Tag Archives: risk management

Environmental Monitoring Programs and The Cost of Failure

What happens when a food company does not have an effective environmental monitoring program in place? The cost of failure can be significant, warns Prof. Ann Draughon, ranging from placing contaminated food in the markets, to managing product recalls, and businesses getting shut down.

Effective Environmental Monitoring, Sampling and Testing (EMS) Programs are absolutely necessary to protect our consumers, and make safe food, and are also required from a regulatory and food safety point of view, and to verify that our food safety programs are working.

In a recent webinar, Prof. Ann Draughon offered some insights on what happens when such an EMS program is not set in place – the cost of failure is much greater, and the repercussions can be severe, she warns.

What is on the horizon with EMS given the new regulatory landscape under the Food Safety Modernization Act and the proposed rules? Prof. Draughon talked about the Mandatory Preventive Controls described in Section 103 of the Act that lists the following controls that FDA will require:

  • Environmental monitoring programs;
  • Sanitation and cleaning requirements;
  • Allergen control;
  • Mitigation of hazards; and
  • Supplier verification.

How will FSMA affect FDA’s regulatory sampling of food facilities and products? The volume of environmental samples will increase at a much higher rate than sampling for allergens or ingredients, she adds. And in order to meet such a high demand for environmental inspection and sampling, it will be important to have in place effective EMS programs. Prevention will be cost-effective and give companies the ability to detect and destroy the microorganism before they cause any issues. Prof. Draughon provided the following numbers as cost of reinspection: $224 per hour for domestic inspections, $325 per hour for foreign inspections, and cost of FDA reinspection in FY 2012 estimated to be around $21,000.

She described two case studies of companies that suffered bankruptcy, and business losses due to massive food safety related recalls, caused by inadequate or lack of environmental monitoring programs.

3M-Envi-Monitoring_March2015-1

“This company is currently bankrupt due to a massive recall. While they had a great food safety plan, they did not back it up with a strong EMS program,” Prof. Draughon explained.

Speaking about the second company, she explained that the strong and capable leadership had done everything right for the company, but what went wrong? “There was a:

  • 3M-Envi-Monitoring_March2015-2Lack of trend analysis of environmental data;
  • Lack of communication within company about any positives Listeria results;
  • Sporadic Listeria positives occurred – while the problem was fixed, they continue to reoccur and the source was never detected or fixed;
  • The company had a reactive EMS, but not proactive,” she explained.

What are some of the recurring problems due to ineffective EMS programs? Prof. Draughon listed these as:

  • Increased risk of recall;
  • Increase loss of product;
  • Increased liability exposure;
  • Build-up of pathogens and spoilage agents or chemicals in environment;
  • Lack of regulatory compliance; and
  • Reaction to problems, not prevention.

Based on this high cost of compliance, Prof. Draughon strongly recommended establishing an effective EMS program, which has the following attributes:

  • Focus on having the appropriate indicators and hazards;
  • Ensure the best procedures selected and validated;
  • Strong sampling plan, which is well-designed and dynamic;
  • Data analysis and data management; and
  • Education and training.

Learn more by listening to the series of webinars on Environmental Monitoring, presented by 3M Food Safety. Click here for more details.

Katie Moore, Intelligent Platforms’ Global Industry Manager for Food & Beverage, GE

Big Picture Understanding for Better Food Safety

By Sangita Viswanathan
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Katie Moore, Intelligent Platforms’ Global Industry Manager for Food & Beverage, GE

Having worked in the food & beverage industry as a plant manager, Katie Moore knows just how important food safety is to a company’s brand and profits. As GE Intelligent Platforms’ Global Industry Manager for Food & Beverage, she uses today’s connected technology to help prevent food safety issues and expensive recalls.

Companies want to do the right thing and try to control what is known. They want to mitigate risks when possible. But without a clear and complete line of sight to real-time process data and information, like whether or not your HACCP processes have been followed, correctly, each and every time as stated in your HACCP Plan, how can you truly have peace of mind going to sleep every night? That’s the gap that’s plaguing food companies and managers, says Moore.

Against the backdrop of evolving food safety rules under the Food Safety Modernization Act, Moore sees manufacturers in the food and beverage industry in a wait-and-watch mode.

“Since these rules are still in the process of being finalized, everyone’s waiting to see what the final regulations will look like. This is the right time for manufacturers to educate themselves, and implement new steps and programs to assess and mitigate risk,” she explains. Moore feels larger companies are much better at addressing these changes, because of having greater resources or collaborations with industry associations, while small and medium sized companies are continuing to implement HACCP and GFSI standards, but are a step or two behind their larger counterparts.

There is a lot of risk management going on, and it all begins with HACCP, says Moore. But a gap she’s noticing is a lot of records still being paper-based.

“There is still a lot of work being done on paper. And data is not being transferred automatically. Because of this, there is no way to go back and learn from what’s going on and identify trends and issues. There is truly no electronic capture of data. This lack of learning and understanding of trends and changes is a big gap,” Moore adds.

A lot of recent recalls are due to supplier problems, so everyone focuses on that. Companies are managing the biggest risk, which is their suppliers, and there are a lot of solutions available to manage supplier compliance. “But true value can be realized when this is tied in with your manufacturing processes and specifications. How is the food handled in my line, my tanks and my processing facility…. If companies have this continuous visibility it will contribute to food safety and quality improvements growing by leaps and bounds. And also companies will be able to track and trace throughout the process, and react a lot quicker,” she describes.

Mergers and acquisitions in the F&B space

These days, there is a lot of consolidation happening in the F&B space. Historically, whenever there is a merger of two food companies, there is a challenge to have in place a sound business continuity plan. For instance, Moore asks, if there’s a recall, then how do we react? If there is an issue isolated to one facility, how can we cover our bases and mitigate risks? How can we make sure our customers get our products? From an IT perspective also, there are some challenges that need to be addressed. For instance, what GFSI scheme are we using? Do we merge these two standards and our supporting IT infrastructure, or continue to work with two separate standards? The key in making this decision is to utilize big data analytics to determine which process has been working most efficiently and to factor in the cost of replacing or retrofitting the extremely expensive manufacturing equipment.

According to Moore, F&B managers need tools that can help them improve compliance to food safety, have better visualization and hence greater visibility either on the plant floor or via mobile platforms, have the ability to pull up a wide range of information and share it with people. F&B companies usually handle a wide range of project management systems, typically working on different software from different vendors.

At GE Intelligent Platforms, Moore says, the products ‘talk’ to different systems and data management software to try and address the challenge of collecting, managing and trending large amounts of data.

So are companies embracing technology solutions to better manage food safety and quality? Moore feels that a driving force is lacking.

“Once something happens and FDA has to react, the chips will start to fall. There will be a lot of recourse to technology that will be required, but right now there’s no driving force. Once FDA puts the hammer down on electronic documentation, F&B companies will start to move faster,” she sums up.

Melanie Neumann, The Acheson Group and Syed Hassan, PepsiCo

Are You Effectively Managing Supply Chain Risk?

By Food Safety Tech Staff
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Melanie Neumann, The Acheson Group and Syed Hassan, PepsiCo

While there are many tools available to help food and beverage companies manage their supply chain, the integration of electronic systems in ensuring effective connectivity can be a challenge. During a Food Safety Tech conference, a panel of industry experts shared their perspectives on how to use tools to manage and communicate recalls, and the importance of focusing on a food safety management system. Melanie Neumann, executive vice president and chief financial officer of The Acheson Group, cited recall communication programs such as Rapid Recall Exchange and Recall Info Link. “They’re great programs in that they The 2015 Food Safety Consortium Conference (November 17-20, 2015 in Schaumburg, IL) features topics on supply chain risk and vulnerabilities. Register now communicate outbound, downstream to the recipients of recalled products. It gets [product] out of the hands of potential consumer purchasers and consumer consumption,” said Neumann. “Here’s what it doesn’t do: They have no way of knowing whether or not they’re communicating out all of the affected product. It still comes back to industry’s responsibility in effective supply chain management to know you’ve captured all of the affected recalled product that those systems are then used to communicate outbound.”