HACCP Manual
Book 1: seCTion 4 h azard a nalysishazard analysis
The hazard analysis is the most difficult and yet the most important component of the overall HACCP program. Its importance is due to the fact that this is when the team
even the novice should be able to lay the foundation for a strong HACCP risk assess-ment. If, during any part of these four analyses, questions arise based on something that might lead to a food safety issue, consult a local food science department, an industry trade group, or a local regulatory officer. Each of these resources brings his or her expertise to the issue without being judgmental or bringing scrutiny on the individual or the company. That being said, as the hazard analysis is performed, many of the possible hazards can be prevented from entering the process by not absorbing the problem from the supplier. Therefore, careful examination of each ingredient and finished product is critical.
The basic approach to hazard analysis is to analyze each finished product for risks. By using the chemical, physical, microbiological, and allergen risk analysis sheets, the finished good is analyzed based on how it is stored (in a frozen, refriger-ated, or ambient state), whether there is a potential to introduce a hazard into the product during processing, and whether, if introduced, the hazard can be removed by the customer. Based on these criteria, the finished good as a whole is determined to contain or not contain the specific hazard.
The next step is to consider each of the raw materials that make up the finished good. They should be analyzed to determine whether they contain any hazards, whether the hazard can be removed during manufacturing, whether the product can be recontaminated between manufacturing and packaging, whether it is detectable by the customer, and whether the ingredient contains a hazard that can be removed by the customer. Based on these criteria, each of the raw materials is determined to con-tain or not concon-tain the hazard.
ChEMiCal risk analysis
A form on the CD (Book 1_HACCP Program\Section 4_Hazard Analysis:Chemical Risk Analysis) and at the end of this chapter can be used to analyze the chemical risks that pertain to the finished products and the ingredients of which they are composed.
A chemical hazard is defined as any chemical in the ingredient or packaging that may contribute to a food safety issue or may be a health hazard. Traditionally, these are chemicals such as pesticides on vegetative ingredients and non-GRAS (generally recognized as safe) chemicals such as food additives contained within imported ingre-dients or as undeclared components within flavors. Although some issues surrounding allergens can be regarded as chemical in nature, the heightened scrutiny in recent years from a regulatory standpoint relegates these to a separate allergen risk analysis.
For each finished product, the team should fill out the chemical risk analysis sheet by doing the following. In the upper section of the risk assessment worksheet for chemical food hazards, the product name, product item number, and date of
in nature, and flavor ingredients that might use a chemical carrier such as ethanol.
Chemical hazards are usually not found within the ingredient supply of ingredients produced in the United States, but they can be found within foreign-produced and imported ingredients.
“Yes” or “no” should be filled in to indicate whether the chemical is removed during manufacturing. An example of a chemical that can be removed is ethanol con-tained in a flavor; pesticides sprayed on fruits and vegetables would not be removed.
If the ingredient can be contaminated between manufacturing and packaging, then a
“yes” is put in this column. If the ingredient contains a hazard, is this hazard detect-able or removdetect-able by the consumer? If so, a “yes” is placed in the next column. In the next to last column, a “yes” or “no” indicates if the ingredient contains a hazard and the supplier can remove it. The last column denotes whether a certificate of analysis (COA) is available from the ingredient supplier.
Once the chemical risk assessment is complete, the next step is to analyze the results and determine a course of action for control of the hazards. As a basic rule, no chemicals should be allowed to be contained in any of the ingredients. If, during the analysis, a chemical hazard is found that cannot be removed during manufactur-ing, then the supplier should be contacted and requested to remove it. If the supplier agrees to this, then it should be required to provide a COA that expressly indicates that the ingredient has been tested for the chemical and found to be free of it. In the unlikely event that the supplier does not wish to remove the chemical or provide the COA, then an alternate supplier or ingredient should be sourced. Care should be taken to verify that all chemicals are removed from all ingredients.
example
How to fill out the chemical risk analysis is demonstrated on the CD (Book 1_HACCP Program Examples\Section 4_Hazard Analysis:Chemical Risk Analysis complete) and at the end of this chapter. In this case, steak sauce was analyzed and each of the ingredients was examined for possible chemical risks. Based on an examination of the supplier documentation and considering the fact that tomatoes and pineapples are agricultural products known possibly to contain pesticides, a “yes” was placed in the appropriate box for the hazard. It was also determined that the supplier could provide a chemical-free COA with every lot to guarantee that the product was chemi-cal free.
coli O157:h7 and peanut butter from Salmonella emphasize the need to be extremely careful when conducting the microbiological risk analysis.
Bacteria, yeasts, molds, and sometimes their end products, such as toxins, are found in many forms throughout the growing, harvesting, manufacturing, and distri-bution environments. Detailed treatises on the morphology and prevalence of each possible microbiological hazard are available from local bookstores, colleges, or trade associations and should be consulted. When the microbiological hazard review is performed, three categories of organisms should be investigated. These are total bacterial load, pathogenic organisms, and yeasts and molds.
Total bacterial load is exemplified by measuring the amount of heterotrophic organisms. These organisms can be tested for by an aerobic plate count (APC), total plate count (TPC), or standard plate count (SPC). APC, TPC, and SPC are acronyms used fairly interchangeably by industry and testing laboratories alike, although TPC is the most common. The food industry uses this test as an indicator to determine the overall level of sanitation within the manufacturing and distribution processes and to determine whether the processing kill step was sufficient. The higher the microbial load found in the TPC is, the greater is the possibility that the processing environ-ment is not clean or that the process was not sufficient enough to kill an adequate number of the organisms present.
Pathogenic organisms (pathogens) are defined as organisms that, when ingested, can cause sickness up to and including death. The FDA defines five classes of patho-genic organisms or toxins. These are pathopatho-genic bacteria, enterovirulent E. coli group, parasitic protozoa and worms, natural toxins, and other pathogenic agents.
Some examples of these organisms and the types of foods in which they are found are:
Salmonella: found in raw meats, poultry, eggs, milk and dairy products, fish, shrimp, frog legs, yeast, coconut, sauces and salad dressings, cake mixes, cream-filled desserts and toppings, dried gelatin, peanut butter, cocoa, and chocolate;
Clostridium botulinum: found in honey and improperly thermally pro-cessed foods;
Staphylococcus aureus: found in meat and meat products; poultry and egg products; salads such as egg, tuna, chicken, potato, and macaroni; bakery products such as cream-filled pastries, cream pies, and chocolate éclairs;
sandwich fillings; and milk and dairy products;
Campylobacter jejuni: found in raw chicken, raw milk, and nonchlorinated water;
Yersinia enterocolitica: found in meats (pork, beef, lamb, etc.), oysters, fish, and raw milk;
Pathogens are all extremely dangerous and harmful to humans and serious care must be taken by the HACCP team to ensure that they are all excluded or killed during processing. None of these organisms should typically be found in any processed ingredient purchased for use in the manufacturing process. The onus is on the sup-plier during growth, manufacture, processing, and distribution of the ingredient to produce it in such a manner to preclude the presence of pathogens in the ingredient and to be able to verify this. In the case of unprocessed ingredients such as raw meat, milk, or field crops, these might contain pathogens that are naturally present and their presence should be noted in the microbiological hazard analysis.
Yeasts and molds are a class of organisms that are found throughout the envi-ronment. They come in various shapes and sizes, utilize different food sources, and may or may not like oxygen. These are easily differentiated using standard micro-biological methodology. Generally, these organisms are undesirable within any raw material or finished good, although there are a few notable exceptions, including probiotics added to products like kefir and yogurt, mold in cheese, yeast added as a leavening agent in baking, and yeast used in the fermentation industry.
As a basic rule, care should be taken to investigate each supplier thoroughly to understand how the ingredient is manufactured and packaged. The core supplier investigation tool for HACCP purposes is the initial document collection as outlined in the HACCP preparation section. This includes the receipt of a specification sheet that lists ingredients, storage requirements, and packaging. Each of the ingredients and subingredients within each ingredient should be considered as the microbiologi-cal risk analysis is conducted.
The CD (Book 1_HACCP Program\Section 4_Hazard Analysis:Microbiological Risk Analysis) or the form at the end of this chapter can be used to fill out the product name, product item number, and date. In the finished product section, how it is stored at each of the manufacturing and distribution steps should be indicated. Whether the product can be contaminated at any point in the process should be considered. If it can, the appropriate box should be filled in and then whether the customer applies a kill step such as heating during preparation before eating.
The next section, ingredients, is the most important risk analysis conducted as part of the HACCP program. Careful analysis can prevent the company from adopting the problems of its suppliers and allow it to gain a better understanding of the types of processing that need to be applied. As each ingredient is evaluated to determine if it contains a microbiological hazard, the following issues need to be considered:
recognized microbiological specifications and testing methods?
Ingredient processing: Does it go through a manufacturing or processing step
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that effectively kills or significantly reduces the ingredients’ microbial load?
Ingredient packaging: Does its package lend itself to keeping the product
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from being contaminated during distribution?
If the ingredient is complex, then each of the subingredients, including process-ing aids such as carriers in flavors, desiccants in spice blends and free-flowprocess-ing agents in dry vegetables, cheese, and frozen inclusions, should be evaluated from the stand-point of whether they have gone through a kill step. When the subingredients natu-rally contain a high microbial load, they may contaminate the end ingredient unless the final kill step is adequate to achieve a thorough kill.
Examining the ingredient’s source, physically and geographically, assists the HACCP team in roughly determining a starting microbial load. The physical origin of the ingredient, whether it is an agricultural product, is important because agricul-tural products that have not undergone further processing inherently contain higher microbial loads. Some notable agricultural products, such as purees, variegates, whole and/or chopped, sliced, diced, or pureed fruits and vegetables, are microbial suspects. Agricultural products also have the potential to be contaminated with natu-rally occurring pathogenic organisms such as Listeria, Staphylococcus, and E. coli.
It is not uncommon to find high total plate counts, high yeast and mold counts, and high coliform counts on plant-based ingredients. Another source-related question to be asked is what country the ingredient is from. Different countries have differ-ent regulatory requiremdiffer-ents—some more microbiologically strict and some less. For example, countries such as Turkey, Iran, and India are the source for many spices, but the microbiological requirements for the final exported product are not as strin-gent as those required for American producers. Alternatively, products produced in Japan traditionally must conform to stricter microbiological requirements than those for U.S. producers.
The ingredient type is also important in evaluating whether it may or does con-tain a microbiological hazard. If the ingredient is highly processed or publicized, and generally recognized microbiological standards exist, it is less likely to contain a microbiological hazard. Ingredients that fall into this class include sugar, corn syrup, dried powders, vinegar, flavors, and salt.
If and how the ingredient is processed lends an insight to whether the ingredient will potentially have a microbial hazard. Those that undergo a significant kill step such as heating, irradiation, thermal processing, or pasteurization will have a lower potential than those that do not. Most processed ingredients undergo some type of kill step during their processing, but it should not be categorically assumed that, if they did, they are clean.
the preceding questions should be considered and whether the ingredient contains a microbial hazard should be indicated. If there is any question whether it does or does not, it should be considered to contain one until it can be verified that it does not. It is necessary always to be safe and err on the side of caution. For those ingre-dients that do contain a hazard, it should be indicated in the next column whether the hazard is removed during processing. Then, whether the ingredient can be recon-taminated between manufacturing and packaging should be indicated. In the next column, whether the ingredient can be recontaminated during distribution or storage should be filled in.
The final two columns on the microbiological risk analysis sheet involve control-ling the defined hazards. In the second column from the right, it is necessary to fill in whether the supplier can remove the microbiological load or reduce it to a manage-able level. If the hazard can be removed or controlled, this is the preferred method of control and it should be required of the supplier. The supplier should be required to provide two types of documents that address the microbiological issue. First, a new specification sheet that documents the new, lower microbiological specification should be provided. Second, the supplier should be required to provide a certifi-cate of analysis for each lot of material sent to the company. Typical limits for each bacterium should be set in accordance with normal ranges for the ingredient. If the supplier refuses to provide the needed or desired level of testing and/or documents, the first course of action is to attempt to negotiate compliance. If or when this fails, consideration should be made to source the ingredient from another supplier. It is innately better to upset even the oldest supplier than to allow unwanted microbiologi-cal hazards into the plant. If the supplier agrees to provide a certificate of analysis, a check mark is placed in the box in the far right column of the sheet.
The effectiveness of the microbiological hazard analysis relies on the care that is taken during the evaluation of the finished good and the individual ingredients contained therein. It is essential that all possible hazards are found, documented, and systematically removed from the incoming ingredients. To this end, suppliers should be put on notice and held accountable to provide ingredients that have no or very low microbial loads and definitely no pathogens.
example
The form found on the CD (Book 1_HACCP Program Examples\Section 4:Micro-biological Risk Analysis Complete) and at the end of this chapter demonstrates how
guarantee that the product carried a microbial load that was within the agreed upon specification. Furthermore, the raisin paste, spice blend, and orange peel also may have higher levels of microbes, so a COA would be required from the supplier. Even though they also are agriculturally based, the supplier puts the garlic and onion pow-der through a kill step and provides a COA.
physiCal risk analysis
The physical risk analysis form on the CD (Book 1_HACCP Program\Section 4_
Hazard Analysis:Physical Risk Analysis) and at the end of this chapter is used to identify physical hazards contained within the ingredients or finished product. These risks are usually the easiest to remove because they are the easiest to see with the naked eye. As with the chemical and microbiological risk analyses, the physical risk analysis examines whether the finished product and the individual ingredients con-tain any risks. On this form, the name of the product, date of analysis, and product item number are filled in at the top.
In the finished product section, how the finished product is stored in the company warehouse, at the distributor, at the retailer, and by the customer is indicated. Next, it is necessary to determine if it is possible, based on the packaging configuration, for the finished product to become contaminated with a physical object. With modern packaging and regulations, retail packaging usually prevents any type of postmanu-facturing physical contamination; however, industrial packaging does lend itself to possible physical contaminants.
On the bottom half of the form, all of the ingredients that make up the finished product should be listed. It is necessary to evaluate whether the ingredient might or does contain a physical hazard. Physical hazards usually come in three categories:
growing or harvesting hazards, manufacturing or processing hazards, and packaging hazards. Growing or harvesting hazards are those associated with growing the ingre-dient or harvesting it from an agricultural setting. These hazards are things such as rocks, wood, stems, rodent and pest pieces, and other foreign material inherently found on the ground and picked up with the base ingredient during harvesting. When evaluating whether the ingredient may contain these types of physical hazards, it is necessary to consider how and where the ingredient was grown, if the physical haz-ard can be removed in its entirety by the supplier, and if the ingredient contains the hazard naturally. For example, when ground-based ingredients such as corn, peas, and soybeans are evaluated, stones, stems, leaves, and insects are included as part of the harvesting process. Generally, they are removed during processing, but in some cases the law makes allowances for low levels of hazards to stay within the food.
indicated. Fill in the next column as to whether the supplier can remove the identified hazard during processing. If the supplier can, determine if it has the capability of testing for the hazard prior to shipment and, if so, whether it can provide a certificate of analysis that identifies this. Place this answer in the final column.
examples
A completed form for a retail steak sauce product is exhibited on the CD (Book 1_HACCP Program Examples\Section 4:Physical Risk Analysis Complete) and at the end of this chapter. The top section shows that the product is stored at room temperature during all four phases of distribution: in the company warehouse, at the distributor, at the retailer, and with the customer. It also reflects that the customer may store the product in the refrigerator, probably after opening. This section also shows that a physical hazard, such as a hair, might get introduced at the customer level because the customer opens the container and would be able to detect any pos-sible hazards upon use.
In the lower section, the analysis indicates that the tomato puree and the raisin paste may contain hazards such as stems and rocks but that these are removed during manufacture and that they are not recontaminated between manufacture and packag-ing. The spice blend, on the other hand, may contain hazards such as rocks and stems but also might contain metal from the milling and screening process. Although the rocks, stems, and metal are removed with screens and magnets during manufacture, it should be noted the manufacturing has the capability to remove them, so a certifi-cate of analysis should be required on a lot-by-lot basis.
allErgEniC risk analysis
The allergen risk analysis form found on the CD (Book 1_HACCP Program\Section 4_Hazard Analysis:Allergen Risk Analysis) and at the end of this chapter is used to identify allergen hazards contained within the ingredients or finished product. In the past, allergens have not been considered as hazards or were considered during chemical risk analysis. However, in light of the current emphasis by regulatory bod-ies for all foodstuffs to contain the proper allergen warnings, a separate risk analysis for allergens is prudent and should be conducted. This follows the same procedure as the chemical, microbiological, and physical hazard analyses but relies very heavily