Sie sind auf Seite 1von 235


Lecture No. 1
• customer satisfaction
• those features of products which meet
customer needs and thereby provide
customer satisfaction (costs more)
• freedom from deficiencies—freedom from
errors that require doing work over again
(rework) or that result in field failures
(costs less) (Juran’s Quality Handbook 5 th
• Degree to which a set of inherent
characteristics fulfils requirements
(ISO 9000:2000).
• The totality of characteristics of a product
or service that bear on its ability to satisfy
stated and implied needs
(ASQ, 1998).
• Product: Result of a process (ISO 9000:2000).
• The ISO 9000 standard recognizes four generic
product categories:
• services, software, hardware, and processed
materials. Food products are examples of
processed materials, while food service
is an example of a service.

• For processed materials e.g. Food products:

• Color
• Flavor
• Protein content
• Microbial load,… extra
• For services:
• Reliability, frequency, and cost
• The quality movement can trace its roots back to
medieval Europe, where craftsmen began
organizing into unions called guilds in the late
13th century.
• Until the early 19th century, manufacturing in the
industrialized world tended to follow this
craftsmanship model.
• The factory system, with its emphasis on product
inspection, started in Great Britain in the mid-
1750s and grew into the Industrial Revolution in
the early 1800s.
• In the early 20th century, manufacturers began
to include quality processes in quality practices.
• After the United States entered World War II,
quality became a critical component of the war
effort:( they have to test products from different
factories to assure that they can work together)
• the military began to use sampling techniques
for inspection, aided by the publication of
military-specification standards and training
courses in Walter Shewhart’s statistical process
control techniques.
• Late in the 19th century the United States
adopted a new management approach
developed by Frederick W. Taylor. Taylor’s goal
was to increase productivity without increasing
the number of skilled craftsmen. He achieved
this by assigning factory planning to specialized
engineers and by using craftsmen and
supervisors, who had been displaced by the
growth of factories, as inspectors and managers
who executed the engineers’ plans.
• The beginning of the 20th century marked the
inclusion of “processes” in quality practices
which is defined as a group of activities that
takes an input, adds value to it and provides an
• Walter Shewhart, a statistician for Bell
Laboratories, began to focus on controlling
processes in the mid-1920s, making quality
relevant not only for the finished product but for
the processes that created it
• He recognized that industrial processes yield
data. For example, a process in which metal is
cut into sheets yields certain measurements,
such as each sheet’s length, height and weight.
Shewhart determined this data could be
analyzed using statistical techniques to see
whether a process is stable and in control, or if it
is being affected by special causes that should
be fixed. In doing so, Shewhart laid the
foundation for control charts, a modern-day
quality tool.(statistical quality control SQC)
• At first, Japan had a widely held reputation for
shoddy exports, and their goods were shunned
by international markets. This led Japanese
organizations to explore new ways of thinking
about quality. “total quality” approach. Rather
than relying purely on product inspection,
Japanese manufacturers focused on improving
all organizational processes through the people
who used them with the help of 2 American W.
Edwards Deming and Joseph M. Juran
• The birth of total quality in the United States was in
direct response to a quality revolution in Japan
following World War II
• The U.S. response, emphasizing not only statistics
but approaches that embraced the entire
organization, became known as Total Quality
Management (TQM)
• Several other quality initiatives followed. The ISO
9000 series of quality-management standards, for
example, were published in 1987 The Baldrige
National Quality Program and Malcolm Baldrige
National Quality Award were established by the
U.S. Congress the same year
• As the 21st century begins, the quality movement
has matured. and new quality systems have
evolved beyond the foundations laid by Deming,
Juran and the early Japanese practitioners of
quality this include:
• In 2000 the ISO 9000 series of quality management
standards was revised to increase emphasis on
customer satisfaction.
• Six Sigma, a methodology developed by Motorola
to improve its business processes by minimizing
defects, evolved into an organizational approach
that achieved breakthroughs – and significant
bottom-line results
• Quality function deployment was developed by Yoji
Akao as a process for focusing on customer wants
or needs in the design or redesign of a product or
• Quality has moved beyond the manufacturing
sector into such areas as service, healthcare,
education and government
• Continuous improvement:(kaizen) is an ongoing
effort to improve products, services or processes.
These efforts can seek “incremental” improvement
over time or “breakthrough” improvement all at
• Coordinated activities to direct and control an
organization with regard to quality (ISO 9000:2000)
• The totality of functions involved in the determination
and achievement of quality (ASQ, 1998).
• The ISO 9000:2000 standard identifies eight quality
management principles these are: customer focus,
leadership, involvement of people, process
approach, system approach to management,
continual improvement, factual approach to decision
making, mutually beneficial supplier relationships.
• Part of quality management focused on fulfilling
quality requirements (ISO 9000:2000)
• The operational techniques and activities that
sustain a quality of product or service that will
satisfy given needs;
• also the use of such techniques and activities.
• (ASQ, 1998) The operational techniques and
activities used to fulfill requirements for quality
(QP, 2002)

• Part of quality management focused on providing

confidence that quality requirements will be fulfilled
(ISO 9000:2000)
• All those planned or systematic actions necessary to
provide adequate confidence that a product or service
will satisfy given needs (ASQ, 1998)
• All the planned and systematic activities implemented
within a quality system that can be demonstrated to
provide confidence a product or service will fulfill
requirements for quality (QP, 2002)
• A term initially coined by the U.S. Naval Air Systems
Command to describe its Japanese-style
management approach to quality improvement
• is a management approach to long-term success
through customer satisfaction. It is based on the
participation of all members of an organization in
improving processes, products, services, and the
culture in which they work.
• product quality is the extent to which all the
established requirements relating to the
characteristics of a product are met
• product safety is the extent to which those
requirements relating specifically to characteristics
or properties that have the potential to be harmful to
health or to cause illness or injury are met. (e.g.,
counts of total bacteria, coliform bacteria) can be
used as indicators of food safety, although they are
not considered specifically as food safety
• In industry, product safety principles and practices have
always been integrated into activities identified within
quality assurance or quality control programs, or within
quality management systems.
• The more recent use of HACCP systems in some
companies has resulted in a well-defined set of activities
that are specifically devoted to product safety.
• The principles and practices of the HACCP system are
similar to those of quality systems and, therefore, the
specific activities required by the HACCP system can be
integrated within quality systems.
• A quality program is an activity or set of activities
performed to ensure that the product quality and
product safety requirements are fulfilled (e.g.
Quality control programs).
• A quality system is an integrated set of
documented product quality and safety activities,
with clearly established inter-relationships among
the various activities (e.g.: quality assurance
systems and quality management systems).
• Quality control program activities consist of
inspecting, testing, and monitoring associated with
raw materials control, process control, and finished
products control.
• The main objective of quality control programs is to
determine whether the quality and safety
requirements are fulfilled by detecting whether
unacceptable levels of hazards or defects exist.
• In companies that operate with quality systems, the
quality control activities are integrated into the
quality systems
• Quality assurance systems are much more extensive in
scope than quality control programs. They include the
inspection, testing, and monitoring activities of quality
control programs, along with additional activities that are
devoted to prevention safety hazards and quality defects.
• Quality assurance systems are intended to provide
confidence to a company’s management, its customers
and to government regulatory agencies that the company
is capable of meeting the quality and safety requirements.
• They include documents that describe operations and
activities that directly relate to quality and safety (ISO
• Quality management systems include quality planning
and improvement activities, in addition to quality
control and assurance activities.
• These systems are intended to provide a company
with the capability to meet all quality requirements.
• The best example of a quality management system is
• The ISO 9001:2000 Quality management system —
requirements standard
• The term was associated with the management
approach to quality improvement used in Japan for
achieving long-term success.
• The TQM approach embodies both management
principles and quality concepts, including:
• customer focus, empowerment of people, leadership,
strategic planning, improvement, and process
• The legal requirements for safety and quality have
been established by many national governments, with
the objective of protecting consumers and ensuring
that the products are fit for human consumption (e.g
Food laws, pharmaceutical laws).
• These food laws and regulations are intended to
ensure that foods and drugs do not:
• cause harm, illness, or injury; are not adulterated or
misbranded; and are wholesome and fit for human
• The responsibility for enforcing laws and
regulations is assigned to government regulatory
agencies. (Sudanese Standards and Metrology
Organization SSMO in Sudan, Food and Drug
Administration FDA in USA)These enforcement
activities fall into two categories.
• First, they include inspection and audit of
establishments that process, handle, and store
the product to ensure that the required sanitary
and controlled conditions are followed;
• audits are used by some regulatory agencies
that enforce HACCP-based regulations.
• Second, they include inspection and analysis of
foods/drugs for harmful substances to ensure
that there is conformance to established limits
and tolerances.
• In addition to laws and regulations, standards also
establish requirements for the safety and quality
however, unless a standard is a part of food
regulations (e.g., standard of identity in the U.S.
• CFR Title 21), it is not a legal requirement.
• The Codex Standards are the best examples of food
• The Codex Alimentarius Commission has the
mandate to implement the joint Food and Agricultural
Organization (FAO)/World Health Organization
(WHO) Foods Standards Program.
• These food standards have been adopted by
countries worldwide and are intended primarily to
protect consumers and to facilitate international food
• They include codes of practice such as The Codex
General Principles Of Food Hygiene, standards for
maximum residual levels (MRL) for pesticides and for
veterinary drugs in foods, and standards for
specifications for food additives.
• Kaizen: Japanese term for continuous
improvement. A step-by-step improvement of
business processes.
• PDCA: Plan-do-check-act as defined by Deming.
Plan Do

Act Check

3.Benchmarking : what do top performers do?

• 1. Process flowchart
• 2. Run Chart


• 3. Control Charts
A control chart (Figure 2.6) is a graphical display of a quality
characteristic that has been measured or computed from a sample
vs. the sample number or time. The chart contains a center line
that represents the average value of the quality characteristic
corresponding to the in-control state.

Performance Metric

• Two other horizontal lines called the upper control limit
(UCL) and the lower control limit (LCL) are also drawn.
• These control limits are chosen so that if the process is in
control, nearly all of the sample points will fall between
them. As long as the points plot within the control limits,
the process is assumed to be in control and no action is
• A point that plots outside of the control limits is
interpreted as evidence that the process is out of control;
investigation and corrective action are
• required in such a case to find and eliminate the causes
responsible for this behavior.
• 4. Cause and effect diagram (fishbone)
• Causes are arranged according to their level of importance
or detail, resulting in a depiction of relationships and
hierarchy of events.
• This helps to identify areas where there may be problems,
and allows for comparison of their relative importance
• They are typically constructed through brainstorming
Machine Man


Method Material
• 5. Check sheet
A check sheet is a structured, prepared form for collecting and analyzing data.
This is a generic tool that can be adapted for a wide variety of purposes.
When to Use a Check Sheet:
When data can be observed and collected repeatedly by the same person or
at the same location.
When collecting data on the frequency or patterns of events, problems, defects,
defect location, defect causes, etc.
When collecting data from a production process
• 6. Histogram

A histogram is used to graphically summarize and display

The distribution of a process dataset. It can be constructed
by segmenting the range of the data into equal-sized bins
(segments, groups, or classes).
7. Pareto Analysis
A Pareto chart graphically summarizes and displays the
relative importance of the differences between groups of data. (adapted by
industry from Pareto principle
“80% of problems come from 20% of the equipment or workforce.”
A Pareto chart graphically summarizes and displays the
relative importance of the differences between groups of data.
50 75%


20 25%
• Is the assurance that food will not cause harm to the
consumer when it is prepared and eaten according to
its intended use. This could be achieved by:
• whether all harmful substances present in the food
have been eliminated, reduced to an established
acceptable level, or prevented from exceeding the
acceptable level (food safety hazards).
• the food has been prepared, handled, and stored
under controlled and sanitary conditions in
conformance with practices prescribed by government
regulations (Good Manufacturing Practices) (GMP).
• Before 1980s, food industry used quality programs
based on inspection and testing of food products for
hazards, and on GMPs for addressing food safety.
• Since the late 1980s, there has been widespread use
of the Hazard Analysis Critical Control Points
(HACCP). system specifically to achieve food safety.
• In 2005 International Standards Organization (ISO)
introduced ISO 22000 series on food safety
• Any substance that is reasonably likely to cause harm,
injury or illness.
• There are three recognized categories of food safety
• biological hazards,
• chemical hazards,
• and physical hazards.
• The origin of these hazards in foods can be:
• from naturally occurring substances or agents in
• from deterioration or decomposition of foods,
• or from contamination of the foods with the hazard at
various stages of their production, harvesting,
storing, processing, distribution, preparation, and
• For many hazards, government regulatory agencies
have established an acceptable level of the hazard in
a food.
• the Codex Alimentarius has also established
acceptable levels of certain hazards as part of its
Food Standards Programme.
• For some hazards, such as pathogenic bacteria (e.g.,
• Salmonella spp.), there is zero tolerance; this means
that the presence or the detection of the hazard in the
food is unacceptable.
• The strategies used to address hazards in foods
include the prevention or elimination of hazards, or
the reduction of hazards to acceptable levels
• For a known food safety hazard, the extent of the
harmful effects of the hazard on the health of the
consumer is established by risk analysis and by
hazard analysis.
• A risk analysis is comprised of risk assessment, risk
management, and risk communication.
• A primary objective of risk analysis is to establish a
national food safety objective for a hazard in a food.
• Pathogenic bacteria: More than forty different
pathogenic bacteria are known.
• Salmonella spp.,
• Eschericha coli 0157:H7, Lysteria monocytogenes,
Clostridium perfringens,
• Clostridium botulinum, Staphylococcus aureus,
• and
• Campylobacter jejeuni
• Viruses:
• hepatitis A and E viruses, the Norwalk group of
viruses, and rotavirus.
• Parasites:
• Entamoeba histolytica, Giardia lambia,
and parasitic worms.
• There are 2 types of chemical hazards:
• permitted chemicals: food additives: they may be
harmful if they are present in the food at levels
above the maximum permitted level.
• Naturally occurring harmful compounds: oxalates
toxins, and alkaloids.
• Unavoidable contaminants: aflatoxins
• Agricultural residues: They include residues of
permitted pesticides, herbicides, fungicides, drugs,
hormones, and antibiotics.
• Industrial contaminants: heavy metals (lead,
mercury, arsenic), organo-chlorinated compounds
such as polychlorinated biphenyls (PCBs).
• Chemical residues: chemical compounds used for
cleaning and sanitizing food contact surfaces of
processing, handling, and storage equipment, and
for lubricating certain parts of food processing
• Food allergens: peanuts, soybeans, milk, eggs,
fish, tree nuts, and wheat.
• Physical hazards in foods: include organic or
inorganic substances, commonly referred to as
foreign objects, foreign matter, or extraneous
materials. Hard and sharp physical hazards are of
particular concern.
• Broken glass, Plastic, Metal pieces, Wood pieces
Personal articles and, stones.
• Other food safety concerns: genetically modified
organisms, irradiated foods
Hazard Analysis Critical
Control Point (HACCP)
• HACCP: Is a system that identifies, evaluates, and
controls hazards that are significant for food safety
(Codex Alimentarius, 1997).
• A systematic approach to the identification, evaluation,
and control of food safety hazards (NACMCF,1997).
• HACCP, which is recognized for its science-based
approach, consists of a set of seven principles that
have been adopted internationally through the work of
the Codex Alimentarius Commission.
• the development and initial use of an HACCP
approach for food safety can be traced to a joint effort
of the U.S. National Aeronautic and Space
Administration (NASA), the U.S. military, and the
Pillsbury Company in the late 1950s and early 1960s.
• One objective of this collaboration was to develop a
strategy that would ensure that foods required for the
space program were free of any unacceptable health
• The need for this preventive approach resulted from
the recognition that the approach in use at that time
for food safety was based primarily on inspection
and testing of foods, and was neither practical nor
effective for ensuring that foods for the space
program were free of unacceptable health hazards.
• This marked the beginning of the use of the HACCP
system for addressing food safety.
• After the initial success with foods for the space
program, the Pillsbury Company pioneered the
development of the HACCP system for food
safety in the manufacture of consumer foods in its
food processing plants.
• The Pillsbury Company announced the use of the
HACCP system for consumer foods in the early
1970s, and subsequently played a leading role in
providing expertise, information and training to
the food industry and to government regulatory
agencies in the U.S.
• This resulted in the general acceptance of the
HACCP system by food manufacturers and
government regulatory agencies; however, the
actual adoption and use of the HACCP system by
food manufacturers was not extensive initially.
• The recognition of the HACCP approach in 1985 by
the National Academy of Sciences as a preventive
approach for ensuring the microbiological safety
• of foods, generated considerable renewed interest
in the use of the HACCPsystem.
• This recognition of the HACCP approach was followed
by substantial contributions from the U.S. National
Advisory Committee on Microbiological
• Criteria for Foods (NACMCF) toward the development
of the HACCP system. The work of NACMCF resulted
in several substantial publications on the HACCP
system; the 1997 edition of NACMCF’s publication
Hazard Analysis and Critical Control Point Principles
and Application Guidelines is used extensively as a
primary reference document on HACCP.
• In 1987, the International Commission on
Microbiological Specifications for Foods (ICMSF) of
the World Health Organization (WHO) endorsed the
use of the HACCP approach.
• More extensive international recognition of HACCP
emerged in 1991 when the Codex Committee on
Food Hygiene prepared a draft report on HACCP for
Codex Alimentarius member countries.
• Essentially, the Codex Committee recommended that
the HACCP system be accepted as the basis for an
internationally recognized approach for addressing
food safety. The final version of the Codex
Alimentarius HACCP system was later incorporated
into the Codex Alimentarius Basic Texts on Food
• The U.S. Food and Drug Administration first formally
used the HACCP approach in 1973 for the
government regulation of low acid canned food
• We can not rely on inspection because, practically we can
not inspect all the products.
• Consumers expect, and have a right to expect safe,
wholesome food.
• The food industry have a responsibility to meet their
• That food is “safe” is often an unwritten requirement of
many customer specifications.
• It goes without saying and, unlike many of the other
attributes of the product (appearance, taste,cost), it is not
• The U.S. Food and Drug Administration first formally
used the HACCP approach in 1973 for the government
regulation of low acid canned food.
• By the late 1980s, HACCP had received broad-based
endorsement and acceptance by the food industry, by
government regulatory agencies in many parts of the
world, and by the scientific community in general.
• Then, several countries embarked on the road toward
development of national regulatory food safety
programs based on HACCP.
• In the early 1990s, the seafood sector was the first to
come under voluntary HACCP-based inspection
programs In the U.S. and Canada.
• Subsequently, mandatory HACCP-based inspection
programs have been developed in the U.S. for the
seafood sector in 1995 the meat and poultry sector in
1996, and the processed juice sector in 2001.
• Legal compliance
• Customer confidence
• International Markets
• Supplier requirements
• Cost savings
• Due diligence
• Waste minimization
• Requires comprehensive process understanding.
• not ideally suited for little known hazards or
• Does not quantify or prioritize risks.
• Does not quantify impact of additional controls
on reducing risk.
• Is a group of a food company’s employees who should
be assembled and given the responsibility by
management to develop and implement an HACCP
system for the company’s establishment at which the
food product is produced.
• The team, which commonly consists of four to eight
people, should be composed of personnel who can
contribute knowledge in quality assurance,
• quality control, food microbiology, food processing,
GMPs, and equipment maintenance.
• Personnel who are responsible for ongoing activities in
inspection, testing, production, cleaning, and
sanitation can also be included in the HACCP team.
• Quality Assurance/Technical: providing expertise in
microbiological, chemical, and physical hazards, an
understanding of risk and hazard significance
• assessment, and knowledge of measures that can be
taken to control the hazards.
• Operations or Production: has responsibility for and
has detailed knowledge of the day-to-day operational
activities required in order to produce the product.
• Engineering: able to provide a working knowledge of
process equipment and environment with respect to
hygienic design and process capability.
• Additional expertise—may be provided both from
within the company and from external consultancies.
The following areas should be considered:
• Supplier Quality Assurance—essential in providing
details of supplier activities and in assessment of
hazard and risk associated with raw materials.
• Research and Development: if the company is one
where new products and process development is a
continuous activity, then input from this area will be
• Distribution/Logistics: for expert knowledge of
storage and handling throughout the distribution
• Procurement: participation of purchasing personnel
will mean that they are made fully aware of the
risks associated with particular products or raw
materials and can assist with communication of
any proposed change in suppliers.
• Microbiologist: if the company has its own
microbiologists, then their expert knowledge is
absolutely needed on the HACCP team.
• Toxicologist: in all but the larger companies, this
knowledge is likely to be located in a consulting
analytical laboratory or university.
• Statistical process control (SPC): there are many
classes available which will be sufficient to give
members of the HACCP team or their colleagues
enough knowledge to carry out basic SPC studies on
their process operations.
• HACCP experts: it may be appropriate initially to co-
opt an external HACCP specialist onto the HACCP
team. This may be useful in helping the company
team to keep on the right track and become familiar
with the HACCP approach.
• Other: facilitation skills are extremely useful and
often can be found within Human Resource or
training departments if available (notetaker who can
capture the discussions and prepare all the
documents during and in between meetings. )
• The HACCP team leader will have a key role in the
success of the HACCP system and he or she is likely
to become the company HACCP expert and be
regarded as such. In the leadership role the team
leader will be responsible for ensuring that:
• The team members have sufficient breadth of
knowledge and expertise.
• • Their individual skills and attributes are taken into
• Individual training and development needs are
• The team and work tasks are organized adequately.
• Time is made available for reviewing progress on
an ongoing basis.
• All skills, resources, knowledge, and information
needed for the HACCP system are available either
from within the company or through identifying
useful external contacts.
• Additional personnel: line supervisors, operators,
• incoming raw materials inspectors, cooks, and
point of sale personnel will be involved later on, in
implementation phase.
• training and education is the most important element in
setting up a successful HACCP system.
• It not only provides the technical skills required in
implementing HACCP, it also helps in changing attitudes of
people where required.
• Senior management commitment: Real commitment can
only be achieved if there is complete understanding of what
it takes to develop and maintain a food safety program and
how HACCP fits into this.
• Identification of a HACCP or broader food safety steering
group followed by in depth education and training will
provide a valuable and visible support to the Preparation
and Planning to Achieve Effective Food Safety
Management implementation of HACCP.
• Procedures, including good manufacturing practices
that address operational conditions providing the
foundation for the HACCP system (NACMCF, 1997).
• “Practices and conditions needed prior to and during
the implementation of HACCP and which are essential
for food safety.”(WHO, 1998).
• PRPs tend to focus on the hygienic operating
environment and QA support programs managed by
people who are knowledgeable and exhibit a supportive
attitude towards food safety.
• Good Agricultural Practice (GAP)
• Good Veterinarian Practice (GVP)
• Good Manufacturing Practice (GMP)
• Good Hygiene Practice (GHP)
• Good Production Practice (GPP)
• Good Distribution Practice (GDP)
• Good Trading Practice (GTP)
Focus is on the
raw materials,
product and
Focus is on the
PRPs production
facility, programs
and people
• Are the practices required in order to conform to
guidelines recommended by agencies that control
authorization and licensing for manufacture and sale
of food, drug products, and active pharmaceutical
products. These guidelines provide minimum
requirements that a pharmaceutical or a food product
manufacturer must meet to assure that the products
are of high quality and do not pose any risk to the
consumer or public.
• Design and Facilities
• Control of Operations
• Maintenance and Sanitation
• Personal Hygiene
• Transportation
• Product Information and Consumer Awareness
• Training
• Entire Food Chain – From Primary
Production to the final consumer

• HACCP based Approach to enhance

Food Safety

• Role for Governments, Industry and


• 4.1. Location
• Establishments should NOT be
• Environmentally polluted areas and industrial activities
which pose a serious threat of contaminating food
• Areas subject to flooding unless sufficient safeguards are
• Areas prone to infestations of pests
• Areas where wastes, either solid or liquid, cannot be
removed effectively
• Design and Layout
• Permits Good Food Hygiene Practices
• Protects against Cross Contamination
• Internal Structure and Fittings
• Walls, Partitions and Floor
• Ceiling and Over head Fixtures
• Windows and Doors
• Food Contact Surfaces
• Temporary Mobile Premises and Vending Machine
• Adequately cleaned, disinfected and
• Equipment and containers should be made of
materials with no toxic effect in intended use
• Equipment should be durable and movable
• Facilitates maintenance, cleaning, disinfection
and monitoring
• Food Control and Monitoring Equipment
• Time temperature
• Critical Limits
• Container for Waste and Inedible Substances
• Identifiable, suitably constructed and, made of
impervious material.
• Containers used to hold dangerous substances
should be identified
• Water Supply
• Drainage and Waste Disposal
• Cleaning
• Personnel hygiene facilities and Toilets
• Temperature Control
• Air quality and Ventilation
• Lighting
• Storage
• Food business operators should control food
hazards through the use of HACCP
• Identify steps in their operations which are critical to
the safety of food;
• Implement effective control procedures
• Monitor control procedures
• Review control procedures periodically

• Time and temperature control

• Specific Process Steps – Chilling, thermal
processing, irradiation, drying, chemical
preservation, vacuum or modified atmosphere
packaging (MAP)
• Microbiological Cross Contamination
• Physical and Chemical Contamination
5.3 Incoming Raw Material Requirements
• Specifications for raw materials should be identified and
• Raw materials or ingredients should be inspected and
sorted before processing
• Stocks of raw materials and ingredients should be subjected
to effective stock rotation
• 5.4 Packaging
Adequate protection
• Packaging materials or gases should be non toxic
• Should not pose threat during storage and use
• In contact with Food
• As an Ingredient
• Ice and Steam
• Potable Water Should be as specified in WHO
Guidelines for Drinking Water Quality or Water of
Higher Standard
• Type of control and supervision needed will depend
• Size of the business,
• Nature of its activities
• Types of food involved
• Managers and supervisors should have knowledge
of food hygiene principles and practices
• Effective monitoring and supervision
5.7 Documentation and Records
• Appropriate records of processing, production and
• Records retained for a period that exceeds the
shelf-life of the product

• Documentation can enhance the credibility and

effectiveness of the food safety control system.
• Managers should ensure effective procedures
• Rapid recall
• Need for public warnings
• Recalled products should be held under
• Supervision until they are destroyed / reprocessed
to ensure their safety
• Establishments and equipment should be kept in an
appropriate state of repair and condition to:
• facilitate all sanitation procedures
• function as intended at critical steps
• prevent contamination of food, e.g. from metal shards,
flaking plaster, debris and chemicals
• The necessary cleaning methods and materials will depend
on the nature of the food business.
• Disinfection may be necessary after cleaning.
• Cleaning and disinfection programmes
• Should be continually and effectively monitored
• Written cleaning programmes should specify:
• areas, items of equipment and utensils to be cleaned
• responsibility for particular tasks
• method and frequency of cleaning
• monitoring arrangements
• Relevant specialist expert advisors
• Preventing Access

• Harbourage and infestation

• Monitoring and detection

• Eradication
• Provision for the removal and storage of waste.
• Waste must not be allowed to accumulate
• 6.5 Monitoring Effectiveness
• Sanitation systems should be monitored for
• Microbiological sampling of environment and food
contact surfaces
• Health Status
• Illness and Injuries
• Personal Cleanliness
• Personal Behavior
• Visitors
• Food must be adequately protected during
• Conveyances / containers for transporting food
should be kept in an appropriate state of
cleanliness, repair and condition
• Cleaning and disinfection should take place
between load

• Lot Identification
• Product Information
• Labelling
• Consumer Education
• Awareness and Responsibilities
• Training Programmes
• Instruction and Supervision
• Refresher Training
• a PRP defined by the hazard analysis as essential in order
to control the likelihood of introducing food safety hazards
to and/or the contamination or proliferation of food safety
hazards in the products or in the processing environment”
(ISO, 2005).
• Based on hazard assessment, an appropriate combination
of control measures shall be selected which is capable of
preventing, eliminating or reducing food safety hazards to
defined acceptance criteria
• OPRP Shall include:
• Food safety hazards to be controlled
• Control measures
• Monitoring procedures that demonstrate the
operational PRPs are implemented
• Corrections and corrective actions
• Responsibilities and authorities
• Records of monitoring
The relationship between HACCP, OPRPs, and
PRPs (Warren 2012)
Failure of a CCP or
OPRP will result in
a high likelihood
HACCP that product may
contain a food
safety hazard
Failure of a PRP
OPRPs may occur
PRPs impact on
product safety
• Are PRP but specific for particular • Generic control for any
industry food operations to
• Output of Hazard Analysis carried improve FS
out • Aim for a generic hygienic
• Has control measures to condition for FS
acceptable levels
• Are not CCPs
• Does not have Critical Limit
• Normally have CCP control further
along the processing
• OPRP Example (1)
• Production processes involves several sieving
and metal detection system.

• Only the last one is a CCP.

• The other sieving / metal detection points are

oPRPs and still must be monitored & controlled.
• OPRP Example (2)
• Cooked food is stored in a walk-in refrigerator.
• Microbiological contamination can arise due to the
inadequately covered food or temperature not
maintained low enough.
• Control measures includes properly covering the
food (oPRP) and
• maintaining the fridge temperature (CCP) at below
4 deg. C
• Standard operating procedures (SOPs): are the
documented procedures that a company has in place
to ensure services and/or products are delivered
consistently every time.
• Sanitation Standard Operating Procedures ( SSOPs):
are written procedures that an establishment develops
and implements to prevent direct contamination or
adulteration of product.
• The regulatory requirements for SSOPs:
• Sanitation SOP development
• Sanitation SOP Implementation
• Sanitation SOP Maintenance
• Sanitation SOP Corrective Actions
• Sanitation SOP Record keeping
• The primary difference between SOPs and GMPs is
specificity. While GMPs are general practices applied
throughout the facility or system, SOPs are very
specific and focus on routine or repetitive activities,
tasks, or functions within the facility or system.
• SSOP development: SSOPs shall:
• describe all procedures an official establishment will
conduct daily, before and during operations, sufficient
to prevent direct contamination or adulteration of
• be signed and dated by the individual with overall
authority upon initial implementation and upon any
• address, at a minimum, the cleaning of food contact
surfaces of facilities, equipment, and utensils; and specify
the frequency with which each procedure is to be
conducted and
• identify the individual responsible for implementation and
maintenance of the SSOPs.
• SSOP implementation:
• Each official establishment shall conduct the
preoperational procedures in the SSOPs before the start
of operation;
• conduct all other procedures in the SSOPs at the
frequencies specified; and
• monitor daily implementation of procedures in the SSOPs.
• SSOP maintenance:
• Each official establishment shall:
• routinely evaluate the effectiveness of the SSOPs
and the procedures therein in preventing direct
contamination or adulteration of products; and
• revise the SSOPs, as necessary, to keep them
effective and current with respect to changes to
facilities, equipment, utensils, operations, or
• SSOP corrective actions:
• shall be taken when either the establishment or
authority determines that the SSOPs, or the
implementation or maintenance of the SSOPs, may
have failed to prevent direct contamination or
adulteration of product(s).
• that include procedures to ensure appropriate
disposition of product(s) that may be contaminated,
restore sanitary conditions, and prevent recurrence of
direct contamination or adulteration of product(s),
appropriate reevaluation and modifications of the
SSOPs or appropriate improvements in the
• execution of SSOPs.
• SSOP record-keeping requirements:
• Daily records shall document the implementation and
monitoring of the SSOPs and any corrective actions
taken; The use of standard operating procedures
(SOPs) be authenticated by the initials of the
responsible employee for implementation and
monitoring of the procedures specified in the SSOPs
and dated.
• be maintained for at least 6 months and made
accessible and available to the authority.
• Agency verification of SSOPs:
• The authority shall verify the adequacy and
effectiveness of the SSOPs including:
• reviewing the SSOPs;
• reviewing the SSOP records;
• direct observation of the implementation of the SSOPs
and any corrective actions taken; and
• direct observation or testing to assess the sanitary
conditions in the establishment.
Common problems in implementing
ssops effectively

• Personnel and management issues: this include:

• Inadequate team building
• Inadequate support by upper management
• Inadequate employee time
• Inadequate training
• SOP functional issues:
• Inadequate monitoring and record-keeping programs
• Improper details
• Impact of regulatory and third party audit requirements
Sanitation SOP: Owner – Joe Green
• This Sanitation SOP is for Beef Slaughter Establishment
M41777 and becomes effective on January 28, 1998.
• Pre-operational
• All food contact surfaces of the facility, equipment, and
utensils on the kill floor will be cleaned daily after
production by rinsing, soaping, and sanitizing.
• All cleaning will be monitored daily by Joe Green before
production begins the next day. Records will be kept on
Form Pre-Op I by Joe Green.
• Operational
• Every day all equipment and surfaces on the kill floor
will be kept as sanitary as necessary to prevent
contamination or adulteration of the carcasses.
• Every day all employees will follow hygienic practices
to keep themselves from contaminating or
adulterating carcasses.
• These actions will be monitored by Joe Green once
each day.
• Records of this monitoring will be kept on Form Ops I
by Joe Green.
• Corrective actions taken during pre-operational
sanitation inspection or during operations will be
written on the back of the Form Pre-Op I or Form
Ops I as necessary.
• (Signature and date of 1/25/98)
• Joe Green
• Modification Log
• 1. (signature and date of Joe Green, 12/11/98)
• 2. (signature and date of Joe Green, 6/17/99)
• These are twelve steps as follows:
• •Step 1: Assemble an HACCP team.
• Step 2: Describe the food product that the HACCP
plan will address.
• Step 3: Identify the intended use of the food product.
• Step 4:Construct a flow diagram of the process that
is used to produce the food product.
• Step 5: Conduct an on-site verification of the process
flow diagram.
• Step 6: Conduct a hazard analysis of (a) all raw
materials and ingredients
• and (b) each step (in the process flow diagram) used for
preparation of the food product (HACCP Principle 1).
• Step 7: Determine which (a) raw materials and
ingredients, and (b) process steps, will be critical control
points at which unacceptable hazards identified in Step
7,will be controlled (HACCP Principle 2).
• Step 8: Establish critical limits or tolerances for each
of the critical control points identified in Step 7
(HACCP Principle 3).
• Step 9: Establish monitoring procedures for each of
the critical control points identified in Step 7 (HACCP
Principle 4).
• Step 10: Establish corrective action procedures to be
followed when monitoring of the critical control points
reveals that the established critical limits have been
exceeded or have not been met (HACCP Principle 5).
• Step 11: Establish verification procedures to confirm
and provide confidence that (a) the critical control
points are being monitored effectively and are under
control, and (b) the HACCP plan for the product is
operating effectively (HACCP Principle 6).

• Step 12: Establish record-keeping and documentation

procedures for records and documents that are
required by the HACCP plan (HACCP Principle 7).
• Step 1: establishes the HACCP team that will perform
steps 2 to 12.
• Step 2: in which the important characteristics relating to
the safety of the product must be clearly described by the
HACCP team.
• This information will be used by the team in the
identification and analysis of all hazards associated with
all aspects of preparation of the product. This include: The
product name, including all alternate or common names
for the product (or the name of a family of similar
• The composition of the product, or the physical or
chemical properties (e.g., pH, Aw, preservatives,
presence of allergenic ingredients) that must be
controlled to ensure the safety of the product
• The packaging of the product, including the package
unit (e.g., can, bag, case), the packaging material
(e.g., foil, plastic, paper), and packaging conditions
(e.g., modified atmosphere packaging)
• The shelf-life of the product and any required storage
temperature (e.g., refrigerated, frozen) and humidity
• The labeling instructions to customer or consumer for
handling, storage (e.g., refrigerated, frozen) and use
(e.g., cooking time and temperature) of the product
• Any special conditions for distribution of the product
(e.g., refrigeration or freezing during shipping)
• The actual use of the product (e.g., ready-to-eat,
heat before consumption, industrial use with further
• The sale of the product (e.g., retail to consumers, to
institutions, to industrial customers).
• To facilitate hazard analysis
• This step should establish where and by whom the product
will be used (e.g., food service or institutional use,
industrial use, or household use by the general consumer).
• Certain groups of the population (e.g., elderly persons,
pregnant women, infants, individuals whose immune
system is compromised) are at higher risk to certain
biological hazards and chemical hazards; therefore the use
of the product by these groups need to be determined.
• Maybe combined with step 2
• The HACCP team, with assistance from personnel who
are familiar with the process, should construct a process
flow diagram that shows a simple but logical step-by-step
outline of the process from which the product will be
• The process flow diagram should identify all key steps
from receiving of raw materials and ingredients for
preparing of the product; all handling, sorting, preparation
and storage of raw materials and ingredients; all
processing treatments including steps at which there are
filters, screens, magnets, and metal detectors; all
packaging, labeling, and storage steps through to shipping
of the product from the establishment.
Receiving of raw material, ingredients, packaging materials
Storage of raw materials, ingredients, packaging materials

Preparation of raw materials and ingredients (one or more steps)

Processing of raw materials and ingredients into

products (one or more steps)

Packaging of finished product

Labeling of packaged finished product

• The HACCP team should verify the process flow
diagram prepared in Step 4 to establishment that the
diagram accurately represents the actual activities and
operations used to prepare the product.
• This is done by observing each step of the process,
from receiving of raw materials to shipping of finished
product, as each activity and operation identified on the
process flow diagram actually takes place.
• Based on the results of this observation, the process
flow diagram should be modified as required.
• The accuracy of the process flow diagram in
representing the actual process required for the
preparation of the product is essential for the
successful development of the HACCP plan.
• If a necessary step for preparation of the product is
not in place, this step should be introduced into the
• Must addresses the three categories of hazards biological,
chemical, and physical.
• should be carried out in two stages:
• hazard identification
• hazard evaluation
• In addition, the control measures for the hazards that need
to be addressed in the HACCP plan should be identified
• at the completion of the hazard analysis.
• Biological hazards:
• Pathogenic microorganisms: Clostridium botulinum
Salmonella spp. Pathogenic: Escherichia coli Listeria
monocytogenes Staphylococcus aureus Clostridium
perfringens Viruses – Parasites
• Chemical hazards: Antibiotics – Cleaning and sanitizing
chemicals– Hormones – Regulated food additives Drugs –
Allergens– Agricultural residues – Toxicants Industrial
• Physical hazards: Glass – Stones Wood – Bones
• Hard plastic – Filth– Metal – Personal articles
• the identification of known potential hazards that are
likely to be associated with the product; this covers the
• ingredients, raw materials, and contact packaging
materials used in preparation of the product; every
aspect of each step of the process; and the
• environment used for the preparation of the product.
• If all the potential hazards are not identified, the
HACCP plan that is developed might be inadequate to
address the safety of the product.
• the HACCP team should consult appropriate sources
of information to determine the known product
• hazards for which the HACCP plan is developed, as
well as known hazards associated with the various raw
materials, ingredients, and the processing operations
used for the product. An example:
• Reference Database for Hazard Identification) which
has been developed by Agriculture and Agri-Foods
• In addition to reference information, valuable
information on potential hazards can be obtained by
closely observing the process as it is operating.
• to determine which of the hazards that have been
identified in the first stage of the hazard analysis are
significant, and therefore need to be addressed in the
HACCP plan for the product.
• By considering their likely occurrence, and the severity
of the risk that they present if they are not controlled.
• In doing so, the HACCP team needs to examine
published information and data, and previous
experiences on occurrence of the hazard in the
• In assessing the severity of the risk presented by a hazard,
the HACCP team must address the severity of health
consequences to consumers of the product by:
• The methods and procedures of preparation, handling,
storage, and distribution of the product
• The effects of both short-term and long-term exposure of
the product containing the hazard to the health of
• The people, including any particular groups (e.g., infants,
pregnant women, the elderly) who are likely to consume the
• Information and data from previous reported incidents
involving the occurrence of the hazard in the product.
• Physical characteristics and composition of the product
during and after processing ( pH, oxidation-reduction
potential ,water activity, fermentable carbohydrate,
acidulants and preservatives)
• Which intrinsic factor must be controlled to assure food
• Does the food permit survival or multiplication of the
pathogen and/or toxins during processing?
• Will the food permit survival or multiplication of the
pathogen and/or toxins during subsequent steps?
• Are there any similar products in the market ? What is
their safety records?
• As part of the hazard analysis the HACCP team must
determine whether control measures for the hazards that
need to be addressed in the HACCP plan are present in
the process.
• If not, modification of the process may be required in
order to institute a control measure,
• Control measures for biological hazards:
• thermal processing to eliminate pathogens
• frozen storage to prevent pathogens
• use of preservatives to prevent pathogens
• testing for the presence of pathogens
• Control measures for chemical hazards:
• formulation control of regulated food additives
• testing for the presence of antibiotics
• testing for the presence of pesticide residues
• Control measures for physical hazards:
• filtering or screening to remove foreign objects
• detection and removal of metal contaminants
• With the information obtained from the hazard analysis
step, the HACCP team must then determine the points at
which there will be control of the hazards that present
unacceptable risks; this will establish the CCPs of the
HACCP plan.
• For doing so, the CCP decision tree is used:
• Is a set of either three(NACMCF) or four (Codex)questions,
which are asked in a particular sequence for each identified
hazard so that the point of control of that hazard within the
HACCP plan can be determined.
• Question 1: Do preventive control measures exist?
• (a) If the answer is Yes, go to Question 2.
• (b) If the answer is No, is control at this step
necessary for the safety of the product?
• (i) if the answer is No, this step is not a CCP; proceed
to the next identified hazard in the process
• (ii) If the answer is Yes, modify the steps in the
process or the product,and return to start of Question
• Question 2: Is this step specifically designed to eliminate
or reduce the likely occurrence of the hazard to an
acceptable level?
• (a) If the answer is Yes, this step is a CCP
• (b) If the answer is No, go to Question 3.
• Question 3: Could contamination with the identified
hazard(s) at this step, occur in excess of acceptable
level(s) or could these hazards increase to unacceptable
• (a) If the answer is Yes, go to Question 4
• (b) If the answer is No, this step is not a CCP; proceed to
the next identified hazard in the process.
• Question 4: Will a subsequent step eliminate the
identified hazard(s) or reduce the likely occurrence
to acceptable level(s)?
• (a) If the answer is Yes, this step is not a CCP;
proceed to the next identified hazard in the process
• (b) If the answer is No, this step is a CCP
• Question 1: Does this step involve a hazard of sufficient
likelihood of occurrence and severity to warrant its
• (a) If the answer is Yes, go to Question 2
• (b) If the answer is No, this step is not a CCP; proceed to
the next step of the process.
• Question 2: Does a control measure for the hazard exist at
this step?
• (a) If the answer is Yes, go to Question 3
• (b) If the answer is No, is control at this step necessary for
the safety of the product?
• (i) If the answer is Yes, modify the step, the process or
product, and return to start of Question 2
• (ii) If the answer is No, this step is not a CCP; proceed
to the next step of the process.
• Question 3: Is control at this step necessary to prevent,
eliminate or reduce the risk of the hazard to
• (a) If the answer is Yes, this step is a CCP; proceed to
the next step in the process.
• (b) If the answer is No, this step is not a CCP; proceed
to the next step in the process.
• For each of the CCPs that have been determined in Step
7, the HACCP team must establish critical limits which
will serve as the criteria for accepting or rejecting a raw
material or ingredient that is a CCP, or a semi-finished or
finished product that is obtained at a process step that is
a CCP.
• is commonly a maximum value of a parameter that must
not be exceeded or a minimum value of a parameter that
must be reached at a CCP.
• If the critical limits at a CCP are not respected, the
product obtained at the CCP will not be acceptable.
• For each of the CCPs that have been determined, the
HACCP team must establish the monitoring procedures
which will be used to monitor or measure the
parameters at the CCP to determine whether the
critical limits are being respected.
• Visual inspection and physical and chemical
measurements are frequently used as monitoring
• the monitoring procedures be reliable
• CCPs for biological hazards Monitoring procedures
• Pasteurization Monitoring of temperature and time
• Acidification Measurement of pH
• CCPs for chemical hazards Monitoring procedures
• Receiving of raw materials Examination of certificate of analysis
• Labeling Inspection of labeled products
• CCPs for physical hazards Monitoring procedures
• Filtering Inspection of filter
• Metal detection Monitoring of product by metal detector
• Are the procedures that are established to prevent
unsafe product from reaching the consumer.
• The HACCP team must establish procedures to be
followed if and when the monitoring of a CCP reveals
that the critical limits are not respected (i.e., a
deviation occurs), and therefore there is a loss of
control of the hazard at the CCP.
• A product that is obtained at a process step where the
CCPs are not respected is a nonconforming product
and is likely to be unsafe if consumed.
• The following points must be addressed in the corrective
action procedures:
• The specific, immediate action to be taken.
• Identification of the cause of the deviation.
• The actions to be taken to correct the cause.
• Determination of the period of time for which the deviation
occurred and the quantity of nonconforming product
• The actions to be taken with respect to the nonconforming
product to ensure that it does not reach the consumer.
• The importance of keeping records of all the actions taken
• the corrective action procedure must identify the personnel
who are responsible for the actions to be taken when there
is a deviation from the critical limits at a CCP.
• the effectiveness of the HACCP plan that has been
• developed and
• the effectiveness of the HACCP system on an
ongoing basis after its implementation.
• to ensure that the critical limits, the monitoring
procedures and the corrective action procedures
established at each CCP are indeed capable
• of controlling the hazard that is required to be
• CCPs for Biological Hazards
Verification activities
• Pasteurization
Review of pasteurization, records,
• microbiological testing of product
• periodically
• Acidification
Review of pH measurement
• records, microbiological testing of
• product periodically
• CCPs for Chemical Hazards Verification activities
• Receiving of raw material
Review of certificates of analysis,
• periodic sampling and testing of
• raw material
• Labeling Review of labeling inspection records
• CCPs for Physical Hazards Verification activities
• Filtering
Review of filter inspection records
• Metal detection
Review of metal detector records
• This HACCP principle covers all records and documents
that are required for all HACCP plans and for the entire
HACCP system.
• the HACCP team must identify which documents will be
required and which records will be kept as part of the
monitoring procedures, corrective action procedures,
and verification procedures.
• The documents which are expected to be maintained
• for an HACCP plan include:
• The composition of the HACCP team along with
assigned responsibility (Step 1)
• The description of the food product (Step 2)
• The identification of the intended use of the product
(Step 3)
• Creation of a process flow diagram (Step 4)
• The verified process flow diagram (Step 5)
• A summary of the hazard analysis, along with the
justification for identification and evaluation (Step 6,
HACCP Principle1)
• A summary of the CCP determination, along with the
justification (Step 7, HACCP Principle 2)
• Any other relevant supporting documents that were
generated during the HACCP plan development (e.g.,
data from validation of CCPs)
• The records which will be generated when the HACCP
plan is used are:
• Records that result from monitoring of the CCPs
• Records that result from corrective actions and
deviations, whenever they occur
• Records that result from verification of CCPs and of
the entire HACCP plan
CCP Hazards Critical Monitoring Corrective Verific
Limits Actions ation Records
• After an HACCP system has been developed and
implemented, it must be maintained effectively on a continuous
• The HACCP team should determine whether the HACCP plan
for a product needs to be modified if:
• The intended use of the product has changed
• There is a change in one or more raw materials, ingredients, or
• packaging materials used for preparing the product
• There is a change in the process for preparing the product
• There is addition, replacement or modification of equipment
used in the process
• A standard: is a document that provides requirements,
specifications, guidelines or characteristics that can be
used consistently to ensure that materials, products,
processes and services are fit for their purpose.
• Quality system standard: is a document that describes the
requirements of a quality system.
• Specification : is a document stating requirements (ISO
• A document that states the requirements to which a given
product or service must conform (QP, 2002).
• The ISO 9000 quality system standards were developed by
the International Organization for Standardization (ISO) in
1987 for use by any organization that needs to develop,
implement and operate with a quality management system.
• ISO Standards are reviewed every five years to ensure they
stay up-to-date – revisions are part of the ISO process and are
to be expected
• The ISO 9000 revised in 1994 and again in 2000 .
• The objective of these periodic revisions is to satisfy the
needs of the standards’ users.
• The 2000 revision, resulted in the following three
• ISO 9000:2000: Quality management systems—
fundamentals and vocabulary
• ISO 9001:2000 : Quality management
• ISO 9004:2000: Quality management systems—
guidelines for performance
• ISO 9001:2000 : defines minimum requirements for an
organization that seeks to have its quality
management system recognized by a formal
registration process.
• ISO 9004:2000: is not used for registration but
provides guidance for performance improvement of a
quality management system.
• The scope of this guidance extends much beyond the
minimum requirements of ISO 9001:2000
• The 1994 revisions were considered minor
revisions with little change in the structure of the
initial 1987 version of the three standards ISO
9001 ISO 9002, and ISO 9003, which were
models for quality assurance.
• But, in the 2000 revisions the structure of the
standards was considerably modified.
• This led to cancellation of the ISO 9001,ISO
9002, and ISO 9003 quality assurance system
standards and their replacement by the single
9001:2000 quality management system
• ISO 9001:2008 revision: only made the existing
requirements of the 2000 version specification
• It also incorporated some changes to make it more
consistent with ISO 14001:2004, the environmental
management system standard.
• Later in 2009, ISO 9004 (which accompanied ISO
9001:2000 for the first time) was revised to promote a
sustainable business approach.
• This version focused on all stakeholders and not just
customers and social conditions.
• The 2000 edition of the ISO 9000 family of standards
cancelled and replaced the 1994 edition of several of
the standards, including:
• ISO 8402:1994 Quality management and assurance
• ISO 9000—1:1994 Quality management and assurance
standards–part 1: guidelines for selection and use
• ISO 9001:1994 Quality systems—model for quality
assurance in design, development, production,
installation and servicing
• ISO 9002:1994 Quality systems—model for
quality assurance in production, installation and

• ISO 9003: 1994 Quality systems—model for

quality assurance in final inspection and test

• ISO 9004–1: 1994 Quality management and

quality system elements—part 1: guidelines
• A formal global review of ISO 9001 was completed in
2012 among ISO member bodies. This resulted in a
decision to revise the standard.
• International experts nominated by ISO member bodies
looked at a number of items to help guide revision activities:
an extensive web-based user survey
new quality concepts and ideas for inclusion in ISO 9001
revised quality management principles
formal interpretations of ISO 9001:2008
support and guidance notes
• The ISO 9000 standard recognizes the following 12
fundamentals, which are the basis for the contents of
the ISO 9001:2000 and ISO 9004:2000 quality
• management system standards. These fundamentals,
which incorporate the eight quality management
principles (Section 3.11.1), are:
• Rationale for quality management systems:
• A quality management system can provide benefits to
an organization. In general, these benefits include:
• Assist in enhancing the satisfaction of the
organization’s customers
• Provide a framework for continual improvement in the
• Provide confidence to the organization and its
customers that the organization has the capability to
provide products that meet the requirements of
customers, regulatory agencies and the organization.
• Requirements for quality management systems and
requirements for products: The ISO 9000standards
distinguish between the requirements of quality
management systems and requirements of products.
• The ISO 9001:2000 standard provides generic quality
management system requirements that are applicable to
any organization but does not provide requirements for an
organization’s products. An organization, its customers,
and government regulatory agencies establish
requirements for products; these requirements are also
part of the quality management system.
• Quality management systems approach:
• In the development, implementation, maintenance, and
improvement of its quality management system, an
organization needs to adopt an approach in which certain
specified activities should be undertaken; the standard
identifies these activities.
• The process approach:
• The process approach is described as systematic
identification and management of an organization’s
processes and the interactions between these
processes. This approach should be used to manage
an organization.
• Quality policy and quality objectives:
• An organization’s quality policy and quality objectives
can provide a focus for the direction of the
organization. The quality policy should provide a
framework for establishing the quality objectives, which
should be consistent with the quality policy.
• Role of top management within the quality management
• An organization’s top management, through the use of
quality management principles (Section 3.11.1), and its
leadership and actions can create an environment for the
involvement of its people and for effective operation of the
organization’s quality management system.
• Documentation:
• Documentation is an essential feature of an organization’s
quality management system. Various types of documents
are needed in a quality management system, each should
serve a particular function.
• Evaluating quality management systems:
• An organization’s quality management system should be
assessed by evaluating the various processes within the
system, by auditing the system, and by top
management’s review of the system. An organization
should also carry out self-assessment of its activities and
• Continual improvement:
• An organization’s quality management system should
include activities that are devoted to continually
improving the system with the objective of enhancing the
satisfaction of its customers and other interested parties.
• Role of statistical techniques:
• An organization should use statistical techniques to
understand and solve problems such as variability, for
continual improvement of its effectiveness and
efficiency, and in making decisions.
• Quality management systems and other management
system focuses:
• An organization’s quality management system can be
integrated with other management systems (e.g.,
financial management
• system, environmental management system, employee
health and safety management system). The quality
objectives of the quality management system can
complement the objectives of the other management
• Relationship between quality management systems and
excellence models:
• The approach of ISO 9000:2000 family of standards has
many similarities to those of excellence models (Section
3.7). However, the ISO 9000 standards provide quality
management system requirements ISO 9001 and
guidance for performance improvement (ISO 9004), while
the excellence models provide assessment criteria for
comparing an organization’s performance against the
performance of other organizations.
• Standards of identity for food: are the mandatory,
federally set requirements that determine what a food
product must contain to be marketed under a certain
name in interstate commerce. Mandatory standards
(which differ from voluntary grades and standards applied
to agricultural commodities) protect the consumer by
ensuring a label accurately reflects what is inside (for
example, that mayonnaise is not an imitation spread, or
that ice cream is not a similar, but different, frozen
• They are issued by the U.S. Department of
Agriculture, the Food and Drug Administration or
the Bureau of Alcohol, Tobacco, Firearms and
Explosives. The Canadian Food Inspection Agency
also issues standards of identity.
• Grade : Category or rank given to different quality
requirements for products, processes, or systems
having the same functional use (ISO 9000:2000).
• Set of internationally recognized food standards
developed by the Codex Alimentarius Commission.
• Codex Alimentarius Commission: A joint, subsidiary
body of the Food and Agricultural Organization (FAO)
of the United Nations and the World Health
Organization (WHO).
• The Codex Alimentarius Commission was established
in 1962 for the purpose of developing, promoting, and
harmonizing standards for food in order to facilitate
international trade.
• Membership on the Commission is open to all member
nations and associate members of the FAO and WHO.
• The Codex Alimentarius Commission has developed
numerous internationally recognized food standards as
well as an internationally recognized HACCP system.
• These laws and regulations are intended to ensure that
foods do not:
• cause harm, illness, or injury; are not adulterated or
misbranded; and are
• wholesome and fit for human consumption.
• A regulatory body, is an organization that has been
empowered by legislation to oversee and control the
quality process and outputs related to it.
• The legal framework of food laws and regulations of a
particular country depends on the overall government
regulatory system of that country.
• In Sudan regulatory agencies are: Federal Ministry of
Health (FMOH), Sudanese Standards and Metrology
Organization(SSMO), Ministry of Agriculture and
Irrigation(MOAI), Ministry of Animal Resources, Fisheries
and Ranges(MOARFR), Ministry of Foreign
Trade(MOFT), Ministry of Environment and Forestry
(MOEF)and Ministry of Industry(MOI).
• Food inspection in the Federal Republic of Sudan is
the responsibility of the Federal Ministry of Health
(Directorate of Environmental Health and Food
Control – FOOD CONTROL SECTION) through Public
Health Officers and their assistants.
• Food inspection is part of the responsibility of Public
Health Officers, who are also responsible for
environmental health services in their specified areas.
• Public Health Officers beside officers from other
authorized institutions are responsible for the
inspection of food at all stages.
• Legal frame: Sudan depends for a long time on the
Public Health Act 1939 which covers all aspects of
public health with a very few and centralized articles
dealing with food hygiene issues.
• Each State has its own Environmental Health
Regulations, which regulates all activities of
environmental health including food safety inspection
and control.
• In 1973 the people’s Assembly passed a federal act called
“FOOD CONTROL ACT 1973” which gives power to the
federal authority to supervise food control activities all over
the country and to regulate exports and imports.
• Depending on Food Control Act 1973, the Federal Minister
of Health issued the following regulations:
• It regulates the addition of all food additives such as colors,
preservatives, flavors, thickening agents …etc. and it
contains a list of permitted food additives and their
recommended levels. The list is subject to periodical
• It deals with hygienic requirements of buildings,
equipment, utensils and food handlers in big food
establishments, whereas small scale food
establishments are covered by the local ordinance.
• Any processed pre-packed food, whether imported or
locally produced, must be registered by the Registration
Committee before it is permitted for sale.
• It deals with the authority for food inspectors to enter
food establishments, in addition to sampling procedures,
quantities of samples and methods of analysis.
• The Federal Ministry of Agriculture and Irrigation plays an
important role in controlling agricultural products by
producers' awareness and by enforcement of its different
Acts and regulations such as:
Federal Pesticides and Pest Control Products Act 1994
Federal Agricultural Fertilizers Act 2010
Federal Seeds and Species Protection Act 2010
• The Federal Ministry of Animal Resources, Fisheries
and Ranges has got its own regulations.
• It carries out inspection in the field of animal, fish and
fishery products and enforces the following Acts and
• Federal Meat Inspection Act 1974
• Federal Veterinary Health Quarantine for Exported
and Imported Live Animals and Meat 2004
• Established in the year 1992 and since then the SSMO
has taken over the full responsibility of issuing all
commodity standards including food.
• The organization issued more than 1,000 food
standards following the CODEX and ISO
• SSMO also enforced the 2008 Act, which gives the
organization the power to inspect all food commodities
produced locally, as well as imported or exported.
• The bulk of work of food safety in Sudan now is
carried by SSMO and the standards issued cover all
types of commodities, code of practices, guidelines,
sanitary requirements and measures for food
establishments and transportation vehicles.
• Certification audits for management systems,
products and food safety are provided on demand by
Sudanese Standards and Metrology Organization
• Laboratory analysis is provided by FMOH, SSMO,
MOAI, MOARFR, in collaboration with universities
and research institutes and centers.
• Inspection for safety of inputs and food safety is
undertaken by FMOH, SSMO, MOAI, MOARFR.
• The FMOH is responsible for the general food safety
issues including food hygiene, prevention and
control of food-borne infections and intoxications.
• SSMO assists processors (industry) and food
importers to adhere to food safety and quality
assurance principles.
• MOAI and MOARFR assist producers, processors
and food handlers to adhere to good agricultural
practice (GAP), animal husbandry and hygienic
• Several federal, state, and local agencies share
responsibilities for regulating the safety of the U.S.
food supply.
• Federal responsibility for food safety rests primarily
with the Food and Drug Administration (FDA), which is
part of the U.S. Department of Health and Human
• and the Food Safety and Inspection Service (FSIS),
which is part of the U.S. Department of Agriculture
• Environmental Protection Agency (EPA) has the legal
responsibility for ensuring that the chemicals used on
food crops do not endanger public health.
• Department of Commerce insures the safety of
imported foods.
• Inspection: is a Conformity evaluation by observation
and judgment accompanied as appropriate by
measurement, testing, or assessing (ISO 9000:2000).
• The process of measuring, examining, testing,
assessing, or otherwise comparing the unit with the
applicable requirements(ASQ, 1998).
• Measuring, examining, testing and gauging one or
more characteristics of a product or service and
comparing the results with specified requirements to
determine whether conformity is achieved for each
characteristic (QP, 2002).
• The Food Safety inspection determines the hygiene
conditions of the food establishment inspected.
• Traditional inspections focus on the general aspects
related to visually inspected cleanliness and
sanitation of equipment and facilities and the food
handling habits of workers.
• What to inspect:
• Pen and pencil Flashlight
• Writing tablet UV light (optional)
• Notebook Thermometer
• Inspection forms Copies of Laws and Regulations
• Watch Hair nets
• Gloves
• Aprons
• Microbiological Sample Kit for Total Plate Count
• HACCP-based inspections or audits verify that a
particular facility has included correct implementation of
GAPs, GMPs, SSOPs and a HACCP program as
necessary. This results in having a system that ensures
the production of safe and wholesome food products.
• FDA also designates certain facilities as high-risk
facilities. Generally,
• these facilities handle types of food that have a greater
potential to cause harm. FDA uses this high-risk
designation to help prioritize
• facilities for inspection. This process allows FDA to
target scarce resources based on relative vulnerability
and risk.
• Seizure, injunction and prosecution: are tools to enforce
the Act developed by FDA .
• after inspection if there is non-compliance the FDA may
issue a warring letter which is: a correspondence that
notifies regulated industry about violations that FDA has
documented during its inspection or investigations.
• Seizure: the action of capturing someone or something
using force.
• Injunction: a judicial order that restrains a person
from beginning or continuing an action threatening or
invading the legal right of another, or that compels a
person to carry out a certain act, e.g., to make
restitution to an injured party.
• Prosecution: the institution and conducting of legal
proceedings against someone in respect of a criminal
• Product recall: is a request to return a product after the
discovery of safety issues or product defects that might
endanger the consumer or put the maker/seller at risk of
legal action. Every establishment should have a recall
policy to protect the health of consumers
• The recall strategy should consider the nature of recalled
products (e.g., carcinogenic products) when normal
disposition means, landfill, crushing, denaturing, etc., are
• In reviewing or developing a recall strategy, the company
should take into account the health hazard evaluation, type
or use of the product, the ease in identifying the product.
• A recall strategy should include a statement on and the
reasons for recommending the desired option under
each of the following elements:
• Depth of recall: The recall may extend to the
consumer or user level, the retail level, or the general
• Public warning: In urgent situations, consideration
should be given to the need for a press release that
could be nationwide or to affected geographical areas
• Effectiveness Check Level: This includes the
method(s) to be used for and depth of recall
effectiveness checks.
• Reconditioning: is the process of turning imperfect,
mislabeled, or even contaminated foods into edible
and profitable goods.
• Example:
• If a company change the shape of some pasta and the
end result is a batch of misshaped macaroni noodles,
they may regrind it in to semolina flour and start over.
• Professional ethics: cover the personal, organizational
and community standards of behavior expected
of professionals.
• How the use of this knowledge should be governed when
providing a service to the public can be considered a
moral issue and is termed professional ethics.
• Professionals are capable of making judgments, applying
their skills and reaching informed decisions in situations
that the general public cannot, because they have not
received the relevant training.
• One of the earliest examples of professional ethics is
the Hippocratic promise to which medical doctors still
adhere to this day.
• Some professional organizations may define their ethical
approach in terms of a number of components these
• Honesty
• Integrity
• Transparency
• Accountability
• Confidentiality
• Objectivity
• Respectfulness
• Obedience to the law
• Loyalty
• Most professions have internally enforced codes of practice that
members of the profession must follow to prevent exploitation of
the client and to preserve the integrity of the profession.
• Code of practice: A written set of guidelines issued by
an organization to its workers and management to help
them conduct their actions in accordance with
its primary values and ethical standards.
• Bioterrorism: The use of biological agents as weapons of terror.
Anthrax bacteria are one such agent, while smallpox is
considered one of the more likely lethal viruses that could serve
as a weapon of bioterror.
• This also include:
• Tampering: to make changes or corrupt in a product using
• The food chain is a possible target for a bio-terrorist
attack. This could be by introduction of an animal or
plant disease or by chemical, biological, physical or
radiological contamination of food or water.
• there are seven areas that relate to the individual
components of a food establishment operation that
should be reviewed and implemented by plant
management in order to prevent bioterrorism
• management of food security;
• physical security;
• employees;
• computer systems.
• raw materials.
• packaging, operations; and
• finished products.
• management of food security: This entails assigning
responsibility for security to qualified individual(s),
encouraging all staff to be alert to any signs of
tampering with product or equipment, other unusual
situations, or areas that may be weak to tampering,
and alerting identified management about any
unusual findings.
• Physical Facility security: Visitors, truck drivers and
service staff must be controlled and access to food
handling and storage areas must be restricted.
• Employees: a system for screening employees,
especially new employees, should be instituted.
Management must know who is and who should be
on premises, and where they should be located.
• Computer Systems: Restrict access to computer
process control systems and critical data systems to
those with appropriate clearance.
• Raw Materials and Packaging: The operator must
use only known, appropriately licensed or approved
sources for all ingredients, compressed gas,
packaging, and labels, and inspect all incoming
materials, and must have the ability to trace back all
input materials.
• Operations: ensure the security of access to the
sources of water and air, use tamper evident
connectors and valves, and arrange periodic
• Finished Products: Keep track of finished products
and investigate missing or extra stock or other
• Procedure for judging the acceptability of lots with
out doing 100% inspection.
• Accept/reject the lot based on sample results.
• Created by Dodge and Roming during world warII
• Not consistent with total quality management of zero
• Dose not estimate the quality of the lot.
• It is a graph of % defective (p) in a lot or batch vs the
probability that the sampling plan will accept the lot.
• Shows probability of lot acceptance as a function of
lot quality level.
• Is based on the sampling plan.
• Curve indicate the discriminating power of the
sampling plan.
• Help in selecting plans that will reduce the risk
• Helps to reduce the high cost of inspection
• Sampling involve risks:
• Good products may be rejected.
• Bad products may be accepted.
• Risks may be for producers: products of acceptable
quality may be rejected (alpha)
• Or may be for consumers: products of bad quality
may be accepted (beta).
• Attribute sampling plans: are generally easier to use
than variables plans. A sample of n units is selected
randomly from a lot of N units. If there are c or fewer
defectives, accept the lot. If there are more than c
defectives, reject the lot.
• For example, suppose you have a shipment of 10,000
sacks . You will inspect 89 of them. If there are 0, 1, or 2
defective bolts, then you may accept the shipment. If
there are more than 2 defectives, then reject the entire
lot of bolts.
• Variables sampling plans
• Rectifying sampling plans
• For variables sampling plans, you can only examine
one measurement per sampling plan.
• For example, if you need to inspect for biscuit
thickness and biscuit width, you need two separate
sampling plans. Variables sampling plans assume
that the distribution of the quality characteristic is
normal. However, the main benefit from using
variables data is that a variables sampling plan
requires a much smaller sample size than an
attributes sampling plan.
• Rectifying sampling plan: is applicable if the defects
that are found can be corrected immediately.
• The steps involved in developing a sampling plan are
• :identify the parameters to be measured, the range of
possible values, and the required resolution
• design a sampling scheme that details how and when
samples will be taken
• select sample sizes
• design data storage formats
• assign roles and responsibilities
• quality assurance/quality control (QA/QC) program
uses a mixture of control techniques, acceptance
sampling, and statistics analysis techniques with the
system making emphasis on control.
• The control depends on the action taken as a result
of sampling or testing.
• One of the most important statistical process control
(SPC) techniques:
• is the control charts.
• a control chart:
• is a graphic display of the actual quality performance
judged against a reference frame showing a central
line representing the average quality value and upper
and lower lines called the upper control limit (UCL)
and lower control limit (LCL).
• These lines are positioned so that nearly all the
sample results fall between them, as long as the
process is in control and the stable system of chance–
causes is operating.
• Control charts were developed in the 1920s by Walter
A. Shewhart of the Bell Telephone Laboratory.
• They are statistical approach to continuously process
variation with the purpose of improving it by removing
the assignable causes of variation.
• Control charts differentiate between the
• process being in control (within an acceptable range of
random variation) and out of control (outside the
acceptable range).
• The control charts can be divided into variable and
attribute control charts.
• Variable control charts: are used for important
variables or continuous quality data, such as weight
control, can seam dimensions, volumes, yield, and
chemical, physicochemical, nutritional, and
microbiological characteristics.
• Numerical values give more information than
necessary and the results are more precise, with fewer
samples than attributes; however, variable charts can
only be applied to a single characteristic or property.
• Attribute control charts: are used for quality
characteristics data that cannot be expressed as a
measurement and are collected by counting.
• For example:
• in the visual examination of can seams, we can
count a variety of defects such as drops, lips, cut-
over, skidding, dents or scratches, etc. and, on the
basis of the results, classify the seams into one
• of two classes, conforming or nonconforming
(pass/fail, good/bad).
• Choose the quality characteristic to be charted:
• Choose a characteristic that is currently experiencing
a high number of nonconformities or items that do not
• Identify the process variables contributing to the end-
product characteristics to identify potential charting
• Choose characteristics that will provide appropriate
data to identify and diagnose problems.
• Determine a convenient point in the production
process to locate the chart. This point should
• be early enough to prevent nonconformities and to
guard against additional work on nonconforming
• items.
• Choose the type of Determine a convenient point in
the production process to locate the chart. This
point should be early enough to prevent
nonconformities and to guard against additional
work on nonconforming items.
• Choose the type of control chart
• Choose the center line of the chart and the basis for
calculating the control limits.
• The center line may be the average of past data, the
average of data yet to be collected, or a desired
(standard) value.
• The limits are usually set at ±3 standard deviations, but
other multiples of the standard deviation may be used for
other risk factors.
• Choose the rational subgroup or sample. It should be
pointed out that the term sample is usually used, but
sample could mean an individual value, and samples of
more than one are desirable for control charts if feasible.
• For variables charts, samples of size 4 or 5 are usually
used, whereas for attributes charts, samples of 50 to 100
are often used.
• Provide a system for collecting the data. If control charts
are to become a shop tool, the collection of data must be
an easy task. Measurement must be made simple and
relatively free of error.
• Calculate the control limits and provide adequate
instruction to all concerned on the meaning and
• interpretation of the results. Production personnel must
be knowledgeable and capable of performing
• corrective action when the charts indicate it.

• It is not possible to label “good” or “bad”

• If we have relatively smaller sample sizes (<20)


Is the average of the



Is the average of the


• The limits within which a tool or process operates,
based upon minimum variability as governed by the
prevailing circumstances (ASQ, 1998).
• A statistical measure of the inherent process
variability for a given characteristic (QP, 2002).
• Process capability index: The value of the tolerance
specified for the characteristic divided by the
process capability (QP, 2002).
• Process control: The methodology for keeping a
process within boundaries; minimizing the variation of
a process (QP, 2002).