Pre-requisite program
Overview
The HACCP plan must be established and implemented on the basis of a pre-requisite program that ensures the environment and activities necessary for the production of safe and hygienic food.
A business operator who intends to be certified as a HACCP-applied establishment must develop and implement a pre-requisite program that contains safety standards and sanitation standards to build a basic system for manufacturing, processing and cooking safe and hygienic food under the relevant legal requirements, such as the Food Sanitation Act.
A pre-requisite program must include the basic and essential sanitation management for a safe and hygienic establishment, such as business establishment, staff, manufacturing facilities, freezing facilities, water, storage, inspection and recall management. The operator must prepare a specific standard including persons in charge, details of work, the period of working and the method of inspecting and recording the HACCP implementation.
Operation of specific pre-requisite program for development, application, improvement and maintenance
Operation
Development of pre-requisite program
To prevent food contamination and deterioration from possible hazards in the process and environment of manufacturing and cooking, food manufacturing and processing facilities and mass catering services must develop a pre-requisite program that specifies the basic hygiene management methods and procedures.
The pre-requisite program is composed of eight parts: 1. business establishment management, 2. hygiene management, 3. manufacturing facility management, 4. refrigerating and freezing facility management, 5. water management, 6. storage and transportation management, 8. inspection management and 8. recall program management. Individual management standards must be prepared for each part.
The management standard must have the signature of the person in charge and approval date on completion of the standard and must have a continuous record of the history when revised or amended after that.
The management standard must contain details on the hygiene management method, the period and the method of monitoring necessary to confirm management activities, and management of implementation records, such as the person in charge and the results.
The pre-requisite program must be prepared and operated systematically to meet all legal requirements for each business establishment and ensure effective hygiene management. However, the detailed standards may vary at the business operator’s convenience (the standard type, form and completion method).
Application of pre-requisite program
The business operator must apply the pre-requisite program to the place of work and then implement verification to assess its effectiveness.
The assessment must confirm that the program is adequate to ensure sanitation security, such as compliance with legal requirements, and is modified if necessary. In addition, the operator is responsible for evaluating the feasibility of the program to identify and secure human and material resources.
Maintenance of pre-requisite program
The business operator must conduct a regular review to confirm and evaluate whether the pre-requisite program can be effective prevention of food contamination and deterioration from hazards in the process of manufacturing and processing and whether workers are implementing the program according to the management standards.
According to the results, the operator must modify the relevant regulations, change its facilities, equipment, working methods or the person in charge or have staff training to ensure effective implementation of the pre-requisite program.
The verification of the program may be conducted together with HACCP system verification and performed individually.
Improvement measure
The business operator is advised to take proper corrective action if he or she determines that implementing and maintaining the program can no longer secure food safety.
Application Standard
Food manufacturing and processing business, etc.
Place of work
- Separate independent buildings or places from the facilities used for purposes other than food treatment
- Prevent leakage or influx of dust and insects from the exterior walls and roofs of the place of work
- Properly sealed entrances and windows
- Divide the place of work into clean zone and general zone and separate them with walls to prevent cross-contamination
- Separate, divide or partition the place of work depending on the characteristic and working processes of the products
- Example of division
| Category | In the case of thermal processing(or sterilization) before inner packaging | In the case of thermal processing(or sterilization) after inner packaging | In the case of no thermal processing(or sterilization) in the entire process |
|---|---|---|---|
| Clean zone | Manufacturing and processing area after thermal processing where food is exposed Inner packaging area |
Manufacturing and processing area where food is exposed Inner packaging area |
Manufacturing and processing area where food is exposed Inner packaging area |
| Semi-clean zone | A working area where thermal processing is performed | A working area where food is exposed other than preprocessing area | A working area where food is exposed other than preprocessing area |
| General zone | A working area where food is treated after inner packaging | A working area where food is treated after inner packaging | A working area where food is treated after inner packaging |
Floor, wall and ceiling of the building
- Use materials that are water-resistant, heat-resistant, chemical-resistant, antibiotic, corrosion-resistant, etc.
- No dents, cracks and holes allowed
- The ceiling must be easy to clean and as bright-colored as possible
Drainage
- A well-drained place of work and drainage pipe without accumulation
- Prevent backflow of drainage
Entrance
- The entrance of the place of work must have the washing, drying and sterilizing equipment nearby
Passage
- The passageway inside the place of work must not be used for other purposes to ensure employees can travel through it quickly and must have paths and routes identified to prevent cross-contamination
Windows
- Make sure broken windows are not scattered or mixed with other things
Sunlight and lighting
- The place of work where food is exposed or inner packaging is performed must be constructed with corrosion-resistant materials and have proper protection from break or debris
- Sorting and inspection area (eye-inspection only if required): 540 lux or more
Additional facilities
Restroom, changing station, etc.
- Separate ventilation facilities such as external discharge terminals must be equipped
- Walls and floors that are water-resistant and corrosion-resistant, making it easy to clean
- Restroom entrances must have the washing, drying and sterilizing equipment nearby
- Changing stations must be managed to separate outside clothing (and shoes) from safe, hygienic clothing (and shoes) to prevent cross-contamination
Working environmental management
Circulation planning and prevention contamination between processes
- Establish and operate circulation planning for logistics and employees to prevent cross-contamination that might occur in the entire place of work
- Establish a management plan for foreign substances that might occur in the entire place of work
- Establish and manage hygiene rules including standards for entry and exit from the structures, working clothes, and cleansing and disinfection for clean zone and general zone
- Establish temperature management planning (and humidity management plan if necessary) for each process including manufacturing, processing, packaging, storage, etc. and install thermometers for managing the implementation of the plan
Ventilation facility management
- Install sufficient ventilation facilities to discharge odors, off-flavor, harmful gas, exhaust and steam arising in the place of work
Protection against insect or hot weather
- An air intake and exhaust pipe that leads outside must be attached with a fly screen or filter and must be regularly cleaned or replaced
- Manage the place of work in a sanitary way to prevent influx and breeding of insects or rodents and establish pest control for checking for the influx of them
- Perform protective measures from insects during extermination and clean facilities or food that have had contact with the insects, either directly or indirectly, after working.
Personal hygiene management
- Employees must always wear sanitary clothes, hats and shoes (and sanitary masks and gloves if necessary) and care for them in a hygienic way
- Employees are not allowed to wear any personal accessories in their place of work
Waste management
- Waste containers must be sealable to help prevent water and odor from leaking out and be cleaned and sterilized as often as possible
- Ensure that waste and wastewater treatment facilities are installed and operated in an isolated site away from the place of work and that waste is disposed of and taken out on a regular basis
Cleaning or disinfection
- A place of work must be equipped with adequate facilities or equipment to clean or disinfect employees, machinery, equipment, containers, etc.
- Establish guidelines or standards for the proper way of washing hands
- Establish standards for cleaning or disinfection regarding the following matters:
- - Employees
- - Sanitary clothes, hats, shoes etc.
- - Surroundings of the place of work
- - Inside workroom
- - Food manufacturing facilities (including transferring pipes)
- - Refrigeration and freezing facilities
- - Water storage facilities
- - Storage and transportation facilities
- - Vehicles, tools and containers for transportation
- - Monitoring and inspection equipment
- - Ventilation facilities (including filters and fly screen)
- - Waste disposal containers
- - Cleaning and disinfection tools
- - Other requirements
- Cleaning or disinfection standards include the following:
- - Areas to be cleaned and disinfected by items
- - Cleaning and disinfection methods and cycles
- - The person in charge of cleaning and disinfection
- - Proper use of tools for cleaning and disinfection (ex: specific use of detergent and disinfectant)
- Keep and take care of equipment and containers for cleaning and disinfection including detergent and disinfectant at a given location in a sanitary way
- For dismantlable cleaning equipment, disassemble and clean the tool at every cleaning and disinfection and follow the Cleaning in Place (CIP) system for facilities and equipment applicable to the system
- Implement necessary protective measures to prevent food contamination from detergent and disinfectants
- Check for the effect of cleaning and disinfection regularly
Management of manufacturing facilities, machinery and equipment
- Appropriately arrange the facilities and equipment based on the working process to prevent contamination of manufacturing and processing or between facilities
- Install and operate the facilities and equipment in a sanitary way to prevent contamination caused by lubricant or other hazards
- The facilities and equipment must be 1. water-resistant and corrosion-resistant that have no ill effects on the human body; 2. easy to clean; 3. cleaned and disinfected with heat, steam or disinfectant
- Install and manage devices for measuring and recording temperature for treatment facilities where the temperature should be raised or lowered
- Take corrective actions such as maintenance work through regular inspection
Refrigeration and freezing facilities management
- Keep the internal temperature of the refrigeration facilities below 10 °C (except for distributing finished products) and freezing facilities below –18 °C
- Temperature change should be observable from the outside and the temperature sensor should be located where the temperature is measured highest
- Conduct regular inspection and maintenance and keep records of the results
Water management
- Food manufacturing and processing must use underground water that is suitable for water quality standards of tap water or drinking water
(For underground water, water sources and intakes must be properly managed so that it is not likely to be contaminated from water from toilets, waste, waste treatment facilities or breeding farms. If necessary, make sure to install sterilizing or disinfecting devices) - Conduct water inspection for underground water regarding all water quality standards at least once a year (every six months for drinking water)
- Conduct water inspection at least once a month regarding micro-organisms in the water according to drinking water quality standards
- Use materials harmless to humans for water storage tanks and pipes and install locking devices to prevent the inflow of pollutants from the outside
- Clean and disinfect the water storage tanks every six months and keep records of the results
- Drinking water pipes and non-drinking water pipes must be distinguished with identifying marks and they are not crossed or joined
Purchasing and warehousing
- Use only raw and subsidiary materials that are confirmed according to inspection report or meet in-house warehousing criteria
Cooperator management
- According to management planning, control the material provided by cooperator such as supplier of raw and subsidiary materials. In addition, establish the inspection system and keep records of the inspection results
- Omit this step if the supplier is a HACCP-certified business establishment under the Food Sanitation Act and the Livestock Product Processing Act
Transportation
- Separate the food being transported from other items (non-food) to prevent cross-contamination
- Keep the internal temperature of refrigerated trucks below 10 °C and freezer trucks below –18 °C and attach the temperature sensor to the outside of vehicles, allowing temperature change to be observable from the outside
Storage
- Manage shipping and receiving status based on first-in-first-out and keep records of the process
- Separate raw and subsidiary materials and finished products and maintain separate distance from floors and wall
- Set the methods for identifying, returning and discarding incongruity products and keep records of the process
- For toxic, inflammable materials and inedible chemicals, hold the materials or chemicals in designated places with good ventilation
Product inspection
- Conduct a self-inspection in a laboratory or have the products inspected following an agreement with the inspection body
- The inspection result shall include details as follows:
- - Sample name
- - Date of manufacture or expiration date (quality maintenance period)
- - Date of inspection
- - Inspection items, standards and results
- - Results and decision date
- - Signature and seal of the inspector and decision maker
- - Other requirements
Inspection of facilities and equipment
- Calibrate the temperature measuring devices at least once a year
- Carry out regular inspection and management of airborne substances such as bacteria to keep the place of work clean
- Calibrate inspection equipment and devices regularly and keep records of the results
Recall program management
- Establish and operate a recall program specifying specific recall procedures and method
- Record and keep necessary information regarding the facilities including production location, date and line
- Devise a proper method for product tracking such as labeling of code or lot management
Catering business (including mass catering service. food service, packaged meal service), etc.
Place of work
- A place of work must be located in areas fending off the effects of pollutant sources
- Prevent the inflow of outside materials such as dust and insects
- Keep the surroundings of places of work clean
- Divide the place of work into clean zone and general zone and separate them with walls to prevent cross-contamination
- Example of division
| Category | In the case of thermal processing(or sterilization) before inner packaging | In the case of thermal processing(or sterilization) after inner packaging | In the case of no thermal processing(or sterilization) in the entire process |
|---|---|---|---|
| Clean zone | Manufacturing and processing area after thermal processing where food is exposed Inner packaging area |
Manufacturing and processing area where food is exposed Inner packaging area |
Manufacturing and processing area where food is exposed Inner packaging area |
| Semi-clean zone | A working area where thermal processing is performed | A working area where food is exposed other than preprocessing area | A working area where food is exposed other than preprocessing area |
| General zone | A working area where food is treated after inner packaging | A working area where food is treated after inner packaging | A working area where food is treated after inner packaging |
Floor, wall and ceiling of the building
- Use materials that are water-resistant, heat-resistant, chemical-resistant, antibiotic, corrosion-resistant, etc.
- No dents, cracks and holes allowed/li>
- The ceiling must be easy to clean and as bright-colored as possible
Drainage
- A well-drained place of work and drainage pipe without accumulation
- Prevent backflow of drainage
- Make sure the pipe connection is made of materials that are harmless to humans
- Make sure the pipe is easy to clean and insulated to prevent condensation
Entrance
- Install fly screen door or buffer zone to prevent the inflow of dust and insects at the entrance to the outside of the place of work
- The entrance of the place of work must have the washing, drying and sterilizing equipment nearby
Passage
- The passageway inside the place of work must not be used for other purposes to ensure employees can travel through it quickly and must have paths and routes identified to prevent cross-contamination
Windows
- Make sure broken windows are not scattered or mixed with other things
Sunlight and lighting
- The place of work where food is exposed or inner packaging is performed must be constructed with corrosion-resistant materials and have proper protection from break or debris
- Sorting and inspection area (eye-inspection only if required): 540 lux or more
Additional facilities
Restroom
- Install separate ventilation facilities such as external discharge terminals
- Walls and floors that are water-resistant and corrosion-resistant
- Restroom entrances must have the washing, drying and sterilizing equipment nearby
Changing station and staff lounge
- Set up changing station and staff lounge where it is not likely to affect the place of work
- Install ventilation facilities leading to the outside of the place of work and separate street dress (and shoes) from safe, hygienic clothing (and shoes) to prevent cross-contamination
Working environmental management
Circulation planning and prevention contamination between processes
- Establish and operate circulation planning for logistics and employees to prevent cross-contamination in the entire work process from bringing in food materials and distributing to shipping
- Establish and manage hygiene rules including standards for entry and exit from the structures, working clothes, and cleansing and disinfection for clean zone and general zone
Temperature and humidity management
- Establish temperature management planning for each process including manufacturing, processing, cooking and storage and install a thermometer (and a hygrometer if necessary) in the place of work
Ventilation facility management
- Install ventilation facilities or ventilation hoods for discharging odors, off-flavor, harmful gas, exhaust and steam
- An air intake and exhaust pipe or ventilation hood that leads outside must be attached with a fly screen, filter or opening and closing facility and regularly cleaned or replaced
Protection against insect or hot weather
- Manage the place of work in a sanitary way to prevent influx and breeding of insects or rodents and establish pest control for checking for the influx of them
- Perform protective measures from insects during extermination and clean facilities or food that have had contact with the insects, either directly or indirectly, after working.
Employee health management
- Conduct employee and staff health examination
- Prohibit food from being directly manufactured, processed or treated by employees carrying foodborne diseases or having symptoms like infectious wounds, skin diseases, inflammation or diarrhea
Personal hygiene management
- Employees must always wear sanitary clothes, hats and shoes (and sanitary masks and gloves if necessary) and care for them in a hygienic way
- Employees are not allowed to wear any personal accessories in their place of work
Waste management
- Waste containers must be sealable to help prevent water and odor from leaking out and be cleaned and sterilized as often as possible
- Ensure that waste and wastewater treatment facilities are installed and operated in an isolated site away from the place of work and that waste is disposed of and taken out on a regular basis
Working hygiene management
Prevention of cross-contamination
- Cooking utensils and containers must be classified by purpose and frequently cleaned and sterilized
- Food must be handled at the height of 60 cm or more from the ground
Preprocessing
- Thaw frozen food by refrigerator thawing, microwave thawing or running water thawing (21 °C or less)
- After thawing, food should be used immediately or kept under refrigeration. Do not thaw the food left
Prevention of cross-contamination
- For food that needs cooling after being cooked, refrigerate it as soon as possible to prevent contamination during the process. Set the proper temperature for cooling and establish time standards
- When subdividing the refrigerated foods, handle a small amount at a time to keep the temperature of the food under 15 °C
Cooking equipment
- Equipped with sufficient cooking equipment including machinery, utensils, etc.
- Set up ultraviolet ray sterilizer for disinfecting cooking utensils or have them sterilized with boiling water
- The facilities and equipment must be 1. water-resistant and corrosion-resistant that have no ill effects on the human body; 2. easy to clean; 3. cleaned and disinfected with heat, steam or disinfectant
- Conduct regular cleaning and disinfection of monitoring equipment, etc, before and after use to prevent cross-contamination
- Take corrective actions such as maintenance work through regular inspection
Refrigeration and freezing facilities management
- Refrigerating, freezing and cooling facilities must come with sufficient capacity and suitable functions depending on the characteristics of the work
- Keep the internal temperature of the refrigeration facilities below 10 °C (except for distributing finished products) and freezing facilities below –18 °C
- Temperature change should be observable from the outside and the temperature sensor should be located farthest from the cooling source
- Conduct regular inspection, maintenance and cleaning and keep records of the results
Water management
- Food manufacturing and processing must use underground water that is suitable for water quality standards of tap water or drinking water
(For underground water, set up water sterilization and disinfection device) - Conduct water inspection for underground water regarding all water quality standards at least once a year (every six months for drinking water)
- Conduct water inspection at least once a month regarding micro-organisms in the water according to drinking water quality standards
- Use materials harmless to humans for water tanks and pipes and install locking devices to prevent the inflow of pollutants from the outside
- Water storage tanks must be designed for easy inspection and cleaning. Ensure to clean and disinfect the water storage tanks every six months and keep records of the results
- Water used for cleaning facilities, equipment, containers and hands in direct contact with food shall meet the water quality standards of drinking water
- Drinking water pipes and non-drinking water pipes must be distinguished with identifying marks and they are not crossed or joined
Purchasing and warehousing
- Use only raw and subsidiary materials that are confirmed according to inspection report or meet in-house warehousing criteria
- Establish and practice the procedure for return or disposal of inappropriate raw and subsidiary materials
- Ensure to secure space for warehousing inspection and keep inspection equipment (including a dust extractor if necessary)
- Inspect raw and subsidiary materials immediately upon delivery of goods and if the inspection is delayed, keep them at given refrigeration and freezing temperature for each material
Transportation
- Make sure that the products are not contaminated by vehicles (including forklift trucks)
- Keep the internal temperature of vehicles moderate and attach the temperature sensor to the outside of cars, allowing temperature change to be observable from the outside (below 10 °C for refrigerator and below –18°C for freezing)
- Separate ready-to-eat foods and raw ingredients and handle transported food in a sanitary way
- Conduct regular cleaning and sterilizing of vehicles, tools and containers for transportation
Storage
- Manage shipping and receiving status based on first-in-first-out and keep records of the process
- Separate raw and subsidiary materials and finished products and maintain separate distance from floors and wall
- Keep uncooked food and cooked food separately
- Set the methods for identifying, returning and discarding incongruity products and keep records of the process
- Identify inedible chemicals and store them separately
Product inspection
- Conduct regular inspections of subsidiary materials and finished goods and keep records of the result
- Conduct a self-inspection in a laboratory or have the products inspected following an agreement with the inspection body
- For self-inspection, ensure to be equipped with sufficient inspection facilities and equipment in a laboratory
Inspection of facilities and equipment
- Calibrate the temperature measuring devices at least once a year
- Carry out regular inspection and management of airborne substances such as bacteria to keep the place of work clean
- Calibrate inspection equipment and devices regularly and keep records of the results
Recall program management (only for packaged goods being distributed and sold in the market)
- Identify the product recalled regarding its distribution channel, expected consumers and the scope of the sellers
- Establish and operate a recall program specifying specific recall procedures and method
- Record and keep necessary information regarding the facilities including production location, date and line
- Devise a proper method for product tracking such as labeling of code or lot management
Model for facility and equipment in food factory
Standard model for facility and equipment in food factory
- Notice, research purpose, status
- Concept of sanitary factory design, green design, etc.
- Overall design of the outside of factory buildings
- General structure of internal facilities, such as the wall, floor, drainage, air conditioning, etc.
- Overall design of facilities
- Protection against insect or hot weather, waste management
These materials have been developed as a reference for business operators to find the information they need.
Data Source : DAESANG Co., Ltd, A Study on Financial Support and Technical Assistance according to the Mandatory of HACCP (I), A 2004 Report on the Study by the Ministry of Food and Drug Safety.
Reference for renovation of food factory facilities
Concept 1 Hygienic structure of HACCP
- Prevent bacterial contamination and create an environment where a microscopic organism is not likely to grow
- Prevent foreign substances from mixing with foods
- Faithfully follow production environment management system
Concept 2 Build functional space
- A pleasant factory environment
- Computer Integrated Manufacturing (CIM)
- Factory Automation (FA)
- Clear circulation planning
- Around-the-clock response system
Concept 3 Economic food factory
- Energy saving
- Efficient use of manpower
- Initial and running cost reduction
Concept 4 Flexible space
- Space, structure and utility planning in response to product line changes
- Response to technological innovation
- Zone and layout planning that takes enlargement at a future date into consideration
Concept 5 Environmental Response Factory
- Clear building exterior that can express a clean and reliable company image
- Harmony with the surroundings and afforestation planning
- Environmental preservation
Characteristics
- As not only for manufacturing foods, but bringing in raw materials and taking out manufactured goods are performed in the food manufacturing business establishment, therefore site layout planning needs to include an optimal circulation of logistics based on access roads, surroundings of the establishment and plans.
The basic concept of layout plan of roads and surrounding facilities
| Entry | The basic concept of layout plan of roads and surrounding facilities | Category |
|---|---|---|
| Requirement 1 | Design the surroundings of the establishment to be easy to clean. | Construction |
| Requirement 2 | Take measures such as pavement works to prevent a puddle or dust. | Construction |
| Requirement 3 | Pave roads, parking lots and receiving and shipping areas. | Construction |
| Requirement 4 | Build drainage ditch for draining rainwater. | Construction |
| Requirement 5 | Drainage (open type): cover the open-type drain with wire mesh to prevent the inflow or reproduction of rodents. | Construction |
| Requirement 6 | Install the gate for carrying in and out products where there is no seasonal wind. | Construction |
| Requirement 7 | Cover the openings such as entrance, windows and outlets and avoid planting trees and grass that attract insects. | Construction |
| Requirement 8 | Make sure greening will take place as far away as possible from the opening of the establishment and select trees or grass that are less likely to attract insects. | Construction |
Basic planning
- Production planning: product type, production volume, manufacturing process review, circulation and zoning planning
- Facility planning: layout, conditions of the interior (temperature and humidity, illumination, etc.), finishing materials (floor, wall, ceiling, waterproof materials, etc.), composition of utility and production facilities
- Construction planning: design of layout, zoning, movement, sanitary area
Zoning
Zoning after analyzing the primary conditions for food manufacturing
- Identify production list, production volume, manufacturing process and its conditions (such as space requirements, details of work, required personnel, temperature, humidity), the movement of humans and objects, expected risks
- Set cleanliness grade for each manufacturing process based on the characteristics understood (clean zone, semi-clean zone, general zone)
- GMP, SOP, SSOP, 해썹(HACCP) 등 운용을 고려하여 구분Classify those zones considering details of work (preprocessing, filling in, packaging), working environment (heating, non-heating, sealing, exposure to the air) and operation of GMP, SOP, SSOP or HACCP
Division of working areas
- General zone: where raw and subsidiary materials .are handled; it usually refers to a preprocessing area for keeping and cleaning raw and subsidiary materials and storage area for packaging materials and finished products
- Clean zone: where materials to be processed are handled; it can be divided into a clean zone and semi-clean zone according to the characteristics of foods
- - Clean zone: for refrigeration, filling in and packaging (ex: filling in after cooking, packing, primary packaging)
- - Semi-clean zone: for processing and heating (cutting, cooking)
Zoning must be performed concerning protection against insect or hot weather, sterilization, cleanliness and maintenance of temperature and humidity
Basic concept of zoning
| Entry | Basic concept of zoning | Category |
|---|---|---|
| Requirement 1 | All other workrooms including office, recreational rooms and machine rooms are separated from manufacturing areas | Design |
| Requirement 2 | Conduct zoning to prevent cross-contamination between areas with different grades of cleanliness | Design |
| Requirement 3 | Classify processes with different conditions for temperature and humidity to build an optimal manufacturing environment | Design |
| Requirement 4 | Ensure zoning of areas for handling powdery materials and water where water vapor or heat may occur to prevent its diffusion to other areas | Design |
| Requirement 5 | The general zone and clean zone are not adjacent to each other | Design |
| Requirement 6 | Use the same room for efficient use of space if the same hygiene management can be performed (ex: secondary and final packaging) | Design |
| Requirement 7 | Thermal processing, which is likely to cause contamination during the process, is performed in a semi-clean zone | Design |
| Requirement 8 | Set the storage area only for waste treatment | Design |
| Requirement 9 | A semi-clean zone is set up between the clean zone and the general zone | Design |
| Requirement 10 | Use different colors for each zone’s ceiling, wall and floor to awaken workers’ consciousness | Design |
Example of zoning
Circulation design
Circulation planning
Build structure and function for preventing cross-contamination and spread of contamination
| Occurrence of cross-contamination | Detailed cause |
|---|---|
| Cross-contamination from humans | Manufacturing personnel, public service personnel, managers, maintenance workers, visitors for field trips, etc. |
| Cross-contamination from objects | Raw materials, semi-finished products, packing materials, wastes, transportation vehicles, etc. |
| Cross-contamination from environments | Air, water, drainage, utility, etc. |
The basic concept for circulation planning
| Entry | Basic concept of zoning | Category |
|---|---|---|
| Requirement 1 | Separate the movements of humans and objects as much as possible | Zoning |
| Requirement 2 | One-way flow is ideal. Avoid the movement that causes frequent travels between different work areas | Zoning |
| Requirement 3 | Avoid the flow where paths with varying grades of cleanliness are going to cross | Zoning |
| Requirement 4 | Apply the barrier system if the work is performed between different zones | Zoning |
| Requirement 5 | Take necessary measures such as cleaning or sterilization before moving objects to an area with high cleanliness grade - The barrier system located at the entrance of the clean zone remove adhesive things to clothes - Hand-washing facilities installed in the route to the high-clean area |
Zoning |
| Requirement 6 | Ensure that the movement of waste is directed toward the less-clean area | Zoning |
Circulation planning (example)
Movement of humans
- Entrance flow
- Employees → employee entrance → changing shoes (at the gate) → changing station (the locker is divided into an upper part for streetwear and the lower part for sanitary clothes) → moving to a hygiene management area through a dedicated passage (located behind the changing station) → passing procedure (wearing working shoes → washing and sanitizing hands → taking air shower) → automatic door (or no-hands door) → entering manufacturing area (it is recommended that the entrance of cooling or packaging room, a clean working area, is equipped with air shower or full-body disinfectant)
- Route to restrooms
- The restroom is located on the opposite side of the manufacturing area, ensuring employees enter the manufacturing area after doing sanitary action in the sanitary area (SA) between the toilet and the manufacturing area
- The workflow between different zones
- In principle, the work is performed within each zone However, if a workflow is needed between different zones, the work passes through the sanitary area before moving to other zones following the zoning plan
- Movement of field trip visitors
- The factory, which has the concept of an open factory, is equipped with visitor passage for reasons of hygiene to keep third-party from entering the manufacturing area, preventing cross-contamination between employees and visitors.
Movement of objects
- Movement of objects in the factory
- One-way flow (arrival of raw materials → semi-manufactured product → finished products → shipping) to prevent cross-contamination
- General zone (arrival of raw materials, storage, packaging, thawing, etc.)
- Arrival and shipping of raw materials from and to the establishment pass through the front room
- Semi-clean zone (stirring/molding/heating or steaming)
- It is recommended that stirring, molding and heating process is separated even though they have the same cleanliness grades (semi-clean working area)
- The stirring process always uses water and requires cleaning for every batch, making the floor wet. Therefore, the process needs to be separated to minimize the risk of microbial reproduction
- Clean working zone (cooling and inner packaging)
- When moving materials or products from the packaging material warehouse (general zone) to the packaging room (clean zone), make them pass through the pass room (pass-box) where the shower machine is installed to remove the dust
- Establish circulation planning for packaged products to be transferred to the warehouse after passing through the front room with an interlock on the doors
- General zone (outer packaging and finished product warehouse)
- It is recommended to enable first-in-first-out by free-rack in the product warehouse
- Ensure to ship the finished products from the rack through the front room
Secure one-way flow and set up the barrier
Purpose
To prevent the spread of contamination caused by an object or person to other working areas
The basic concept of one-way flow and setting up the barrier
| Entry | Basic concept | Category |
|---|---|---|
| Requirement 1 | Classify cleanliness grades and arrange working area so that the manufacturing process (arrival of raw materials → processing → shipping) should flow one-way to prevent cross-contamination | Regulation |
| Requirement 2 | Set up the barrier such as the front room or path-room to prevent cross-contamination between different areas, fending off dust and insects | Construction |
| Requirement 3 | It is recommended to have a dedicated passage for supplying subsidiary materials and taking out waste in an efficient way | Operation |
| Requirement 4 | Install a separate hygiene management room with hygiene facilities at the entrance of the working area so that employees should comply with a series of hygiene procedures | Construction |
| Requirement 5 | Set up the front rooms between different manufacturing rooms. In some cases, it is helpful to utilize the spaces as a room for both people and objects with hygiene facilities installed | Construction |
| Requirement 6 | Plan a dedicated passage for people to travel between different manufacturing rooms to prevent raw materials from being contaminated | Operation |
| Requirement 7 | Install a door with high airtightness considering cross-passage | Construction |
| Requirement 8 | Set up the front room or pass room with an interlock device installed before the clean zone | Construction |
| Requirement 9 | Let the air move from the clean zone to the outside, preventing the inflow of pollutant | Construction |
Hygiene management area
- Hand washing and sanitizing
- - Automatic cleaning is recommended
- - Use air-drying device or disposable paper towels
- - As a rule, before entering the clean zone, use an automatic drying machine (ex: jet towel) after washing hands or otherwise install a hand sanitizer
- Shoe changing room
- - Equipped with a roller brush or full-body mirror
- - Set up shoe changing room where employees can change their shoes between outside shoes and sanitary shoes
- - Other areas are not regarded as working areas and apply the standard for outdoor shoes
- Changing station
- - Equipped with a roller brush or full-body mirror
- - The locker is divided into two parts (or three parts) for separating streetwear and sanitary clothes
- - Ensure to give a slope to the upper part of the locker to prevent dust collection or things left alone
- - In the case of a hanger instead of a locker, it is desirable to use a sterile lamp at night
Types and characteristics of barrier
- Air shower product
- Cleans air from the jet nozzle removes adhesive things to humans or objects such as hair and dust and then collect them through the lower filter
- Front room
- No windows and with an interlock and mothproof lamps installed
- A door with high airtightness
- Increases airtightness using rubber packing around the door
- Pass-room (pass-box)
- Moves things between workrooms or to the outside, which is designed to prevent the inflow of dust or outside air
- Air curtain
- Provides air with sufficient wind speed to prevent loss of heat or purified air and the inflow of dust and insects
- Dock shelter
- Installed on the dock to cover the top and sides of trucks, keeping the entrance and truck from the outside
- High-speed seat shutter
- Used at the entrance of factory or warehouse and automated transportation line, maintaining indoor air quality and preventing dust and insects
- Actual pressure adjustment
- Positive pressure ventilation in areas with high cleanliness