SECTION 2: Risk Assessment (Part B)


  • Risk Assessment
  • Pervasiveness of Pathogens in Food
  • FDA Definition of Potentially Hazardous Food
  • People Who Are Immune Compromised



    PART B

  • Integration of HACCP and Process Safety Management with ISO 9000 and the Malcolm Baldrige Award
  • System Documentation
  • Continuous Quality Improvement
  • The Unit as a Food Process System
  • Types of Establishments Included in the Scope of Retail Food Operations
  • HACCP-Based TQM (Total Quality Management) Unit Processes System
  • Beginning a HACCP System



    Integration of HACCP and Process Safety Management with ISO 9000 and the Malcolm Baldrige Award
            How, then, does food HACCP-based Process Safety Management interface with the ISO 9000 series as well as the Malcolm Baldrige criteria?  Quality, as defined by Crosby (34), comprises the needs, wants and expectations of the customer.  Quality is in the beholder's eyes.  Therefore, quality becomes:

      1. Safe food and environment expected by the consumer.
      2. Pleasurable food and dining experience expected by the customer.
      3. Operating efficiency and effectiveness leading to profits expected by the owners of the business.

            Actually, ISO 9000 is simply a specification of the forms and processes for the quality control elements of a product-producing system.  It does not deal with the results of the process.  It alludes to management and training, but directs its effort to the documentation of the quality control procedures.  It does not use the most modern quality control philosophy of employee behavioral management for quality control, but focuses on documentation.
            Modern quality management says that quality control is performed by the trained, motivated, and empowered employees on the line striving to perform jobs safely and accurately.  Because they handle each portion of food, they can do 100% inspection of what is produced and served.
           Quality control is performance of tasks according to prescribed procedures and guidelines that have been designed and tested by management to meet customer needs, wants, and expectations.
          Quality assurance is the management approach to designing the process to be as capable as possible of yielding products and services that meet customer quality needs, wants, and expectations with a high probability of zero deviations.  It also includes training, coaching, and enabling line employees to achieve quality control.
          Quality improvement is the top management process of planning, organizing, directing, and controlling the system of management and technology in order to maintain and improve the quality of products.  Each time a task is performed, information is gathered and fed back to the design process so that during the next product and service cycle of the system, the processes are changed.  In this way, there is less likelihood of a deviation in the process performance from a target standard, and less risk of a product or service defect.  It also includes benchmarking against the competitors to continually innovate new products and services.  Most importantly, it compares the current disease-prevention capability of the products and services, and strives to  improve continually the safety and quality of the products the customer receives.
            Total Quality Management (TQM) is a term currently applied to the integration of employee quality control with management quality assurance and quality improvement.
            For example, employees are encouraged to become members of a quality management team.  Their input and involvement ensure the production of safe, high-quality products and services. Total Quality Management (TQM) teams are groups of people doing similar work, such as employees and managers, who work together to identify operational errors and problems; determine causes; analyze solutions; and specify policies, procedures, and standards or guidelines that emphasize and assure the quality of both food and service.
            TQM teams often cross organization boundaries.  The team may consist of five to eight employees such as a cook, bartender, food server, maintenance person, bus person, and cashier.  Each shift should be represented.  Initially, the leader is usually a supervisor.  The TQM team analyzes problems observed by both management and employees.  By setting objectives that support policies and standards or guidelines, they move one step at a time toward achievement of the specified objectives.  Regular meetings are arranged so that the TQM teams can review procedures, set objectives, and send them forward for resolution.  Formal but brief documentation of meetings is recorded in order to evaluate progress, note agreed-upon procedures, state objectives, and record successes.

    System Documentation
            Operating procedures must be written so that they can be taught, reviewed, and improved.  What is needed is a policies, procedures, and standards or guidelines manual for quality management.  Table 2-6 is the table of contents of a retail food operations manual (168).  The manual combines the principles of hazard analysis, quality control, quality assurance, continuous quality improvement, and the principles of ISO 9000 and Process Safety Management into components that comprise the basis for a company's HACCP-TQM program.

    Table of Contents

     Section I. Management - Good Manufacturing Practices
    A. Operate observing food safety policies and procedures
    B. Maintaining  policies and procedures
        1. PIC (Person in Charge)
        2. Smoking area
        3. Ethical truth in menu practices
    C. Hazard analysis and control
    D. Manager communication and employee training
    E. Operational improvement
    F. Handling emergencies
    G. Program enforcement, recognition, and renewal

    Section II. Organization and Personnel
    A. Organization
         1. Organization chart
         2. HACCP TQM team
         3. Job responsibilities
         4. Double hand wash log
         5. Employee improvement
    B. Personnel
         1. Employee responsibility
         2. Disease control
         3. Cleanliness
         4. Disposable gloves
         5. Heavy duty gloves
         6. Hand cuts and abrasions
         7. Contact with blood or body fluid from another person
         8. Personal cleanliness
            a.  Fingernails
            b.  Jewelry and hard objects in pockets
            c.  Handkerchiefs and facial tissues
            d.  Chewing gum, smoking, and eating
            e.  Personal medication and personal belongings
         9. Handling food
       10. Hand and fingertip washing
       11. Unauthorized persons
       12. Traffic pattern

    Section III. System Description
    A.  Operation description
    B.  Types of foodservice / distribution
    C.  Facility plan
    D.  Facility food flows
    E.  Facility pest control
    F.  Menu items grouped by HACCP categories
    G.  Recipe HACCP - Receiving, storage, and ingredient pre-preparation and menu item production flow

    Section IV. RESERVED (no text)

    Section V. Supplier Policies, Procedures, and Standards
    A. Purchasing
    B. Supplier certification
    C. Ingredient specification
    D. First aid materials

    Section VI. Food Production Policies, Procedures and Standards
    A. General production policy
    B. Home prepared food
    C. Milk
    D. Receiving
         1. Inspection of incoming products
         2. Substandard products
         3. Food containers
         4. Container disposal
         5. Labeling
         6. Use-by-date
         7. Food storage areas
         8. Stock rotation
         9. Mixing old food and new food
       10. Food storage times and temperature
       11. Recommended times to cool food
       12. Proper storage conditions
    E. Pre-preparation
         1. Ingredient inspection and control
         2. Food thawing
         3. Chemical additives
         4  Raw food handling
         5. Separate raw and cooked food
         6. Food washing
         7. Cutting up raw food
    F. Preparation
        1. Potentially hazardous food
        2. Hard foreign objects
        3. Food pasteurization
        4. Safe preparation of multi-portion, thick, more than 2-inch items
        5. Leftover roasts or other thick items
        6. Safe preparation of single portion, thin, less than 2-inch thick items
        7. Batters
        8. Sauces, soups, and beverages
        9. Controlling growth of pathogens with acid ingredients
      10.  Fruits, vegetable, legumes, and cereals
      11. Bread and bakery items
      12. Hot combination dishes (casseroles, stews, etc.)
      13. Cold combination dishes (salads and sandwich spreads
      14. Blanching
      15. Reconditioning
      16. Frozen desserts
    G. Holding, serving, and transporting
        1. Food holding temperatures
        2. Conveyors
        3. Serving, packaging, and transporting
        4. Salad bar
        5. Handling food and money
        6. Dishware
        7. Food tasting
        8. Food causing allergic reactions
        9. Standards of identity-packaged foods
      10. Food labels of food packaged / sold in a food establishment
      11. Bulk food that is available for consumer self-dispensing
      12. Bulk unpackaged foods such as bakery products and unpackaged foods that are portioned to consumer specification
      13. Carry-out and banquet food
      14. If food falls on the floor
    H. Storing prepared food
        1. Food cooling time
        2. Storage to prevent cross-contamination
        3. Storage time
        4. Storage containers
        5. Leftovers
        6. Unwrapped food
        7 Work station cleanliness
        8. Frequency of surface sanitation
        9. Serving utensils and cutting boards
      10. Beverage dispensing equipment
      11. Milk product dispensers
      12.  Dispensing tableware and flatware
      13. Self-service food, dishes, and utensils
      14. Table condiments
      15. Ice scoops
      16. Food serving temperatures
    I. Consumer
         1. Consumer information
         2. Product complaints
         3. Returned food
         4. Food sabotage

    Section VII. Sanitation Guidelines
    A. Cutting boards and food contact surfaces
    B. Detergents
    C. Sanitizing solutions: use and preparation
    D. Changing detergent solutions
    E. Cleaning and sanitizing food contact surfaces
    F. Cleaning cloths
    G. Sponges
    H. Brooms and brushes
    I. Cooling equipment cleaning
    J. Washing machinery, cleaning and use
    K. Washing flatware
    L. QC inspection
    M. Storage of dishware
    N. Cleaning equipment storage
    O. Chemicals separation

    Section VIII. Maintenance Guidelines
    A. Equipment and utensil construction
    B. Equipment operation
    C. Food contact surface equipment
    D. Non-food contact surface equipment
    E. Gaskets
    F. Using sanitized equipment
    G. Temperature measuring equipment
    H. Food product thermometer calibration
    I. Equipment calibration
    J. Cooling or refrigeration units
    K. Freezers
    L. Surplus equipment and items for repair
    M. Dunnage racks, shelving, pallets, dollies, etc.
    N. Backflow prevention valves for plumbing
    O. CO2 backflow prevention valves
    P. Warewashing equipment

    Section IX. Pest Control Guidelines
    A. Area around facility or grounds
    B. Pest control and materials used

    Section X. HACCP-TQM Employee Training Program and Record
    A. Training
    B. New employee training
    C. Training for performance mastery
    D. Initial training for all new employees and managers
    E. Continuing education and correct procedure reinforcement
    F. Record of training
    G. One minute of praise

    Section XI. Self-inspection, Continuous Quality Improvement
    A. Product process monitoring / sampling plan
    B. Daily self-inspection
    C. Retail food operation food hazard control checklist
    D. Receiving report
    E. Calibration verification form

    Section XII. Food Safety Program Verification and Capability Certification
    A. Opening Conference
    B. Closing conference
    C. Written report
    D. Rating employer's program

            Employees are empowered to do their best to perform processes according to the rules, policies, standards, or guidelines specified in the manual.  Thus, there is a greater probability of production and service of safe food products of specified quality.
            The manual is key to the zero-defect goal.  Since all process-tasks-steps are described in the manual, it is the basis for training employees.  Thus, the manual becomes the basis for process evaluation and improvement.  After the processes are completed each day, each employee is given a chance to suggest ways to improve the system.  All suggestions are referenced to what is written so that the training / operations manual can be improved immediately and then, the new way of doing a process can be integrated immediately into operations.
            Of course, there will always be some defects because of the natural variation of ingredients and supplies to the process, as well as normal variations due to the people running the equipment that produce the products.  The closer the input is to design standards or guidelines for supplies, ingredients, personnel procedures, etc., the closer the processes perform to design targets, and the more stable the process is, the more likely it is that a standard product will be produced within upper and lower control limits.
            Process capability (Cp) indices (102) can be used in food processes to evaluate the ability of a stable process to produce food in the future within specification limits.  For example, all hamburgers will be cooked to at least 155°F (68.3°C) and not over 165°F (73.9°C).  The formula for calculating a simple process potential index is:

            Cp = Allowable process spread / Actual process spread
                  = [Upper specification limit (USL)] - [Lower specification limit (LSL)] / 6 standard deviations (sigma) of the process

            When the difference in USL and LSL is the same as 6 sigma, the Cp = 1, and the process is considered to be very marginal in capability.  For example, with the hamburger, the allowable process spread is 10°F.  If 6 sigma were 10°F, the Cp would be 1, and the process should be improved, because it would produce a hamburger beyond specification limits about 0.14% of the time.  For the same process spread of 10°F, if 6 sigma were 6.25°F, the capability would be 1.6, and the process would produce an out-of-specification hamburger [0.79 ppm or about 1 in 1,000,000 hamburgers (a much more desirable performance)].  The key is to reduce the standard deviation in the process.

    Continuous Quality Improvement
            The procedures manual describes how each task is to be done.  The manual is developed, based on the principles of systems analysis and process safety management.  Each process has input.  Activities (procedures) convert the input into an output product or service, which is designed to meet the needs, wants, and expectations of the customer.  Each employee monitors / measures his or her performance against the standard and records performance so that management has a solid base of data on which to prioritize and make quality improvement decisions.  The "customer" may be the next person on the production line.  Ultimately, however, the customer is the person who receives service and consumes the food.  The activities in the process producing the output may be, for example, cleaning the cutting board so that it is safe to use for the next food item or washing feces off of fingertips.  The continuous quality improvement cycle is shown in Figure 2-1.

    Figure 2-1.

            As shown at the top of the figure, there are five (5) stages to management development (34).  In Uncertainty, no one knows what will happen in the next minute.  Quality is by luck.  In Awakening, management asks if this type of uncertainty must continue.  During Enlightenment, management becomes informed about food safety pre-control HACCP and Total Quality Management (TQM).  During Wisdom, management constructs and implements a problem prevention HACCP-TQM program and trains employees to master controls.  During Certainty, while the operation is not perfect, management can predict with a high degree of accuracy exactly where effort must be put to assure the lowest risk.  There are no unknowns.
            There are four (4) components to the TQM process.
    1. The HACCP-TQM team meets and uses performance information from operation checklists to determine points of weakness.  They analyze the weaknesses and find better procedures that are written into revised quality assurance procedures and standards manuals.  Management commits resources and issues plans and goals.
    2. The personnel are trained in new procedures.  The operation is staffed, and resources and equipment are acquired.  The operation is ready to strive for zero defects.
    3. The doors open, and the operation starts the next production cycle of preparing and serving food.  Supervisors coach and provide positive reinforcement.  Quality performance checklists are filled out during operations, comparing targets to actual performance.
    4. Employee teams review performance, and, if they can, take action to correct deficiencies.  Then, they send the quality checklists back to management (Step 1) to provide continuous quality improvement.  At the same time, customer surveys are considered so that the operation continually strives to exceed customer expectations.
    The Unit as a Food Process System
          What is included in the retail food system definition?  Figure 2-2 provides process control nomenclature and a systematic way to look at the processes in order to make flow diagrams of them.  At the top of the system is Management as the first element of a HACCP-based design, providing resources, leadership, enforcement, and a good environment in which people can function.
    Figure 2-2.
            The next step is consideration of what consumers need or desire and the hazard threshold levels necessary for consumer product safety.  While there are few government standards, the industry must have guidelines in order to develop acceptably safe food.  Guidelines are necessary for the input of the process in order to design the food process Environment, Facilities, Equipment, Employees, and Supplies that will give a consumer safe output.  The Process takes the input elements and makes them safe for the Consumer.  Highly contaminated, raw food can be made safe if retail food operators know the level of contamination so that they can institute a proper HACCP program to assure that the food not only nourishes the consumer but is safe for consumption.  For example, contaminated ground beef and chicken can be sold to a consumer in a retail food market, as long as the consumer is informed and aware of handling and cooking procedures that must be accomplished in order to make the food safe to eat [e.g., ground beef:  cook to 155ºF (68.3ºC) food temperature, hold at 155ºF (68.3ºC) for 15 seconds for a 5D reduction of salmonellae], and how to clean the food contact surfaces that the food touches.

    Types of Establishments Included in the Scope of Retail Food Operations
            Table 2-7 is a list of the kinds of establishments included in the scope of retail food operations.  Many of these facilities are not included in the FDA scope of advisement for government regulatory reasons.  However, when the hazards and controls are analyzed, all types of foodservice facilities require food safety HACCP information, just as retail food operators do.

    Table 2-7.  Types of Establishments Included in the Scope of  Retail Food Operations

    Food markets, restaurants, foodservice units, home food preparation
    Roadside stands and rural meat markets
    Home catering
    Convenience stores
    Vending, feeding the public at sports events
    Temporary food establishments (food carts, fairs, festivals)
    Nursing homes
    Cruise ships
    Military field feeding
    In-flight feeding
    Feeding athletes at games
    Religious institution feeding
    Feeding people on camping trips in the wilderness

            The same basic hazard analysis and hazard controls, if applied correctly by each type of operation, will assure the food sold or given to the consumer is safe.

    HACCP-Based TQM (Total Quality Management) Unit Processes System
            Before beginning a discussion of the hazards and control, it is important to understand the process in retail systems.  Figure 2-3 shows how the system is divided into processes for analysis.  It is convenient to use typical systems terminology.  The total group of activities will be called a system.  The inputs, processes, and outputs define a system.  In any retail food system, there are eight (8) components that must be addressed to assure the production of a safe, quality product.  These are:  1) management; 2) consumer; 3) environment; 4) facilities; 5) equipment; 6) personnel; 7) supplies; 8) product processes.  The processes of all of these system components function to provide food at an acceptable risk.  Each of the eight  components has processes.

    Figure 2-3.

            A process can then be broken down into tasks and steps.  This logic is fully compatible with computer-structured language programming.  Thus, using the procedure for writing structured computer language, it is possible to systematically analyze and write a recipe or cleaning procedure that controls or minimizes process defects.  A simple example is as follows.

    Begin=>Get tools and material=>Do until (critical level)=>Check: If not complete, go back and continue to do. If complete, go on=>Clean up=>Put away=>End

            Every task and action that takes place in the facility, from cleaning the floor to cooking meat, to changing light bulbs, is a process with hazards that require controls to assure that safety / quality guidelines are met and not exceeded.  Control limits that are exceeded are a source of foodborne illness incidents, loss of customers, and waste.  Each process can always be described in terms of input, processes (procedures), and output.  Four examples of processes are given:  training employees, washing fruits and vegetables, cooking thick foods, and removing fecal pathogens from fingertips.
            The process, then, is further divided into tasks.  For example, for Process N [Figure 2-3 (removing soil and fecal pathogens from fingertips)], first, the water must be potable, then the water must be turned on.  Secondly, the employee must wet the hands and get the fingernail brush.  Third, soap is put on the brush and on fingertips, etc.
            Tasks are finally divided into steps, which are the individual actions that control the process.  In the case of the task of washing fingertips, the employee first takes the nail brush in the clean hand.  The second step is to scrub under the fingernails to loosen soil.  Step 3 is to scrub the nails and fingers on both hands.  Step N is to rinse the hands in 75-to-110ºF (24-to-43ºC) water flowing at 2 gallons per minute.  Until every process in the food system is safety certified to the step level, the system is not assured to produce a safe output of products.
            When a process authority or government official certifies a process as safe, he or she must review the process, using the principles of FMEA (Failure Mode Effect Analysis).  A FMEA is a systematic method of identifying and preventing process and product problems before they occur.  FMEAs are focused on preventing process deviations and hence, enhancing safety.  Ideally, FMEAs are conducted in the food product (recipe) design or process development stages.  However, conducting an FMEA on existing products and processes can also yield benefits.  The objective of a food safety FMEA is to look at a food process for all of the ways a process can fail and thus, produce an unsafe product.  Even the simplest foods have many opportunities for failure in terms of microbiological, chemical, and particulate risks.  For example, spores can germinate, and the resulting vegetative cells grow out, in retail food, the growth of spoilage microorganisms can produce histamine in scombroid fish, chemical sanitizers can contaminate food, and metal or plastic package clips can fall into open containers of food. The production process must be tested to find out how the controls can fail.  In this way, the hazards, standards, and controls at each step can be set to achieve an acceptable risk, and the process can be certified as acceptably safe.

    Beginning a HACCP Program
            To begin a HACCP continuous improvement program, management must make a long-term commitment to food safety assurance and form a HACCP development team.  Next, the operation's food system must be described in order to identify all of the threats that can become hazards such as those listed in Table 2-8.

            The total system from production to consumption has the three (3) components:  input, process, and output.  The output for the system is food for the consumer that is both pleasurable, safe, and assures repeat customer sales.  The health status of the consumer is never known.  Some consumers may be healthy, and some may be immune compromised due to age, illness, antibiotics, or chemotherapy.  Consumers may also have a variety of sensitivities to toxic and allergic compounds in the food.  If customers do not eat the food at the establishment (e.g., carry-out or take-home food after dining out), they may also time-temperature abuse the food if they are not properly informed how to handle the take-out food correctly.  Depending on the intended use of the food that is being taken out, the food operator can introduce various hurdles such as temperature, time, water activity, oxidation reduction, chemical additives, and packaging into the product design in order to reduce the risk of illness from multiplication of pathogens in the food after it is given to the customer.  For example, the spores of C. perfringens survive retail food processing (especially in meat and poultry) and, if given about 10 hours of 90 to 100°F (32.2 to 37.8°C) temperature abuse, are almost sure to cause illness (100).
             After examining the output and setting microbiological, chemical, and physical (hard foreign object) hazard safety levels based on the consumer, the input of supplies and material is considered.  The lower the level of the pathogens, chemicals, and hard foreign objects in the input material, the less the food will need to be processed by the cook in order for the food to be safe.  Many foods will be contaminated with various environmental organisms such as C. botulinum, B. cereus, L. monocytogenes, and Yersinia enterocolitica (27).  However, when there are fewer pathogenic microorganisms in the growing environments of food animals, poultry, fish, etc., or fruits and vegetables, there is less likelihood of fecal pathogens such as Salmonella spp. and C. jejuni being on the food.  If people wish to eat raw foods such as oysters; steak tartare; or raw, cured products, it is essential that there is supplier HACCP certification, and that the ingredients be produced with a pathogen level below the illness threshold level of the consumer.
            Based on the output hazards and the hazards in the input supplies and material, the process criteria for the environment, facilities, equipment, personnel, and food processing are developed.  The food process will take the raw ingredients and exclude-prevent, eliminate-remove, reduce, or control the threats to human health, and produce finished products that, when eaten by the consumer, will have a safe hazard level that will not cause illness and will nourish the consumer.

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