(Table of Contents Incorporating ISO 9004 and USDA NACMCF HACCP Requirements)
Copyright 1993 by Hospitality Institute of Technology and Management, Inc.
All rights reserved.
 1. TQM program performance measurement, planning, and organization.
   a. Management commitment and responsibility. (4.1)*
       *[Numbers in ( ) refer to ISO 9004 paragraphs.]
      1) Organization quality philosophy, values, and policies. (4.2)
      2) Organization mission.
      3) TQM leadership.
   b. TQM resource allocation. (5.2.4)
   c. TQM cost effectiveness measurement. (6.0)
   d. TQM system, process, and quality loop (5.1)
   e. TQM documentation and records (17.0)
   f. TQM organization. (5.2)
      1) Organization structure.
      2) Executive, management, supervisory and employee responsibilities, accountability and authority.
   g. TQM planning and development.
      1) TQM library and knowledge base.
      2) TQM research and development, and performance capability/design certification. (8.0)
         a) Documentation and change control of new products and services.
         b) Customer satisfaction testing -- performance conformance assurance
         c) Re-qualification of products and services.
         d) Inspection and calibration services.
      3) Key results area, objectives, and accountability measures. (4.3)
      4) Executive HACCP-TQM team.
      5) Problem identification, solving, removal, and prevention.
      6) Opportunity identification, analysis, action program.
      7) TQM system performance information and auditing to find opportunities to improve.
      8) TQM in marketing. (7.0)
         a) Accurate product/menu item descriptions.
         b) Customer comment/complaint handling.
         c) Research to measure degree of customer satisfaction with products and services.
         d) Development of customer cautions and warnings and liability commitments.
         e) Procedure for handling returned goods, field repairs.
      9) TQM in procurement. (9.0)
    10) Materials documentation from supplier to consumption. (16.0)
    11) Company emergency plans.
2. Process (hazard) analysis and control. (10.0, 11.0)
   a. Specify the system. (4.4)
      1) Outputs.
         a) Consumer sensitivities, nutritional requirements, and immune status.
         b) Levels of hazards that can be consumed by this population.
         c) Products and services specifications, distribution process and abuse, consumer use and abuse.
      2) Inputs.
         a) Suppliers, and levels of hazards in the ingredients and supplies.
         b) Personnel and capability.
         c) Environment.
         d) Facilities.
          e) Equipment.
      3) Processes.
         a) Identify each food process and ingredients.
         b) Flow diagram/document the tasks and steps of the processes.

              Identify food, times, temperatures, water activity, pH, additives that effect the product.
   b. Do a hazard analysis for each process and product. (19.0) (Principle 1)*

        *[(Principle ___) refers to USDA HACCP principle.]
      1) The evidence of hazards to the health: There are four degrees of hazard certainty:
         a) HAZARD: has been continually identified by food safety experts from foodborne illness investigations

             as agents and causes responsible for foodborne illness outbreaks.
         b) LIKELY HAZARD: has been shown by food safety experts in reproducible laboratory studies

             to be likely hazards and causes of foodborne illness outbreaks, or has a strong theoretical rationale based on scientific data.
         c) PROPOSED HAZARD: has been proposed in refereed professional journals by some investigators

             as a hazard or cause of foodborne illness.
         d) NOT A HAZARD: has never been identified as a cause of any known foodborne illness cases

             and has no laboratory-demonstrated basis or strong theoretical rationale for being a potential hazard
             or cause of foodborne illness.
      2) The microbiological, toxin, chemical, and hard foreign object status of the material being used.
      3) The likelihood and consequence to the consumer of the ultimate hazard in the food or beverage.
      4) The effect of processing on the level of hazard contamination, recontamination, or multiplication
          during subsequent handling, storage, service, and use of leftovers.
      5) The knowledge and sensitivity of the consumer at risk and likelihood of food abuse.
      6) The cost/benefit ratio associated with the application of the hazard control criteria.
      7) Capability of the management to exercise pre-control and operational control.
      8) Example of questions to be considered to identify the hazards associated with each step
          in the flow diagram are listed in Appendix A.
      9) Determine the safe and risk levels of the hazards.
   c. Establish and certify preventive measures at each step for each hazard that: (Principle 2)
      1) Keep the hazards out.
      2) Keep the hazards below a non-risk level.
      3) Reduce the hazards to a non-risk level by some form of processing or additive.
   d. Establish critical limits/criteria for preventive measures for hazards associated with each step. (Principle 3)
   e. Control of measuring and testing equipment. (5.3) (13.0)
3. Written program.
   a. Establish monitoring procedures for each hazard control with process variables, target values and critical limits,

       and the action to be taken by an employee to keep the process in control. (Principle 4)
   b. Provide clearly stated TQM goals and objectives for all personnel.
   c. Write a TQM action plan that clearly describes how each requirement will be met.
   d. Develop a TQM zero-defect-based operation and training policies, procedures, and standards manual.
   e. Write plans for conducting and documenting a regular review of the plan and program effectiveness

       and then using this knowledge to improve the plans and programs.
4. Personnel communications and training. (18.0)
   a. Communicate the food safety program to all employees in an ongoing program.
   b. Allow for employee input in bringing hazardous food operating conditions to management's attention.
   c. Provide training prior to all new job assignments, including training on specific hazard controls

       and in self-inspection, testing, and monitoring of the processes which they are doing to accomplish food safety goals.
   d. Update training at least annually or as work processes and ingredients change.
   e. Maintain records of training (date/topic/content/attendance).
   f. Training supervisors in pertinent food safety matters, food safety leadership, coaching,

       and employee empowerment to track action at any time to prevent a problem.
   g. Evaluate training needs to determine specialized training and retraining.

       Use supervisors and employees to give feedback as to how to improve training.
5. Process control problem identification, investigation, and corrective action.
   a. Establish record keeping procedures (deviation file) (see Appendix B for a HACCP flow tabulation format)
       that document performance of and changes to hazard controls, to include:
      1) Personnel.
      2) Environment.
      3) Facilities.
      4) Equipment.
      5) Supplies and ingredients.
      6) Product processes/packaging.
      7) Storage, distribution, and consumer.
   b. Establish corrective action when monitoring indicates that the process is "trending" out of control,
       or has deviated beyond a critical limit. (14,0, 15.0) (Principle 5)
   c. Develop procedures for process control problem reporting, problem investigation, corrective action, and follow-up.
   d. Conduct workplace prevention inspections. Evaluate which process/tasks are stable and perform to standard

       and which are not, so that the process can be continually improved.
   e. Write reports following process control problems showing what preventive/corrective action is being taken

       to prevent similar problems, for example:
      1) Equipment, environmental facilities modified or added.
      2) Customer service procedures modified.
      3) Work method modified.
      4) Supplier standards modified.
      5) Employee retrained or special needs accommodated.
   f. Maintain, summarize, and analyze foodborne illness data (e.g., first reports of illness) to determine tasks

      and operations where incidents have occurred. Take action to prevent recurrence.
6. Program verification, enforcement, recognition and renewal. (5.4)
   a. Establish procedures for verification that the HACCP program is working. (12.0, 20.0) (Principle 6)

       Examples of verification activities are listed in Appendix C.
   b. Write an enforcement statement on safe food operation practices, food safety rules, and standard operating procedures.
   c. Provide for verification audits that all hazards are identified, controls are adequate, and actual operations
      are in compliance with the company's policies, procedures, and standards.
   d. Maintain records of disciplinary actions and warnings.
   e. Recognize efforts and achievements.
   f. Renew enthusiasm by providing for celebration of safety achievements.

Examples of Questions to be Considered in a Hazard Analysis

The hazard analysis consists of asking a series of questions which are appropriate to each step in a HACCP plan. It is not possible in these recommendations to provide a list of all of the questions which may be pertinent to a specific food or process. The hazard analysis should question the effect of a variety of factors upon the safety of the food.

A. Can employee health or personal hygiene practices impact upon the safety of the food being processed?
B. Do the employees understand the process and the factors they must control to assure the preparation of safe foods?
C. Will the employees inform management of a problem which could impact upon safety of the food?

A. Does the water supplier have a HACCP program and adequate controls for parasites and viruses in the water?
B. Are there opportunities for pathogens to get in the air supply from sources such as local farms?
C. Is there adequate control of insects and pests extending at least 50 feet from the building?

A. Does the layout of the facility provide an adequate separation of raw materials from ready-to-eat foods if this is important to food safety?
B. Is positive air pressure maintained in product packaging areas? Is this essential for product safety?
C. Is the traffic pattern for people and moving equipment a significant source of contamination?
D. Are conditions adequate to assure safe food and can they be maintained?

A. Will the equipment provide the time-temperature control that is necessary for safe food?
B. Is the equipment properly sized for the volume of food that will be processed?
C. Can the equipment be sufficiently controlled so that the variation in performance will be within
     the tolerances required to produce a safe food?
D. Can the equipment be maintained so as to assure the safety of the food?
E. Is the equipment reliable, or is it prone to frequent breakdowns?
F. Is the equipment designed so that it can be cleaned and sanitized?
G. Is there a chance for product contamination with hazardous substances (e.g., glass)?
H. What product safety devices are used to enhanced consumer safety?
   1. Metal detectors.
   2. Magnets.
   3. Sifters.
   4. Filters.
   5. Screens.
   6. Thermometers.
   7. Deboners.
   8. Dud detectors.

Supplies (ingredients)
A. Does the food contain any sensitive ingredients that may present microbiological hazards
      (e.g., Salmonella, Staphylococcus aureus); chemical hazards (e.g., aflatoxin, antibiotic or pesticide residues);
       or physical hazards (e.g., stones, glass, metal)?
B. Is potable water used in formulating or in handling the food?

Product Processes
A. Intrinsic factors: Physical characteristics and composition (e.g., pH, type of acidulents, fermentable carbohydrate,
     water activity, preservatives) of the food during and after processing.
   1. Which intrinsic factors of the food must be controlled in order to assure food safety?
   2. Does the food permit survival or multiplication of pathogens and/or toxin formation in the food during processing?
   3. Will the food permit survival or multiplication of pathogens and/or toxin formation during subsequent steps in the food chain?
   4. Are there other similar products in the market place? What has been the safety record for these products?
B. Procedures used for processing.
   1. Does the process include a controllable processing step that destroys pathogens? Consider both vegetative cells and spores.
   2. Is the product subject to recontamination between processing (e.g., cooking, pasteurizing) and packaging?
C. Microbial content of the food.
   1. Is the food commercially sterile (e.g., low-acid canned food)?
   2. Is it likely that the food will contain viable spore-forming or non-spore-forming pathogens?
   3. What is the normal microbial content of the food?
   4. Does the microbial population change during the normal time the food is stored prior to consumption?
   5. Does the subsequent change in microbial population after the safety of the food, pro or con?
D. Packaging.
   1. Does the method of packaging affect the multiplication of microbial pathogens and/or the formation of toxins?
   2. Is the package clearly labeled "Keep Refrigerated" if this is required for safety?
   3 Does the package include instructions for the safe handling and preparation of the food by the end user?
   4. Is the packaging material resistant to damage thereby preventing the entrance of microbial contamination?
   5. Are tamper-evident packaging features used?
   6. Is each package and case legibly and accurately coded?
   7. Does each package contain the proper label?

Distributor and Consumer
A. Conditions of storage between packaging and the end user.
   1. What is the likelihood that the food will be improperly stored at the wrong temperature?
   2. Would an error in improper storage lead to a microbiologically unsafe food?
B. Intended use.
   1. Will the food be heated by the consumer?
   2. Will there likely be leftovers?
C. Intended consumer.
   1. Is the food intended for the general public?
   2. Is the food intended for consumption by a population with increased susceptibility to illness
      (e.g., infants, the aged, the infirm, immuno-compromised individuals)?

HACCP Flow Tabulation Format
Process step 
Chemical, physical, biological hazards 
Critical limits 
Monitoring procedures/
person(s) reponsible 
Corrective action(s)/
person(s) responsible 
HACCP records 
Verification procedure/
person(s) responsible 
    Yes or no  1. 
Examples of Verification Activities
A. Verification procedures may include:
   1. Establishment of appropriate verification inspection schedules.
   2. Review of the HACCP plan.
   3. Review of CCP records.
   4. Review of deviations and dispositions.
   5. Visual inspections of operations to observe if CCPs are under control.
   6. Random sample collection and analysis.
   7. Review of critical limits to verify that they are adequate to control hazards.
   8. Review of written record of verification inspections which certifies compliance with the HACCP plan
       or deviations from the plan and the corrective actions taken.
   9. Validations of the HACCP plan, including on-site review and verification of flow diagrams and CCPs.
 10. Review of modifications of the HACCP plan.

B. Verification inspections should be conducted:
   1. Routinely, or on an unannounced basis, to assure selected CCPs are under control.
   2. When it is determined that intensive coverage of a specific commodity is needed
       because of new information concerning food safety.
   3. When foods produced have been implicated as a vehicle of foodborne disease.
   4. When requested on a consultative basis or established criteria have not been met.
   5. To verify that changes have been implemented correctly after a HACCP plan has been modified.

C. Verification reports should include information about:
   1. Existence of a HACCP plan and the person(s) responsible for administering and updating the HACCP plan.
   2. The status of records associated with CCP monitoring.
   3. Director monitoring data of the CCP while in operation.
   4. Certification that monitoring equipment is properly calibrated and in working order.
   5. Deviations and corrective actions.
   6. Any samples analyzed to verify that CCPs are under control. Analyses may involve physical, chemical,
       microbiological or organoleptic methods.
   7. Modifications to the HACCP plan.
   8. Training and knowledge of individuals responsible for monitoring CCPs.

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