Risk Assessment: Is Your Supply Chain Compliant?

Skye Lininger
December 6, 2018

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iStock-1070830466Consider how transformative it would be if food, beverage, and dietary supplement manufacturers and brand owners could, with the click of a button, have access to the compliance status of all of their suppliers and their materials. Companies spend valuable time and money every year collecting this information. But now there is a quick, affordable way to continually monitor and proactively manage supplier compliance.

What if you could guarantee that your business would never again:

  • Launch products containing materials from non-FSMA-compliant suppliers?

  • Deliver products with materials that couldn’t pass an audit?

  • Make label claims without sufficient scientific proof to back them up?

  • Continue to work with suppliers who don’t provide compliance documentation? 

Over the past several years, and especially since the Food Safety Modernization Act became law in 2011, food and beverage companies have renewed their compliance enforcement efforts.

Unfortunately, due to the lack of modern software automation, most supplement manufacturers don’t have a clear picture of whether their suppliers are fully compliant. They might lag behind food and beverage manufacturers in terms of supplier transparency, but with the deadlines for the Food and Drug Administration’s nutritional label changes looming on the horizon, supplement makers must play catch up quickly. 

We’ve spoken with hundreds of supplement companies and almost all have stories about the high risks they face with outdated documentation, incomplete product dossiers, and unfinished supplier qualification forms.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

Why is This?

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 companies manage hundreds of suppliers and thousands of materials with outmoded spreadsheets or email folders. At most companies, the knowledge required to retrieve this information is in the hands of just a few key people. If a key employee moves on, that knowledge is lost. 

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

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

  • Exchange data and documentation easily.

  • Track which information is missing.

  • Provide automatic expiration alerts.

  • Allow for complete product dossiers for compliance, label accuracy, and risk management.

Our solutions are designed to validate material compliance under DSHEA and FSMA, and substantiate label claims and manage the proof required. Up-to-date FDA regulatory information is included 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.


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