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April 2006
Regardless of the resource limitations you may have, you can still use the principles of HACCP to guide your inspections. Many of you already have the technical food safety knowledge needed to effectively use a HACCP approach.
For the purposes of this discussion, "hazards" are defined as the specific biological, chemical, or physical properties or agents that, if uncontrolled, may lead to illness or injury. Risk factors are the poor conditions, procedures, or practices that result in out-of-control food safety hazards. As stated in Chapter 1, risk factors include -
Conducting a risk-based inspection requires you to focus on evaluating the degree of active managerial control that an operator has over risk factors. In order for you to properly assess active managerial control, you will need to spend the majority of your time observing the practices and procedures that are likely to lead to out-of-control risk factors and asking food workers questions to assess the operation.
Retail and food service operators implement "control measures" to ensure food safety. Control measures are actions or activities that are used to prevent, eliminate, or reduce food safety hazards. You will need to determine the control measures that should be implemented to prevent the occurrence of risk factors in each food preparation process. In order to determine the risk factors common to each operation, it is important for you to understand that the food preparation processes and all the associated control measures initiated by a retail or food service operator represent a food safety management system. It will be necessary for you to ask questions in order to gain information about the system already in place. Once you have done this, you will be able to determine the degree of active managerial control present in the facility and will be able to assist the operator in strengthening the system.
In focusing your inspection, it is important for you to realize that your nonverbal communication is just as important as your verbal communication in relaying important food safety messages to retail and food service operators. You set the example for them to follow during all phases of your inspection. The following are ways that you set the example:
As an experienced food safety professional, you already demonstrate these personal practices in each of your inspections. You will need the additional support of your program management, however, in providing you with state-of-the-art equipment needed to perform a risk-based inspection. Utilizing the proper equipment demonstrates competency and preparedness to the operator and may convince the operator to also use the appropriate equipment. For instance, when you check the temperature of thin hamburgers using a needle probe thermocouple, you demonstrate to the operator the proper method for taking temperatures of thin products. At a minimum, you should have the following equipment to conduct a risk-based inspection:
In planning for inspections you should consider the importance of timing. Several operational steps at retail such as receiving, preparation, and cooling can only be evaluated during limited time periods. Times may need to be varied from inspection to inspection to ensure that all critical processes are evaluated.
With the limited time allotted for inspections, you must develop clear priorities to make the most efficient use of your time in each facility. Although basic sanitation issues generally do not change during the course of a routine inspection, critical practices and procedures leading to risk factors may only be observable during limited time intervals. For this reason, assessment of the active managerial control of risk factors should generally be performed before reviewing basic sanitation issues.
By setting priorities early in the inspection, observations attributed to out-of-control risk factors can be distinguished from those related to general sanitation and maintenance. You can set priorities by completing four activities early in your inspection:
Having an open dialogue with the person in charge during all phases of your inspection gives you an opportunity to learn important information about the existing food safety management system. It is important to know both the strengths and weaknesses of the existing food safety management system early in your inspection so that you can focus your inspection on weak areas. For instance, through your questioning, you learn that the facility cooks chicken that is used in several end products such as soups and salads. You also learn that the facility checks the temperature of the chicken to make sure that it is cooked, but you quickly realize that no further monitoring is conducted when the chicken is cooling. Knowing this, you begin your inspection by checking cooling.
Even if you are unable to have a discussion with the person in charge at the beginning of the inspection, questions about practices and procedures related to risk factors and Food Code interventions, like the facility's employee health policy and consumer advisory, can certainly be asked as you conduct your inspection. It is important to ask enough questions to fully understand the system being utilized in the establishment. This is especially true when evaluating whether the employees are adhering to the established no bare hand contact and handwashing policies.
Asking the person in charge questions about important activities such as receiving, cooling, and preparation is also important in relating the seriousness of out-of-control risk factors. If the person in charge has the time, have him or her accompany you as you conduct your inspection. This will ultimately save you time because you can point out violations as they are observed. These violations should still be marked on your inspection form, but you can obtain immediate corrective action to abate the problem before someone gets sick. You can also use this time to share your knowledge about critical processes. By communicating the public health rationale behind your regulations, you will leave the person in charge with a clear understanding for why active managerial control of risk factors must be a top priority in the day-to-day operation of the business.
In order to detect trends of out-of-control risk factors, it is important for you to review past inspection reports prior to conducting your inspection. This can be done in your office or on-site at the facility. This activity is especially important in jurisdictions where health inspectors rotate from one inspection to the next. If the same risk factor is out-of-control during more than one inspection, it is strongly recommended that the operator develop an intervention strategy to prevent its recurrence (see Chapter 3). Knowledge of what has been corrected from the last inspection also gives you the opportunity to provide some positive feedback to the operator and allows you to track corrected violations in accordance with your jurisdiction's policy.
The menu, whether written as in the case of restaurants, or a list of foods prepared and sold found in retail food stores, can be reviewed in a fairly simple manner. The review can either be done simultaneously with a quick walk-through of the operation (discussed later) or as a discussion with management at the beginning of the inspection. The menu/food list also does not need to be reviewed during every inspection. If a review was done during a recent inspection, you can simply ask the person in charge if there have been any changes since the last inspection. A review of the menu/food list allows you to begin to group food items into one of three broad process categories (discussed later) that will allow you to focus your inspection on risk factors associated with each process. Conducting a review of the menu/food list also allows you to establish inspection priorities by identifying -
By identifying high-risk foods or high-risk food preparation processes, you can focus your inspection on those foods or processes that will most likely cause foodborne illness if uncontrolled. High-risk foods include products like raw chicken that naturally carry a high pathogenic load. If such products are used in a facility, practices related to cross-contamination and cooking should be a priority during the inspection. If there are foods that go through the temperature danger zone several times, cooling and holding practices should be reviewed. If the establishment is primarily a "Cook and Serve" operation, then time can best be spent on observing cooking practices.
The menu/food list review might be the only time you are made aware of specialized processes such as formulating a food so that it is not potentially hazardous or high-risk seasonal menu items such as raw oysters. Foods such as shellstock and certain fish for raw consumption require documentation that should be reviewed during the inspection. You may discover items on the menu such as Caesar salad or hollandaise sauce. Further inquiry is needed regarding the preparation of these items since they are sometimes prepared with raw eggs.
Several operational steps like receiving, preparation, cooking, and cooling may not be inspected as vigorously in retail and food service inspections due, in part, to the hours of the day in which these steps occur. If a facility is inspected in the afternoon hours, for example, receiving and food preparation might have already occurred. You should ask questions to obtain information about the operational steps that you cannot directly observe in order to evaluate the establishment's active managerial control.
As you discuss the menu or food list with the person in charge, it is suggested that you conduct a quick walk-through of the facility to observe what is going on at that time. Conducting a quick walk-through is especially important to observe several activities that might otherwise go unnoticed until later in the inspection:
Noting that receiving or food preparation is occurring at the beginning of the inspection allows you to take advantage of "real-life" production processes and will help you to obtain a clear picture of the establishment's true practices. Receiving and food preparation only occur during limited times, so you may want to stop and observe these operational steps while they are happening.
For example, during the initial walk-through with the person in charge, you may see that salad is being prepared. In response, you might want to take some time to observe the preparation practices. This also offers you an excellent opportunity to interact with the food employees to observe if the food is being properly handled using utensils and to find out how the ingredients were received and stored prior to preparation. Speaking directly to the food service employees preparing the food is also an excellent way to assess the effectiveness of the establishment's food safety training and Standard Operating Procedures (SOPs) for critical processes such as cooling.
Early in the inspection, it is also ideal to check the temperatures of potentially hazardous foods in the cooling process from the morning preparation if the inspection is in the afternoon or last night's meal service if the inspection is occurring in the morning. Also, you might want to ask whether any food is currently being cooked or reheated. The observations you make, along with the feedback you get from questioning the person in charge or the food service employees, will help you evaluate whether foods appear to have been properly processed.
Although some establishments have formal HACCP plans in place, many do not. Even without a HACCP system, every establishment needs to have active managerial control of risk factors. This may be achieved through several means, such as training programs, manager oversight, or standard operating procedures. For example, some establishments incorporate control measures into individual recipes, production schedules, or employee job descriptions to achieve active managerial control.
While a person in charge may require the maintenance of in-house written records by employees to ensure that monitoring is being performed using the correct method and at the proper frequency, risk factors may be managed without the use of formal record keeping. Monitoring, whether through direct observations or by taking appropriate measurements, is by far the most important step to ensuring food safety. If an operator is effectively monitoring all critical activities in the establishment and taking corrective actions when needed, safe food will result. With a few exceptions, maintaining formal records at retail is not required; therefore, records may not be in place for use during your inspection. As a result, it will be necessary to use direct observations and interviewing to determine whether an establishment is adequately monitoring risk factors in their existing food safety management system.
Every establishment has some type of set pattern of procedures even if it is simply described as "the way we do things." A small, independent operation may not have written procedures, yet it may have adequate procedures that are routinely followed. Good communication is required to discover these types of informal management systems.
Many retail and food service establishments have implemented effective food safety management systems by establishing controls for the food preparation methods and processes common to their operation. Control of food preparation processes rather than individual food items is often called the "process approach" to HACCP. The process approach using the principles of HACCP can best be described as dividing the many food items in an operation into three food preparation processes then analyzing the risk factors associated with each process. By placing managerial controls on specific operational steps in the flow of food, foodborne illness can be prevented.
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, and serving. Keep in mind that the terminology used for operational steps may differ between food service and retail food store operations.
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:
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 which go through the danger zone only once are classified as Same Day Service, while foods that go through more than once are Complex.
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 item like a chicken salad sandwich that is created using several components that may be 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.
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), 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 that are not depicted here:
| Example Products | Baked Meatloaf | Baked Chicken |
|---|---|---|
| Example Biological Hazards | Salmonella | Salmonella |
| E. coli O157:H7 | Campylobacter | |
| Clostridium perfringens | Clostridium perfringens | |
| Bacillus cereus | Bacillus cereus | |
| Various fecal-oral route pathogens | Various fecal-oral route pathogens | |
| Example Control Measures (there may be others) | Refrigeration 41 °F or below | Refrigeration 41 °F or below |
| Cooking at 155 °F for 15 seconds | Cooking at 165 °F for 15 seconds | |
| Hot Holding at 135 °F or above OR Time Control for 4 hours or less | Hot 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 employees | No bare hand contact with RTE food, proper handwashing, exclusion/restriction of ill employees |
Several of the most common risk factors associated with each food preparation process are discussed below. Remember that while you should generally focus your inspection on these risk factors, there may be other risk factors unique to an operation or process that are not listed here. You should evaluate each operation and food preparation process independently.
In order to have active managerial control over personal hygiene and cross-contamination, an operator must implement control measures in all phases of the operation. The following control measures should be evaluated during your inspection regardless of the food preparation process used -
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, such as 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. During your inspection, you can ensure that the food received in the facility is as safe as possible by checking that the food is received in good condition and from approved sources. Without a kill step to destroy pathogens, the primary responsibility of the operator will be to prevent further contamination by ensuring that employees follow good hygienic practices. In addition, 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, an inspection involving this food preparation process should focus on ensuring that the facility has active managerial control over the following:
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 facility 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, an inspection involving this food preparation process should focus on ensuring that the facility has active managerial control over the following:
Food source and receiving temperatures/cold holding prior to cooking are also important if dealing with certain marine finfish due to concerns with ciguatera toxin and scombrotoxin. Consult Annex 3 for other special considerations related to seafood.
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 will 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 Listeria monocytogenes, which could grow during refrigerated storage. The key to managing the operational steps within this food preparation process is to minimize the time foods are at unsafe temperatures.
In addition to the facility-wide considerations, an inspection involving this food preparation process should focus on ensuring that the facility has active managerial control over the following:
Food source and receiving temperatures/cold holding prior to cooking are also important if dealing with certain marine finfish due to concerns with ciguatera toxin and scombrotoxin. Consult Annex 3 for other special considerations related to seafood.
The Food Code provides specific measurable criteria, often referred to as critical limits, designed to prevent, eliminate, or reduce hazards in foods. These critical limits are based on the best available science and pertain to control measures applied at operational steps. Common examples include time/temperature standards and no bare hand contact with RTE food.
At a minimum, an operator's food safety management system should be based on achieving the same level of safety established by the critical limits in the Food Code. When determining the degree of active managerial control an operator has over risk factors, you should observe whether the operator has established the appropriate control measures and critical limits and whether appropriate monitoring procedures are in place.
A sample list of questions to assist you in assessing an operator's active managerial control of risk factors at operational steps throughout the flow of food is in Annex 4 of this Manual. This list can be used in conjunction with any inspection form or simply as a tool to help you organize your inspection. In addition, Annex 4 of the 2001 FDA Food Code (or Annex 5 in the 2005 FDA Food Code) contains additional information on assessing the active managerial control of foodborne illness risk factors.
Systems to control basic operational and sanitation conditions within a facility, often referred to as Good Retail Practices (GRPs), Prerequisite Programs, or Standard Operating Procedures (SOPs), are the foundation of a successful food safety management system. With this in mind, consider how the establishment actively monitors these activities. Just as monitoring is required by the establishment to ensure that risk factors are controlled, monitoring of basic sanitation conditions in the facility allows the operator an excellent opportunity to detect weaknesses and initiate actions for improvement. Although the main focus of an inspection should be on evaluating the active managerial control of risk factors, overall sanitation should not be overlooked.
Basic operational and sanitation programs must be in place to -
Examples of concerns addressed by the programs above include the following:
Although retail and food service operators have the responsibility for establishing food safety management systems, you, the regulator, have a vital, multi-faceted role in consumer protection. Your primary responsibility is to ensure the operator has effective control of risk factors. Once you have conducted a menu review and established a dialogue with the person in charge and food service workers, you will have enough information to mentally place menu items into one of the three process flows. Your inspection can then focus on assessing the operator's active managerial control of risk factors associated with each process.
Once out-of-control risk factors are identified, your role shifts to assisting an operator with strengthening the existing food safety management system through intervention strategies designed to achieve immediate and long-term compliance. With your help, retail and food service operators can achieve long-term behavioral change resulting in a reduction in risk factor occurrence and an increase in public health protection.
