Guest Blog: Making Regulatory Compliance a Competitive Advantage

Editor’s Note: The following guest blog is written by Chrystele Delobel, director, strategic planning, monitoring and government relations, Selerant, who will speak on “Compliance by Design" as part of the New Product Development panel discussion at SupplySide West. The two-hour session will take place on Wednesday, Oct. 7, from 2 to 4 p.m. at Mandalay Bay in Las Vegas. Visit http://west.supplysideshow.com/edu-more.aspx for more information and to get registered.

Over the past decades, there has been a huge political commitment worldwide to ensure food safety and consumer protection. While emerging countries have been accelerating the revision and harmonization of their food safety and regulatory frameworks to facilitate commercial exchange and global trade, developed countries have modernized their policies, legislation and standards to ensure high-level of consumer protection. The trend is a clear movement toward risk-assessment based regulations.

Today, international and intergovernmental organizations are even undertaking horizon scanning and forward-looking exercises such as foresight studies related to food safety. The objective is to identify issues at the edge of current thinking that may have a significant impact in the medium- to long-term future of food safety. This process allows the identification of the key drivers that may be the underlying causes of change in food safety, with the ultimate goal to ensure the policies, legislation or standards in place can cope with potential emerging risks, and also that adequate methods (such as analysis and risk assessment) are available.

In this context, before putting a new product on the market, food operators must take global markets into consideration due to evolving regional and national rules, as well as cultures and languages. From the food industry perspective, the challenge is to keep innovating, producing and selling safe and compliant products. However, designing and producing a safe and compliant product is far from being a simple and easy task for the food industry.

It involves stringent processes such as hazard analysis critical control points (HACCP) procedures and GMPs (good manufacturing procedures), with the aim to prevent and control food contamination. However, it also involves many associates and many functions within a company, at different levels. For instance:

In addition to these functional interactions, companies need extensive knowledge of numerous regulatory requirements at the ingredient and finished product levels, including ingredient restrictions, compositional requirements, contaminant and residue maximum levels, microbiological criteria, labeling requirements, and much more.

In a globalized and interconnected world, food business operators must master a huge quantity of data related to their ingredients and products to ensure they release the best possible offerings. In addition, companies receive a plethora of information from a variety of sources on regulatory constraints, food safety standards, scientific development and business news globally.

To keep a competitive advantage, there is a real need to digitize and structure the information, leveraging on the technology to get, on a real-time basis, the relevant information to the appropriate person at the right time. The principles are: 1) to facilitate the management of complex interactions between the company processes; 2) in a collaborative environment across the different functions; 3) to ensure product compliance to internal and external requirements; 4) while integrating long-term scenarios from foresight studies into the company processes and day-to-day management of food safety.

This can be achieved with product lifecycle management (PLM) software, provided the software has efficient expert rules for regulatory compliance evaluation and can integrate tools using artificial intelligence to master the web-based information. In this “big data" world, machine learning techniques are crucial for processing and delivering such a huge amount of data. The use of supervised learning models to analyze data and recognize patterns to automatically categorize the information provides a very efficient early warning system.

Integrating with the Product Development Process

It starts by structuring, in a PLM, the company processes from the product idea to the final bill of materials, and by gathering in a central database all the data related to ingredient and product specifications, formula and packaging design and testing, as well as internal and external requirements. In a PLM, we must distinguish four main pillars (i.e. macro-functionalities):

Process management: It models the internal processes and workflows. This facilitates project management, task definition, resource allocation but also collaboration between the different associates, ensuring a proper follow up of the activities related to the new product development process.

Product development: This is the place where all the components of the final product (ingredients, packaging, formulas and recipes) will be tested (leveraging on past experiences stored in the system) and validated through pre-defined approval workflows.

Data management: This functionality ensures the complete traceability, versioning and reporting related to projects and products. It builds the internal knowledge database of ingredient and product portfolios.

Compliance: This is the main pillar that can guarantee the design of compliance-driven recipes. Expert rules and safety/regulatory data must be efficiently integrated into the product development process and the functionality available to different associates (i.e. product developers, regulatory managers, quality teams) anytime. The regulatory and/or internal constraints must be linked to the product from the marketing brief and throughout the product development for the different target markets/customers. The up-to-date constraints can then be consolidated and verified at any time during the development and manufacture to ensure an always safe and compliant product throughout the years.

To build an efficient and integrated compliance functionality within a PLM, the key challenge is to structure the relevant information and keep the database up-to-date. For example, vendor and raw material specifications must be broken down to the composition in terms of regulated substances/ingredients, allergens, nutritional values, country of origin, contaminant and residues, microbiological criteria, etc. From a regulatory perspective, this would include not only legislation amendments and food-safety news related to ingredients/substance limits (i.e. food additive conditions of use, contaminant and residue maximum limits, microbiological criteria, indirect food additives), but also labeling and compositional requirements, claims conditions, allergen and nutrient declaration rules, and safety trends.

The data structure and the PLM regulatory expert rules must be efficiently built. Both should integrate end-to-end processes to enable computer-assisted compliance evaluation by product and by markets, and thus facilitate the review from the business experts to adjust formulas according to the initial positioning and requirements.

Chrystele Delobel has more than 14 years of experience, acquired in both private life-science industries and inter-governmental organizations in the fields of regulatory compliance, quality management and development of tools for quality control. After having started up and led Selerant’s regulatory and scientific affairs department, Delobel is now responsible for strategic development and government relations.