FSMA Compliance for Packaging and Labels

Posted on November 18, 2016
  • November 18, 2016
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FSMA Compliance with Specright

FSMA Compliance with Specright

It’s no secret that the Food Safety Modernization Act (FSMA) is the most sweeping set of regulations to hit the food industry in the United States, and some of the biggest questions food producers face is what is FSMA compliance and what does it mean? One impact that might be overlooked is documentation for packaging and labels. Specright’s cloud-based solution for specification management can help food producers manage the documentation and specifications relating to their food packaging and labels.

In a nutshell, FSMA requires food producers to create a Hazard Analysis Plan documenting everything from sanitization processes to the chemicals used in the glue to attach labels to food packaging. In order to comply with FSMA, documentation is key and making that documentation available within 24 hours of an FDA audit/inspection is critical. It is also critical for food producers to have attained the proper documentation from all their suppliers, no matter where they are in the world.

Failure to comply means that your production facilities can be forced with shutdowns and production stoppages at the request of the FDA. Companies failing to comply face a possibility of thousands and up to millions of dollars in lost revenues.

For packaging, food producers must be able to document themselves or get their suppliers to disclose specifications such as material composition, allergens and additives, physical and chemical properties, and microbiological susceptibility for their packaging and material. These specifications or documentation needs to be current and readily available.

A specific example of how food-packaging specifications must be documented is the coating layer added over printing. It must be documented to ensure that this layer is adequate and suitable for use for food packaging. There could be a potential chemical or odor migration into food. This is of special concern if the ink is touching the product or coming into contact with the surface of packaging, e.g., nested printed rigid plastic cups, rolls of film, stacks of flat cartons, etc.

With the FDA reporting almost half of its recalls due to incorrect or incomplete listing of ingredients and allergen on labels, food labels are a critical area in food safety, and perhaps one of the areas of the FDA’s new regulations where it is easiest to take control. The labeling process will be subject to the same hazard analysis as every other factor of production in the facility and every manufacturer will need a procedure to prevent any possibility of mislabeling – even from ingredients purchased from suppliers around the world.

From requiring and storing certificates from suppliers documenting known allergens to specifying how labels are printed (i.e.: forbidding multiple SKUs from being printed on the same sheet at one time), food producers can easily get better control over their labels to avoid costly recalls.

Cloud-Based Specification Data Management for FSMA

Specright’s Specification Data Management system gives food producers the traceability for labels and packaging. It provides a documentation solution that is available 24/7. Some areas within documentation that Specright helps to manage are:

  • Approval workflows for artwork revisions/obsoleteness
  • Traceability into change/approval history for accountability
  • Traceability into supplier communication
  • Audit suppliers for compliance with label and packaging specs

If your company is using outdated technology like PDF files, spreadsheets or inflexible ERP solutions to manage your packaging/label specs, consider the Specright Specification Data Management Platform. Our customers use Specright’s Exchange to share accurate, approved specs with suppliers real-time, reducing their risks for recalls due to improper packaging/labels. Plus, our packaging Engineering Services team can perform audits of your packaging on a regular basis.

Get a demo of Specright today!


Rebecca Janzon is Marketing Manager for Specright. She has 20+ years in experience in the areas marketing/communications/PR working in marketing roles at SKF, Atlas Copco, Nobel Biocare and Cochlear. She brings a wealth of knowledge in SaaS, engineering services, computer software, and the medical devices segments.