Food & beverage industry regulations, standards and initiatives, such as the FDA’s Food Safety Modernization Act (FSMA) and the Global Food Safety Initiative (GFSI), have a considerable impact on manufacturers’ processes and procedures. No longer is it enough to provide Standard Operating Procedures (SOPs) and paper-based records related to receiving ingredients. For example, current regulations and certifications require a record of every supplier or contract manufacturer site that provides ingredients or finished goods and a corresponding risk-based audit history by manufacturers and importers.
The challenge is that most F&B manufacturers do not have visibility into where the ingredients and goods they source actually come from, and existing IT systems were never designed to store the type of data required by these regulations.
A Changing Regulatory Landscape
Each regulatory and industry organization follows its own mission and perspective when devising rules for food quality and safety processes, often in response to incidents and issues that were in focus at the time.
For example, the FDA’s Food Safety Modernization Act (FSMA), signed into law in January 2011, is focused on prevention, rather than just response to problems. FSMA requires food facilities to assess the potential for hazards in their operations, implement and monitor effective prevention measures, and have a documented corrective action plan in place. The still-evolving set of rules also gives the FDA mandatory recall authority.
Another widely adopted standard is Good Manufacturing Practices (GMP), formed in the mid-20th century after a series of incidents made evident the need for standards. GMP provides guidance for manufacturing, testing, and quality assurance in food production and serves as an independent verification that a manufacturer is meeting minimum manufacturing practices.
Many food companies use GMP for compliance with other established safety and quality programs, including the SQF (Safe Quality Food) Program, which allows manufacturers to provide verifiable proof of robust food safety control systems and use of high production, as well as ISO 22000 and ISO 9001. Other standards that may apply include the Global Standard for Food Safety established by the British Retail Consortium (BRC), and the International Food Standard (IFS).
The food industry created the Global Food Safety Initiative (GFSI) after a rise in the number of food recalls in the 1990s. GFSI drives continuous improvement in food safety management systems and helps manufacturers demonstrate the discipline and efficiency of their operations.
Supporting Compliance Through Technology
Sparta Systems’ EQMS solution automates food safety and quality management processes, creating a central place to bring together all of the quality-related processes used through the supply chain into a single, integrated system. Required specifications, SOPs, certificates of analysis and supplier documentation can be handled through the documentation management solution, with quality management workflows ensuring that documents are received and updated per quality procedures. Track, manage and report on incidents and corrective actions to support facility registrations with the FDA. And manage internal and external audits to support HACCP, HARPC and GMP quality plans.
With Sparta Systems’ EQMS solution, food and beverage companies have seen measurable reductions in the number of recall events as well as the cycle times associated with change control, CAPAs and supply quality management.