The Value of Third Party Audits

Recent statements by several experts about the legitimacy of third party audits are missing the point. Third party audits are far from Ponzi schemes. They act to protect the buyer when they are realistically representative of the safety of foods and the buyer uses then as a basis for buying decisions. If there is a major shortcoming, it is that buyers do not always adhere to the audit findings, and choose their suppliers on some other basis. Buyers on the other hand are obligated to get the products needed to sell at the retail level. We all need food, and the retail industry cannot stop supplying consumers every time there is a potential problem revealed in an audit. Buyers of food are not police officers empowered to cut off suppliers with questionable sanitation. On the other hand, reputable firms are blind when they purchase unsafe products that would have been very apparent if tested or a visit to the facility made.

As I have argued, apparently in vain, the lack of a foundation of food safety throughout the food supply is the real culprit, not the weaknesses of the third party model. There should be no one, not one firm operating without the oversight of a government agency enforcing minimum standards. As some have written, minimum standards are all we can expect from government, but that is a lot. Without them, its naïve thinking that the industry will “police” itself. That is not what industries do; they expect government to do this. One of the paradigms that must be broken is that getting rid of government inspectors and turning all food safety totally over to industry is the wave of the future. Industry associations have argued this and to an extent have short-circuited the food safety system, but they have been pretty quiet of late and these same associations are now calling for intensive oversight.

I believe very strongly in industry self control, but we need to realize that the way business works, that self-control will be stronger or weaker depending on the entities involved. Therefore I argue that we need both; we need a validated industry self control model and an effective governmental oversight model working in tandem.

What happened at PCA was deplorable but it is not the standard for the third party audit industry. Most auditors understand and report risks, they do not allow relationships that develop on the job to sway them.  Many just go about their business politely and professionally, but still record the errors they see, there is a knack to doing this that we learn. The best auditing firms are very aggressive about not allowing inappropriate relationships to happen, sure, it does, but the best of us discourage it. Auditors are not just vendors that show up at a plant; that is something that industry must also come to realize.

As I have also written, I have faith that this is all working for the best, because basically I have faith in this country and its ability to rise above the obstacles, especially now that we have reached a “Jungle” experience again after 100 years.

Now with consumers, legislatures, media and government appalled by what happened in Plainview and Blakely I predict we will see a real partnership between industry and government. I also believe third party auditing firms will play an important role in bringing order out of the chaos.

In conclusion, once our government enforces basic sanitation throughout the food chain, third parties will be able to do what they do best, and that is separate the Good, from the Excellent from the Superior. It is ridiculous that there is even one firm operating in “Poor” or less capacity such as I observed at PCA. Third parties in reality should never see this. This is lax government oversight. Do not expect third parties to fix the poorest operating facilities, it is not their role, that role belongs to the public health community and fixing that problem will fix most others.

Investigation Techniques in Foodborne Illness Outbreaks

Inspections during Foodborne Illness Outbreaks

When a public health agency becomes aware of an outbreak of foodborne illness, they put into place interventions to stop the transmission. Central to that effort is an environmental assessment referred to as an inspection. Companies may also employ third party inspectors during outbreaks to determine the strength of prevention efforts. Legal firms and private investigators interested in understanding how these outbreaks occur, and why, increasingly conduct inspections during or after foodborne illness outbreaks (See WALB Article on PCA).

www.safefoodsblog.com/uploads/file/WALB Article.pdf 

The Causes of Foodborne Illness

The key principle guiding the inspector is the understanding of the causes of outbreaks. Pathogens cause disease when they are present in sufficient numbers in food to produce an infection or intoxication. How they get into food and survive to the consumer depends on a series of related factors that the inspector must develop as the basis for his inspection techniques.

The Agent, the Host and the Environment

It is fundamental to understand the relationships between the host, the environment and the agent. The characteristics of the host or victim such as age and health status play a role in disease transmission. In addition to the vulnerability of the host, the victim must consume the food so there are logistic considerations about the host and his exposures. The location of the victim, the amount or form of the food consumed, and other facts about consumption and handling relate to whether the person will come in contact with the pathogen. Onset of illnesses and types of symptoms are particular to pathogens and help to provide confirmation of the agent at work.

The Environmental Route of Exposure

The environment plays an essential role in supporting the disease transmission pathway. Disease transmission through the environment occurs when a reservoir of the agent is present and exploits a means of spread. Since the organism in most cases is not motile, it needs a vehicle to get from its reservoir to the food. There it must survive and/or proliferate in the food product. Environmental conditions significantly affect contamination, growth of bacteria, and survival of any pathogen in the food.

Contamination, Growth and Survival

The act of contamination can occur through people, water, vectors such as pests, surfaces, and potentially through the air. Growth of the pathogen occurs when sufficient moisture and temperature are available to the organism for a sufficient time. Facts about the food itself and its ability to support microbial growth include its nutrient content, water content and level of acidity, as well as any processing aids used that influence growth. Survival of the organisms in the food or environment is dependent upon the surface available for colonization, cleaning and sanitary practices, and treatments used on the product such as cooking or pasteurization.

Etiologic Agents

Foodborne agents include over 200 known pathogens; bacterial pathogens that exist in a spore or vegetative cell, viruses, parasites, and toxins. The ability of the organism to survive environmental conditions depends on a number of factors, but Salmonella, Listeria, E coli O157:H7and several other pathogens appear to be hardy enough to survive for long periods, possibly months in ideal conditions. Some spore forming organisms such as Clostridium botulinum need anaerobic conditions to grow, and anaerobic conditions in product and packaging favor other pathogens as well. The reservoir of the pathogen is often difficult to discern. The value of environmental-microbial testing to inspection is that it can identify locations where the organisms have been harboring. Suspicious areas always include moist areas as well as surfaces receiving repeated exposure to dirt and environmental contamination such as floors and drains. There is always a possibility that incoming raw products continually seed the production environment with contamination. It is also possible that multiple reservoirs of the organism in the environment or in people lead to cross contamination throughout the production system.

The Inspection and Analysis

With the understanding of the pathway of infection and the complex relationships between the agent, host and environment, investigators apply an analysis of the food production process. Inspection is a process of observation and the inspector analyzes his observations to determine the likely exposures of the final product to contamination and to identify the process steps that allow proliferation and survival.

Analysis of Production

Food production processes start with the receipt of raw materials but the process at any one step in the food supply are interconnected with all other points right up to consumption. The inspector conducts a visual inspection of the structure, environment, equipment, layout and other factors while focusing on the production process.

Raw materials can contain the pathogen, and include packaging as well as the other ingredients ultimately used in the finished product. While visual observations may reveal potential problems, microbiological and other analysis may be necessary to determine the safety of incoming materials. It is safe to say the opportunity for contamination is significant in raw agricultural commodities grown in the soil and raw meat and other raw, animal foods.

Receiving is usually followed by storage although there may be some immediate use of products as they arrive Stored products may be subjected to hazardous environmental conditions such as pests, dirt, chemicals and foreign of objects Any moisture or signs of vermin where food or packaging is stored increases the risk for contamination.

Foods may be staged into production and be in various forms during processing. Since handling of products occur during production (or preparation), the human element becomes important as does machinery and equipment used, utensils, and the flow of foods through the process itself. Any point can lead to contamination or growth of bacteria if the process is not controlled. Cross contamination can occur when there is poor maintenance of food contact surfaces or under poor storage conditions.

Packaging occurs in food processing while service occurs at the retail level as the final step in the production process. Transportation is an intermediate step in the supply chain and can lead to contamination of finished products. Servers in food service environments can also contaminate foods that were otherwise safe to consume. The key is to analyze the entire food production process and avoid missing hazardous steps.

Evidence Gathering

Photographs, samples and other techniques such as interviewing provide additional evidence in the development of theories of causation and bolster the data obtained through the inspection process. The inspection findings may also benefit from a statistical approach and ranking of factors in terms of their significance and severity. A final report captures the data from all findings and often leads to a conclusion about how foods became contaminated.

Inspection during Foodborne Illness Outbreaks is an Essential Tool

Inspection as a tool in foodborne disease investigation is a critical part of preventing the further spread of pathogens. Inspections also lead to an understanding of the complex associations that influence the probability that a foodborne agent reached a product by a specific pathway. Inspections form a central piece in determining what went wrong and how to prevent similar outbreaks it in the future.

Inspectors should make it clear to operators that they must apply the outbreak inspection findings to the process under study as a matter of urgency and take corrective actions to improve it and other similar processes.

Whether or not an inspection is routine or occurs during or after an outbreak, the ultimate value of inspection in general is to improve the food supply. When applied in a very systematic fashion, inspections during foodborne illness outbreaks can move food safety efforts forward very effectively and dramatically protect the public in the future.

Third Party Audits-Passing the Buck or Coming Full Circle?

In the absence of food safety regulations in many commodities or the lack of oversight in general, companies have turned to the private regulation of the food supply. On an individual and voluntary basis, dozens of auditing firms and hundreds of private parties are looking closely at the safety of thousands of suppliers. The supplier-food safety scheme is pushing all the way back from the retailer to the primary producer or farmer. As each link in the supply chain tightens standards, there will be a corresponding improvement in the safety of final products.

The third party food safety business model is that buyers ”accredit” or approve the third party food-safety firms they will accept audits from, and suppliers are free to hire whatever firm they wish to satisfy the buyer. The supplier pays the auditing firm directly and the auditing firm sends the audit findings to the buyer. The buyer does not pay for the audit and the findings do not bind his purchasing decision.

Third party audits have the capacity to improve food safety and provide another means of protection in the wake of government inaction or even failure. Third parties use private food safety standards developed either in partnership with prospective buyers or in formal expert groups at the national and international levels. They provide the basis for determining “conformance” whereas regulations provide the basis or scope of the regulatory inspection, which is “compliance”. Third party audits cannot take the place of regulatory inspection in protecting the consumer for the simple fact that only government has the legal power to enforce compliance. Third party audits since they are voluntary often take on a collaborative air. A buyer maintaining good working relationships with his auditing companies makes good business sense and adversarial relationships are not productive. Bias can easily slip in when the audit customer and the auditing firm grow too close. Bias can enter from the supplier side as well. When choosing an auditing firm a supplier may decide to select a firm based on price, personal knowledge of the company and its personnel, as well as the strength of the auditing system and its recognition.

The premise for any company to hire an auditing firm is the needs of the buyer who is more than likely requesting the audit. The consumer benefits from the third party scheme in more consistently safe products but protection is weak when the most hazardous facilities continue to operate. Disqualification of a supplier is the responsibility of the buyer, but the audit findings in no way bind the buyer. Third parties can rate a firm but they cannot dictate to the buyer who to use. In such an unregulated system, unsafe operations continue to operate and distribute unsafe food to consumers who continue to become ill and die. Unsafe operations continue even when audits reveal clear significant problems and more troubling, sometimes auditors do not clearly report unsafe conditions.

Bias can work in another way. Since the auditing firm really wants the suppliers business, relationships between suppliers, auditors and firms may develop. If those personal relationships cloud the findings and discretion of the auditor, the system becomes very weak.

Shifting the weight for protecting the consumer to third parties alone is not a good system and is simply “passing the buck”. There must be at the basis for the model, a comprehensive and competent authority with enforcement powers and consistent presence. We cannot rely upon independent third parties for this. Government authority backing up the system greatly improves the third party model and gives it credibility especially when efforts are coordinated with industry. Government acting in tandem with industry third parties and thus the industry itself brings us full circle in the evolution of food protection efforts. Such an effort would pave the way for a significant improvement in the safety of foods and the protection of consumers.