SMEIndonesia.org – Food safety is a collective responsibility of government, industry and consumers. All food operators are responsible under Indonesia’s law for the safety of the food they produce and distribute. The Guide to Food Safety is a voluntary tool that provides the Indonesian food industry with generic guidance on how to design, develop and implement effective preventive food safety control systems. This will help to enhance food safety and prevent foodborne illness, foodborne injury and food spoilage.
We should recognizes that various food safety programs and codes of practice have been implemented by the provinces and federally registered sectors, such as meat and fish processing sectors. This Guide to Food Safety is not designed or intended to supersede or replace any existing requirements of federal, provincial and territorial governments.
The Guide to Food Safety can apply to Indonesia food operations, from primary production through to final consumption, regardless of the size of the operation or the commodity. It may be adopted by all food operators, including importers, manufacturers, packers, distributors, retailers, food services and institutions.
- The guide will be of particular value to food manufacturers and importers who do not currently implement preventive food safety control systems.
- Operators of small- or medium-sized operations and those who are new to food production or handling may find this guide very useful to develop their own preventive food safety control system.
- Operators who already have a preventive food safety control system in place may find the guide helpful to obtain complementary information.
The Guide to Food Safety is based upon the Recommended International Code of Practice – General Principles of Food Hygiene adopted by the Codex Alimentarius Commission (Codex) in 2003. It is consistent with Codex’s recommendations to enhance food safety by applying a systematic preventive approach.
The Guide to Food Safety is outcome-based. It is flexible enough for food operators to apply various preventive system approaches that are designed to help produce safe food, such as
- Hazard Analysis Critical Control Point (HACCP), and
- International Organization for Standardization (ISO) standards.
The Guide to Food Safety complements the Industry Labelling Tool, which provides information on food labelling and advertising requirements.
How to use this guide
The Guide to Food Safety is designed to aid Indonesia food operators to build preventive food safety control systems that
- meet their operational needs, and
- comply with Indonesia food legislation.
Each chapter of the guide addresses specific components of a preventive food safety control system. Each section within the chapters identifies the desired outcomes, followed by suggested guidelines to achieve these outcomes.
All operations are unique, so they have different hazards and controls. As a result, there will be situations where some of the guidelines contained in the Guide to Food Safety are not applicable. Users of the guide are encouraged to apply the guidelines to their operations, and adapt them as necessary to effectively identify and manage their food safety hazards. Regardless of how this guide is used, Indonesia food operators are responsible to ensure their products are in compliance with all applicable Indonesia food legislation.
In this guide, the term “should” indicates a recommended guideline for operators to implement. “Should” also gives the operator the flexibility to choose different approaches that achieve the same outcome but are still suitable to the situation.
Terms such as “where appropriate” and “as necessary” mean that operators should determine whether and how a specific guideline applies to their operation.
Readers will find a glossary of technical terms at the end of this guide.
There is also a list of additional resources, including websites of federal, provincial and international programs, guidance documents and legislation. These give readers information and tools to develop preventive food safety control systems (for example, Food Safety Enhancement Program (FSEP)Footnote 1, Quality Management Program (QMP), HACCPGeneric Models, ISO standards).
Chapter 1: Pre-Requisite Programs
The primary food safety objective for any food operation is to supply food that is safe for human consumption. This chapter provides guidance on developing pre-requisite programs (that is, hygienic and operational conditions). These are universal steps or procedures that control the conditions within a food operation.
Effective pre-requisite programs promote conditions that help to produce safe food. They are essential to support the foundation of a preventive food safety control system as described in Chapter 2. Pre-requisite programs include many control measures necessary for producing safe food. Implementation of these control measures is encouraged before processing begins.
Maintaining appropriate documentation and records is an important element of effective pre-requisite programs because they provide an indication of whether the control measures are implemented effectively. Because of this, when pre-requisite programs are implemented, they should include written policies and/or procedures.
1.1 Design and Construction of Premises
Buildings are located, designed, constructed and maintained to facilitate hygienic operations.
- Buildings should be located away from potential sources of environmental contaminants (for example, smoke, chemical pollution).
- The surrounding area should be maintained (for example, free from accumulated garbage) and adequately drained to minimize the potential for contamination from debris, pests, water, etc.
- Building exteriors should be designed and properly maintained to prevent contaminants or pests from entering (for example, appropriately located air intakes, properly maintained roof, foundation and walls, and protected openings).
- Windows and ventilation openings should be equipped with clean close-fitting screens or filters to prevent the intake of contaminated air, dust and insects.
- Filters should be cleaned or replaced according to the frequency specified in the maintenance program.
- Where there is a possibility of cross-contamination (for example, from receipt to storage of incoming materials, during processing, packaging and shipping of finished product), activities should be adequately separated by physical or other effective means (such as scheduling the processing of ready-to-eat foods prior to raw foods or scheduling adequate sanitation between activities).
- All interior structures (including floors, walls, ceilings, doors, overhead fixtures, stairs and elevators) should be constructed of materials that are durable, non-corrosive, smooth, impervious, non-absorbent and cleanable. These materials should also be suitable for manufacturing, distributing and handling food and should be maintained to prevent contamination. For example:
- Windows in areas where glass breakage could result in the contamination of food should be constructed of alternative materials or they should be adequately protected.
- Doors should be close-fitting and, where appropriate, self-closing.
- Where appropriate, wall, floor and ceiling joints should be sealed and angles coved.
- Floor drains should be located so that they are readily accessible for cleaning, sanitizing and inspecting (for example, avoid places under or near filling or packing equipment). Drainage should be adequate to prevent pooling water.
- Ceilings and overhead fixtures should be maintained to minimize the build up of dirt and condensation, and the shedding of particles.
- Light intensity (that is, the lux level) should be sufficient for the intended activity. Lighting should not alter food colour.
- Light bulbs and fixtures located in areas where there is exposed food or packaging materials should be of a safety type (for example, shatterproof) or protected. This is to prevent food from being contaminated from breaking glass.
- Ventilation systems should be designed and constructed so that air does not flow from contaminated areas to clean areas.
- Ventilation should provide sufficient air exchange to:
- prevent unacceptable accumulation of heat, steam, condensation, dust or other contamination (including mould, bacteria and extraneous matter); and,
- control ambient temperature, odours and humidity.
- Ventilation systems should be adequately maintained and cleaned.
Facilities are located, designed, constructed and maintained to facilitate hygienic operation.
- Washrooms, lunchrooms and change rooms should be separate from processing areas. If possible, these rooms should not open directly into processing areas.
- Washrooms, lunchrooms and change rooms should be maintained in a clean condition.
- An adequate number of conveniently located hand-washing stations with trapped waste pipes to drains should be available. They should be provided in the food processing, storage, distribution and handling areas.
- Washrooms and hand-washing stations should have:
- hot and cold (or suitable temperature controlled) potable running water;
- soap dispensers;
- sanitary hand drying equipment or supplies;
- cleanable waste receptacle; and
- alcohol based sanitizer, where appropriate.
- Washrooms and hand-washing stations should have:
Waste disposal facilities
- Effluent or sewage lines should not be located directly over or through processing, storage, distribution or handling areas, unless they are controlled to prevent contamination.
- Facilities should be designed and constructed without any cross-connection between the sewage system and any other waste effluent system within the premises.
- Drainage and sewage systems should be equipped with appropriate traps and vents to effectively capture contaminants (for example, sewer gases and pests).
- Adequate facilities and equipment should be provided and maintained to store waste and inedible material before their removal from the premises. These facilities should be designed to prevent contamination.
- Containers used for waste should be clearly identifiable. They should be leak-proof and, where appropriate, covered, to prevent contamination of food.
- Waste should be removed and containers cleaned and sanitized often enough that potential for contamination is minimized.
Equipment cleaning and sanitizing facilities
- Equipment cleaning and sanitizing facilities should be:
- adequately separated from food processing, storage, distribution and handling areas to prevent contamination; and
- constructed of corrosion-resistant materials that can be easily cleaned and can be provided with potable water at temperatures appropriate for the cleaning chemicals used.
1.1.3 Food contact surfaces
Food contact surfaces should be designed, constructed and maintained to facilitate hygienic operation.
- Food contact surfaces should be non-corrosive, non-absorbent, non-toxic, and free from pitting, cracks or crevices. They should also be built to facilitate and withstand repeated cleaning and sanitizing.
- Non-food chemicals (including cleaning solutions and lubricants used for food contact surfaces) should be appropriate for the intended use and should be used in accordance with the manufacturer’s instructions.
1.1.4 Water, ice and steam
Water, ice and/or steam that come into contact with food and/or food contact surfaces is potable and protected from contamination.
- An adequate supply of potable water (for example, volume, temperature and pressure) should be available to meet operational and cleanup needs.
- Potable water should be analyzed at a frequency adequate to confirm that it meets the requirements of:
- Health Indonesia drinking water quality and
- any applicable provincial, municipal and territorial requirements (for example, for microbial analysis, water from municipal water may be analysed semi-annually and water from other sources may be analyzed monthly).
- Non-potable water systems should not be connected with, or allowed reflux into, potable water systems, in order to avoid cross-contamination.
- All hoses, taps and other similar sources of possible contamination should be designed to prevent back-flow or siphonage.
- Where it is necessary to store water, storage facilities should be adequately designed and maintained to prevent contamination (for example, covered). Storage facilities should also be made of food grade material.
- Where water filters are used, they should be regularly changed or effectively maintained.
- If chemical treatments are used, they should be monitored and controlled to deliver the desired concentration and to prevent contamination.
- If water treatment chemicals are used, they should be appropriate for the intended use and should be used in accordance with the manufacturer’s instructions.
- Water re-circulated for reuse should be treated, analyzed, monitored and maintained for the intended purpose and in accordance with applicable provincial, territorial or municipal requirements. Re-circulated water should have a clearly identified separate distribution system.
- Seawater used for processing should be from an approved source and safe. It should also be in sanitary condition and meet microbiological requirements as prescribed in applicable legislation.
- Potable water should be used to manufacture ice on-site to prevent product contamination.
- Purchased ice should be made from potable water and treated as an incoming material.
- Potable water should be used to generate steam to prevent product contamination.
- Steam supply should be adequate to meet operational needs.
- Boiler feed water should be tested regularly. The chemical treatment process should be designed to prevent contamination.
- Boiler treatment chemicals should be appropriate for the intended use and should be used in accordance with the manufacturer’s instructions.
- Traps should be provided as necessary for adequate condensate removal and for eliminating foreign materials.
1.2 Controls of Operation
1.2.1 Transportation, receiving/shipping, storage and handling
All incoming materials (food and non-food) and finished products are transported, received/shipped, stored and handled under conditions that prevent, eliminate or reduce damage and/or contamination.
- The operator should verify that all food carriers are suitable for transporting food. For example:
- The temperature during transportation should be controlled to prevent product deterioration (refer to section 1.2.2 for details on temperature control).
- Adequate cleaning and sanitizing programs should be in place (such as cleaning certificates, wash tickets, Letter of Guarantee and/or record of the previous material transported prior to loading or unloading).
- Procedures should be in place to ensure carriers are cleaned adequately and are free from contamination (verified by the operator by conducting visual inspection before loading and upon receipt, by sensory evaluation of ingredients and/or by analysis, as appropriate).
- Where the same carriers are used for different food products, cleaning and sanitizing procedures should be in place to prevent cross-contamination of the food (for example, raw versus cooked or ready-to eat food, allergens in products with no allergens).
- Where the same carriers are used for food and non-food products, whether in the same shipment or not, procedures should be in place to restrict the transporting of non-food products that can pose a risk to the food products being transported.
- For bulk carriers, the operator should have additional cleaning and sanitizing procedures in place. For example:
- Bulk tanks should be designed and constructed to permit complete drainage and to prevent contamination. They should be designated to transport a specific commodity and be used for this purpose only.
- Cleaning criteria should include the condition of hoses, pumps, inlets, outlets and seals, where applicable.
- Where direct contact with food may occur, materials used in carrier construction should be suitable for food contact.
- Carriers should be loaded, arranged, and unloaded in a manner that prevents damage and contamination of the food and/or food packaging material.
Incoming food materials and finished products
- Operators should have procedures in place to confirm that incoming food materials meet all purchasing and other documented specifications (for example, visual inspection upon receipt, certificates of analysis, review of labels for allergens, and approved suppliers list).
- For imported ingredients and/or products, operators should verify that the suppliers are capable of providing food products that comply with Canadian legislation.
- Incoming materials should be received and stored in appropriate areas separate from processing areas and finished products (for example, ready-to-eat products).
- Products should be stored and handled to prevent contamination (for example, microbial growth due to high temperature, rusting of cans) and damage (for example, forklift damage, stacking heights should be controlled).
- Procedures should be in place to ensure that ingredients stored in opened packages are not contaminated.
- Products that are sensitive to environmental conditions (for example, humidity, light) should be stored in appropriate conditions to prevent deterioration.
- A stock rotation procedure should be implemented to minimize deterioration and spoilage (for example, use the “first in, first out” principle).
- Ingredients containing allergens should be clearly identified and stored to prevent cross-contamination with ingredients and products not containing allergens and with other materials and products.
- Returned, non-conforming or suspect products should be controlled, clearly identified and segregated in a designated area until they can be disposed of appropriately.
Food packaging materials
- The operator should inspect food packaging materials before use to prevent using damaged, defective or contaminated packaging, which may lead to contamination of the product.
- The operator should have effective procedures in place to confirm that contaminated, damaged or defective reusable containers are properly cleaned and sanitized, repaired or replaced, as appropriate.
- The operator should have controls in place to prevent contamination of packaging (for example, by pests and non-food chemicals) and to confirm that packaging material is used for its intended purpose only.
- Non-food chemicals should be received and stored in a designated, dry and well-ventilated area. This area should be separate from all food processing, storage, distribution and handling areas (for example, in a separate storage room), so that no possibility exists for cross-contamination of food, food contact surfaces or packaging materials.
- Chemicals should be stored and mixed in clean, correctly-labelled containers and dispensed by trained, authorized personnel.
1.2.2 Temperature control
Temperature is controlled appropriately during transportation, handling and storage of food to minimize deterioration of the product.
- Ingredients and products should be transported, handled and stored at appropriate temperatures that minimize deterioration, such as microorganism spoilage and rusting of cans.
- Ingredients and products requiring refrigeration should be transported and stored at an appropriate temperature (for example, 4°C or less but not frozen).
- Frozen ingredients and products should be transported and stored at temperatures which do not permit thawing (for example, below 0°C).
- Temperatures of food handling areas should be appropriate to the type of products handled and controlled to prevent product deterioration (for example, processing fresh cut vegetables should be done in a refrigerated environment).
- Temperatures should be appropriately monitored with proper temperature recording devices.
Equipment and utensils are designed, constructed and installed to facilitate hygienic operations and are effectively maintained and calibrated to function as intended.
Equipment and utensils
- Equipment should be clearly identified, designed, constructed and installed so that it:
- functions according to the equipment’s intended use;
- is accessible for thorough cleaning, sanitizing, maintenance and inspection;
- prevents the contamination of product (for example, location of lubricant reservoirs);
- is vented to prevent excessive condensation (for example, filler bowls, blanchers, retorts), where applicable; and
- is properly drained and, where appropriate, is connected directly to drains.
- Utensils should be:
- stored or used during operations in a way that prevents or minimizes the contamination of product; and
- clearly identified and used only for their intended purpose.
Maintenance and calibration
- Effective maintenance and calibration programs should be in place to ensure that all equipment (including specialized instrumentation) and utensils function as per their intended purpose and that there is no potential for introducing biological, chemical or physical hazards (for example, count tools before and after use, and clean and sanitize area following maintenance and calibration activities).
- The operator should implement written maintenance and calibration programs, which include:
- a list of equipment and utensils (with their location) requiring regular maintenance and calibration;
- instruction on how to perform the maintenance and calibration activities;
- the maintenance and calibration frequencies;
- identification of the person(s) who is assigned the responsibility for the maintenance and calibration procedures; and
- where applicable, the name(s) of an external company or companies conducting maintenance and/or calibration activities.
- Maintenance and calibration of equipment should be done according to the manufacturer’s instructions/manual and be completed by trained personnel.
1.2.4 Personal hygiene and health
All people entering food processing, storage, distribution and handling areas have an appropriate degree of personal cleanliness and take the appropriate precautions to prevent the contamination of food and food contact surfaces.
Personal hygiene practices
- The operator should implement an effective written personal hygiene program that identifies hygienic behaviour and habits that should be followed to prevent contamination of food.
- Any behaviour which could result in contamination of food should be prohibited in food processing, distribution, storage and handling areas. This includes eating, using tobacco, chewing gum, or unhygienic practices such as spitting.
- Unhygienic practices should be prohibited, such as using food product fallen on the floor or on non-food contact surfaces.
- Access of personnel and visitors should be controlled to prevent contamination.
- There should be a hygiene procedure for visitors (including contractors, pest control company representatives, maintenance staff, etc) entering the premises. It should be either posted, or provided verbally or on a written form, to clearly indicate the operator’s requirements.
- All people entering food processing, storage, distribution and handling areas should wash their hands:
- before starting work;
- after handling chemicals;
- after handling incompatible food products (for example, raw versus cooked or ready-to eat) or contaminated materials;
- after breaks;
- after coughing or sneezing or blowing their nose; and
- after using toilet facilities.
- Hand-washing notices should be posted in appropriate areas.
- Protective clothing, footwear and gloves, appropriate to the operation in which the employee is engaged, should be worn and maintained in a sanitary manner. Employees in processing areas should wear effective hair restraints, such as hair nets.
- All persons entering food handling areas should remove jewellery and other objects which may fall into food, or otherwise contaminate food (for example, watches, pins, pen caps).
- Personal effects, including street clothing, should be stored separately from food processing, distribution, storage and handling areas.
- Processing equipment (for example, refrigerators and freezers) should not be used for personal storage (such as storing lunches).
- The traffic pattern of personnel should prevent cross-contamination of the product (for example, from a raw area to a cooked or ready-to-eat area).
Communicable diseases and injuries
- No person who is known to be infected with a disease likely to be transmitted through food, or showing symptoms of such disease, should be permitted to work in food-handling areas.
- The operator should require employees to inform management when they are suffering from a communicable disease or from symptoms which may be indicative of a communicable disease. Such symptoms could include jaundice, diarrhea, vomiting, fever, sore throat with fever, visibly infected skin lesions (for example, boils, cuts), and discharges from the ears, eyes or nose.
- Employees having open cuts or wounds should not handle food or food contact surfaces unless the injury is completely protected by a secure waterproof covering (for example, rubber gloves).
Personnel have adequate technical knowledge and understanding of the operation(s) or process(es) for which they are responsible and understand the precautions necessary to prevent the contamination of food and food contact surfaces.
- The operator should implement a written training program for employees.
- Training should be appropriate to the complexity of the process and the tasks assigned.
- Appropriate training in personal hygiene and hygienic handling of food should be provided to all food handlers at the beginning of their employment.
- Managers and supervisors should have the necessary knowledge of food hygiene principles and practices to be able to identify potential risks and take the necessary action to remedy deficiencies.
- Personnel should be trained to have current knowledge of equipment and process technology (for example, apprenticeship training, training for retort or pasteurization personnel).
- Personnel should be trained to understand the importance of the critical factors for which they are responsible (for example, the parameters for control measures, the procedures for monitoring, the corrective actions to be taken if a deviation occurs and the records to be kept).
- Personnel responsible for maintaining or calibrating equipment that affects food safety should be appropriately trained to:
- identify deficiencies that could affect product safety; and
- to take the appropriate corrective actions (for example, in-house repairs, contract repairs).
- Individuals performing maintenance on specific equipment should be appropriately trained.
- Personnel responsible for the sanitation program and pest control should be appropriately trained to understand the principles and methods required for effective cleaning and sanitizing, and for pest control.
- Personnel responsible for water treatment and water safety monitoring should be appropriately trained to understand the principles and methods and should be competent in procedures to protect the safety of food.
- Personnel responsible for recall should be appropriately trained to understand proper recall procedures, to be able to implement recalls effectively.
- Personnel responsible for maintaining or calibrating equipment that affects food safety should be appropriately trained to:
- Appropriate personnel should be trained to understand all relevant food legislation and the food safety implications of improperly labelled products, such as allergen identification.
- All employees, including maintenance, cleaning and customer service employees, should be trained on allergen control measures.
- Training should be reinforced and updated at appropriate intervals, such as when employees are assigned a new duty.
The premises, equipment and food contact surfaces are maintained in clean and sanitary condition.
- Chemicals should be appropriate for the intended use and should be handled and used carefully in accordance with the relevant instructions.
- The sanitation program should be carried out in a way that does not contaminate food or packaging materials during, or after, cleaning and sanitizing (for example, no contamination from aerosols or chemical residues).
- The effectiveness of the sanitation program should be monitored and verified (for example, by conducting routine inspections of the premises and equipment or microbiological testing). Where necessary, the program should be adjusted.
- Operations should begin only after appropriate sanitation measures have been taken (for example, after doing a pre-operation inspection for satisfactory sanitation).
- The operator should implement a written sanitation program for the premises (including the shipping, receiving, processing, storage, distribution and handling areas) which specifies:
- areas to be cleaned;
- the cleaning agents to be used;
- mixing instructions;
- temperature controls;
- the person or people responsible; and
- the frequency of the activity.
- Special sanitation and housekeeping procedures required during manufacturing, storage, distribution and handling should be specified within the document (for example, removal of product residues during breaks, glass breakage procedures).
Equipment and utensils sanitation
- The operator should implement a written sanitation program for all equipment and utensils, which specifies:
- the equipment to be cleaned;
- the cleaning agents to be used;
- mixing instructions;
- temperature controls;
- the person or people responsible;
- the frequency of each activity; and
- the procedures for cleaning and sanitizing, including disassembly and assembly instructions.
- Additional cleaning and sanitizing procedures should be written for both cleaned-out-of-place (C.O.P.) equipment and cleaned-in-place (C.I.P.) equipment.
- Cleaning and sanitizing equipment should be designed for its intended use and should be properly maintained.
Food contact surfaces sanitation
- Food contact surfaces should be effectively cleaned, sanitized, inspected and maintained on a regular basis.
- Non-food chemicals, including cleaning solutions and lubricants used for food contact surfaces, should be appropriate for the intended use and should be used in accordance with the manufacturer’s instructions.
1.2.7 Pest control
The premises are free of pests.
- The operator should implement an effective, written pest control program for the premises and equipment. This program should prevent the entry of pests and should detect and eliminate any pests which may gain entry. The program should include:
- the person who is assigned responsibility for pest control;
- the name of the pest control company or the name of the person contracted for the pest control program, where applicable;
- the list of chemicals used, their concentration (in accordance with label instructions), and the location, method and frequency of application;
- a map of the location of pest control devices that are monitored; and
- the type and frequency of inspection to verify the effectiveness of the program.
- Pesticides used should be registered under the Pest Control Products Act and Regulations. Pesticides must be used in accordance with the label instructions (available on the Pest Management Regulatory Agency‘s Pesticide Public Registry).
- Chemical treatment of equipment, premises or ingredients to control pests should be as per label instructions. They should also be applied so that the maximum residue limit specified in the Food and Drugs Act andRegulations is not exceeded (for example, the number of fumigation treatments per lot is limited).
- Poisonous rodenticides should not be used within the premises.
1.2.8 Product coding and recall
Potentially unsafe food products are identified rapidly and removed efficiently from the marketplace.
- The operator should have a system for assigning codes or lot numbers to incoming materials, packaging materials and finished products, etc. This will help to identify recalled products.
- Codes or lot numbers provided on packaging should be legible and durable for the lifespan of the product.
- The operator should record the amount of product manufactured for each code.
- The operator should have records of processing, inventory and distribution for each lot.
- Distribution records should contain sufficient information to permit a recall of a particular code or lot number, such as:
- the product identification and size;
- the code or lot number;
- the quantity; and
- customer names, addresses, and phone numbers to the initial level of product distribution.
- The operator should implement a written recall program that allows the operator to effectively locate all affected food products and other products that may cause a similar hazard to public health.
- The recall program should identify the contact information of those who are responsible for implementing a recall, as well as their roles and responsibilities.
- The written recall procedure should follow the steps outlined in the guidelines called “Food Recall: Make a Plan and Action It!“, on the CFIA website. There is specific guidance for importers, manufacturers, distributors and retailers.
- The recall program should be tested at least once a year through appropriate means (for example, a mock recall). It should be tested to verify the ability to rapidly identify, control and recall all the potentially affected products.
- The operator should identify and correct any deficiencies in the recall procedure.
- Recalled products should be separated from other products and access controlled until appropriate disposition of the product has been determined. This can be done by using hold tape, tags or a designated storage area.
1.2.9 Complaint handling
Complaints are handled effectively to identify possible deficiencies in the operations.
- Product complaints are an important indicator of possible deficiencies of the preventive food safety control systems and/or pre-requisite programs.
- The operator should develop and implement written procedures to handle product complaints. These should identify the person or people responsible for receiving, evaluating, categorizing, investigating and addressing complaints.
- The information received from the complainant should be documented and should include:
- the date;
- the name of complainant, and their address and phone numbers;
- the nature and details of the complaint (for example, illness, allergic reaction, quality issue, labelling issue);
- the product affected (including name, description, size, date of manufacture, code, lot number or UPC); and
- where the product was obtained.
- Complaints should be accurately categorized according to safety concerns and other regulatory concerns, such as labelling.
- Complaints related to safety and contamination should be investigated by appropriately-trained technical personnel.
- The operator should determine the potential cause and the scope of the issue, and should conduct appropriate follow-up investigations.
Accurate information related to manufacturing, handling, storage and distribution is documented and the records properly maintained.
- Records play an essential role in determining whether the food operation conforms to its pre-requisite programs. Procedures should be established to identify record-keeping requirements.
- Documentation and record-keeping should be appropriate to the nature and size of the operation. They should also assist the business in verifying that controls are in place and are being maintained.
- The operator should establish record-keeping procedures to demonstrate:
- water, ice and steam potability;
- microbiological and chemical safety of the incoming and finished products;
- control of processing, storage, distribution, handling and composition of the product (for example, temperature controls, levels of added nutrients and food additives);
- the formulations and codes of incoming ingredients and final products; and
- the effectiveness of the maintenance and calibration programs for equipment and utensils, the sanitation program, the pest control program and the training program.
- Examples of records may include temperature logs, formulation sheets, equipment maintenance checklists and pest control records.
- Records should be legible and should accurately reflect the actual events, conditions and activities.
- Any changes to records should be traceable (for example, errors are identified by a strike out and followed by initials).
- Each entry on a record should be signed and dated by the responsible person at the time the specific event occurred.
- Record-keeping requirements and responsibilities should be communicated to staff.
- Records should be kept in a secure location, maintained and readily available for a period of time that exceeds the shelf life of the product. This is in keeping with Codex’s Recommended International Code of Practice – General Principles of Food Hygiene (for example, one year after the best before date of the product, or two years after production if there is no best before date).
- Records could be in electronic format, as long as they can be retrieved upon request. They should be password-protected and should be backed up frequently, on a set schedule.
- Refer to section 2.10 for additional record-keeping guidelines concerning preventive food safety control systems.
Chapter 2: Preventive Food Safety control Systems
A preventive food safety control system is a written plan outlining the actions and measures taken to ensure that food:
- is safe for the consumer;
- is fit for human consumption; and
- conforms to safety and labelling requirements as prescribed by all applicable Canadian food legislation.
This chapter provides guidance on developing a preventive food safety control system using a science-based and systematic approach. It provides guidelines to assess food safety hazards and establish preventive control measures.
The guidance outlined in this chapter is outcome-based. It is also flexible enough for operators to choose the most appropriate preventive food safety control programs for their operations, such as HACCP, FSEP, QMP, ISO and Good Importing Practices (GIP). Whichever control program is implemented, it must result in safe food production, and final food products that meet the requirements of Canadian food legislation.
Management awareness and on-going commitment is critical to develop, implement and maintain an effective preventive food safety control system. The effectiveness of the system will also depend on management and employees having the appropriate knowledge of food hygiene principles and practices, and the necessary skills to apply them.
The successful control of food safety hazards also depends on the full commitment and involvement of all personnel in meeting the requirements of a preventive food safety control system.
Before implementing a preventive food safety control system, effective pre-requisite programs (as outlined in Chapter 1) should be in place. This is so that the foundation for a preventive food safety control system is in place.
2.1 Assemble the TeamFootnote 2
A preventive food safety control system is developed by a team with appropriate expertise and knowledge.
- Management should be committed to and supportive of developing, implementing, maintaining and continuously improving a preventive food safety control system. They should demonstrate this by providing sufficient resources and training, as necessary.
- The team should include representatives from all areas who are knowledgeable of the relevant food products, manufacturing, storage, distribution and handling processes. This could include people from shipping and receiving, operations, sanitation, quality assurance, maintenance and engineering.
- The team should be able to:
- confirm that all food products comply with applicable food legislation, including quality and labelling;
- identify significant food safety hazards (for example, biological, chemical and physical hazards), as well as the appropriate control measures;
- define the scope of the preventive food safety control system;
- confirm that all necessary pre-requisite programs have been effectively implemented; and
- develop, implement and maintain an effective preventive food safety control system.
2.2 Describe the Product and Its Intended Use
The description of the finished product and its intended use is sufficient to identify all potential hazards.
- All products and their intended use (for example, for further processing, ready-to-eat food) should be clearly described. This will help adequately identify and address potential hazards associated with the processing, storage, distribution and handling steps, as well as potential hazards affecting sensitive segments of the population.
- The description of product should include:
- product common name(s);
- important product characteristics including physical/chemical structure (for example, water activity (Aw), pH);
- formulations, including a complete list of ingredients and allergens;
- special treatments (for example, heat-treatment, freezing, brining, smoking);
- packaging type and packaging material;
- shelf-life may be determined via microbial testing, lipid deterioration, moisture analysis, water activity value (Aw), sensory evaluation such as taste, odour and texture, etc.
- labelling instructions for consumers (for example, keep frozen, cook prior to eating);
- special distribution control (for example, temperature, humidity); and
- distribution, including intended target audience.
- The description of the intended use of the product should include:
- the end use of the food (for example, ready-to-eat food product, ingredient for a product destined for further processing); and
- the intended user of the product (such as sensitive populations including the elderly, infants, and malnourished, ill or immuno-compromised individuals).
2.3 Construct Flow Diagrams and Plant SchematicsFootnote 3
An accurate and detailed process-flow diagram that identifies potential sources and controls of hazards, and a plant schematic that shows product and employee traffic flow, to identify potential areas of cross-contamination.
- The process-flow diagram should cover all steps of the operation, from receiving to final shipping, regardless of its size or complexity.
- The process-flow diagram should be simple and should not contain unnecessary details.
- The plant schematic (the floor plan) should indicate the flow of incoming materials from receiving through storage, preparation, processing, packaging, as well as storage and shipping of finished products.
- The plant schematic should indicate movement of products, waste, chemicals and employees throughout the premises, including change rooms, washrooms and lunchrooms.
- The plant schematic should identify potential areas for cross-contamination in the plant (for example, locations where allergens could unexpectedly come in contact with non-allergen ingredients, locations where raw materials could come in contact with cooked products).
- The process-flow diagram and plant schematic should be verified by walking through the processing, storage, distribution and/or handling areas. This will confirm that all steps have been included and that product and employee flows are accurate.
- Variances that may occur on different shifts or during different business cycles should be considered.
2.4 Conduct a Hazard Analysis
Hazards associated with ingredients and incoming materials, processing steps, product flow and employee traffic patterns are identified.
- A hazard is anything that may cause injury or illness if not controlled, reduced or prevented. Food hazards may be biological, chemical or physical.
- The team should identify all hazards specific to their operation and the composition of their products.
- The team should identify potential hazards associated with all the ingredients, incoming materials and each processing step. The hazards identified should take into consideration the intended end use of the product.
- Tools to assist in identifying hazards include:
- the Reference Database for Hazard Identification developed by the CFIA;
- reference texts;
- scientific publications; and
- additional information from industry associations and governments that are publicly available.
- Biological hazards include micro-organisms such as bacteria, viruses, parasites, fungi and moulds.
- The risk of biological hazards may vary depending on the severity of consequences of the hazard. Some micro-organisms are pathogenic and are able to cause foodborne illnesses (for example, Salmonella, Listeria monocytogenes, Bacillus cereus, E. coli O157:H7). Toxins produced by some micro-organisms cannot be inactivated by heat treatment (for example, Clostridium botulinum, Staphylococcusaureus); these can cause severe health consequences.
- Sources of biological hazards include raw materials from suppliers, cross-contamination, inadequate time or temperature control, employees, food contact surfaces or the air.
- Chemical hazards include:
- chemicals intentionally used in food processing (for example, processing aids, food additives, sulphites, machine lubricants);
- chemicals that are by-products of processing (for example, nitrosamines, chloramines);
- industrial chemicals (for example, cleaning agents, oils, gasoline, lubricants, ammonia);
- naturally-occurring toxicants (for example, products of plant, animal or microbial metabolisms such as aflatoxins);
- agricultural chemicals (for example, pesticides, antibiotics, fungicides, rodenticides, algicides, fertilizers);
- nutrients (for example, over-fortification and under-fortification of vitamins and minerals); and
- food allergens (for example, peanuts, tree nuts, sesame seeds, milk, eggs, fish, crustaceans, shellfish, soy, wheat and sulphites).
- Chemical hazards may occur naturally or may be introduced during any stage of food processing. For example, allergens may be introduced either by presence in an ingredient or in a component of an ingredient (or through cross-contamination of either).
- Physical hazards include glass, plastic, metal, wood, rubber, stone, bone, dust, and insect parts.
- Physical hazards can be introduced anywhere along the food processing line from equipment or employees, or can be inherent in the raw materials.
2.5 Determine and Apply Control MeasuresFootnote 4
Control measures are determined and applied to prevent, eliminate or reduce identified food safety hazards to acceptable levels.
- The team should establish appropriate control measures to reduce the identified food safety hazards to acceptable levels at each processing step.
- The determination of appropriate control measures should be scientifically based and documented. A decision tree may be used to help determine control measures.
- Operators should implement control measures to prevent cross-contamination and reduce the identified biological, chemical and/or physical hazards to an acceptable level at each processing step. This will enhance the safety and compositional integrity of the final food product.
- For biological hazards, control measures may include an appropriate time/temperature cooking step or other post-processing treatment to destroy microbiological organisms.
- For chemical hazards, such as allergens, control measures may involve implementing an allergen prevention plan, which outlines multiple measures to control allergens.
- For physical hazards, control measures may include suitable detection or screening devices.
- Other control measures may include making sure that the food additives and nutrients used are permitted and are within permitted levels, and making sure that the product composition accurately reflects the formulation.
- Many control measures should be already covered by the pre-requisite programs. Implementation of these control measures is encouraged before processing begins.
- Control measures for hazards that are expected to occur should be identified, tested and evaluated.
- For each control measure, the team should establish predetermined and documented parametersFootnote 5 that separate what is acceptable from what is not acceptable.
- If a regulatory limit exists (for example, level of vitamin and mineral fortification as prescribed by the Food and Drug Regulations, the prescribed regulatory limit should be used as a parameter for the control measures.
- Parameters should be developed and implemented using accepted scientific methods, which may include the details of experimental studies.
- Parameters may involve observations (qualitative) or measurements (quantitative). Examples of parameters include measurements of temperature, time, moisture level, pH, water activity (Aw) and available chlorine. They also include sensory parameters such as visual appearance and texture.
The parameters of control measures are validated.
- Validation assesses whether the preventive food safety control system is effectively controlling all hazards in the way that it was designed to. Validation involves obtaining evidence to ensure control measures are effective at all times. This is to confirm that the control measures or preventive food safety control systems, when implemented as intended, are capable of controlling the hazard within the established limits and that this level of control can be achieved consistently.
- Validation should be performed by the team when new control measures or new preventive food safety control systems are designed or amended.
- During the validation, all control measures within the preventive food safety control system, including the pre-requisite programs, should be reviewed to confirm that the control measures continue to be effective in controlling the identified hazards.
- All control measures should be validated periodically (for example, once a year).
Control measures are monitored to assess if the food safety hazards are controlled.
- All control measures should be monitored at a scheduled frequency to assess whether a food safety hazard is being controlled. The monitoring should be frequent enough to detect a trend towards loss of control of a hazard.
- The following should be specified and appropriate to the type of manufacturing, storage, distribution or handling process and associated risks:
- the procedures (what/how);
- the frequency (when); and
- the individual responsible for the monitoring (who).
- Examples of monitoring activities include taking temperature readings of refrigerators and freezers, observations of hygienic practices of employees, and taking water samples for analysis.
- Data derived from monitoring should be evaluated by a designated person with knowledge and authority to carry out corrective actions when necessary.
- Process adjustments should be made before a deviation occurs (for example, when monitoring results indicate a trend towards loss of control of a hazard).
2.8 Corrective Action
Corrective action is taken when a deviation occurs.
- Corrective actions should be taken to address deviations that occur when the established parameters or other specified requirements for a control measure are not met.
- Immediate corrective actions should be taken when a food safety issue is involved.
- Procedures should be established to indicate the corrective actions to be followed, when they should be implemented, the person responsible for taking the corrective actions and the information to be recorded.
- Corrective actions should include measures to:
- regain control of the process;
- determine the appropriate method to control all affected products (for example, put on hold); and
- determine and correct the root cause of the deviation to prevent a reoccurrence (for example, reassess the situation).
- Examples of corrective actions include:
- rejecting incoming materials that do not meet specifications;
- cleaning utensils that have not been sanitized effectively;
- putting affected products on hold;
- conducting food safety assessments; and
- implementing preventive measures.
- Effectiveness of the corrective actions should be evaluated and measures taken to prevent a recurrence of the deviation.
- Data derived from corrective actions should be evaluated by a designated person with knowledge and authority to carry out adjustments to the system when necessary.
The preventive food safety control system is verified to confirm the effectiveness of control measures.
- Verification assesses if the preventive food safety control system is being implemented as designed (for example, the monitoring and corrective action procedures are followed properly).
- Verification involves examining the accuracy, correctness or effectiveness of validated processes or process controls. This is done through testing, investigation or comparison against a standard.
- Examples of verification activities include reviewing records, testing incoming ingredients and finished products, observing employee practices, etc.
- The system should be reviewed whenever a change in the operation, product or process occurs. This will help existing food safety controls to remain effective.
- In most cases, a complete verification requires that both record review and on-site verification be done. This task should be carried out by someone other than the person who is responsible for performing the monitoring and corrective actions.
- Controls measures should be verified at a frequency appropriate to the food safety hazards associated with the product and process(es).
Accurate information related to the safety of products is documented and the records properly maintained.
- In addition to the pre-requisite program record-keeping requirements identified in section 1.3 of Chapter 1, all records of the preventive food safety control system should be available to demonstrate the adequacy of procedures and methods used in food processing.
- Records on the adequacy of procedures and methods, such as thermal processes and hermetic seal verifications, should be verified and signed by a qualified individual.
- The team should develop and maintain appropriate documentation and records for all control measures, including monitoring, corrective action, verification and validation of records.
Allergen: Any substance capable of producing an abnormal immune response in sensitive individuals. (Allergène)
Carrier: A mechanism or device by which something is conveyed or transported. (Transporteur)
Cleaning: The removal of soil, food residue, dirt, grease or other objectionable matter. (Nettoyage)
Codex Alimentarius Commission: A subsidiary body of the Food and Agriculture Organization and the World Health Organization of the United Nations. (Commission du Codex Alimentarius)
Contaminant: Any biological or chemical agent, foreign matter, or other substances added to food, which may compromise food safety or suitability. (Contaminant)
Contamination: The introduction or occurrence of a contaminant in food or food environment. (Contamination)
Control: The state wherein an operation meets established parameters and process requirements, consistently resulting in a safe product. (Contrôle)
Control measures: Procedures established to prevent, eliminate or reduce identified hazards to acceptable levels. (Mesures de contrôle)
Corrective action: The actions to be taken to maintain control when monitoring indicates a deviation, and dealing with any affected product when there is a deviation. (Mesure corrective)
Deviation: Failure to meet an established parameter or other specified requirement for control measures. (Écart)
Documents: For the purposes of this text, documents refers to written formulae, procedures or specifications used by, or required of, a food industry operator. (Documents)
Food: Includes 1) any article manufactured, sold or represented for use as food or drink for human beings, 2) chewing gum, and 3) any ingredient that may be mixed with food for any purpose whatever. (Aliment)
Food hygiene: All conditions and measures necessary to ensure the safety and suitability of food at all stages of the food chain. (Hygiène alimentaire)
Food industry: All food operators, including importers and domestic manufacturers, packers, distributors, and other food handlers. (Industrie alimentaire)
Hazard: A biological, chemical or physical agent in food, or a condition of a food, that may cause an adverse health effect. (Danger)
Hazard analysis: The process of collecting and evaluating information on hazards and conditions leading to their presence, to decide which ones are significant for food safety. (Analyse des dangers)
Hazard Analysis and Critical Control Point (HACCP): An approach recommended by the Codex Alimentarius Commission as a means to enhance food safety. It functions to identify, evaluate, and control hazards that are significant for food safety. (Analyse des dangers et maîtrise des points critiques (HACCP))
Incoming material: All incoming materials used in the operation, including food ingredients, additives, packaging materials, cleaning supplies, etc. (Matières premières)
Lot: Definitive quantity of a commodity produced essentially under the same conditions. (Lot)
Lux level: The lux (lx) is an unit of luminous emittance defined by the International System of Units (SI). It is used to measure the apparent intensity of light hitting or passing through a surface. (Niveau de lux)
Monitoring: A planned sequence of observations or measurements to assess whether a control measure (or other activity) is under control. (Surveillance)
Operator: The person who is responsible for the safety of the food. The term “operator” includes importers and domestic manufacturers, packers, distributors, retailers, food services and institutions. (Exploitant)
Packaging material: The type of container in which the product is packaged (for example, glass, wood, plastic, cardboard). (Matériel d’emballage)
Potable water: Drinkable water that will not cause illness. (Eau potable)
Premises: Any building or area for food manufacturing, storage, distribution or handling in which food is produced, received, stored, distributed and/or handled, and the surroundings under the control of the same management. (Bâtiments)
Pre-requisite programs: Universal steps or procedures that control the operational conditions within a food operation, and promote environmental conditions that are favourable for producing safe food. (Programme préalable)
Recall: A system by which products that may be hazardous to consumers are removed from the marketplace. (Rappel)
Records: For the purposes of this document, observations and measurements recorded by operators related to the safety of products or used to determine adherence to control measures. (Dossiers)
Sanitizing: Reducing the level of micro-organisms to a level that will not compromise the safety of a food product. (Assainissement)
Spoilage: The process of decay in food products. (Détérioration)
Step: A point, procedure, operation or stage in the food chain, including receipt of raw materials. (Étape)
Validation: Obtaining evidence to show that the control measures, when implemented as intended, are effective in controlling the hazard to the appropriate level and that this level of control can be achieved consistently. (Validation)
Verification: Applying methods, procedures, tests and other evaluations, in addition to monitoring of a control system or its records performed on a regular basis to determine whether the preventive food safety control system is effective. (Vérification)
Annex I: Example of a Process Flow Diagram (breakfast cereal)
Description for flowchart – Description of Processing Steps for Breakfast Cereal Products
Annex II: Example of a Plant Schematic Diagram
Description for flowchart – Description of plant schematic diagram
Description for flowchart – Description of plant schematic diagram
The team may be an individual, as long as they have the appropriate expertise and knowledge.