Risk Assessment: Is Your Supply Chain Compliant?

by | September 15, 2022

Consider how transformative it would be if food and beverage brands had instant access to the compliance status of all their suppliers. For more than a decade, CPG companies have doubled down on risk assessment in the wake of the U.S. Food Safety Modernization Act (FSMA). 

Each year, emerging and established brands spend valuable time and money to mitigate potential risks, while simultaneously ensuring compliance. With the latest food traceability rule from the FDA going into effect on Nov. 7, 2022, such expenditures are only likely to increase. To stabilize, the industry needs a quick, affordable way to continually monitor and proactively manage supplier compliance.

Dietary supplement struggles without automation

Unfortunately, due to the lack of software automation, most dietary supplement manufacturers don’t have a clear picture of whether their suppliers are compliant. They might lag behind food and beverage manufacturers in terms of supplier transparency, but with the FDA’s nutritional label changes and changing consumer preferences, supplement makers must play catch up quickly. 

We’ve spoken with hundreds of dietary supplement companies. And almost all have stories about the risks they face with outdated documentation, incomplete product dossiers, and unfinished supplier forms. It’s not unusual to hear that 60% of a manufacturer’s suppliers haven’t provided complete compliance documentation.

Industry intelligence leads to efficiency

Our analysis reveals the supplement industry is woefully behind in adopting and deploying cost-effective software solutions that allow for robust data collection, storage, and analysis. Most brands manage hundreds of suppliers and thousands of materials with outdated spreadsheets or email folders. At those companies, the knowledge required to retrieve this information is in the hands of just a few critical people. If one of those employees moves on, that knowledge is lost. 

What if your team had an additional buffer against:

  • Launching products containing materials from non-FSMA-compliant suppliers?
  • Delivering products with materials that couldn’t pass an audit?
  • Making label claims without sufficient scientific proof to back them up?
  • Continuing to work with suppliers who don’t provide compliance documentation? 

Without a reliable system to help manage the complex compliance and regulatory processes required, companies are putting themselves at risk. When audited, or when a company is acquired and prospective buyers ask for proof of compliance, executives feel that sense of urgency. In each example, companies then must spend time and money solving the problem and managing negative fallout. 

Networked solutions speak for themselves

Fortunately, TraceGains has developed a suite of affordable, cloud-based software solutions to help food, beverage, and dietary supplement manufacturers better work with their suppliers:

  • Centralize supply chain data and documents with automated workflows and expiration alerts.
  • Gain clarity and visibility on the compliance status for every supplier and ingredient.
  • Configurable reports and dashboards to spot issues and track progress.
  • Highlights risk by supplier, item, and geography, identifying the most critical threats to the business.

We designed our Networked Intelligence solutions to validate material compliance under DSHEA and FSMA, substantiate label claims, and manage the required validations. Access up-to-date FDA regulatory information with the latest legal status and warnings. Centralized compliance insight into materials, suppliers, and bulk formulas allows you to make informed decisions about the products you develop, and the suppliers and materials you use.

Reach out today to find out how TraceGains can help your business grow while reducing your risk.

Originally published December 18, 2020. Updated September 15, 2022.

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