Gear It Up
Knowing the ins and outs of Part 11 is probably the first step to boosting the performance of a flaccid HACCP program or quality management system, Freitag says. “You need to identify what’s important to your operation and you have to look at the cost of maintaining [this]because it can be pretty rigorous,” he adds. “One also has to believe that automation controls your environment and creates transparency.” Freitag’s firm has mainly dealt with pharmaceutical companies, but it has begun working with Thinkage LLC, a Bridgewater, N.J.-based food industry consulting firm, in developing and tailoring Part 11-based record keeping platforms for the food industry.
“Information is now part of the product and that electronic information can be bundled with a food product so that your end users, the restaurateurs and retailers, have the confidence in the product,” says Mark Grace, president of Thinkage. But what to do with the data is perhaps the biggest issue, and Grace suggests that food companies know the basics of what they want to track. “You are going to have to know basic questions: Why you are measuring something? If you are doing HACCP, you have to set up the ‘why’? But that’s not all. You’re going to also have to establish corrective actions,” he says. Thinkage helps its clientele through this by constructing “decision models” that takes data through appropriate actions steps. Take for example, temperature monitoring in a HACCP program. “If there’s an issue with temperature, say at meat a processing company, and the cooking temperature is too low, an alarm goes off,” Grace explains. “Then, an alarm goes off that says that throughput is higher than normal. The decision is to slow the line down and let the heating device catch up. You will also need a system that ensures that personnel are carrying out those decisions.” Karu from Sparta Systems echoes this same sentiment, saying a food company must find the root causes of problems and try to prevent such events from happening again. “When a company has a problem, they log it into the system. This way, they have a consistent way of evaluating an issue, which, later on, allows them to do trending and analysis over various sites to identify reoccurring [problems],” he says. “If somebody found that problem and recorded it, it’s not going to go away. It’s all about the quality of the product and safety.” Also, a quality management system, Karu says, gives upper management greater visibility of what’s going on throughout company departments. “It creates a transparency throughout the company, meaning you can’t hide,” he says. “There is no place to hide and that sometimes frightens people because everyone answers to somebody. So in the end, it actually creates a much better environment because people know these regulations need to be followed., and it creates a better, safer product going to market.”
Modifying the Machine
With Part 11 bolted on and an evaluation of what kinds of performance upgrades are desired, the machine, the HACCP program or quality management system, can be hopped up with horsepower. While Sparta Systems’ clientele is predominantly life sciences companies, like drug makers, it is looking to diversify into the food industry. “We are talking to a number of them,” Karu says of food companies Sparta has targeted. Many, he says, could easily install Sparta’s Part 11-compliant TrackWise, a quality management software platform that monitors a host of functions, including audits, corrective and preventive actions (CAPA), validation, complaints, training, safety incidents as well as events and supplier management. “A quality management system will not allow any balls to be dropped,” he adds. And accountability is what it boils down to, says Terri Bringgold, marketing communications manager for Ecolab’s Food and Beverage Division (St. Paul, Minn). Ecolab’s Quadexx is an allocation and formulation system for sanitation chemicals, and she says the onus ultimately falls upon personnel. The system is leased to meat and poultry processors as well as breweries, Bringgold says. Sanitation managers log onto myecolab.com and gain access to a Web site constructed specifically for that company. That site documents every transaction. For example, when a worker pulls a product to clean a particular area, they have to put in a password or use a swipe card to gain access to the Quadexx system. The system will then record the transaction so that plant management can track what’s going on,” Bringgold says. “It cuts down on waste and improves efficiency. And if there is a problem, as in someone didn’t clean a particular piece of equipment, the sanitation manager can look and see what the problem. It takes the guess work out.” Like Sparta Systems’ TrackWise, SSA’s ERP LX and LN software allows companies to manage manufacturer-to-customer demands; high volume order and fulfillment; product development and documentation control; supply chains; and overall performance. SSA claims to serve 11 of the top 15 consumer packaged goods/food and beverage companies with its SSA ERP LX and LN software platforms. Along with RFID and Web-based tools, emerging DNA-based technologies also take the guess work out, says SSA Global’s Wiersma, adding that managing the supply chain is a key factor. “If you think about how to trace from farm to fork, one of the best ways to do that is DNA, especially for a cow or pig that is pulled apart into many pieces and shipped in many different directions,” he says. DNA samples of an animal are taken before it is slaughtered so that it can be traced all the way through the supply chain. “That’s the route that I’m following. As a manufacturer, we could be a couple of steps away from where the product is coming from, and I have to rely on everyones record keeping. That is a key component of this. You are one supply chain of many supply chains,” he adds. “I could be testing meat as it comes into the door or as it goes through processing, [but] the DNA stays the same. If you can’t localize the problem, production is hindered.” In the bigger picture, however, Grace of Thinkage believes that using technology to power up HACCP programs and quality management systems surpasses the benefits of conventional, if not archaic paper-based methods. “It’s still an economic way to collect data, but there are a number of errors associated with that method,” he says. “It is also very difficult to calibrate a pencil.” One thing is for sure, the apparent contest between electronic- and paper-based could turn out like the tale of the tortoise and the hare. Food companies will ultimately decide whether to stay on the slow and steady or power up and put the proverbial pedal to the metal. -FQ
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