FDA Logo U.S. Food and Drug AdministrationCenter for Food Safety and Applied Nutrition
U.S. Department of Health and Human Services
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April 2006

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Managing Food Safety: A Manual for the Voluntary Use of HACCP Principles for Operators of Food Service and Retail Establishments

Table of Contents

Chapter 2 - The Process Approach

APPLYING HACCP PRINCIPLES TO RETAIL AND FOOD SERVICE

What is the process approach?

Since the early 1980's, retail and food service operators and regulators have been exploring the use of HACCP in restaurants, grocery stores, and other retail food establishments. Most of this exploration has centered on the question of how to stay true to the definitions of HACCP yet still make the principles useful to an industry that encompasses a very broad range of conditions. Through this exploration, HACCP principles have been slightly modified to apply to the varied operations found at retail.

When conducting the hazard analysis, food manufacturers usually use food commodities as an organizational tool and follow the flow of one product. This is a very useful approach for producers or processors since they are usually handling one product at a time. By contrast, in retail and food service operations, foods of all types are worked together to produce the final product. This makes a different approach to the hazard analysis necessary. Conducting the hazard analysis by using the food preparation processes common to a specific operation is often more efficient and useful for retail and food service operators. This is called the "Process Approach" to HACCP.

The process approach can best be described as dividing the many food flows in an establishment into broad categories based on activities or stages in the flow of food through your establishment, then analyzing the hazards, and placing managerial controls on each grouping.

What is the flow of food?

The flow of food in a retail or food service establishment is the path that food follows from receiving through service or sale to the consumer. Several activities or stages make up the flow of food and are called operational steps. Examples of operational steps include receiving, storing, preparing, cooking, cooling, reheating, holding, assembling, packaging, serving, and selling. Keep in mind that the terminology used for operational steps may differ between food service and retail food store operations.

What are the three food preparation processes most often used in retail and food service establishments?

Most food items produced in a retail or food service establishment can be categorized into one of three preparation processes based on the number of times the food passes through the temperature danger zone between 41° F to 135 ° F:

The Danger Zone Diagram explained above.

A summary of the three food preparation processes in terms of number of times through the temperature danger zone can be depicted in a Danger Zone diagram. Note that while foods produced using process 1 may enter the danger zone, they are neither cooked to destroy pathogens, nor are they hot held. Foods that go through the danger zone only once are classified as Same Day Service, while foods that go through more than once are classified as Complex food preparation.

The three food preparation processes conducted in retail and food service establishments are not intended to be all-inclusive. For instance, quick service facilities may have "cook and serve" processes specific to their operation. These processes are likely to be different from the "Same Day Service" preparation processes in full service restaurants since many of their foods are generally cooked and hot held before service. In addition, in retail food stores, operational steps such as packaging and assembly may be included in all of the food preparation processes prior to being sold to the consumer.

It is also very common for a retail or food service operator to have a single menu item (i.e. chicken salad sandwich) that is created by combining several components produced using more than one kind of food preparation process. It is important for you to remember that even though variations of the three food preparation process flows are common, the control measures - actions or activities that can be used to prevent, eliminate, or reduce food safety hazards - to be implemented in each process will generally be the same based on the number of times the food goes through the temperature danger zone.

THE HAZARD ANALYSIS

In the "process approach" to HACCP, conducting a hazard analysis on individual food items is time and labor intensive and is generally unnecessary. Identifying and controlling the hazards in each food preparation process listed above achieves the same control of risk factors as preparing a HACCP plan for each individual product. Example: An establishment has dozens of food items (including baked chicken and meatloaf) in the "Preparation for Same Day Service" category. Each of the food items may have unique hazards (See Annex 3, Table 1), but regardless of their individual hazards, control via proper cooking and holding will generally ensure the safety of all of the foods in this category. An illustration of this concept follows:

As with product-specific HACCP, critical limits for cooking remain specific to each food item in the process. In the scenario described above, the cooking step for chicken requires a final internal temperature of 165°F for 15 seconds to control the pathogen load for Salmonella. Meatloaf, on the other hand, is a ground beef product and requires a final internal temperature of 155°F for 15 seconds to control the pathogen load for both Salmonella and E. coli O157:H7. Note that there are some operational steps, such as refrigerated storage or hot holding, that have critical limits that apply to all foods.

The following table further illustrates this concept. Note that the only unique control measure applies to the critical limit of the cooking step for each of the products. Other food safety hazards and control measures may exist:

Process 2: Preparation for Same Day Service
Example Products Meatloaf Chicken
Example Biological HazardsSalmonellaSalmonella
E. coli O157:H7Campylobacter
Clostridium perfringensClostridium perfringens
Bacillus cereusBacillus cereus
Various fecal-oral route pathogensVarious fecal-oral route pathogens
Example Control Measures

(there may be others)
Cooking at 155°F for 15 seconds Cooking at 165°F for 15 seconds
Refrigeration 41°F or belowRefrigeration 41°F or below
Hot Holding at 135°F or above OR Time Control for 4 hours or lessHot Holding at 135°F or above OR Time Control for 4 hours or less
No bare hand contact with RTE food, proper handwashing, exclusion/restriction of ill employeesNo bare hand contact with RTE food, proper handwashing, exclusion/restriction of ill employees

DETERMINING RISK FACTORS IN PROCESS FLOWS

Several of the most common risk factors associated with each food preparation process are discussed below. Remember that while you should generally focus your food safety management system on these risk factors, there may be other risk factors unique to your operation or process that are not listed here. You should evaluate your operation and the food preparation processes you use independently.

In developing your food safety management system, keep in mind that active managerial control of risk factors common to each process can be achieved by either designating certain operational steps as critical control points (CCPs) or by implementing prerequisite programs. This will be explained in more detail in Chapter 3. The HACCP plans that you will develop using this Manual, in combination with prerequisite programs, will constitute a complete food safety management system.

Facility-wide Considerations

In order to have active managerial control over personal hygiene and cross-contamination, you must implement certain control measures in all phases of your operation. All of the following control measures should be implemented regardless of the food preparation process used:

 

Food Preparation Process 1 - Food Preparation with No Cook Step

Example Flow: RECEIVE - STORE - PREPARE - HOLD - SERVE

Several food flows are represented by this particular process. Many of these food flows are common to both retail food stores and food service facilities, while others only apply to retail operations. Raw, ready-to-eat food like sashimi, raw oysters, and salads are grouped in this category. Components of these foods are received raw and will not be cooked prior to consumption.

Foods cooked at the processing level but that undergo no further cooking at the retail level before being consumed are also represented in this category. Examples of these kinds of foods are deli meats, cheeses, and other pasteurized products. In addition, foods that are received and sold raw but are to be cooked by the consumer after purchase, i.e. hamburger meat, chicken, and steaks, are also included in this category.

All the foods in this category lack a kill (cook) step while at the retail or food service establishment. In other words, there is no complete trip made through the danger zone for the purpose of destroying pathogens. You can ensure that the food received in your establishment is as safe as possible by requiring purchase specifications. Without a kill step to destroy pathogens, your primary responsibility will be to prevent further contamination by ensuring that your employees follow good hygienic practices.

Cross-contamination must be prevented by properly storing your products away from raw animal foods and soiled equipment and utensils. Foodborne illness may result from ready-to-eat food being held at unsafe temperatures for long periods of time due to the outgrowth of bacteria.

In addition to the facility-wide considerations, a food safety management system involving this food preparation process should focus on ensuring that you have active managerial control over the following:

 

Food Preparation Process 2 - Preparation for Same Day Service

Example Flow: RECEIVE - STORE - PREPARE - COOK - HOLD - SERVE

In this food preparation process, food passes through the danger zone only once in the retail or food service establishment before it is served or sold to the consumer. Food is usually cooked and held hot until served, i.e. fried chicken, but can also be cooked and served immediately. In addition to the facility-wide considerations, a food safety management system involving this food preparation process should focus on ensuring that you have active managerial control over the following:

Approved food source, proper receiving temperatures, and proper cold holding prior to cooking are also important if dealing with certain marine finfish due to concerns with ciguatera toxin and scombrotoxin. Consult Annex 2 of this Manual for special considerations related to seafood.


Food Preparation Process 3 - Complex Food Preparation

Example Flow: RECEIVE - STORE - PREPARE - COOK - COOL - REHEAT - HOT HOLD - SERVE

Foods prepared in large volumes or in advance for next day service usually follow an extended process flow. These foods pass through the temperature danger zone more than one time; thus, the potential for the growth of spore-forming or toxigenic bacteria is greater in this process. Failure to adequately control food product temperatures is one of the most frequently encountered risk factors contributing to foodborne illness. In addition, foods in this category have the potential to be recontaminated with L. monocytogenes, which could grow during refrigerated storage. FDA recommends that food handlers minimize the time foods are at unsafe temperatures.

In addition to the facility-wide considerations, a food safety management system involving this food preparation process should focus on ensuring that you have active managerial control over the following:

Approved food source, proper receiving temperatures, and proper cold holding prior to cooking are also important if dealing with certain marine finfish due to concerns with ciguatera toxin and scombrotoxin. Consult Annex 2 of this Manual for special considerations related to seafood.

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