Even in a gridlocked Congress, the Food Safety Modernization Act (FSMA) mustered enough yea votes to pass both houses and land on President Obama’s desk. The almost complete lack of opposition sealed the legislation’s approval: Cognizant of the damage recalls have done to the entire industry’s image in recent years and the erosion of public confidence, major brand owners supported passage.
Those same brand owners, either overtly or tacitly, have also thrown their support behind the certified audit programs under the Global Food Safety Initiative (GFSI) umbrella. The time and additional expense of these intensive inspections and systems reviews are offset not only by improved customer relations with key accounts but also the brand owners’ desire to push the standards out to their own suppliers. The 2009 salmonella recall involving peanut butter and peanut paste from Peanut Corporation of America ensnared more than 2,100 products from 210 food companies. It served as both a wakeup call and a stark reminder that a company’s products are only as safe as the weakest link in the supply chain allows them to be. “A lot of what has been done in the past with third-party audits was deficient,” confides a facility manager at one food company that underwent SQF certifications at its facilities last year. “What has been done has not nearly been rigorous enough.”
GFSI’s roots are in Europe, where retailers led the charge for standardized audits such as BRC, created in 1998 by the British Retail Consortium. To bring consistency to the independent reviews, GFSI created a benchmarking system to ensure requirements for prerequisite programs, HACCP planning and execution, and the food safety management system were consistent between the various standards. Several audit programs are geared to food and beverage manufacturers. By far, the largest in North America is SQF 2000, managed by the Food Marketing Institute’s Safe Quality Food Institute, with BRC gaining traction. Manufacturers also can be audited under the International Food Standard (IFS) and FSSC 22000. Other GFSI-sanctioned programs are geared toward agricultural operations or have not been extended to North American manufacturers.
“If it isn’t written down, it didn’t happen” is a guiding principle of all the standards, and documenting the execution of good manufacturing practices (GMPs) and staff training is perhaps the most challenging aspect of the audit programs. Upfront documentation work stretches out the timeline for GFSI reviews, “but the true test of how long it’s going to take is management commitment and resource allocation” to the process, according to Robert Prevendar, director of food safety certification systems at Ann Arbor, MI-based NSF International Inc. Prevendar suggests food manufacturers budget five months to complete a GFSI certification process, though he allows, “Five months is optimistic. It’s achievable, but it’s almost a bare minimum.”
In fact, a year may be a more realistic timeline. As a USDA-inspected plant with organic and gluten-free certifications, Kettle Cuisine knows the audit drill well, yet its quest for SQF level 2 certification stretched over 12 months. “SQF changed the responsibility from a QA function to a production program,” says Karen Bishop-Carbone, director of quality assurance at the Chelsea, MA maker of soups sold primarily through supermarkets’ grab-and-go prepared meal programs. Food safety requires top-down management, but an effective program requires bottom-up execution, and Kettle Cuisine invested considerable time training a bilingual staff that peaks at 150 workers to assume an expanded role in executing and recording quality and safety checks.
A letter from a retail customer triggered Kettle Cuisine’s SQF quest. John Corso, president of Coastal Sunbelt Produce Co., Savage, MD, didn’t wait for inquiries from food service accounts to begin the SQF process, which also took his company a full year. “We had very robust documentation going in,” says Corso, and participation in USDA’s Quality through Verification (QTV) provided a solid foundation. But there are no shortcuts in a certification system that “brought in a different approach,” he says.
Electronic record-keeping facilitated documentation requirements and helped Shearer’s Foods Inc. attain SQF Level 3 certification for its Massillon, OH plant in two and a half months, according to Don Asplin, corporate director of food safety. Salty snacks with low pH and minimal water activity are low-risk foods, but management commitment and a company focus on quality, compliance and record management drove Shearer’s fast-track certification process. “Either people want to do food safety and quality, or they’re going to cut corners,” says Asplin. Core programs such as pest control are executed in house and are subject to self-audits and continuous improvement to ensure no corners are cut.
A broken system?The case for more rigorous and consistent third-party audits was bolstered by an existing audit system that bore a certain Lake Wobegon quality, where virtually every production facility was judged to be above average. The PCA plant at the center of the 2009 recalls was certified as superior under third-party audits. GFSI proponents seized on the PCA event to advocate for a system that addressed perceived deficiencies, such as requirements that nonconformance issues cited in audits be corrected prior to certification, and institution of arm’s length rules to minimize conflicts of interest that arise when auditors also offer advice and counsel to food manufacturers.
Some see a parallel between the get-tough approach of the GFSI standards and a more aggressive regulatory stance. FSMA gives public health agencies the power to conduct unannounced inspections, demand access to documents and, for the first time, require a HACCP plan for all food manufacturing facilities. Independent auditors won’t be making surprise inspections, but they will hold plants to FSMA requirements, says Thomas Carl Ambrosia, an auditor for the certification body (CB) TUV SUD America, Peabody, MA. “Third-party auditors are now miniature USDA inspectors,” says Ambrosia, who has performed food safety audits for 35 years and is certified under all 35 SQF product categories.
Others see the emphasis on manufacturing site audits as the first salvo in an effort to bring greater accountability and transparency to the entire supply chain. They see parallels with industries such as medical supplies, where it is not enough for a packaging supplier to be ISO certified: The suppliers of resins and other materials to the supplier also must be certified. “The back-end supply chain is where the problems often lie,” points out Katie Dowling, senior solutions consultant at Sparta Systems, Holmdel, NJ. “When there’s a problem with a company’s granola bar, it’s not the granola bar but the ingredients that came from outside the plant and went into the bar.” Dowling’s firm provides quality management software that maintains a rolling schedule of audits and generates documentation reports, including any nonconformance issues and the corrective actions taken.
The level of detail in supporting documents goes well beyond what has been customary. “If you operate a fryer for breaded meats, you need to document the oil coming in, the waste stream of crumbs removed from that oil, where the rework and work in process comes out, and other parts of the entire process,” suggests John Surak, principal of Surak and Associates, Clemson, SC. He was one of three US representatives on the ISO technical committee that drafted ISO 22000. The standard serves as a framework for a food safety management system but was deemed insufficient by GFSI as a food safety standard. The deficiency was addressed with PAS 220, a GMP-oriented standard developed by Kraft, Nestlé and others. The certification program offered by FSSC 22000 combines PAS 220 and ISO 22000.
Surak is certified by the International HACCP Alliance and the American Society of Quality to train HACCP trainers and conduct quality audits. He cannot conduct any of the GFSI audits, though he can consult with manufacturers working toward certification. That kind of arm’s length relationship is encouraged by all, and required by some, of the audit programs. “If I am going to be your auditor, I cannot consult or train,” TUV SUD’s Ambrosia says. “I’m not supposed to cut you a break. The code of ethics says my allegiance must be to the standard, not the CB or the customer.”
Laying the groundworkGFSI-sanctioned audits require an approach to food safety that is unfamiliar to most food professionals, including many in the food safety/quality management area. Lacking the in-house expertise to navigate the system, companies frequently retain consultants to conduct pre-audits and assist in gap analysis of existing programs and the certification requirements. Costs vary, but one auditor estimated food companies typically spend $20,000, including $5,000 for the certification audit itself.
Approximately one in 10 companies that begin the process does not complete it. In some cases, self-assessment lays bare facility deficiencies that require capital spending to correct. “Some companies hire us to put what they already know in a nice-looking report they can present to management for capital spending approval,” says Charles Caban, senior process engineer for the Atlanta A/E firm The Austin Company. “Sometimes, going into the job we know that it would cost more to update the old facility than to build a new one.
“Capital money has been under tight reins the last couple of years,” Caban adds, and necessary improvements to a ventilation system or other infrastructure projects can quickly torpedo the certification process. More frequent reasons for failure to attain certification include a lack of management commitment or the delegation of too much responsibility to safety directors and insufficient involvement of other staff.
“Management commitment is a fundamental requirement, but you also must involve the people on the line, the maintenance department and every area involved in handling the product,” asserts NSF’s Prevendar.
“Time is involved, and time is always connected to finances,” remarks Kettle Cuisine’s Bishop-Carbone. “We saw an impact in payroll, we saw it in facilities management, we saw it in IT.” Time and expense were viewed as an investment, she adds, and recommendations by a consultant who performed a pre-audit proved valuable in adjusting policies that conflicted with aspects of the certification program.
Before deciding which certification to pursue, manufacturers first should ask their key customers what their preferences are, recommends James Cook, food safety technologist in the Fairfield, NJ offices of SGS Group, a CB with auditors certified under most of the programs. Once the best alignment with customer requirements and the company’s existing food safety system is determined, a copy of the standards and the guidance document should be purchased. Scheduling a certification audit is premature until documentation issues and gap analyses are performed. Documentation detail is often a stumbling block: Kettle Cuisine regularly administers food safety quizzes to workers, Bishop-Carbone says, but auditors expect documentation of when those quizzes are administered, what issues were uncovered, and what corrective actions were taken.
“It took me 10 months to get a USDA-inspected company up and running and confident it would pass the certification audit,” says Cook. “The documentation part took six months.”
Boots on the groundEstimates of the number of US food plants that have successfully completed one of the GFSI audits range from 3,000 to 3,500, a fraction of the plants currently providing processed foods to retailers and food service accounts.
Estimates of the country’s production base vary significantly. More than 150,000 sites are registered with the FDA, though that figure undoubtedly includes distribution facilities and farm-level operations. Maureen Olewnik, vice president-audit & technical services at AIB International, Manhattan, KS, believes the manufacturing base is closer to 30,000. A census of US food and beverage plants published by Food Engineering in 1998, listed approximately 17,000 facilities. These figures suggest at least 80 to 90 percent of food plants have yet to undergo a GFSI audit.
If the GFSI programs are to become America’s food safety standard, recruitment and training of qualified auditors will have to be expanded significantly. SQF has the largest pool of certified food safety auditors, with more than 300, according to Bob Garfield, SQF senior vice president, and it has more auditors than the other standards programs combined. “You would need 30,000 auditors to cover the entire US market,” Ambrosia believes.
Wary of diluting the auditor base or compromising their brands, standards owners used to tightly control the training opportunities for aspiring auditors. That is beginning to change. According to Garfield, SQF is allowing some of its CBs to train their own auditors to conduct SQF audits, rather than requiring all auditors to be trained by SQF personnel. Those CBs must first be approved by SQF and are subject to monitoring. Of the 20 CBs certified under SQF’s program, five are allowed to conduct auditor training.
“People who have reached retirement age or whose plants were shut down” represent the best talent pool to fill the auditor ranks, suggests Roger Roeth, food and training manager at Dayton, OH-based Eagle Food Registrations Inc. “Unfortunately, you’re not going to get young people right out of college,” given the requirement for five or more years’ experience in food production for most of the programs. Travel requirements can be grueling, though compensation is attractive, with certified auditors typically commanding $50 or more an hour.
The fastest growing segment of Eagle’s business is not at food or beverage plants but at the facilities of packaging suppliers and warehouses and distribution centers. That reflects the outward push from customers like McDonald’s and Walmart. The Bentonville, AR chain required private-label suppliers to be GFSI certified two years ago, while suppliers of branded food products faced a 2010 deadline for certification. As a practical matter, retailers and food service customers are focusing on suppliers of higher-risk products. “Make no mistake: The intention is to bring in many or most of their suppliers under GFSI,” according to Ron Vail, an auditor trainer at AIB.
Absent an adequate infrastructure, GFSI requirements could go the way of Walmart’s RFID mandate. The retailer set a January 2006 deadline for RFID tags on all pallets and cases of products bound for three Walmart DCs, but the mandate was abandoned. To require RFID would have meant many empty shelves and unhappy shoppers.
AIB’s Olewnik believes the GFSI system will overcome its growing pains and become firmly established in the food manufacturing community. GMP audits remain the most frequently performed reviews conducted by AIB’s 120 auditors, who perform more than 10,000 plant reviews a year worldwide, “but we are seeing a growing trend on the GFSI side, and we think that will become the norm,” she says.
The establishment of a two-tier system, with some food manufacturers eschewing certification and supplying customers who don’t require it, is a possibility, or an alternative to the GFSI approach could evolve. “There may be companies unable or unwilling to keep up with the standards,” points out Coastal Sunbelt’s Corso. Whether the majority of food suppliers accept the expense of certification audits doesn’t concern him. “We’ve been laser-focused on delivering quality to our customers, and our emphasis on food safety and process improvement has separated us from the pack,” he says.
Until a critical mass of production facilities attains certification, customers will have to temper their GFSI requirements. In the meantime, food professionals will wrestle with the requirements of a new system requiring a different approach to food safety.
For more information:
Maureen Olewnik, AIB International, 785-537-4750, firstname.lastname@example.org
Charles Caban, The Austin Co., 770-329-0089, charles.caban@the austin.com
Roger Roeth, Eagle Food Registrations Inc., 937-293-2000, email@example.com
Robert Prevendar, NSF International Inc., 734-769-8010
Bob Garfield, Safe Quality Food Institute, 202-230-0635
James Cook, SGS Group, 973-461-1493, firstname.lastname@example.org
Katie Dowling, Sparta Systems, 732-203-0400
John Surak, Surak and Associates, 864-654-8743, email@example.com
Thomas Carl Ambrosia, TUV SUD America Inc., 570-925-2614, firstname.lastname@example.org
Whose scheme is it, anyway?Britain and America are separated by a common language, it is said, and that disconnect is illustrated in the Global Food Safety Initiative’s (GFSI) vernacular for the food safety audit standards under the GFSI umbrella.
GFSI’s roots are in Europe, and the organization defers to the Brits for English nomenclature. Consequently, the certification programs benchmarked by GFSI bear the unfortunate name “schemes.” To an American ear, it raises suspicion; from an American mouth, it sounds like an affectation.
Regardless of the term programs or schemes, the owners of the half-dozen standards approved for use by food manufacturers oversee audits that have been harmonized to include consistent expectations while allowing for minor differences in execution. The management of those standards-SQF 2000, BRC, FSSC 22000, IFS, Synergy 22000 and Dutch HACCP-must meet the requirements of the American National Standards Institute (ANSI) in the United States.
The accreditation bodies overseeing those standards (for example, the Safe Quality Food Institute in the case of SQF) act as brand owners who ensure the integrity of their programs. The groups train and certify auditors to their standards, but they rely on certification bodies (CBs) to hire and supervise certified auditors. Certification bodies include NSF International (formerly Cook and Thurber), Silliker Inc., AIB International and a number of CBs that have become active in US food safety audits in recent years, including Eagle Food Registrations, Det Norske Veritas and TUV SUD America.
Certified auditors are the boots on the ground. Once they have satisfied the requirements of the licensing program, they are free to perform audits for any of the CBs, though some choose to work for one CB exclusively. Annual performance reviews, refresher courses and licensing fees are required, just as food plants must be recertified at least annually.
The birth of independent auditsUntil an E. coli O157:H7 outbreak in 1993 sickened 700, including four fatalities among children, third-party independent audits of food plants were almost unheard of events. The outbreak was linked to the Jack in the Box (JIB) chain, which responded by hiring David Theno to implement a HACCP-based food safety management system for its restaurants and demand that key suppliers open their plants and their records for inspection.
Now retired from JIB but still active in the Del Mar, CA consultancy Gray Dog Partners, Theno believes customer demands for continuous improvement in food safety have resulted in positive change. Few manufacturers in the early 1990s had HACCP plans, and the ones that existed were little more than checklists. Today, leading manufacturers “have turned food safety from a chore into a management program,” he says.
Owners of the certification programs under GFSI suggest gaining plant certification will help reduce the number of audits performed, with some retailers promising to accept any of the GFSI reviews. It’s a comforting thought, Theno concedes, but he is among many skeptics. If he still were responsible for a food service or retail operation, Theno says he would insist on sending inspectors to suppliers’ plants to assure all product attributes and specifications are being met. But he empathizes with plant personnel who must cope with a growing number of audits and inspections. “One plant operator told me, ‘I’ve added a staff person to serve as a tour guide,’ and that’s not productive,” says Theno. He also is concerned that details and procedures required are adding unnecessary complexity that might degrade the effectiveness of a food safety program.