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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 High-Care Management within food safety and quality management systems, the following information should be considered to ensure effective outcomes:
The terms High-Care and High-Risk are often used in conjunction with each other. The two terms are similar in their applications into food businesses; the main difference between the two is the fact that High-Risk is slightly elevated; High-Risk aims to prevent product contamination by pathogenic micro-organisms; High-Care aims to minimize product contamination by pathogenic micro-organisms.
High-Care systems and premises rely on heightened levels of food safety management to achieve the anticipated outcomes of safe foods and rely on the effective development, documentation, and implementation of pre-requisite programs that are genuinely maintained on an ongoing basis. Because of the very realistic potential public health risks that can occur from contaminated High-Care foods, the premises, equipment, and surroundings must be constructed and maintained most appropriately.
Products intended to be consumed as Ready to eat (RTE) or Ready to reheat (RTRH) need to be manufactured within facilities that have specialized controls for microbiological safety. The requirements for High-Care production facilities should embody the true representation of the Food Industry ‘Best Practice’, as this mitigates risk for consumers, and by proxy, for the businesses manufacturing such products.
Ready-to-eat products are relevant for the application of High-Care practices due to their status. Ready to reheat items are relevant as consumers may not always follow instructions for storage and use, which can very realistically result in foodborne illness.
Procedures for product design and development must be developed, documented, and implemented to ensure the process yields appropriate outcomes. The product design and development should include structured consideration of HACCP, production trials, specifications, packaging, labeling, and shelf-life consideration for microbiological, chemical, physical, and organoleptic parameters including challenge testing where applicable.
It is important to consider within any Product Design and Development flow process that applications will need to be applied in a logical sequence. Each stage of the Product Design and Development process contains a set of prescribed and concurrent activities incorporating industry best practices. The activities during a stage are generally anticipated to be applied in parallel, not in sequence. This ensures that they are carried out quickly and effectively. Process stages must be cross-functional to allow all areas of the food business to contribute.
When considering the implementation of Product Design and Development elements for High-Care processes and products, additional emphasis must be placed on the microbiological status of raw materials. This is because the management of microbiological risks within a High-Care scenario relies heavily on the assumption of microbiological limits of process inputs. A lack of consideration of raw material microbiological status can very realistically result in a significant microbiological non-conformance.
As with any risk-based activity, implemented Product Design and Development protocols need to follow the established steps, including Development, Documentation, Implementation, Monitoring, Corrective Action, Verification, Validation, and Skills and Knowledge.
The physical facilities and structure of a food establishment must be properly designed, constructed, installed, operated, and maintained to allow the receival, storage, production, and dispatch of safe food. The design and construction of the premises and the items within it have a direct link to the control of the entry of pests and potentially their harborage and ability to cause contamination of processes or products. The design and construction of premises and equipment are also directly related to the control of cross-contamination by staff and visitor traffic flows, process flows and waste flows.
Many factors are important to premises and equipment design being supportive of food safety including:
The internal and external design and layout of food establishments should permit good food hygiene practices, including protection against cross-contamination during and between food production operations. This may include a defined one-way product flow, the segregation between high and low-risk areas, and entry to High-Care areas via specially designated and managed-to-change facilities.
Sanitary facilities such as toilets should not be adjoined to operational areas within any food business. As a minimum, a double door and airlock between the sanitary facilities and low-risk production areas would be acceptable.
Adequate suitably designed and constructed facilities should be provided for cleaning food utensils and equipment. Such facilities should have an adequate supply of hot and cold potable water where required.
High-Care ‘zones’ within a Food Business usually refer to the areas of the site flow process following a microbiological reduction. High-Care based controls are implemented until the foodstuff is fully packaged. Items that undergo a final microbiological kill step or microbiological reduction step while contained within their fully sealed packaging may not be classed as High-Care.
It is generally considered best practice for High-Care ‘processes’ to be identified as such within HACCP documentation, such as the process flow diagram. High-Care ‘zones’ should also be clearly defined within site floor plans and layouts.
Where a food business cannot fully meet the expectative requirements for the design and construction of High-Care areas and facilities, the business must provide substantial evidence of effective, validated implementation of microbiological controls.
In most cases, the requirements for High-Risk scenarios are generally considered to be more effective and controllable for microbiological growth and contamination risk to products and processes. In this context, High-Risk applications may apply to a High-Care scenario, but not the opposite. For example, High-Risk status food items may be used within a High-Care area as they have had a higher level of microbiological intervention, whereas High-Care status food items require additional considered controls to be implemented to control related risks.
The methods and facilities implemented for transferring items to and from High-Care areas require significant risk assessments to ensure they are effective in controlling microbiological risk. These may be implemented to include methods:
In cases where equipment requires settings for the transfer of items from lower risk to High-Care areas, it is preferable that such settings can only be controlled from the lower or higher risk area. Where the systems implemented transfer items from lower risk to High-Care areas, for example, through a wall, cleaning should be able to be facilitated from both sides. Consideration must also be given to ensuring adequate and effective storage and work-in-progress facilities within the High-Care area, for items transferred into that area, particularly for rapid cooling and temperature where spore-forming pathogens may be an issue. Validation and verification activities for transfer methods are required on an ongoing basis to ensure the effective implementation of microbiological controls. Post heat treatment cooling temperature and time frame profiles must meet legal and product-specific requirements.
Above and beyond the construction and design requirements of all food businesses, sites facilitating High-Care processes and products require additional facilities and functions to ensure microbiological risks are controlled. Examples of High-Care design and construction considerations are provided as follows:
Cleaning and Sanitation applications within High-Care areas may require additional attention to detail to ensure outcomes meet expectative requirements. These are some examples of additional considerations for High-Care scenarios:
Appropriate Cleaning and Sanitizing procedures, in their planning and application, will reduce the risk of cross-contamination of product or process.
Factors in the ability of Cleaning and Sanitation applications to reduce cross-contamination include:
Documented cleaning and sanitation procedures need to be in place to monitor and control related issues. This documentation must outline the boundaries that need to be addressed in ensuring safe and quality food production. Cleaning and sanitation procedures need to be developed, documented, and implemented for all areas of consequence to food safety and quality.
Where written cleaning schedules and procedures are used, they should specify:
Where appropriate, Cleaning and Sanitation programs should be formatted in consultation with relevant specialist expert advisors, including your Cleaning and Sanitation chemical suppliers where applicable.
The use of appropriate uniforms is important to any food business. Uniforms including protective clothing, footwear, and headwear should be provided where applicable to ensure the control of hazards. Best practice for food production relies on uniforms being:
Aprons and overalls should be changed daily or more frequently if deemed unhygienic. They should be removed and hung in a designated area whenever the wearer leaves the food production area, in particular when going to the toilet or for a break.
It is important that the laundering, handling, and storage of uniforms is defined within documented procedures to ensure control over related hazards. This may take the form of ensuring uniform suppliers or service providers are included within the approved supplier program, their laundering chemicals are food industry approved, and that their procedures for laundering are suitable and effective.
In High-Care scenarios, laundering processes need to be supported by verification and validation activities to ensure appropriate levels of compliance are maintained. Ideally, laundered uniforms for delivery to High-Care applications should be protected from contamination, for example, within a sealed sanitary plastic bag.
High-Care processes involve the use of components that may be raw, or that have not undergone the equivalent of a ‘Heat Based’ Microbiological Reduction step. In this context, where such items are transferred for use into a High-Care environment, confidence in the microbiological safety of the item must be based on rational risk assessments conducted by a technically competent individual or team.
The criteria used for these risk assessments must directly address the specific microbiological hazards associated with each raw material. Raw material specifications should also be referenced as part of this process, particularly regarding microbiological status and pathogens specific to each assessed raw material.
Outcomes of such Risk Assessments should be fully documented and be included within ongoing reviews of raw materials and approved supplier processes. Validation and verification documentation should also be maintained to support risk assessment outcomes.
These risk assessment activities must be undertaken and finalized as part of product design and development processes, well before production trials or even receipt of any raw material. This will ensure the integrity of the product design and development process in identifying and controlling potentially significant microbiological breaches.
When considering the frequency and scope of monitoring of incoming raw materials, it is important to ensure implementations for High-Care materials are implemented in a manner that facilitates an appropriate consideration of risk. In many cases, due to the enhanced risk associated with non-heat-treated items being used within High-Care scenarios, such items should undergo more scrutiny as elements of receival and pre-use inspections. Enhanced scrutiny may include:
The food industry produces a large number of by-products or waste, which must be disposed of or recycled. Food businesses create several types of waste; the appropriate handling and management of which is essential to prevent cross-contamination of the foodstuffs being handled by the business.
Suitable provision must be made for the removal and storage of all waste variants that occur as a consequence of operating any food business. Waste must not be allowed to accumulate in food handling, storage, or other operational working areas and the adjoining environment except so far as is unavoidable for the proper functioning of the food business. Waste storage, processing, and handling areas must be kept appropriately clean and sanitized. Waste and Recyclables Management systems should be monitored for effectiveness and periodically verified by methods such as pre-operational inspections or, where appropriate, microbiological sampling of the operational environment.
High-Care applications require special measures for the prompt removal of waste, recyclable materials, and other items that may otherwise impact microbiological controls. Waste removal from High-Care areas is commonly facilitated through the use of hatches, interlock or airlock doors, or designated transfer conveyors.
To avoid the additional risk of contamination, waste receptacles should be captive to their designated area of use based on risk. This means that waste bins, tubs, and containers must remain within the areas in which they are used. These items should not be taken out of such areas, without the application of a validated, effective cleaning and sanitation process that does not increase the risk of microbial contamination within the High-Care area to where they are to be used. Similarly, new items should also be subjected to validated, effective cleaning and sanitation processes before entry to High-Care areas.
It is important to consider that waste by definition may also include items such as out-of-specification products, which may need to be held until a decision is made regarding their disposal.
The incorrect application of Waste and Recyclables Management within any food business may pose a risk of cross-contamination and compromise the production of safe food. It is also important to consider that the lack of appropriate applications of Waste and Recyclables Management within a food business can also negatively impact the effectiveness of other business systems such as pest and vermin control. Inappropriately handled and managed waste and recyclables, particularly around the exterior of food premises can harbor and sustain pest presence, which may lead to issues within the site.
Due to the enhanced risk of non-compliance within High-Care scenarios, all people entering and interacting with such areas must be appropriately trained and deemed competent within the required skill and knowledge requirements. The application of training and competency should cover elements not only for operational aspects but also for tasks such as Entry and Exit and Transfer to and from High-Care areas.
Food handlers involved in any stage of food production should receive sufficient training in hygienic food handling practices and personal hygiene. Some of the most successful approaches to obtaining task-related skills and knowledge include:
It is the responsibility of management to ensure that all employees are fully aware of food safety and food hygiene practices that are important to their job in the food business.
The use of chemicals within any food business must include elements that not only promote food safety but which also promote the general safe use, handling, and storage of all cleaning, sanitation, pest control, maintenance, and other chemicals. This can generally be facilitated by ensuring documented procedures for chemical control are documented and available to everyone using chemicals.
Chemical usage procedures may include:
A minimum of a basic understanding of Food Microbiology Management is an elemental requirement for food industry personnel who participate in the development, implementation, and review of HACCP plans and finished product testing among other food safety and quality management system elements. This ensures that relevant microbiological hazards are effectively controlled and do not impact the safety or quality of finished food products.
Pathogens can be transferred from one food to another, either by direct contact or by food handlers, contact surfaces, or the air. Raw, unprocessed food should be effectively separated, either physically or by time, from ready-to-eat foods, with effective intermediate cleaning and where appropriate disinfection. Access to processing areas may need to be restricted or controlled. Where risks are particularly high, access to processing areas should be only via a changing facility. Personnel may need to be required to put on clean protective clothing including footwear and wash their hands before entering. Surfaces, utensils, equipment, fixtures, and fittings should be thoroughly cleaned and where necessary disinfected after raw food, particularly meat and poultry, has been handled or processed.
It is paramount to food safety that visitors and contractors behave appropriately when visiting a food manufacturing business. Any visitors and contractors on the premises and their actions are the responsibility of the management.
Visitors and contractors entering a food manufacturing, processing or handling area should, where appropriate, wear protective clothing and adhere to the other personal hygiene provisions in this section. A policy to this effect should be documented, and a copy provided to each contractor and visitor before entering the site.
It is generally considered standard practice for visitors and contractors to be signed into a food business and identified by an appropriate badge. Visitors may also be required to review documented materials relating to food safety and workplace health and safety before admission to critical areas of operation. Depending on the purpose of the visit, visitors, contractors and internal staff not attired appropriately may be required to wear a hygienic outer covering such as a fresh lab coat or full uniform while visiting food production areas. Visitors and contractors should be accompanied by an authorized staff member at all times unless they have conducted appropriate induction training and have passed established medical and security screening protocols.
As elements of established site security protocols, employees of the business should be encouraged through specified training to challenge anyone seen within operational areas of the site if they are not appropriately identified or accompanied by an authorized person.
For higher-risk or larger food businesses, it is common for a Visitor and Contractor induction process to be developed, documented, and implemented to ensure the ongoing compliance of Visitors and Contractors to the food business. This is particularly important where, for example, maintenance contractors are used long-term and are permitted to work unaccompanied within operational areas of the food business. In this context, it is important to consider that Visitors and Contractors, though they are expected to comply with the standard policies and procedures, may not appreciate their legal responsibilities in meeting such requirements.
In instances where, for example, maintenance contractors are used ‘long term’, it is also common for re-induction to be scheduled, conducted, and recorded to ensure ongoing compliance with the nominated Visitor and Contractor requirements.
It is also common for labor hire companies to conduct relevant training and induction processes on behalf of the company to which they will provide temporary staff. In this case, it is important that a food business that is using labor supplied through a company responsible for relevant and induction training to verify and validate the facilitation and outcomes of such activities. This is commonly considered as an element of the approved supplier of service provider programs.
An adequate supply of potable water with appropriate facilities for its storage, distribution, and temperature control, should be available whenever necessary to ensure the safety and suitability of food. Potable water is a water source that meets the analytical criteria of the most recent edition of World Health Organization Guidelines for Drinking Water Quality, or water of a prescribed higher standard. Water used within food businesses must meet the potability standards of the countries in which the associated food products are processed and sold. Non-potable water for use in fire control, steam production, refrigeration, and other similar purposes where it would not contaminate food should have a separate controlled system. Non-potable water systems should be identified and should not connect with, or allow contact into potable water systems. Chemical additives for such systems should also be of an approved food grade where applicable.
Only verified potable water, should be used in food handling and processing applications, with the following exceptions:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific High-Care Management 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 High-Care Management:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific High-Care Management Documentation requirements in relation to their items.
You may wish to visit the High-Care Management Templates section of haccp.com for examples of High-Care Management 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 High-Care Management 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 High-Care Management do not negatively impact the safety and quality of the food items dispatched from the business.
Implementation of High-Care Management 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 High-Care Management 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 High-Care Management 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 High-Care Management 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 High-Care Management:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific High-Care Management Monitoring requirements in relation to their items.
You may wish to visit the High-Care Management Templates section of haccp.com for examples of High-Care Management 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 to 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 High-Care Management related non-conformance:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific High-Care Management 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 High-Care Management:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific High-Care Management 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 High-Care Management:
– Confirmation of nominated food safety and food quality control limits for High-Care Management. These limits may apply to regulatory, industry, customer, or finished product specifications;
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific High-Care Management 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 High-Care Management must be ongoing, including regularly scheduled reviews to ensure the effectiveness of training and competency outcomes.
Team members who have defined responsibilities regarding High-Care Management should have knowledge including:
Team members who have defined responsibilities regarding High-Care Management should have skills including:
Team members who have defined responsibilities regarding High-Care Management 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 High-Care Management 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.