This month marks a huge milestone for the Food and Drug Administration and the widest-sweeping regulations for the food industry in years: The preventative controls rule in the Food Safety Modernization Act (FSMA) is now being enforced for some businesses. The new requirements put more emphasis on controlling the safety and quality of food before it reaches the consumer.
“There is an old saying among those in the regulatory bodies,” says Dan Bernkopf, vice president, food safety and quality assurance applications for SafetyChain Software. “You have to say what you do and do what you say, document it all and, at some point, make sure it is working.”
However, in the thick of daily food production with countless moving parts and processes, saying what you do and doing what you say can be challenging. More and more companies are realizing the value of automating food safety management systems (FSMSs) and leveraging technology to do so. With more stringent recordkeeping requirements, processors are striving to not only improve the data, but also the storage of and access to it. This need has fed the growth of automated FSMSs available to help the day-to-day management of a facility as well as drive overall business goals.
Automating food safety management
At the most basic level, an FSMS provides food and beverage manufacturers the ability to control documents used to track food quality and safety events. FSMA requires companies to have a written food safety plan that outlines all their standard operating procedures (SOPs) and prerequisite programs (PRPs), which are both designed to execute Good Manufacturing Practices (GMPs) and basic conditions and activities needed to maintain a hygienic environment. This also includes putting in place corrective and preventative actions if the preventative controls fail, and a food safety event occurs.
“The FSMS is there to support the food safety plans,” says Brandon Henning, industry solutions director for Sparta Systems, a provider of quality management software. “Supporting the food safety plan through manual methods may not be effective, which will lead to not passing an audit.”
Depending on the size of the company, using manual processes to track food safety and quality data for products and the supply chain can take up an abundance of time and resources. Returning emails and phone calls, doling out tasks and following up to make sure those tasks were completed require a potentially large amount of effort and people.
“When you are trying to organize, maintain and manage data and documents pertaining to food safety, the burden is enormous,” says Bernkopf.
Businesses are now expected to evaluate hazards that could affect food safety, specify what controls are in place to minimize any safety or quality risks, monitor these controls and maintain records that document all these actions, including any corrective actions.
“In order to perform well, processors should practice internal document control, record collection and management, internal audit scheduling, execution and management, supplier auditing, document and record collection and management, end-to-end batch traceability, reporting and analysis,” says Andrew Kennedy, co-founder of FoodLogiQ, software providing food traceability.
An automated FSMS is designed to help companies continuously and effectively do all this as well as interpret the data collected. Any automated system should provide processors the ability to not only store data, but be able to act on that data, identifying weaknesses before they become a liability, says Ashley Powers, sales engineer for RizePoint, compliance management software. Processors must have instant access to everything from their HAACP plans to their latest health department inspection report.
“The key part of this is the management of the data,” says Jill Bender, vice president of marketing for SafetyChain. “It’s one thing to have data organized better, but to be able to have the data to act upon, that’s really the key. Getting that information when you need it, at the most pertinent time, that’s truly what the automation should afford you to do.”
Darryle Guarino, CEO of GFSC Group Inc. and creator of Gorilladox software, says an FSMS should tie everything together for processors to save time and money and get them audit ready. The software should help processors obtain visibility at the floor level and “manage all the prerequisite programs that are required in a GFSI or HACCP program, including pest control, calibrations, everything included in multiple programs, but have it all in one place.”
Electronic management systems should provide the tools for a business to operate more efficiently. Additionally, from a logistics standpoint, automated solutions can yield many benefits and perks, says Kennedy.
“Specifically, they can help companies to minimize headcount as it is a scalable process for fast-growing companies,” he explains. “It can also work to reduce errors of commission and omission, speed up the quality and safety incident investigation and recall process, provide critical information to operations, simplify third-party audit prep—and above all, improve the product.”
Assisting in preventative controls
To help processors continuously track food safety and quality data, an automated FSMS needs to help execution of food safety actions at every level, including the entry point of ingredients and materials into a facility. Overseeing suppliers and managing their requirements can be one of the more difficult tasks to do. FoodLogiQ’s Kennedy advises processors to look for a number of tools in FSMSs to address this, such as including a supplier portal in the system and providing the capability to create and manage a supplier questionnaire.
“Importantly, a system should provide timely alerts of higher-risk profile suppliers, products and sites for quick follow-up actions,” says Sireesha Mandava, senior director of TraQtion. “This is imperative given today’s rapidly changing global supply chains and regulatory landscape.”
To do this, she explains TraQtion’s Intelligent Compliance Engine continually runs its algorithm in the background to check and send alerts, helping to provide faster visibility to problem areas and prioritizing critical responses. Also, enhanced product evaluations are done to automatically identify products that meet or do not meet specifications.
“FSMSs should have the capability to track supply chains to any number of levels,” Mandava says. “The advanced systems will go beyond that to assess risks based on the ongoing activity in the supply chain.”
Having more visibility into the supply chain through automated processes can help processors control the materials coming into their facilities by making sure suppliers are in compliance. This visibility can be achieved by better managing the process of selecting and qualifying suppliers as well as ongoing monitoring.
“This can include support for supplier scorecards, management of approved supplier lists, the tracking of supplier nonconformances and resulting corrective and preventative actions (CAPAs), and the facilitation of supplier audits,” says Henning.
For instance, Gorilladox software has a proof of suppliers program, which allows companies to enter suppliers’ contact information. Notifications are sent out whenever updated documents need to be resubmitted, and corrective action requests are automatically created if a renewal date passes. Additionally, suppliers are automatically rated based on the promptness of their replies.
Mobile record collection is another feature of an automated FSMS to streamline and optimize execution of a food safety plan. Before cloud- and mobile-based technologies, desktop software solutions limited the ability of quality assurance teams to be out on the floor monitoring food safety compliance or to go anywhere else besides behind a desk.
“It’s managing data at the point of origin and being able to act upon it then that are probably the most relevant benefits of automating the process,” says SafetyChain’s Bender. “For instance, collecting data on a tablet versus a manual form—it’s a smart workflow that has an available app that has all your requirements and specifications within it.”
This pertains to multiple situations wherever the need may be, such as someone on the plant floor or the receiving dock. The employee can input data and get instant results regarding whether the product meets the specs, and if it does not, an alert activates immediately.
“SafetyChain now has interactive electronic forms that if there is a noncompliant event, actionable instructions are given to begin the resolution of what just occurred,” says Bernkopf. “When a noncompliant event is entered into the electronic form and is submitted as a record, an immediate notification goes out to the appropriate stakeholder.”
However, an out-of-spec notification via paper forms would be noticed only at the end of a period time, possibly at the end of the shift or even production day. The automated system demonstrates a huge reduction in the time lag between recording a problem and acting upon it. “This is fabulous for food safety,” says Bernkopf. “It can actually prevent products with issues going into commerce, or it can reduce the amount of product involved.”
FSMA’s preventative controls stipulate that food and beverage manufacturers need to fill any gaps in the food safety plan. This could include, but is not limited to, process controls, allergen controls, sanitation controls, etc. Bender says using a mobile approach to catch any issues and dealing with them earlier are very parallel to the FSMA preventative approach.
Managing and maintaining in the cloud
As noted, cloud-based software has revolutionized food safety management. Employees are able to be more mobile and have easier and faster access to the information they need. Plus, automating a facility’s day-to-day food safety management frees up time to look at the bigger picture of the operations. Having an easy-to-read dashboard accessible from anywhere providing accurate data visualization in real time can allow more insight into long-term trending.
“Quality and compliance are automatically tracked from macro to micro detail, problems are anticipated, and corrective measures can be taken immediately, from anywhere at any time,” says Mandava.
All the data collected, even from multiple facilities, goes into a central repository and can be assessed from this location. Information contained in an automated FSMS could include product test results, in-bound certification of analyses (COA), CAPA data and more. Looking for long-term trending information using a manual paper record process has traditionally required reentering data. Paper forms usually contain many data points, and to create a history of one data point, every one of those forms that have that data needs to be gathered up and reprocessed.
“But with electronic forms, it’s entering data once and done,” says Bernkopf. “With paper recordkeeping, you are data rich and information poor, meaning you have to recombine it to get information. With electronic documents, you don’t have to do that, so you are data rich and information rich.”
Food companies are being watched more closely by consumers now than perhaps ever, and any product problem can be instantly broadcast to the world via social media. A streamlined, automated approach allows companies to quickly identify issues before they become disasters for a brand, says Powers.
“Also, the in-depth business analytics help clarify and provide transparency into the organization at all levels,” she says, adding that more information integrated into a unified source will result in better reporting and trend analysis as well as generate actionable items to ensure follow through. “By having a strong FSMS, companies have the ability to maintain and update assessments and enterprise compliance information. If the information is automated, updates get pushed out in real time to everyone who needs the information.”
With the manual notification process, the room for human error grows since people can be inadvertently left off distribution lists or other mishaps. Additionally, cloud-based systems are particularly useful to communicate food safety information for companies that have multiple plants since they allow accessibility to the system from any computer or device connected, anywhere in the world. Moreover, automated FSMSs can connect personnel, both those inside the company and outside of it.
“A key advantage of employing a cloud-based system is that data can move seamlessly between external entities, such as suppliers, auditors, labs or transportation, and internal departments within an enterprise,” says FoodLogiQ’s Kennedy. “An additional benefit is that software updates are pushed instantly to all users.” Also, if the regulations shift, cloud-based FSMSs can be quickly updated to conform to changes, rule revisions and/or best practices.
Automated workflow and automated reminders do a lot of the heavy lifting of food safety management, but of course, employees have to be able to actually use the software. Guarino focused on this aspect of usability when he built Gorilladox. With his 20 years of experience in food and beverage plants, he wanted his software to be tailored to the end-user on the floor.
“We built the system to cover the gaps,” he says. “It’s very user friendly. People can learn it, even those who never turned on a computer; that’s the litmus test.”
The ultimate goal of performing all food safety tasks is to produce safe and quality products. The goal of managing these activities well is to be ready for auditors and anyone else who may unexpectedly inspect your facility. As with the major changes happening to food safety regulations, the auditing process is also evolving. GFSC Group’s Guarino explains that in the past, companies used to just hand over piles of documents to auditors, and that was enough.
“Those days are over. Today’s GFSI auditors are dialed in—they are going to read your plan and challenge you to prove it. That’s where more documents are not better,” he says, which is why automated FSMSs should be more direct. “What you want to do is have your employees prove they are doing the action, then verify and validate that action.”
Government auditors are not the only ones who might come knocking to inspect a facility. Third-party and internal audits might be done for a variety of reasons, such as companies genuinely desiring improved food safety practices, troubleshooting, marketing purposes or adhering to a customer’s requirement. In addition to the increasing amount of entities asking about food safety and quality practices, the speed of business has also ramped up.
“The current environment we are in is that when someone asks a question—whether that is a retailer, consumer or regulatory body—you need to instantly answer,” says SafetyChain’s Bernkopf.
Being able to produce the data from any facility anywhere in a matter of seconds is becoming more than just a perk, but rather expected in this business climate. An automated FSMS contains all data, documents and plans in one place, so responding to an inquiry can be achieved by just logging in.
Sidebar: Choosing a GFSI-recognized scheme
The Global Food Safety Initiative (GFSI) is a global, industry-driven collaborative platform to advance food safety. The main objective is to provide thought leadership and guidance on food safety management systems necessary for safety along the supply chain.
GFSI is not a scheme in itself, nor does it carry out accreditation or certification activities, but it does recognize food safety management schemes. Schemes are assessed against the GFSI Guidance Document, which contains internationally recognized food safety requirements developed by multi-stakeholders. If successful, the scheme attains formal recognition.
Food businesses can select from a variety of these schemes, which include FSSC 22000, SQF and BRC. However, it can be a bit daunting when first evaluating the myriad schemes and determining the best fit for the facility’s needs. The first step to choosing one is to find out which suits the specific activity.
“In my experience with GFSI schemes, SQF has great support in the US for food companies, logistics and importers,” says Andrew Kennedy, co-founder of FoodLogiQ. “For fresh produce, GlobalGAP and Primus GFS are currently recognized, and the USDA AMS is working on certifying a GAP standard.”
Ashley Powers, sales engineer for RizePoint, advises processors to “always choose a scheme that is the most universal and most widely reviewed. This could be different depending on what country the company is in and does business with.”