4 Construction and layout of buildings
4.1 General requirements
Buildings shall be designed, constructed and maintained in a manner appropriate to the nature of the processing operations to be carried out, the food safety hazards associated with those operations and the potential sources of contamination from the plant environs. Buildings shall be of durable construction which presents no hazard to the product.
NOTE An example of "durable construction" is self-draining roofs which do not leak.
4.2 Enviroment
Consideration shall be given to potential sources of contamination from the local environment.
Food production should not be carried out in areas where potentially harmful substances could enter the product.
The effectiveness of measures taken to protect against potential contaminants shall be periodically reviewed.
4.3 Locations of establishments
The site boundaries shall be clearly identified.
Access to the site shall be controlled.
The site shall be maintained in good order. Vegetation shall be tended or removed. Roads, yards and parking areas shall be drained to prevent standing water and shall be maintained.
5. Layout of premises and workspace
5.1 General requirements
Internal layouts shall be designed, constructed and maintained facilitate good hygiene and manufacturing practices. The movement patterns of materials, products and people, and the layout of equipment, shall be designed to protect against potential contamination sources.
5.2 Internal design, layout and traffice patterns
The building shall provide adequate space, with a logical flow of materials, products and personnel, and physical separation of raw from processed areas.
NOTE Examples of physical separation include wall, barriers or partitions, or sufficient distance to minimize risk.
Openings intended for transfer of materials shall be designed to minimize entry of foreign matter and pests.
5.3 Internal structures and fittings
Process area walls and floors shall be washable or cleanable, as appropriate for the process or product hazard. materials of construction shall be resistant to the cleaning system applied.
Wall floor junctions and corners shall be designed to facilitate clean.
It is recommended that wall floor junctions be rounded in processing areas.
Floors shall be designed to avoid standing water.
In wet process areas,floors shall be sealed and drained. Drains shall be trapped and covered.
Ceilings and overhead fixtures shall be designed to minimize build-up of dirt and condensation.
External opening windows, rood vents or fan, where presenst, shall be insect screened.
External opening doors shall be closed or screened when not in use.
5.4 Location of equipment
Equipment shall be designed and located so as to facilitate good hygiene practices and monitoring.
Equipment shall be located to permit access for operation, cleaning and maintenance.
5.5 Laboratory facilities
In-line and on-line test facilities shall be controlled to minimize risk of product contamination.
Microbiology laboratories shall be designed, located and operated so as to prevent contamination of people, plant and products. They Shall not open directly on to a production area.
5.6 Temporary or mobile premises and vending machines
Temporary structures shall be designed, located and constructed to avoid pest harbourage and potential contamination of product.
Additional hazards associated with temporary structures and vending machines shall be assessed and controlled.
5.7 Storage of food, packaging materials, ingredients and no-food chemicals
Facilities used to store ingredients, packaging and products shall provide from dust, condensation, drains, waste and other sources of contamination.
Storage areas shall be dry and well ventilated. Monitoring and control of temperature and humidity shall be applied where specified.
Storage areas shall be dry and well ventilated. Monitoring and control of temperature and humidity shall be applied where specified.
All materials and products shall be stored off the floor and with sufficient space between the material and the walls to allow inspection and pest control activities to be carried out.
The storage area shall be designed to allow maintenance and cleaning, prevent contamination and minimize deterioration.
A separate, secure (locked or otherwise access controlled) storage area shall be provided for cleaning materials, chemicals and other hazardous substances.
Exceptions for bulk or agricultural crop materials shall be documented in the food safety management system.
6. Utilities-air, water, energy
6.1 General requirements
The provision and distribution routes for utilities to and storage areas shall be designed to minimize the risk of product contamination. Utilities' quality shall be monitored to minimize product contamination risk.
6.2 Water supply
The supply of potable water shall be sufficient to meet the needs of the production process(es). Facilities for storage, distribution and, where needed, temperature control of the water shall be designed to meet specified water quality requirements.
Water used as a product ingredient, including ice or steam (including culinary steam), or in contact with product or product surfaces, shall meet specified quality and microbiological requirements relevant to the product.
Where used supplies are chlorinated, checks shall ensure that the residual level at the point of use remains within limits given in relevant specifications.
Non-potable water shall have a separate supply system that that is labelled and not connect to the potable water system. Take measures to prevent non-potable water refluxing into potable system.
It is recommended that water can come into contact with the product should flow through pipes that can be disinfected.
6.3 Boiler chemicals
Boiler chemicals, if used, shall be either:
a) approved food additives which meet relevant additive specifications; or
b) additives which have been approved by the relevant regulatory authority as safe for use in water intended for human consumption.
Boiler chemicals shall be stored in a separate, secure (locked or otherwise access-controlled)area when not in immediate use..
6.4 Air quality and ventilation
The organization shall establish requirements for filtration, humidity(RH%) and microbiology of air used as an ingredient or for direct product contact. Where temperature and/or humidity are deemed critical by the organization, a control system shall be put in place and monitored.
Ventilation (natural or mechanical) shall be provided to remove excess or unwanted steam, dust and odours, and to facilitate drying after wet cleaning.
Room air supply quality shall be controlled to minimize risk from airborne microbiological contamination.
Protocols for air quality monitoring and control shall be established in areas where products which support the growth or survival of microorganisms are exposed.
Ventilation systems shall be designed and constructed such that air does not flow from contaminated or raw areas to clean areas. Specified air pressure differentials shall be maintained. Systems shall be accessible for cleaning, fiter changing and maintenance.
Exterior air intake prots shall be examined periodicaky for physical integrity.
6.5 Compressed air and other gases
Compressed air, carbon dioxide, nitrogen and other gas systems used in manufacturing and/or filling shall be constructed and maintained so as to prevent contamination.
Gases intenses for direct or incidental product contact (including those used for transporting, blowing or drying materials, products or equipment) shall be from a source approved for food contact use, filtered to remove dust, oli and water.
where oil is used for compressors and there is potential for the air to come into contact with the product, the oil used shall be food grade.
Use of oil free compressors is recommended.
Requirements for filtration, humidity (RH%) and mircobiogy shall be specified.
Filtartion of the air should be as close to point of use as is practicable.
6.6 Lighting
The lighting provided (natural or artificial) shall allow personnel to operate in a hygienic manner.
The intensity of the lighting should be appropriate to the nature in a hygienic manner.
Light fixtures shall be protected to ensure that materials, product or equipment are not contaminated in the case of breakages.
7. Waste disposal
7.1 General requirements
Systems shall be in place to ensure that waste materials are identified, collected, remove and disposed of in a manner which prevents contamination of products or production areas.
7.2 Containers for waste and inediable or hazardous substances
Containers for waste and inedible or hazardous substances shall be:
a) clearly identified for their intended purpose;
b) located in a designated area;
c) constructed of impervious material which can be readily cleaned and sanitized;
d) closed when not in immediate use;
e) locked where the waste may pose a risk to the product.
7.3 Waste management and removal
Provision shall be made for the segregation, storage and removal of waste.
Accumulation of waste shall not be allowed in food-handling or storage areas. Removal frequencies shall be managed to avoid accumulations, with a minimum daily removal.
Labelled materials, products or printed packaging designated as waste shall be disfigured or destroyed to ensure that trademarks cannot be reused. Removal and destruction shall be carried out by approved disposal contractors.
7.4 Drains and drainage
Drains shall be designed, constructed and located so that the risk of contamination of materials or products is avoided. Drains shall have capacity sufficient to remove expected flow loads. Drains shall not pass over processing lines.
Drainage direction shall not from a contaminated area to a clean area.
8. Equipment suitability, cleaning and maintenance
8.1 General requirements
Food contact equipment shall be designed and constructed to facilitate cleaning, disinfection and maintenance.
Food contact equipment shall be constructed of durable materials able to resist repeated cleaning.
8.2 Hygienic design
Equipment shall be able to meet esatablished principle of hygienic design, including:
a) smooth, accessible, cleanable surfaces, self draining in wet process areas;
b) use of materials compatible with intended products and cleaning or flushing agents;
c) framework not penetrated by holes or nuts and bolts.
Piping and ductwork shall be clean, drainable, and with no dead ends.
Equipment shall be designed to minimize contact between the operator's hands and the products.
8.3 Product contact surfaces
Product contact surfaces shall be constructed from materials designed for food use. They shall be impermeable and rust or corrosion free.
8.4 Temperature control and monitoring equipment
Equipment used for thermal thermal processes shall be able to meet the temperature gradient and holding conditions given relevant product specifications.
Equipment shall provide for the monitoring and control of the temperature.
8.5 Cleaning plant, utensils and equipment
Wet and dry cleaning programmes shall be documented to ensure that all plant, utensils and equipment are cleaned at defined frequencies.
The programmes shall specify what is to be cleaned (including drains), the responsibility, the method of cleaning (e.g.CIP), the use of dedicated cleaning tools, removal or disassembly
requirements and methods for verifying the effectiveness of the clean.
9. Management of purchassed materials
9.1 General requirements
Purchasing of materials which impact food safety shall be controlled to ensure that the suppliers used have the capability to meet the specified requirements. The conformance of incoming materials to specified purchase requirements shall be verified.
9.2 Selction and management of suppliers
There shall be a defined process for the selection, approval and monitoring of suppliers. The process used shall be justified by hazard assessment, including the potential risk to the final product, and shall include:
a) assessment of the supplier's ability to meet quality and food safety expectations, requirements and specifications;
b) description of how suppliers are assessed;
NOTE Examples of a description of how suppliers are assessed include:
a) audit of the supplying site prior to accepting materials for producting;
b) appropriate third party certification.
c) monitoring the performance of the supplier to assure contined approval status.
NOTE Monitoring includes conformity with material or product specifications, fulfilment of COA requirements,satisfactory audit outcomes.
9.3 Incoming material requirements (raw/ingredients/packaging)
Deliver vehicles shall be checked prior to, and during, unloading to verify that the quality and safety of the material has been maintained during transit (e.g.integrity of seals, freedom from infestation, existence of temperature records).
Materials shall be inspected, inspected, tested or covered by COA to verify conformity with specified requirements prior to acceptance or use. The method of verification shall be documented.
Note The inspection frequency and scope can be based on the hazard presented by the material and the risk assessment of the specific suppliers.
Materials which do not conform to relevant specifications shall be handle under a documented procedure which ensures they are prevented from unintended use.
Access points to bulk material receiving lines shall be identified, capped and locked. Discharge into such systems shall take place only after approval and verification of the material to be received.
10. Measures for prevention of cross contamination
10.1 General requirements
Programmes shall be in place to prevent, control and detect contamination. Measures to prevent physical, allergen and microbiological contamination shall be included.
10.2 Microbiological cross-contamination
Areas where potential for microbiological cross-contamination exists (airborne or from traffic patterns) shall be identified and a segregation (zoning) plan implemented. A hazard assessment shall be carries out to determine potential contamination sources, susceptibility of the product control measures suitable for these areas as follows:
a) separation of raw from finished or ready to eat (RTE) products;
b) structural segregation-physical barriers, walls or separate buildings;
c) access controls with requirements to change into required workwear;
d) traffic patterns or equipment segregation- people, materials, equipment and tools (including use of dedicated tools);
e) air pressure differentials.
10.3 Allergen management
Allergens present in the product,either by design or by potential manufacturing cross-contact, shall be declared. The declaration shall be on the label for consumer products, and on the label or the accompanying documentation for products intended for further processing.
Products shall be protected from unintended allergen cross-contact by cleaning and line change-over practices and/or product sequencing.
NOTE Manufacturing cross-contact can arise from either;
a) traces of product from the previous production run which cannot be adequately cleaned from the product line due to technical limitations; or
b) when contact is likely to occur, in the normal manufacturing process, with products or ingredients that are produced on separete lines, or in the same or adjacent processing areas.
Rework containing allergen(s) shall be used only:
a) in products whict contain the same allergen(s) by design; or
b) through a process whict os demonstrated to remove or destory the allergenic material.
NOTE For general rework requirememt, see Clause14.
Employees handling food should receive specific training in allergen awareness and associated manufacturing practices.
10.4 Physical contamination
where brittle materials are used, periodic inspection requirements and defined procedures in case of breakage shall be put in place.
Brittle materials, such as glass and hard plastic components in equipment, should be avoided where possible.
Glass breakage records shall be maintained.
Based on hazard assessment, measures shall be put in place to prevent, control or dect potential contamination.
NOTE1 Examples of such measures include:
a) adequate covers over equipment or containers for exposed materials or products:
b) use of screens, magnets, sleces or filiters;
c) use of dection or rejection devices such as metal deterctors or X-ray
NOTE 2 Sources of potential contamination include wooden pallets and tools, rubber seals, and personal protective clothing and equipment.
11. Cleaning and sanitizing
11.1 General requirements
Cleaning and sanitizing programmes shall be established to ensure that the food-processing equipment and environment are maintained in a hygienic condition. Programmes shall be monitored for continuing suitability and effectiveness.
11.2 Cleaning and sanitizing agents and tools
Facilities and equipment shall be maintained in a condition which facilitates wet or dry cleaning and/or sanitation.
Cleaning and sanitizing agents chemicals shall be clearly identified, food grade, stored separately and used only in accordance with the manufacturer's instructions.
Tools and equipment shall be of hygienic design and maintained in a condition thich does not present a potential source of extraneous matter.
11.3 Cleaning and sanitizing programmes
Cleaning and sanitizing programmes shall be established and validated by the organization to ensure that all parts of the establishment and equipment are cleaned and/or sanitized to a define schedule, including the cleaning of cleaning equipment.
Cleaning and/or sanitizing programmes shall specify at a minimum:
a) areas, items of equipment and utensils to be cleaned and/or sanitized;
b) responsibility for the teaks specified;
c) cleaning/sanitizing method and frequency;
d) monitoring and verification arrangements;
e) post-clean inspections;
f) pre start-up inspections.
11.4 Cleaning in place (CIP) systems
CIP systems shall be separated from active product lines.
Parameters for CIP systems shall be defined and monitored ( including type, concentration, contact time and temperature of and chemicals used).
11.5 Monitoring sanitation effectiveness
Cleaning and sanitation programmes shall be monitored at frequencies specified by the organization to ensure their continuing suitability and effectiveness.
12. Pest control
12.1 General requirements
hygiene, cleaning, incoming materials materials inspection and monitoring procedures shall be implemented to avoid creating an environment conducive to pest activity.
12.2 Pest control programmes
The establishment shall have a nominated person to manage pest control activities and/or deal with appointed expert contractors.
Pest management programmes shall be documented and shall identify target pasts, and address plans, methods, schedules, control procedures and, where necessary, training requirements.
Programmes shall include a list of chemicals which are approved for use in specified areas of the establishment.
12.3 Preventing access
Buildings shall be maintained in good repair. Holes, drains and other potential pest access points shall be sealed.
External doors, windows or ventilation openings shall be designed to minimize the potential for entry of pests.
12.4 Harbourage and infections
Storage practices shall be designed to minimize the availability of food and water to peasts.
Material found to be infested shall be handled in such a way as to prevent contamination of other materials,products or the establishment.
Potential prst harbourage (e.g.burrows, undergrowth, stored items) shall be removed.
Where outside space is used for storage, stored items shall be protected from weather or pest damage (e.g.bird droppings).
12.5 Monitoring and detection
Pest-monitoring programmes shall include the placing of detectors and traps in key locations to identify pest activity. A map of detectors and traps shall be maintained. Detectors and traps shall be designed and located so as to prevent potential contamination of materials, products or facilities.
Detectors and traps shall be of robust, tamper-resistant construction. They shall be appropriate for the target pest.
The directors and traps shall be inspected inspected at a frequency intended to identify new pest activity. The results of inspections shall be analysed to identify trends.
12.6 Eradication
Eradication measures shall be put in place immediately after evidence of infestation is reported.
Pesticide use and application shall be restricted to trained operatives and shall be controlled to avoid product safety hazards.
Records of pesticide use shall be maintained to show the type, quantity and concentrations used; where, when and how applied, and target pest.
13. Personnel hygiene and employee facilities
13.1 General requirements
Requirements for personal hygiene and behaviours proportional to the hazard posed to the process area or product shall be established and documented. All personnel, visitors and contractors shall be required to comply with the documented requirements.
13.2 Personnel hygiene facilities and toilets
Personnel hygiene facilities shall be available to ensure that the degree of personal hygiene required by the organization can be maintained. The facilities shall be located close to the points where hygiene requirements apply and shall be clearly designated.
Establishments shall:
a) provide adequate numbers, locations and means of hygienically washing, drying and, where required, sanitizing hands (including wash-basins, supply of hot and cold or temperature controlled water, and soap and/or sanitizer);
b) have sinks designated for hand washing, whose taps should not be hand operated, separate from sinks for food use and equipment-cleaning stations;
c) provide an adequate number of toilets of appropriate hygienic design, each with hard-washing, dying and, where required, sanitizing facilities;
d) have employee hygiene facilities that do not open directly no to production, packing or storage areas;
e) have adequate changing facilities for personnel;
f) have changing facilities sited to enable personnel handing food to move to the production area in such a way that risk to the cleanliness of their workwear if minimized.
13.3 Staff canteens and designated eating areas
Staff canteens and designated areas for food storage and consumption shall be situated so that the potential for cross-contamination of production areas is minimized.
Staff canteens shall be managed to ensure hygienic storage of ingredients and preperatures, and time limitations, shall be specified.
Employees' own food shall be stores and consumed in designated areas only.
13.4 Workwear and protective clothing
Personnel who work in, or enter into, areas where exposed products and/or materials are handled shall wear work clothing that is fit purpose, clean and in good condition (e.g. free from rips, tears or fraying material).
Clothing mandated for food protection or hygiene purposes shall not be used for any other purpose.
Workwear shall not have buttons. Workwear shall not have outside pockets above waist level. Zips or press stud fastenings are acceptable.
Workwear shall be launderde to standards and at intervals suitable for the intended use of the garments.
Workwear shall provide adequate coverage to ensure that hair, perspiration, etc. cannot contaminate the product.
Hair, bears, and moustaches shall be protected (i.e completely enclosed) by restraints unless hazard analysis indicates otherwise.
Where gloves are used for product contact, they shall be clean and in good condition. Use of latex gloves should be avoided where possible.
Shoes for use in processing areas shall be fully enclosed and made from non-absorbent materials.
Personal protective equipment, where required, shall be designed to prevent product contamination and maintained in hygienic condition.
13.5 Health status
Subject to legal restrictions in the country of operation, employees shall undergo a medical examination prior to employment in food contact operations (including site catering), unless documented hazard or medical assessment indicates otherwise.
Additional medical examinations, where permitted, shall be carried out at intervals defined by the organization.
13.6 Illness and injuries
Where permitted by employees shall be required to report the following conditions to management for possible exclusion form food-handling areas; jaundice, jaundice, diarrhoea, vomiting, fever, sore throat with fever, visibly infected skin lesions (bolls, cuts or sores) and discharges from the ear, eye or nose.
13.7 Personal cleanliness
Personnel in food production areas shall be required to wash and, where required, sanitize hand:
a) before starting any food-handling activities;
b) immedicately after using the toilet or blowing the nose;
c) immedicately after handling any potentially contaminated material.
Personnel shall be required to refrain from sneezing or coughing over materials or products. Spitting (expectorating) shall be prohibited.
Fingernails shall be kept clean and trimmed.
13.8 Personal behaviour
A documented policy shall describe the behaviours required of personnel in processing, packing and storage areas. The policy shall at a minimum cover:
a) permissibility of smoking, eating, chewing in designated areas only;
b) control measures to minimize hazards presented by permitted jewellery, such as that worn by personnel in processing and storage areas, taking into account religious, ethnic, medical and cultural imperatives;
c) permissibility of personal items, such as smoking materials and medicines, in designated areas only;
d) prohibition of the use of nail polish, false nails and false eyelashes;
e) prohibition of carrying of writing implements behind the ears;
f) maintenance of personal lockers so that they are kept free from rubbish and soiled clothing;
g) prohibition of storage of product contact tools and equipment in personal lockers.
14. Rework
14.1 General requirements
Rework shall be stored, handled and used in such a way that product safety, quality, traceability and regulatory compliance are maintained.
14.2 Storage, identification and traceability
Stored rework shall be produced from exposure to microbiological, chemical or extraneous matter contamination.
Segregation requirements for rework (e.g allergen) shall be documented and met.
Rework shall be clearly identified and/or labeled to allow traceability. Tranceability records for rework shall be maintained.
The rework classification or the the reason for rework designation shall be recorded (e.g. product name, production date, shift, line of origin, shelf-life).
14.3 Rework usage
Where rework is incorporated into a product as an “in-process” step, the acceptable quantity, type and conditions of rework use shall be specified. The process step and method of addition, including any necessary pre-processing stages, shall be defined.
Where rework activities involve removing a product from filled or wrapped packages, controls shall be put in place to ensure the removal and segregation of packaging materials and to avoid contamination of the product with extraneous matter.
15. Product recall procedures
15.1 General requirements
Systems shall be in place to ensure that products failing to meet required food safety standards can be identified, located and removed from all necessary points of the supply chain.
15.2 Product recall requirements
A list of key contacts in the event of a recall shall be maintained.
Where products are withdrawn due to immediate health hazards, the safety of other products produced under the same conditions shall be evaluated.. The need for public warnings shall be considered.
16. Warehousing
16.1 General requirements
Materials and products shall be stored in clean, dry, well-ventilated spaces protected from dust, condensation, fumes, odours or other sources of contamination.
16.2 Warehousing requirements
Effective control of warehousing temperature, humidity and other environment conditions shall be provided where required by product or storage specifications.
It is recommended that where products are stacked, consideration is given to measures necessary to protect the lower layers.
Waste materials and chemicals (cleaning products, lubricants, and pesticides) shall be stored separately.
A separate area or rotation systems (FIFO/FEFO) shall be observed.
Where the same vehicles, conveyances, and containers are used for food and non-food products, cleaning shall be carried out between loads.
Bulk containers shall be dedicated to food use only. Where required by the organization, bulk containers shall be dedicated to specified material.
17 Product information and consumer awareness
Information shall b e presented to consumers in such a way as to enable them to understand its importance and make informed choices.
Information may be provided by labelling or other means, such as company websites and advertisements, and may include storage, preparation and serving instructions applicable to the product.
18 Food defence, biovigilance, and bioterrorism
18.1 General requirements
Each establishment shall assess the hazard to product posed by potential acts of sabotage, vandalism or terrorism and shall put in place proportional protective measures.
18.2 Access controls
Potentially sensitive areas within the establishment shall be identified, mapped, and subjected to access control. Where feasible, access should be physically restricted by use of locks, electronic card key or alternative systems.
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