During the design phase of a novel food processing system, the most important task is to consider all of the food safety related concerns and implement the solutions well in advance in the development process. Applying the appropriate tools to determine the risk levels and corresponding control systems is critical for innovative process/product development. 
 
During the last five years, the Food Industry has slowly shifted to a risk-based approach to regulate their product and process development activities more effectively.  A true meaning of validation has been studied and implemented to integrate more scientifically rigorous quality system, food safety, good engineering practices, qualification and testing methodologies, and risk-management considerations. This new approach put additional emphasis on the true meaning of the validation as a Good Manufacturing Practice beyond just a complicated documentation program. The new approach has also changed the concept of the timing for validation which is not the final verification step prior to the production anymore. It starts from the design stage and becomes an integrated part of the food production systems. 
 
As mentioned by Wong, W. and Chatterjee, B. (2007),  traditional validation is based on meeting corporate and market demand — regardless of the cost to the stakeholders of the company. The old adage “validate anything that moves but don’t move anything that’s already validated” sums up the traditional view of validation. This mindset essentially discourages innovation and continuous improvement and is partly why validation is perceived as a necessary evil rather than a value-added activity. Despite extensive sampling and testing, companies are often unable to achieve process stability. Processes fail because the drivers for stability have not been properly identified and eliminated or controlled.  Validation is not a project and 
 
The risk can be defined as the combination of the probability of occurrence of harm and the severity of that harm to all stakeholders in the food development process. The risk can be defined such that it can be mitigated through 

1. the level of scientific understanding of how the formulation and manufacturing process factors affect food safety, efficacy, and product quality; and 
2. the capability of process control strategies to prevent or mitigate the risk of producing an unsafe/poor-quality product. Risk-Based Validation approaches validation by reducing risk to acceptable limits in order to provide confidence the process will satisfy its specified requirements.

Risk-based validation is predicated upon understanding what does and does not drive the variability of the process, equipment or facility we are qualifying. Without this understanding it is impossible to effectively apply the risk-management tools necessary to refine the validation exercise. 
 
The shift in mindset to a more scientifically driven, risk-based framework has transformed the expectations for system validation. The ability to leverage the benefits of risk-based validation is predicated on the assumption that key parameters, which drive process variation, have been identified and controlled well in advance in the development process. Through the incorporation of classic risk-management tools along with well- engineered process and product-development studies, it is possible to focus and affect the product’s process predictability, driving value into the validation exercise and removing waste from the validation effort.
 
Risk-based validation is especially important for novel technologies with unknown consequences. The time as the third dimension must be considered in addition to system qualifications and capabilities. This approach is in alignment with the Food Safety Objectives (FSO) initiatives that will be explained by Dr. Nathan Anderson of the US FDA. Typical examples of Engineering Design Qualifications (DQ) and risk analysis as part of the overall qualifications (IQ, OQ, PQ) and validation activities will be discussed.