(This article by Roy Costa, a registered sanitarian and president of the consulting firm Environ Health Associates Inc., was originally posted here on June 18, 2015.) In today’s world of food safety requirements, food producers large and small and at all levels of the supply chain are subject to increasingly rigorous industry-driven food safety standards and audits. Third-party audit standards have been revitalized by the all-too-apparent ineffectiveness of the way external parties verify food safety programs, as brought to light in several foodborne illness outbreaks. Following the Jensen Farms incident, auditing firms have tightened the process for certification, for example, by raising the minimum score required for certification from 85 percent to 90 percent. In addition, the administration bodies at the major third-party auditing firms are intensely scrutinizing audit results and the performance of auditors. The anticipation of the implementation of FDA’s FSMA turns the pressure up even higher, and it is likely that the third-party standards will incorporate large sections of the new federal rules. Change is good, and there is a need for better evaluations. The goal, of course, is to provide the industry with auditors who are qualified and capable of identifying unsafe operations so that operators can address them. It is also essential that buyers are made aware of potential problems and so they can make more informed choices about qualifying suppliers. Auditors now spend about 90 percent of their time in an audit looking at paperwork. The management systems documentation evaluation portion of the audit can take an entire day. Auditors require documentation to verify that an operator is carrying out a total quality management system based on a continuous improvement model. Even small companies must now dedicate personnel strictly to keep up with the increasing demands of more and more detailed documentation. Outbreaks of foodborne illness are caused by the contamination of foods by pathogens. Investigations of these events very often reveal major lapses in sanitation. It is therefore of great concern when a food safety auditor is spending 90 percent of their time looking at paperwork when the real risks are in the plant or operating environments. There is also a risk that the industry will become so focused on record-keeping that basic sanitation and other key elements of a food safety program, such as employee hygiene, training and supervision, will begin to falter. Another troubling aspect of the increasing demand for documentation is the effect this is having on smaller or family-owned and -operated food businesses. The premise for the food safety management system is a good one, but the practical aspects of applying the literally hundreds of management protocols, and all the while keeping up with the fundamental aspects of sanitation and hygiene, has become a major burden for small firms. While we say the third-party system is a “voluntary system,” that is really not correct. There is simply no market for suppliers without a food safety system. Producers at all levels must implement elaborate managements systems and keep them constantly updated and verified, regardless of the nature of the company, its size or complexity. To expect a firm operated by a husband and wife, for example, to document every conversation about food safety or have detailed job descriptions is an unrealistic expectation and adds nothing to the safety of the products produced. In our zeal to perfect our auditing methods, we can lose sight of reality. A tiered system is probably not possible given the way our third-party standards are developed, but placing small operations — a major portion of the food industry — in an unfair situation is not acceptable. The inability of an auditor to deal with human elements in the audit process makes a fair determination of conformance with the standard impossible. Rigid, inflexible rules, when they exist just for the sake of rules, are distasteful to everyone concerned and cheapen the value of our service to the industry.