Specific Provisions for TQF Canned Food Factories

TQF-PCS-016

TQF Management Technical Specifications—Certification Regulation Ver. 2.0

1 / 66 ©Taiwan Quality Food Association

[Canned Food]

Specific Provisions for TQF Canned Food Factories

1 Purpose

This specifications provide special guidance for food factories to ensure that during food processing, packaging and transportation, the personnel, premises, facilities, equipment, and sanitary, processing, and quality management are in conformity with good manufacturing practices benchmark and that through the principle of hazard analysis and critical control points (HACCP) will prevent operating under unsanitary conditions, and in environments that may cause food contamination or quality deterioration. It also aims to reduce operation errors and to establish a sound quality assurance system to ensure food safety and product quality stability.

2 Scope of application

The scope of this guidance is applicable to food factories which supply properly packaged canned food for human consumption.

3 Definition of special terms

3.1 Food: Refers to the products and their raw materials for human consumption, either

for eating, drinking or chewing.

3.1.1 Canned Foods: Foods sealed in hermetic containers where commercial

sterilization is performed before and after seaming to ensure long-term storage at room

temperature.

3.1.1.1 Low-acid canned foods (LACFs): Non-alcoholic beverages and canned

foods with a pH value above 4.6 and water activity above 0.85 after

contents reach an equilibrium, and sterilized using a method with a

sterilizing value (F0) above 3.0.

3.1.1.2 Acidified canned foods: Canned foods made with low-acidic or acidic

foods with pH value adjusted by acidifiers and/or acidic foods to maintain

their final pH value below 4.6 (water activity (Aw) above 0.85).

3.1.1.3 Acid canned foods: Canned foods without added acidifiers or acidic foods

during processing, with a pH value at or below 4.6 (water activity (Aw)

above 0.85) in the final equilibrium.

3.1.1.4 Low water activity canned foods: Canned foods that do not have any added

acidifying agent or acidic food during processing and with water activity

below 0.85 and a pH value at 4.6 or above.

3.2 Food factory: refers to the registered factories and manufacturers of properly

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packaged food, which main products are included in the product categories of

product certification application.

3.3 Materials: Refers to raw materials and packaging materials.

3.3.1 Raw materials Refers to the constituents in edible parts of finished product, including primary raw materials, secondary raw materials, and food additives.

3.3.1.1 Primary raw materials: Refers to the major materials used for

manufacturing finished products.

3.3.1.2 Secondary raw materials: Refers to the raw materials used for

manufacturing finished products excluding primary materials and food

additives.

3.3.1.3 Refers to the material which is added to or brought into contact with food

in the course of manufacturing, processing, mixing, packing, transport and

storage of food, with the purpose of coloring, seasoning, preserving,

bleaching, emulsifying, flavoring, stabilizing the quality, fermentation,

increasing viscosity, nutrition fortification, preventing oxidation or other

necessary purpose and added to or come in contact with food unit or

compound.

3.3.2 Packaging material: Refers to the material used as the inner and outer

packaging.

3.3.2.1 Inner packaging material: Refers to the container which is brought into

direct contact with food, such as bottle, tin can, carton, pouch etc. and to

the packaging material which wraps and covers directly the food, such as

foil, film, paper, waxed paper etc. All those materials shall be in

compliance with food sanitation and hygiene laws and regulations.

3.3.2.2 Outer packaging material: Refers to the packaging material which is not

brought into direct contact with food, such as label, carton, wrapping

materials etc.

3.4 Product: Refers to semi-finished product, bulk product and finished product.

3.4.1 Semi-finished product: Refers to the partly processed product which

must undergo further processing before it becomes a finished product.

3.4.2 Bulk product: Refers to the product which had undergone complete

processing, but not packaged or labelled.

3.4.3 Finished product: Refers to the product which has undergone all stages

of manufacturing with packaging and labeling.

3.5 Premises: Refers to the entire or partial plant construction or facilities which are

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used in food processing, packaging, storage etc. or their relevant operation.

3.5.1 Food processing and operation areas: Refers to the areas for handling

raw material, manufacturing, processing and preparation, and packaging

and storage.

3.5.1.1 Raw material handling area: Refers to the area that is provided for raw

material to undergoing preparation, thawing, sorting, cleaning, trimming,

cutting, peeling, hulling, entrails removal, blanching or salting operation.

3.5.1.2 Processing and preparation area: Refers to the area that is provided for

materials processing operations to undergoing cutting, grinding, mixing,

blending, moulding, shaping, cooking, extracting and improving food

characteristic or preservation (such as oil extraction, starch separation,

bean paste manufacturing, emulsification, coagulation, fermentation,

sterilization, freezing or drying, etc.).

3.5.1.3 Packaging room: Refers to the place for packaging of finished product,

which includes the rooms for inner and outer packaging.

3.5.1.3.1 Inner packaging room: Refers to the place for inner packaging

operation in which the packaging material is in direct contact with the

product content.

3.5.1.3.2 Outer packaging room: Refers to the place for outer packaging operation in which the packaging material is not in direct contact with the product content.

3.5.1.4 Sterilization site: A workplace for sterilizing products.

3.5.1.5 Inner packaging material preparation room Refers to the place where the inner packaging materials that can be used directly without requiring any further cleaning and disinfection procedures go through pre-forming or have their outer packaging removed.

3.5.1.6 Buffer room Refers to the area that was set up at the entrance of the controlled operation area to avoid its direct connection with the exterior, when raw materials or semi-finished products are not going through normal manufacturing process and have directly accessed to the operation area.

3.5.1.7 Weighing room

Refers to the area for weighing operation of raw materials, secondary raw materials, food additives, ingredients etc..

3.5.2 Controlled operation area

Refers to the areas where higher degree of cleanliness are required, including clean operation area and semi-clean operation area. The entrance for both people and raw material and the prevention of pests and vectors invasion in those areas

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shall be strictly controlled.

3.5.2.1 Clean operation area

Refers to the area such as the inner packaging room among others where it

is required highest degree of cleanliness.

3.5.2.2 Semi-clean operation area

Refers to the processing, preparation areas among others where the

required degree of cleanliness were below the clean operation area.

3.5.3 General operation area Refers to the storage of raw material, storage of ingredients and outer packaging room among others where the required degree of cleanliness were below the controlled operation area.

3.5.4 Non-food handling area

Refers to the quality control (laboratory) room, office, rest room and toilet where there is not direct involvement with food preparation or processing.

3.6 Cleaning

Refers to the operation of removing dust, scrap, stain, dirt or other possible

impurities that may contaminate the food.

3.7 Disinfection

Refers to appropriate operations to effectively kill and remove pathogenic

micro-organisms without affecting food quality or safety, by using chemical

reagent and (or) physical method in compliance with food hygiene.

3.8 Sealed containers: A sealed container that can prevent the intrusion or

exchange of foreign substances (e.g. microorganisms, water vapor, gases),

including metal, glass, retort pouches, plastic, and laminate composite

containers; and other containers meeting the above requirements.

3.9 Commercial sterilization

3.9.1 Commercial sterilization of foods: A commercial sterility processing

method used to ensure that there are no active microorganisms or spores

that are hazardous to human health are present in foods; and inhibit the

activity of food spoilage microorganisms to ensure that no

microorganisms can grow or toxins are produced in products during

storage and transportation at ambient temperature before expiration.

3.9.2 The equipment and containers for aseptic processing and packaging of

foods by using commercial sterilization: A commercial sterility

processing method used to achieve the commercial sterilization of

equipment and containers with thermal treatment, chemicals (e.g.

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hydrogen peroxide), or other effective methods and to ensure that there

are no active microorganisms or spores that are hazardous to human

health are present in foods; and inhibit the activity of food spoilage

microorganisms to ensure that no microorganisms can grow or toxins

are produce in products during storage and transportation at ambient

temperature before expiration.

3.10 Aseptic processing and packaging system: A canned food manufacturing system in

which foods and containers are individually sterilized appropriately before filling,

transporting, and seaming in an aseptic environment.

3.11 Sterilizing value (F0-value): Measured in minutes, which represents the ability to

kill bacteria or their spores (e.g. clostridium botulinum), with possessing a Z-value

of 18°F, expressed in terms of equivalent thermal death time at a temperature of

250°F (121.1°C). For example, the heating condition of a 95 grams canned food

product is the following: heat for 9 minutes with an initial temperature of 60°C and

sterilizing at 120°C for 40 minutes. If the F0-value of this condition is 7.5, it means

that the equivalent thermal death time at 250°F (121.1°C) is 7.5 minutes.

3.12 D-value and Z-value: The D-value refers to the time required for killing 90% of the

microorganisms at a temperature, i.e. the time required for the thermal destruction

curve to move one log cycle. The Z-value is the degree of temperature changed

needed for a change of the D-value with a factor of 10 for certain bacteria. In other

words, it is the required degrees of temperature of the thermal resistance curve of

bacteria to move one log cycle.

3.13 Sterilizing condition: Controls and sterilization processes adopted to achieve the

commercial sterilization for the safety of canned foods.

3.14 Critical factors of sterilization: The properties and processing requirements of

specific canned foods that will affect the lethality of sterilization effect and cause

product safety, which including can shape and size, formula, sugar Brix, starch

concentration, viscosity, solid contents or ingredients, total volume or solid-to-

liquid ratio, initial temperature, heating time, slicing size and shape, filling method,

the way of loading and stocking of product, sterilizing temperature and time, water

activity, vacuum degree, and headspace.

3.15 Initial temperature: The equilibrium temperature at the coldest point, before the

start of sterilization process in the loaded canned food.

3.16 Heating-up time: the time from when the steam starts to be introduced into the

sterilizer until the start of sterilization.

3.17 Insulation test: The test of placing the sample at a selected temperature for a period

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of time to allow the growth of microorganisms.

3.18 Food-grade detergent

Refers to the substances employed in cleaning the equipment, utensils, containers

and packaging materials and shall not bring any risk for the food safety and

hygiene.

3.19 Foreign matters:

Refers to any contaminant or undesirable substances which are mixed or adhered in

the raw material, semi-finished product, finished-product or inner packaging

materials during processing (excluding raw material), making the food to be unsafe

and unhygienic.

3.20 Pest

Refers to small animal or insect which direct or indirectly contaminate the food or

disseminate diseases, such as rats, cockroaches, flies and vermin.

3.21 Pathogenic micro-organism

Refers to the microorganism capable of causing food quality deterioration and

having public health significance.

3.22 Prevention of vector-borne infestation

Refers to appropriate and tangible isolation means to prevent vector invasion, such

as traps, fence with appropriate aperture, gauze, etc.

3.23 Sanitation management personnel

Refers to the staff responsible for the sanitation of the interior and exterior

environment of a plant, the premises and facilities and the health and hygiene of

personnel.

3.24 Food contact surface

Refers to the food direct or indirect contact surfaces, including utensils and

equipment contact surface with the food. The food indirect contact surface: Refers

to the contact surface between food and those surfaces from which drainage onto

the food or onto surfaces that contact the food ordinarily occurs under normal

processing condition.

3.25 Shall

Refers to a requirement that is mandatory.

3.26 Should

Refers to a guideline or recommendation.

3.27 Food appliances and utensils

Refers to the devices, tools or utensils in direct contact with food or food

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additives.

3.28 Safe moisture level

Refers to a reference level of moisture which can prevent the survival of

pathogenic microorganisms, under pre-established processing, storing and

distributing conditions. Basically, a maximum safe moisture level for food is

indicated by water activity (Aw). The water activity is considered to be safe to the

food if there is sufficient data to show that it does not contribute to the growth of

pathogenic microorganisms under a certain water activity.

3.29 Water activity

Refers to the indicator of free water in foods, and is the quotient of the water vapor

pressure of the food divided by the vapor pressure of pure water under the same

temperature.

3.30 High water activity finished product

Refers to finished product’s water activity that are above 0.85 (inclusive).

3.31 Low water activity finished product

Refers to finished product’s water activity that are below 0.85.

3.32 Appropriate

Refers to the measures taken for intending to complete the expected target or result

under good sanitary operation condition.9

3.33 Lot number

Refers to the specific letters, numbers or symbols for tracing back its processing

history of each batch, while “lot” alone refers to the specific quantity of product

produced during a specific period of time or location.

3.34 Labeling

Refers to the text, pictures or symbols affixed on food, food additive or container

of food-grade detergent and packaging for indicating its name or a descriptive

information.

3.35 Isolation

Refers to the partition of sites and facilities by physical means.

3.36 Separation

Separation has a broader meaning than isolation, including, physical and non-

physical means of partition. Separation of operation area may be accomplished by

one or more of the following ways, such as separation in terms of space, time, and

control of air flow, use of closed system or other effective methods.

3.37 Food Safety Management System

A systematic approach to the identification, evaluation and control of food safety

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hazards, invoke the principle of hazard analysis and critical control points

(HACCP), and manage food safety hazards throughout the reception of raw

materials and ingredients, the manufacture, packaging, storage and distribution.

3.38 Critical Control Points (CCP)

Refers to a point, step, or procedure of food manufacturing at which control can be

applied and prevent, eliminate or reduce a food safety hazard to an acceptable

level.

3.39 Control limits

Refers to a maximum and/or minimum value to which a physical, biological or

chemical parameter must be controlled at a CCP to prevent, eliminate or reduce to

an acceptable level the occurrence of a food safety hazard.

3.40 Deviation

Failure to meet a critical control limit.

3.41 Hazard Analysis and Critical Control Points (HACCP) Plan

The written document which is based upon the principles of HACCP and which

delineates the procedures to be followed.

3.42 Hazard

A biological, chemical, or physical agent that is most likely to cause illness or

injury on consumers in the absence of its control.

3.43 Hazard Analysis

The process of collecting and evaluating information on hazards associated with

the food under consideration to decide which are significant and must be addressed

in the HACCP plan.

3.44 Monitoring:

To conduct a planned sequence of observations or measurements to assess whether

a CCP is under control and to produce an accurate record for future use in

verification.

3.45 Control Measure:

Any action or activity that can be used to prevent, eliminate or reduce a significant

biological, chemical, or physical hazard.

3.46 Validation:

That element of confirmation focused on collecting and evaluating scientific and

technical information to determine if the HACCP plan, when properly

implemented, will effectively control the hazards.

3.47 Verification:

Activities other than monitoring, that determine the validity of the HACCP plan

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and that the system is operating according to the plan, to confirm its effectiveness.

4 Factory Environment

4.1 The food factory shall not be located in areas which are liable to contamination,

except otherwise, there is an effective measure to prevent contamination.

4.2 The surroundings of the plant shall always be easy to clean. The ground shall be

free from puddle of water, mud, dirt, etc. that can cause food contamination, also to

prevent it from being source of pollution. The open ground of the plant site shall be

paved with cement, asphalt or grasses may be planted to prevent dust and beautify

the environment.

4.3 The roads in the vicinity or within the plant shall be paved with cement to prevent

contamination from dust.

4.4 The processing plant shall be free from any facility able to cause odors, harmful

(toxic) gases, smoke, or other unsanitary condition.

4.5 Raising poultry, livestock or pets shall be prohibited inside the plant, with

exception of guard dogs, but they should be properly constrained to avoid

contaminating food.

4.6 A proper drainage system shall be installed inside the plant, the drainage channels

shall be at a proper degree of inclination and the drainage system shall be cleaned

regularly and kept unblocked. Drainage shall be free from bad odor, water puddle,

seeping, silt, dirt, breakage or propagation of vector that could cause food

contamination.

4.7 The surrounding of the production site shall be constructed and designed to

adequately protect against the entrance of external contamination. If fences are

installed, at least 30 cm from the ground shall be constructed with insulated

materials.

4.8 Premises built with staff dormitory and cafeterias, staff lounges, offices or

laboratory, shall be isolated and separated from the manufacturing, preparation,

processing, and food or food additives storage areas, and have good lighting and

ventilation; must be equipped with devices to prevent vector intrusion or microbial

contamination, cleaned regularly and assigned a specialist in charge.

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5 Premises and Facilities

5.1 Lay-out and Space:

5.1.1 The premises shall be designed to meet food process flow, sanitation

and hygienic requirement, providing good order and tidy conditions,

and to prevent cross-contamination.

5.1.2 The premises shall provide sufficient space for required facilities,

including sanitation facilities, storage areas, staff amenities, etc.

Adequate working space shall be provided to ensure food safety and

sanitation. Food utensils and devices shall have a clean place for

storage. Operational areas for vegetarian food production shall not share

the same production line for the production of non-vegetarian food, and

their utensils and devices shall not be shared. Ovo-vegetarian,

lactovegetarian, ovo-lactovegetarian and strict vegetarian production

site shall have their production line, utensils and devises effectively

separated from the non-vegetarian.

5.1.3 The food processing equipment in a food plant shall be provided with

proper working space or aisles with enough distance in between the

equipment or between the equipment and the walls. It shall provide with

sufficient width to permit employees to carry out their operations

(including cleaning and sanitizing) without contaminating the food,

food-contact surfaces, or packaging material with their clothing or

physical contact.

5.1.4 Laboratory in a food plant shall be provided with enough space for the

installation of experimental table and instruments to perform physical,

chemical, sensorial and (or) microbiological test. Microbiological

testing laboratory shall be properly separated from the other testing

areas, especial isolation shall be made when the laboratory is equipped

with pathogenic microbial testing facility.

5.2 Premises separation

5.2.1 Different purposes premises (e.g. warehouse for raw material,

packaging material, and raw material handling area) shall be built

separately or be effectively separated.

5.2.2 Premises shall be effectively separated or isolated from one another

according to the cleanliness level classification (Table 1).

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Table 1 Cleanliness Classification of the Processing Zones of Canned Food Factories (Note 1)

Plant facility (arranged by processing order)

Classification of cleanliness level

Receiving Zone Cold Storage Raw materials storage Packaging material storage Raw material handling area Extraction Room (delivery by using closed system equipment

and pipelines) Inner packaging washing area (**) Empty bottles (cans) arrangement area Sterilization treatment area (for closed system equipment and

pipeline)

General operation area

Processing and preparation area Extraction Room (open system equipment) Sterilization treatment area (for closed system equipment) Inner packaging materials preparation room Buffer room Interior packaging (products that are packaged before

sterilization)

Semi-clean operation

area

Controlled operation

area

Interior packaging (products that are sterilized before packaging)

Clean operation

area

Seamed Products Sterilization Zone Exterior Packaging Area Finished product storage

General operation area

Quality control (testing) area Office (***) Change room and hand washing and sanitizing area Toilet other

Non-food handling area

Notes: 1. The classification of cleanliness level of the different operation area can be improved according to actual conditions, and comply with the specific provisions when there is one. 2. The exit of the inner packaging container washing area shall be located within the controlled operation area. 3. The office shall not be located in the controlled operation area (except for the production management and quality control area, but appropriate control measures area required).

5.3 Premises structure The Plant buildings shall be durable, easy to maintain, be kept clean and shall be able to prevent food, food-contact surfaces and inner packaging materials from being contaminated (such as vector intrusion, habitat, breeding, etc.)

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5.4 Safety facilities

5.4.1 The electricity system installed inside the plant shall be waterproof.

5.4.2 Power supply shall be grounded and with circuit breaker.

5.4.3 The electrical outlet and power switch in workplaces with high

humidity shall be waterproof.

5.4.4 The electrical outlet used for different voltage shall be clearly marked

and labeled.

5.4.5 Fire alarm system shall be set in all buildings and working area,

in accordance with the Fire Services Act.

5.4.6 Ventilation devices shall be equipped in working zones where CO2 and

N2 gases are used.

5.4.7 Fire extinguisher devises and equipment shall be installed in appropriate

places with strict control to prevent food contamination.

5.5 Floor and Drainage

5.5.1 Floor shall be smooth, non-slippery, and kept clean; it shall also be free

from corrosion, cracks or accumulation of water or dust. Floors of the

controlled operation area shall be constructed with water impermeable

materials.

5.5.2 Proper slope (no less than 1/100) and adequate floor drainage system

shall be provided in all areas where floors are subject to flooding-type

cleaning or where normal operations release or discharge water or other

liquid waste on the floor.

5.5.3 Wastewater or effluent disposal shall be made into an adequate

sewerage treatment system or disposed of through other adequate

means.

5.5.4 Drainage system shall be equipped with screen that allow water to flow

and trap to prevent solid wastes from flowing, and free of filthy odor.

5.5.5 No other pipelines shall be arranged inside the drainage system and it

shall remain unobstructed. The joint between the side and the bottom of

the ditch shall have a proper arc (the radius of the curvature shall be

3cm or above).

5.5.6 Drainage outlet shall be equipped with devices to prevent vectors from

entering the facility.

5.5.7 The flow direction of indoor drainage should be from the area with

higher requirement of cleanliness to the area with lower requirement of

cleanliness, and should be designed to prevent the backflow of

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wastewater.

5.6 Roof and Ceiling

5.6.1 The roofs inside the processing, packaging and storage rooms shall be

easy to clean to prevent dust accumulation, water condensation, mold

growth and it shall not shed particle matters. The V-type supported roof

in the controlled operation area or food exposure area (except for raw

material handling area) which are easy to harbor contaminant, shall be

provided with smooth ceiling easy to be clean. When the construction is

made of reinforced concrete, the roof shall be smooth and free from

cracks and open joints.

5.6.2 The surface of flat-type roof or ceiling shall be constructed with white

or light-colored water proof materials. Where paint spray is required,

the paint shall be anti-mold, not easy to flake off and easy to clean.

5.6.3 Pipes and cables of steam, water or electricity shall not be located

directly above the exposed food, otherwise devices shall be installed to

prevent dust and water condensation from falling, and their exterior

shall be kept clean and cleaned regularly. Air ducts should be located at

the ceiling.

5.6.4 Stairways or over-pass across production lines shall be constructed and

designed so as to avoid food and food contact surfaces in the vicinity

from being contaminated and equipped with safety devices.

5.7 Walls and Windows

5.7.1 The walls inside controlled processing area shall be constructed with

non-absorbent, smooth, easy to clean, water-impermeable and light-

colored materials (except from closed-type fermentation tank, and

outdoor operations). The corner and column feet of the wall shall have

an appropriate arc (with a radius of curvature of 3 cm or above, as

shown in Figure 4-01) to facilitate cleaning and avoid dust and filth

accumulation, except from dryer operation area.

5.7.2 Windows that are opened frequently during operation shall be equipped

with easy-to-dismantle, easy to clean and rust resistant gauze to protect

against food contamination and to prevent vectors from entering the

facility. Windows shall be kept clean and shall not be opened during

operation in the clean operation area. The windowsill in the controlled

production area shall be sloped 45 degree or more (as shown in Figure

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4-02), if the depth of the windowsill is more than 2 cm. If the depth is

less than 2 cm, the windowsill corner shall be filled with impervious

material.

5.7.3 Windows, doors, and opening entrances in the controlled processing

area shall be provided with automatic closing screened door (or air

curtain), and (or) provided with shoe cleaning and sanitizing equipment

(operation area that needs to be kept dry shall set up shoe changing

facilities). Doors shall be made of smooth, easy to clean and

impermeable strong material, and be kept closed.

5.8 Lighting

5.8.1 Facilities shall be provided with adequate lighting in all areas of the

building, and be kept clean to prevent food contamination. In principle,

the lighting facilities shall not be suspended over exposed food in any

step of the production line, or otherwise, lighting facilities shall be

equipped to prevent food contamination in case of breakage or fall.

5.8.2 Lighting shall be provided so that there shall be no less than 110 lux for

working tables in the general operation area, 220 lux or above for

working tables in the controlled operation area and 540 lux or above for

inspection tables. The source of artificial light shall not alter the original

food color.

5.9 Ventilation

5.9.1 The processing, packaging and storing areas shall be well ventilated,

and the ventilation system shall be kept clean. When necessary effective

ventilation system should be installed to prevent the temperature from

being too high, the air condensation or odor formation, and to keep

indoor air fresh. Clean operation area of perishable ready-to-eat

products and finished products that require transportation at low

temperature shall be equipped with air-conditioning equipment

5.9.2 In the presence of filthy odors and gases (including vapor and toxic

gases) or dusts that may contaminate food, appropriate means of

exclusion, collection or control shall be provided.

5.9.3 The exhaust vent of the controlled operation area shall be equipped with

devices to prevent vectors from entering the facility, and the intake vent

shall be equipped with air purification devices. Both equipment should

be easily disassembled for cleaning or replacement.

5.9.4 Airflow direction from low-cleanliness areas to high-cleanliness areas

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should be avoided, when air conditioning, air intake and exhaust

systems, or fans are used in the plant to prevent food, food contact

surfaces and internal packaging materials contamination

5.10 Water Supply

5.10.1 Water supply shall be capable of providing sufficient water, with

adequate water pressure and quality to all the food plant. If necessary,

there should be water storage facilities and hot water available.

5.10.2 The reservoirs (towers and tanks) shall be made of non-toxic materials

that do not contaminate the water, they shall be cleaned regularly at

least once a year, kept clean and recorded. Measures shall be taken to

prevent water contamination.

5.10.3 Water used for food manufacturing shall meet potable water quality

standards. When potable water are not used, there shall be a water

purification and disinfection equipment, and pH and chlorine residual

need to be tested, and recorded on a daily basis.

5.10.4 Water used that will have direct contact with foods or for preparing

canned foods shall comply with the drinking water standard.

Water having direct contacts with foods or used for formulating canned foods

shall comply with the drinking water standard.

5.10.5 Pipeline of non-potable water (such as cooling water or waste water)

that shall not be in contact with foodstuffs and the pipeline of water for

food manufacturing shall be clearly distinguished by color and

transported in completely separate piping system, there shall be no

backflow or cross-connection.

5.10.6 Groundwater sources should be located at a distance of more than 15

meters from sources of potential pollution or contamination (septic

tanks, waste dumps, etc.), and water storage facilities should be kept at

a distance of more than 3 meters away from sources of pollution or

contamination (septic tanks, waste dumps, etc.).

5.11 Hand-washing facilities

5.11.1 A sufficient number of hand-washing and hand-dryer facilities shall be

provided at suitable and convenient locations (e.g., at the entrance to the

controlled operation area, toilet and processing area). If necessary,

warm or hot and cold water should be provided, and faucets with

adjustable hot and cold water should be installed.

5.11.2 Liquid soap shall be provided near the hand-washing facilities, and if

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necessary, hand sanitizers dispensers shall also be provided when

needed (e.g., when hands are at risk of contaminating food if not

disinfected).

5.11.3 The hand washing sink shall be made of impervious material such as

stainless steel and ceramic, and designed so that it can be easily cleaned

and disinfect.

5.11.4 Hand dryer or paper towel shall be used for hand drying. When paper

towels are used, they should be thrown into an easy to clean receptacles

(preferably use foot pedal hands free bins). When using hand dryer, it

shall be cleaned and disinfected regularly to prevent contamination.

5.11.5 Faucets shall be foot pedal operated, elbow operated or electric eye

sensor operated, to prevent re-contamination after cleaning or

disinfecting hands.

5.11.6 Drainage of hand washing facilities shall be fitted with devices to

prevent backflow, vector entry and filthy odor.

5.11.7 A concise and easy understanding hand-washing instruction shall be

posted in the vicinity of the hand-washing facilities.

5.12 Hands-sanitizing room

5.12.1 Separated hands-sanitizing room should be provided in the entrance and

exit of the controlled operation area. (It is a must for the perishable

ready-to-eat food production plant).

5.12.2 In addition to the elements in 5.11, the room should be equipped with

working shoes or boots sanitizing facilities, but shoes changing areas

should be provided in working areas that need to be kept dry. When

boots dips are used, the solution should be kept clean and be able to

cover the shoes upper part. The free residual chlorine concentration

should be maintained at 200ppm or more when chlorine solutions are

used.

5.13 Storage areas

5.13.1 Storage areas for raw material, packaging material, semi-finished and

finished products shall be stored separately and have sufficient space

for transport. Chilled or frozen storage shall be provided when needed.

5.13.2 Raw materials and finished products storage shall be separated or

isolated from the other areas, and different types of items in the same

storage shall also be properly separated.

5.13.3 The storage area shall be constructed so as to minimize the quality

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deterioration of the raw materials, semi-finished products and finished

products and to prevent contamination. The storage area shall also be

constructed with strong materials, provide sufficient working space and

should be well organized and easy to keep clean. These areas should

also be equipped with devices to protect against the entry of vectors.

5.13.4 Storage areas shall be laid out to permit effective and orderly

segregation of the various categories of materials stored. Materials shall

be stored on pallets, shelves, or other effective method, and keep tidy,

clean, and be at a distance of at least 5cm from the floor and walls.

5.13.5 Chilled (frozen) storage for food products that are more prompt to

microbial growth shall be equipped with accurate temperature sensor,

temperature indicator or automatic temperature recorder, and also

automatic controller or temperature alarm system shall be installed to

alert of abnormal temperature variation.

5.13.6 Chilled (frozen) storage shall be equipped with an alarm switch that

connects to the monitoring department in case a working personnel is

locked inside accidentally or due to any failure and needs to contact and

get assistance from the exterior.

5.13.7 Temperature shall be recorded in the storage area, and also record

humidity when necessary.

5.14 Change room

5.14.1 Change room shall be located in an appropriate and convenient location

near the controlled operation area, and separate dressing room shall be

provided for men and women. Adequate lighting and ventilation shall

also be provided. The change room of a perishable ready-to-eat factory

shall be located near the hand washing and sanitizing area.

5.14.2 There shall be enough space for staff to change clothes, and facilities

such as mirror, dust remover devices and sufficient number of personnel

cabinets or lockers and shoes racks shall be provided in these rooms.

5.15 Toilet facilities

5.15.1 Toilets shall be located in appropriate and convenient places of the plant

to prevent contaminating water source and in sufficient number for the

staff to use.

5.15.2 Flush toilets shall be installed using materials that are impermeable,

easy to clean and sanitize.

5.15.3 Hand washing facilities within the toilet shall be in compliance with

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element 5.11, and shall be installed near the exit.

5.15.4 Toilet doors shall remain close and shall not face directly toward the

controlled operation area, unless a buffer facility with air curtain control

system to prevent contamination is provided.

5.15.5 Toilets shall be equipped with adequate illumination and well ventilated

to prevent odors. Windows and doors in the toilets shall be equipped

with rustproof screens.

5.15.6 The words "Wash hands after using the toilet" should be clearly

marked.

6 Machine and Equipment

6.1 Design

6.1.1 Food processing equipment shall be designed and constructed in a way

that does not pose a threat to food hygiene. It shall easily be cleaned,

disinfected (and easy to disassemble as possible) and inspected.

Lubricants, metal fragments, contaminated water or other substances

shall not represent a food safety hazard when using these equipment.

6.1.2 The food contact surfaces shall be smooth, free of cracks or

recesses as to reduce the accumulation of food debris, dirt and

organic matter and thus minimize the potential microbiological

growth.

6.1.3 Dead angle, difficult-to-clean areas, or the areas that are prone to

external contamination shall be avoided in utensils and containers, such

as steamers/cookers, mixing tanks, storage tanks (barrels), etc.

6.1.3.1 Utensils and containers shall be equipped with detachable lids and shall

have a flanges design on the rim. Lids that open in the middle shall be

ringed or hinged and pulled from the middle to the sides. Seams that are

designed to be opened in the middle shall be flanged to prevent water, dust,

and foreign matter from entering.

Such utensils and containers shall be equipped with detachable lids

and flanges. Lids opened in the middle shall be ringed or hinged

and pulled from the middle to the sides. The seam in the middle

shall be flanged to prevent water, dust, and foreign matter from

entry.

6.1.3.2 The rim contours on the flange or the bottom shall be round and curves,

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and sharp angles shall be avoided.

6.1.3.3 Drains shall be equipped at the bottom (the lowest point).

6.1.4 The feeder pump shall be designed for quick disassembly, with a

polished surface, and be free of hollows and cracks to prevent

microorganism from accumulation.

6.1.5 The plants shall avoid installing driving devices, such as motors and

bearings, in overhead locations where foods are exposed. If it is

unavoidable, it shall have appropriate protective devices or trays

underneath such devices to contain the oil and prevent it from falling

onto the foods.

6.1.6 Finished coating (e.g. plating, painting, etc.) surfaces of equipment,

utensils and piping shall ensure that it does not represent any risk to

food and food contact surfaces contamination.

6.1.7 The equipment and utensils, that is within the manufacturing or

processing zones but do not have direct contact with foods, shall have

the structures designed to easily meet the level cleanliness required.

6.2 Material

6.2.1 Equipment and utensils in direct contact with food used in the food

handling area shall be made of nonabsorbent materials that do not

transmit toxic substances, odors, and corrosion resistant, capable of

withstanding repeated cleaning and sanitation. At the same time,

materials that could cause corrosion shall be avoided.

6.2.2 Wood shall not be used as food contact surfaces material unless it is

proved that it will not become a source of contamination.

6.3 Food processing equipment

6.3.1 The food processing equipment in a food plant shall be properly laid out

to meet process flow with sufficient space to avoid cross-contamination.

The production capacity of each equipment should be compatible with

each other.

6.3.2 Instruments or recorders used for measuring, controlling or recording

shall be in good condition and be of suitable accuracy for the intended

use, and periodically calibrated.

6.3.3 Compressed air or other gases which are introduced into food or

used to clean food contact surfaces or equipment shall be

adequately pretreated to prevent indirect contamination.

6.3.4 An LACF factory shall be equipped with appropriate machinery and

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equipment based on the product needs.

6.4 Sterilization system for low acid canned foods (LACFs)

6.4.1 Static sterilizers

6.4.1.1 Static steam sterilizers

6.4.1.1.1 Mercury-in-glass thermometer

6.4.1.1.1.1 Each sterilizer shall be equipped at least one mercury-in-glass

thermometer with a total length of the scale marks at least 7

inches long, and a maximum of 55 scale division, with accuracy

as low as 0.5°C.

6.4.1.1.1.2 A mercury-in-glass-thermometer shall be calibrated, by an

accredited organization at least once a year, before use. The latest

calibration date and respective calibration data shall be labeled on

the thermometer.

6.4.1.1.1.3 The mercury line in glass shall not be separated and the

thermometer shall be installed in a position where the sterilizer

operators can correctly read the scale.

6.4.1.1.1.4 The mercury bulb shall be installed inside the kettle of the

sterilizer or inside the temperature well linking the kettle. An air

release valve of no less than 1/16th of an inch in diameter shall

be equipped in the temperature well. During the sterilization

process, the valve shall be opened for steam to be continuously

released.

6.4.1.1.1.5 During the sterilization process, the temperature indicated by the

mercury-in-glass thermometer shall be used as the sterilization

temperature, and the temperature indicated on the automatic

temperature recorder shall not function as a substitute.

6.4.1.1.2 Temperature recorder

6.4.1.1.2.1 Each sterilizer shall be equipped with at least one temperature

recorder that can accurately record temperature. The number of

scale marks per inch for a 10°C range of sterilization temperature

recorder chart shall not exceed 25°C in the recorder grid, and the

scale division of a 5°C range of sterilization temperature recorder

chart shall not exceed 1°C. The mercury bulb shall be installed

inside the kettle of the sterilizer or inside the temperature well

linking the kettle. An air release valve of no less than 1/16th of an

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inch in diameter shall be equipped in the temperature well.

6.4.1.1.2.2 During the sterilization process, the valve shall be opened for

steam to be continuously released.

6.4.1.1.2.3 The temperature indication of the recorder shall be adjusted in

consistent, as much as possible, with that of the mercury-in-glass

thermometer, provided that the temperature read from the record

shall not be higher than that of the mercury-in-glass thermometer.

6.4.1.1.2.4 The recorder is equipped with a steam controller and is composed

of a temperature recording controller. In addition to the vertical

kettle device temperature record control device, the other

pipelines of temperature recorder should be connected with the

mercury thermometer temperature sensor adjacent device.

6.4.1.1.2.5 Vertical retort, temperature record controller shall be installed

under the basket at the bottom of sterilizer, and shall avoid steam

spraying directly to the temperature sensor.

6.4.1.1.2.6 Horizontal retort, the temperature sensor should be installed

between the water surface of the kettle and the center of the kettle

to prevent steam from directly touching the temperature sensor.

6.4.1.1.2.7 Measures to prevent unauthorized access shall be in place to

prevent unauthorized personnel or sterilizing operators from

arbitrary changing the temperature recorder settings. Measures

may include using a lock or posting warning signs indicating

“Authorized Personnel Only”.

6.4.1.1.2.8 The pneumatic temperature controller shall be equipped with an

effective filtering system to ensure the air is clean and dry.

6.4.1.1.3 Pressure gauge

6.4.1.1.3.1 Each sterilizer shall be equipped with at least one pressure gauge

on a coiled tube. The gauge dial shall be at least 4½ inches in

diameter, with reading ranging from 0-3.5kg/cm2. Each span of

scale mark shall be 0.1kg/cm2.

6.4.1.1.3.2 A pressure gauge shall be calibrated by an accredited

organization at least once a year before use. Pressure shall not be

a reference parameter for the sterilization condition.

6.4.1.1.3.3 Each sterilizer shall be equipped with an adjustable pressure

relief valve or pressure control valve on the overflow pipe to

prevent the pressure in the tank from increasing drastically when

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the inlet valve is fully opened.

6.4.1.1.4 Steam controller

6.4.1.1.4.1 An automatic steam controller shall be equipped to maintain the

correct sterilization temperature of a sterilizer. An integrated

temperature recorder and steam controller is also acceptable.

6.4.1.1.4.2 When using a hand-operation instead of automatic steam

controller, during the sterilizing process shall ensure to meet the

sterilizing operation requirement and recorded.

6.4.1.1.5 Steam inlet pipe

6.4.1.1.5.1 The diameter of the smallest orifice (such as inlet pipes, valves

and fittings) shall not be less than 1 inch (approximately 25mm),

in other words, the internal diameter shall be greater than 26 mm

(cross sectional area 530mm2). The information of diameters,

apertures and number of holes should refer to the related

regulations which is announced in “The regulation on Good

Hygiene Practice for Food, GHP“, TFDA. The steam inlet of

Vertical retort shall be located at the central line of the bottom.

6.4.1.1.5.2 If the length of the horizontal kettle is within 9 meters

(approximately 30 feet), the inlet of the kettle shall be at the

longitudinal centerline of the tank bottom. If the length of the

kettle exceeds 9 meters, two or more steam inlets shall be

installed. The inlet steam inlet device shall distribute the heat

within the kettle evenly.

6.4.1.1.6 Introduction of steam

6.4.1.1.6.1 Steam shall be introduced from the bottom of retort to equalize

the heat distribution within the retort.

6.4.1.1.6.2 Vertical retorts may use any method that has been approved to

average the heat distribution

6.4.1.1.6.3 The steam turbine of the horizontal retort shall extend to the full

length of the bottom of the retort, and the steam injection holes

shall be evenly distributed above the steam injection pipe.

6.4.1.1.7 Steam distribution pipes and steam nozzles

6.4.1.1.7.1 The size of steam distribution pipes shall not be larger than the

steam inlet pipe and shall not be less than one inch in diameter.

The steam distribution pipes of horizontal sterilizers shall extend

across the total length of the sterilizer and have three rows of

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nozzles, including one at the center top and two at 45°

intersecting the top center line. Nozzles of each of these two rows

shall be alternated.

6.4.1.1.7.2 For vertical sterilizers, nozzles shall be aligned on the overhead

or on both sides of the vertical sterilizers.

6.4.1.1.7.3 The number of nozzles shall ensure that the total cross sectional

area of the nozzles of a vertical or a horizontal sterilizer has

minimum of 1.5 to 2 times the cross sectional area of the inlet

steam pipe.

6.4.1.1.8 Vapor release valve

6.4.1.1.8.1 The cross section diameter of the valve shall at least be ⅛ inch

(except for valves installed in the temperature well). Vapor

release valves shall be installed in a location where operators can

observe their operation and be fully opened at all times during the

sterilization process to maintain good steam circulation.

6.4.1.1.8.2 Vapor release valves for a horizontal sterilizer shall be installed

within 12 inches away from both ends of the sterilizer’s top, and

the interval between valves shall be within 8 feet.

6.4.1.1.8.3 Vapor release valves for a vertical sterilizer shall be installed on

top of the lid. When installing vapor release valves in other

positions, manufacturers shall submit thermal distribution data to

prove that the air inside the sterilizer is completely drained and

steam circulation is good.

6.4.1.1.8.4 All vapor release valves shall be installed in a manner so that

operators can ensure their functions throughout the sterilization

process.

6.4.1.1.9 Sterilization baskets and container racks shall be made with metal

bars, metal mesh plates, or other suitable materials. When using metal

mesh plates, the mesh diameter shall be equivalent to 1 inch, the mesh

interval shall be 2 inches apart from center to center, or the total mesh

cross sectional area shall not be smaller than 36% of the plate area.

When partitions are used on each level of containers, the mesh size of

the partition shall be the same as that of the metal mesh plate. During

the sterilization process, containers shall be arranged in a manner

complying with the sterilization process specified on the procedure

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(exempted when none).

6.4.1.1.10 Basket frame support

No sterilizer baffle shall be installed at the bottom of a static

sterilizer. Horizontal sterilizers shall be equipped with basket frame

supports to allow there is a 4cm (1.5 inch) gap between the wall of

sterilizer and basket frame.

6.4.1.1.11 Pressure air pipes

Pressure air pipes for pressure cooling shall be equipped with an

appropriate type of valves. Valve specifications, such as globe valves

or ball valves, shall be the same as that of water intake pipes to

prevent air from infiltrating into the sterilizer during the sterilization

process.

6.4.1.1.12 Water inlet pipes, drainage pipes, drainage valves, and safety valve

water inlet pipes shall be equipped with an appropriate type of valve,

such as globe valves or ball valves, to prevent cold water from

leaking into the sterilizer during the sterilization process. In addition,

gate valves shall not be used on water inlet pipes. Water shall enter

the sterilizer from the top to ensure even cooling of cans inside the

sterilizer. The size of drainage pipes shall not be smaller than that of

the water inlet pipes. Filters shall be installed on the drains. Each

sterilizer shall be equipped with a safety valve whose diameter shall

not be smaller than that of the steam inlet pipe.

6.4.1.1.13 Main steam pipe

Main steam pipes shall be appropriately constructed and equipped

with a water discharge valve. A pressure gauge with correct

indications that can be clearly read by operators shall be installed on

the end of the main steam pipes in the sterilization zone. The pressure

of the main steam pipes shall be maintained at over 6kg/cm2.

6.4.1.1.14 Air release pipelines

6.4.1.1.14.1 An air release device shall be designed to ensure the release of

air inside a sterilizer before sterilization begins.

6.4.1.1.14.2 The cross sectional area of the pipe diameter shall be larger than

that of the steam inlet pipe. Valves shall be gate type, plug type,

or other types appropriate to quickly fully opening the air

release valve. In addition, the air release pipe shall not be

directly connected to a closed pipeline and shall remain at

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normal open position.

6.4.1.1.14.3 Air release pipes shall be installed atop horizontal sterilizers or

on the lid of a vertical sterilizer in the opposite position of the

steam intake pipe.

6.4.1.1.14.4 The outlet of an air release pipe shall be open to atmosphere.

Right angle bends or other conditions that will hamper airflow

shall be prevented in the piping. An air release pipe shall be

below 46cm long, and can transport the steam off the

sterilization zone with an air release pipeline that have a sizes

larger than the air release pipe and with a condensed water

outlet at the bottom.

6.4.1.1.14.5 The cross sectional area of an air release main pipe shall be

larger than the total cross sectional area of the connected air

outlets or an air release pipeline.

6.4.1.1.14.6 When connecting air release pipes of several static sterilizers to

one air release master pipeline, the cross sectional area of the air

release master pipeline shall be larger than the total cross

sectional area of the connected air release pipes and no valve

shall be installed on the master pipeline.

6.4.1.1.14.7 Most importantly, the sterilization time shall not be calculated

before the air release procedure is completed or before the reach

of temperature required.

6.4.1.2 Static pressurized hot water sterilizers


6.4.1.2.1.1 Each sterilizer shall be equipped at least one mercury-in-glass

thermometer with a total length of the scale marks at least 7

inches long, and a maximum of 55 scale division, with accuracy

as low as 0.5°C.

6.4.1.2.1.2 A mercury-in-glass-thermometer shall be calibrated, by an

accredited organization at least once a year, before use. The latest

calibration date and respective calibration data shall be labeled on

the thermometer.

6.4.1.2.1.3 The mercury line in the glass shall not be separated and the


operators can correctly reading the scale.

6.4.1.2.1.4 During the sterilization process, the bulb shall be immersed

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under water by at least 50mm (2 inches). The temperature

indicated by the mercury-in-glass thermometer shall be used as

the base sterilization temperature, and shall not be substituted

by the temperature from the automatic temperature recorder.

6.4.1.2.1.5 For horizontal sterilizers, a mercury-in-glass thermometer shall

be installed at the center on the side of the sterilizer.


Same as static steam sterilizers.





6.4.1.2.5 Sterilization baskets and container racks arrangement


6.4.1.2.6 Steam pipes and steam nozzles

Same as static steam sterilizers. Nozzles of a vertical sterilization

shall be aligned in a row, facing downward at a degree of 15°.

Nozzles shall not be clogged.

6.4.1.2.7 Basket frame supports


6.4.1.2.8 Drainage valves


6.4.1.2.9 Water level gauge

Each sterilizer shall be equipped with one water level gauge for

reading the water level inside the sterilizer, during the heating,

sterilizing, and cooling processes. The water inside the sterilizer shall

cover up the containers at the top level (4-6 inches is recommended).

Operators shall check and record the water level before sterilization

and at any time during the sterilization process.

6.4.1.2.10 Supply and control of air

6.4.1.2.10.1 Air pressure control shall be achieved by the automatic pressure

controller (Actuator). Air shall be supplied at an appropriate

pressure and flow. Air pipes shall be equipped with a check

valve to prevent water in the sterilizer from flowing back into

the pipe. During the heating, sterilizing, and cooling processes,

continuous air or water circulation shall be maintained. Air shall

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be used to facilitate air circulation. Compressed air shall be

input through the steam inlet pipeline between the steam inlet

and the steam control valve at the bottom of the sterilizer.

6.4.1.2.10.2 For air pressurized cooling air pipes, the valve of the pipe shall

be equipped with a ball valve or ball plug valve. Gate valves

should not be used.

6.4.1.2.10.3 When automatic pressure controller operation is not carried out

but hand-operation, the pressure shall be manually controlled to

ensure compliance with the sterilizing operating conditions.

6.4.1.2.11 Water circulation system

Nozzles on the water spreading pipe shall be evenly distributed. The

total cross sectional area of nozzles shall be smaller than the cross

sectional area of the output pipe of the pump water. Filters shall be

installed at the outlet of pump at the bottom of the sterilizer to prevent

debris from entering the water circulation system. A warning

indicator shall be equipped on the circulation pump to alert operators

when the pump stops.

6.4.1.2.12 Supply of cooling water

6.4.1.2.12.1 Check valves shall be installed along the cooling water pipeline.

Cooling water for horizontal sterilizers shall be introduced from

inlet side of the circulation pump. Cooling water for vertical

sterilizers shall be input from in between of the top water level

and containers on the top level (should be 2 inches under the

overflow pipe).

6.4.1.2.12.2 When cooling is carried out in a retort, the horizontal retort shall

be filled with water from the spray pipe on the top. The vertical

retort shall be filled with water from spray ring on the top. The

water spray pipe of the horizontal retort shall have three or more

rows of water spray holes to spray water downwards (when using

three rows of water spray holes, the central row of ones shall be

vertically downward, and the other two rows shall be at an angle

of 45 degrees with it).

6.4.1.2.12.3 The inlet pipe shall be fitted with a ball valve or ball plug valve.

Gate valves shall not be used.

6.4.1.2.13 Headspace inside sterilizers

An adequate head space between the top of a sterilizer and water level

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shall be maintained (at least 4 inches is recommended) to facilitate

internal pressure control.

6.4.2 Rotary sterilizers

6.4.2.1 Discontinuous steam pressurized sterilizers









6.4.2.1.5 Vapor release valve

The valve shall at least be ⅛ inch (except for valves installed in the

temperature well). the installation position shall be within 20

centimeters (about 8 miles) from the ends of the centerline of the

kettle top, and the distance between the bolt and the spigot shall not

be more than 240 cm (approximately 8 miles), and should be able to

make operators aware of its operating conditions, and throughout the

sterilization process must be kept fully open to maintain a good steam

cycle.

6.4.2.1.6 Air release and condensed water discharge

Air inside sterilizers shall be vented before sterilizing. When

sterilization begins, open the drain valve or drain plug for adequate

time to drain out the condensed water.

6.4.2.1.7 RPMs of sterilizers

Rotations per minute (RPMs) shall comply with the sterilization

requirements. Measures shall be taken to prevent unauthorized access

to or the designated operators from making arbitrary changes of the

RPM settings. It may include using a lock or posting labels such as

“Authorized Personnel Only”. Every time when can sterilization, the

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RPMs of sterilizers and the period shall be recorded.

6.4.2.2 Discontinuous hot water pressurized sterilizers









6.4.2.2.5 Supply and control of air

Same as static hot water sterilizers.

6.4.2.2.6 RPMs of sterilizers

Same as discontinuous steam pressurized sterilizers.

6.4.3 Aseptic processing and packaging systems

6.4.3.1 Product sterilization

6.4.3.1.1 Temperature display devices

6.4.3.1.1.1 Each product sterilization unit shall be equipped with at least one

mercury-in-glass thermometer or other temperature display device

(e.g. thermocouple recorder). A mercury-in-glass thermometer

shall be equipped with scale marks with accuracy as low as 0.5°C,

a total length of the scale marks of at least 7 inches long, and a

maximum of 55 scale divisions.

6.4.3.1.1.2 Every thermometer shall indicate the date of least calibration. The

thermometer shall be calibrated by an accredited organization at

least once a year and qualified before use.

6.4.3.1.1.3 The mercury line in glass shall not be separated and the


operators can correctly read the scale.

6.4.3.1.1.4 During the sterilization process, the temperature indicated by the

mercury-in-glass thermometer or temperature display device shall

be used as the sterilization temperature, and shall not be substituted

by the temperature indicated on the automatic temperature

recorder.

6.4.3.1.1.5 For non-use mercury thermometers, the sterilization temperature

shall be based on the indicated temperature of the temperature

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indicating device. The temperature measurement shall be between

the outlet of the product sterilizing holding pipe and the inlet of the

cooling pipe, and the temperature of the product can be directly

sensed.


6.4.3.1.2.1 Each product sterilization unit shall be equipped with temperature

recorders that can accurately record the temperature. A recorder

shall be installed at the outlet of a constant temperature insulation

pipe, in between of the thermostat insulated pipe and cooling

device inlet, which can directly detect product temperature.

6.4.3.1.2.2 The number of scale marks per inch for a 10°C range of

sterilization temperature recorder chart shall not exceed 25°C in

the recorder grid, and the scale division of a 5°C range of

sterilization temperature recorder chart shall not exceed 1°C. The

temperature indication of the recorder shall be adjusted in

consistent with that of the mercury-in-glass thermometer, provided

that the temperature read from the record shall not be higher than

that of the mercury-in-glass thermometer.

6.4.3.1.2.3 Measures to prevent unauthorized access shall be in place to

prevent unauthorized personnel or the sterilizing operators from

arbitrary changing the temperature recorder settings. Measures

may include using a lock or posting warning sign indicating such

as “Authorized Personnel Only”.

6.4.3.1.3 Temperature controller

An accurate temperature control shall be equipped at the outlet of the

sterilization unit to ensure products are maintained at the designated

sterilization temperature. The scale division of a 5°C range of

sterilization temperature recorder chart shall not exceed 1°C.

6.4.3.1.4 Product heat exchanger

A heat exchanger shall be designed, operated, and controlled to

ensure a positive pressure of sterilized products that is greater than

that of cold unsterilized products in the heat exchanger to prevent the

latter from infiltrating into the former.

6.4.3.1.5 Differential pressure control recorder

A differential pressure control record shall be equipped at the outlet

of sterilized products and the outlet of unsterilized products of a heat

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exchanger. The scale marks per inch shall not exceed 20psi, with

accuracy up to 2psi for each mark division. Differential pressure

control recorders should be calibrated by accredited organizations

before use and calibrated once every three months.

6.4.3.1.6 Quantitative pump

A quantitative pump shall be installed in front of the thermostat-

insulated pipe to ensure product flow velocity specified in the

sterilization requirements. Measures shall be in place to prevent

unauthorized access or the sterilizing operators from arbitrary

changing the settings. Measures may include using a lock or posting

warning sign indicating such as “Authorized Personnel Only”.

6.4.3.1.7 Thermostat insulated pipe

A pipe shall be designed to ensure continuously retention of products

in the pipe for an adequate time and comply with the sterilization

requirements. No heating devices of any kind shall be installed

between the inlet and outlet of the pipe. The pipe shall be inclined at

a minimum gradient of 0.25in/ft. (2.1cm/m).

6.4.3.1.8 Diversion system

A diverter shall be installed at the product pipelines between a cooler

and a product filler/aseptic storage tank. The system shall be designed

to automatically divert products away from a filler or aseptic storage

tank, and an alarm shall be installed once the temperature of the

thermostat insulated pipe or the differential pressure of the heat

exchange is lower than the specified sterilizing condition.

6.4.3.1.9 Subsequent equipment after the thermostat insulated pipe

Equipment installed behind the thermostat insulated pipe, including

product cooling device, aseptic storage tank, or other equipment that

containing rotating shafts or valve handles, and equipment

connections which with potential threats of microbial intrusion shall

be equipped with a steam seal or other blocking devices, and

appropriate methods for operators to monitor those operation shall be

in place.

6.4.3.1.10 Handling of temperature drop of the thermostat insulated pipe

When the temperature of a thermostat insulated pipe drops below the

specified sterilizing condition, the operators shall divert products off

the filler or aseptic storage tank. When under-sterilized products have

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been filled into the containers, operators shall segregate them from

the sterilized products and handle them in accordance with the

“Sterilization Anomaly Handling Procedure”. The products within

and after the thermostat insulated pipe that have been affected by the

temperature drop shall be re-sterilized until meeting the commercially

sterilization standard before diverting the products to the filler or

aseptic storage tank.

6.4.3.1.11 Handing of differential pressure anomaly of the heat exchanger

When the differential pressure between the sterilized products and

unsterilized products is below 1psi, the operators shall divert products

off the filler or aseptic storage tank. When under-sterilized products

have been filled into containers, it shall be segregated from the

sterilized products and handled in accordance with the “Sterilization

Anomaly Handling Procedure”. A corrective actions shall be taken for

the differential pressure variation and sterilizing the affected products

until they meet the commercially sterilization standard before re-

starting of sterilization and filling operation.

6.4.3.1.12 Handling of anomaly in aseptic storage thank

When the aseptic storage tank occurs anomaly on its maintain of

positive pressure or other protection measures used, which may cause

deficiency of the aseptic condition of the storage tank, all potentially

affected products shall be eliminated, and the aseptic storage shall be

re-sterilized until it meets the commercially sterilization standard

before re-starting of product sterilization and filling operation.

6.4.3.2 Container sterilization and filling and seaming of product

6.4.3.2.1 Time for container sterilization

Appropriate measures shall be applied to control container

sterilization conditions (germicide concentration, sterilization time,

and sterilization speed) and comply the designated level(s) of

sterilization. A speed regulator shall be equipped with measures to

prevent unauthorized access or the sterilizing operators from arbitrary

changing settings. Measures may include using a lock or posting

warning sign indicating such as “Authorized Personnel Only”.

6.4.3.2.2 Handing of anomaly

When filling conditions are below the requirements designated by the

sterilization conditions, filling shall be stopped or appropriate

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methods shall be used to segregate filled products, such as diverting

products off the filler or blocking containers from entering the filler

with a diversion system. The finished products that are not complying

with the sterilization standard shall be segregated from those

sterilized products and handled in accordance with the “Sterilization

Anomaly Handling Procedure”.

6.4.4 Sterilization records

6.4.4.1 At the binging of sterilization and during the process, at least once every

hour to test and record the following items.

6.4.4.1.1 The temperature presented by the temperature indicator and

temperature recording device at the outlet of the product sterilizing

maintaining pipe.

6.4.4.1.2 The pressure on the both end-side of heating exchange device of a

product.

6.4.4.1.3 Product flow rate (can be counted using quantitative or filling

packaging methods).

6.4.4.1.4 Aseptic air pressure in sterile storage tanks or other measures to

maintain sterility.

6.4.4.1.5 Inspection of steam seals or other blocking devices on equipment and

piping to prevent the ingress of microorganisms.

6.4.4.2 Recording device: containers and lidding materials of sterilization system,

product filling and sealing systems, shall be capable of performing the

required degree of sterilization continuously. If necessary, automatic

recording devices shall be used to record the flow rate, temperature,

concentration or other factor. If the containers are sterilized in batches, the

sterilization conditions should be recorded.

6.4.5 If the sterilization equipment differs from the above descriptions, the canned

food factory shall submit proof of the test of even thermal distribution for its

sterilization equipment, which is issued by a government recognized entity.

6.5 Quality control equipment

6.5.1 The food factory shall have adequate testing equipment for the routine

QC testing and inspection to determinate the quality of raw materials,

semi-finished and finished products. When necessary, testing and

inspection shall be performed by an approved contractors or institutes

when suppliers do not possess the equipment on site.

6.5.2 The food plants shall equip with specified testing instruments and apparatus

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which is appropriate for analyzing the ingredients, materials, semi-finished

products, and finished products:

6.5.2.1 Analytical scale (with maximum sensitivity at 0.1 mg).

6.5.2.2 pH meter (with sensitivity down to two decimals).

6.5.2.3 Brix hydrometer.

6.5.2.4 Incubator.

6.5.2.5 Microbial test equipment.

6.5.2.6 Residual chlorine analyzer.

6.5.2.7 Can seam micrometer.

6.5.2.8 Can vacuum or pressure testing device.

6.5.2.9 Can vacuum leak testing device.

6.5.2.10 Tensile strength tester (required for retort pouch packaged food factories).

6.5.2.11 Pouch residual air analyzer (required for retort pouch food packaged

factories).

6.6 Establishment of sterilization conditions

6.6.1 LACF sterilization conditions shall be established by a qualified organization

that having suitable equipment and capacity, and is recognized by the

government. Data for calculating, evaluating, and validating sterilization

conditions shall be set in order and properly retained by the organization

during the period of using such sterilization conditions.

6.6.2 The sterilization conditions of acid canned foods shall be established by those

who have been qualified by the training course on sterilization technology

management that offered by a government recognized organization, and who

have manufacturing experience of acid canned foods.

6.6.3 Sterilization conditions shall be established in consideration of food properties;

preparation and processing methods; shape and size of foods; liquid filled;

solid-to-liquid ratio; container specifications; and the species, habits, and total

contaminated number of putrefactive bacteria; and the critical factors for

sterilizing.

6.6.4 The setting of sterilizing conditions of every different product, shall be

presented near to the sterilization machines or placed in a place where is easily

accessible to sterilizing operation workers.

6.6.5 The management of important factors of sterilization

6.6.5.1 The important control factors for the setting of sterilization conditions

should be determined and recorded at a sufficient frequency to ensure that

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all important control factors are within the set limits.

6.6.5.2 All heat distribution data, including exhaust gas, temperature rising time

and final temperature, shall be tested by the central health welfare authority

approved organizations which have the heat pasteurization expertise of low

acid canned foods.

6.6.5.3 In the sterilization conditions, when the highest loading volume or solid

volume is set, it shall be measured and recorded at an appropriate

frequency to ensure that the solids content of the product does not exceed

the set volume.

6.6.5.4 In the sterilization conditions, when setting the degree of vacuum, the

upper gap, the viscosity, etc., it should be checked and recorded at an

appropriate frequency to ensure conforming to the intended sterilization

conditions.

6.6.5.5 Non-continuous rotary retort steam pressurization and sterilization shall set

the rotation speed of the retort, the upper gap (or the highest loading

capacity) inside the tank, the viscosity and the arrangement of the cans as

important factors.

7 Organization and Personnel

7.1 Organization and duties

7.1.1 The food factory shall have and disclose the organizational structure

and its responsibilities related to food safety activities, including the

specialist in charge for food safety and quality and their authority to

supervise and carry out the tasks. Personnel in charge of the

management of the production, quality assurance, sanitation, food

safety and other departments shall be assigned as a specialist to

supervise, monitor or perform their respective functions and activities.

7.1.2 Production specialist are in charge of raw material handling, processing

and packaging operations. Quality assurance supervisor are responsible

for the establishment of quality standards and sampling requirements,

testing and traceability management of raw materials, intermediate and

finished products. Sanitation and hygiene supervisor are responsible for

the sanitary aspects of the internal and external environment, premises

and facilities, personnel hygiene, production and cleaning operation and

personnel hygiene training. The food safety control specialist is

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responsible for the implementation and maintenance of the food safety

control program based on the HACCP principles and the TQF

specifications and product certification scope; While the specialist

responsible for labor safety management are in charge of the food plant

safety and defense.

7.1.3 A committee to promote the TQF system shall be established. The

committee should consist of at least three person from senior executives

and department specialists, in which the senior executives or their

designees are necessary members and are responsible of identifying the

food safety management system and verifying the HACCP plan of TQF

product certification, and to formulate, implement and manage relevant

records; in the means time, the committee is also responsible for

planning, reviewing, supervising and assessing the quality management

of the matters concerning the food plant’s quality management. The

senior executives shall supervise the implementation and maintenance

of food safety and provide sufficient manpower and resources to

achieve the goal of food safety management and to ensure that effective

and sustainable resources are continuously provided to meet the

operation, maintenance and improvement of the food safety

management system.

7.1.4 The Quality Assurance Department shall be independent from the other

departments and shall have full authority to manage quality assurance

tasks. The person in charge shall have the authority to stop production

or product release.

7.1.5 The Quality Assurance Department shall designate a food testing and

inspection personnel to analyze and test the general and sanitary-

hygienic quality of the products.

7.1.6 A working group for sanitation and hygiene management (which can be

incorporated into the relevant committees that implement the TQF

system) shall be established, comprising of the specialist of sanitation

management and personnel of other departments. The group shall be

responsible for planning, evaluating, instructing and monitoring, and

auditing sanitation and hygiene matters of the whole plant. The name of

the person should be clearly marked based on the appropriate

workplace.

7.1.7 The person in charge of the production and the person in charge of the

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quality control area shall not be the same. However, personnel of other

departments are allowed to share interdepartmental responsibilities.

7.2 Personnel and qualification

7.2.1 The person in charge of production, quality control, sanitation management

and safety management shall be a college graduate from related fields, or have

a high school or vocational education diploma, or a higher degree with at least

four years experiences in food manufacturing.

7.2.2 Food testing personnel should have passed the government-certified

examination for food testing technicians or be graduated from related fields at

university degree. If the personnel is graduated from high school, vocational

education or unrelated university degree, the personnel shall have gone

through government-approved professional training (i.e., food testing training

course), and hold a certificate of completion.

7.2.3 The person in charge of a department and the technical assistants shall

receive, within three years of employment, professional pre-

employment or on-the-job training by attending the training courses

organized by government entities, research institutions or private

training organizations and hold a certificate of completion.

7.2.4 Food manufacturing factories which is specified in the categories of “Act

Governing Food Safety and Sanitation” shall be equipped with sanitation

management personnel, who are with qualifications and duty descriptions

complied with the “Regulations Governing the Establishment of the Sanitation

Control Personnel of Food Manufacturing Factory”.

7.2.5 All category of specialized technical personnel shall comply with the relevant

laws and regulations stipulated by the central competent authority.

7.2.6 At least one member of the related committee implementing TQF Technical

Specification shall be a certified food technologist or being graduated from a

food related department with a university degree, and have attended and

passed the training courses in Good Hygiene Practice (GHP) and Hazard

Analysis and Critical Control Points (HACCP) organized by training agencies

approved by the central competent authority.

7.2.7 A canned beverage factory shall be equipped with management personnel for

can seaming and sterilization in accordance with following regulations:

7.2.7.1 Container seaming mechanics taking charge of the adjustment,

maintenance, repair and recording of seaming machines must graduate

from at least a junior high school or an elementary school with three years

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of can seaming experience and pass accredited container seaming

technology training.

7.2.7.2 Sterilization equipment operators taking charge of the operation, recording,

and maintenance of sterilization equipment must at least graduate from

junior high schools or equivalent and pass accredited sterilization

equipment operation training.

7.2.7.3 Sterilization technical management personnel taking charge of production

management of the beverage sterilization system must be a university

graduate or equivalent (senior high schools, senior high schools of

industry, senior high schools of agriculture, and senior high schools of

commerce with over three years of practical work experience) and pass

accredited sterilization technology management training.

7.3 Education and training

7.3.1 New employees should receive appropriate education and training so

that their capacity of execution are in line with the production,

sanitation, hygiene and quality management requirements. Employees

should set annual training plans to be carry out and documented. The

annual training program should include on-site and off-site training

courses, and the effectivity in enhancing the management and

implementation capacity of the TQF certification shall be considered

during its planning.

7.3.2 Training on GHP and HACCP shall be conducted periodically (even

inside the factory) for employees engaged in food manufacturing and

related operations.

7.3.3 Personnel of the Quality Assurance Committee responsible for the food

safety management system shall, at least once every three years, be

subjected to HACCP related professional training, seminars,

workshops, meetings or other courses approved by the central

competent authority, with a cumulative training duration of more than

12 hours.

7.3.4 All departmental managers shall be committed to their responsibilities,

lead by example, and supervise and educate their staff to follow the

established operating procedures or rules.

7.3.5 Employees are required to obtain a certificate of participation in a

hygiene seminar or training course conducted by the competent health

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authority or approved related institution.

8 Sanitation and Hygiene Management

8.1 Establishment and implementation of the “Standard Operation Procedure for

Sanitation Management”.

8.1.1 The food plant shall establish standards for sanitation management as the basis

for sanitation and hygienic management and assessment, which shall include

the provisions of this chapter, even when amendments are made.

8.1.2 A sanitation inspection plan shall be established with specification of

schedules and items to be checked, and a sanitation management personnel

shall be designated to carry out the sanitation inspection in according to the

plan to confirm the sanitation condition of the specific day and that it was

actually carried out and recorded.

8.1.3 Pests and vector control measures should be developed, implemented and

documented.

8.2 Environmental sanitation management

8.2.1 Roads adjacent to the factory, along with passages ways and garden inside the

factory shall always be kept clean. The open ground inside the plant shall be

kept in good state of repair without damage, accumulation of water and no

dust.

8.2.2 Vegetation inside the plant shall be trimmed periodically, and accumulation

and storage of unnecessary equipment and articles are prohibited to prevent

pests from entering the facility.

8.2.3 Premises and plant facilities shall be kept in good sanitary condition and

properly maintained to protect against the contamination of food.

8.2.4 Gutters shall be kept unobstructed, with no accumulation of sludge, and waste

water shall be properly addressed and treated.

8.3 Plant facilities sanitation management

8.3.1 Sanitary standards and sanitation management regulations for operation zones

shall be established in accordance with the cleanliness classification specified

in 5.2.

8.3.2 Sanitary standards and sanitation management regulations for factory

equipment shall be established and exactly implemented in accordance with

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the regulations outside of the factory.

8.3.3 Facilities inside the plant shall be kept clean and in good state of maintenance

at all times. When the roof, ceiling and walls of the factory are damaged, they

shall be repaired immediately, and the ground and drainage facilities shall not

be damaged or stagnant.

8.3.4 Raw material handling areas, processing and preparation areas, and toilets

shall be cleaned daily (including floors, drains, and walls) before production

and disinfected when necessary.

8.3.5 Steam generated during the operation shall not be allowed to remain inside the

factory for a long period of time and shall be vented out through effective

facilities.

8.3.6 Production and storage areas shall take effective measures to prevent

or eliminate pests and vectors, such as screens, air curtain, fences or

insect traps.

8.3.7 The surface of lighting and pipes shall be kept clean at all times and be swept

or cleaned periodically.

8.3.8 Cool storage shall be sorted, set in order, and kept clean at all times, and

conditions affecting food sanitation such as pooling on floors and moldy walls

shall be prevented.

8.3.9 No pest or vector or traces of it shall be found inside the plant. However, when

present the source shall be eliminated using methods that do not cause

contamination of food, food contact surfaces and inner packaging material

(pesticides shall be avoided).

8.3.10 Raw materials, inner packaging materials or other unnecessary articles that are

not being immediately used shall not be keep in the controlled operation area.

8.3.11 Equipment and tools for cleaning and sanitizing shall be stored at specific

designated location.

8.3.12 Do not place or store any substance in the processing area that pose a risk to

food safety.

8.3.13 Periodical cleaning and daily inspection of chlorination treatment (prior to

production), and regular monitoring to avoid contamination of processing

water quality are recommended if reservoirs (tower or pool) are used. When

using non-potable water, a personnel shall be designated in charge of checking

the residual chlorine and pH value every day, and at least once a year a

government recognized inspection agency shall be sent to ensure that water

meets potable water quality standards (with exception of boiler water, cooling

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water for refrigeration compressor or evaporator, or floor cleaning water etc.).

8.4 Machinery and equipment sanitation management

8.4.1 Equipment and utensils for manufacture, processing, formulation, packaging,

and storage shall be cleaned and sterilized periodically. The “machinery and

equipment sanitation management standards and regulations” shall be

established and exactly implemented. The cleaning and sterilization of utensils

and equipment shall not contaminate foods, food contact surfaces, and food

interior packaging materials.

8.4.2 Every day after manufacturing ends, sugar (salt) liquid barrels, sugar (salt)

liquid filters, sanitation pumps, rubber tubes, plastic hoses, and all kinds of

gauges and containers shall be disassembled (except for CIP) and thoroughly

cleaned.

8.4.3 When water needs to be disposed from the equipment, it shall be design to

properly collect the water and direct it to the drainage system to avoid any

contamination.

8.4.4 Cleaning agents or disinfectants used in the cleaning operation shall

not contaminate food, food contact surfaces and inner packaging

materials.

8.4.5 Juice extractors, fine filters, and centrifuges shall be disassembled and washed

immediately after use.

8.4.6 Fillers shall be thoroughly washed, and the inlet shall be disinfected with

disinfectants such as chlorine after washing.

8.4.7 After using a seaming machine, parts and blind spots, such as the chuck,

seaming roll, and lifter, and other areas that are prone to contamination shall

be washed thoroughly.

8.4.8 Container cleaning equipment, such as bottle washing machines and can

cleaning machines, shall be cleaned and maintained periodically.

8.4.9 Aseptic filling systems shall be sterilized before use. All pipelines shall be

cleaned and disinfected by means of cleaning in place (CIP) after construction

and disassembled for cleanliness inspection periodically.

8.4.10 After cleaning and sterilization, movable equipment and utensils shall be

stored in appropriate places that can prevent the food contact surface from

contamination and ensure they are ready for use.

8.4.11 The water used to clean the equipment and tools in direct contact with food

shall meet potable water quality standards.

8.4.12 Equipment or facilities used in food manufacturing shall not be used for other

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non-food production purposes.

8.5 Personnel hygiene management

8.5.1 Workers having direct contacts with foods shall keep their hands clean at all

times to prevent contamination. Such workers shall not have long fingernails,

polished fingernails, or wear ornaments. Workers shall also wash and/or

sanitize their hands thoroughly with appropriate equipment before work

(including leaving work and return to their post afterwards) or on any

occasions that may contaminate their hands.

8.5.2 New employees shall have a health examination in a health or medical

institution prior to employment. During the course of their employment,

employer shall take the initiative to establish routine health examinations

which shall include relevant examinations in compliance with the Good

Hygiene Practice (GHP) provision.

8.5.3 Employees infected with hepatitis A, hand skin diseases, rash,

abscess, wound, tuberculosis, typhoid or other infectious diseases

even in its incubation period, that may contaminate food shall not be

working in direct contact with food.

8.5.4 Workers in the operation zone shall keep their hands clean or wear clean and

sanitized waterproof gloves.

8.5.5 Operators must wear a clean work clothes and hair nets to prevent hair,

dandruff and foreign materials from falling into and contaminating the food,

food contact surface or inner packaging material. Shall wear mask when

necessary.

8.5.6 No smoking, chewing gum or betel nut, eating, drinking and other behavior

that may cause food contamination is allowed in the production area. It is

necessary to take precautions to protect against contamination of food, food-

contact surfaces, or food-packaging materials with microorganisms or foreign

substances, including but not limited to sweat, saliva, cosmetics, and

medicines applied topically.

8.5.7 Hand washing or (and) disinfection shall be properly done according to the

hand washing procedures and instructions.

8.5.8 Personal clothing should be stored in the change room and should not brought

into food handling area or equipment, appliances and utensils cleaning areas.

8.5.9 Before entering food factory (including work shift), or after using the toilet

(the sign indicating washing hands after use should be posted in the toilet), or

because of spitting, nose blowing lead to possible contamination of the hands,

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hands shall be washed properly and even disinfect when necessary.

8.5.10 The access of visitors or off-site staffs shall be properly controlled. Hygienic

requirements for them should comply with those for on-site operation

personnel.

8.6 Management of chemicals and supplies such as detergents and disinfectant

8.6.1 Detergents and sanitation agents should have been proven that it is safe and

applicable for the purpose being used.

8.6.2 Inside the food operation area, with the exception of those agents necessary for

environmental protection and sanitation purposes, other agents are not allowed

in the food operation area.

8.6.3 Sanitizing agents, sanitizers, and dangerous reagents shall comply with

relevant specifications, and shall be clearly identified and labeled with

indication of its toxicity, instruction of how to use, and emergency handling

and stored and kept locked in a specific designated location to avoid food from

being contaminated. A specialist in charge should be assigned of their storage

and record the amount of usage.

8.6.4 Strict preventive measures and limitations shall be taken regarding the use of

pesticides and sanitizing agents, to protect against contamination of food,

food-contact surfaces, or food-packaging materials. They shall be used by or

under the supervision of a sanitation personnel who understands their potential

harm to the human body (including in the event of food contamination).

8.7 Waste material

8.7.1 Handling of waste material shall comply with waste material cleaning law and

related regulations of the provisions of removing and handling, and shall be

collected, classified and properly disposed according to their characteristics.

Perishable waste shall be removed at least once a day, the container shall be

cleaned and disinfected after emptied.

8.7.2 Waste disposal areas shall not present bad odors or harmful (toxics) gases. It is

necessary to prevent the harboring of pests and the food, food contact surface,

water source and ground from being polluted.

8.7.3 Waste material and receptacles shall not be allowed to accumulate inside the

food operation area or outside the building to prevent the breeding of pests and

vectors.

8.7.4 Raw materials handling, processing, packaging, storage and other areas, shall

have waste receptacles that are easy to clean and disinfect (with exception of

the ones that are discarded after usage), can be closed (or sealed), and

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regularly (at least once a day) removed from the plant. Reusable containers

should be cleaned and disinfected immediately after discarding the content. If

a large number of waste is generated, it shall be transported outside the

facility, as soon as possible, and also away from the plant, in order to prevent

pests breeding, and the contamination of water sources, ground, ground water

etc.. The machines and equipment used for waste handling shall be cleaned

and disinfected immediately upon finishing operation.

8.7.5 When there is waste exposure that may put human health and food safety in

direct danger such as chemicals, radioactive materials, pathogenic

microorganisms and food spoilage, etc. special storage facilities shall be set

up.

8.7.6 Harmful (toxic) gases, waste water, litter, noise pollution, etc. shall be avoided

or handled in accordance with relevant laws and regulations in order to prevent

environmental pollutions.

9 Food Production Management

9.1 Establishment and implementation of the "Standard Operation Procedure for Food

Manufacturing".

9.1.1 The Production Department is responsible for the establishment and revision

of the "Standard Operation Procedure for Food Manufacturing", and approved

by the quality assurance and related departments.

9.1.2 The "Standard Operation Procedure for Food Manufacturing" shall specify the

recipe, standard operation procedure, process control standard (including at

least the manufacturing process, control object, control item, control standard

value and precautions, etc.) and machinery and equipment operation and

maintenance standards.

9.1.3 The employees shall be educated and trained to carry out their work in

accordance with the "Standard Operation Procedure for Food Manufacturing"

so as to be in compliance with the production, sanitation, hygiene and quality

control requirements.

9.2 Raw material handling

9.2.1 The food factory shall establish raw material inspection standard procedure for

its reception, and shall not use primary or secondary raw materials from which

microorganisms and toxic substances (e.g., cyanide in the cassava) cannot be

removed or reduced to an acceptable level during normal processing. Semi-

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finished products or finished products the raw materials, manufacturing

environment, manufacturing process and quality control shall meet the hygiene

requirements of the Good Manufacturing Practices of food factories. The same

requirements will stand for semi-finished or finished products, which are used

as raw materials, and are produced by their own factory or outsourced.

9.2.2 Raw materials shall go through sensorial inspection before use, and if

necessary, go through selection and removal of foreign matters or

substandard specification materials.

9.2.3 A procurement plan shall be established and implemented for purchasing

perishable fresh ingredient agricultural products, such as fruits and vegetables.

They shall be shipped to the factory from the production site or supplier as

quickly as possible and processed as soon as possible. Unprocessed ingredients

shall be refrigerated or stored in the ingredient zone or storage zone for proper

management to prevent contamination and quality deterioration.

9.2.4 Fresh raw materials, should be cleaned when necessary, and the water should

meet potable water quality standards. If water is recycled, it shall be properly

disinfected, and filtered, when necessary, so as to avoid raw materials from

secondary contamination.

9.2.5 Approved raw materials and substandard raw materials shall be stored

separately, and clearly identified.

9.2.6 Food additives used in processing shall be qualified and registered by the

Ministry of Health and Welfare (MOHW) and with complete product labeling.

9.2.7 Ingredients and food additives shall be separately stored in appropriate

conditions with good ventilation, appropriate temperature, and appropriate

humidity by variety and by lot number. Records of temperature and humidity

of the warehouse shall be maintained.

9.2.8 Ingredients shall be used based on the first in and first out (FIFO) principle

and be used within expiry date. Frozen ingredients shall be thawed in

conditions that can prevent them from quality deterioration.

9.2.9 Raw materials shall be stored in such a way that they can be protected

from contamination and damages, and minimize quality deterioration.

When temperature and humidity control are needed, control limits shall be established. Frozen raw materials should be kept below -18℃, and

refrigerated raw materials below 7℃ and above the freezing point of

water.

9.2.10 Effective vector prevention measures, as well was measures to prevent damage

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on the external package from contaminating ingredients and food additives,

shall be implemented in the ingredient storage zone.

9.2.11 Unused ingredients and food additives after production shall be sealed and

packaged properly according to storage needs before storing in appropriate

locations to prevent contamination. The use of such ingredients and food

additives shall be prioritized during the period when their quality remains

qualified.

9.3 Canned food container handling

9.3.1 When receiving containers, suppliers shall provide a proof of quality or

sampled for testing its quality and hygiene.

9.3.2 The storage shall be prevented from contamination, when the temperature and

humility are required to be controlled during the storage shall established

managing methods and standards, and recorded.

9.3.3 Shall adopt an appropriate mothed to keep container clean before use.

9.3.4 During delivering, moving, canning, etc., bruising should be avoided and

intrusion of debris should be prevented.

9.4 Manufacturing operation

9.4.1 All food manufacturing operation procedures, including packaging and

storage, shall be in accordance with the principles of food safety and

sanitation. Food shall be quickly processed under controlled condition to

minimize microbial growth and food contamination as possible.

9.4.2 When the control of temperature, humidity, pH value, water activity,

pressure, flow rate and time are needed during operation procedures, a

related control methods and control limits shall be established and

recorded, to ensure that food is not spoiled or being contaminated by

mechanical failure, time delays, temperature changes and other

factors.

9.4.3 Ingredients shall be processed as quickly as possible. Where production is

lagged by mechanical failures, timely and effective responsive actions shall be

taken on formulated or mixed semi-finished products to prevent deterioration,

quality change, or contamination. When production resumes, such semi-

finished products or finished products that have been lagged behind shall be

examined and assessed. Seriously deteriorated semi-finished products or

finished products shall be discarded immediately and eliminated from

processing.

9.4.4 A double check system shall be established and exactly implemented for the

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weighing and use of food additives, and records shall be maintained.

9.4.5 When storing formulated semi-products in storage barrels, workers shall pay

attention to contamination by foreign matter and avoid long-term storage.

Where refrigeration is required, the refrigeration temperature shall be between

freezing point and 7°C.

9.4.6 In the course of operation, appropriate methods shall be used to

prevent pathogenic microorganism growth, and to prevent food

degradation during manufacturing, storage and transportation, such as

sterilization, irradiation, pasteurization, freezing, refrigeration, and pH or

water activity control.

9.4.7 The path for transporting semi- finished products and finished products via

pipes shall be strictly controlled to prevent mixing with other products or

foreign matter, such as acid solutions, alkaline solutions, syrups, or cleaning

water, to affect quality.

9.4.8 Filters, metal detectors, and other effective measures shall be equipped in

appropriate locations of formulating barrels, storage barrels, and other

pipelines to prevent foreign matter from mixing with semi- finished products

and finished products.

9.4.9 The operation, utilization and maintenance of equipment, containers and

utensils which are in contact with the raw materials, semi-finished and finished

products shall not contaminate food during processing and storage. Equipment,

containers and utensils in contact with raw materials or contaminants shall not

be used for handling finished food products unless thoroughly cleaned and

disinfected. Food containers that contain semi-finished food shall not be

directly put on the ground to avoid splashing water contamination or cross-

contamination from the bottom of the container. When entering from the

general operation area into the controlled operation area, appropriate cleaning

and disinfection measures shall be established to prevent food contamination.

9.4.10 Sterilized can after cooling down, using conveyor belt for conveying shall

avoid the contact between conveyor belt and roll seal (seal); damaged

conveyor belt and caning buffering device shall be replaced, the conveyor belt

and track which is contact with seal shall be kept clean.

9.4.11 Water for making ice cubes which directly come into contact with food

during processing shall meet the standard of potable water, and the ice

cubes shall be made under sanitary conditions.

9.4.12 An aseptic filling zone shall be appropriately segregated, and operation shall

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be implemented in accordance with the environmental sanitation management

standards for clean zones. Sanitation and filling conditions shall comply with

the operating specifications to prevent re-contamination.

9.4.13 Containers, such as empty cans, empty bottles, or empty boxes, for filling shall

be washed, and re-sterilized as necessary, before use.

9.4.14 The filling of products shall be managed, to ensure compliance with the

volume of sterilization condition presented in clause 6.6, this specific

provision.

9.4.15 When heating for re-sterilization after filling and sealing, products shall not be

retained for a long period of time to prevent temperatures from falling below

the initial sterilization temperature and thereby affecting sterilization safety.

9.4.16 Degassing after filled shall be managed and to ensure compliance with the

volume of sterilization condition presented in clause 6.6, this specific

provision. When using degassing device, it shall be cleaned and maintained.

9.4.17 Ultra-high temperature (UHT) short-time sterilizers shall be disassembled and

checked for leakage periodically.

9.4.18 Appropriate corrective actions shall be taken for anomalies in the

manufacturing process; anomalies shall be reviewed to prevent recurrence; and

records shall be maintained.

9.4.19 Effective methods shall be used to prevent products under processing or in

storage from contamination by ingredients or scraps.

9.4.20 Handling raw material blanching

9.4.20.1 During blanching, temperature (especially temperature of the inlet and

outlet) and time shall be strictly controlled, quickly cool down and moved

to the next operation procedure. Equipment shall be routinely cleaned to

prevent thermo-resistant bacteria growth and contamination, and to

minimize its contamination. If the blanched food is cooled before filling,

the cooling medium should conform to the principle of safety, hygiene and

sanitation.

9.4.20.2 Blanching devices shall be cleaned thoroughly. Those who adopts hot

water blanching shall drain and refill hot water frequently, and preventing

blanched water from contamination.

9.4.20.3 The water for washing raw material and cooling shall comply with

“Potable water quality standard”.

9.4.21 Foods that rely on pH control to prevent pathogenic micro-organism growth,

such as acidic or acidified foods, shall be regulated and keep the pH below 4.6.

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This requirement should be achieved by one or more of the following effective

methods:

9.4.21.1 Adjustment of pH values of raw material, semi-finished product and

finished product.

9.4.21.2 Controlling the amount of acidic or acidified food added to the low acid

food.

9.4.22 When selecting inner packaging materials, it must protect food during

normal storage and distribution, and to avoid migration of harmful

substances into food and meet sanitation and hygiene standard. Inner

packaging materials shall not be reused with the exception of glass

bottles, stainless steel containers and barrels (e.g. used as water or

invert syrup container), but they shall be properly cleaned. If necessary,

they shall be effectively sterilized.

9.4.23 An effective system, such as labeling with thermochromic inks or

thermochromic papers, shall be established to control the need for sterilization

to prevent sterilized and unsterilized cans from mixing.

9.4.24 The initial temperature of the contents in a container during each time of

sterilization shall be tested and recorded before sterilization to ensure the

initial temperature of sterilization is not below the minimum initial

temperature specified by the sterilization requirements.

9.4.25 Pre-sterilization operation: before sterilization operation, all the contact

surfaces of sterilizer and afterword equipment shall reach the requirement of

commercial sterilization, and shall have appropriate device to present its

effective.

9.4.26 An accurate wall mount clock shall be used for counting sterilization time.

Wristwatches or pocket watches shall not be used.

9.4.27 A sterilization work report shall not be completed in advance or supplemented

afterwards. Records shall be faithfully maintained.

9.4.28 Sterilization operation reports and automatic temperature recording document

shall be checked and signed by sterilization manager within a week after the

operation.

9.4.29 The document of sterilization and sealing shall be kept at least for 5 years.

9.4.30 In the air release and sterilization processes, LACF factories shall maintain the

steam pressure of the main steam pipes at 6kg/cm2 or higher.

9.4.31 During the sterilization process, the temperature read from the mercury-in-

glass thermometer shall be the sterilization temperature that shall not be

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substituted by the temperature on the temperature recorder.

9.4.32 Cold chlorinated water shall be added to cooling water from sterilization

(except for retort pouches). The minimum volume of ionized residual chlorine

at the outlet shall be 0.2ppm.

9.4.33 The product temperature of cooled cans shall be lukewarm and not higher than

40℃.

9.4.34 Handling sterilization anomalies

9.4.34.1 Where controls relating to commercial sterilization safety, such as air

release, sterilization, critical factors, seaming completeness, and

acidification controls, are found to have deviated from the sterilization

conditions (requirements), all affected products shall be re-processed and

re-sterilized or retained for evaluation. Where deviation is found during the

process, corrective actions recommended by the organization(s)

establishing the sterilization conditions shall be implemented.

9.4.34.2 Retained products shall be evaluated by a government accredited

organization. Products with threats to public health safety shall be re-

processed/re-sterilized or destroyed.

9.4.34.3 Records shall be exactly maintained for the status, cause(s), handling

method(s), correction procedures, and correction outcomes of a

sterilization anomaly and archived individually.

9.5 Control of critical factors

9.5.1 The internal time for monitoring and recording the time, temperature, and

critical factors of sterilization shall be 15 minutes in principle, with a

maximum of not more than 60 minutes.

9.5.2 All control points of the aseptic processing and packaging system, such as the

flow speed, temperature, and concentration of the sterilization medium; and

the speed of containers passing through the sterilization system and seaming

shall be checked and recorded at appropriate times (at least once an hour).

10 Quality Control

10.1 Establishment and implementation of the "Standard Operation Procedure for

Quality Control"

10.1.1 The Quality Assurance Department is responsible for the establishment of the

“Standard Operation Procedure for Quality Control", and it shall be approved

by the Production Department and effectively implemented to ensure that food

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produced are suitable for human consumption. The content of the manual shall

include the provisions from section 10.2 to 10.6, as a basis for quality control

ensuring product quality. It is also applicable when amended.

10.1.2 “Process and Quality Control Engineering Flow Chart” that are based

on critical control factors shall be established for every product. Its

contents shall include the scope, control points, control limits, sampling

frequency and testing methods etc., and shall be implemented and

recorded.

10.1.3 A quality control standard shall include the following items:

10.1.3.1 Ingredient specifications and quality acceptance criteria.

10.1.3.2 Process quality control standards and methods.

10.1.3.3 Finished product specifications and OQC sampling inspection criteria.

10.1.3.4 Methods of tests and analyses.

10.1.4 Records of quality inspections shall be maintained. A quality record shall

include the following items:

10.1.4.1 The name of the sample, sampling location, sampling size, lot number and

other explicit codes, sampling date, and inspection date.

10.1.4.2 The references of special inspection methods, where necessary.

10.1.4.3 Records of inspection results to be compared with the established

specifications.

10.1.4.4 The name of test operators and date of tests.

10.1.5 Testing methods shall be based on promulgated normative. When a modified

testing method is adopted, it shall be checked regularly against the

promulgated normative and recorded. When there is no national normative or

regulation, the supplier shall provide clear product specification, testing items

and internationally recognized testing methods as supporting documents.

10.1.6 A control system shall be established to avoid possible biological and chemical

contamination during testing, and effectively implemented.

10.1.7 Drugs or chemicals used in quality control tests shall be used under effective

conditions and controlled.

10.1.8 An annual calibration program for measuring instruments (e.g., thermometers,

pressure gauges, weighing scale, etc.) that are important to the manufacturing

process shall be established and recorded. Meters or thermometers and

pressure gauges mounted on heat sterilization equipment that are closely

related to food safety and hygiene shall be calibrated by an authorized entity at

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least once a year, and effectively implemented and recorded.

10.1.9 Appropriate statistical methods shall be used to analyze the quality control

data recorded.

10.1.10 All food factories shall be up-to-date with all current relevant regulations or

normative information.

10.2 Contract management The food factory shall establish and maintain written procedures for contract review and for its operational coordination.

10.2.1 Contract review

Upon acceptance of each order placed by customers, it is necessary to review

that the requirements have been clearly written and ensure that the customer

requests and requirements can be properly met.

10.2.2 Contract amendment

Amendment of contract or purchase order shall be documented and

communicated accurately to relevant departments and executed in accordance

with the revised content.

10.3 Quality control of raw materials

10.3.1 For the quality control of raw materials it is necessary to specify the quality

specifications of raw materials and packaging materials (including source

information and control points for risk and hazard), testing items, inspection

criteria, sampling plan (sample containers should be properly identified) and

testing methods, and effectively implemented.

10.3.2 Suppliers evaluation procedure shall be established, which shall include the

method applied and frequency, be effectively implemented and recorded.

When possible, on-site assessment of suppliers shall be conducted.

10.3.3 Each batch of raw materials (additives) shall be inspected and approved by

quality assurance personnel before released for use. Traceability and source

control measures of raw material shall be established (including supplier's raw

material quality certificate and certificate of origin, raw material provenience

details and testing reports). Establishment of a TQF certificated products

quality history or curriculum (including product name, lot number,

manufacturing plant, expiration date, ingredients of raw material and its origin,

raw materials testing report, finished product testing report information). Raw

materials that were not approved during inspection shall be clearly identified,

and appropriately managed.

10.3.4 Prior to release for use, it is necessary to verify that those raw materials with

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potential contamination of pesticides, heavy metal or toxins are safe and the

amount of residues permitted are in compliance with regulatory requirements.

10.3.5 The acceptance of packaging materials should include the source, the

application of materials and their use and storage, etc., in order to avoid

contamination of the product. Inner packaging materials shall meet hygienic

and sanitation normative standards, and suppliers of those packaging materials

should provide periodic test reports to verify the compliance with food safety,

sanitation and hygiene requirements. The testing reports shall be provided

again by the supplier upon changing suppliers or specification.

10.3.6 Special designated storage for food additives shall be set up and be managed

and controlled by authorized personnel who is responsible for issuing the

materials and controlling the expiration date. Log sheets with list of food

additives type, registration number under the health authority, material check-

in and check-out etc. shall be documented.

10.3.7 Raw materials which are provided by the consignor for contract manufacturing

shall be properly stored and controlled, and any missing, damaged, or out of

specs materials shall be recorded and reported to the contract supplier. When

contract manufacturing products apply for certification, the food factory shall

be able to trace back the source of the raw materials and confirm the

composition, purity, etc. of the product, providing supporting documents to

ensure the quality of the products. Qualification for the TQF product

certification will be withdrawn from the supplier for providing false

information.

10.4 Quality control during processing

10.4.1 Hazard Analysis and Critical Control Points shall be performed, and testing

items, criteria and methods for sampling and testing shall be established,

effectively implemented and documented.

10.4.2 Corrective actions and preventive measures shall be established when

deviation from control limits occur during processing, and immediate

investigation and corrective action shall be taken and documented.

10.4.3 The sufficiency of ionized residual chlorine in water for washing ingredients

shall be analyzed periodically, and records shall be maintained.

10.4.4 The temperature and time of blanching or steaming/cooking shall be checked

periodically and records shall be maintained.

10.4.5 The cleanliness and suitability for use of utensils and equipment for

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formulation and mixing shall be checked before use.

10.4.6 Measuring devices, such as the Brix hydrometer, hydrometer, and scale, shall

be calibrated periodically.

10.4.7 The appearance and characteristics, normal taste, and purity of juice, syrup,

water quality and other secondary ingredients, and food additives shall be

confirmed before use. The dose shall be correct as formulated. Records shall

be maintained.

10.4.8 The appearance, taste, degree Brix, acidity, and foreign matter on

semi-finished products shall be examined after formulation to ensure

there are no anomalies.

10.4.9 The water for making ice that has direct contact with foods during processing

shall comply with the drinking water standard. Such ice shall be made in a

sanitary environment.

10.4.10 Where dichlorination of water for processing is required before formulation,

residual chlorine shall be analyzed immediately afterwards to ensure there is

no residual chlorine contained in the water.

10.4.11 When hot filling is required, the filling temperature shall be checked to ensure

compliance with the control conditions.

10.4.12 During the seaming process, the products seamed first shall be examined for

sealing or seaming integrity. Seaming shall be adjusted where necessary.

Seaming integrity shall be implemented periodically throughout the production

process to ensure seaming integrity and safety. Records shall be maintained.

10.4.12.1 Double seaming of metal containers

10.4.12.1.1 Appearance inspection: Implemented every 30 minutes after

operation begins. Inspection items include appearance defects, seam

thickness (T), seam width (W), countersink (C), and body height. An

M-V control chart shall be produced for the reference of capping. A

can shall be opened for inspection when appearance anomalies are

detected.

10.4.12.1.2 Can opening inspection: To be implemented before and after

operation. Operation shall begin only after the requirements are met.

After operation begins, a can opening inspection shall be

implemented every four hours. Inspection and recording items shall

include appearance and interior detects, seam thickness (T), seam

width (W), the length of the cover hook (CH) and body hook (BH),

overlap (OL) and percentage of overlap (OL%), countersink (C),

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internal droop (ID), wrinkling (WR), and pressure ridge (PR). When

serious defects are found in the can opening inspection, the seamer

shall be shut down for mechanical re-adjustments before re-running

the can opening inspection.

10.4.12.1.3 When turning on a seamer after trouble shooting or mechanical

adjustment, the appearance inspection and can opening inspection

shall be implemented, and seam thickness (T) and countersink (C)

shall also be checked. Detailed records of adjustments and inspection

results shall be maintained.

10.4.12.1.4 Cold water shall be filled in cans to test the degree of vacuum of

vacuum capping machines.

10.4.12.2 Capping of glass containers

10.4.12.2.1 The sealing efficiency of capping machines shall be inspected every

day before operation or restarting machines after suspension.

Operation shall begin only after the requirements are met. Records

shall be maintained.

10.4.12.2.2 The interval of appearance inspection and recording shall not exceed

30 minutes. The interval of can opening inspection and recording

shall not exceed four hours. The appearance and can opening

inspections after sterilization and cooling may be combined with the

can opening inspection of finished products.

10.4.12.2.3 Cold water shall be filled into cans to test the degree of vacuum of

vacuum capping machines.

10.4.12.3 Heat sealing of retort pouches

10.4.12.3.1 The sealing efficiency of sealers shall be inspected every day before

operation or restarting machines after suspension. Operation shall

begin only after the requirements are met. Records shall be

maintained.


30 minutes. The interval of the compressive strength test and interior

residual air test and recording shall not exceed four hours.

Appearance and can opening inspections shall be conducted after

sterilization and cooling and may be combined with the can opening

inspection of finished products.

10.4.12.3.3 Appearance inspection of retort pouches’ sealing, shall be free from

defects such as pin holes, uneven seals, residual inclusions at seals, or

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incomplete seals; the quality and inspection methods shall comply

with related requirement of inspection of sterilization-bag-packaged

food and packaged food of republic of china standard.

10.4.12.4 Other sealing systems

10.4.12.4.1 To be inspected every day before operation or restarting machines

after suspension of use. Operations shall begin only after the

requirements are met. Records shall be maintained.


30 minutes. The interval of the compressive strength test and interior

residual air test and recording shall not exceed four hours.

Appearance and can opening inspections shall be conducted after

sterilization and cooling and may be combined with the can opening

inspection of finished products.

10.4.13 The inspection frequency and the control boundary of control items shall be

established according to the item characteristics. A quality control chart shall

be established to ensure the stability of quality, sanitation, and safety.

10.4.13.1 Blanching temperature should be checked every 30 minutes (a -Rm

control chart is recommended).

10.4.13.2 Filling quality or quantization shall be checked every hour (a -R control

chart is recommended).

10.4.13.3 The degree of vacuum of vacuum capping machines or the center

temperature of degassed cans shall be checked every hour (a -R control

chart is recommended).

10.4.13.4 Contents shall be checked every hour (a -R control chart is

recommended).

10.4.13.5 Seam appearance (W, T, C, H) shall be checked every 30 minutes (an M-

V control chart is recommended).

10.4.14 When anomalies are found within the process inspection results, abnormal

semi-finished products and finished products shall be effectively segregated,

cause(s) shall be traced, and corrective actions taken as quickly as possible.

10.4.15 The sterilization work report of an LACF factory shall include: product name;

lot number (or symbol); date; can type; sterilizer (machine) number; rough

number of cans; pressure, initial temperature, air release time (start and finish

times) of the main steam pipes; sterilization time (start and finish times);

sterilization temperature indicated on the mercury-in-glass thermometer and

temperature recorder; product temperature after cooling; ionized residual

x

x

x

x

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chlorine in cooling water; and other required items.

10.4.16 Items required for records of various sterilization methods:

10.4.16.1 Static sterilizers: air release start and finish times; air release time;

temperature at the end of air release; time and temperature at the

beginning, in the middle, and at the end of sterilization (time and

temperature in the middle of sterilization can be omitted when an

automatic controller is equipped).

10.4.16.2 Rotary sterilizers: Status of the condensate check valve, rpm, and

designated sterilization conditions, such as top open space, viscosity, solid

upper limit, content lower limit, and solid percentage.

10.4.16.3 Retort pouch processing and packaging:

10.4.16.3.1 Temperature at the inlet and outlet of the constant temperature

insulation pipe, thermometer, and temperature recorder.

10.4.16.3.2 Temperature at the final outlet of the heater, thermometer, and

temperature recorder.

10.4.16.3.3 The pressure recorded in the differential pressure controller when

product heat exchange is used.

10.4.16.3.4 Product flow speed: Flow speed can be detected from the speed of the

quantitative pump or filling and sealing speed.

10.4.16.3.5 The flow speed and temperature of the sterilization medium.

10.4.16.3.6 Container retention time in the sterilization medium, and temperature-

related data shall be recorded. The lot number for identifying

containers shall also be recorded.

10.4.16.4 Acidified canned foods: Process pH control points, sterilization critical

factors, and sterilization time and temperature.

10.4.16.5 When controlling critical factors (e.g. water activity) with heat treatment is

used in sterilization, the product formula, heat treatment conditions, water

activity, and other critical factors shall be recorded.

10.5 Quality control of finished products

10.5.1 Quality specifications, testing items, testing standards, sampling and testing

methods shall be established.

10.5.2 Finished product inspection: Representative samples shall be taken from each

lot of finished products in accordance with the finished product specifications

and OQC sampling criteria established by a factory for the finished product

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inspection. The inspection items of finished canned products shall include:

10.5.2.1 Contents (e.g. degree Brix).

10.5.2.2 Solid quantity or content quantity.

10.5.2.3 pH value.

10.5.2.4 Degree of vacuum.

10.5.2.5 Taste.

10.5.2.6 Foreign matter.

10.5.3 Every lot of finished products shall be subject to quality testing. Non-

conforming products shall be appropriately managed.

10.5.4 A sample retention plan shall be established to retain samples from each lot of

finished products. A food storability test shall be conducted on finished

products, as necessary, to test food preservation capacity.

10.5.5 Every lot of product shall be sampled and inspected for its can-opening quality

within a working-day, and recorded the results.

10.5.6 The can opening inspection shall be conducted on each lot of finished products

within one workday, and records shall be maintained.

10.5.7 A 10-day incubation test at 37°C for shall be conducted on samples taken from

each lot after sterilization. After the test is completed, the can opening

inspection shall be conducted in accordance with 10.5.2, and records shall be

maintained.

10.6 Testing condition Raw materials, semi-finished products, final semi-finished products and finished products shall be properly identified, handled and controlled. When the regulation of "Food Businesses Shall Enact Food Safety Monitoring Plan and Mandatorily Conduct Tests and Meet the Minimum Testing Cycle and Other Relevant Matters" enacted by the Ministry of Health and Welfare is applicable to the raw material, semi-finished product or finished product being produced, it shall comply with the requirements of that regulation.

10.7 Non-conforming product handling

10.7.1 The factory shall establish a non-conforming product control plan, effectively

implemented and recorded.

10.7.2 Non-conforming products shall be effectively separated and make sure that

they are not placed on the market; those introduced into the market shall be

recalled and appropriately managed. The quality control of the third-party: food manufactories shall establish and maintain the documented procedure of any service that is related to food safety matters (such as equipment maintenance, instrument calibration, disinfection, and vector control, logistics, etc.). Each document shall be stored properly, easy to access when necessary and reviewing periodically.

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11 Warehousing and transportation management

11.1 Warehousing and sanitation management

11.1.1 A storage and transport control procedure shall be established, it shall include

storage area separation, storage conditions, inventory control, storage

management, etc.., and be effectively implemented and recorded.

11.1.2 Storage and transport method and its surroundings shall avoid direct exposure

of sunlight, rain, wide fluctuation of temperature or humidity and any direct

impact or collisions and water accumulation to prevent the food ingredients,

composition, quality and concentration from being affected by undesirable

external factors, and maintaining food degradation at a minimum level.

11.1.3 Storage shall be always keep clean and organized, swept and cleaned, and

storage items shall not be placed directly on the ground. Cold chain storage

and transportation equipment shall be available when necessary, to ensure

products are maintained in insulated (temperature control) condition.

11.1.4 Temperature (and humidity, if necessary) in the storage shall be recorded, and

the storage items shall be regularly checked, when abnormalities are detected,

corrective action shall be immediately performed. When possible risk of

quality deterioration are presented due to damaged packaging or prolonged

storage, food products shall be re-inspected to ensure that they have not been

contaminated and the deterioration of quality is still acceptable.

11.1.5 When temperature and humidity control are necessary, control methods and

parameters limit shall be established, documented and recorded.

11.1.6 Food items rotation shall be based on the “first in first out” principle; products

shall be stable and ventilated when stacked.

11.1.7 There shall be measures to prevent cross-contamination of any item that may

contaminate raw materials, semi-finished products or finished products; those

that cannot effectively prevent cross-contamination shall be prohibited from

being stored or transported together with raw materials, semi-finished products

or finished products.

11.1.8 Containers and vehicles for transportation shall be checked to prevent

contamination of ingredients or the factory area. Containers and vehicles for

shipping shall be checked before loading to ensure product cleanliness and

sanitation. When temperature control is required during transportation,

vehicles with effective temperature control shall be used, and records shall be

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maintained.

11.1.9 Transportation methods to protect finished products from the influence of

unfavorable environmental factors on quality shall be specified.

11.1.9.1 When transporting finished products in a truck without a cover, canvas,

plastic, and other protection against sunshine and rain shall be used.

11.1.9.2 Appropriate protection shall be provided for finished products packed in

easy-to-break bottles, carbon boxes, or aluminum packs to prevent impact

and/or squeezing from affecting product quality and safety during

transportation.

11.1.9.3 Items with potential threats of contamination shall not be transported with

finished products.

11.1.10 Incoming delivery containers and vehicles transporting purchased goods into

the plant shall be inspected, so as not to cause raw materials or plant site

environmental contamination. Outgoing delivery containers and vehicles used

for food product shipping or dispatch shall be also inspected before loading to

assure food safety, sanitation and hygiene conditions. Good transportation

requiring temperature control shall have an effective temperature control

system, and be documented and recorded. The food factory shall require

logistic operations to be in accordance with the temperature conditions of the

products. Low temperature foods shall be promptly loaded and unloaded at a

temperature of 15 degrees Celsius and product temperature shall be detected

and recorded.

11.2 Storage and transport records Inventory and shipping records shall be established, including lot number, time, location, destination, quantity etc., in order to be recalled quickly when any problem comes up.

12 Labeling

12.1 Product labeling shall be in compliance with the Act Governing Food Safety and

Sanitation. When that regulation is not applicable, other relevant laws and

regulations of central competent authorities shall be applied. The label of products

for export shall comply with the requirements of laws and regulations of the

intended country.

12.2 Retail products label shall be presented in Chinese and generic symbols with the

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following information and must be set off in a frame text box (in the below order):

12.2.1 Product name.

12.2.2 List of ingredients. When it is a mixed ingredient, each component shall

be also listed.

12.2.3 Weight, volume or quantity.

12.2.4 List of food additives.

12.2.5 Name, address, customer service line or phone number of the

manufacturer or company in charge. When only the name of the

company in charge is indicated, the use of the TQF product certification

mark is not permitted.

12.2.6 Country of origin.

12.2.7 Nutrition label.

12.2.8 Genetically modified food ingredients.

12.2.9 Expiration date. When required by the central competent authority, date

of manufacture, shelf life or preservation conditions shall be also

indicated. This information shall be printed on the packaging rather than

tagged.

12.2.10 Lot number: Product lot shall be indicated by explicit or implicit code,

which enables tracing back the raw materials and ingredients records

involved in the manufacturing of a product.

12.2.11 Instructions for consumption or cooking and any special storage

conditions, if necessary.

12.2.12 Other information required as indicated by the central competent

authority.

12.3 It is recommended that finished products be labeled with bar code.

12.4 Product’s outer packaging shall be labelled with the lot number to facilitate storage

management and product recall.

12.5 Allergen information: Allergen labelling shall comply with the regulations of

the country of origin and the allergen management of sales area.

13 Customer Complaint Procedure and Product Recall

13.1 Customer complaint system shall be established for written or verbal complaints

and suggestions. The quality control personnel (and when necessary, with the

coordination of other relevant departments) shall investigate the root cause and

make improvements, and assign a personnel to contact the customer who filed the

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complaints or suggestions for explanation (or apologies) or in appreciation for

his/her comments.

13.2 A system for product recall and destruction of finished products shall be

established, including degree of product recall, scope and due date, mock recall

shall be conducted at least once a year.

13.3 The written or oral complaints and suggestions made by the customer and the

finished product recall shall be recorded, indicating product name, lot number,

quantity, reason, handling date and final resolution method. It is recommended that

the records be statistically analyzed and reviewed periodically, and the result

distributed to related departments as a reference for improvement.

13.4 Food factories shall establish anomalies or defect handling procedures to address

significant and potential problems that may arise from external or internal

problems or customer complaints.

14 Record Management

14.1 Records

14.1.1 Sanitation management specialist personnel shall record the result of

regular sanitary inspections, fill out the hygiene management log, which

include daily sanitizing work and personnel hygiene conditions and

detailed records of the corrective actions and preventive measures.

14.1.2 The Quality Assurance Department shall record and review the results

of quality control of raw materials, semi-finished product and finished

product and even the customer complaint and product recall results.

Corrective action and preventive measures shall be recorded in detail.

14.1.3 The Production Department shall complete the production records and

process operation control records, and also corrective action and

preventive measures shall be recorded in detail.

14.1.4 All food factory records and documents shall be presented in Chinese

and truly recorded.

14.1.5 Stationaries that not easy to be erased shall be used for record writing.

Every record shall be signed and dated by responsible persons and

supervisor, signature shall be use in principle, when seal are used

instead then special control procedure shall be established. If the

content of the record are modified, the original text shall not be

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completely illegible so that the original text cannot be read, the person

who made the modification shall sign next to revised text.

14.2 Record verification All production and quality control records shall be reviewed respectively by the Production and Quality Control Departments to ensure that all operations are in compliance and immediate actions shall be taken whenever an anomaly or deviation is found.

14.3 Recordkeeping All food factory records including inventory regulated under this provision, shall be kept at least 5 years and readily accessible.

15 Establishment of Management System and Auditing

15.1 Food factory shall establish an integral effective TQF management system. The

design and control of the organization and implementation system shall have

structural integrity and coordination.

15.2 Management system audit

15.2.1 Food factory shall establish an effective internal auditing system to

conduct both regular and non-regular audits. The assessment shall be

carried out by all levels of management staffs in order to identify

potential problems of the plant and to give a reasonable solution,

corrective action and tracking.

15.2.2 An internal auditor shall be properly trained, and it shall be documented

and recorded.

15.2.3 Food factory shall establish an effective internal audit plan and specify

the frequency of audits (on a three-month basis), and shall be

effectively implemented and recorded. 15.3 Document management system

15.3.1 Shall establish procedure document which cover the requirements of applied

certification scopes and products, according to safety and quality management

policy.

15.3.2 The issuance, renewal and abrogation of the documentation shall be signed

and approved by responsible person or authorized person for implementing

and recorded.

15.3.3 This is also applicable for revisions that will ensure that the staffs responsible

for the quality operation have the valid version of the operation document and

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is placed in the workplace for the operator to be implemented. 15.4 Traceability system

15.4.1 Food factory shall establish, implement and maintain a product traceability

system according to “food and its related products traceability system

management approach” enacted by TFDA, with lot number or other trace

back method that can identify the name and address of the production

manufactory. The system should be able to trace back the product from the

customer end to the raw material supplier, and to track forward from the raw

material to the finished product and have them recorded.

15.4.2 The OEM products shall also comply with the requirements of traceability

system in this scheme. 15.5 Emergency procedure

Food factory shall stablish procedures and contingency plans for potential emergencies and conduct regular drills.

15.6 Improvement and update

15.6.1 During the course of operation, improvements shall be made based on

the sanitation issues, and reviewed and discussed with the sanitation

control team. Continuous operation improvement and update shall be

done when necessary in accordance with regulations and TQF

requirements.

15.6.2 During the course of operation, the food factory shall identify

improvement opportunities when problems occurred in the

production process, quality control, management system,

customer complaint, deviation responses, product recall, labeling,

supplier assessment, internal audit and food safety management

system implementation, and reviewed and discussed with the

Quality Management Committee. Continuous operation

improvement and update shall be done when necessary in

accordance with this provision. In the event of a major or sudden

food safety incident, or for any reason the product was removed

from the shelf and recalled, the supplier shall notify Taiwan

Quality Food Association and the certification body with priority.

16 Supplementary Specifications

16.1 When the content of these technical specifications are in conflict with existing

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national laws and regulations, then the existing laws and regulations shall prevail.

Compliance dates for the implementation of the Food Safety Control System

(HACCP) is subject to the announcements of the central authority. Manufacturers

shall establish the HACCP system before any announcement of the central

authority.

16.2 These technical specifications and its amendment shall come into force from the

date of publication.

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Figure 4-01. The corner and column feet of the wall shall have an appropriate arc

Wall

3 cm 3 cm 3 cm 3 cm

3 cm

3 cm

Floor

Wall Outer Side Inner Side

Windowsill

Windowsill

Figure 4-02. The angle between interior windowsill and surface level

Surface level

Specific Provisions for TQF Canned Food Factories

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