Chapter 3 Developing Your Food Safety System

Getting Started - Using a Team How to Use This Guide Procedural Step 1: Group Menu Items Chart 1: Process-Specific Lists Procedural Step 2: Conduct Hazard Analysis Food Safety Management Worksheets and Summaries for Operational Steps Operational Step 1: Receiving Operational Step 2: Storage Operational Step 3: Preparation Operational Step 4: Cooking Chart 2: Food Code Temperatures/Times Operational Step 5: Cooling Operational Step 6: Reheating Operational Step 7: Holding Operational Step 8: Set Up and Packing Operational Step 9: Serving Procedural Step 3: Identify Critical Control Points and Critical Limits Procedural Step 4: Monitor Critical Control Points Procedural Step 5: Develop Corrective Actions Procedural Step 6: Conduct On-Going Verification Description Procedures Frequency Observations, Documentation - Examples Procedural Step 7: Keep Records Procedural Step 8: Conduct Long-Term Verification

GETTING STARTED

Using a Team

Use of this Guide is most effective when a team approach is used for designing and implementing a plan based on the HACCP principles. A team could be comprised of the owner and the chef or cook. Although managers are responsible for designing the system, implementation involves the efforts and commitment of every employee. Education and training of both management and employees are important in their respective roles of producing safe foods. You may consider working with outside consultants, university extension services, and regulatory authorities to ensure your HACCP system is based on the best available science and will control identified hazards.

HOW TO USE THIS GUIDE

This Guide contains a model for assessing significant food safety hazards at each operational step in the flow of food. A short introduction to each step highlights important food safety concerns. For each operational step there is a worksheet and a worksheet summary page which discuss the CCPs and critical limits. These critical food safety limits are included in the Food Code. In addition, Annex 3 of the Food Code provides the public health reasons behind each control measure.

This Guide addresses the significant food safety concerns for each operational step in the flow of food. For each step, a summary sheet and accompanying worksheet are provided to assist you in focusing on the controls that need to be in place in order to manage food safety hazards.

PROCEDURAL STEP 1

Group Menu Items

To get started, review how your menu items flow through your operation, note whether they undergo a cook step for same day serving, receive additional cooling and reheating following a cook step, or have no cook step involved. Refer to Chapter 2 for organizing your menu items by Process 1, 2, and 3.

Looking at your menu, place each menu item or similar menu items (like "hot soups" or "cold salads") into the appropriate group. You may discover that more than one food process is conducted within your operation. You will also need to consult the Annexes to identify menu items that need very careful and special attention throughout the use of this Guide. These menu items may pose special hazards that are not always readily apparent. If your operation serves any of the menu items listed in the Annexes, consult with your regulatory authority for additional information. To accomplish the first procedural step in developing your food safety management system, identify the food processes specific to your menu items.

CHART 1: PROCESS-SPECIFIC LISTS

List your menu items that belong to one of the three processes.

PROCESS #1	PROCESS #2	PROCESS #3
List menu foods: Examples: salad greens fish for sushi fresh vegetables oysters or clams served raw tuna salad Caesar salad dressing coleslaw sliced sandwich meats sliced cheese	List menu foods: Examples: hamburgers soup du jour hot vegetables entrees for "special of the day" cooked eggs	List menu foods: Examples: soups gravies sauces large roasts chili taco filling egg rolls

Process number 1: Food preparation with no cook step - ready-to-eat food that is stored, prepared, and served.

Process number 2: Food preparation for same day service - food that is stored, prepared, cooked, and served.

Process number 3: Complex food preparation - food that is stored, prepared, cooked, cooled, reheated, hot held, and served.

PROCEDURAL STEP 2

Conduct Hazard Analysis

In developing a food safety system, you need to identify the hazards that exist in the flow of foods in your operation from receiving to serving. Hazards include:

• pathogens or toxins present in food when you receive them,

• pathogens that may be introduced during preparation (example: using a raw animal food as one ingredient),

• pathogen growth or toxin production during storage, preparation, or holding.

• pathogens or toxins that survive heating, and

• contaminants, (i.e., pathogens, chemicals, physical objects), that are introduced to food by food workers or equipment.

Since you have grouped your menu items, including ingredients, into the three processes on Chart 1, you can identify hazards that are associated with each process. You will see that the more complex the process is, the greater are the opportunities for hazards to occur.

In consultation with your regulatory authority, you need to identify the hazards associated with various foods and ingredients, such as:

• Salmonella and Campylobacter jejuni in raw poultry,

• E. coli O157:H7 in raw ground beef,

• Staphylococcus aureus toxin formation in cooked ham,

• Bacillus cereus spore survival and toxin formation in cooked rice,

• Clostridium perfringens spore survival and subsequent growth in cooked foods, and

• Hazards specific to seafood, (see Annex 1).

This list is only a brief sample of hazards associated with specific foods. By identifying the hazards, you will be able to determine CCPs and critical limits on the worksheet. Another way of fulfilling the hazard analysis step is to understand the hazards associated with your specific menu items (Annex 3 of the Food Code is a resource for this purpose) and to adhere to the critical limits established in the Food Code. Those critical limits are based on the anticipated hazards.

Food Safety Management Worksheets and Summaries for Operational Steps

Worksheets and summaries are provided to enable you to:

• identify those operational steps in the food flow that are specific to your operation,

• write in your SOPs which are the general procedures that cross all flows and products (refer to Chapter 4, Prerequisite Programs, for further discussion),

• reference the CCPs and critical limits pertaining to those process steps,

• develop monitoring procedures and corrective actions which are customized to fit your operation, and

• consider the type of record keeping you need to document you are controlling significant food safety hazards.

HACCP allows the flexibility for you to customize a food safety management system specific to your operations. The worksheets are provided to assist you in developing procedures to:

• monitor CCPs,

• take corrective actions when critical limits are not met,

• establish a verification procedure, and

• establish a record keeping system.

Review the following worksheets and the summary page for each operational step. Determine the ones that are applicable to your operation and make copies of them so you can fill in your groupings of menu items (which you did preliminarily in Procedural Step 1). Then continue to use the forms and complete the information as you work through Procedural Steps 3 through 9.

RECEIVING

At receiving, your main concern is contamination from pathogens and the formation of harmful toxins. Obtaining food from approved sources and at proper temperatures are important purchase specifications for preventing growth and contamination during receiving. Approved sources are suppliers who are regulated and inspected by appropriate regulatory authorities.

Ready-to-eat, potentially hazardous food is a special concern at receiving. Because this food will not be cooked before service, microbial growth could be considered a significant hazard for receiving refrigerated, ready-to-eat-foods. Having SOPs in place to control product temperature is generally adequate to control the hazards present at receiving of these products. Besides checking the product temperature, you will want to check the appearance, odor, color, and condition of the packaging.

Federal regulations require that processors of seafood and seafood products for interstate distribution have a HACCP plan. These establishments are approved sources for seafood, and you may ask your interstate seafood supplier for documentation that the firm has a HACCP plan in place. Processors of seafood and seafood products that are sold or distributed only within a state may or may not be required to have a HACCP plan, depending on the state, local, or tribal regulations.

Special consideration should be given to certain species of finfish and raw molluscan shellfish. Molluscan shellfish (oysters, clams, mussels, and scallops) that are received raw in the shell or shucked must be purchased from suppliers who are listed on the FDA Interstate Certified Shellfish Shippers' List or on a list maintained by your state shellfish control authority. Shellfish received in the shell must bear a tag (or a label for shucked shellfish) which states the date and location of harvest, in addition to other specific information.

Finfish harvested from certain areas may naturally contain a certain toxin that is not readily apparent. This toxin is called ciguatera. Other finfish may develop toxins after harvest if strict temperature control is not maintained. This toxin is called scombrotoxin. Temperature control is important at receiving because this toxin can not be eliminated by cooking. For more information on toxins in reef finfish, histamine formation in certain species, and parasites in raw finfish requiring control, refer to Annex 1.

Operational Step 1: RECEIVING

PROCESS	MENU ITEM	HAZARD	CCP	CRITICAL LIMITS	MONITORING	CORRECTIVE ACTIONS	VERIFICATION	RECORDS
PROCESS # 1	Examples: Salads Sushi	* Microbial contamination * Bacterial growth * Parasites * Scombrotoxin * Ciguatera or other toxin contamination * Chemical contamination	yes _____ or no _____	Receive at 41°F or below Approved source Seafood HACCP plan Proper chemical storage/use
PROCESS # 2	Examples: Hamburgers Mahi-mahi	* Microbial contamination * Bacterial growth * Scombrotoxin * Ciguatera or other toxin contamination * Chemical contamination	yes _____ or no _____	Receive at 41°F or below Approved source Seafood HACCP plan Proper chemical storage/use
PROCESS # 3	Example: Soups	* Microbial contamination * Bacterial growth * Ciguatera or other toxin contamination * Scombrotoxin * Chemical contamination	yes _____ or no _____	Receive at 41°F or below Approved source Seafood HACCP plan Proper chemical storage/use
SOPs
Process number one: Food preparation with no cook step - ready- to-eat food that is stored, prepared, and served. Process number two: Food preparation for same day service - food that is stored, prepared, cooked , and served. Process number three: Complex food preparation - food that is stored, prepared, cooked, cooled, reheated, hot held, and served.

STORAGE

When food is in refrigerated storage, your management system should focus on preventing the growth of bacteria that may be present in the product. This is primarily achieved through temperature control. Special attention needs to be given to controlling and monitoring the temperatures of potentially hazardous ready-to-eat foods.

When determining the monitoring frequency of product storage temperature, it is important to make sure that the interval between temperature checks is established to ensure that the hazard is being controlled and time is allowed for an appropriate corrective action. For example, If you are storing potentially hazardous ready-to-eat foods under refrigeration, you may decide to set a critical limit for the refrigeration units to operate at 41°F or below. You may also want to set a target, or operating limit, of 40°F for example, in order to provide a safety cushion that allows you the opportunity to see a trend toward exceeding 41°F and to intervene with appropriate corrective actions.

Monitoring procedures for ready-to-eat food ideally include internal product temperature checks. You need to assess whether it is realistic and practical for you to do this, depending on the volume of food you are storing.

You may choose to base your monitoring system on the air temperature of the refrigerated equipment as an SOP. How often you need to monitor the air temperature depends on:

• whether the air temperature of the refrigerator accurately reflects the internal product temperature - (remember, your food safety refrigeration temperature must be based on the internal product temperature of the food stored within a refrigeration unit, not the air temperature),

• the capacity and use of your refrigeration equipment,

• the volume and type of food products stored in your cold storage units,

• the SOPs that support monitoring this process, and

• shift changes and other operational considerations.

Standard operating procedures can be developed to control some hazards and assist in implementing a food safety system that minimizes the potential for bacterial growth and contamination. The control of cross contamination can be done by separating raw foods from ready-to-eat products within your operation's refrigeration and storage facilities.

Special consideration should be given to the storage of scombroid fish due to the potential formation of histamine, a chemical hazard. To control histamine formation in scombroid toxin-forming fish, it is recommended that storage be a CCP with the critical limit not to exceed 41°F, as stated in the Food Code, unless you can show through scientific data that the food safety hazard will not result.

Operational Step 2: STORING

PROCESS	MENU ITEM	HAZARD	CCP	CRITICAL LIMITS	MONITORING	CORRECTIVE ACTIONS	VERIFICATION	RECORDS
PROCESS # 1	Example: Salads Sushi	* Bacterial growth * Cross contamination * Parasites * Chemical contamination	yes _____ or no _____	Store at 41°F or below Separate raw from ready-to-eat food Freeze fish to be consumed raw @ -4°F for 7 days or -31°F for 15 hours Proper chemical storage/use
PROCESS # 2	Example: Hamburgers Mahi-mahi	* Bacterial growth * Scombrotoxin * Cross contamination * Chemical contamination	yes _____ or no _____	Store at 41°F or below Separate raw from ready-to-eat food Proper chemical storage/use
PROCESS PROCESS # 3	Example: Soups	* Bacterial growth * Scombrotoxin * Cross contamination * Chemical contamination	yes _____ or no _____	Store at 41°F or below Separate raw from ready-to-eat food Proper chemical storage/use
SOPs
Process number one: Food preparation with no cook step - ready-to-eat food that is stored, prepared, and served. Process number two: Food preparation for same day service - food that is stored, prepared, cooked , and served. Process number three: Complex food preparation - food that is stored, prepared, cooked, cooled, reheated, hot held, and served.

PREPARATION

Of all the operational steps in food processes, preparation has the greatest variety of activities that must be controlled, monitored, and in some cases documented. It is impossible to include in this model a summary guide that covers the diversity in menus, employee skills, and facility design that impact the preparation of food. The preparation step may involve several processes, including thawing a frozen food, mixing together several ingredients, cutting, chopping, slicing, or breading.

At the preparation step, SOPs can be developed to control some hazards and assist in implementation of a food safety system that minimizes the potential for bacterial growth and contamination from employees and equipment.

Front-line employees will most likely have the greatest need to work with the food. A well designed personal hygiene program that has been communicated to all employees will minimize the potential for bacterial, parasitic, and viral contamination. Your program must include instructions to your employees as to when and how to wash their hands. Procedures need to be in place that either eliminate employees' hand contact with ready-to-eat foods, or implement an alternative personal hygiene program that provides an equivalent level of control of bacterial, parasitic, and viral hazards. It is also very important to identify and restrict ill employees from working with food, especially if they have diarrhea.

Procedures must be in place to prevent cross contamination from utensils and equipment. Designated areas or procedures that separate the preparation of raw foods from ready-to-eat foods minimize the potential for bacterial contamination. Proper cleaning and sanitizing of equipment and work surfaces are an integral SOP to this operational step.

Batch preparation is an important tool for controlling bacterial growth because limiting the amount of food prepared minimizes the time the food is kept at a temperature that allows growth. Planning your preparation ahead assists in minimizing the time food must be out of temperature at this operational step. Batch preparation also breaks the growth cycle of bacteria before they can reach dangerous levels.

When thawing frozen foods, maintaining proper product temperature and managing time are the primary controls for minimizing bacterial growth. Procedures need to be in place to minimize the potential for microbial, chemical, and physical contamination during thawing.

Use of prechilled ingredients to prepare a cold product, such as tuna salad, will assist you in maintaining temperature control for this process.

Special consideration should be given to disallowing bare hand contact in the preparation of ready-to-eat foods. You need to control the introduction of hazards during preparation. How will you accomplish controlling the hazard presented by hand contact with ready-to-eat food? You should review your operation to determine whether this operational step will be controlled as a CCP or an SOP.

Operational Step 3: PREPARATION

PROCESS	MENU ITEM	HAZARD	CCP	CRITICAL LIMITS	MONITORING	CORRECTIVE ACTIONS	VERIFICATION	RECORDS
PROCESS # 1	Example: Salads	* Bacterial growth * Cross contamination * Contamination from employees * Chemical contamination	yes _____ or no _____	Store at 41°F or below or use time to control growth Separate raw from ready-to-eat food Restrict ill employees; control bare hand contact Proper chemical storage/use
PROCESS # 2	Examples: Hamburgers Mahi-mahi	* Bacterial growth * Cross contamination * Contamination from employees * Chemical contamination	yes _____ or no _____	Store at 41°F or below or use time to control growth Separate raw from ready-to-eat food Restrict ill employees; control bare hand contact Proper chemical storage/use
PROCESS # 3	Example: Soups	* Bacterial growth * Cross contamination * Contamination from employees * Chemical contamination	yes _____ or no _____	Store at 41°F or below or use time to control growth Separate raw from ready-to-eat food Restrict ill employees; control bare hand contact Proper chemical storage/use
SOPs
Process number one: Food preparation with no cook step - ready-to-eat food that is stored, prepared, and served. Process number two: Food preparation for same day service - food that is stored, prepared, cooked , and served. Process number three: Complex food preparation - food that is stored, prepared, cooked, cooled, reheated, hot held, and served.

COOKING

This operational step only applies to those foods that you have listed in Processes #2 and #3. Cooking foods of animal origin is the most effective operational step in food processes for reducing and eliminating biological contamination. Hot temperatures will kill most harmful bacteria and with relatively few exceptions, such as cooking plant foods, this is a CCP. It is at this step that food will be made safe to eat. Therefore, product temperature and time measurements are very important. If the appropriate product temperature for the required amount of time is not achieved, bacteria, parasites, or viruses may survive in the food.

Critical time and temperature limits vary according to the type of food. Employees should view ensuring proper cooking temperatures as an essential element in producing an acceptable product. A final cooking time and temperature chart for specific foods is included for your review. Simply reference the foods specific to your food establishment and incorporate the appropriate critical time and temperature limits into your management system.

You will need to determine the best system for you to use that will ensure that the proper cooking temperature and time are reached. Checking the internal product temperature is the most desirable monitoring method. However, when large volumes of food are cooked, a temperature check of each individual item may not be practical. For instance, a quick service food service operation may cook several hundred hamburgers during lunch. If checking the temperature of each hamburger is not reasonable for you to do, then you need to routinely verify that the specific process and cooking equipment are capable of attaining a final internal product temperature at all locations in or on the cooking equipment.

Once a specific process has been shown to work for you, the frequency of record keeping may be reduced. In these instances, a record keeping system should be established to provide scheduled product temperature checks to ensure that the process is working.

Special consideration should be given to time and temperature in the cooking of fish and other raw animal foods. To control the pathogens, it is recommended that cooking be a CCP, based upon the critical limits established by the Food Code, unless you can show through scientific data that the food safety hazard will not result.

Operational Step 4: COOKING

PROCESS	MENU ITEM	HAZARD	CCP	CRITICAL LIMITS	MONITORING	CORRECTIVE ACTIONS	VERIFICATION	RECORDS
PROCESS # 1	Example: Salads Sushi	Does not apply	Does not apply	Does not apply	Does not apply	Does not apply	Does not apply	Does not apply
PROCESS # 2	Examples: Hamburgers Mahi-mahi	* Bacterial, parasitic, or viral survival or growth	yes _____ or no _____	Cook to Product Internal Temp Time See Chart 2
PROCESS # 3	Example: Soups	* Bacterial, parasitic, or viral survival or growth	yes _____ or no _____	Same as Process #2
SOPs
Process number one: Food preparation with no cook step - ready-to-eat food that is stored, prepared, and served. Process number two: Food preparation for same day service - food that is stored, prepared, cooked , and served. Process number three: Complex food preparation - food that is stored, prepared, cooked, cooled, reheated, hot held, and served.

CHART 2: FOOD CODE COOKING TEMPERATURES AND TIMES

PRODUCT	FINAL INTERNAL TEMPERATURE	TIME
1a. Poultry Wild Game Animals Stuffed Fish Stuffed Meat Stuffed Pasta Stuffed Poultry Stuffed Ratites or Stuffing containing Fish Meat Poultry or Ratites	1a. 165°F	1a. 15 seconds
1b. Animal foods cooked in a microwave oven	1b. 165°F; food rotated, stirred, covered	1b. Cover and allow to stand for 2 minutes
2a. Pork, ratites, or injected meats	2a. 155°F	2a. 15 seconds
2b. Ground meat, fish, or game animals commercially raised for food	2b. 155°F	2b. 15 seconds
2c. Game Animals under a voluntary inspection program	2c. 155°F	2c. 15 seconds
2d. Raw shell eggs that are NOT prepared for immediate service	2d. 155°F	2d. 15 seconds
3a. Raw shell eggs broken and prepared in response to consumer order and for immediate service	3a. 145°F	3a. 15 seconds
3b. Fish and Meat including Game Animals except as specifically referenced on this chart	3b. 145°F	3b. 15 seconds
4a. Fruit and vegetables cooked for hot holding	4a. 140°F or above	4a. Instantaneous
4b. Ready-to-eat food from a commercially sealed container for hot holding	4b. 140°F or above	4b. Instantaneous
4c. Ready-to-eat food from an intact package (from a food processing plant inspected by the regulatory authority with jurisdiction over the plant) for hot holding	4c. 140°F or above	4c. Instantaneous
5a. Beef Roast/Corned Beef Roasts Preheated Oven Temperatures	5a. LESS THAN 10 lbs. (i) Still Dry: 350 F or more (ii) Convection: 325°F or more (iii) High Humidity: 250°F or less MORE THAN 10 lbs (I) Still dry: 250°F or more (ii) Convection: 250°F or more (iii) High Humidity: 250°F or less
5b. Beef Roast/Corned Beef Roasts Internal Food Temperature for Specified Amount of Time	5b. ACHIEVE ONE OF THE FOLLOWING: (I). 130°F for 121 Minutes (ii). 132°F for 77 Minutes (iii). 134°F for 47 Minutes (iv). 136°F for 32 Minutes (v). 138°F for 19 Minutes (vi). 140°F for 12 Minutes (vii). 142°F for 8 Minutes (viii). 144°F for 5 Minutes (ix). 145°F for 3 Minutes

COOLING

This operational step is only used for those foods that you have listed in Process #3. One of the most labor intensive operational steps is rapidly cooling hot foods to control microbial growth. Excessive time for the cooling of potentially hazardous foods has been consistently identified as one of the factors contributing to foodborne illness. Foods that have been cooked and held at improper temperatures provide an excellent environment for the growth of disease causing microorganisms that may have survived the cooking process (spore-formers). Recontamination of a cooked food item by poor employee practices or cross contamination from other food products, utensils and equipment is a concern at this operational step.

Special consideration should be given to large food items, such as roasts, turkeys, thick soups, stews, chili, and large containers of rice or refried beans. These foods take a long time to cool because of their mass and volume. If the hot food container is tightly covered, the cooling rate will be further slowed down. By reducing the volume of the food in an individual container and leaving an opening for heat to escape by keeping the cover loose, the rate of cooling is dramatically increased.

Commercial refrigeration equipment is designed to hold cold food temperatures, not cool large masses of food. Some alternatives for cooling foods include:

• Using rapid chill refrigeration equipment designed to cool the food to acceptable temperatures quickly by using increased compressor capacity and high rates of air circulation;

• Avoiding the need to cool large masses by preparing smaller batches closer to periods of service;

• Stirring hot food while the food container is within an ice water bath; or

• Redesigning your recipe so that you prepare and cook a smaller or concentrated base and then add enough cold water or ice to make up the volume that you need. This may work for some water-based soups, for example.

Whatever the cooling method you choose, you need to verify that the process works. Once again if a specific process has been shown to work for you, the frequency of record keeping may be reduced. A record keeping system should be established to provide scheduled product temperatures checks to ensure the process is working.

Operational Step 5: COOLING

PROCESS	MENU ITEM	HAZARD	CCP	CRITICAL LIMITS	MONITORING	CORRECTIVE ACTIONS	VERIFICATION	RECORDS
PROCESS # 1	Examples: Salads Sushi	Does not apply	Does not apply	Does not apply	Does not apply	Does not apply	Does not apply	Does not apply
PROCESS # 2	Examples: Hamburgers Mahi-mahi	Does not apply	Does not apply	Does not apply	Does not apply	Does not apply	Does not apply	Does not apply
PROCESS # 3	Example: Soups	* Bacterial growth * Cross contamination * Contamination from employees or equipment	yes _____ or no _____	Cool food from 140°F to 70°F within 2 hours and from 70°F to 41°F within 4 hours Separate raw from ready-to-eat food Restrict ill employees; control bare hand contact
SOPs
Process number one: Food preparation with no cook step - ready to eat food that is stored, prepared, and served. Process number two: Food preparation for same day service - food that is stored, prepared, cooked , and served. Process number three: Complex food preparation - food that is stored, prepared, cooked, cooled, reheated, hot held, and served.

REHEATING

This operational step applies only to those foods that you listed in Process #3. If food is held at improper temperatures for enough time, pathogens have the opportunity to multiply to dangerous numbers. Proper reheating provides an important control for eliminating these organisms. It is especially effective in reducing contamination from bacterial spore-formers which survived the cooking process and may have multiplied because foods were held at improper temperatures.

Although proper reheating will kill most organisms of concern, it will not eliminate toxins, such as that produced by Staphylococcus aureus. If microbial controls and SOPs at previous operational steps have not been followed correctly and Staph toxin has been formed in the food, reheating will not make the food safe.

Incorporating a comprehensive personal hygiene program throughout the process will minimize the risk from Staph toxin. Along with personal hygiene, preventing cross contamination through the use of cleaned and sanitized equipment and utensils is an important control measure.

Special consideration should be given to the time and temperature in the reheating of cooked foods. To control the pathogens, it is recommended that reheating be a CCP, based upon the critical limits established by the Food Code, unless you can show through scientific data that the food safety hazard will not result.

Operational Step 6: REHEATING

PROCESS	MENU ITEM	HAZARD	CCP	CRITICAL LIMITS	MONITORING	CORRECTIVE ACTIONS	VERIFICATION	RECORDS
PROCESS # 1	Examples: Salads Sushi	Does not apply	Does not apply	Does not apply	Does not apply	Does not apply	Does not apply	Does not apply
PROCESS # 2	Examples: Hamburgers Mahi-mahi	Does not apply	Does not apply	Does not apply	Does not apply	Does not apply	Does not apply	Does not apply
PROCESS # 3	Example: Soups	* Bacterial, parasitic or viral survival or growth	yes _____ or no _____	Reheat to 165°F within 2 hours
SOPs
Process number one Food preparation with no cook step - ready-to-eat food that is stored, prepared, and served. Process number two: Food preparation for same day service - food that is stored, prepared, cooked , and served. Process number three: Complex food preparation - food that is stored, prepared, cooked, cooled, reheated, hot held, and served.

HOLDING

All three processes may involve holding. Proper temperature of the food while being held is essential in controlling the growth of harmful bacteria. Cold temperature holding may occur in Processes 1, 2, or 3. Hot temperature holding occurs primarily only in Processes 2 and 3. Where there is a cooking step as a CCP to eliminate pathogens, all but the spore-forming organisms should be killed or inactivated. If cooked food is not held at the proper temperature, the rapid growth of these spore-forming bacteria is a major food safety concern.

When food is held, cooled, and reheated in a food establishment there is an increased risk from contamination caused by personnel, equipment, procedures, or other factors. Harmful bacteria that are introduced into a product that is not held at proper temperature have the opportunity to multiply to large numbers in a short period of time. Once again management of personal hygiene and the prevention of cross contamination impact the safety of the food at this operational step.

Keeping food products at 140°F or above during hot holding and keeping food products at or below 41°F is effective in preventing microbial growth. As an alternative to temperature control, the Food Code details actions when time alone is used as a control, including a comprehensive monitoring and food marking system to ensure food safety.

How often you monitor the temperature of foods during hot holding determines what type of corrective action you are able to take when 140°F is not met. If the critical limit is not met, your options for corrective action may include evaluating the time the food is out of temperature to determine the severity of the hazard and based on that information, reheating the food, if appropriate, or discarding it. Monitoring frequency may mean the difference between reheating the food to 165°F or discarding it.

When determining the monitoring frequency of cold product temperatures, it is important to make sure that the interval between temperature checks is established to ensure that the hazard is being controlled and time is allowed for an appropriate corrective action. For example, If you are holding potentially hazardous ready-to-eat foods under refrigeration, such as potato salad at a salad bar, you may decide to set a critical limit at 41° F or below. You may also want to set a target, or operating limit, of 40° F for example, in order to provide a safety cushion that allows you the opportunity to see a trend toward exceeding 41°F and to intervene with appropriate corrective actions.

Special consideration should be given to the time and temperature in the hot or cold holding of potentially hazardous foods to control pathogens. It is recommended that hot or cold holding be a CCP, based upon the critical limits established by the Food Code, unless you can show through scientific data that the food safety hazard will not result.

Operational Step 7: HOLDING

PROCESS	MENU ITEM	HAZARD	CCP	CRITICAL LIMITS	MONITORING	CORRECTIVE ACTIONS	VERIFICATION	RECORDS
PROCESS # 1	Examples: Salads Sushi	* Bacterial, parasitic, or viral introduction, survival, or growth	yes _____ or no ______	41°F
PROCESS # 2	Examples: Hamburgers Mahi-mahi	* Bacterial, parasitic, or viral introduction, survival, or growth	yes _____ or no ______	140°F or 41°F
PROCESS # 3	Example: Soups	* Bacterial, parasitic, or viral introduction, survival, or growth	yes _____ or no ______	140°F or 41°F
SOPs
Process number one: Food preparation with no cook step - ready-to-eat food that is stored, prepared, and served. Process number two: Food preparation for same day service - food that is stored, prepared, cooked, and served. Process number three: Complex food preparation - food that is stored, prepared, cooked, cooled, reheated, hot held, and served.

SET UP AND PACKING

Set up and packing is an operational step used by some retail food establishments including caterers (e.g., restaurant/caterer or interstate conveyance caterer), commissaries, grocery stores (for display cases), schools, nursing homes, hospitals, or services such as delivery of meals to home-bound persons. Set up and packing can be controlled through an SOP and may involve wrapping food items, assembling these items onto trays, and packing them into a transportation carrier or placing them in a display case. An example would be an airline flight kitchen where food entrees are wrapped, assembled, and placed into portable food carts which are taken to a final holding cooler. Hospital kitchens would be another example where patient trays are assembled and placed into carriers for transportation to nursing stations. Food may be placed into bulk containers for transportation to another site where it is served.

This operational step might not be considered a CCP, but it is a special consideration when setting up your program. This process can be controlled by strict adherence to SOPs to minimize the potential for bacterial contamination and growth, to eliminate bare hand contact with ready-to-eat foods, to ensure proper handwashing, and to ensure food comes into contact with cleaned and sanitized surfaces.

Following final assembly into either individual trays or into bulk containers, the food may be held for immediate service or for transportation to another site for service. This hot holding or cold holding operational step needs to be evaluated in the same manner as other holding operational steps on the worksheet. Temperature control or using time as a control measure during transportation, and holding and serving at a remote site must be evaluated and managed as part of your food safety system.

Special consideration should be given to time/temperature controls and the prevention of cross contamination from equipment and utensils and contamination from employees' hands. This process may be adequately controlled through an SOP; however, holding and transportation should be considered CCPs.

Operational Step 8: SET UP AND PACKING

PROCESS	MENU ITEM	HAZARD	CCP	CRITICAL LIMITS	MONITORING	CORRECTIVE ACTIONS	VERIFICATION	RECORDS
PROCESS #1	Examples: Salads Sushi	* Bacterial Growth * Microbial contamination from employees	yes _____ or no ______	41°F No bare hand contact or equivalent alternative
PROCESS #2	Examples: Hamburgers Mahi-mahi	* Bacterial Growth * Microbial contamination from employees	yes _____ or no ______	140°F or 41°F No bare hand contact or equivalent alternative
PROCESS #3	Example: Soups	* Bacterial Growth * Microbial contamination from employees	yes _____ or no ______	140°F or 41°F No bare hand contact or equivalent alternative
SOPs
Process number one: Food preparation with no cook step - ready-to-eat food that is stored, prepared, and served. Process number two: Food preparation for same day service - food that is stored, prepared, cooked, and served. Process number three: Complex food preparation - food that is stored, prepared, cooked, cooled, reheated, hot held, and served.

SERVING

This is the final operational step before the food reaches the customer. When employees work with food and food-contact surfaces, they can easily spread bacteria, parasites, and viruses and contaminate these items. Managing employees' personal hygienic practices is important to controlling these hazards. A management program for employee personal hygiene includes proper handwashing, the appropriate use of gloves and dispensing utensils, and controlling bare hand contact with ready-to-eat foods.

Minimizing the growth of bacteria is also a concern at hot and cold holding customer display areas. Maintaining food products at proper temperature within these display units will control the growth of microorganisms. Refer to the HOLDING worksheet for additional information.

Special consideration needs to be given to minimizing contamination from the customer. Customer self-service displays, such as salad bars, require specific procedures to protect the food from contamination. Some suggestions for protecting food on display include:

• The use of packaging,

• Counter, service line, or salad bar food guards,

• Display cases,

• Suitable utensils or effective dispensing methods,

• Not mixing an old product with fresh, and

• Having employees monitor self-serve stations.

Preventing cross contamination from soiled utensils and equipment will minimize the potential for bacterial contamination of ready-to-eat foods.

Operational Step 9: SERVING

PROCESS	MENU ITEM	HAZARD	CCP	CRITICAL LIMITS	MONITORING	CORRECTIVE ACTIONS	VERIFICATION	RECORDS
PROCESS # 1	Example: Salads Sushi	* Bacterial, parasitic, viral, or physical contamination	yes _____ or no _____
PROCESS # 2	Examples: Hamburgers Mahi-mahi	* Bacterial, parasitic, viral, or physical contamination	yes _____ or no _____
PROCESS # 3	Example: Soups	* Bacterial, parasitic, viral, or physical contamination	yes _____ or no _____
SOPs
Process number one: Food preparation with no cook step - ready-to-eat food that is stored, prepared, and served. Process number two: Food preparation for same day service - food that is stored, prepared, cooked , and served. Process number three: Complex food preparation - food that is stored, prepared, cooked, cooled, reheated, hot held, and served.

PROCEDURAL STEP 3

Identify CCPs and Critical Limits

The CCPs column identifies places in the flow of food where you can have a significant impact in controlling food safety hazards. A measurable critical limit has been identified for each of these CCPs. These critical limits provide the baseline for measuring the effectiveness of your food safety procedures.

For each of your operational steps, within your operation, review the CCPs and critical limits needed to minimize or eliminate significant food safety hazards. Does your operation currently have control measures in place that are at least equivalent to these critical limits?

On the worksheet, you will need to decide whether the operational step is a CCP or whether the hazard is controlled by your SOPs that address the prerequisite program elements discussed in Chapter 4.

In some operational step worksheets, such as the Cooking step, the Guide recommends that the step be considered a CCP, because there is no practical alternative to ensure control of the hazard. In other operational steps, you may have a choice as to how you will control the hazard. For example, in the preparation step for ready-to-eat foods, you will identify contamination from employees' hands as a hazard. When controlling that hazard as a CCP, you must also identify the critical limits, establish monitoring and corrective actions, verification procedures, and records. Alternatively, you may choose to control that hazard by instituting an SOP that disallows bare hand contact with ready-to-eat food. You will need to decide the most effective method of controlling the hazard, i.e., as a CCP or through use of an SOP.

PROCEDURAL STEP 4

Monitor Critical Control Points

Use the worksheet to develop procedures, customized to your operation, for monitoring your CCPs. Consideration should be given to determining answers to the following questions.

• What critical limit at the CCP are you measuring?

• How is it monitored?

• When and how often will the CCP be monitored?

• Who will be responsible for monitoring it?

Monitoring is observing or measuring specific operational steps in the food process to determine if your critical limits are being met. This activity is essential in making sure your critical food processes are under control. It will identify where a loss of control occurs or if there is a trend toward a loss of control of a critical food process. Needed adjustments will then become obvious.

In your food safety management system, certain processes have been identified as CCPs. What you are going to monitor depends on the critical limits you have established at each CCP. Minimum critical limits for many CCPs have been established by the Food Code. For example, cooking hamburger (which is the CCP) to 155°F for 15 seconds (which is the critical limit) will kill most harmful bacteria. Therefore, final temperature and time measurements are very important and you need to determine how you will effectively monitor the critical limits for each CCP.

Is monitoring equipment needed to measure a critical limit? The equipment you choose for monitoring must be accurate and routinely calibrated to ensure critical limits are met. For example, a thermocouple with a thin probe might be the most appropriate tool for measuring the final product temperature of hamburger patties.

When deciding how often you need to monitor, make sure that the monitoring interval will be reliable enough to ensure the hazard is being controlled. Your procedure for monitoring should be simple and easy to follow.

Individuals chosen to be responsible for a monitoring activity may be a manager, line-supervisor, or a designated employee. Your monitoring system will only be effective if employees are given the knowledge, skills, and responsibility for serving safe food. Train your employees to carefully follow your procedures, monitor CCPs, and take corrective action if critical limits are not met.

PROCEDURAL STEP 5

Develop Corrective Actions

Decide what type of corrective action you need to take if a critical limit is not met.

• What measures do you expect employees to take to correct the problem?

• Is the corrective action understood by your employees?

• Can the corrective action be easily implemented?

• Are different options needed for the appropriate corrective actions, depending on the process and monitoring frequency?

• How will these corrective actions be documented and communicated to management so the system can be modified to prevent the problem from occurring again?

Whenever a critical limit is not met, a corrective action must be carried out immediately. Corrective actions may be simply continuing to heat food to the required temperature. Other corrective actions may be more complicated, such as rejecting a shipment of raw oysters that does not have the required tags or segregating and holding a product until an evaluation is done.

In the event that a corrective action is taken, you should reassess and modify if necessary your food safety system based upon the HACCP principles. Despite the best system, errors occur during food storage and preparation. A food safety system based upon the HACCP principles is designed to detect errors and correct them before a food safety hazard occurs. It is a benefit to industry and regulators to be able to show that immediate action is taken to ensure that no food product that may be injurious to health is served to or purchased by a customer. It is important to document all corrective actions in written records.

PROCEDURAL STEP 6

Conduct On-Going Verification

Description

Because HACCP is a system to maintain continuous control of food safety practices, implementation of the plan needs to be audited or verified. Verification is usually performed by someone other than the person who is responsible for performing the activities specified in the plan. That person might be a manager, supervisor, designated person, or the regulatory authority.

There is on-going verification, which is conducted frequently, such as daily, weekly, monthly, etc., by designated employees of the establishment. It is important to note that routine monitoring should not be confused with audit or verification methods or procedures.

There is long-term verification, which is done less frequently. This will be discussed in Procedural Step 8.

Verification is an oversight auditing process to ensure that the HACCP plan and SOPs continue to:

• be adequate to control the hazards identified as likely to occur, and

• be consistently followed (i.e., a comparison is made regarding observed, actual practices and procedures with what is written in the plan).

On-going Verification activities include:

• observing the person doing the monitoring: is monitoring being done as planned?

• reviewing the monitoring records:
  • are records completed accurately?

  • do records show that the predetermined frequency of the monitoring is followed?

  • was the planned corrective action taken when the person monitoring found and recorded that the critical limit was not met?

  • do records of the calibration of monitoring equipment indicate that the equipment was operating properly?

Verification Procedures

Procedures may include the following activities:

• observe the person conducting the activities at the CCPs and recording information,

• check monitoring records,

• check corrective action records,

• periodically review the total plan,

• test product in process or finished product,

• review equipment calibration records, and

• review recording thermometer accuracy (large operations and some processes such as large quantity cook and chill operations or smokers, etc.)

Verification Frequency

Verification should occur at a frequency that can ensure the HACCP plan is being followed continuously to:

• avoid adulterated/unsafe product getting to the consumer,

• be able to take corrective action without loss of product,

• ensure prescribed personnel practices are consistently followed,

• ensure personnel have the tools for proper personal hygiene and sanitary practices (e.g., handwashing facilities, sanitizing equipment, cleaning supplies, temperature measuring devices, and sufficient gloves, etc.),

• follow/comply with the control procedures established, and

• conduct calibrations as needed depending upon the type of equipment (some may be verified daily and others annually).

Verification Observations/Documentation - Examples

System verification:

Handwashing facilities and practices:

Process verification:

PROCEDURAL STEP 7

Keep Records

In order to develop the most effective record keeping system for your operation, determine what documented information will assist you in managing the control of food safety hazards. Some recorded information should already be part of your food safety system, like shellfish tags, and an additional record may not be needed. Your record keeping system can use existing paperwork, such as delivery invoices, for documenting product temperature. Another method could be maintaining a log to record the temperatures. A record keeping system can be simple and needs to be designed to meet the needs of the individual establishment. It can be accomplished many different ways that are customized to your operation as long as it provides a system to determine that activities are performed according to the HACCP plan.

Accurate record keeping is an essential part of a successful HACCP program. Records provide documentation that the critical limits at each CCP were met or that appropriate corrective actions were taken when the limits were not met. Records also show that the actions performed were verified.

Involve your employees in the development of your management system. Ask them how they are currently monitoring CCPs. Discuss with them the types of corrective actions they take when a critical limit is not met. Employees are an important source for developing simple and effective record keeping procedures. Managers are responsible for designing the system, but effective day-to-day implementation involves every employee.

The simplest record keeping system that lends itself to integration into existing operations is always best. A simple yet effective system is easier to use and communicate to your employees.

Record keeping systems designed to document a process rather than product information may be more adaptable within a retail food establishment, especially if you frequently change items on your menu. Accurately documenting processes like cooking, cooling, and reheating, identified as CCPs, provides active managerial control of food safety hazards. Consistent process control by management reduces the risk of foodborne illness.

Simple logs for recording refrigeration equipment temperature are perhaps the most common SOP records currently maintained. However, product temperature records are commonly CCP records.

Other records may include:

• writing the product temperature on delivery invoices,
• keeping a log of internal product temperatures of cooked foods, and
• holding shellstock tags for 90 days.

Some retail establishments have implemented comprehensive HACCP systems where records are maintained for each CCP. These records may be quality control logs; but, they can also constitute CCP records if they are designed to monitor activities that are, in fact, CCPs. The level of sophistication of record keeping is dependent upon the complexity of the food operation. For example, a cook-chill operation for a large institution would require more record keeping than a limited menu, cook-serve operation.

Once a specific process has been shown to work for you, such as an ice bath method for cooling certain foods, the frequency of record keeping may be reduced. In these instances, a record keeping system provides a scheduled check (verification) of the process to ensure that it effectively controls the risk factor. This approach is extremely effective for labor-intensive processes related to:

• cooking large volumes of food where a temperature check of each individual item is impractical,

• implementing a verified process will allow employees to complete the procedure within the course of a scheduled work day,

• cooling foods or leftovers at the end of the business day, or

• maintaining cold holding temperatures of ready-to-eat potentially hazardous foods in walk-in refrigeration units.

PROCEDURAL STEP 8

Conduct Long-Term Verification

Once your food safety system is implemented, you will need to confirm that it is effective over time, an activity referred to in this document as long-term verification. You may benefit from both internal (quality control) verifications and external verifications that may involve assistance from the regulatory authority or consultants.

Long-term verification is conducted less frequently (e.g., yearly) than on-going verification. It is a review or audit of the plan to determine if:

• any new product/processes/menu items have been added to the menu,

• suppliers, customers, equipment, or facilities have changed,

• the SOPs are current and implemented,

• the worksheets are still current,

• the CCPs are still correct, or if new CCPs are needed,

• the critical limits:

  are set realistically and are adequate to control the hazard (e.g., the time needed to cook the turkey to meet the Food Code internal temperature requirement), and

• monitoring equipment has been calibrated as planned.

Long-term verification helps the operator:

• ensure the food safety management system is implemented and the HACCP plan is being followed,
• improve the system and HACCP plan by identifying weaknesses,
• eliminate unnecessary or ineffective controls, and
• determine if the HACCP plan needs to be modified or updated.

Procedural Step 8: Long-Term Verification

Name of person responsible for long-term verification: _____________________________ Title: ___________________________ Frequency at which the long-term verification is done: _______________________________ Reason, other than frequency, for doing a long-term verification: ________________________________________________________________________ Date of last long-term verification: _______________________ The length of time this record is kept on file: ______________
1.
(a) Has a new product, process, or menu item been added since the last verification?	No ___
	Yes ___ Go to Question #2	Does this change necessitate a change on the worksheet? No ____ Yes ____
(b) Has the supplier, customer, equipment, or facility changed since the last verification?	Yes ___ No ___ Go to Question #2
2. Do the existing worksheets contain accurate and current information?	No ___ -->	Worksheet information updated:	Date: _______	Name: __________________
	Yes ___ Go to Question #3
3. Are the existing CCPs correctly identified?	No ___ -->	CCP's updated:	Date: _______	Name: __________________
	Yes ___ Go to Question #4
4. Are the existing critical limits appropriate to control each hazard?	No ___ -->	CL's updated:	Date: _______	Name: __________________
	Yes ___ Go to Question #5
5. Do the existing monitoring procedures ensure that the critical limits are met?	No ___ -->	Monitoring procedures updated:	Date: _______	Name: __________________
	Yes ___ Go to Question #6
6. Do existing corrective actions ensure that no injurious food is served or purchased?	No ___	Corrective Actions updated:	Date: _______	Name: __________________
	Yes ___ Go to Question #7
7. Do the existing on-going verification procedures ensure that the food safety system is adequate to control hazards and is consistently followed?	No ___	On-going verification procedures updated:	Date: _______	Name: __________________
	Yes ___ Go to Question #8
8. Does the existing record keeping system provide adequate documentation that the critical limits are met and corrective actions are taken when needed?	No ___	Record keeping procedures updated:	Date: _______	Name: __________________
	Yes ___ Go to Question #9
9. Are the existing SOPs current and implemented?	No ___	Does this necessitate a change in your plan? If so, start again with number 1.
	Yes ___
The long-term verification procedure is now complete. The next long term verification is due ___________________. The changes made to the food safety management system were conveyed to the line supervisor or front-line employees on ________________.
	Completed by:	Name _________________________________________________________ Title _________________________________________________________ Date ____________________________________

NOTICE: This is a Draft document to guide operators in voluntarily applying HACCP principles in food establishments in the retail segment. It will be trial tested in a structured FDA pilot. The pilot, Notice of which will appear in the Federal Register, is an open process and as experience is gained from the various phases of that pilot, this Guide will be modified. The Agency recognizes that this document has areas that need to be further clarified and developed with broader input and based on industry's experiences with the practicalities of integrating the HACCP approach in their operations. The Guide will continue to evolve and improve. It is anticipated that the field application of this guidance document will identify additional processes, special food considerations, or other facets of a HACCP program that need to be addressed. It is also expected, as reflected in the Annex, that the listing of commodity-specific hazards will be expanded to further assist operators in developing their HACCP systems. The Agency fully recognizes the diversity of "retail food establishments" and their varying in-house resources to implement HACCP. That recognition is combined with an understanding that the success of such implementation is dependent upon identifying realistic and useful ways of making it happen that are customized to the operation. FDA is open to record keeping applications that minimize the burden of instituting a HACCP system while providing the added consumer protection. FDA is most interested in receiving comments from parties who may review or use this Guide either within the pilot program or outside of that process. Of particular interest to the Agency are alternative ways of controlling hazards, input regarding special food considerations as described in Annex 2, and specific comments with respect to providing additional practical HACCP guidance for the retail industry. To submit comments, please photocopy the pages of concern, mark them up with your suggested changes, and forward them to: Dr. John E. Kvenberg HACCP Policy Strategic Manager (HFS-10) Office of Policy, Planning and Strategic Initiatives Food and Drug Administration 200 C Street, S. W. Washington, DC 20204