothing should be stored in a personal locker in the dressing room, and other personal items should not be brought into the production workshop. 8.7.12 Unrelated personnel are not allowed to enter the production site. Visitors and visitors shall comply with the hygiene requirements for on-site operators. 8.8 Health management
Health management shall be carried out in accordance with the relevant provisions of GB14881. 8.9 Pest control and pest eradication management
Pest control and pest eradication management shall be carried out in accordance with the relevant provisions of GB14881. 8.10 Toxic and harmful substances management
Toxic and harmful substances management shall be carried out in accordance with the relevant provisions of GB14881. 8.11 Sewage and waste management
8.11.1 Sewage discharge shall comply with the requirements of GB8978. If it does not meet the standards, purification measures shall be taken and it shall be discharged after meeting the standards. 8.11.2 Waste management shall be carried out in accordance with the relevant provisions of GB14881. 8.12 Sanitary facility management
Sanitary facility management shall be carried out in accordance with the relevant provisions of GB14881. 8.13 Work clothes management
Work clothes management shall be carried out in accordance with the relevant provisions of GB14881. 9 Production process management
9.1 Formulation and implementation of production operating procedures
9.1.1 The factory shall formulate the "Production Operating Procedures" (hereinafter referred to as "Procedures"), which shall be the responsibility of the production department, and the approval of the quality management department and relevant departments or organizations shall be obtained.
9.1.2 The "Procedures" shall formulate (specify) standard production operating procedures, production process management point control methods and standards (at least including production process flow, control points or control objects, control items, control standards or control objectives, control measures and precautions) and mechanical equipment operation and maintenance standards.
9.2 Raw material processing
9.2.1 The raw milk and related raw and auxiliary materials put into production shall comply with the provisions of the "Quality Management Manual" and the requirements of the corresponding standards. When semi-finished products from inside or outside the factory are used as raw materials, their raw materials, production environment, production process and quality control should still comply with the requirements of relevant good operating practices.
9.2.2 Raw materials should be visually inspected before use, and selected when necessary to remove non-compliant parts and foreign debris. 9.2.3 Qualified and unqualified raw materials should be stored separately and clearly and conspicuously marked. 9.2.4 Raw materials and ingredients should be stored to avoid contamination and damage, and quality deterioration should be minimized. Those that need to be frozen should be kept below -18°C, and those that need to be refrigerated should be kept below 7°C. 9.2.5 Raw materials with damaged outer packaging should be stored separately, with the reason indicated, and can only be used after passing inspection. 9.2.6 Materials that can be reused (such as rework materials) or continued to be used should be stored in clean, sealable containers, and clearly marked on the outside of the container.
9.2.7 Thawing of frozen raw materials should be carried out under conditions that prevent deterioration. 9.3 Production operation management
9.3.1 Production operations should comply with safety and sanitation principles and should be carried out under controlled conditions that minimize the growth of microorganisms and food contamination. One way to achieve this requirement is to take strict control measures such as physical factors (such as time, temperature, water activity, pH value, pressure, flow rate, etc., and the specific control standards are formulated by the quality management department) and operation processes (such as freezing, dehydration, heat treatment, acidification and refrigeration, etc.) to ensure that dairy products will not be corrupted or contaminated due to mechanical failure, time delay, temperature change and other factors. 9.3.2 Dairy products that are prone to spoilage should be stored under conditions that comply with the "Regulations" or relevant standards. 9.3.2.1 The center temperature of refrigerated dairy products should be kept below 7°C and above the freezing point. 9.3.2.2 Frozen dairy products should be kept in an appropriate frozen state, and the center temperature of the finished product should be kept below -18°C. 9
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9.3.2.3 If acidic or acidified dairy products are stored at room temperature in closed containers, they should be heated appropriately to kill mesophilic microorganisms. 9.3.3 Methods used to kill or prevent harmful microorganisms, such as sterilization, irradiation, low-temperature sterilization, freezing, refrigeration, pH or water activity control, etc., should be appropriate and sufficient to ensure the quality of dairy products during processing, storage and transportation. 9.3.4 Effective measures should be taken to prevent food from being contaminated by raw materials or waste materials during processing or storage. 9.3.5 The operation, use and maintenance of equipment, containers and utensils used for conveying, loading or storing raw materials, semi-finished products and finished products should avoid contamination of food in processing or storage. Equipment, containers and utensils that have come into contact with raw materials or contaminants shall not be used to handle finished food unless they are thoroughly cleaned and disinfected. All containers for food in process shall not be placed directly on the ground or on contaminated wet surfaces: to prevent splashing water contamination or indirect contamination caused by contamination on the outside of the bottom of the container. 9.3.6 The water used for ice cubes that come into direct contact with food during processing shall comply with the provisions of GB5749 and be made under sanitary conditions. 9.3.7 Effective measures (such as screens, traps, magnets, electronic metal detectors, etc.) should be taken to prevent metal or other foreign matter from mixing into dairy products.
9.3.8 For foods that need to be sterilized, the sterilization temperature (especially the temperature at the inlet and outlet of the equipment) and time should be strictly controlled and the food should be cooled quickly and quickly moved to the next section. At the same time, the equipment should be cleaned regularly to prevent the growth and contamination of heat-resistant bacteria and minimize contamination. If sterilized food needs to be cooled before filling, the cooling water should comply with the provisions of GB3749. 9.3.9 Dairy products (such as milk powder) that rely on controlling water activity to prevent the growth of harmful microorganisms should be processed to a safe moisture content (water activity control standard) and maintained. The effective control measures are as follows: adjust its water activity; control the ratio of soluble solids to water in the finished product; use waterproof packaging or other methods to prevent the finished product from absorbing water, so that the water activity does not exceed the control standard. 9.3.10 Dairy products that rely on controlling pH to prevent the growth of harmful microorganisms should be adjusted and maintained at a pH below 4.6. 9.3.11 The inner packaging material should be able to properly protect the food during normal storage, transportation and sales, prevent harmful substances from migrating into the food, and meet hygiene standards. Used items must not be reused, but glass bottles and stainless steel containers are not limited. They should be thoroughly cleaned, disinfected, washed again and inspected before use. 9.3.12 Large-area flushing should be avoided during the production process. If necessary, the nozzle should be lowered as much as possible for close-range flushing to reduce splashing of water droplets and keep the surrounding environment dry.
9.3.13 Electric welding, cutting, grinding and other work should not be carried out during the production process to prevent Avoid odor and debris contamination. 9.4 Equipment maintenance and repair
Daily maintenance and repair of equipment should be strengthened to keep the equipment clean and hygienic; correct operating procedures should be strictly followed; faults should be eliminated in a timely manner to prevent situations that affect the sanitary quality of the product. Before each production, check whether the equipment is in normal condition and whether it can operate normally; all production equipment should be regularly inspected and maintained and records should be kept. 10 Quality Management
10.1 Preparation and implementation of the quality management manual 10.1.1 The factory should formulate a "Quality Management Manual" (hereinafter referred to as the "Manual", which will be the responsibility of the quality management department and strictly followed after approval by the production department to ensure that the dairy products produced meet the standards specified in the "Manual". Actual work If it is not in accordance with the provisions of the Manual, it should be recorded and handled appropriately. The Manual should include the provisions of 10.2, 10.3, and 10.4 of this standard and the following contents: a) Sampling methods for raw materials, semi-finished products, and finished products; b) Precautions for sampling sites;
Matters related to the implementation of the inspection plan; d)
Determination of inspection results;
Matters related to the notification of the quality management department to the production department and warehouse management department based on the determination results; e)
f) Storage of samples;
Matters related to the inspection of inspection equipment;
Matters related to the preservation of experimental inspection methods and samples; i) Matters related to sampling when it is necessary to re-test. 10
10.1.2 If the method used for inspection adopts a modified simplified method, it should be checked against the standard method regularly. 10.1.3 Measurement management
GB 12693-2003
10.1.3.1 Measurement equipment should be managed by a dedicated person. Units with conditions may set up a measurement room to be responsible for the management of measurement equipment, including daily calibration, maintenance and repair, registration and other work.
10.1.3.2 The measuring instruments used in production (such as thermometers, pressure gauges, weighing machines, etc.) should be calibrated regularly and records should be kept. Thermometers and pressure gauges installed in heating and sterilization equipment that are closely related to the safety and hygiene of dairy products should be calibrated at least once a year by a nationally recognized measurement unit.
10.1.4 Quality management records should be processed with appropriate statistical methods to provide a correct basis for judgment. 10.1.5 The factory should establish an effective internal supervision and inspection system for GMP-related management measures, strictly implement them and keep records. 10.2 Quality management of raw materials
10.2.1 The manual should specify the quality specifications, inspection items, acceptance criteria and inspection methods of raw materials in detail, formulate and implement the operating procedures such as weighing, sampling, inspection, judgment, review, processing and use. 10.2.2 Each batch of raw materials and packaging materials must be inspected and qualified before entering the factory for use. When purchasing, the supplier should be required to provide inspection certificates or test reports.
10.2.3 Raw materials that are rejected should be marked (unqualified or prohibited) and stored separately. 10.2.4 Qualified raw materials should be handled according to the principle of "first in, first out". 10.2.5 Raw materials entering the factory should be assigned batch numbers according to production date, vehicle type or supplier number, and the batch numbers should be used in the production record sheet for easy traceability.
10.2.6 Raw materials whose packaging containers are damaged during the sampling process should be handled immediately to prevent deterioration. 10.2.7 For raw materials that have been stored for a long time and whose quality may change, regular sampling should be carried out to confirm the quality. 10.2.8 For those that require special storage conditions due to quality preservation, Storage conditions should be controlled and recorded. 10.2.9 Raw milk should be subjected to the following hygienic inspections. 10.2.9.1 Freshness inspection: acidity inspection (lactic acid expression method), viable bacteria inspection (such as Methylene blue bacteria inspection), alcohol test, etc. 10.2.9.2 Inspection of special ingredients: antibiotic inspection, preservative inspection and adulteration identification inspection, etc. 10.2.10 When raw materials may contain pesticides, heavy metals or mycotoxins, their contents should be confirmed to meet national standards before use. Whether the content meets the standards should be determined based on the inspection certificate or the inspection certificate provided by the supplier. The results of the test report and the sampling inspection. 10.2.11 Food additives should be stored in a special warehouse or counter, and managed by a dedicated person. Attention should be paid to the correct method of collecting materials and the validity period, and the types, purchase quantities and usage quantities used should be registered in a special book. Its use should comply with the provisions of GB2760. 10.3 Quality management during processing
10.3.1 The factory should adopt the HACCP management method, and identify the critical control points based on the results of hazard analysis and risk assessment, and formulate control standards and control measures as well as corrective measures to be taken in case of deviation from the control standards. The manual should specify the inspection items, inspection standards, sampling and inspection methods of the control points in detail and strictly implement them. 10.3.2 Strictly implement the production operation procedures, and the formula and process conditions shall not be changed without approval. 10.3.3 In order to grasp the quality of each step of the production process and facilitate future tracing, the factory should sample semi-finished products at the control points in the production process, supervise and record the situation, and prepare management reports such as quality record sheets and production sheets. 10.3.4 The quality of the final semi-finished products should be analyzed batch by batch, and they can only be filled and packaged into finished products after confirming that their quality is qualified. 10.3.5. Conduct microbial (colony count, coliform) inspection on the first finished product and other sampled finished products after packaging every day, and conduct fungus and yeast inspection when necessary to confirm whether the cleaning and disinfection operations are correct and thorough. 10.4 Quality management of finished products
10.4.1 The manual should specify the quality specifications, inspection items, inspection standards, sampling and inspection methods of finished products in detail. The lower limit of quality specifications shall not be lower than the national standards. In principle, the inspection methods shall be based on the national standard methods. If non-national standard methods are used, they shall be regularly checked with the standard methods.
10.4.2 Representative samples shall be taken from each batch of finished products, and the following inspection and analysis items shall be implemented: physical and chemical inspection, microbiological inspection, sensory inspection, outsourcing 11
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