While it may seem that audit mania has taken over in food safety, such activities address real-world concerns and can foster …

BakingBusiness.com | May, 2016 | by Laurie Gorton.


Welcome to the brave new world of food safety and all the audits that populate it. Actually, food processors have been living the audited-and-inspected life all along to meet Food and Drug Administration (FDA) requirements, but it has become all that more intense during the past decade.
Now, with Food Safety Modernization Act (FSMA) regulations going into effect, operators can expect additional scrutiny. Fortunately, the many audits, inspections and certifications involved have the potential to build food businesses better able to cope with today’s mounting insecurities and to ensure safe foods for consumers.
“There are more audits today than ever before,” observed Joe Stout, president and founder, Commercial Food Sanitation, LLC, a company that provides sanitation training and benchmarking. He’s seen food safety audits rise to the point where a food processor can be audited every week by one customer or another.
Audits, inspections and certifications have become a fact of life. “They are a necessary part of doing business in the food industry, but nobody particularly likes them,” said Richard Stier, a consulting food scientist who advises food facilities worldwide about food safety. “However, smart companies should look at these audits as a learning experience and part of their continuous improvement effort.”

However, there is a silver lining, according to Jim Kline, president, The Ensol Group, a consulting firm specializing in bakery and snack plant projects. “It’s interesting to me that as American food processors have faced rising numbers of audit requests, these operations have come up in their food safety performance,” he reported.
Do audits push better performance? The British Retail Consortium (BRC), a food safety standards-setting organization, reported that in 2015 of the 1,786 bakery sites worldwide audited to its standards, 81.4% achieved its top “A” grade.


Becoming FSMA-ready
New food safety laws and regulations in the US and Canada now ratchet up the stakes. A series of food contamination events that took place during the final years of the 20th century set the stage for these 21st century rules. Although FSMA, signed into law in 2010, and the Safe Food for Canadians Act, passed in 2012, raise food safety standards to the level of prevention, compliance with these laws won’t be the only way food-safe manufacturing will be judged by food-industry customers.

“I don’t think audit pressure will lighten up under FSMA,” Mr. Stout said. “Food plant operators are very nervous about it, and they’re concerned about getting everything right.” Satisfying the demand for safe food makes food manufacturing a challenging field. Audits and inspections are all about “getting things right.”

These activities and the certification of performance to established standards are usually associated with supply chain relationships between supplier and customer.However, they set the stage for compliance with government regulations, too.
“Standard-setting organizations like the Safe Quality Food (SQF) Institute, BRC and Food Safety System Certification (FSSC) have done side-by-side comparisons with FSMA regulations,” said Kristopher Middleton, technical manager, US Food Division, Eurofins, which has a significant practice in food plant auditing. “Being certified will help prepare to comply with FSMA.”

Karil Kochenderfer, GFSI’s North American representative, put it even more simply: “Think of GFSI as a business-to-business FSMA.” FSSC, one of the ISO 22000 family of standards, and SQF recently did a comparison of standards with FSMA and found essential elements to be complementary. “The enormity of FSMA may be daunting,” Ms. Kochenderfer said. “But if you’ve been doing GFSI, you are 80 to 90% down the road to FSMA compliance.

“GFSI and the Canadian Food Inspection Agency partnered, leading to a gap analysis on GFSI and the requirements of Canada’s new food safety law,” she continued. “In December, the Canadian government announced that if you have your plant certified through a third-party audit, including those recognized by GFSI, you will meet or exceed the requirements of Canada’s act.”


Procedures, practicalities
An audit is different from an inspection. “On more than one occasion, I’ve been in a food plant where the staff is confused about how inspections and audits differ,” said Kalliopi Zerva, global innovation manager, AIB International, a third-party audit group recognized by GFSI.
“An inspection is an assessment of a moment in time that identifies positive or negative conditions as observed by the inspection team,” she noted. “Consider it a snapshot of what is happening in a plant at the time the inspection takes place. “An audit is a systematic evaluation to determine if programs and related activities achieve planned expectations,” Ms. Zerva continued. “It includes reviewing and challenging written programs, documentation of activities and records, corrective actions, and trends.”


Certification represents another level of compliance and can be conducted only by accredited certification bodies, said Camila Yoo, food safety professional, AIB International. “Certification would be issued for the facilities that proved the organization meet the requirement of a standard.” Several certification schemes are currently recognized by GFSI, such as FSSC 22000, BRC, SQR and International Featured Standards.

AIB International also offers non-certification inspections such
as its AIB Good Manufacturing Practice inspection. Mr. Kline simplified the difference by saying, “An inspection is something an owner requires, while an audit provides an independent view on how the facility performs to the standards set out.”

Together, inspections, audits and certifications build on each other. “Each reviews the facility’s food safety or quality assurance programs,” Mr. Middleton explained.

“Certification, however, is the most robust and takes into it the management’s commitment to the program.”

Some standards have been criticized as being too much involved in ticking off points on a checklist and not giving enough scrutiny to actual operating conditions.

Advancing from procedures to practicalities can be difficult, but each step has its merits. “Standards like GFSI do a lot of good at getting a company to organize and maintain its documentation,” Mr. Stout said. “The challenge is how to make it work. The execution has to be as good as the paperwork promises.”


Third-party organizations can add value to the process through gap analysis and inspections ahead of actual audits, according to Mr. Stier. “By taking an advisory role in a pre-audit inspection, I can tell facility operators about gaps to be addressed before the auditor comes in, about compliance to the standards,” he said. “The objective is to be critical and help the people.”



Collaboration and culture
There’s a good reason that standard-setting groups emphasize the collaborative process not only in writing their rules but also in putting them to work. “Food safety is not something that one person does; food safety is everybody’s responsibility,” Ms. Kochenderfer said. “And it involves all of us, so let’s collaborate.”
Working together is fundamental to creating a food safety culture in individual plants as well as broad food industries. And it starts at the top. Ms. Kochenderfer explained the five components involved. First is the commitment of senior leadership. Second is employee training and their recognition of how they affect food safety by their actions. Third is capital investment in machinery that operates in a food-safe manner. Fourth is development of a food safety plan. Fifth is continuous improvement of the plan.


“The development of a food safety culture is what’s important,” she emphasized. “Companies quickly recognize that what’s good for their customers is also good for their own business. It’s not just talk. It’s a marketplace reality.”

Mr. Kline confirmed the importance of executive-suite involvement. “When food safety is adopted and embraced at top level management, it can then be sold throughout the organization to all individuals. Food safety is the right thing to do. And it must be communicated adequately throughout the organization,” he said.


Auditing your suppliers
Just as your customers audit your bakery or snack food plant so should you audit your raw material suppliers. Responsibility up and down the supply chain is a foundational principle of today’s food safety world.

“A risk assessment should be done for all suppliers,” Mr. Middleton advised. “The rules coming into effect with FSMA require that a supplier be audited before the ingredient is first used.”

The frequency of inspection depends on several factors. Ms. Yoo outlined them: the inherent food safety risks of the ingredient, the supply volume, the history you’ve had with the supplier and any emerging hazards or trends that indicate a supplier or supply region could be at risk. Assessing the risk that an ingredient may pose is a regular part of HACCP.

Most bakery and snack product ingredients and packaging materials are low risk, and such food operations may have hundreds of suppliers. “It’s not realistic to audit them all,” Mr. Middleton noted. “Therefore, many rely on certificates of audit from suppliers. In such cases, the facility should review the supplier’s full audit report along with the certificate.”

Suppliers of high-risk raw materials should be audited annually while low-risk materials such as packaging can be audited less frequently. “But all suppliers need to be audited at least every three years,” Mr. Middleton summarized.

When starting with a new supplier, Mr. Kline recommended auditing once a quarter. “If you go two quarters and are satisfied, then you can move the audit to an annual schedule. The audits help you establish that you have a partner who is in step with your food safety program, who has embraced effective food safety practices.”


Yes, audits, inspections and certifications add another level of complexity to operating a bakery or snack food plant, but they are part of doing business.Mr. Middleton explained, “Audit standards are not meant to make life difficult for food processors but to make sure life doesn’t get more difficult by preventing problems, by having systems in place to ensure your product is safe. They won’t solve everything, but they will reduce the likelihood of incidents happening.”

A member of the AACC International Food Safety Quality Task Force, Scott Jensen, key accounts manager for analytical instrument maker Foss, said it best. “Sitting there across the table from an auditor can be terrifying,” he noted. “They’re finding your weak spots. But they are finding them before a lawyer shows up, before you’re sitting in front of a jury.”


Recognizable measures: moving from BISSC to ANSI Z50
A judge’s reputation affects the credibility of the judgement. So it is with certification standards. A known gets more acceptance than an unknown. Audit standards like GFSI or ISO carry an implicit “nameplate authority” when it comes to judging the food safety aspects of processing operations.

Among bakers, the Baking Industry Sanitation Standards Committee (BISSC) was the standard for sanitary equipment design. Not so among public health agencies.

“There is a lot of machinery out there carrying the BISSC certification symbol, but most local and state sanitation officials don’t know BISSC,” said Philip Domenicucci, baking systems specialist, AMF Bakery Systems, and vice-chairman of the American Society of Baking (ASB)’s Z50 committee. “However, they do know ANSI.”

In 2001, the industry was approached by an independent standards-setting organization to help create a new bakery equipment standard. Not wanting to lose control of its own sanitation standard and enforcement, industry groups (American Bakers Association, BEMA and others) decided instead to rewrite BISSC into a version acceptable to the American National Standards Institute (ANSI) and have the existing ASB Z50 committee manage it. ANSI standards reflect best industry practice and are typically written by the industry through a balanced committee of equipment manufacturers, bakers and allied members. BISSC was disbanded in 2003.

The result was a set of equipment design standards covering both safety and sanitation. “Safety refers to the safe operation of the equipment,” Mr. Domenicucci explained. “For equipment manufacturers, it is the key to limiting liability. When a machine, built to approved standards like those written under ANSI criteria, is delivered to the customer, it becomes the responsibility of the end user to maintain the equipment in safe, clean and sanitary condition. Until the Food Safety Modernization Act (FSMA) rules arrived, there wasn’t the same pressure on the sanitation side.”

Would having ANSI Z50 certificates for a bakery’s processing equipment make a difference when being inspected for compliance with FSMA? “The short answer is yes,” Mr. Domenicucci said. “At the very least, the baker would have a record of the machine being built to recognizable sanitation standards that could be shown to the inspector.

“Speaking for the committee, there needs to be better use of the Z50.1 and Z50.2 standards,” he added.


Coming to agreement
Has this happened to you? You meet with an equipment vendor to work out a new line, yet you run into problems articulating what sanitary equipment design means in this new age of FSMA and the proliferation of sanitation standards.

That’s a problem heard loud and clear by the OpX Leadership Network, a community within PMMI, the association for packaging and processing technologies. The result is “One Voice for Hygienic Equipment Design for Low-Moisture Foods,” a protocol published by PMMI that provides both basic sanitary design criteria and a means of collaboration between consumer packaged goods (CPG) and original equipment manufacturer (OEM) companies.

“The CPG companies came to us to resolve the problem of the plethora of sanitary standards and guidelines: ANSI, 3A, USDA, GMA and so forth,” said Stephen Perry, PhD, managing director, OpX. “They did not know how to corral all these standards to get everyone on the same page. They told OpX that they needed to set the minimum requirements for equipment to manufacture low-moisture foods in sanitary fashion.”

The OpX solutions group wrote the new document in two parts. One describes the One Voice joint collaboration process; the other lays out agreed-upon equipment criteria — the aspects that audits and inspections by third-party agencies and FDA would examine.

“This is not a standard as such but a guidance document on how, when and what to use as sanitary equipment design principles and how to do so in a collaborative way,” Dr. Perry explained. “Our goal was to show how the involvement of more people in the collaboration process can improve sanitary performance in the plant.”

Announced in 2015, the guidelines are now in use by several large CPG companies and their OEMs. OpX is putting together a scorecard that will track awareness, adoption and advocacy for this program.