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RegulatoryAudits/Certification/GFSI

Are Food Plant Audits Overrated?

April 1, 2009

The U.S. has recently experienced a very large outbreak of salmonellosis resulting from a small company that clearly was not in compliance with the food safety practices needed to prevent product contamination with foodborne pathogens. Much has been made in media reports that the facility received “superior” ratings on an audit in March 2008, yet egregious violations were found when the U.S. Food and Drug Administration (FDA) conducted an investigation at the plant as a result of the outbreak being attributed to this facility. The New York Times (Michael Moss and Andrew Martin, March 6, 2009) has questioned the value of audits, stating “…in case after case, the audits have failed to prevent major outbreaks.” What is the value of audits and why did this one apparently fail?

It is important to recognize several things about audits. First, most audits are just a “snapshot in time”—the auditor observes practices and conditions that are occurring at the time of the audit. A successful auditor will use techniques to try to expand the picture beyond the one he sees during the audit by reviewing records and asking probing questions of operators about how they do certain things and why. If the auditor doesn’t ask for or get the appropriate records, the picture will be incomplete. Likewise, if the auditor does not frame the questions appropriately, the responses may not be sufficiently informative.

Second, audits are only one tool for managing the supply chain. As with maintaining a car, you need more than one tool and you need the right tools for the job at hand. Effective supply chain management relies on knowing the supplier’s practices (and food safety philosophy) by using combinations of questionnaires, company visits, certificates of analysis, verification testing of compliance to company specifications and third-party audits. Suppliers must have comprehensive food safety-management systems that include adequate, appropriate employee training. In addition to ingredient specifications, the purchasing group should be made aware of specific food safety practices that suppliers should be using and without which a company won’t buy from the supplier. The third-party audit firm should be chosen with equal care. The audit firm should be accredited to international standards and must use auditors with knowledge, expertise and training appropriate to the commodity/ingredient/ product. And finally, a company must choose the right tool in terms of the type of audit it requests. A GMP audit and a food safety-system audit will provide very different information. The wrong type of audit, the wrong auditor and relying only on an audit alone can all lead to failure.  

Third-party audits have played, and by necessity will continue to play, a very important role in assuring the safety of the food supply. But they are only one of many tools we have to ensure food safety, and not a tool that can be used without others.

Bob Brackett is the Grocery Manufacturers Association’s (GMA’s) Senior Vice President and Chief Scientific and Regulatory Affairs Officer. Dr. Brackett oversees all of the association’s scientific and regulatory activities, including the operation of its in-house food safety laboratory. Prior to coming to GMA, Dr. Brackett served in various positions within the FDA’s Center for Food Safety and Applied Nutrition, eventually attaining the position of Center Director.


Author(s): Bob Brackett

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