Gale Prince is considered one of the industry’s top experts when it comes to food safety, regulatory requirements, food defense, quality control, safety of imports and product traceability. Formerly with the Kroger Co. as director of corporate regulatory affairs, Mr. Prince is now president of Sage Food Safety Consultants, Cincinnati, OH. Recently,Baking & Snackasked Mr. Prince to provide his latest insights about third-party audits and food safety initiatives.

Baking & Snack: How reliable are third-party audits, and what is your perspective on the number of audits that many food companies are subjected to from their customers?

Gale Prince:Third-party audits add value to a firm’s food safety programs by bringing an outsider’s perspective. Often, individuals within a firm lose sight of food safety problems from being too close to operations on a day-to-day basis. Over the years, we have seen a few auditing system failures when individuals falsified information in the interest of cover-up for economic gain. In recent years, there have been some excellent examples of audit failures in the financial community and even with regulatory oversight programs. When we look at the number of audits performed in the financial arena and for food safety, the audits do identify problems and are a critical function in further advancing the controls of publicly traded companies’ financial accounting practices and also their food safety programs.

These audits brings with them best practices and insights to assist firms in food safety improvement programs. Such audits are an excellent training tool for plant employees. Most companies use third-party audit firms to improve their food safety programs, and the industry and consumers have benefited from their use over the years.

How much is too much when it comes to audits?

That is a good question. You only need a good food safety audit once or twice a year depending on third-party findings. While additional audits may bring a new idea or two with a little different perspective from another set of eyes, they should not be that much different in key food safety elements. The differences may be due to expertise of the auditor, the individual facility or the type of operation. The United Fresh Produce Association analyzed third-party audit firms’ inspection criteria and found that about 90 to 95% of all of the inspections cover the same points. A comparison chart for these auditing firms can be found on theUnited Fresh Produce Association’s website. This comparison was done to help reduce the number of multiple audits of the same facility.

The food safety audit must bring value to the audited firm with a true review of the firm’s programs and intense review of the production operations to see that written programs are in place and are working. The purpose of the audit should not be for the sole purpose of satisfying buyers’ requirements for a food safety audit to be conducted. A properly conducted audit takes a substantial amount of management time and can be a substantial cost to a firm. Hopefully, in the future, we should be able to have one third-party audit per year to meet the needs of all customers who require them.

What is your perspective on the Global Food Safety Initiative (GFSI), and how effective will it be in ensuring food safety?

While some firms have required third-party inspections of their suppliers for years, this practice has expanded in recent years as result of the various regulations by countries in the European community. Retailers have complied with the variety of laws in each country by developing their own audit program. At first, it was heavily focused upon social issues, and more recently, it has shifted the focus to food safety. It was at that point EU-based retailers promoted extensively the requirements of their suppliers to comply with GFSI standards and have a food safety audit in compliance with one of the auditing schemes recognized by GFSI. These programs require a firm to document all food safety program elements. This is the good point about the Global Food Safety Initiative.

Realistically, how will the Food Safety Modernization Act (FSMA) affect food safety?

FSMA will have a major impact on food safety, but not overnight. While some of the requirements went into effect on Jan. 4, 2011, I do not expect that direct results of the act will be seen by the consumer for a few years. Implementation of the act by FDA is a major undertaking in development of regulations required by the act and the field forces for enforcement. For years, I have done extensive evaluation of product recalls to determine reasons for failure that resulted in a recall. In 2009, there were more than 600 food companies that had recalls. Most recalls were related to violations of FDA’s Good Manufacturing Practices (GMPs) that have been in the regulations for more than 20 years. This demonstrates the importance of FDA having the resources in place to implement the law and regulations currently in place. At this time, food manufacturers need to take a critical look at their operations for compliance with the current GMPs ahead of the increased inspection programs and the new more restrictive regulations coming with FSMA.

How optimistic are you that the act will actually have the proper funding to make it effective?

The act has been passed and signed into law by President Obama. It is essential that the agency has proper funding to develop the regulations required by the act. The food industry is required to comply with the act as signed by the president, but it is very difficult without the details provided by the regulations. Therefore, the industry must hope that Congress properly funds FDA to implement the act.