To define detail, scope and purpose.
To establish the developed detail in a viewable format to facilitate information.
To facilitate the application of the documentation.
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This information can be used to develop food safety and quality programs that meet the requirements of modern regulatory, customer and industry standards:
When considering the development, documentation and implementation of Good Manufacturing Practices within food safety and quality management systems, consider the following information to support effective outcomes:
Good Manufacturing Practices (GMP) policies set out broad and specific guidelines for a food industry operation, covering:
GMP policies also introduce food handlers and other people involved in the operation to appropriate workplace practices, provide documentation on hygiene, cleaning and the control of production processes within the bounds of governing legislation, and help assure that all finished food products are safe and of suitable quality. GMP are often used as the foundation for the specific food hygiene requirements of a designated sector of food production.
Every food industry sector faces particular challenges in applying GMP. The nature of the foods produced makes the results of manufacturing processes critical to consumer welfare, and failures can seriously harm consumer health. For this reason, many jurisdictions issue formal guidelines as legislation and food codes, and many require ongoing GMP training and management of food industry employees. Well-managed GMP form the basis of the prerequisite programs that support HACCP based food safety management.
The term Good Manufacturing Practices is often used alongside Good Hygiene Practices (GHP). Related variations include Good Transport Practices, Good Warehousing Practices and Good Laboratory Practices. All are bound by the requirement to produce safe and suitable outcomes against legislative requirements, industry guidelines and recognised best practice.
Both GMP and GHP commonly address:
In addressing legislation, industry codes of practice and food laws, the two primary concerns of GMP and GHP are:
The Good Manufacturing Practices Policy and the Good Hygiene Practices Policy should set out what food handlers and associated people need to follow to meet these requirements.
Production processes aim to produce food that is safe and suitable for human consumption by:
Consider the following in applying process control within any food business:
Adequate programs must be in place to monitor and control the interactions of personnel with the production of safe and suitable food, so that safe food handling practices are followed. Staff training must be verified as relevant and accurate for specific tasks, and must make people responsible for their actions within the whole process. Ongoing training, particularly in personal hygiene, personal conduct and hygienic handling of food, reinforces positive food safety outcomes.
Personnel requirements may include records of staff training and of the training content issued, and a personnel training policy covering on the job and task specific training. Refer also to process control management and training, competency and resources requirements.
The conditions under which food is handled from production to final consumption determine its quality and safety. The basic rules for the hygienic handling, storage, processing, distribution and final preparation of food along the food production chain are set out in the Codex Alimentarius General Principles of Food Hygiene. They include requirements for design and facilities, control of operations including temperature, raw materials, water supply, documentation and recall procedures, maintenance and sanitation, personal hygiene and training of personnel.
Hygienic practices are an integral part of all food safety management systems, including HACCP. The General Principles are recommended for adoption by governments, industry (including primary producers, manufacturers, processors, foodservice operators and retailers) and consumers. They cover all circumstances necessary to ensure food safety and suitability at every stage of handling, processing, storage and distribution.
The aims of food hygiene are to:
Food hygiene is achieved through effective systems that:
Food hygiene involves:
The aspects of food hygiene control systems below are essential to ensuring appropriate outcomes on an ongoing basis.
Primary production requires special attention to the identification and control of all food safety hazards, because it is most often the first step in the food supply chain. It can define the safety of the foods involved at later steps, including supply, processing and customer availability.
The control of chemical use is paramount in primary production, because chemicals such as pesticides, insecticides, fertilisers, antibiotics and fungicides are applied directly to foods or their surroundings. Residues may still be present in or on foods when they reach consumers. These hazards are controlled by following prescribed application rates and procedures, and by observing appropriate withholding periods. Refer also to chemical control.
Primary production is also the step at which foods are readily exposed to higher than acceptable levels of pathogenic bacteria, through soil, animal faeces or other environmental factors. These hazards are generally controlled through well-structured procedures that define practices supporting the production of safe and suitable foodstuffs.
Inadequate temperature control is one of the most common causes of food-borne illness and food spoilage. Controls include the time and temperature of cooking, cooling, processing and storage. Systems should ensure temperature is controlled effectively wherever it is critical to food safety and suitability.
Temperature control systems should take into account:
Such systems should also specify tolerable limits for time and temperature variations. Temperature recording devices should be calibrated at regular intervals and tested for accuracy. Refer also to storage and handling requirements.
Other steps that contribute to maintaining appropriate food hygiene outcomes may include:
As part of GMP and GHP procedures, food business management should document a policy and take all reasonable measures and precautions to address the requirements in the sections below.
Many materials are prohibited in food production areas because of their potential to harm consumers. The presence of the following items in production, packaging, storage and handling areas is of major concern:
Refer also to good housekeeping practices.
Any person who is shown by medical examination or supervisory observation to have, or who appears to have, an illness, an open lesion (including boils, sores or infected wounds) or any other abnormal source of microbiological contamination should be excluded from any operations where there is a reasonable possibility of food, food contact surfaces or food packaging materials becoming contaminated. The exclusion should continue until the condition is corrected. Personnel should be instructed to report such health conditions to their supervisors. Refer also to personal hygiene standards.
All persons working in direct contact with food, food contact surfaces and food packaging materials should follow hygienic practices while on duty, to the extent necessary to protect against contamination of food. Methods for maintaining cleanliness include, but are not limited to:
Refer also to personal hygiene standards.
Personnel responsible for identifying sanitation failures or food contamination should have the education, experience or combination of both needed to produce clean and safe food. Food handlers and supervisors should receive appropriate training in food handling techniques and food protection principles, and should be informed of the dangers of poor personal hygiene and unsanitary practices.
Responsibility for assuring compliance by all personnel with all requirements should be assigned to competent supervisory personnel.
The grounds around a food business under the control of the operator should be kept in a condition that protects against contamination of food. Methods for adequate maintenance of grounds include, but are not limited to:
If the grounds are bordered by land that is not under the operator’s control and is not maintained in the designated manner, take care within the facility, through inspection, pest control measures or other means, to exclude pests, dirt and filth that may be a source of food contamination.
Buildings and structures should be suitable in size, construction and design to facilitate maintenance and sanitary operations for food manufacturing. The facility should:
The potential for contamination may be reduced by adequate food safety controls and operating practices, or by effective design, including separating operations where contamination is likely to occur by one or more of the following means:
Refer also to premises design and construction standards.
Buildings, fixtures and other physical facilities should be kept in a sanitary condition and in sufficient repair to prevent food from becoming unsafe or unsuitable. Cleaning and sanitising of utensils and equipment should be conducted in a way that protects against contamination of food, food contact surfaces and food packaging materials.
Cleaning and sanitising chemicals and equipment should be free from undesirable microorganisms and safe and adequate for the conditions of use. Compliance may be verified by any effective means, including purchasing these substances under a supplier’s guarantee or certification and examining them for contamination.
Appropriately certified toxic materials may be used or stored in a facility where food is processed or exposed when they are:
Toxic cleaning compounds, sanitising agents and pesticide chemicals should be identified, held and stored in a way that protects food, food contact surfaces and food packaging materials from contamination. Follow all applicable regulations for the application, use and holding of these products. Refer also to preventative maintenance and reactive maintenance standards, cleaning and sanitation and chemical control.
Animals should not be allowed in any area of a food business, except assistance animals. Guard or assistance dogs may be permitted in some areas if their presence is unlikely to result in contamination of food, food contact surfaces or food packaging materials.
Take effective measures to exclude pests from processing areas and to protect food on the premises from contamination by pests. Use insecticides and rodenticides only under precautions and restrictions that protect food, food contact surfaces and food packaging materials from contamination. In general, toxic baits are laid externally, and non-toxic baits for monitoring purposes are laid in food processing and storage areas. Refer also to pest and vermin control.
All food contact surfaces, including utensils and the food contact surfaces of equipment, should be cleaned as frequently as necessary to protect against contamination of food.
Surfaces and materials, particularly those in contact with food, should be non-toxic, suitably durable, and easy to maintain and clean. When selecting equipment and utensils for a commercial food manufacturing facility, stainless steel is the most favoured material because it is durable and easy to clean. Wood is avoided where possible because it can harbour bacteria and tends to chip and splinter, creating a risk of physical contamination. Seams on food contact surfaces should be smoothly bonded or maintained to minimise the accumulation of food particles, dirt and organic matter, and so minimise the opportunity for microorganisms to grow.
Food contact surfaces used for manufacturing or holding low moisture food should be dry and sanitary at the time of use. When these surfaces are wet cleaned, they should, when necessary, be sanitised and thoroughly dried before subsequent use. Non food contact surfaces of equipment should be cleaned as frequently as necessary to protect against contamination of food.
In wet processing areas, when cleaning is necessary to protect against the introduction of microorganisms into food, all food contact surfaces should be cleaned and sanitised before use and after any situation in which they may have become contaminated. Where equipment and utensils are used in a continuous production operation, clean and sanitise the utensils and food contact surfaces of the equipment as necessary.
Single service articles, such as utensils intended for one time use, paper cups and paper towels, should be stored in appropriate containers and handled, dispensed, used and disposed of in a way that protects against contamination of food or food contact surfaces.
Sanitising agents should be adequate and safe under the conditions of use. Any facility, procedure or machine is acceptable for cleaning and sanitising equipment and utensils if it is established that it will routinely render them clean and provide adequate treatment.
Equipment and fittings in the manufacturing or food handling area that do not contact food should be constructed so they can be kept clean. Holding, conveying and manufacturing systems, including gravimetric, pneumatic, closed and automated systems, should be designed and constructed so they can be maintained in a sanitary condition. Refer also to equipment design and construction standards.
Store cleaned and sanitised equipment and utensils in a location and manner that protects food contact surfaces from contamination, for example hung, shelved with the food contact side down, wrapped or covered.
Fit each freezer and cold storage compartment used to store food capable of supporting the growth of microorganisms with an indicating thermometer, temperature measuring device or temperature recording device for monitoring purposes.
Instruments and controls used to measure, regulate or record temperatures, pH, acidity, water activity or other conditions that control or prevent the growth of undesirable microorganisms in food should be accurate and adequate in number for their designated uses. Refer also to calibration of measuring and testing equipment.
Treat compressed air or other gases mechanically introduced into food, or used to clean food contact surfaces or equipment, so that food is not contaminated with unintended contaminants.
Define the requirements for any instance in which product is dropped and contacts a non-food contact surface. A dropped product policy may include corrective actions for:
Consider not only the potential for physical, biological and chemical contamination of dropped product, but also damage that affects the quality of the product made available to consumers.
Inspect and segregate, or otherwise handle, raw materials and ingredients as necessary to confirm they are clean and suitable for processing into food, and store them under conditions that protect against contamination and minimise deterioration. Wash or clean raw materials as necessary to remove soil or other contamination. Water used for washing, rinsing or conveying food should be safe and of adequate sanitary quality, and may be reused if it does not increase the level of contamination of the food. Inspect containers and carriers of raw materials on receipt to ensure their condition has not contributed to contamination or deterioration of the food.
Raw materials and other ingredients should either not contain levels of microorganisms that may cause food poisoning or other disease in humans, or should be pasteurised or otherwise treated during manufacture so that they no longer contain levels that would make the product unsafe. Compliance may be verified by any effective means, including purchasing raw materials and other ingredients under a supplier’s guarantee or certification. Refer also to approved supplier management.
Raw materials and other ingredients susceptible to contamination with aflatoxin or other natural toxins should comply with applicable food regulations and action levels for poisonous or deleterious substances before they are incorporated into finished food. Compliance may be achieved by purchasing under a supplier’s guarantee or certification, or verified by analysing these materials for aflatoxin and other natural toxins.
Thaw frozen raw materials that require thawing before use in a way that prevents other ingredients from being contaminated.
Hold liquid or dry raw materials and other ingredients received and stored in bulk in a way that protects against contamination. Items such as bulk grain, flour and oils are often kept in silos outside the facility, so product security should also be considered.
When ice is used in contact with food or as an ingredient, it should be made from safe water of adequate sanitary quality. Refer also to water and ice quality standards.
Conduct packaging and storage of food under conditions and controls that minimise the potential for microbial growth and contamination. One way to comply is careful monitoring of physical factors such as time, temperature, humidity, water activity, pH, pressure and flow rate, and of manufacturing operations such as freezing, dehydration, heat processing, acidification and refrigeration, to ensure mechanical breakdowns, time delays, temperature fluctuations and other factors do not contribute to decomposition or contamination of food.
Compliance may be achieved by any effective means, including:
Perform filling, assembling, packaging and other operations in a way that protects food against contamination. Compliance may be achieved by any effective means, including:
Food that relies on water activity control to prevent the growth of undesirable microorganisms, such as dry mixes, nuts, intermediate moisture food and dehydrated food, should be processed to and maintained at a safe moisture level. Compliance may be achieved by monitoring water activity and protecting finished food from moisture pickup, using a moisture barrier or other means, so water activity does not rise to an unsafe level.
Acidified food that relies principally on pH control to prevent the growth of undesirable microorganisms should be monitored and maintained at a pH of 4.6 or below. Compliance may be achieved by monitoring the pH of raw materials, food in process and finished food, and controlling the amount of acid added. Refer also to packaging standards, storage and handling requirements and validation activities.
Cross contamination can occur when pathogenic microorganisms are transferred from one food or food contact surface to another, carried by utensils, hands or other foods. Another form involves allergens, usually from improper cleaning between production runs, and is known as cross contact. Cross contamination can be controlled in the food processing environment through effective cleaning and sanitising procedures and staff participation in procedures that reduce its occurrence. Controlling cross contamination is critical where raw and ready to eat products are prepared. Refer also to allergen management.
Signage is commonly used across food industry sectors to promote food safety and quality, as well as occupational health and safety. Signage must be appropriately constructed and fitted so it does not become a food hazard. It is generally accepted that signage should be made of flexible, waterproof and cleaning chemical resistant materials. This excludes hard or brittle substances such as rigid plastic or acrylic, which could enter foods as physical hazards.
When signage refers to procedures, policies or other components of the documented food safety and quality system, it should reference their content. Include the signage in a register, for example the document register, so it is amended whenever the associated policies or procedures are amended. Refer also to document and data control.
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Good Manufacturing Practices Development requirements in relation to their items.
The following references provide further guidance on food hygiene and prerequisite programs. Refer to the current edition of each.
Document: A document provides guidance and/or direction for performing work, making decisions, or rendering judgments that affect the safety or quality of the products or services that customers receive.
Documented policies, procedures, work instructions, and schedules form the basis of any food safety and quality management system. The following documentation formats may be considered to ensure ongoing compliance with specified requirements for Good Manufacturing Practices:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Good Manufacturing Practices Documentation requirements in relation to their items.
You may wish to visit the Good Manufacturing Practices Templates section of haccp.com for examples of Good Manufacturing Practices documentation, record, and resource formats commonly applied within food safety and quality systems.
Implementation: Implementation is the application of documented food safety and quality system elements into the actual business operation. The implementation of Good Manufacturing Practices within any food business requires genuine commitment from senior management, staff and visitors to ensure the nominated goals of implementation are achievable on an ongoing basis. It is a step that requires significant planning and consideration of general and specific food business circumstances to ensure the outcomes of Good Manufacturing Practices do not negatively impact the safety and quality of the food items dispatched from the business.
Implementation of Good Manufacturing Practices must include a clear definition of responsibilities and authorities for all levels of participation by senior management, staff and visitors to the site.
When implementing Good Manufacturing Practices within a food safety and quality system, you may wish to consider the following requirements before completion:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Good Manufacturing Practices Implementation requirements in relation to their items.
Monitoring: Monitoring is the act of reviewing and confirming measurable parameters of a defined process or product status.
Monitoring requirements within food industry sectors are generally identified against limits of acceptability defined within HACCP plans, implementation procedures, and work instructions. Monitoring usually includes some element of record-keeping, which may be maintained manually or through digital systems. It is important to consider that advancements in technology have spawned many systems and processes which are self-monitored or self-adjusting when variances are identified. Regardless of the system used, the goal of any monitoring activity is to provide sufficient evidence that any limit of acceptability has been met.
Traditional Good Manufacturing Practices monitoring requirements include manual recording and the application of corrective actions when the results of monitoring are found to be outside acceptable limits. Corrective Actions should also generally be strongly linked to the monitoring process where applied to ensure full traceability of the applied actions.
Common Good Manufacturing Practices monitoring activities and records include:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Good Manufacturing Practices Monitoring requirements in relation to their items.
You may wish to visit the Good Manufacturing Practices Templates section of haccp.com for examples of Good Manufacturing Practices documentation, record, and resource formats commonly applied within food safety and quality systems.
Corrective Action: Corrective action is mandatory action to be taken when a deviation to the Quality System occurs, particularly with a Critical Control Point.
Preventative Action: At any step in the process where a hazard has been identified, preventative action must be put into place to prevent re-occurrence.
Corrective Action and Preventative Action are implemented to ensure that any identified non-conformance issues are documented, investigated, and rectified within appropriate time frames. Corrective action is any action applied to regain control over a product, process, policy, or procedure that has been identified as being non-conforming or outside nominated limits of acceptability. Preventative action is any action applied to prevent any identified non-conformance from reoccurring.
The outcomes of corrective and preventative actions should result in regained process control after effective application. Specified corrective actions are commonly linked to the HACCP Plans and the food business certification process.
Below are Corrective Action and Preventative Action examples which may be associated with Good Manufacturing Practices related non-conformance:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Good Manufacturing Practices Corrective Action requirements in relation to their items.
You may wish to visit the Corrective Action and Preventative Action section of haccp.com for examples of best practice applications for this food safety and quality system element.
Verification: The act of reviewing, inspecting, testing, checking, auditing, or otherwise establishing and documenting whether items, processes, services, or documents conform to specified requirements.
Verification is the detailed review of all food safety and quality system elements to confirm that they are effectively developed, documented, implemented, monitored, and reviewed. All food safety and quality system elements, including documented policies, procedures, training, HACCP plans, and their operational applications must be verified on an ongoing scheduled basis. The verification process commonly includes a defined schedule for which verification activities are required, how often they are conducted, who is responsible, and detailed documented procedures for each nominated verification activity.
The general goal of an established verification process is to ensure any systemic non-conformance issues are identified and rectified within an appropriate time frame. When non-conformance issues are identified through the verification process, Corrective Actions and Preventative Actions should be implemented to ensure they do not impact the effectiveness of the food safety and quality system.
The following examples of verification activities may apply to Good Manufacturing Practices:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Good Manufacturing Practices Verification requirements in relation to their items.
You may wish to visit the Verification Activities section of haccp.com for examples of best practice applications for this food safety and quality system element.
Validation: The process of gathering evidence to provide a scientific basis for the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the qualification of systems and equipment.
Validation is the provision of evidence to support the limits of control or acceptability for food safety or quality parameters nominated within systemic elements. Limits of control or acceptability are commonly included within documented food safety and quality systems elements such as procedures, HACCP plans, and specifications.
Common sources of validation include regulatory and legislative standards, finished product specifications and customer requirements, industry codes of practice and guidelines, verified and validated research, historical product, and process control outcomes, and analytical testing.
The general goal of an established validation process is to ensure any systemic non-conformance issues are identified and rectified within an appropriate time frame. When non-conformance issues are identified through the validation process, Corrective Actions and Preventative Actions should be implemented to ensure they do not impact the effectiveness of the food safety and quality system.
Validation activities are commonly defined within the verification schedules and procedures of established food safety and quality management systems.
The following examples may apply to validation of the limits of control or acceptability for Good Manufacturing Practices:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Good Manufacturing Practices Validation requirements in relation to their items.
You may wish to visit the Validation Activities section of haccp.com for examples of best practice applications for this food safety and quality system element.
Skills and Knowledge: Skills and knowledge are attributes of human interactions commonly linked to competency within any specified job-related task.
Training and competency requirements for Good Manufacturing Practices must be ongoing, including regularly scheduled reviews to ensure the effectiveness of training and competency outcomes.
Team members who have defined responsibilities regarding Good Manufacturing Practices should have knowledge including:
Team members who have defined responsibilities regarding Good Manufacturing Practices should have skills including:
Team members who have defined responsibilities regarding Good Manufacturing Practices should have access to resources including:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Good Manufacturing Practices Training, Competency, and Resources requirements in relation to their items.
You may wish to visit the Training, Competency and Resources section of haccp.com for examples of best practice applications for this food safety and quality system element.
