13.1.1.1 The site shall assess local activities and the site environment to identify any risks that may have an adverse impact on product safety and implement controls for any identified risks. The assessment shall be reviewed in response to any changes in the local environment or activities. The construction and ongoing operation of the premises on the site shall be approved by the relevant authority.
13.1.2.1 Floors shall be constructed of smooth, dense, impact-resistant material that can be effectively graded, drained, are impervious to liquid, and easily cleaned.
13.1.2.2 Drains shall be constructed and located so they can be easily cleaned and do not present a food safety hazard.
13.1.2.3 Waste trap system shall be located sufficiently far away from any food sector packaging handling area or entrance to the premises to prevent contamination.
13.1.2.4 Walls, partitions, ceilings, and doors shall be of durable construction.
13.1.2.5 In food sector packaging manufacturing, handling, and storage areas, wall-to-wall and wall-to-floor junctions shall be designed to be easily cleaned and sealed to prevent the accumulation of debris.
13.1.2.6 In food sector packaging manufacturing, handling, and storage areas, doors shall be of solid construction and windows shall be of shatterproof glass or similar material.
13.1.3.1 Lighting in food sector packaging manufacturing, handling, and storage areas shall be of appropriate intensity to enable the staff to carry out their tasks efficiently and effectively.
13.1.3.2 Light fittings in food sector packaging manufacturing, handling, and storage areas shall be shatterproof, manufactured with a shatterproof covering, or fitted with protective covers and recessed into or fitted flush with the ceiling. Where fixtures cannot be recessed, structures shall be protected from accidental breakage, manufactured from cleanable materials, and included in the cleaning and sanitation program.
13.1.3.3 Light fittings in areas where the product is stored shall be designed to prevent product contamination.
13.1.4.1 All external windows, ventilation openings, doors, and other openings shall be effectively sealed when closed and proofed against dust, vermin, and other pests. External personnel access doors shall be effectively insect-proofed and fitted with a self-closing device and proper seals to protect against entry of dust, vermin, and other pests.
13.1.4.2 Methods shall be in place to adequately control dust that may result from the manufacturing process.
13.1.4.3 External access doors and overhead dock doors used for product, material, pedestrian, or vehicle access shall be effectively designed, maintained, and fitted with proper seals to protect against entry of dust, vermin, and other pests.
13.1.4.4 Electric insect control devices, pheromone, or other traps and baits shall be located so as not to present a contamination risk to food sector packaging or manufacturing equipment. Poison rodenticide bait shall not be used inside food sector packaging manufacturing, handling, or storage areas.
13.1.5.1 Adequate ventilation shall be provided in enclosed packaging manufacture and handling areas.
13.1.6.1 Specifications for new equipment and procedures for purchasing equipment to ensure it is appropriate for the task shall be documented and implemented.
13.1.6.2 Equipment shall be designed, constructed, installed, operated, and maintained so as not to pose a contamination threat to food sector packaging and to allow for cleaning beneath and behind it. Tools, utensils, and containers used for handling raw materials or packaging, work-in-progress, and food sector packaging shall be made of foodsafe materials.
13.1.6.3 Vehicles used in food sector packaging manufacturing, handling, or storage areas shall be designed and operated so as not to present a food safety hazard.
13.1.6.4 Non-conforming equipment shall be identified, tagged, and segregated for repair or disposal in a manner that minimizes the risk of inadvertent use, improper use, or risk to the integrity of finished product. Records of the handling, corrective action, and/or disposal of non-conforming equipment shall be maintained.
13.1.6.5 In sites where food sector packaging is manufactured, product contact surfaces shall be constructed of materials that will not contribute to a food safety risk to the manufacture of packaging materials.
13.1.7.1 The external grounds and areas surrounding the premises, including external storage buildings, machinery, and equipment shall be maintained to prevent accumulated debris and waste and control vegetation. These areas shall be inspected routinely to ensure they will not attract pests and vermin or present a food safety hazard to the sanitary operation of the site.
13.1.7.2 Paths, roadways, and loading and unloading areas shall be maintained so as not to present a food safety hazard to the operation of the premises. They shall be adequately drained to prevent pooling of water. Drains shall be separate from the site drainage system and regularly cleared of debris.
13.2.1.1 The methods and responsibility for the maintenance and repair of the facility, equipment, and buildings shall be documented, planned, and implemented in a manner that minimizes the risk of contamination of food sector packaging material or equipment.
13.2.1.2 Routine maintenance of the equipment in any food sector packaging manufacturing, handling, or storage area shall be performed according to a maintenance control schedule and recorded. The maintenance schedule shall include the building, equipment, vehicles, and other areas of the premises critical to the maintenance of food safety.
13.2.1.3 Equipment failures shall be documented, and repair activities shall be incorporated into the maintenance schedule.
13.2.1.4 Site supervisors shall be notified when maintenance or repairs are to be undertaken in any food sector packaging manufacturing, handling, or storage area.
13.2.1.5 The maintenance supervisor and the site supervisor shall be informed if any repairs or maintenance pose a potential threat to food safety from foreign objects or contaminants (e.g., pieces of electrical wire, damaged light fittings, and loose overhead fittings). When possible, maintenance is to be conducted outside manufacturing times.
13.2.1.6 Temporary repairs, where required, shall not pose a food safety risk and shall be included in routine inspections (refer to 2.5.4.3) and in the cleaning program. There shall be a plan in place to address completion of temporary repairs to ensure they do not become permanent solutions.
13.2.1.7 Equipment located over raw or packaging materials, food sector packaging, or product conveyors shall be lubricated with food grade lubricants and their use controlled to minimize the contamination of the product. Machinery lubricant controls shall be in place to prevent contamination of food sector packaging from gear box oils, bearing lubricants, hydraulics, or any other source.
13.2.1.8 Paint used in food sector packaging manufacturing, handling, and storage areas and product contact zones shall be suitable for use, intact, and free of chips and shall not be used on any food contact surfaces.
13.2.2.1 Maintenance staff and contractors shall comply with the site’s personnel hygiene requirements (refer to 13.3.4).
13.2.2.2 All maintenance and other engineering contractors required to work on-site shall be trained in the site’s food safety and hygiene procedures or shall be escorted at all times until their work is completed.
13.2.2.3 Maintenance staff and contractors shall remove all tools, parts, and debris from areas where maintenance and repairs were conducted once it has been completed. They shall inform the appropriate supervisor so that hygiene and sanitation actions and a pre-operational inspection can be conducted prior to the restarting of operations.
13.2.3.1 The methods and responsibility for calibration and re-calibration of measuring, testing, and inspection equipment used for monitoring activities outlined in prerequisite programs, food safety plans and other process controls, or to demonstrate compliance with customer specifications shall be documented and implemented. Software used for such activities shall be validated as appropriate.
13.2.3.2 Procedures shall be documented and implemented to address the resolution of potentially affected food sector packaging should measuring, testing, and inspection equipment be found to be out of calibration state.
13.2.3.3 Calibrated measuring, testing, and inspection equipment shall be protected from damage and unauthorized adjustment.
13.2.3.4 Equipment shall be calibrated against national or international reference standards and methods or to an accuracy appropriate to its use. In cases where standards are not available, the site shall provide evidence to support the calibration reference method applied.
13.2.3.5 Calibration shall be performed according to regulatory requirements and/or to the equipment manufacturers’ recommended schedule.
13.2.3.6 A directory of measuring, testing, and inspection equipment requiring calibration and records of calibration tests shall be maintained.
13.2.4.1 A documented pest prevention program shall be effectively implemented. It shall: 13.2.4.2 Pest contractors and/or internal pest controllers shall: 13.2.4.3 Pest activity risks shall be analyzed and recorded. Inspections for pest activity shall be undertaken on a regular basis by trained site personnel and the appropriate action taken if pests are present. Identified pest activity shall not present a risk of contamination to raw materials or food sector packaging. Records of all pest control inspections and applications shall be maintained.
13.2.4.4 Raw materials or packaging, processing aids, work-in-progress, or food sector packaging that is found to be contaminated by pest activity shall be effectively disposed of and the source of pest infestation investigated and resolved.
13.2.4.5 Pesticides shall be clearly labeled and stored per 13.6.2 if kept on-site.
13.2.4.6 No animals shall be permitted on-site in food sector packaging manufacturing, handling, or storage areas.
13.2.5.1 The methods and responsibility for the effective cleaning of food sector packaging manufacturing, handling and storage areas, and staff amenities shall be documented and implemented.
13.2.5.2 Cleaning equipment, tools, racks, and other items used in support of the cleaning and sanitizing program shall be clearly identified, stored, and maintained in a manner that prevents contamination of food sector packaging manufacturing, handling, and storage areas and equipment.
13.2.5.3 Adjacent production equipment shall be covered or shut down and raw and packaging materials, work-in-progress, and food sector packaging shall be moved from the vicinity if using compressed air hoses to clean.
13.2.5.4 Pre-operational inspections shall be conducted following cleaning and sanitation operations to ensure manufacturing areas, product contact surfaces, equipment, staff amenities, and other essential areas are clean before the start of production. Inspections shall be conducted by qualified personnel to ensure the areas are cleaned at a defined frequency.
13.2.5.5 The responsibility and methods used to verify the effectiveness of the cleaning procedures shall be documented and implemented. A verification schedule shall be prepared. A record of pre-operational hygiene inspections, cleaning and sanitation activities, and verification activities shall be maintained.
13.2.5.6 Appropriate cleaning agents shall be purchased in accordance with applicable legislation and suitable for use. The site shall ensure that only trained staff handle cleaning agents and that it is according to manufacturer instructions. Documentation, storage, usage, and disposal of cleaning agents shall comply with 13.6.2.
13.3.1.1 Personnel who are known to be carriers of infectious diseases that present a health risk to others on-site shall not engage in the manufacture of food sector packaging or enter areas where food sector packaging is exposed.
13.3.1.2 The site shall have measures in place to prevent contact of raw and packaging materials, work-in-progress, food sector packaging, and product contact surfaces from any bodily fluids, open wounds, coughing, sneezing, spitting, or any other means. In the event of an injury that causes spillage of bodily fluid, a properly trained employee shall ensure that all affected areas have been adequately cleaned and that all affected materials have been quarantined and/or disposed of.
13.3.1.3 Personnel with exposed cuts, sores, or lesions shall not engage in handling raw and packaging materials, work-in-progress, food sector packaging, and product contact surfaces. Minor cuts or abrasions on exposed parts of the body shall be covered with a colored bandage containing a metal-detectable strip or an alternative suitable waterproof and colored dressing.
13.3.2.1 Personnel shall have clean hands, and hands shall be washed by all personnel, including staff, contractors, and visitors: 13.3.2.2 Handwash stations shall be provided in appropriate areas that support the capability of site personnel and visitors to wash their hands as outlined in 13.3.2.3.
13.3.2.3 Handwash stations shall have: 13.3.2.4 Signage in appropriate languages instructing people to wash their hands before entering the food sector packaging manufacturing, handling, and storage areas shall be provided in a prominent position in break rooms, at break rooms exits, toilet rooms, and in outside eating areas if applicable.
13.3.2.5 When gloves are used, personnel shall maintain the handwashing practices outlined above.
13.3.3.1 The site shall have a clothing and hair policy that protects raw and packaging materials, work-in-progress, food sector packaging, and product contact surfaces from unintentional contamination.
13.3.3.2 Clothing worn by staff engaged in handling food sector packaging shall be maintained, stored, laundered, and worn so as not to present a contamination risk to products.
13.3.3.3 Clothing worn by staff engaged in manufacturing and warehouse processes shall be made from materials that will not contaminate raw and packaging materials, workin-progress, and food sector packaging. Clothing and shoes shall be clean at the commencement of each shift, maintained in a serviceable condition, and changed where they present a product contamination risk.
13.3.3.4.1 When protective clothing (e.g. frocks, smocks, aprons, boots, gloves, face shields, etc.) is used, hooks racks, cabinets, or other forms of off the floor storage shall be provided for temporary storage when staff leave the manufacturing area and shall be provided in close proximity or adjacent to the personnel access doors and handwashing stations.
13.3.3.4.2 All clothing stored on-site shall be maintained and stored so as not to present a contamination risk to raw or packaging materials, work-in-progress, and food sector packaging.
13.3.3.5 Gloves used when handling food sector packaging material shall be clean and replaced when needed.
13.3.3.6 Jewelry and other loose objects shall not be worn or taken into any area where raw and packaging materials, work-in-progress, or food sector packaging is exposed. Wearing plain bands with no stones and medical alert bracelets that cannot be removed can be permitted; however, the site will need to consider their customer requirements and the applicable food legislation.
13.3.3.7 All exceptions shall meet regulatory and customer requirements and shall be subject to a risk assessment and evidence of ongoing risk management.
13.3.4.1 All visitors shall be trained in, and comply with, applicable food safety and hygiene procedures before entering food sector packaging manufacturing, handling, or storage areas. Visitors shall be trained in, and comply with, additional food safety policies, such as maintenance and cleaning procedures, as appropriate to the purpose of the visit. Where applicable, policies shall define exceptions for visitors when they are escorted at all times.
13.3.4.2 All visitors shall wear suitable clothing and footwear when entering any food sector packaging manufacturing, handling, or storage areas.
13.3.4.3 Visitors shall enter and exit food sector packaging manufacturing, handling, and storage areas through the designated entrance points.
13.3.4.4 Visitors exhibiting visible signs of illness shall be prevented from entering areas in which food sector packaging is handled or processed.
13.3.5.1 Staff amenities shall have documented cleaning procedures, be supplied with appropriate lighting and ventilation, and shall be made available for the use of all persons engaged in the handling and storage of food sector packaging.
13.3.5.2 Where applicable, facilities shall be provided to enable staff to change into and out of protective clothing as required. Provision shall be made for staff to store their street clothing and personal items separate from food sector packaging manufacturing, handling, or storage areas.
13.3.5.3 Toilet rooms shall be: 13.3.5.4 Sanitary drainage shall not be connected to any other drains within the premises and shall be directed to a septic tank or a sewerage system in accordance with regulations.
13.3.5.5 A procedure shall document how to minimize the potential for contamination to the premises, personnel, raw and packaging materials, work-in-progress, and food sector packaging in the event of a sewage backup.
13.3.5.6 Handwash stations shall be provided immediately outside or inside the toilet room and designed as outlined in 13.3.2.3.
13.3.5.7 Separate break room facilities shall be provided away from food sector packaging manufacturing, handling, or storage areas. Break rooms shall be kept clean and tidy and free from waste materials and pests.
13.3.5.8 Where outside eating areas are provided, they should be kept clean and free from waste materials and maintained in a manner that minimizes the potential for introduction of contamination including pests to the site.
13.4.1.1 All personnel engaged in food sector packaging manufacture, handling, and storage operations shall comply with the following practices: 13.4.1.2 Personnel working in or visiting food sector packaging manufacturing, handling, or storage operations shall ensure that: Eating, drinking, smoking, or spitting is not permitted in areas where food sector packaging is manufactured, handled, stored, or exposed. Drinking water is permitted in food sector packaging manufacturing, handling, and storage areas in a method that will not cause a food safety risk to raw and packaging materials, workin-progress, food sector packaging, and equipment. 13.4.1.3 The manufacturing process shall be controlled such that food sector packaging is safe and free from contamination. Procedures shall be in place to prevent cross-contamination of food sector packaging from contaminated materials, cleaning agents, or chemicals.
13.4.1.4 The flow of personnel in food sector packaging manufacturing, storage, and handling areas shall be managed such that the potential for contamination is minimized.
13.5.1.1 Adequate supplies of hot and cold clean water shall be provided for use during manufacturing operations as needed and to enable effective cleaning of the premises and equipment.
13.5.1.2 The delivery of water within the premises shall ensure potable water is not contaminated. Testing of the backflow system, where possible, shall be conducted at least annually and records shall be maintained.
13.5.1.3 The use of non-potable water shall be controlled such that: 13.5.1.4 Where water is stored on-site, storage facilities shall be adequately designed, constructed, and maintained to prevent contamination.
13.5.2.1 Water shall comply with local, national, or internationally recognized potable water microbiological and quality standards as required when used for: 13.5.2.2 Microbiological analysis of the water supply shall be conducted to verify the cleanliness of the supply, the monitoring activities, and the effectiveness of the treatment measures implemented. Samples for analysis shall be taken on-site at sources supplying water for the process, handwashing, and/or cleaning, or from within the site. The frequency of analysis shall be risk-based and at a minimum annually.
13.5.2.3 Water shall be analyzed using reference standards and methods.
13.5.3.1 Dry ice, compressed air, and other gasses (e.g., nitrogen, carbon dioxide) that contact food sector packaging or product contact surfaces shall be food-grade, clean, and present no risk to food safety.
13.5.3.2 Compressed air and other systems used to store or dispense gases that come into contact with food sector packaging or product contact surfaces shall be maintained and regularly monitored for quality and potential food safety hazards. The frequency of analysis shall be risk-based and at a minimum annually.
13.6.1.1 The site shall document and implement a storage plan that allows for the safe, hygienic storage of raw and packaging materials, work-in-progress, food sector packaging, finished product returns, production equipment, processing aids, and chemicals that impact food safety.
13.6.1.2 The responsibility and methods for ensuring effective stock rotation principles are applied shall be documented and implemented to ensure that all raw materials, work-in-progress, rework, and food sector packaging are utilized within their designated shelf life, where applicable.
13.6.1.3 Equipment storage rooms shall be designed and constructed to allow equipment to be stored in a hygienic manner.
13.6.1.4 Where raw and packaging materials, work-in-progress, and food sector packaging are held under temporary or overflow conditions that are not designed for the safe storage of those goods, a risk analysis shall be performed to ensure the integrity of those goods is maintained, they are not at risk of contamination, and there are no other food safety concerns.
13.6.1.5 Rooms and equipment used for the storage of raw and packaging materials, work-in-progress, and food sector packaging shall be constructed to protect the product from contamination and deterioration.
13.6.1.6 Where required, procedures shall be in place for effective storage of printing plates, cylinders, and print blankets.
13.6.2.1 Hazardous chemicals and toxic substances, including solvents and agents with the potential for contamination of food sector packaging, shall be: 13.6.2.2 Storage of hazardous chemicals and toxic substances shall be: 13.6.2.3 Hazardous chemicals and toxic substances shall be correctly labeled and: 13.6.2.4 Employees who handle hazardous chemicals and toxic substances, including pesticides and cleaning chemicals, shall: 13.6.2.5 The site shall dispose of obsolete inventory and empty containers of chemicals, pesticides, and toxic substances in accordance with site and regulatory requirements and ensure that: 13.6.2.6 In the event of a hazardous chemical or toxic substance spill, the site shall: 13.6.3.1 The practices applied during transport, loading, and unloading of raw and packaging materials and food sector packaging shall be documented and implemented. Practices shall be conducted to prevent cross-contamination, maintain appropriate storage conditions, and ensure product integrity.
13.6.3.2 Vehicles (e.g., semi-trucks, trailers, vans, containers) used for transporting food sector packaging shall be inspected prior to loading to ensure they are clean, in good repair, suitable for the purpose, and free from odors or other conditions that may impact negatively on the food sector packaging.
13.6.3.3 Vehicles (e.g. semi-trucks, trailers, vans, containers) used for transporting food sector packaging from the site shall be secured from tampering using a seal or other acceptable device or system as agreed upon by the carrier and customer.
13.7.1.1 The responsibility and methods used to prevent foreign matter contamination of raw and packaging materials, work-in-progress, food sector packaging, and product contact surfaces shall be documented, implemented, and communicated to all staff.
13.7.1.2 Inspections shall be performed to ensure that the site and equipment remain in good condition and equipment has not become detached or deteriorated and is free from potential contaminants.
13.7.1.3 Containers, storage and transport vessels, equipment, utensils, and tools made of glass, porcelain, ceramics, and brittle plastics shall not be permitted in food sector packaging manufacturing, handling, and storage areas. Exceptions shall include product made from, or packaged in these materials, measurement instruments with glass dial covers or MIG thermometers required under regulation or part of the processing equipment, and other essential items shielded with shatterproof coverings.
13.7.1.4.1 Glass, porcelain, ceramics, and brittle plastics that are permitted in manufacturing areas shall be listed on a glass inventory and inspected at a frequency based on risk to confirm that they have not been damaged or to monitor for further damage prior to repair or replacement.
13.7.1.4.2 Regular inspections of product handling/contact zones shall be conducted (refer to 2.5.4.3) to ensure they are free of glass or similar material and to establish changes to the condition of objects listed in the glass inventory.
13.7.1.5 Wooden pallets and other wooden objects used in food sector packaging manufacturing, handling, and storage areas shall be dedicated for that purpose, clean, and maintained in good order. Their condition shall be subject to regular inspection.
13.7.1.6 Wooden pallets, wooden top frames, and wooden utensils used in food sector packaging, manufacturing, handling, and storage areas shall be dedicated for that purpose, clean, maintained in good order, and subject to regular inspection.
13.7.1.7 Loose, deteriorated, or damaged objects on and above structures and equipment in food sector packaging manufacturing, handling, and storage areas shall be controlled, repaired, or replaced to prevent foreign object contamination and other food safety hazards affecting raw and packaging materials, work-in-progress, and food sector packaging.
13.7.1.8 Knives and cutting tools used in manufacturing operations shall be controlled, kept clean, and well maintained so as not to present a hazard to raw materials, work-in progress, or food sector packaging. Snap-off blades shall not be used in food sector packaging manufacturing, handling, or storage areas.
13.7.2.1 In circumstances where glass or similar brittle material breakage occurs, the affected area and equipment shall be isolated, cleaned, and thoroughly inspected prior to restarting operations. Utensils and equipment used for clean-up and footwear of those walking in the vicinity shall be inspected and cleaned if necessary.
13.8.1.1 The responsibility and methods used to collect, handle, and store waste prior to removal from the premises shall be documented and implemented. This shall include consideration of the path of waste removal to prevent cross contamination in food sector packaging manufacturing, handling, and storage areas. Disposal of hazardous chemicals and toxic substances shall comply with 13.6.2.5.
13.8.1.2 Waste shall be contained in bins identified for its purpose, located in designated areas, and removed at a routine frequency that avoids build-up in food sector packaging, manufacturing, handling, and storage areas.
13.8.1.3 Waste disposal equipment, trolleys, vehicles, and collection bins shall be maintained in a serviceable condition and cleaned regularly so as not to attract pests and other vermin. Designated waste accumulation and storage areas shall be well-maintained while awaiting external collection.
13.8.1.4 Reviews of the effectiveness of waste management shall form part of regular site inspections (refer to 2.5.4.3), and the results of the inspections shall be included in the relevant inspection reports.
13.8.1.5 Where applicable, a documented procedure shall be in place for the controlled disposal of trademarked or printed packaging materials and finished products. Where a contracted disposal service is used, the disposal process shall be reviewed regularly to confirm compliance.
