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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, the following information should be considered to ensure effective outcomes:
Good Manufacturing Practices policies exist to establish both broad and specific guidelines for a particular industry operation regarding personal appearance and hygiene, cleaning and sanitation, food handling and manufacturing practices, and other relevant industry specified interests, assurances that food handlers and other peoples involved in the nominated industry sector are introduced to appropriate workplace-related practices, providing documentation concerning personal appearance and hygiene, cleaning and sanitation, and controlling the production processes within the bounds of governing legislation, and assuring that all finished food products safe and of suitable quality. Good Manufacturing Practices are often used as the foundation for the specific food hygiene requirements relating to a designated sector of food production.
All sectors of the food industry have special challenges when it comes to Good Manufacturing Practices. The nature of the foods produced by your business makes the results of your manufacturing processes of great importance to the welfare of the intended consumers of such products. The consequences of non-compliance with appropriate production guidelines can potentially have a disastrous effect on consumer health, sometimes with tragic results. The concepts of appropriate food manufacturing processes and practices are important enough to warrant formal guidelines issued as legislation and food codes. Food law mandates ongoing GMP training and management of food industry employees and requires that the scope and purpose of such is to enhance and sustain the continued use of GMP management of all food industry sectors. Appropriate and well-managed GMP concepts form the basis of pre-requisite programs for high-caliber food safety and quality management programs including Hazard Analysis Critical Control Point-based food safety.
The term Good Manufacturing Practices is often used in conjunction with Good Hygiene Practices. Other variations include Good Transport Practices, Good Warehousing Practices, and Good Laboratory Practices; all of which are bound by the requirement to produce safe and suitable outcomes against legislative requirements, industry guidelines, and recognized best practices.
Both GMP and GHP contain policies including:
In addressing the legislative requirements or industry codes of practice or food laws, the two primary concerns of GMP and GHP are:
In addressing these requirements, The Good Manufacturing Practices Policy and The Good Hygiene Practices Policy should provide the basis of what food handlers and associated people need to follow in meeting the legislative requirements.
Production processes aim to produce food that is safe and suitable for human consumption by:
The following considerations should be made in the application of process control within any food business:
Adequate and relevant programs must be in place to monitor and control the interactions of personnel regarding the production of safe and suitable food. The goals of such programs will ensure safe food handling practices. Staff training must be verified as to its relevance and accuracy in specific tasks, and in making people responsible for their actions within the holistic process. Ongoing training, particularly in personal hygiene, personal conduct, and hygienic handling of food will reinforce the positive nature of outcomes relating to food safety. Personnel requirements may include the maintenance of documentation for staff having undertaken training, and the relevant content of the training information issued; personnel training policy including requirements for on-the-job and task-specific training.
The conditions under which food is handled from the point of production until final consumption determine the quality and safety of the food we eat. The basic rules for the hygienic handling, storage, processing, distribution, and final preparation of all food, along the food production chain, are set out in the Codex Alimentarius General Principles of Food Hygiene. They include requirements for the 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 form an integral part of all food safety management systems, including the Hazard Analysis Critical Control Point system. The General Principles are recommended for adoption by governments, industry including primary producers, manufacturers, processors, foodservice operators, and retailers and consumers. The general principles of Food Hygiene cover all aspects of circumstances that are necessary to ensure the safety and suitability of food at all stages of its handling, processing, storage, and distribution.
The aims of food hygiene are to:
Food hygiene is achieved through effective systems which:
Food Hygiene involves:
The following aspects of food hygiene control systems are imperative in ensuring appropriate outcomes on an ongoing basis:
Primary production requires special attention regarding the identification and control of all food safety hazards, as it is most often the first step in the food supply chain. This factor can define the safety of the foods involved at later steps including supply, processing, and customer availability.
The control of chemical use is paramount within Primary Production, as it is a point at which chemicals such as pesticides, insecticides, fertilizers, antibiotics, fungicides among others are applied directly to foods or their surroundings. This produces issues of concern where the chemical content within, or on the foods produced are still present at the time the products become available to consumers. Adhering to the prescribed application rates and procedures for chemicals, in conjunction with allowing the appropriate withholding periods form the basis upon which such hazards are controlled.
Primary Production is also the step at which foods are readily exposed to higher than acceptable levels of pathogenic bacteria, whether it is through the soil, animal feces, or other environmental factors. These types of hazards are generally controlled through well-structured and developed procedures, which define practices that facilitate the production of safe and suitable foodstuffs for consumers.
Inadequate food temperature control is one of the most common causes of food-borne illness or food spoilage. Such controls include the time and temperature of cooking, cooling, processing, and storage. Systems should be in place to ensure that temperature is controlled effectively where it is critical to the safety and suitability of food.
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.
Other steps which contribute to maintaining appropriate food hygiene outcomes may include:
As part of GMP and GHP Procedures, the food business management should document a policy and take all reasonable measures and precautions to ensure the following:
Many materials are often prohibited in food production areas due to their potential for causing harm to consumers.
The presence of the following items in production, packaging, storage, and handling areas is of major concern:
Any person who, by medical examination or supervisory observation, is shown to have, or appears to have, an illness, open lesion, including boils, sores, or infected wounds, or any other abnormal source of microbiological contamination by which there is a reasonable possibility of food, food-contact surfaces, or food-packaging materials becoming contaminated, should be excluded from any operations which may be expected to result in such contamination until the condition is corrected. Personnel should be instructed to report such health conditions to their supervisors.
All persons working in direct contact with food, food-contact surfaces, and food-packaging materials should conform to 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:
Personnel responsible for identifying sanitation failures or food contamination should have a background of education or experience, or a combination thereof, to provide a level of competency necessary for the production of clean and safe food. Food handlers and supervisors should receive the appropriate training in proper food handling techniques and food-protection principles and should be informed of the danger of poor personal hygiene and unsanitary practices.
Responsibility for assuring compliance by all personnel with all requirements of supervision should be assigned to competent supervisory personnel.
The grounds about a food business under the control of the operator should be kept in a condition that will protect against the contamination of food.
Methods for adequate maintenance of grounds include, but are not limited to:
If the food business’ grounds are bordered by grounds, not under the operator’s control, and not maintained in the designated manner, care should be exercised in the plant by inspection, extermination, or other means to exclude pests, dirt, and filth that may be a source of food contamination.
Plant buildings and structures should be suitable in size, construction, and design to facilitate maintenance and sanitary operations for food-manufacturing purposes.
The plant and facilities should:
Buildings, fixtures, and other physical facilities of the plant should be maintained in a sanitary condition and should be kept in repair sufficient to prevent food from becoming adulterated. Cleaning and sanitizing of utensils and equipment should be conducted in a manner that protects against contamination of food, food-contact surfaces, or food packaging materials.
Cleaning and sanitizing chemicals and equipment used in cleaning and sanitizing procedures should be free from undesirable microorganisms and should be safe and adequate under the conditions of use. Compliance with this requirement may be verified by any effective means including the purchase of these substances under a supplier’s guarantee or certification and examination of these substances for contamination.
The following necessary and appropriately certified toxic materials may be used or stored in a facility where food is processed or exposed:
Toxic cleaning compounds, sanitizing agents, and pesticide chemicals should be identified, held, and stored in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials. All relevant regulations formed by National, State, and Local government agencies for the application, use, or holding of these products should be followed.
No animals should be allowed in any area of food business with the acceptance of assistance animals. Guard or assistance dogs, for example, may be permitted in some areas of a plant if the presence of the dogs is unlikely to result in contamination of food, food-contact surfaces, or food-packaging materials. Effective measures should be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests. The use of insecticides or rodenticides is permitted only under precautions and restrictions that will protect against the contamination of food, food-contact surfaces, and food packaging materials. In general terms, toxic pest control baits are normally laid externally and non-toxic baits for monitoring purposes are laid in the food processing and storage areas.
All food-contact surfaces, including utensils and food contact surfaces of equipment, should be cleaned as frequently as necessary to protect against contamination of food.
Surfaces and materials, in particular 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 favored material for these items, favored for its durability and easiness to clean. Wood tends to be avoided where possible due to its nature of harboring bacteria and tendency to chip and splinter posing the potential risk of physical contamination to the product. Seams on food-contact surfaces should be smoothly bonded or maintained to minimize the accumulation of food particles, dirt, and organic matter and thus minimize the opportunity for the growth of microorganisms.
Food contact surfaces used for manufacturing or holding low-moisture food should be in a dry, sanitary condition at the time of use. When the surfaces are wet-cleaned, they should, when necessary, be sanitized and thoroughly dried before subsequent use. Non-food-contact surfaces of equipment used in the operation of food plants 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 micro-organisms into food, all food-contact surfaces should be cleaned and sanitized before use and after any situation during which the food-contact surfaces may have become contaminated. Where equipment and utensils are used in a continuous production operation, the utensils and food-contact surfaces of the equipment must be cleaned and sanitized 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 should be handled, dispensed, used, and disposed of in a manner that protects against contamination of food or food-contact surfaces.
Sanitizing agents should be adequate and safe under conditions of use. Any facility, procedure, or machine is acceptable for cleaning and sanitizing equipment and utensils if it is established that the facility, procedure, or machine will routinely render equipment and utensils clean and provide adequate cleaning and sanitizing treatment.
Equipment and fittings in the manufacturing or food-handling area that do not come into contact with food should be so constructed that they can be kept in a clean condition. Holding, conveying, and manufacturing systems, including gravimetric, pneumatic, closed, and automated systems, should also be designed and constructed in such a way that enables them to be maintained in an appropriate sanitary condition.
Cleaned and sanitized equipment and utensils should be stored in a location and manner that protects food-contact surfaces from contamination, for example, hanging, shelved food contact side down, wrapped or covered.
Each freezer and cold storage compartment used to store food capable of supporting the growth of microorganisms should be fitted with an indicating thermometer, temperature-measuring device, or temperature-recording device for monitoring purposes.
Instruments and controls used for measuring, regulating, or recording 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.
Compressed air or other gases mechanically introduced into food or used to clean food-contact surfaces or equipment should be treated in such a way that food is not contaminated with unlawful indirect food additives.
It is important to define the requirements for any instance in which product is dropped, and contacts any non-food contact surface. A dropped product policy may include corrective actions for:
Consideration should not only be given to the potential for physical, biological, and chemical contamination of dropped products, but also for damage to the product which affects the quality of the product made available to consumers.
Raw materials and ingredients should be inspected and segregated or otherwise handled as necessary to ascertain that they are clean and suitable for processing into food and should be stored under conditions that will protect against contamination and minimize deterioration. Raw materials should be washed or cleaned as necessary to remove soil or other contamination. Water used for washing, rinsing, or conveying food should be safe and of adequate sanitary quality. Water may be reused for washing, rinsing, or conveying food if it does not increase the level of contamination of the food. Containers and carriers of raw materials should be inspected on receipt to ensure that their condition has not contributed to the contamination or deterioration of food.
Raw materials and other ingredients should either not contain levels of microorganisms that may produce food poisoning or other diseases in humans, or they should be pasteurized or otherwise treated during manufacturing operations so that they no longer contain levels that would cause the product to be adulterated within the meaning of the relevant food legislation. Compliance with this requirement may be verified by any effective means, including purchasing raw materials and other ingredients under a supplier’s guarantee or certification.
Raw materials and other ingredients susceptible to contamination with aflatoxin or other natural toxins should comply with current food regulations, and action levels for poisonous or deleterious substances before these materials or ingredients are incorporated into finished food. Compliance with this requirement may be accomplished by purchasing raw materials and other ingredients under a supplier’s guarantee or certification or may be verified by analyzing these materials and ingredients for aflatoxin and other natural toxins.
Frozen raw materials requiring thawing before use should be thawed in a manner that prevents other ingredients from being contaminated.
Liquid or dry raw materials and other ingredients received and stored in bulk form should be held in a manner that protects against contamination. Often items such as bulk grain, flour, and oils are kept in silos external to the facility. In these instances, consideration to product security should also be given.
When ice is used in contact with food or as an ingredient, it should be made from safe water that is of adequate sanitary quality.
Packaging and storage of food should be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, or the contamination of food. One way to comply with this requirement is careful monitoring of physical factors such as time, temperature, humidity, water activity, pH, pressure, flow rate, and manufacturing operations such as freezing, dehydration, heat processing, acidification, and refrigeration to ensure that mechanical breakdowns, time delays, temperature fluctuations, and other factors do not contribute to the decomposition or contamination of food. Compliance with this requirement may be accomplished by any effective means, including:
– Maintaining refrigerated foods at 5 Degrees Celsius or 40 Degrees Fahrenheit or below as appropriate for the particular food involved, frozen foods in a frozen state at -18 Degrees Celsius or 0 Degrees Fahrenheit and hot foods at 60 Degrees Celsius or 140 Degrees Fahrenheit or above. Work-in-progress should also be handled in a manner that protects against contamination;
Filling, assembling, packaging, and other operations should be performed in such a way that the food is protected against contamination. Compliance with this requirement may be accomplished by any effective means, including:
Food such as, but not limited to, dry mixes, nuts, intermediate moisture food, and dehydrated food, that relies on the control of water activity for preventing the growth of undesirable microorganisms should be processed to and maintained at a safe moisture level. Compliance with this requirement may be accomplished by:
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 of cross-contamination involves allergens, and usually occurs due to improper cleaning between production runs; this is more commonly known as Cross Contact for Allergens. Cross-contamination can be controlled within the food processing environment through effective and adequate cleaning and sanitizing procedures, along with staff participation in procedures implemented to reduce its occurrence. Controlling cross-contamination is critical where raw and ready-to-eat products are being prepared, and certain activities can minimize and eliminate its potential.
Signage is commonly used within all food industry sectors to promote food safety and quality, as well as occupational health and safety. Signage must be appropriately constructed and fitted, so as not to become a food hazard. It is generally accepted that signage should be constructed of flexible, waterproof, and cleaning chemical resistant materials. This excludes hard or brittle substances such as rigid plastic or Perspex, which may potentially enter foods as physical hazards.
When signage is referenced to procedures, policies, or other components of the documented food safety and quality systems, references should be made to the content of such. The relevant signage should be included within a register, for example, the document register, to ensure that the signage is amended whenever the associated policies or procedures are amended.
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.
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 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 and or self-adjusted 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 monitoring activities and record formats 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 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 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.
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:
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.
haccp.com was created to support food businesses and food industry professionals in achieving and maintaining the stringent requirements of food industry compliance.