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From: Food Quality & Safety magazine, February/March 2006

A Perfect Blend, Part 3

Risk Management Considerations if and when HACCP and ISO are Combined

by Lydia Guillot

One way to determine both the drawbacks and benefits of combining HACCP and ISO is to formulate risk analysis, which involves management, assessment and communications. These three aspects help to clarify the picture of risks and benefits involved with what is being proposed. In this article, risk management and assessment factors will be examined. In future articles, risk communication of using both ISO and HACCP in the same poultry system will be examined in further detail.

Risk management is a tool that is used to weigh the cost and benefits of various programs. Risk management is intertwined with risk assessment and risk communication in order to provide the best measurement of implementation or shelving a particular program. The program in question seeks to combine HACCP and ISO standards. The next step is to ask “Is the risk worth the cost?” from a risk management point of view. Before risk management, risk assessment must be considered.

In this case, poultry plants are being considered. This involves slaughter and processing operations; the inflow of personnel whether from the industry production or government point of view; the use and maintenance of machinery; volume and type of production; inspection services rendered; sanitation issues; employee training, including hygiene and handling of product especially once exiting the chilling system; and, finally, how product is handled once in processing areas and in the freezers and coolers.

It is important to consider the history of the extent to which an establishment has gone and will go in order to 1) implement the reduction of pathogens and other hazards, and 2) verify hazard and pathogen reduction.

How are these measures qualified and quantified? What tests are done so that physical hazards and chemical hazards are minimized? What records of such testing demonstrate this control of one’s process and how consistent is the data? Does the establishment’s machinery reduce all three types of hazards or is the plant merely concerned with pathogen reduction, i.e., control of bacteriological hazard? Can the plant demonstrate that the physical and chemical hazards are non-existent within the operations? Is the documentation present? Is the plant’s process fluid enough to be amenable to changes within the process?

Within the mode of risk assessment, there are several steps that take place to provide the final goal of obtaining scientific information with which to base one’s decision.

Those steps are:

  • Hazard identification; what are the hazards in the poultry plant taking into consideration its history as well as its long term goal for production. These would include all the possible physical, chemical and biological hazards in the particular establishment;
  • Release assessment (hazard characterization) is that information which is derived from determining the biological pathways that might allow pathogenic agents to gain a foothold and hamper pathogen reduction. This is involved in setting up HACCP, i.e. where would a pathogen most likely succeed in affecting the product?
  • Exposure assessment is involved with what routes are necessary for the consumer to be exposed to a hazard. This is where exposure of consumers to various hazards must be ascertained and stopped through decisions made by an establishment;

Consequence assessment (risk characterization) determines the relationship between exposure and risk. How risky is the establishment’s process and is this getting out to consumers? There are both direct and indirect risks. For example, what is the probability that a consumer will ingest metals, oils, or pathogens once the product leaves the facility (direct risk)? What is the cost in terms of medical insurance, doctor’s fees, hospital costs, when the consumer ingests a hazardous substance? What about lawsuit and the ensuing fees when the consumer makes a complaint (indirect risk)? In doing a risk assessment, one can do quantitative using mathematical models and qualitative in which various issues are discussed and considered scientifically. The above discussion is an example of qualitative risk assessment.

Having done the risk assessment, risk management then becomes easier. Risk management incorporates information derived from risk assessment and uses educated judgment to make a decision whether or not to proceed with the program. The Agricultural Outlook published by the ERS (Economic Research Service) in May 1997 described how risk management was useful to farmers with limited resources. In this instance, risk management uses crop losses, price declines, and other economic issues to provide farmers with a strategy for recovery.

According to the Risk Management Decision Criteria, there are five aspects to consider in any risk management decision: 1) economic gain or burden, 2) health issues, 3) environmental issues, 4) social issues, 5) geo-political issues.

In this case of applying risk management criteria to combining HACCP and ISO in a poultry establishment, these apply readily. The economics in a poultry establishment are very real, especially smaller operations. While HACCP may only take $25,000 to operate and ISO only $31,000 to operate, smaller plants do not have the luxury of that liquid assets that larger plants do.

On the other hand, it takes more to implement ISO in a larger establishment, and the gains may not be as significant as in the smaller establishments. And while HACCP is already mandatory in all meat and poultry establishments, many are still recovering from having to bring themselves into compliance with the new regulations.

Will the implementation of ISO improve health issues? That may not be seen for many years, but ISO reduces rework potential, reduces dressing defects, and adds to food safety and quality improvement, according to Jeff Chilton of Chilton Consulting Services.

Sadao Komemushi of the School of Agriculture in Nakamchi, Japan, states that where HACCP has weak points, ISO would be able to strengthen those particular points. In this case, ISO would address dressing defects that the vendors, openers, and eviscerators fail to remove from a chicken carcass prior to reaching the line inspectors, such as failing to remove the bursa of fabricious from the tail area, removal of lung tissue, removal of oil glands, feathers, etc. Each of these is not at present considered food safety issues. Yet each one does contribute to food safety issues because of fecal material (in the case of intestines) or inedible material (in the case of lung tissue). For instance, the presence of the bursa of fabricious may indicate that feces may be leaking which means that pathogenic bacteria may also present.

While bacteria are undetectable at a microscopic level, and while the pressure washers used on a poultry line may be eliminate visible fecal material, the fact remains is that there is a high degree of probability that pathogenic bacteria are still present and contaminating the carcass. This is due to the structure of pathogenic bacteria and the fact that not all the washers in the word will remove all fecal material. ISO would increase accountability for the upkeep of machinery and facilities, as logs and records are important in the implementation of ISO, as they are in HACCP. Also, foreign countries themselves will be looking to import from countries that have implemented ISO in poultry and red meat plants, because the ISO standards are global standards. Foreign countries use ISO. It would be the job of the federal agencies to sell ISO to industry domestically, because at the present time, companies believe that it is enough to have HACCP, and that the finished product standards sufficiently provide tools for maintaining dressing and trimming.

Environmental issues are also important in poultry establishments, as many of the facilities have been in operation for at least 20 years in the same building. For that reason, the facilities are fairly old. When additions are made, they are done so onto the older facilities. In many instances, the roofs have not be upgraded and there are leaks which are only repaired when pointed out and documented by the USDA inspector, although those leaks are quite visible to anyone walking through.

As it is now, the sanitation performance standards (SPS) allow the inspector to point these items out and for the plant to address facilities and other items. On the other hand, ISO would make plants more accountable in terms of looking after their own facilities. The economic issue comes into play, but from a regulatory standpoint this is a necessary consideration in reducing or eliminating unsanitary conditions. Unsanitary conditions are those that promote the presence of biofilms and of opportunistic bacteria. Unsanitary conditions are the battleground of SPS regulations at the moment. ISO would be a tremendous help in making the SPS more effective. Social issues are intangible issues, involving cultural, global, religious, and diversity issues. How will people of certain cultures feel about the use of ISO along with HACCP? Is this infringing upon anyone’s privacy? Does it interfere with the practicing of religion? What about the production of foods from various cultures? Actually what would be done would be to incorporate those production modes into HACCP and ISO, depending upon whether the issues are food safety or quality. Regardless of culture, foods need to be produced safely and sanitarily.

There are of course custom establishments, which are exempt from some aspects of inspection. But establishments are all required to be under the federal regulations governing HACCP, and if ISO is employed establishments will be required to employ ISO as well. Will it be offensive to any culture, religious or other grouping? These are all considerations that establishments will be made more accountable under ISO. Geo-political issues are those that determine the relationship of one country to another. How will this combination affect the U.S. relationship with Mexico, Aruba, Canada, England, Nairobi, etc.? Will we require exporting countries to employ ISO? Do exporting countries already have ISO in place? We do require of Mexico for example to have HACCP in place in their establishments. 11 If the government comes to adopt the use of ISO and HACCP together, will this be required in other countries? It would probably be easier in other countries, as many look to ISO to help them improve their quality control programs and have added HACCP to further help promote food safety. Companies in other countries use ISO and others want to use ISO in order to help them increase quality prior to the use of HACCP, so that both food safety and quality will be in place.

According to Christina Bedillion of NSF Systems, most companies in the U.S. are not interested in ISO because they believe their own quality system is sufficient for maintaining compliance with the regulation. On the other hand, foreign countries that export from various U.S. companies may require exporting companies to have ISO certification, since U.S. requires companies in other countries to have HACCP in place. It may boil down to a political issue, but it actually is for the benefit of the US that ISO be combined with HACCP.

Lydia Guillot is a veterinary medical officer/public health veterinarian for USDA. Reach her at



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