(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,
a. Management commitment and responsibility.
*[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
2) TQM research and development,
and performance capability/design certification. (8.0)
and change control of new products and services.
satisfaction testing -- performance conformance assurance
of products and services.
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)
product/menu item descriptions.
to measure degree of customer satisfaction with products and services.
of customer cautions and warnings and liability commitments.
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)
sensitivities, nutritional requirements, and immune status.
of hazards that can be consumed by this population.
and services specifications, distribution process and abuse, consumer use
and levels of hazards in the ingredients and supplies.
each food process and ingredients.
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)*
___) refers to USDA HACCP principle.]
1) The evidence of hazards
to the health: There are four degrees of hazard certainty:
has been continually identified by food safety experts from foodborne illness
as agents and causes responsible for foodborne illness outbreaks.
HAZARD: has been shown by food safety experts in reproducible laboratory
to be likely hazards and causes of foodborne illness outbreaks, or has
a strong theoretical rationale based on scientific data.
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
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
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
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.
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.
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:
5) Supplies and ingredients.
6) Product processes/packaging.
7) Storage, distribution,
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
3) Work method modified.
4) Supplier standards modified.
5) Employee retrained or special
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
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
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
F. Is the equipment designed so that it can be cleaned
G. Is there a chance for product contamination with hazardous
substances (e.g., glass)?
H. What product safety devices are used to enhanced consumer
1. Metal detectors.
8. Dud detectors.
A. Does the food contain any sensitive ingredients that
may present microbiological hazards
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
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
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
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?
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
6. Is each package and case legibly and
7. Does each package contain the proper
Distributor and Consumer
HACCP Flow Tabulation Format
A. Conditions of storage between packaging and the end
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
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)?
Examples of Verification Activities
Chemical, physical, biological hazards
||Yes or no
A. Verification procedures may include:
1. Establishment of appropriate verification
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
3. Director monitoring data of the CCP while
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,
or organoleptic methods.
7. Modifications to the HACCP plan.
8. Training and knowledge of individuals
responsible for monitoring CCPs.
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