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Primary Production

Applying Best Practice Concepts to Mitigate Primary Production Risk

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  • Development

To define detail, scope and purpose.

Development

This information can be used to develop food safety and quality programs that meet the requirements of modern Regulatory, Customer and Industry Standards:

  • We take the time to explain the expectations and requirements of food safety and quality compliance as these relate to your food safety and quality programs.
  • You may choose to use our Premium Resources to build, enhance or upgrade your food safety and quality program.
  • We encourage you to share this webpage with any food compliance associates and peers you believe may benefit from our commitment to providing our users with user friendly information and resources to a achieve superior Food Compliance Culture.
  • We welcome your suggestions for additions of general or specific content through the haccp.com Contact Page.

Key Definitions for Primary Production

  • Chemical Hazard: The danger posed to food safety by the contamination of food by chemical substances, such as pesticides, detergents, additives, and toxic metals.
  • Hazard Analysis Critical Control Point or HACCP: HACCP is a food safety methodology that relies on the identification of Critical Control Points in all stages of food business processes.
  • Preventative Maintenance: Preventative maintenance includes tasks performed on equipment, premises, and surroundings to prevent failure. It is a proactive process designed to prevent food safety and quality incidents. Preventative maintenance includes regular scheduled and procedurized inspection, cleaning, and replacement of worn parts, materials, and systems. Preventive maintenance helps to prevent parts, materials, and systems failure by ensuring they are in good working order.
  • Primary Production: The production of raw materials for consumption or further processing.
  • Reactive Maintenance: A form of maintenance in which equipment and facilities are repaired only in response to a breakdown or a fault.
  • Transport: Transport or transportation is the movement of items from one location to another.
  • Withholding Period: The time interval after the use of a chemical in or on foods before which the foods can be safely consumed.

Primary Production Development

When considering the development, documentation, and implementation of Primary Production within food safety and quality management systems, the following information should be considered to ensure effective outcomes:

About Primary Production

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.

Procedures must be developed, documented, and implemented to ensure a food business facilitating Primary Production does not introduce hazards into food consumption or further processing.

Primary Production Elements

It is important to consider the following elements in relation to maintaining appropriate Primary Production standards:

Primary Production Risk Management

It is important to consider the staff who are involved with the monitoring of primary production critical limits. They must be competent in all food safety-related activities involved and must be of sound ability to make objective judgments. Hazards present may include Chemicals, Foreign Objects, and Pathogenic microorganisms.
Primary production should be managed in a way that ensures that food is safe and suitable for its intended use. Where necessary, this should include:

  • Avoiding the use of geographical areas where the environment poses a threat to the safety of food;
  • Controlling contaminants, pests, and diseases of animals and plants in such a way as not to pose a threat to food safety;
  • Adopting practices and measures to ensure food is produced under appropriately hygienic conditions; and
  • Reducing the likelihood of introducing a hazard that may adversely affect the safety of food, or its suitability for consumption at later stages of the food chain.

The potential effects of primary production activities on the safety and suitability of food should be considered at all times. In particular, this includes identifying any specific points in such activities where a high probability of food contamination may exist, and taking specific measures to minimize that probability. The HACCP-based approach may assist in the management of such measures.

Primary producers should implement appropriate and effective measures to:

  • Control contamination from air, soil, water, feedstuffs, chemical, and natural fertilizers, pesticides, veterinary drugs, or any other agents or chemicals used in primary production;
  • Control plant and animal health so that it does not pose a threat to human health through food consumption, or adversely affect the suitability of the product; and
  • Protect food sources from fecal and other contamination.

In particular, care should be taken to manage waste and store harmful substances such as agricultural chemicals appropriately. On-farm programs that achieve specific food safety goals have become a valuable element of primary production.

Primary Production Environment

Specific consideration must be given to the environments used for primary production – Specifically related to the identification and control of potential hazards. Factors for consideration may include:

  • The potential for raw sewage to flow onto or into primary production areas;
  • Any previous chemical applications within the bounds, or around current or proposed primary production sites; and
  • The capability of the primary production, and associated processing sites to withstand environmental issues such as flooding.

Detailed risk assessments should be documented to demonstrate how these elements have been considered in each Primary Production scenario.

If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Primary Production requirements in relation to their items.

Primary Production Development Key Points

  • Primary Production programs must be developed to meet relevant Regulatory, Industry, and Customer standards and requirements;
  • The Senior Management of your business facilitate a commitment to ensuring adequate resources to the development of your Primary Production program;
  • Should you require additional resources for the development of Primary Production program elements, please discuss this with the relevant Senior Management representative;
  • A properly developed Primary Production program will provide a strong framework for your business to maintain compliance with relevant Regulatory, Industry, and Customer standards and requirements;
  • A poorly-developed Primary Production program will not fully support your business and may contribute to significant non-compliance against Regulatory, Industry, and Customer standards and requirements.
  • Documentation

To establish the developed detail in a viewable format to facilitate information.

Documentation

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 Primary Production:

  • Primary Production policy;
  • Primary Production development procedures;
  • Primary Production implementation procedures and work instructions;
  • Primary Production monitoring procedures;
  • Primary Production corrective and preventative action procedures;
  • Primary Production verification schedule;
  • Primary Production verification procedures;
  • Primary Production validation schedule;
  • Primary Production validation procedures;
  • Primary Production training procedures.

If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Primary Production Documentation requirements in relation to their items.

You may wish to visit the Primary Production Templates section of haccp.com for examples of Primary Production documentation, record, and resource formats commonly applied within food safety and quality systems.

Primary Production Documentation Key Points

  • Primary Production programs must be documented to meet relevant Regulatory, Industry, and Customer standards and requirements;
  • All documented Primary Production program elements must be controlled to ensure compliance;
  • Key documented Primary Production program elements should be available to your business team at all times to ensure they can facilitate required tasks;
  • A properly documented Primary Production program will provide a strong framework for your business to maintain compliance with relevant Regulatory, Industry, and Customer standards and requirements;
  • A poorly documented Primary Production program will not fully support your business and may contribute to significant non-compliance against Regulatory, Industry, and Customer standards and requirements.
  • Implementation

To facilitate the application of the documentation.

Implementation

Implementation: Implementation is the application of documented food safety and quality system elements into the actual business operation.

The implementation of Primary Production 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 Primary Production do not negatively impact the safety and quality of the food items dispatched from the business.

Implementation of Primary Production 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 Primary Production within a food safety and quality system, you may wish to consider the following requirements before completion:

  • Communication and display of the Primary Production policy;
  • Completion of Verification and Validation of Primary Production development procedures;
  • Availability of Primary Production implementation procedures and work instructions;
  • Availability of Primary Production monitoring procedures and record templates (where applicable);
  • Availability of Primary Production corrective and preventative action procedures and record templates (where applicable);
  • Availability of the Primary Production verification schedule;
  • Availability of Primary Production verification procedures;
  • Availability of the Primary Production validation schedule;
  • Availability of Primary Production validation procedures;
  • Completion of Primary Production training procedures;
  • Completion of product design and development requirements related to Primary Production;
  • Completion of process design and development requirements related to Primary Production;
  • Completion of training for team members who have responsibilities and involvement within Primary Production;
  • Completion of competency approval for team members who have responsibilities and involvement within Primary Production.

If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Primary Production Implementation requirements in relation to their items.

Primary Production Implementation Key Points

  • Primary Production programs must be Implemented to meet relevant Regulatory, Industry, and Customer standards and requirements;
  • Your Primary Production program must be fully implemented as per relevant documented Policies, Procedures, and Work Instructions;
  • The implementation of Primary Production requires a commitment to the provision of resources by the Senior Management of your business;
  • A properly implemented Primary Production program will provide a strong framework for your business to maintain compliance with relevant Regulatory, Industry, and Customer standards and requirements;
  • A poorly implemented Primary Production program will not fully support your business and may contribute to significant non-compliance against Regulatory, Industry, and Customer standards and requirements.
  • Monitoring

To review, confirm and document evidence of the implementation against documented limits.

Monitor

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 Primary Production 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 Primary Production:

  • Receival Records: Receival records are commonly maintained to include details of batches or lots of items received. These recorded batch or lot numbers can be used to assist in traceability activities.
  • Primary Production Records: Primary Production records commonly contain details of the batch or lot of items as they are used.
  • Chemical Records: A chemical application log, also known as a spray record, is used to record the application of chemicals, and most importantly, their withholding periods.
  • Packaging Records: Packaging records are commonly inclusive of the identification and traceability details of items being packaged, along with the finished packaged product batch or lot coding.
  • Dispatch Records: Dispatch records commonly include details of the customer to which finished packaged items are destined. Record formats are commonly inclusive of the batch or lot details of the product being dispatched.

If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Primary Production Monitoring requirements in relation to their items.
You may wish to visit the Primary Production Templates section of haccp.com for examples of Primary Production documentation, record, and resource formats commonly applied within food safety and quality systems.

Primary Production Monitoring Key Points

  • Monitoring provides real-time confirmation and evidence that your risk-based FS&Q Controls are effectively implemented;
  • Primary Production programs must be monitored to meet relevant Regulatory, Industry, and Customer standards and requirements;
  • Monitoring of Primary Production must be facilitated as per relevant documented Policies, Procedures, and Work Instructions;
  • Nominated monitoring records for Primary Production must be maintained as per relevant documented Policies, Procedures, and Work Instructions;
  • A properly monitored Primary Production program will provide a strong framework for your business to maintain compliance with relevant Regulatory, Industry, and Customer standards and requirements;
  • A poorly monitored Primary Production program will not fully support your business and may contribute to significant non-compliance against Regulatory, Industry, and Customer standards and requirements.
  • Corrective Action and Preventative Action

To apply “real time” interventions to documented monitoring limits.

Corrective Action and Preventative Action

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, preventive action must be put into place to prevent re-occurrence.
Corrective Action and Preventative Action are implemented to ensure identified non-conformances are documented, investigated, and rectified within appropriate timeframes.
Corrective action is any action applied to regain control over a product, process, policy, or procedure that has been identified as being non-conforming 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 Primary Production related non-conformances:

  • Review of the Primary Production policy;
  • Review of Primary Production development procedures;
  • Review of Primary Production implementation procedures and work instructions;
  • Review of Primary Production monitoring procedures;
  • Review of Primary Production corrective and preventative action procedures;
  • Review of the Primary Production verification schedule;
  • Review of Primary Production verification procedures;
  • Review of the Primary Production validation schedule;
  • Review of Primary Production validation procedures;
  • Review of Primary Production training procedures;
  • Re-training in Primary Production;
  • Review of management review activities to include Primary Production as an agenda item;
  • Initiation of ‘product hold’ procedures where safety or quality may be compromised;
  • Initiation of a product recall or product recall procedures where investigations show that there is a substantial safety and or quality risk to the released product;
  • Contacting stakeholders including customers regarding any confirmed or potential Primary Production concerns involving their product.

If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Primary Production 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.

Primary Production Corrective Action and Preventative Action Key Points

  • The implementation of Corrective Action and Preventative Action provides confidence that your FS&Q Program is effectively implemented and that FS&Q criteria are being met;
  • Where deviations or variations are observed, Corrective Action and Preventative Actions must be facilitated to meet relevant Regulatory, Industry, and Customer standards and requirements;
  • Corrective Action and Preventative Action of Primary Production must be facilitated as per relevant documented Policies, Procedures, and Work Instructions;
  • Records of Corrective Action and Preventative Action must for Primary Production be maintained per relevant documented Policies, Procedures and Work Instructions;
  • Proper application of Corrective Action and Preventative Action for your Primary Production program will provide a strong framework for your business to maintain compliance with relevant Regulatory, Industry, and Customer standards and requirements;
  • Poor application of Corrective Action and Preventative Action for your Primary Production program will not fully support your business and may contribute to significant non-compliance against Regulatory, Industry, and Customer standards and requirements.
  • Verification

To review and confirm documented monitoring and corrective actions against documented parameters.

Verify

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-conformances are identified and rectified within an appropriate timeframe. When non-conformances 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 Primary Production:

  • Review of the Primary Production policy;
  • Review of Primary Production development procedures;
  • Review of Primary Production implementation procedures and work instructions;
  • Review of Primary Production monitoring procedures;
  • Review of Primary Production monitoring records;
  • Review of Primary Production corrective and preventative action procedures;
  • Review of the Primary Production verification schedule;
  • Review of Primary Production verification procedures;
  • Review of the Primary Production validation schedule;
  • Review of Primary Production validation procedures;
  • Review of Primary Production training procedures;
  • Review of Primary Production performance since the last review and historically;
  • Analytical testing of product or process to ensure the effectiveness of Primary Production;
  • Inclusion of Primary Production as an agenda item within the Management Review Process.

If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Primary Production 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.

Primary Production Verification Key Points

  • Your verification program provides evidence that your FS&Q Controls have worked;
  • Primary Production programs must be verified to meet relevant Regulatory, Industry, and Customer standards and requirements;
  • The verification of Primary Production must be facilitated as per relevant documented Policies, Procedures, and Work Instructions;
  • Nominated verification records for Primary Production must be maintained as per relevant documented Policies, Procedures, and Work Instructions;
  • A properly verified Primary Production program will provide a strong framework for your business to maintain compliance with relevant Regulatory, Industry, and Customer standards and requirements;
  • A poorly verified Primary Production program will not fully support your business and may contribute to significant non-compliance against Regulatory, Industry, and Customer standards and requirements.
  • Validation

To confirm the documented monitoring or procedural limits.

Validate

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 inappropriate limits of control or acceptability are identified and rectified within an appropriate timeframe. When non-conformances 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 Primary Production:

  • Confirmation of nominated food safety and food quality control limits for Primary Production. These limits may apply to regulatory, industry, customer, or finished product specifications;
  • Confirmation of analytical testing methods being used to confirm the effectiveness of Primary Production and ensure the accuracy of outcomes.

If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Primary Production 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.

Primary Production Validation Key Points

  • Your validation program provides evidence that your FS&Q Controls will work;
  • Primary Production programs must be validated to meet relevant Regulatory, Industry, and Customer standards and requirements;
  • The validation of Primary Production must be facilitated as per relevant documented Policies, Procedures, and Work Instructions;
  • Nominated validation records and supporting documentation for Primary Production must be maintained as per relevant documented Policies, Procedures, and Work Instructions;
  • A properly validated Primary Production program will provide a strong framework for your business to maintain compliance with relevant Regulatory, Industry, and Customer standards and requirements;
  • A poorly validated Primary Production program will not fully support your business and may contribute to significant non-compliance against Regulatory, Industry, and Customer standards and requirements.
  • Training, Competency and Resources

Skills, knowledge and competency requirements to facilitate development, documentation, implementation, monitoring, corrective action, verification and validation of every Food Safety and Quality System Element.

Skills and Knowledge

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 Primary Production must be ongoing, including regularly scheduled reviews to ensure the effectiveness of training and competency outcomes.

Team members who have defined responsibilities regarding Primary Production should have knowledge including:

  • Basic Primary Production requirements;
  • Positive outcomes of Primary Production;
  • Negative outcomes of a lack of Primary Production;
  • Current Primary Production procedures, methods, and techniques;
  • General operational, corporate, and social awareness regarding Primary Production;
  • Regulatory, industry, and customer requirements regarding Primary Production.

Team members who have defined responsibilities regarding Primary Production should have skills including:

  • Competency regarding basic Primary Production;
  • Effective application of current Primary Production procedures, methods, and techniques;
  • The basic development, documentation, and implementation of HACCP and Pre-requisite Programs within the food industry sector.

Team members who have defined responsibilities regarding Primary Production should have access to resources including:

  • Primary Production training;
  • Primary Production associations and events;
  • Regulatory standards, industry and customer information and updates regarding Primary Production;
  • Incidents within the food industry sector regarding Primary Production;
  • Commitment to Primary Production by senior management;
  • Suitably qualified food industry professionals with verified experience in Primary Production;
  • Effective communication systems including email, internet, and phone through which Primary Production information can be sent and received within suitable timeframes.

If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Primary Production 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.

Primary Production Training, Skills, and Knowledge Key Points

  • Your Training, Skills, and Knowledge program ensures all participating personnel, visitors, and contracted have the required skills and knowledge to effectively facilitate the requirements of your FS&Q Program;
  • Training, Skills, and Knowledge programs for Primary Production must be facilitated to meet relevant Regulatory, Industry, and Customer standards and requirements;
  • Training, Skills and Knowledge programs for Primary Production must be facilitated as per relevant documented Policies, Procedures, and Work Instructions;
  • Training, Skills, and Knowledge records for Primary Production must be maintained as per relevant documented Policies, Procedures, and Work Instructions;
  • Properly applied Training, Skills, and Knowledge programs for Primary Production will provide a strong framework for your business to maintain compliance with relevant Regulatory, Industry, and Customer standards and requirements;
  • Poorly applied Training, Skills, and Knowledge programs for Primary Production will not fully support your business and may contribute to significant non-compliance against Regulatory, Industry, and Customer standards and requirements.
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