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 Product Design and Development within food safety and quality management systems, the following information should be considered to ensure effective outcomes:

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, labelling and shelf life consideration for microbiological, chemical, physical and organoleptic parameters including challenge testing where applicable.
Further information on regulatory requirements can be found within the haccp.com HACCP: Regulatory Hazards Management Food Standard Element.
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.

For best outcomes, each stage of the Product Design and Development process following the idea stage can be preceded by a gate. Gates are the points in the process where a decision must be made. The gatekeepers can choose to Proceed, Kill, Hold, or Rework the project.
Gates are in effect quality control checkpoints which should highlight answers to the following questions:
This is where project prioritisation and resource allocation decisions are made. At the end of a gate meeting, a decision must be reached. If the decision is to Proceed, this confirms resource commitments and support from management.
Gatekeepers are the team of senior management who make decisions to Proceed, Kill, Hold, or Rework the project at gates. For most positive outcomes, gatekeepers should be from a different functional area, and have the authority to commit financial and human resources to the project. A predetermined set of criteria is applicable to each gatekeeper to ensure fair outcomes.

The seven most common sequential stages of the Product Design and Development Process are as follows:
1. The Idea Stage
The idea stage is also commonly known as the Initial stage. This is where your food business identifies requirements for resources such as equipment, technical specialists, capability to meet regulations, testing and analysis resources. The decision to proceed with the idea is also generally made at this stage once the relevant considerations have been assessed with positive outcomes.
2. The Concept Stage
The concept stage is also commonly known as the Business Case stage. This is where a detailed description of the food product is documented. Peripheral requirements such as testing and analysis procedures and targets are defined, along with an assessment of the target markets to ensure the project is commercially viable.
3. The Prototype Stage
The prototype stage is also commonly known as the Development stage. This is where a product sample or prototype is produced, including the defining and documentation of process stages required to achieve the intended finished product. It is also at this stage that the HACCP system and quality controls are first implemented as a method of reviewing product realisation capability. Labelling and packaging design is also started within this stage of the process, along with other risk or commercial risk assessments to ensure the viability of the project.
4. The Pilot Production Stage
The pilot production stage is also commonly known as the “Implementation” stage. This is where the preliminary production system is finalised, along with the finished product parameters. This stage also involves the critical task of validating production systems to ensure appropriate outcomes. Regulatory approvals are often also facilitated at this stage. Business commercial realisation details are also completed at this stage. Further information can be found within the haccp.com Process Control Management Food Standard Element.
5. The Market Production Stage
The Market Production Stage is also commonly known as the Actual Production stage. This is where the production of actual product begins within the established facility. Product to be supplied into the marketplace is generally re-validated to ensure the anticipated parameters have been met. Commercial viability is also often re-confirmed at this stage.
6. The Launch Stage
The launch stage is also commonly known as the Product Realisation stage. This is where the implemented process is fine-tuned to ensure the product specifications can be met on an ongoing basis. Cost efficiencies are also generally reviewed at this stage. Marketing plans are finalised and implemented.
7. The Post Launch Review
The post launch review is also commonly known as the Product Design and Development Review stage. This is where the food business reviews all aspects of the project scope and purpose outcomes. Outcomes of process and product performance against specifications are reviewed, along with non-conformance issues or identified opportunities for improvements within the Product Design and Development Process.
Questions considered within the post launch review may include:
A common application within all of these stages is to designate specific tasks, responsibilities and outcomes for:
At the completion of each stage of the Product Design and Development process, a decision needs to be made regarding whether or not to continue into the next stage of the process, or to re-work that stage based upon current status and outcomes. It is important to consider that if you are developing a product for a customer, they may wish to be involved in all or specified elements of the Product Design and Development process. The outcome of each gate decision, and the reasons for it, should be recorded.
Contract review is a systemic requirement which promotes and nurtures supplier and customer relationships. For legal reasons, and for the transparency of customer expectations, contracts should be developed, documented, implemented and reviewed on an ongoing basis between suppliers and customers. Contract review processes are often closely linked to customer focus related systemic elements.
It is also important to consider that Contract Review requirements may not just be applicable to customers; they can be reversed and applied with similar methods for suppliers of materials or services. Further information can be found within the haccp.com Approved Supplier Management Food Standard Element.
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Product Design and Development requirements in relation to their items.

Shelf life is set during product design and development and must be supported by evidence. It is influenced by the product formulation, the process, the packaging, and the storage and distribution conditions, and it should consider microbiological, chemical, physical, and organoleptic parameters.
Shelf life considerations commonly include:
Further information can be found within the haccp.com Food Microbiology Management Food Standard Element.
Document: A document provides guidance and/or direction for performing work, making decisions, or rendering judgements 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 Product Design and Development:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Product Design and Development Documentation requirements in relation to their items.
You may wish to visit the Product Design and Development Templates section of haccp.com for examples of Product Design and Development 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 Product Design and Development 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 Product Design and Development do not negatively impact the safety and quality of the food items dispatched from the business.
Implementation of Product Design and Development 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 Product Design and Development 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 Product Design and Development 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. Records should be controlled and retained as described within the haccp.com Document and Data Control Food Standard Element. 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 Product Design and Development 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 Product Design and Development:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Product Design and Development Monitoring requirements in relation to their items.
You may wish to visit the Product Design and Development Templates section of haccp.com for examples of Product Design and Development 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 identified non-conformance issues 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 Product Design and Development related non-conformance:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Product Design and Development 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 Product Design and Development:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Product Design and Development Verification requirements in relation to their items.
You may wish to visit the Verification Activities section of haccp.com for examples of best practice applications for this food safety and quality system element.
Validation: The process of gathering evidence to provide a scientific basis for the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the qualification of systems and equipment.
Validation is the provision of evidence to support the limits of control or acceptability for food safety or quality parameters nominated within systemic elements. Limits of control or acceptability are commonly included within documented food safety and quality systems elements such as procedures, HACCP plans, and specifications.
Common sources of validation include regulatory and legislative standards, finished product specifications and customer requirements, industry codes of practice and guidelines, verified and validated research, historical product and process control outcomes, and analytical testing.
The general goal of an established validation process is to ensure any systemic non-conformance issues are identified and rectified within an appropriate time frame. When non-conformance issues are identified through the validation process, corrective actions and preventative actions should be implemented to ensure they do not impact the effectiveness of the food safety and quality system.
Validation activities are commonly defined within the verification schedules and procedures of established food safety and quality management systems.
The following examples may apply to validation of the limits of control or acceptability for Product Design and Development:
If your food business supplies foodstuffs manufactured to a customer’s specifications, it is important to consider any specific Product Design and Development 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 Product Design and Development must be ongoing, including regularly scheduled reviews to ensure the effectiveness of training and competency outcomes.
Team members who have defined responsibilities regarding Product Design and Development should have knowledge including:
Team members who have defined responsibilities regarding Product Design and Development should have skills including:
Team members who have defined responsibilities regarding Product Design and Development 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 Product Design and Development 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.