by Kari Hensien | Sep 26, 2016 | FSMA, RizePoint
You asked the essential questions about FSMA compliance, and now your FSMA plan is probably in full swing. With FSMA’s hundreds of guidelines and requirements, this is obviously a tall order, and if you’re not careful it can have a significant impact on your business. So the question is “How do you consistently meet FSMA requirements without putting stress on your business or raising your operational costs?”
Technology is the answer.
How Food Safety Tech Helps
To be successful, you need a flexible and complete auditing platform that performs a wide range of functions. You’ll need to do all the following with one platform:
- consistently monitor, test, and audit your preventative controls
- perform regular quality checks
- accurately document the results to verify compliance
- use data to enable continuous improvement
- manage your suppliers
With this type of technology foundation in place, improving the quality and safety of your products and meeting FSMA requirements becomes more manageable and significantly less expensive.
How to Choose the Right Food Safety Tech
This is all well and good in theory, but you next question is probably “What does an efficient, effective FSMA auditing solution look like, how much will it cost, and what core characteristics and capabilities should it include?”
The good news is that recent technology advancements have already changed the game in your favor. With the convergence of three major technology trends — cloud, mobile, and blockchain — it has become much easier to implement an advanced, FSMA-friendly food safety auditing and verification system, either as an extension of your existing auditing framework or as a standalone food safety auditing solution. Here are just a few of the key advantages and capabilities this type of next-generation auditing solution can offer your organization:
- Speed and Mobility: A cloud-based auditing system with a strong mobile component allows internal food safety managers and external suppliers to use their smartphones or tablets to conduct FSMA and other food safety audits. It then easy send the results to a centralized cloud-based engine where they instantly become part of a centralized and searchable body of knowledge.
Blockchain tech takes it a step further, linking your data in “unbreakable” chains. This means you can respond quickly to any recall scenarios as well as generate immediate reports for the FDA. These processes took days before blockchain, and now each can be addressed in seconds to minutes.
- Intelligence: Collecting and making FSMA auditing information available quickly is important, but it’s not enough. By making good use of cloud-based intelligence, your auditing solution can also recognize important food safety issues or problems as they occur, compare results from specific locations to a larger body of company-wide results, and then automatically initiate action. This kind of machine intelligence essentially connects individual food safety auditing results to your larger food safety standards and processes, making it easy to quickly turn food safety data into company-wide improvements.
- Flexibility and Efficiency: Achieving consistent FSMA compliance involves monitoring and tracking hundreds of ever-changing details and preventative controls across all of your different departments and locations. This requires an auditing foundation that’s flexible enough to accommodate high levels of complexity. With the right kind of cloud-based auditing foundation, you make it possible for the appropriate people and teams to quickly create, modify, and manage a centralized collection of FSMA checklists and instructions, so local managers, employees, and suppliers always have access to the latest standards, requirements, and information.
- Control: Every auditing process, including FSMA, includes diverse teams of people filling many different roles. For your food safety auditing system to function properly, you need the ability to grant very specific access rights to people and groups based on those roles. For example, with the proper controls in place, you can give local managers access to their own customized sets of tools and information. You can also give FSMA experts at the corporate level permission to create and modify food safety questions and instructions that are limited to their job functions. In other words, by building fine-grained access control into your FSMA monitoring and auditing solution, you can easily add resources that focus exclusively on FSMA requirements without getting in the way of other core auditing functions.
The bottom line is that when you deploy a mobile, cloud-based auditing solution with these capabilities and characteristics, you create a framework that allows you to quickly create custom surveys and checklists, make them easily accessible to specific people or groups in your organization, collect the results in near real-time, and thoroughly analyze them to gain new insights. Add the visibility and speed that blockchain tech provides, and you ultimately have the power to confidently meet complex FSMA requirements, document your compliance, and adapt quickly to regulatory changes without disrupting your core business or negatively impacting your operational costs.
by Kari Hensien | Sep 8, 2016 | FSMA, RizePoint
It’s compliance time. The law we have been talking about since January 4, 2011 is going live this month. The FDA’s Food Safety Modernization Act (FSMA) is the most sweeping reform of food safety laws in more than 70 years.
Given the magnitude of the legislation, it is easy to be overwhelmed by what the law means and when mandatory compliance begins. In this post, we’ll look into the compliance dates in more detail, including the recently announced date changes for produce packing houses.
COMPLIANCE BY INDUSTRY
Compliance dates vary by business type so the first thing you need to determine is your FDA-defined business type. If your business has fewer than 500 employees, then you are a small business and have more time to comply with FSMA. If your business holds produce – but does not alter produce – then you are a produce packing facility (careful now, there are many “packing” definitions so it’s best to double check with the FDA on this one). Produce packing facilities now have until January 26, 2018 to comply with the Preventative Controls and Current Good Manufacturing Practices rules.
There are dozens of business types and each one will be affected by FSMA a little bit differently. For instance, most restaurants do not register with the FDA and are thus exempt from the Preventive Controls rule. However, a restaurant could import specialty food items, and those items might fall under the Foreign Supplier Verification Program rule. In short, it’s important to know the classification of your business before determining your compliance dates.
COMPLIANCE DEADLINES
The FDA recently extended deadlines for a variety of businesses, with produce packing houses being the largest sector affected (I admit, I do not know the ins and outs of the cotton gin industry). The chart below summarizes the key FSMA compliance deadlines; the dates listed in orange are the new deadlines announced by the FDA on August 23, 2016.
As a reminder, all rules require documentation and reporting. To read about how RizePoint can help with your FSMA compliance, visit https://9019c3a60e.nxcli.io/solutions/fsma/
*FDA Definitions
- Small business: fewer than 500 full-time equivalent employees
- Very small business: (averaging less than $1 million per year (adjusted for inflation) in both annual sales of human food plus the market value of human food manufactured, processed, packed, or held without sale)
- Packing houses: facilities that only pack and/or hold raw agricultural commodities that are produce and/or nut hulls and shells
- Food contact substances: A food contact substance is any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if the substance is not intended to have any technical effect on the food.
by Kari Hensien | Sep 1, 2016 | FSMA, RizePoint
Like every government regulation, the Food Safety Modernization Act (FSMA) is dense and complicated—with hundreds of rules and requirements, rolling implementation timelines and enough legal jargon to make even the most dedicated food safety expert’s eyes glaze over. But complicated or not, FSMA is here to stay, and as more requirements take effect, it’s starting to make a serious impact.
So what’s the best way to understand FSMA—and start coming to terms with its complex and still evolving requirements? That’s obviously a broad question with an answer that could easily fill volumes. But sometimes, it’s helpful to step back and look at the big picture. Because although FSMA is certainly far-reaching and complex, most of its requirements fall into a few relatively simple categories that naturally lead to a series of logical steps. By understanding these higher-level “pillars of FSMA” and how they apply to your business, you can begin to demystify and make sense of FSMA regulations—and develop an achievable roadmap for compliance.
So here’s a quick summary of these key “pillars of FSMA,” along with a few suggestions for applying them to your organization.
1. Perform a Detailed Hazard Analysis
If you’re in the food and beverage industry, you almost certainly have a food safety program in place. However, FSMA changes the game by shifting the focus from simply limiting the scope of contaminations to preventing them from occurring in the first place.
To make sure that shift takes place, FSMA requires you to perform a thorough written Hazard Analysis that documents potential hazards that could affect your manufacturing processes, sanitation efforts, and supply chains.
You can choose to perform this Hazard Analysis internally, engage outside food safety experts, or both—as long as the final product meets specific FSMA regulations and requirements. Basically, this Hazard Analysis exercise is designed to help you proactively identify and address significant food safety hazards before they lead to outbreaks or other issues. And even more important, it forms the foundation for your FSMA compliance efforts.
2. Develop Effective Preventative Controls
After you perform a thorough analysis to determine which food safety hazards qualify as “significant” for your organization, you can design and implement specific preventative controls to address them. These controls generally address four main categories—processes, sanitation, food allergens, and suppliers.
In some ways, FSMA preventative controls are similar to the Hazard Analysis and Critical Control Points (HACCP) system you may already use, but FSMA controls typically go above and beyond these standard critical control points. The preventative controls you define and implement should also include specific parameters for controlling all of the significant hazards that might affect your business. These controls essentially make it possible to turn the findings of your written Hazard Analysis into meaningful processes and actions.
3. Oversee and Manage Your Compliance Efforts
Performing a thorough Hazard Analysis and defining effective Preventative Controls requires careful thought, planning, and expertise. When those pieces are in place, you can begin to monitor the effectiveness of your preventative controls, take corrective actions, and carefully document your efforts. Traditionally, food and beverage companies have used a variety of different approaches to manage and document their food safety efforts—from manual checklists and rooms full of paper records to various spreadsheets and custom databases. However, as more Food Safety Modernization Act requirements take effect, you should carefully consider moving to a unified, purpose-built software solution that can provide more advanced auditing and verification capabilities.
4. Verify the Safety of Imported Foods
Until recently, there was really no reliable way to make sure imported foods met U.S. safety standards. FSMA addresses this issue with a Foreign Supplier Verification Program (FSVP). If your business imports food, FSMA requires you to conduct a hazard analysis, evaluate your foreign suppliers’ safety performance, and verify their FSMA compliance.
In many ways, the FSVP mirrors the steps you use to assess, monitor, and verify your own compliance, so it makes sense to simply extend these same compliance processes to foreign suppliers. Once again, the right kind of auditing and compliance software platform can make this a much simpler exercise.
Begin Your Successful FSMA Journey Today
Of course, I don’t want to oversimplify or understate the scope of FSMA. Making the shift from reactive to proactive quality management certainly requires new ways of thinking, higher levels of commitment, and significant technology investments. But I also believe that wrapping FSMA requirements in these broader, more approachable categories can help you achieve compliance more confidently—and make it possible to chart a smart, efficient course through the sea of FSMA details.
For more information visit: https://9019c3a60e.nxcli.io/solutions/fsma/
by Kari Hensien | Jul 27, 2016 | FSMA, RizePoint
Why FSMA?
Here’s a (not very) shocking confession: Like most of the CEOs I know and interact with, I’m not a huge fan of government regulation. The reasons are fairly obvious. As a group, business leaders place a high value on flexibility, efficiency, and the freedom to innovate, and the restrictive bureaucracy and slow pace of today’s regulatory environment can create some fairly brisk competitive headwinds. When we’re forced to deal with those headwinds over and over again, it’s all too easy to fall into that familiar “government is the problem” mindset.
However, when we collectively take a step back, it’s not that difficult for even the most laissez-faire and individualistic business leaders among us to see the other side of the regulations coin. Because in addition to running businesses, we’re all people with lives and families who recognize the value of a society where we can consistently count on the quality and safety of the food and water we consume, whether it’s buying produce at the grocery store or enjoying a meal at a local restaurant.
And of course, if you run a food manufacturing or food service business, you simply can’t ignore the often irreparable damage that even one food safety incident can inflict on your brand and reputation. Recent headlines are filled with cautionary tales that none of us can afford to ignore. Images of CEOs appearing before various congressional committees, struggling to answer questions about foodborne illness outbreaks at their companies, have kept many of us up at night. And if they haven’t, they probably should.
Understand
That leads us to the Food Safety Modernization Act (FSMA), which represents perhaps the largest and most sweeping reforms to food safety regulations since before World War II. Given all of the complex tensions between our legitimate impulses to avoid the costs and burdens of regulation, our basic human desire for safe food and water, and the tremendously damaging impact foodborne illnesses can have on our businesses, how should smart CEOs approach and prioritize FSMA? Should we dismiss it as another case of “government overreach” and work to minimize its impact in our organizations? Or does it make better business sense to fully embrace FSMA—and use it as a tool to confront and eliminate the potentially disastrous consequences of poor food safety?
To find the best answers to these questions, it’s important to explore some of the core motivations behind FSMA and understand what it’s designed to accomplish. In many ways, FSMA was born from a shared recognition among food industry leaders, the FDA, and consumers that—given the nearly 48 million cases of foodborne illnesses in the United States each year—it was high time to make major changes to food safety practices on a national scale. This led to a collaborative effort among the food industry, consumer groups, and the government to rethink and modernize food safety practices, and this work eventually coalesced into a basic outline for the final FSMA legislation.
Prioritize
Unlike previous food safety legislation, FSMA focuses on using rigorous Hazard Analysis and Critical Control Points to proactively identify and eliminate risks before problems occur—rather than reacting to issues and outbreaks after the fact. This includes new standards for testing and manufacturing processes, mandatory registration and reporting, and other requirements. Although it may be tempting for CEOs and boards of directors to view these additional rules as government-imposed burdens, I believe FSMA—with its proactive, preventative approach—actually creates interesting opportunities for smart business leaders. By understanding, embracing, and prioritizing FSMA, you can avoid food safety problems and prevent outbreaks before they damage your business and reputation, rather than scrambling to repair the damage after it’s too late. And with FSMA, you embed food safety practices and protocols into the heart of your organization, which translates directly into a safer, more sustainable food system.
Embrace
One final note. FSMA compliance certainly isn’t easy. But with the right approach, it is possible to meet FSMA requirements and take advantage of the legitimate business benefits it offers without slowing your business down or sending operational costs through the roof. We have plenty of experts at RizePoint who would love to share their ideas—whether it’s integrating Hazard Analysis and Preventative Controls into your food safety plan or leveraging today’s latest cloud and mobile technology to streamline how you monitor, audit, and document your FSMA compliance efforts.
In the final analysis, no CEO in his or her right mind—including me—is a fan of gratuitous, burdensome regulations. But in the case of FSMA, the benefits for business leaders clearly outweigh the costs—especially if you develop a smart, efficient path to compliance. It’s time for business leaders in the food industry to get invested in FSMA and take advantage of the opportunities it provides. Because this is one case where playing by the rules is also very good for business.
by Kari Hensien | Jan 26, 2016 | Food Safety, FSMA, RizePoint
As John Knotwell described in his recent blog, “In Food We Trust,” food safety is critical for the sustainability of any food service organization. What I find interesting is that when asked the question, “Whose responsibility is food safety as it relates to contaminated food?” the answers vary depending on who is asked: growers, food service companies, or suppliers.
Whether the contamination was product-driven or behavior-driven, it is ultimately the responsibility of the restaurant to ensure that all food products are 100% safe. When this responsibility is compromised, legal implications quickly follow — and not just out-of-court settlements, but also the possibility of federal law violations. Whose reputation is hurt the most? Historically, it is where the food was consumed. However, stricter regulations backed by increased funding may help the increasing food safety saga.
FSMA and Self-Regulation
The FDA Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011. In November 2015, the FDA released additional regulations for farmers and food importers to prevent food safety problems. These added requirements are expected to reduce foodborne illness, rebuilding trust in the food supply and increasing trust in chains serving food products. It doesn’t mean, however, that food retailers should sit back and let the suppliers take on all the burden.
The FSMA provides strong incentives for self-regulation. If you consider the potential sales declines and dramatic loss of consumer confidence in your brand, the financial incentives to protect your markets and reputation are just as important as protecting public health. Unfortunately, many organizations implement changes after a situation happens, or when regulators put new laws into place like the FSMA.
FSMA Title 2 requires all facilities — including those that transport, hold or receive food — to keep records of internal audits, food safety plans, and recalls. The FDA must have access to these on-demand. This regulatory accountability makes it vital for food service enterprises to systematically track and report on internal audits and inspections.
One recent example is in the case of the restaurant chain that experienced both E.coli and NoroVirus outbreaks. After the devastating outcome that continues many months later, they have decided to go to a central supplier (versus a distributed supply chain) to reduce their risk. Of course, the organization recognizes the importance of customer safety, but they are now intensely reacting, trying to regain broken trust. Like others before them, they realize that having a centralized point of internal audit documentation — from supplier through preparation and point of sale — is critical.
Strengthen the trust between your brand and the consumer
We have all learned that life can be altered in an instant, and the food safety arena is no different. Your company may be enjoying growth and revenue success, but it can just as quickly become negative. In my previous article titled Food Safety: Are You in Control?, I spoke about how adverse publicity can have an impact on shareholder value and with your customers. Although the FSMA is designed to increase food safety across the supply chain, the ultimate responsibility lies with you and your team. Your goal of providing a safe food product and quality of service is critical. You must have a “unified source of truth” where you can identify issues, manage corrective actions, enhance business processes and assure compliance. By closing the gap in food safety compliance, you will live up to your brand promise and increase guest satisfaction. To learn more, visit https://9019c3a60e.nxcli.io/solutions/foodservice/.
About the Author
Frank Maylett is President and CEO at Steton. he brings more than 20 years of experience leading, selling and expanding software service organizations. Prior to Steton he was Executive Vice President for Global Sales, Services and Alliances at Workfront/AtTask Inc. In that role he dramatically grew SaaS revenue and increased productivity, positioning Workfront as the leader in Enterprise Work Management. Frank has also worked for inContact, Kabira Technologies, IBM and Novell. Frank is a 2014 recipient of Selling Power Magazine 50 Best Companies in America to Sell For award, ranking at number 20, and the 2013 recipient of Utah Business Magazine Sales and Marketing Executive of the Year (SAMY Award) for excellence in sales leadership.
