Don’t do “it” because FDA says so, or the USDA, or ISO, or any other regulatory agency. Do “it” because it makes sense-dollars and cents! “It” refers to best practices. When a manufacturer implements a best practices strategy, it minimizes problems with food safety and produces a better bottom line. Processors can pursue best practices without the help of automation, but will find in today’s competitive world that automation is a prerequisite to be a supplier to many retailers such as Wal-Mart in the US and Tesco in the UK.
But one size doesn’t fit all. “Food and beverage manufacturing processes vary tremendously from production process to production process as well as in the size of the company and facility. It would be incorrect to define a single best practice for all food and beverage facilities,” says Paul Moylan, Rockwell global food and beverage industry leader.
James Stanley, Emerson Process business development specialist, suggests that certain “shared best practices” probably exist in general, but the methods used by any one producer may be so specialized and proprietary that these “best practices” might even be considered intellectual property, which can give a producer an edge over its competition.
Where best practices startIn the food and beverage industries, best practices begin with good manufacturing practices (GMP) as covered in FDA’s 21 CFR 110.80. Gerry Broski, marketing manager for Thermo Fisher Scientific, concentrates on the basics. “The fundamentals of best practices in the food industry start with a good Hazardous Area Critical Control Point (HACCP) plan.” A common CCP is an in-line metal detector designed to prevent metal contaminants from making it through the production process to a customer. Other points might include freeze temperatures and times, sterilization temperature and hold time.
As though FDA’s basic rules weren’t enough, FDA Section 555.250 Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens (2001) and the Bioterrorism Act of 2002 have given manufacturers new challenges. Karen Roberts, Cognex senior marketing manager, suggests that the risks for a manufacturer in not taking 555.250 seriously can result in consumer litigation, FDA recalls, recall expenses and loss of brand image. FDA has enacted various labeling laws to address the disclosure of product content. Solutions to making sure labeling is correct include the proper applications of vision systems and bar code scanners to verify that the right product goes into specified containers.
There is pressure on small food companies in the next year to become compliant with FDA 21 CFR Part 11, which requires them to track and trace ingredients, monitor and control key process variables (such as temperature, water content, humidity, pressure, etc.), and track products as they are shipped. The use of electronic signatures and record keeping, while not an FDA mandate, certainly makes it much easier to produce records quickly and potentially limit the extent of a recall. According to GE food & beverage Marketing Manager Brandon Henning, while most companies follow some internal best practices when it comes to complying with 21 CFR, much of the food industry lags behind the pharma industry, especially in the automation necessary to execute it.
Jeff Baxter, Progressive Software Solutions (PS2) systems engineer, sees a two-part problem with FDA regulations. First, though the FDA enforces HACCP well, it has problems enforcing other regulations on a consistent basis. Second is getting processors to sign on to 21 CFR Part 11. Many smaller food companies don’t take electronic record keeping seriously. They rationalize, “well, we recognize it’s a bit of a gamble, but what do you think the odds are that the FDA is going to spotlight us?” When Baxter asks them if they can manually produce the required information in a day’s time, the response is typically, “we think we can.”
Compliance with regulations, according to Gavin Clements, LINK business manager at FMC FoodTech, probably has more to do with human nature than technology. He says FDA documents tend to be relatively generic but with a lot of content, which can be open to interpretation depending the processor’s location and individual FDA inspector. Clements feels that even HACCP regulations are left open to interpretation in how they’re applied. What’s more, even though FMC FoodTech supplies 21 CFR Part 11 compliant equipment and software, the end user must still take the initiative to use it properly.
In addition to the FDA regulations, ISO has defined a new specification (ISO 22000:2005), which further addresses food safety management. ISO would like manufacturers to use ISO 9001 to address quality management. According to food quality and safety consultant and Clemson Professor Emeritus John Surak, both ISO standards have similar and compatible structures. ISO 22000 incorporates the five preliminary steps and the seven principles of HACCP. Surak sees the strength of ISO 22000 in its ability to link a producer’s quality management system to its business process by establishing a food safety policy with measurable objectives and increasing management responsibilities for the food safety team leader. (For more on ISO 22000, see sidebar below.)
Automation helpsBest practices is a business strategy and can be augmented by automation. RedPrairie’s VP of Product Marketing, Tom Kozenski, suggests that processors pursue best practices with an integrated hardware/software approach. While the hardware monitors the mixing process, the software tracks all of the components that make up the finished goods. However, manufacturers must make GMPs part of best practices. Wonderware’s third party manager, Jay Jeffries, likens GMPs as defined in FDA’s 21 CFR 110.80 as providing the rules of discipline that any food manufacturer needs to follow, for example recording temperatures at critical control points. Automation serves as the “notebook” or repository that records all the crucial data with time stamps so humans don’t have to do it manually.
Matt Ruth, director of the food and beverage group at Advanced Automation, stresses stick-to-itiveness and goal setting. “Best practices are ones where you sit down, define what you want to accomplish, and actually stick to the task.” To make best practices work, engineers and managers must be able to translate these practices and align them with their company’s goals. For small companies that can’t afford large automation systems, Ruth recommends goal setting centered around food quality, efficiency, reuse of system designs and traceability, and then developing a platform that provides any or all of these goals incrementally within a planned budget.
Gary Gold, vice president of Berner Foods, has some suggestions for small companies instituting a best practices strategy. It’s worked for Berner; its number of employees has tripled in four years, overall equipment effectiveness (OEE) has gone from 28% to 45-50%, and production output has zoomed. Gold suggests the following:
- Don’t look behind to see what competitors are following you; keep going forward relentlessly.
- Adopt all regulatory standards (FDA, USDA, ISO, etc.) and invite the inspectors to hang around.
- Take on each and every quality aspect of the business and embrace them all.
- Welcome outsiders to tell you what you’re doing wrong.
- Have a ten-year plan going forward with a no-exit strategy.
- Keep all employees up to speed on the company’s progress. A smart workforce is a key best practices strategy.
- Have the right software tools keyed to your business.
Best practices needs to be all inclusive. For example, Kevin Mellor, director process technology at ConAgra, says that his company is defining best practices at all levels-from how operators run machines to the use of HMI and SCADA systems, and right up to the enterprise level SAP. Real-time plant floor data, along with sales data, needs to be available throughout the organization. Operating plants, however, should not forget how important it is to establish best practices for handling such seemingly mundane tasks as putting new roll stock on machines. On a Benhil margarine stick machine, for example, operators helped reduce the time it takes to change a roll from an average 26 seconds to 6 seconds. As part of best practices the operation is video-taped, and a simple set of instructions is made available for training or reference. ConAgra uses this same philosophy to develop a set of best practices for every operation and task within the entire corporation.
According to Greg Lisso, vice president, engineering and environmental affairs of Pilgrim’s Pride, best practices are shared across every area of his company’s business through a process of continuous improvement (CI). “[CI] helps drive achievement of our company vision, mission statement and strategic business goals. Each area of our business develops operational best practices that are aligned with these goals. Several of these best practices are related to automation and controls.” For example, his corporate engineering group uses best practices to help design, evaluate, implement and manage automation projects. The engineering group works closely with the corporate risk management and procurement departments, using best practices to pre-qualify potential vendors and suppliers and manage contractual relationships.
Equipment solutions should work togetherPoint-source FDA-compliant solutions can be embedded in equipment that is used at CCPs. Clements says his company is embedding 21 CFR Part 11-compliant software in equipment such as freezers and cookers. With the records produced by the software, manufacturers can quickly narrow down a run of undercooked burgers not meeting spec-not only satisfying FDA rules, but also preventing waste and potential recall of an unaffected product run. When a manufacturer adds more equipment at CCPs, it can tie the data outputs together via serial connections or an Ethernet LAN into a computer with additional software such as FoodTech’s LINK or an MES product.
In addition to LAN technologies, newer device technologies are providing the feedback necessary to get useful data more easily and cheaply to monitor machines. According to John Kowal, Elau global marketing manager, because a servomotor provides feedback on the torque it applies to a cap on a bottle, for example, 100% verification of proper cap application is now possible. In addition, mechatronic packaging machine designs that originated in pharma are also finding their way into food. In mechatronics, servos replace complex and contamination-prone mechanical drivetrains. Finally, Kowal sees an interest among food and beverage makers in the software tools used in the pharma industry to support traceability, manage program changes and simplify validation.
While manufacturers purchase various metal detectors to satisfy FDA requirements and their own food quality needs, these inspection systems shouldn’t be just another point-source application. Mark D’Onofrio, Lock Inspection Systems VP and general manager, is surprised by how few food manufacturers are tying their metal detection systems into a central data management system. “Tracking batch runs and contaminant events today is just as important as the inspection system itself,” he says. When buying metal detectors, the manufacturer should have connectivity clearly in mind and make sure that whatever it buys can be easily set up to work with a management system, which also automates the recordkeeping process. D’Onofrio observes that many processors are still relying on hand-written line reports.
Another word of advice concerns the mechanical connection of equipment-the conveyor. Scott Lucas, president, Dorner Manufacturing, suggests that conveyors should no longer be a last-minute item to order in an automated packaging line. To maximize OEE, careful consideration should be given to speed, capacity, footprint, sanitation requirements, guiding, wear items and most important-product transfer and equipment interfaces. Is there indexing required or a servo motor? What PLC will be used? How will real-time information be communicated for the packaging line? This up-front work helps meet the OEE goals for an automated packaging line once installed.
Software solutionsSoftware should encapsulate best practices, foster continuous improvement, and be simple enough for operators to use, but challenge them to greater productivity. Stanley relates his experiences of running a food plant in the past by saying that it was sometimes necessary to “dumb the process down,” not because the operators weren’t intelligent, but to build in interlocks. Today, he says, operators are empowered to run the process, and are trained on their own equipment in their own plant.
Mark Sutcliffe, president of MVI Technology, believes it’s possible to provide a very simplistic user interface (like a touch-screen voting machine) that empowers operators to act on information they can use to improve performance and productivity-rather than just allow supervisors to make these decisions. But key to making this happen is software that integrates manufacturing execution systems (MES), automation, distributed control systems (DCS), and ERP so the right people have access to their specific real-time information needs. To provide actionable information to the right people takes a real-time statistical process control (SPC) system that looks at the process as it goes along-not eight or more hours after the fact as an ERP system often does.
Surak notes that ERP software works great for finance because it’s designed for accounting. He contends that by using SPC as part of their best practices, manufacturers can create a system of continuous improvement because SPC answers questions about the process: How does it work? Is it working correctly? What are the sources of variation? SPC should always be part of the MES automation solution. However, Surak warns, know the answers to these questions before automation, or the automation will produce unusable results.
Ruth says, if a manufacturer implements SPC, careful consideration must be given to the physical logistics of implementing it. For example, it may require manual handling of a product at certain intervals such as picking loaves of bread to weigh. Ideally, the weigh scale would be tied into the entire system and prompt the operator to perform specific tasks. Collecting the weight automatically can be a challenge as well. For example, it may require an investment in a new weigh scale or conveyors, or even refitting the whole line. The latter could be very cost prohibitive for small producers. For small producers, the solution may lie between all manual and completely automatic.
MES vs. ERPShould a food manufacturer first purchase MES or ERP software if it already has control and HMI functionality in place such as Wonderware or Iconics? The argument for ERP is that this software is good at making business decisions. But how good is it for making shop floor decisions? Most ERP software products originated with accountants in mind, and therefore, may not be fine-tuned for manufacturing execution or shop-floor operations. Several MES providers, such as CSB-System International and CDC Software began their companies with direct shop floor experience-often in food and other comparable industries such as pharma or chemicals-where best practices are a must.
A key benefit of MES, according to Siemens Director of US Marketing for MES, Maryanne Steidinger, is its ability to identify quality failures so they are isolated at the moment the failure occurs, and before being passed onto the public. This is a key compliancy factor of the Bioterrorism Act and is easily achieved using MES.
Sutcliffe says that appropriate MES software for the food industry should be packaged specifically for its intended application. It should not be a generalized package that takes a consultant and system integrator to get up and running. “The automation vendors are in the automation business-not in the actual intelligence business, not in the business of making cakes. Our software is about making cakes. The supervisor interface already has built in 21 CFR Part 11 signatures and tracking; why should the customer have to work out the structure for it?”
Surak agrees concerning ERP software. A manufacturer should not have to change the way it does business or its best practices to suit an ERP solution. If the ERP package can’t easily be tailored to the specific needs of a food business, then it’s not the right software package. Surak also points out that at the HMI/SCADA level, a lot of accumulated data is not necessarily useful from a continuous improvement standpoint. If a manufacturer has to do data mining to determine what happened in the past day or two, this process will not be as useful as watching the current trends in a process via an animated graph. For example, are the cookies trending up in weight, or does there seem to be a trend downward in pasteurization temperature or CIP sanitizer temperature?
With Wonderware batch and HMI software plus Microsoft’s Navision ERP system, a system integrator built an ISA S-95 compliant solution that puts best practices to work. Mark N. Matassa, account executive for system integrator, InSource Solutions, notes that Nutramax Labs, Edgewood, MD, wanted to improve the throughput and efficiency of its Cosamin® DX food supplement line. Cosamin DX, for improving cartilage and reducing joint pain, undergoes strict quality control measures and is produced with the same kind of control that any pharma manufacturer uses. However, Nutramax couldn’t keep up with orders. After installing batch and HMI software provided by Wonderware, electronic procedures and work instructions were implemented following the company’s own good manufacturing practices. After bringing the new system on line, Cosamin’s production capacity and throughput increased by about 25% in four months. In addition, the company can meet all FDA regulations for track and trace plus electronic record keeping. Currently FDA doesn’t regulate these products, but should it, Nutramax will already be in step-unlike most of its competitors.
Best practices should not be used to please FDA. According to Lisso, “Best practices in our quality control and production departments are followed to ensure food safety and compliance with customer requirements-our overriding responsibilities. The best practices facilitated through our corporate continuous improvement philosophy have and continue to help our company reduce costs, operate more efficiently and improve compliance to customer requirements.”
Best practices begin with good engineering practices and good manufacturing practices as described by the FDA. FDA, USDA, ISO and other regulations can provide a good yardstick for food manufacturers to determine what they need to do to achieve GMPs. Best practices come about with involvement from key personnel in the plant and enterprise, and require a firm commitment in goal setting and understanding the manufacturing processes before automation can be applied. Knowing how to apply the correct automation strategy to work with a company’s best practices strategy will keep the company competitive going forward.
For more information:
Paul Moylan, Rockwell, pemoylan@ ra.rockwell.com, 919-290-2654
James Stanley, Emerson Process, firstname.lastname@example.org, 512-832-3386
Gerry Broski, Thermo Fisher Scientific, email@example.com, 763-783-2600
John Lewis, Cognex, firstname.lastname@example.org, 508-650-3140
Brandon Henning, GE, email@example.com, 434-978-6139
Jeff Baxter, PS2, firstname.lastname@example.org, 541- 924-1741
Gavin Clements, FMC FoodTech, gavin.clements@ fmcti.com, 425-883-2244
Jay Jeffries, Wonderware, , 423-975-2917
Matt Ruth, Advanced Automation, matt.ruth@advanced automation.com, 610-458-8700 ext. 274
John Kowal, Elau, john.kowal@ elau.com, 847-490-4270
Mark D’Onofrio, Lock Inspection Systems, email@example.com, 800-227-5539
Scott Lucas, Dorner Mfg., firstname.lastname@example.org, 800-397-8664
Robyn West, CDC Software/MVI Technologies, email@example.com, 786-235-0682
Mark N. Matassa, Insource Solutions, 804-378-8981
Tom Kozenski, Kozenski, Red Prairie, firstname.lastname@example.org, 262-317-2205
Maryanne Steidinger, Siemens, email@example.com, 215-646-7400
Sidebar 1: What is ISO 22000?ISO 22000:2005 specifies requirements for a food safety management system where an organization in the food chain needs to demonstrate its ability to control food safety hazards in order to ensure that food is safe at the time of human consumption.
It is applicable to all organizations, regardless of size, involved in any aspect of the food chain who want to implement systems that consistently provide safe products. The means of meeting any requirements of ISO 22000:2005 can be accomplished through the use of internal and/or external resources.
ISO 22000:2005 specifies requirements to enable an organization to:
- plan, implement, operate, maintain and update a food safety management system aimed at providing products that, according to their intended use, are safe for the consumer,
- demonstrate compliance with applicable statutory and regulatory food safety requirements,
- evaluate and assess customer requirements and demonstrate conformity with those mutually agreed customer requirements that relate to food safety, in order to enhance customer satisfaction,
- effectively communicate food safety issues to suppliers, customers and relevant interested parties in the food chain,
- ensure that the organization conforms to its stated food safety policy,
- demonstrate such conformity to relevant interested parties, and
- seek certification or registration of its food safety management system by an external organization, or make a self-assessment or self-declaration of conformity to ISO 22000:2005.
Sidebar 2: Best practices in packaging deliver profitability and measure sustainabilityPackaging sustainability is fast becoming an essential best practice for food companies. Major retailers, including Wal-Mart, now place more emphasis on sustainability factors – including packaging and packaging operations.
Georgia-Pacific introduced a Packaging Systems Optimization (PSO) program to help companies align essential business and environmental objectives by streamlining their packaging operations and reducing total systems costs while measuring sustainability.
PSO is an assessment program that looks for sources of inefficiency and waste across the packaging supply chain. Using a five-phase process, a team of Georgia-Pacific’s experts examine packaging supply chains from sourcing to manufacturing to distribution.
PSO starts with planning and a site assessment. The PSO team looks for packaging redesign opportunities to drive costs and waste out of the box itself. This includes an examination of package design, shelf impact, SKU consolidation, packaging materials and packaging alternatives.
The team then looks well beyond the box to examine opportunities for improvements in productivity, warehousing, material handling and transportation, which are also significant cost and sustainability drivers for companies.
The PSO team then develops a detailed plan with recommendations for profitability, packaging performance and sustainability enhancements. This may involve developing new box design concepts, for example, to better and more safely ship food free from damage while reducing fiber content. The team then builds, evaluates and refines packaging prototypes, examining their impact across the packaging supply chain.
Typically within three weeks, the team comes back to customers with a Total Cost Analysis (TCA) report. The report includes total cost-savings and sustainability goals, such as reduced fiber content (tons), energy efficiency (BTUs) and greenhouse gas (GHG).
In Phase 5, the implementation phase, Georgia-Pacific works closely with customers on further planning, equipment recommendations where necessary and tracking of results.