Nobody can afford a recall. But if you have to initiate one, you want to keep it as small as possible. And if you have to fumble around looking for your HACCP documentation and paper or Excel records showing you met your CCP criteria, you may inadvertently recall several weeks’ worth of production when only a single day’s or shift’s production would have been necessary. So, if you’re still running on paper or Excel, it’s time to think about committing to electronic recordkeeping and HACCP software.
Fortunately, the architecture of today’s HACCP software and other allied quality assurance tools makes these systems available to a wider audience of processors that can’t afford to be without them. In many cases, the software is available in a SaaS (software as a service) or cloud model (that allows users to pay a monthly fee based on their needs). With these options, users don’t need to buy servers and databases and invest in a complex, secure network infrastructure. And since most systems are browser based, users can operate them on mobile devices on the plant floor or workstations running Windows, Mac, Linux or UNIX operating systems. In addition, most of these tools also integrate seamlessly with ERP and shop floor data collection and analysis/control systems.
Compliance and HACCP tools
Under the Food Safety Modernization Act (FSMA), FDA-regulated food processors are “to comply with the requirements for hazard analysis and risk-based preventive controls (HARPC).” This means facilities must evaluate hazards, identify and implement preventive controls to address hazards, verify the preventive controls are adequate to control identified hazards, take corrective action when needed and maintain a written plan and documentation.
HACCP is not necessarily without risk, nor is it a typical quality control inspection program. By definition, HARPC takes HACCP a step further, introducing a feedback loop, providing control over the entire process—much like controls theory (albeit a simple and quick analogy). HACCP software—once thought of as a way of generating forms to document a HACCP plan—has been extended by many software providers to follow the HARPC model by providing additional support for preventive controls.
Designed on the CODEX-based principles of risk assessment and the identification of controls for all hazards, Icicle software automatically generates all the forms required to meet a CODEX-based HACCP system, according to Steve Burton, CEO of Burton Software Inc. With the software, processors work with the elements with which they are familiar (e.g., products, ingredients, formulae, processes, etc.); a wizard helps them complete hazard analyses and address the issue of risk. The system then generates a set of 12 functional forms, including the HACCP plan and a change log.
“Any changes needed in formulation, ingredient packaging or equipment are easily updated and automatically changed on all forms involved,” says Greig Beilhartz, a food and safety consultant who served for 31 years as a Canadian government inspector and trainer for the CFIA. The cloud-based software supports SQF Level 3, BRC and Canada’s FSEP with full support for ISO 22000 in the offing, says Burton. The software can be an affordable solution, even for very small processors.
“I think it is very important for the industry to understand the difference between HACCP compatible and HACCP compliant,” says Greg Quas, HACCP Builder president. “Many [software] products say they are HACCP compliant, when in all actuality, they can only be HACCP compatible—because to be compliant means you need to have a complete program in place.” HACCP Builder has released an FSIS module, designed specifically to address 2013 FSIS HACCP enforcement, for facilities regulated by FSIS.
“EtQ provides a web interface to document all the information regarding a HACCP plan,” says Bhavin Virani, EtQ senior implementation specialist. The HACCP plan is broken down into different process steps, which provide detailed information about the overall HACCP plan. The system then gives the user the ability to identify hazards identified with each step and provide a risk analysis. There is an opportunity to identify controls to mitigate the risk. EtQ also provides the ability to identify monitoring procedures for the HACCP plan and generate monitoring records, which become the evidence of HACCP monitoring.
SafetyChain software, which was designed to support food safety and quality assurance (FSQA) documentation and data controls throughout the supply chain, provides the ability to set up, manage and maintain USDA or internal HACCP, FDA preventive controls and GFSI schema programs, according to Barbara Levin, SafetyChain senior vice president and co-founder. The system was originally developed with a focus on USDA HACCP regulations, and includes the ability to aggregate food safety data for USDA’s required preshipment review as well as quality attribute data for GFSI and internal positive release programs. The software provides the ability to associate documentation, including prerequisite programs (e.g., GMP, sanitation, preventive maintenance, food defense, etc.) within the software system while supporting HACCP/preventive controls. According to Levin, the software has embedded within it the GFSI code for BRC, SQF and FSSC 22000, which can be used as a cross-reference tool.
Interfacing with a facility’s process controls is an important aspect connected with HACCP-compatible software. CAT2’s Food Safety and Quality Management tool (also known as HAT) allows operators to collect weight, size, temperature, grading and defect data on the plant floor and perform yield, retention and AQL (acceptance quality limits) checks, according to Rachel Shaver, CAT2 training manager. When values enter an alarm state, a page, text message, email or scoreboard alert notifies plant personnel, allowing them to respond immediately and proactively to the process, reducing failures and downtime and improving efficiency. “For HACCP and prerequisite checks, failures can also be tagged, generating an electronic corrective action/preventive action form,” Shaver says.
While ensuring electronic records conform to 21 CFR Part 11 in terms of electronic signatures has become a way of life in pharmaceuticals, electronic signatures also are becoming more important in the food and beverage industry. “We have installed solutions on sites where customers have had approved BRC and FDA audits,” says Seamus McNamara, Verify Traceability director. “Our systems are designed for compliance with 21 CFR Part 11 and in compliance with GAMP 5 [Good Automated Manufacturing Practice, a pharma industry directive]. Our solutions provide a complete, paperless management system for HACCP, traceability and total quality control. The system can also alert management automatically when there is a reading outside limits.”
“Our HACCP software provides a solution for the development of HACCP studies and specific CCP forms, as well as data collection and reporting,” says George Howlett, Safefood 360 CEO. Besides being based on various HACCP models including CODEX and USDA, the software is also fully compliant with FDA electronic records and electronic signatures (21 CFR Part 11). “The software comes complete with all the modules needed to meet the requirements for a complete food safety program under GFSI, FSMA and retailer standards.” These include management systems, general prerequisite programs (PRPs), operational controls (CCPs), LIMS (laboratory information management system), document control, alerts and action management.
“A key step to building a HACCP plan for a [food or beverage] product involves assessing the associated risks related to biological, chemical and physical hazards that may be present in the manufacturing process,” says Jim Shepherd, Plex Systems, vice president of strategy. “The Plex Manufacturing Cloud provides a framework for logging and classifying each potential hazard, and also has the ability to log the probability of occurrence and severity if this issue does occur.” The system allows operators to associate a corrective and/or preventive action procedure to the CCP within the HACCP program. So far, the regulating bodies haven’t formed a consensus on the appearance of a HACCP document, but if processors follow the widely accepted HACCP or HARPC (as described in FSMA) procedures and document the results, they should be in compliance, adds Shepherd.
Dealing with suppliers adds another dimension to the process—one that is often out of a processor’s control. However, a TraceGains system can not only model an internal HACCP process flow, it can track the COAs (certificates of analysis) of each incoming ingredient lot and all supplier documentation, says William R. Pape, TraceGains Inc., executive vice president.
Other modules can be used to handle supplier data, according to Pape. Supplier document management provides a full-service management program for all supplier documents. The supplier compliance module provides tracking programs to ensure each received lot meets compliance and ties together all the information silos: purchasing, COA, receiving, in-house or third-party lab testing, and floor feedback. The supplier impact module provides a 360° view of each supplier and allows the evaluation of its goods based on more than just price and on-time delivery.
It’s up in the clouds
Although SaaS has many benefits such as continuous feature and maintenance updates, an affordable monthly charge, built-in security and no onsite hosting equipment, some companies complain about proprietary formats and being locked in forever to one supplier. Consequently, many large food and beverage processors with their own IT staffs are not so eager to move their applications into the cloud; they prefer having control over their own data and don’t mind operating server farms, security systems and all the other network infrastructure that goes into maintaining large systems.
But TraceGains’ product is available only as a SaaS, according to Pape. The same is true for SafetyChain, Safefood 360, HACCP Builder, Verify Traceability and Plex’s HACCP software, which is part of the Plex Manufacturing Cloud. Look for a cloud version of CAT2’s solution in early 2014. The trend is definitely in moving to cloud-based software.
“The vision of Burton Software [provider of Icicle] is to make enterprise-grade technology, normally available to large companies with in-house IT staffs, server rooms and heavy-duty database systems, affordable to all food manufacturers—even very small food producers—since users only need a browser and an Internet connection,” says Burton. The system also can operate as an on-premise implementation, since some companies have expressed cloud trust concerns. “The concern is rare because cloud hosting providers’ data centers are more secure than those of most food production facilities, and the cost of deploying and maintaining an enterprise-grade system locally is simply not feasible for Icicle clients compared to the low marginal cost of a cloud-based solution,” explains Burton.
Though it hasn’t been the norm for ERP systems to provide HACCP modules, ERP systems can be a repository for data collected from instrumentation systems, which can be used to verify a HACCP plan is working. “We have all the data necessary once you have defined your HACCP plan and implemented your operational systems [e.g., modules to support advanced graphical track and trace, QI or LIMS],” says Mike Edgett, Infor, director of industry marketing, process manufacturing. “Control of the supply chain and business process must lie within the ERP, LIMS, etc. We can trigger events when we cross any kind of boundaries defined in a HACCP plan or when we have any kind of nonconformance incidents.”
“It is important that the quality data collection system work in conjunction with the HACCP program,” states Plex’s Shepherd. The Plex Manufacturing Cloud facilitates data collection for critical control points through mobile devices and mobile scanning devices. This information collected through the Plex quality system can be compiled, analyzed and used to alert quality managers of issues related to the HACCP plan or any other quality issue, adds Shepherd.
Some software providers that have built shop floor systems over the years and added HACCP modules to them also have other connected modules that complement HACCP. For example, CAT2’s Shaver notes that LIMS and traceability are essential, but an inventory control module also is necessary to place a product on hold and prevent it from being shipped if a food safety or quality problem is detected. Other software modules in the CAT2 system handle live weighing and receiving, dry goods receiving, mixing, production control and labeling, yields, warehouse management and executive reporting.
“We have a HACCP module that integrates with our shop floor production management system,” says McNamara. “We have a complete end-to-end business management platform for food companies that also integrates with accounting systems like QuickBooks and SAGE, etc.”
SafetyChain’s platform is built on a modular solution. While many other modules are available, they are not necessary to run the HACCP module within the platform, according to Levin. Some modules support supplier document compliance and COA automation; in-bound receiving logs; external and internal lab integration; FSQA mobile data capture; FSQA automation from equipment; comprehensive, real-time analysis of FSQA data to specifications, with real-time alerting when deviations are found; scheduling of FSQA tasks with real-time notifications; outbound COA generation; preshipment reviews; regulatory/third-party and customer compliance; and audit automation.
Virani lists modules that support HACCP in EtQ’s software suite. For example, one module identifies corrective actions, should there be a deviation from the standard procedure. An audits module reviews processes and HACCP plans to ensure the correct procedures are followed. An employee training module documents training records related to the HACCP plan, while the document control module provides a system to manage supporting procedures.
With the ability for HACCP software to live in the cloud, comes the question: Should processors make it easy to communicate with their suppliers and customers? After all, the security is built in, so it’s a matter of who sees what and how much.
Safefood 360’s Howlett says a processor can set up a portal where all its suppliers can access the elements of the processor’s HACCP control program relevant to them. Various actions such as risk assessment, self-assessment, specification upload and management, HACCP program management, audit programs, certification programs and nonconformance management can all be handled. The software supports this functionality out of the box, without the need for installation or IT support.
Pape notes a supplier portal should be configured to show only selected data to suppliers. The TraceGains system can be configured to send real-time e-notifications to suppliers when various nonconformances are encountered.
Ideally, opening the portal to suppliers allows for quality management throughout the entire supply chain, adds McNamara. One module, VerifyFood.com, from Verify Traceability is designed to provide complete supply chain traceability and HACCP management.
Yes, open a portal as part of an audit, says EtQ’s Virani. “The determination can be made on a need basis depending on the involvement of the supplier in HACCP and how much impact it has. It is crucial that suppliers are aware of the critical control points so those risks are mitigated on their end before [their products] arrive at the processor’s dock,” he adds.
“The decision to allow vendors and customers entry into the SafetyChain solution is strictly up to each subscribing company,” says Levin. “Yes, it can be accessed in whole or part. The SafetyChain platform has rules- and roles-based security built into the application. This allows any SafetyChain user to give access to its suppliers or customers if it deems it to be appropriate.”
Data can be tailored according to each supplier. “To protect your privacy and data integrity, we suggest creating web-based reports with security parameters,” says CAT2’s Shaver. “These reports can be accessed on an as-needed basis or sent via email out on a subscription basis.”
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Many HACCP solutions are available to help processors meet both regulatory and customer demands—and get a handle on product quality and consistency. HACCP solutions are available as standalone systems with communication to other systems; they can also be found in some ERP systems, shop floor software, quality systems and supply chain systems—to name a few. Pay-as-you-go SaaS solutions provide processors the opportunity to investigate their options now, before customers demand electronic records and proof of HACCP/HARPC systems.
Shaver provides a great takeaway: “In my opinion, the two most troublesome aspects of managing HACCP are not knowing about deviations when they occur and having to dig through file cabinets or multiple Excel spreadsheets to retrieve data. The more time that goes by, the more product that will need to be retained, and the more you have to search for information, the more time and money are lost.” v
For more information:
Greg Quas, HACCP Builder, 866-577-4030, ext. 1, firstname.lastname@example.org
Bhavin Virani, EtQ, 800-354-4476, email@example.com
Barbara Levin, SafetyChain Software, 888-235-7540, firstname.lastname@example.org
Rachel Shaver, CAT2, 501-328-9178, email@example.com
Steven Burton, Burton Software Inc., 604-231-1650, firstname.lastname@example.org
Seamus McNamara, Verify Traceability, 00353 61 338393, email@example.com
George Howlett, Safefood 360, 646-360-0210, firstname.lastname@example.org
Jim Shepherd, Plex Systems, 248-391-8001, email@example.com
William R. Pape, TraceGains Inc., 720-465-9400, firstname.lastname@example.org
Mike Edgett, Infor, 800-260-2640, email@example.com
What are hazard analysis and risk-based preventive controls?
FDA’s proposed hazard analysis and risk-based preventive control requirements are similar to Hazard Analysis and Critical Control Points (HACCP) systems, which were pioneered by the food industry and are required by FDA for juice and seafood. Under the proposed rule, operators of a facility would be required to understand the hazards that are reasonably likely to occur in their operation and put into place preventive controls to minimize or prevent the hazards. Although this proposed rule aligns well with HACCP, it differs in that preventive controls may be required at points other than critical control points, and critical limits would not be required for all preventive controls.
Each covered facility would be required to prepare and implement a written food safety plan, which would include the following:
• A hazard analysis that identifies and evaluates known or reasonably foreseeable hazards for each type of food manufactured, processed, packed or held at the facility.
• Preventive controls, which would be required to be identified and implemented to assure hazards that are reasonably likely to occur will be significantly minimized or prevented. Preventive controls would be required to include, as appropriate: (1) process controls, (2) food allergen controls, (3) sanitation controls and (4) a recall plan. However, the preventive controls required would depend on which, if any, hazards are reasonably likely to occur.
• Monitoring procedures to provide assurance that preventive controls are consistently performed and records to document the monitoring.
• Corrective actions that would be used if preventive controls are not properly implemented. Processors would be required to correct problems and minimize the likelihood of recurrence, evaluate the food for safety and prevent affected food from entering commerce when necessary. If specific corrective action procedures were not identified for the problem, or if a preventive control were found to be ineffective, the facility would also be required to reevaluate the food safety plan to determine whether modifications are needed.
• Verification activities to ensure preventive controls are effective and consistently implemented. Verification activities might include validation the preventive controls are adequate for their purpose and are effective in controlling the hazard, activities to verify that controls are operating as intended and a review of monitoring records.
• Recordkeeping, starting with a written food safety plan, including a hazard analysis. Processors also would be required to keep records of preventive controls, monitoring, corrective actions and verification.
A qualified individual would be required to prepare the food safety plan, develop the hazard analysis, validate the preventive controls, review records and conduct a reanalysis of the food safety plan (or oversee these activities). To be qualified, an individual would be required to successfully complete training in accordance with a standardized curriculum or be otherwise qualified through job experience to develop and apply a food safety system.
For more details, visit “FSMA Proposed Rule for Preventive Controls for Human Food: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food,” FDA website.
Bringing HACCP and traceability to the small business
In business for more than 40 years, Dublin, Ireland-based Le Gourmet Wholefoods specializes in the importation, repackaging, sale and distribution of ethnic and domestic dried food products.
“Traceability, quality and food safety are all key items for success in a food business today. As legislation requirements in these areas continue to grow, we needed a cost-effective system to manage these issues without adding significant operating cost burdens,” says Owner Hugo Karlsson Smythe.
“When we moved to our new, modern facilities in Tallaght, it was the perfect opportunity for us to fully automate our complete business process. The eQ Trace platform [from Verify Traceability] has a comprehensive suite of modules that allows us to link all of our operations into one automated, business process,” explains Hugo.
“The eQ Trace system allows us to offer a level of service comparable to, or surpassing, that of very large organizations. Great emphasis has been given to quality systems, food safety management, HACCP and traceability, allowing us to fulfill current EU and Irish Health Regulations to the highest standards.”
Food safety demands tracking suppliers
Ottens Flavors is a 127-year-old Philadelphia-based company that develops and markets flavors across the globe. Ottens’ products are sold to hundreds of food manufacturers, including the major brands known throughout the US and the world.
Ottens was experiencing escalating expectations from its customers. New pressures, including the Food Safety Modernization Act, BRC, Global Food Safety Initiative, HACCP documentation, food quality, food safety audits and compliance requirements, put added accountability on Ottens and its global footprint. The company chose TraceGains as a solution to address its volume of suppliers and the data the suppliers were generating.
“TraceGains helped us with document control, cost-oriented automation and supplier scorecarding,” says Greg Rowe, supply chain manager for Ottens Flavors. “We are now able to automate our processes. That really helps us reduce the headcount from an automation point of view. It also helps us be in compliance with BRC audits.”
Cathy Templeton, director of global quality systems at Ottens Flavors, explains that, from a quality perspective, she needs to evaluate how Ottens is doing in getting certificates of analysis on time and in compliance with Ottens’ specifications. Additionally, she looks at vendor compliance with raw materials and performance. “TraceGains brings all these pieces together so we can track our performance in all aspects of our relationships with vendors,” says Templeton.