The New Advisory Role of Regulatory Teams

For manufacturers, regulatory compliance thresholds around material sets, nutrition, safety, QMS, procurement, and more are getting more stringent across global markets, as are the potential penalties for non-compliance.

Many countries have already implemented and enforced sugar and salt taxes. The list of "banned' ingredients varies from country to country, leading to a complex web of regulatory standards that internal processes must be able to quickly adjust to. 

As such, the role of regulatory teams is starting to shift at mid-sized manufacturers. 

Gone are the days of regulatory teams merely reviewing products and putting a stamp of approval on set material percentages. Hiring additional regulatory personnel to perform compliance checks won’t make a dent in the workload anymore.

The global supply chain is simply too interconnected and fluid for manual compliance tasks--oversight must be constant and integrated into every step of the product lifecycle. This global oversight is leading to an internal overhaul of the day-to-day work of regulatory managers. Here’s how:

1. They’re becoming go-to consultants within scientific affairs

As compliance tasks become automated within the PLM process, regulatory managers are taking on more of an advisory role within scientific affairs departments.

Instead of checking off if product materials meet the proper levels allowed by law (although that’s still part of it) regulatory teams are becoming product advocates that work to:

• Monitor global regulatory changes and maintain fluency in the food law landscape of relevant markets.
• Evaluate which products and distributions markets need to change in response to new regulations and evaluating how those changes will impact all supply chain processes.
• Evaluate the response readiness for recalls and contaminations.
• Advise on the nutritional soundness of the products.
• Defend the product within scientific communities.
• Act as ambassadors of product integrity within the organization.

Download our ebook: 5 Operational Changes Impacting Food & Beverage Manufacturers in 2019

2. They’re spearheading product integrity and traceability research

As regulatory teams spend less time on manual compliance checks, they’re spending more time researching and answering internal and external questions around comprehensive product quality. The deeply interconnected nature of multi-layer formulations and global supply chains means traceability has never been harder--or more important--for regulatory groups to stay on top of to maintain product compliance. 

Today, regulatory groups have a growing need to be able to:

• Track ingredient ratios and regulated product attribute on a microbiological level to prevent or respond to quality issues.
• Quickly find formulas that need to be updated in response to compromised or changing supply chains.
• Advise on how to reduce the cost of manual traceability and compliance tasks.
• Manage a master view of formulations to understand the scope of how many multi-layer formulations will need to change in response to new compliance standards.

3. They’re ensuring specifications include the most current regulatory standards 

On a formulation level, regulatory teams are advising R&D and product scientists on how to expand product specifications to ensure these regulatory standards are a core component of every product stage gate.

Regulatory teams and working hand-in-hand with product groups to:

• Implement compliance and safety data thresholds for ingredient and material attributes directly within product specifications.
• Implement controls that stop product stages from advancing if specifications don’t meet internal quality standards.
• Ensure that vendor and supplier data meets compliance standards and is automatically incorporated on product specifications.
• Generate a history of changes to those categories throughout development processes.

4. They’re modernizing labeling and packaging processes 

Regulatory groups aren’t just advising on the nutritional level; they’re also helping to facilitate a more reactive loop between material sourcing, formulation, and packaging and labeling processes.

This is, in part, because consumer preferences and regulatory changes are starting to require more detailed ingredient categories and subcategories on product labels. Additionally, new taxes on non-biodegradable packaging means Regulatory groups need to be involved with updating manufacturing to meet these demands.

Regulatory teams have taken on the task of:

• Spearheading efforts to use alternative packaging, device refills and more to avoid unnecessary fines.
• Ensuring that brands are tracking granular raw material sources and attributes and accurately representing those details on product labels.
• Implementing daily label specifications linked to daily recipes that can be swapped in and out as conditions change. 

The volume and scale of tracking regulatory and compliance standards across a global brand means regulatory groups need to automate and embedded regulatory tasks throughout the PLM process to remain effective. Automation through PLM also means regulatory teams at food and beverage manufacturers have a new opportunity to influence innovation, improve traceability, and ensures company and product growth occurs with compliance and quality in mind.