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Q&A: Preventing Recalls in a Fast-Paced Industry

The FDA recently proposed new rules as part of the Food Safety Modernization Act (FSMA). As the food regulatory landscape continues to change quickly, it is more important than ever for food facilities to employ the latest technology to prevent product recalls before they occur.

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This article originally ran in the March 2013 issue of Food Manufacturing.

Interview with Barbara Levin, SVP and Co-Founder, SafetyChain Software

The FDA recently proposed new rules as part of the Food Safety Modernization Act (FSMA). As the food regulatory landscape continues to change quickly, it is more important than ever for food facilities to employ the latest technology to prevent product recalls before they occur. Barbara Levin of SafetyChain Software spoke with Food Manufacturing about how food safety software can help food manufacturers be proactive when it comes to food safety.

Q: What regulations are included in the new food safety rules recently proposed by the FDA?

A: The recently announced FSMA rules are still under review, so we’re not sure what the final rules will look like. One of the new rules is the Preventative Controls for Human Food rule. The regulations around this rule would basically require all producers and manufacturers of food sold in the United States to have formalized, documented programs to prevent their products from causing foodborne illnesses and other contamination, as well as corrective action plans for issues that do arise. This is for food that is produced domestically or at a foreign plant. The second long-anticipated rule is for Produce Safety Standards, and calls for standards that are both science- and risk-based for the safe harvesting and production of produce on farms1.

Q: How should food companies prepare for these new rules?

A: A good place to start is to look at all food safety programs to determine:

  • Are your food safety and prerequisite programs, such as sanitation, well documented?
  • What are your verification practices? Are you saying what you will do and doing what you say?
  • Do your programs go beyond documentation and tests? Are you using technology such as mobile devices, for example, to record direct observation?
  • Are your employees well trained on your good manufacturing practices (GMPs)?
  • And perhaps most important, are you focusing merely on reaction to a food safety event or are you also practicing prevention? In other words, do you have appropriate interventions in place to help reduce or eliminate food contamination before it happens?

Q: What services and products does SafetyChain offer for food manufacturers?

A: SafetyChain Software specializes in Food Safety Chain Management — cloud-based, food safety and quality assurance (FSQA) solutions designed to help ensure safety and quality at all points along a food supply chain in real-time.

Our SafetyChain for Food™ suite helps food manufacturers keep non-compliant ingredients and raw materials from coming into production and non-compliant finished products from going out. It’s designed to create operational efficiencies that can save time and money — optimizing inbound material performance and lowering cost of goods made while also automating many FSQA tasks during the manufacturing process.

A few examples of capabilities include automation of supplier compliance; certificate of analysis (COA) and specification management; regulatory and internal compliance management; HACCP and GFSI program automation; safety and quality data management and real-time non-compliance stakeholder alerts; auto-scheduling of Standard Operating Procedure (SOP) reviews; audit management; and finished product compliance. All safety and quality data — along with corrective actions records — create a central repository of data for reporting and analytics for continuous improvement on key performance indicators (KPIs); the ability to respond to on-demand audits; root cause analysis; supply chain optimization and more.

Q: Dole Fresh Vegetables recently implemented SafetyChain for Food. How does the system help Dole with its food safety initiatives?

A: According to Nye Joell Hardy, Dole Fresh Vegetables’ Senior Food Safety Manager, Dole is focused on a pro-active, prevention-based approach to food safety versus waiting for suppliers’ safety assessments. This includes ensuring all food safety programs are followed at the start of every point of production, from planting to harvest to post-harvest. Dole’s current and continued phases of its SafetyChain for Food deployment include using the solution to:

  • Proactively ensure supplier compliance in the field — pre-harvest, during harvest and post-harvest — for all food safety requirements.
  • Conduct immediate food safety assessments from data sent via mobile devices with real-time alerts when corrective actions are required.
  • Respond to regulatory, non-regulatory and customer audits “on demand.”
  • Have real-time food safety traceability access to the electronic “paper chain” for mock and potential withdrawals and recalls.
  • Prepare for compliance with announced and anticipated FSMA rules.

Q: What are the benefits of realtime food safety and quality software?

A: There are several key benefits, including the ability to:

  • Help prevent food safety events — such as withdrawals, rejections and recalls — versus react to them. All safety and quality attribute tests results — from suppliers, internal/third-party labs and even equipment such as weighing machinery, for example — are analyzed in real-time to specifications. When non-compliant results are detected, immediate alerts are sent via text and email, allowing corrective actions or interventions to be taken before ingredients or raw materials go into production — or before non-conforming finished products are shipped to customers.
  • Keep cost of goods made within KPIs. Auto-notification for process variations can, for example, help reduce re-works. Another scenario might be auto-alerts when Critical Control Points (CCPs) are close to being reached. For example, if your cooling equipment on a particular line is not supposed to go above 44°(CL), alerts can go out at 40°, allowing corrective actions before yield and materials are at risk.
  • Eliminate the vast majority of manual processes and errors, saving both time and money and speeding sales throughput.
  • Have “predictive quality” based on continuous improvements from real-time data and analysis. For example, if salt content from a particular ingredient supplier is always on the high side of set limits, the specifications can be lowered and narrowed to a range that is acceptable.
  • Protect market value and brand by keeping non-conforming ingredients from going into production and non-compliant finished products from reaching customers.

Q: What should food manufacturers consider when looking to incorporate food safety software into their processes?

A: There are many types of food safety software on the market. When looking to integrate software solutions into overall FSQA processes and practices, important points for consideration include:

  • Does the software allow you to go paperless and automate communications both upstream and downstream? For example, can supplier documents be sent electronically? Can COAs to customers be automated to shorten release times while speeding product distribution?
  • Does the solution allow you to manage inbound, internal and outbound FSQA information to avoid data and document silos internally and across your organization (i.e. multiple plants in different locations)?
  • Does the solution handle quality in addition to safety? We all know of the potentially devastating effects of food safety events, but consistency in quality attributes is what keeps consumers coming back for more, lowers your manufacturing costs and strengthens the brand.
  • Does the software facilitate performance and trend analysis?  In other words, does it create actionable data?
  • And very important, does the system integrate with other existing solutions in your enterprise such as ERP, supply chain, inventory management, procurement and distribution systems?


1Summarized from source material on Leavitt Partners blog dated January 10, 2013.

For more information on Food Safety Chain Management, or SafetyChain for FoodTM, please visit Barbara Levin can be contacted at [email protected].