Institute of Technology (IoT)

Department of Engineering

Food Quality & Safety Management (QMS)

Chapter-III: Quality programs and quality systems
for the food industry
Target Year:- IV/II
FEB, 2024
By: Yoobsan Ejeta Oda Bultum, Ethiopia
Quality programs and quality systems for the food industry
• Quality Control
• Quality Assurance
• Quality management systems-- QMS structure, principles
• Total quality management
• Statistical quality control

ISO quality system standards

– QMS structure, implementing QMS,
– ISO 9000:2000 series
– ISO 14000
• A Techno-managerial approach Quality management model; Statistical quality control, Quality Audits, Good
Manufacturing practice, Sanitation and hygiene, SOP, pest control,

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Diagram of the relationship between GMP, GHP, HACCP, QMS
Cont’d…

• principles and practices associated with quality programs and quality systems that can be applied

to operations in the food industry;

• They differ in their scope of activities and complexity of their structural framework

• Quality control programs are basic quality programs; quality management systems are more

complex

• Both quality programs and quality systems are used extensively in the food industry.

• The objective of these programs and systems is to achieve the food quality and food safety

requirements
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 Food Quality Management System Conceptual Model

• A conceptual model of food quality

management functions based
on a techno – managerial approach

 The conceptual FQM functions model

shows an organization in its
environment, wherein technological and
managerial functions interact, striving
for food quality that meets or exceeds
customer and consumer requirements.
 Five managerial functions have been
identified that contribute to the
realization of quality, i.e., design,
control, improvement, assurance, and
policy and strategy of quality.
Food quality management functions model
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Distinction between quality programs and quality systems
• A Quality program is an activity or set of activities performed to ensure that the food
quality and food safety requirements of a food are fulfilled.

• Quality system: An integrated set of documented food quality and food safety activities,
with clearly established inter-relationships among the various activities
• The objective of a quality system is to provide a food company with the capability to
produce a food that fulfills all quality requirements.
 Examples of quality programs are Quality control programs
 Examples of quality systems are Quality assurance systems and quality management
systems.
• Food quality requirements are established by laws and regulations and by customers and
consumers.

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Reasons for setting up a quality system:
a) to improve your product and service quality
b) to give customers confidence that their needs to be met.
c) to standardize your business by giving it a consistent approach to its operations
d) to improve work processes, efficiencies, morale and reduce waste

 The ISO 9000 family of standards is used as a basis for describing the principles and
fundamentals for quality management systems.
 The ISO 9001 standard: the most widely used quality standard in the business world

• QC and QA are two aspects of QMS

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Quality control programs
• Operational techniques and activities that are used to fulfill requirements for quality
• It Consists of inspecting, testing and monitoring of products and processes and
corrective actions.
• the function of QC is associated with the production line - i.e., with specific processes
and unit operations
• The goal of a food company’s quality control program is to ensure that all
requirements are fulfilled so that only safe foods of acceptable quality are sent to its
customers or to consumers.

 In companies that operate with quality systems, the quality control activities are
integrated into the quality systems

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The basic tools of quality control:
1. Ingredient Specifications
2. Approved Supplier List
3. Product Formulas
4. Product Standards (Specifications)
5. Manufacturing Procedures
6. Critical Control Point Identification/Sampling Program
7. In-Process Analysis, Records and Reporting Packaging Specifications
8. Label Specifications
9. Cleaning and Sanitizing Program
10. Good Manufacturing Practices (GMP) Requirements
11. Recall Program
12. Warehousing, Shipping and Receiving Program
13. Laboratory Analysis
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Quality assurance systems
• All those planned and systematic actions necessary to provide adequate confidence that a
product or service will satisfy given requirements for quality.
• QA are much more extensive in scope than QC control programs.
• They include QC activities, and additional activities that are devoted to prevention of food
safety hazards and quality defects. The activities are integrated and interrelated to form a
system
• The primary function of a QA department is to provide confidence to a food company’s
management, its customers and to government regulatory agencies that the company is
capable of meeting the food quality and food safety requirements.
• The QA department should be considered as in-house consultants, advisors, and trainers;
it evaluates the quality program and gives advice, recommendations, and instructions for its
improvement
 In companies that operate with QMS, QA activities are integrated into the QMS.

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QA program is built around three fundamental functions:
 Quality control
 quality evaluation
 quality audits

 Quality audit: is a planned, systematic examination of a manufacturing program and its

implementation to determine its adequacy and the degree of conformance to it.
• Quality audits are programs designed to verify a product or manufacturing process over
time.

Activities in QA
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 QA system includes components
 The quality plan- established to formalize the structure and organization of the QA
program.
 Documentation and records
 Product standards- Product specifications and Purchase specifications
 Process control- purchased product, GMP, HACCP, Process operation and
manufacturing process specifications, Calibration, Inspection and test methods, Product
protection
 Hygiene and housekeeping- cleaning and disinfection, waste disposal, pest control, and
staff health and hygienic conduct
 Corrective action and quality improvement- timely and effective action to limit the
problem
 identify its root cause in order to implement corrective action to prevent a recurrence
 Training-consistent staff training is paramount importance for improving quality
 monitoring of staff performance and Records of the training
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• The basic responsibilities of a QA department are recording and reporting the results
from:
1. Line inspection and control of Supplies, ingredients and raw materials; Operating
procedures; Finished products
2. Physical evaluation of raw and processed products, and ingredients
3. Chemical evaluation of raw and processed products, and ingredients
4. Microbiological evaluation of raw and processed products, and ingredients
5. Warehousing conditions for shelf-life time, temperature control, and handling procedures
6. Sanitation control of products, processes, and storage
7. Waste disposal control
8. Compliance with Federal, State and Municipal requirements and standards
9. Specification compliance during marketing and distribution for consumer confidence
10. Additional responsibilities include training, developing test and operational procedures,
occupational safety regulations, research and development projects

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 Quality management systems
• Quality management systems (QMS) are elaborate management systems that can be used
by any organization to develop and achieve its quality objectives.
• QMS is more comprehensive-include quality planning and quality improvement, in
addition to QC and QA 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
• In the past, the terms total quality control and companywide quality control were
occasionally used in the same context as quality management systems.
* A QMS is defined as “A set of coordinated activities to direct and control an organization
in order to continually improve the effectiveness and efficiency of its performance.”

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 The QMS relies on a variety of interactions and inputs within an organization

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The inputs of a Quality Management System
What are the requirements of a Quality Management System?
 Fully documented QMS ensure two requirements are met:
1. The customers’ requirements – deliver desired product and service consistently
meeting their needs and expectations.
2. The organisation’s requirements – at an optimum cost with efficient use of resources
– materials, human, technology and information.
 QM system provides many benefits to industries
1) Improve customer satisfaction
2) Improve efficiency and effectiveness, & reduce cost
3) Reduce rework and waste
4) Create a well-planned business
5) Add credibility to the business
6) Enable the business to compete /increase market share
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 Structure of QMS: What goes into a Quality Manual?

 The quality manual: document specifying the

QMS of an organisation
• The quality manual is a document setting out the
general quality policies, procedures and
practices of an organization.
• It Provide an index to the company's QMS;
inform customers the existence of the QMS;
evidence in auditing, reviewing and evaluating
the QMS

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 Quality Policy – the overall intentions and direction of an organisation related to quality as
formally expressed by top management
 Quality Process – a set of interrelated or interfacing activities which transform inputs into
outputs

 Quality Procedures- ‘Specified way to carry out an activity or a process’

 QPs are used to implement the core and supporting processes of an organization .
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 Work instructions- procedures specific to activities or assigned tasks.
• This describes, in detail, how tasks are carried out and the responsible staff for carrying
them out
 Quality plans- a document specifying the quality requirements for a particular contract or
product and monitor adherence to those requirements.
• it is a ‘customized Quality Manual’ and refer to detailed contract-specific
Process Maps, QPs and WIs

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 Quality Management Principles
• Quality management principle is defined by ISO/TC 176 as “a comprehensive and
fundamental rule or belief, for leading and operating an organization, aimed at continually
improving performance over the long term by focusing on customers while addressing the
needs of all other interested parties.”
 Eight fundamental quality management principles are:
1. Customer focus
2. Leadership
3. Involvement of people
4. Process approach
5. System approach to management
6. Continual improvement
7. Factual approach to decision making
8. Mutually beneficial supplier relationships
 This principles form the basis underlying the ISO 9000 series 20
1. Customer Focus
• Organizations depend on their customers and therefore should understand current and future
customer needs, should meet customer requirements and strive to exceed customer expectations.
– The impact- Inward seeking focus to Outward seeking focus.
2. Leadership
• Leaders establish unity of purpose and direction for the organization. They should create and
maintain the internal environment in which people can become fully involved in achieving the
organization’s objectives.
• This leadership is required to ensure there is a common purpose for everyone within the
organization.
3. Involvement of People
• People at all levels are the essence of an organization and their full involvement enables their
abilities to be used for the organization’s benefit.
– Motivated , innovative, creativity, committed and accountable
4. Process Approach
• A desired result is achieved more efficiently when activities and related resources are managed as a
process.
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• Therefore, an organization should use the process approach to manage its activities.
5. Systems Approach to management
• Identifying, understanding and managing interrelated processes as a system contributes to the
organization’s effectiveness and efficiency in achieving its objectives.
6. Continual Improvement
• Continual improvement of the organization’s overall performance should be a permanent
objective of the organization.
• Improved Performance through improved organizational capabilities; Flexibility to react quickly
to opportunities.
7. Factual approach to decision making
• Effective decisions are based on the analysis of data and information
• Informed decisions; increased ability to review, challenge and change opinions and decisions
8. Mutually Beneficial Supplier Relationships
• An organization and its suppliers are interdependent and a mutually beneficial relationship
enhances the ability of both to create value
• create value for both parties; Optimization of costs and resources; open communication and
Sharing information
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 Total Quality Management
• In the globalization environment, the increasing levels of competition have resulted in
quality becoming of increasing importance to organizations.
• Consequently, Total Quality Management (TQM) has become a key management
philosophy
• During the mid-1980s, The term total quality management (TQM) was introduced in North
America
• The term was associated with the Japanese style management approach to quality
improvement for achieving long-term success

 During the 1980s and 1990s many North American businesses adopted the TQM approach in
their quality management systems, with the objective of achieving competitive advantage in
the global marketplace.
• Total:- Involvement of all levels in the organization
• Quality:- Degree of excellence a product or service provides
• Management:- Art of handling, controlling, directing
• Total quality management is a management philosophy that seeks to integrate all functions and
processes within an organization in order to achieve continuous improvement of quality of
performance.
• Definition of TQM describes a management approach to long-term success through customer
satisfaction.
• Core terms are
 Continuous improvement
 Customer satisfaction
• TQM is a process for managing quality; a philosophy of continuous improvement.
• The primary goal is customer satisfaction; Defines quality as exceeding customers
expectation…………Customer-defined quality
 Other terms synonymous to TQM: continuous quality improvement, quality management, total
quality control, companywide quality assurance
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TQM Philosophy
• TQM revolves around three main themes: the customer, the process and the people
 TQM focus on meeting customer needs and organizational culture
• Satisfying customer needs and expectations

• Continuous improvement of the processes

• Empowerment of people

• The core values are the company vision and mission and management commitment

 The objective of TQM is continuous improvement of the quality of goods and services to
achieve customer satisfaction by involving all employees, customers and use of quality
tools.

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Principles of TQM- Concepts that make up the philosophy of TQM
• TQM approach operates on the basis of the following management principles and quality
concepts

1. Focus on customer

2. leadership

3. Continuous improvement

4. Employee empowerment

5. Process management/Process-oriented

6. Strategic planning / systematic approach

7. Fact- based decision making

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 Continuous improvement:-
• powerful concept to achieve high quality
• A philosophy of never-ending improvement
• learning and problem solving
• The Plan–Do–Study–Act Cycle
• Benchmarking

• Major areas of improvement

– technologies, materials, people, operations, product quality and safety etc…

 A central principle of TQM is identifying the root cause of mistakes, eliminating, and
preventing repetition of such mistakes by changing the process.

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 Deming Wheel: Plan–Do–Study–Act Cycle
• Activities that need to be performed for continuous improvement of process
• Circular, never ending problem solving process

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Characteristic features of TQM

• Focus on identifying root causes of quality problems and correcting them at the source

• Encompass the entire organization

• Concern with quality is customer driven

• Attempts to embed quality in every aspect of the organization

• Concern with technical aspects as well as involvement of people

• Management Commitment

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Total quality management tools
 The seven statistical quality control tools useful in identifying and analyzing quality
problems:
1. Cause-and-Effect Diagrams---Fishbone Diagram

2. Flowcharts

3. Checklists

4. Control Charts

5. Scatter plots

6. Pareto diagrams

7. Histograms
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Evolution of TQM

Timeline showing the differences between old and new concepts of quality
 The old concept was reactive, designed to correct quality problems after they occur
 The new concept is proactive, designed to build quality into the process
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The Pioneers /Gurus of TQM- quality leaders

 The concepts and principles of TQM have been evolved with substantial contributions
from several recognized experts in the field of QM
 Frederick Taylor
 Walter A. Shewhart
 W. Edward Deming
 Joseph M. Juran
 Armand V. Feiganbaum
 Phillip B. Crosby
 Kaoru Ishikawa
 Genichi Taguchi

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 The 14 points for management proposed by Edwards Deming are most widely
recognized in Quality Management
Deming’s 14 Points – principles to guide companies in quality improvement
1) Create Consistency of Purpose with a plan
2) Adopt new philosophy of quality
3) Cease dependence on mass inspection
4) Select a few suppliers based on quality
5) Improve constantly the system
6) Institute training on the job
7) institute leadership among supervisors
8) Drive out fear
9) Eliminate barriers between departments
10) Eliminate exhortations for the workforce ,… slogans X
11) Eliminate numerical quotas for production
12) Remove barriers to pride of workmanship
13) Institute vigorous education and retraining
14) Create a structure in top management to implement the preceding 13 points

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 Quality Awards and excellence models
• Governments in some developed countries have instituted recognition programs for organization
that established TQM approach in their QMS.
• These recognition programs are excellence models for organizations that use TQM to achieve
world-class quality
 Malcolm Baldrige National Quality Award
 The Deming Prize
 ISO 9000 Certification
 ISO 14000 Standards
• The objective of these recognition programs is to promote and foster the use of quality
management principles, concepts, and practices within organizations, and particularly for achieving
competitive advantage in the global marketplace
 Why TQM Efforts Fail
• Lack of a genuine quality culture
• Lack of top management support and commitment
• Over- and under-reliance on SPC methods 34
 Highlights
 TQM focus on identifying root causes of quality problems and correcting them at the source

 stresses that quality is customer driven

 TQM attempts to embed quality in every aspect of the organization.

 concerned with technical aspects of quality as well as the involvement of people, such as
customers, company employees, and suppliers

 Concepts of the TQM philosophy: customer focus, continuous improvement, employee

empowerment, team approach, fact based decision making, use of quality tools, product design,
process management, and managing supplier quality etc.

 Seven Quality Tools used in improving quality

 Quality Gurus all made key contributions: Walter A. Shewhart, W. Edwards Demings, Joseph M.
Juran, Armand V. Feigenbaum, Philip B. Crosby, Kaoru Ishikawa 35
 TQM and ISO 9000
 The latest changes for the ISO 9001:2000 Standard’s Process Model seem to complete the
embodiment that TQM philosophy is that quality is a process that can be managed.

 TQM is a philosophy of perpetual improvement while ISO 9000 is a Quality System

Management Standard.

 The ISO Quality Standard sets in place a system to deploy policy and verifiable objectives.
As such, ISO implementation is a basis for TQM implementation.

 Where there is an ISO system, about 75% of the steps are in place for TQM. The
requirements for TQM can be considered ISO plus.

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