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 Site and Supply Chain Biosecurity within food safety and quality management systems, the following information should be considered to ensure effective outcomes:
Site and Supply Chain Biosecurity must be risk assessed, controlled, and monitored on an ongoing basis to ensure appropriate outcomes are maintained. HACCP Risk Assessments are commonly used to identify specific potential hazards that may result from a lack of control in Site and Supply Chain Biosecurity. Hazards such as Pests, Diseases, and Invasive Species are commonly considered as part of Biosecurity Risk Assessments.
What is at stake from poor Biosecurity Controls? The outcomes of poor Biosecurity Controls may include:
Despite the complexity and broad spectrum of potential Biosecurity Hazards, many quick and simple methods can be applied to reduce risk:
The restriction and control of access are some of the most critical elements in maintaining effective and efficient Site and Supply Chain Biosecurity programs. Potential security measures may include perimeter controls through the use of fencing, gates, guard stations, and key card or radio frequency emitting device access. All entryways, windows, vents, and delivery docks should be secured. Exterior lighting and closed-circuit camera systems may also be used to support outcomes.
If you are aware of general or specific Site and Supply Chain Biosecurity hazards, these should be communicated to relevant persons clearly and concisely. Such communications should be formally managed to ensure they reach their intended targets. Contemporary Site and Supply Chain Biosecurity systems may include the digital dissemination of known Biosecurity risk.
It is also important that some biosecurity hazards are legally obliged to be communicated to Regulatory Authorities where they are observed. Failure to comply with this requirement may potentially result in a Regulatory Breach which could have further business impacts.
General and specific Site and Supply Chain Biosecurity Signage should be used to continually promote awareness of risk. This may include additional signage where known biosecurity risks are evident.
Where the transport of sensitive materials is involved, Signage may also include prescribed Regulatory or Industry Documentation for the movement of such items. For example, ‘Transfer Certificates’ may be required for the movement of sensitive materials from one geographical area to another.
It is paramount to food safety that visitors and contractors behave and conform appropriately when interacting with any part of the food supply chain. Any visitors and contractors and their actions are the responsibility of business management.
Visitors and contractors entering a risk area should, where appropriate, wear protective clothing and adhere to the other hygiene provisions within this section. A policy to this effect should be documented, and a copy provided to each contractor and visitor before entering the site.
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.
It is generally considered standard practice for visitors and contractors to be signed in to a site and be identified by an appropriate badge. Visitors may also be required to review documented materials relating to biosecurity before admission to critical areas of operations. 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 disposable jumpsuit. 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.
Entry and Exit provisions for Biosecurity Risk scenarios may include:
Where ‘hygiene’ maintenance is required for entry and exit, appropriately constructed and maintained facilities and amenities must be provided at all times commensurate with Biosecurity Risk.
Visitor and Contractor Training
For higher-risk scenarios, 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. This is particularly important where, for example, maintenance contractors are used ‘long term’ and are permitted to work unaccompanied within biosecurity risk areas. 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.
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Site and Supply Chain Biosecurity 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 Site and Supply Chain Biosecurity:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Site and Supply Chain Biosecurity Documentation requirements in relation to their items.
You may wish to visit the Site and Supply Chain Biosecurity Templates section of haccp.com for examples of Site and Supply Chain Biosecurity 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 Site and Supply Chain Biosecurity 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 Site and Supply Chain Biosecurity do not negatively impact the safety and quality of the food items dispatched from the business.
Implementation of Site and Supply Chain Biosecurity 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 Site and Supply Chain Biosecurity within a food safety and quality system, you may wish to consider the following requirements before completion:
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 Site and Supply Chain Biosecurity 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 Site and Supply Chain Biosecurity 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 Site and Supply Chain Biosecurity:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Site and Supply Chain Biosecurity Monitoring requirements in relation to their items.
You may wish to visit the Site and Supply Chain Biosecurity Templates section of haccp.com for examples of Site and Supply Chain Biosecurity 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 in relation 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 is 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 Site and Supply Chain Biosecurity Plans and the food business certification process.
Below are Corrective Action and Preventative Action examples which may be associated with Site and Supply Chain Biosecurity related non-conformance:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Site and Supply Chain Biosecurity 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, Site and Supply Chain Biosecurity 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 Site and Supply Chain Biosecurity:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Site and Supply Chain Biosecurity 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, Site and Supply Chain Biosecurity 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 Site and Supply Chain Biosecurity:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Site and Supply Chain Biosecurity 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 specific job-related task.
Training and competency requirements for Site and Supply Chain Biosecurity must be ongoing, including regular scheduled reviews to ensure the effectiveness of training and competency outcomes.
Team members who have defined responsibilities regarding Site and Supply Chain Biosecurity should have knowledge including:
Team members who have defined responsibilities regarding Site and Supply Chain Biosecurity should have skills including:
Team members who have defined responsibilities regarding Site and Supply Chain Biosecurity 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 Site and Supply Chain Biosecurity 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.