IM ECEN 3463 Total Quality Management

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COMPILER: Engr. CHRISTIAN P. ENOVAL

Dr. BEN B. ANDRES
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Republic of the Philippines

POLYTECHNIC UNIVERSITY OF THE PHILIPPINES
Office of the Vice President for Academic Affairs
College of Engineering
Electronics Engineering (ECE) Department
COURSE GUIDE
I. Course Code: ECEN 3463
II. Course Title: Total Quality Management in ECE
III. Course Overview
A. Course Description
The course deals with the Foundations of Total Quality Management, Key Aspects
of the Quality System, TQM Tools and the Improvement Cycle, Conformance and
non-conformance to quality standards, The Quality Organization within an
Organization, Control of Quality Records, Internal Quality audits, Quality and
Business Process Re-engineering, Training for Total Quality Management, and
TQM Application to Electronics Engineering Fields.
B. Course Learning Outcomes
At the end of the course, the student should be able to
• Identify and explain the basic concepts and Foundations of Total Quality
Management
• List the Key Steps in the Control of Quality
• Identify and explain specific TQM Tools and the Improvement Cycle
• Distinguish Conformance and non-conformance to quality standards
• Classify the Quality Organization within an Organization
• Evaluate Control of Quality Records
• Evaluate Internal Quality audits
• Discuss Quality and Business Process Re-engineering
• Identify the Training for Total Quality Management
• Discover the TQM Application to Electronics Engineering Fields
C. Course Topics
To ensure the accomplishment of the learning outcomes, this course will cover
the following topics:
• Basic concepts and foundations of total quality management

• Key steps in the control of quality
• TQM tools and the improvement cycle
• Conformance and non-conformance to quality standards
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• Quality organization within an organization

• Control of quality records
• Internal quality audits
• Quality and business process re-engineering
• Training for total quality management
• TQM application to electronics engineering fields
IV. Course Study Guide
This material was prepared for students to be equipped with theoretical and technical
know-how for the subject ECEN 3464: Total Quality Management in ECE.
It is a self-paced material; hence, please be guided to -
1. Manage time well. Schedule properly reading the material and doing the activities
set. It is targeted that at the end of the semester, all activities set will be sent back
to the Electronics Engineering Department.
2. Focus. Make sure that you do things one at a time. Read the material over and
over until you are able to get the point of the lesson. If some areas are not clear
enough, you can refer to related books, the suggested readings, and videos as it may
deem necessary.
3. Give your best. In doing the assessment task whether formative or summative,
target the highest standards because you are a better student. You have the
knowledge and skills that you need to finish with the quality of work.
4. Submit on time. Once you are finished with the instructional material, it is
expected for you to send back your answers to activities and assessment.
5. Answer Assessment. Copy the question in a separate sheet and show solutions
and answers neatly complete, legibly, and concise. Also, Box in Final Answers
6. Work independently. It is expected that you work on the material on your own.
You can ask help from others but do your best to do it first.
7. Motivate yourself. Whatever knowledge or skill you are gaining from the course will
definitely help you take a step closer to be an Electronics Engineer. Enjoy what
you are doing and everything else will follow.
8. Reach Out. If any part of the lesson, you need help and guidance, do not hesitate
to contact your respective professors or to the ECE Department.
V. References
1. Russell, R.S., and Taylor, B.W. III, Operations Management-Creating Value Along the
Supply Chain, John Willey and Sons, Inc., 7th Edition, 2011
2. Kumar, S.A., and Suresh,N, Production and Operations Management, New Age
International Ltd, 2nd edition, 2008
3. Pekar, J.P., Total Quality Management : Guiding Principles for Applications, American
Society for Testing and Materials, 1995
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Prepared By:
Engr. CHRISTIAN P. ENOVAL Dr. BEN B. ANDRES

ECE Faculty ECE Faculty
Recommending Approval: Approved:
Engr. GEOFFREY T. SALVADOR Dr. REMEDIOS G. ADO

ECE Chairperson Dean, College of Engineering
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Table of Contents Page
Basic concepts and foundations of total quality management 6

Activities / Assessment 20
Key steps in the control of quality 20

TQM tools and the improvement cycle 30

Conformance and non-conformance to quality standards 56

Quality organization within an organization 68

Control of quality records 79

Internal quality audits 90

Quality and business process re-engineering 98

Training for total quality management 106

TQM application to electronics engineering fields 115

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TOPIC 1: BASIC CONCEPTS AND FOUNDATIONS OF TOTAL

QUALITY MANAGEMENT
Overview:
In manufacturing, a measure of excellence or a state of being free from defects,

deficiencies and significant variations. It is brought about by strict and consistent commitment to
certain standards that achieve uniformity of a product in order to satisfy specific customer or user
requirements. ISO 8402-1986 standard defines quality as "the totality of features and
characteristics of a product or service that bears its ability to satisfy stated or implied needs." If
an automobile company finds a defect in one of their cars and makes a product recall, customer
reliability and therefore production will decrease because trust will be lost in the car's quality.
Quality of something can be determined by comparing a set of inherent characteristic with

a set of requirements. If those inherent characteristics meet all requirements, high or excellent
quality is achieved. If those characteristics do not meet all requirements, a low or poor level of
quality is achieved.
Learning Objectives:
• Elaborate the Components of quality
• Explain the TQM approach
• Explore about Innovation, design and improvement
• Product quality characteristics and service quality characteristics
• Quality parameters and specific dimensions of quality
Course Materials:
I. WHAT IS QUALITY?
“getting what you pay for” – Student

“a degree or level of excellence.” - Oxford American Dictionary
“A subjective term for which each person has his or her own definition. “ - American Society for
Quality (ASQ)
In technical usage:
(1) The characteristics of a product or service that bear on its ability to satisfy stated or implied
needs
(2) A product or service free of deficiencies.
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II. QUALITY FROM THE CUSTOMER’S PERSPECTIVE
• The consumer is the most important part of the production line. Quality should be aimed
at the needs of the consumer, present and future.
• Since customers have different product needs, they will have different quality
expectations. This results in a commonly used definition of quality as a service’s or
product’s fitness for its intended use, or fitness for use; how well does it do what the
customer or user thinks it is supposed to do and wants it to do?
• Quality of design: involves designing quality characteristics into a product or service.
III. DIMENSIONS OF QUALITY FOR MANUFACTURED PRODUCTS
1. Performance: The basic operating characteristics of a product

2. Features: The “extra” items added to the basic features
3. Reliability: The probability that a product will operate properly within an expected time frame
4. Conformance: The degree to which a product meets preestablished standards.
5. Durability: How long the product lasts; its life span before replacement.
6. Serviceability: The ease of getting repairs, the speed of repairs, and the courtesy and
competence of the repair person.
7. Aesthetics: How a product looks, feels, sounds, smells, or tastes.
8. Safety: Assurance that the customer will not suffer injury or harm from a product; an
especially important consideration for automobiles.
9. Other perceptions: Subjective perceptions based on brand name, advertising.
IV. DIMENSIONS OF QUALITY FOR SERVICES
1. Time and timeliness: How long must a customer wait for service, and is it completed on time?
2. Completeness: Is everything the customer asked for provided?
3. Courtesy: How are customers treated by employees?
4. Consistency: Is the same level of service provided to each customer each time?
5. Accessibility and convenience: How easy is it to obtain the service?
6. Accuracy: Is the service performed right every time
7. Responsiveness: How well does the company react to unusual situations, which can happen
frequently in a service company?
V. QUALITY FROM THE PRODUCER’S PERSPECTIVE
Product or service design results in design specifications that should achieve the desired
quality. However, once the product design has been determined, the producer perceives quality
to be how effectively the production process is able to conform to the specifications required by
the design referred to as the quality of conformance. What this means is quality during production
focuses on making sure that the product meets the specifications required by the design.
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Achieving quality of conformance involves design, materials and equipment, training, supervision,
and control.
An important consideration from the customer’s perspective of product quality is product

or service price. From the producer’s perspective, an important consideration is achieving quality
of conformance at an acceptable cost. Product cost is also an important design specification. If
products or services cannot be produced at a cost that results in a competitive price, then the final
product will not have acceptable value—the price is more than the consumer is willing to pay
given the product’s quality characteristics. Thus, the quality characteristics included in the product
design must be balanced against production costs.
VI. FINAL PERSPECTIVE ON QUALITY
a. Quality management: It is a method for ensuring that all the activities necessary to design,
develop and implement a product or service are effective and efficient with respect to the system
and its performance.
b. Quality Improvement: W. Edwards Deming is best known for his management philosophy
establishing quality, productivity, and competitive position. He has formulated 14 points of
attention for managers, some of these points are more appropriate for service management:
• Break down barriers between departments;
• Management should learn their responsibilities, and take on leadership;
• Improve constantly;
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• Institute a programme of education and self-improvement.
The following diagram is the Shewhart cycle (PDCA) for quality improvement, made
popular by Deming.
Shewhart Cycle
The philosophy is to keep improving the quality of an organization. It is defined by four keys:
• Plan: Design or revise business process components to improve results
• Do: Implement the plan and measure its performance
• Check: Assess the measurements and report the results to decision makers
• Act: Decide on changes needed to improve the process
The consolidation phase enables the organization to take stock of what has been taking place
and to ensure made to processes that require documentation (both to allow processes to be
repeatable and to facilitate recognition of the achievement of some form of quality standard).
c. Quality Assurance: It is part of quality management focused on providing confidence that

quality requirement will be fulfilled.
Productions quality starts with process capable of producing to design Specification and
continuous with an inspection program arises if standards are being met. As said earlier the initial
deviation concerning specification is based on precision sought by customers and accuracy
attainable by production facilities. Given a process capable of obtaining the required precision
unacceptable variations still occurs. Bluent tools, misalignment due to wear and tear of machinery,
workers unless they can contribute to inferior output from a process inherently capable of
acceptable quality. Coordinator controlled activities to prevent this and ensuring what customer
wants they get.
Goal of quality assurance

▪ Provide management with the data necessary to be informed about product quality.
▪ Make confidence and be sure that product quality is meeting.
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d. Quality Inspection: The single act most costly associated with quality control in inspection.
In addition to maintaining quality inspectors provide information by which the performance of
sorters, machines, departments and plans can be evaluated.
e. Cost of Quality
▪ Prevention costs ▪ Appraisal costs

Quality planning ◼ In-process and inter-processinspection
Formal Technical Reviews
Test equipment ◼ Equipment calibration andmaintenance
Training ◼ Testing
▪ Failure costs
Internal failure costs ▪ External Failure costs
Rework ◼ Complaint resolution
Repair ◼ Product return andreplacement
Failure mode analysis
◼ Help line support
f. Quality Standards ◼ Warranty work
The International Organization for Standardization (ISO) created the Quality Management
System (QMS) standards in 1987. These were the ISO 9000:1987 series of standards comprising
ISO 9001:1987, ISO 9002:1987 and ISO 9003:1987; which were applicable in different types of
industries, based on the type of activity: designing, production or service delivery. The standards
have been regularly reviewed every few years by the International Organization for
Standardization. The version in 1994 and was called the ISO 9000:1994 series; comprising of the
ISO 9001:1994, 9002:1994 and 9003:1994 versions. The last revision was in the year 2000 and
the series was called ISO 9000:2000 series. However the ISO 9002 and 9003 standards were
integrated and one single certifiable standard was created under ISO 9001:2000. Since
December 2003, ISO 9002 and 9003 standards are not valid, and the organizations previously
holding these standards need to do a transition from the old to the new standards. The ISO
9004:2000 document gives guidelines for performance improvement over and above the basic
standard (i.e. ISO 9001:2000).
The Quality Management System standards created by ISO are meant to certify the
processes and the system of an organization and not the product or service itself. ISO 9000
standards do not certify the quality of the product or service.
Recently the International Organization released a new standard, ISO 22000, meant for
the food industry. This standard covers the values and principles of ISO 9000 and the HACCP
standards. It gives one single integrated standard for the food industry and is expected to become
more popular in the coming years in such industry. The most elaborated and accepted concept
of quality management is the model of the EFQM Excellence Model.
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g. Process control: Process control is a statistics and engineering discipline that deals with
architectures, mechanisms, and algorithms for controlling the output of a specific process. See
also control theory.
A commonly used control device called a ‘’’programmable logic controller’’, or a PLC, is

used to read a set of digital and analog inputs, apply a set of logic statements, and generate a set
of analog and digital outputs. Using the example in the previous paragraph, the room temperature
would be an input to the PLC. The logical statements would compare the set point to the input
temperature and determine whether more or less heating was necessary to keep the temperature
constant. A PLC output would then either open or close the hot water valve, an incremental
amount, depending on whether more or less hot water was needed. Larger more complex
systems can be controlled by a Distributed Control System (DCS) or SCADA system.
In practice, process control systems can be characterized as one or more of the following forms:
• Discrete – Found in many manufacturing, motion and packaging applications. Robotic
assembly, such as that found in automotive production, can be characterized as discrete
process control. Most discrete manufacturing involves the production of discrete pieces of
product, such as metal stamping.
• Batch – Some applications require that specific quantities of raw materials be combined
in specific ways for particular durations to produce an intermediate or end result. One
example is the production of adhesives and glues, which normally require the mixing of
raw materials in a heated vessel for a period of time to form a quantity of end product.
Other important examples are the production of food, beverages and medicine. Batch
processes are generally used to produce a relatively low to intermediate quantity of
product per year (a few pounds to millions of pounds).
• Continuous – Often, a physical system is represented though variables that are smooth
and uninterrupted in time. The control of the water temperature in a heating jacket, for
example, is an example of continuous process control. Some important continuous
processes are the production of fuels, chemicals and plastics. Continuous processes, in
manufacturing, are used to produce very large quantities of product per year (millions to
billions of pounds).
Applications having elements of discrete, batch and continuous process control are often
called hybrid applications.
h. Quality circle: A quality circle is a volunteer group composed of workers who meet together
to discuss workplace improvement, and make presentations to management with their ideas.
Typical topics are improving safety, improving product design, and improvement in manufacturing
process. Quality circles have the advantage of continuity; the circle remains intact from project to
project.
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VII. The Determinants of Quality
The degree to which a product or service successfully satisfying its intended purpose has four
primary determinants.
1) Quality of design
2) How well it confirms to the design
3) Ease of use
4) Service after delivery
VIII. Quality of design
Quality of design refers to the intentions of designers to include or exclude certain features
in a product or service (eg: different automotives with different size appearance, fuel economy,
comfort, material used etc).
These differences reflect choices made by designers that determines the quality of design.
There design decisions take into account customer wants, production or service capabilities,
safety, and liability cost and similar other considerations. Designers may work closely with
marketing and operations department. A poor design can result in difficulties in production or
service. For example, materials might be difficult to obtain specifications to meet, procedure
difficult to follow, similarly a superior design usually cannot offset the workmanship.
➢ Quality of Conformance
Refers to the degree to which goods and services conform (ie to achieve) the intent of
designers. This is affected by factors such as the capability of equipments, skills, training,
taking prompt corrective action etc. (That is the reason we want designers to work in close
coordination with manufacturing and inspection department during pilot job and procedures
for manufacture developed accordingly.
➢ Ease of Use
The determinants of quality does not stop once the product or service has been sold. Ease of
use and user instructions are important. They increase the chances but do not guarantee, that
the product will be used for its intended purposes and in such a way that it will continue to
function properly and safely. (ie user misused case)
Much of the same can be applied to services also. Customers, patients, clients must be clearly
informed. Much of the instructions takes the form of printed instructions, labels and what to
do if something goes wrong.
➢ Service after delivery

For a variety of reasons products do not always perform as expected and services do not
always yield the desired results. Through recall adjustment replacement, buyback etc this
situation is remedied.
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Quality of care should be defined in light of both technical standards and patients'
expectations. While no single definition of health service quality applies in all situations, the
following common definitions are helpful guides:
❖ Technical performance
❖ Access to services
❖ Effectiveness of care
❖ Efficiency of service delivery
❖ Interpersonal relations
❖ Continuity of services
❖ Safety
❖ Physical infrastructure and comfort
❖ Choice
IX. SIX-SIGMA
6-Sigma refers to a quality improvement and business strategy concept started by

Motorola in the United States in 1987. In statistical terms, 6-Sigma is the abbreviated form of 6
standard deviations from the mean, which mathematically translates to about 2 defects per
billion. Thus, strictly speaking, your process is said to have achieved 6-sigma if it is producing no
more than 2 defects per billion parts produced.
No company is probably nearly perfect enough to achieve this quality level. Consequently,
the term 6-Sigma in the industry has somehow taken on the equivalent defect rate of 3.4 ppm,
which in reality corresponds to roughly 4.5 sigmas. Thus, in the industry today, a person speaking
of 6-sigma is most likely referring to a quality level equivalent to 3.4 defects per million.
Regardless of how one wishes to use the term 6-sigma, though, it is apparent that its purpose
when its concept was first incepted is to make processes as consistent as possible in order to
reduce the defect rates of their outputs. Consistency of meeting customer specifications as well
as the probability of meeting them consistently in the future is the essence of 6-sigma.
6-Sigma has evolved into a continuous, disciplined, and structured process of improving
operations to make products that are consistently meeting customer requirements. In effect, 6-
Sigma no longer simply means excellent finished products, but more importantly, excellent
processes, services, and administration. When Motorola started 6-Sigma in the 80's, it was
applied to repetitive manufacturing processes. Presently, however, the use of 6-Sigma is well-
established in almost all aspects of doing business in a wide range of industries. 6-Sigma
encourages leanness, simplicity, and doing things right the first time, so that wastes and
corresponding costs are avoided. Statistics-based problem solving, results-orientation, and
quantifiable top and bottom-line returns are also ingredients of 6-Sigma. Lastly, 6-Sigma is driven
by the voice of the customer.
X. ISO 14000
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The ISO 14000environmental management standards exist to help organizations

minimize how their operations negatively affect the environment (cause adverse changes to air,
water, or land), comply with applicable laws, regulations, and other environmentally oriented
requirements, and continually improve on the above.
ISO 14000 is similar to ISO 9000quality management in that both pertain to the process
(the comprehensive outcome of how a product is produced) rather than to the product itself. As
with ISO 9000, certification is performed by third-party organizations rather than being awarded
by ISO directly. The ISO 19011 audit standard applies when auditing for both 9000 and 14000
compliance at once.
➢ Standards
The material included in this family of specifications is very broad. The major parts of ISO 14000
are:
• ISO 14001 is the standard against which organizations are assessed. ISO 14001 is
generic and flexible enough to apply to any organization producing any product or service
anywhere in the world.
• ISO 14004 is a guidance document that explains the 14001 requirements in more detail.
These present a structured approach to setting environmental objectives and targets and
to establishing and monitoring operational controls.
These are further explicated by the following:
• ISO 14040 discusses pre-production planning and environment goal setting.
• ISO 14020 covers labels and declarations.
• ISO 14030 discusses post-production environmental assessment.
• ISO 14062 discusses making improvements to environmental impact goals.
• ISO 14063 is an addendum to 14020, discussing further communications on
environmental impact.
• ISO 19011 which specifies one audit protocol for both 14000 and 9000 series standards
together. This replaces ISO 14011 meta-evaluation—how to tell if your intended regulatory
tools worked. 19011 is now the only recommended way to determine this.
• ISO 14001 is an internationally accepted specification for an environmental management
system. It specifies requirements for establishing an environmental policy, determining
environmental aspects and impacts of products/activities/services, planning
environmental objectives and measurable targets, implementation and operation of
programs to meet objectives and targets, checking and corrective action, and
management review.
XI. ISO 9000
ISO 9000 is a family of standards for quality management systems. ISO 9000 is
maintained by ISO, the International Organization for Standardization and is administered by
accreditation and certification bodies. For a manufacturer, some of the requirements in ISO 9001
(which is one of the standards in the ISO 9000 family) would include:
• A set of procedures that cover all key processes in the business;
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• Monitoring manufacturing processes to ensure they are producing quality product;

• Keeping proper records;
• Checking outgoing product for defects, with appropriate corrective action where
necessary; and
• Regularly reviewing individual processes and the quality system itself for effectiveness.
A company or organization that has been independently audited and certified to be in

conformance with ISO 9001 may publicly state that it is "ISO 9001 certified" or "ISO 9001
registered." Certification to an ISO 9000 standard does not guarantee the compliance (and
therefore the quality) of end products and services; rather, it certifies that consistent business
processes are being applied.
Although the standards originated in manufacturing, they are now employed across a wide
range of other types of organizations, including colleges and universities. A "product", in ISO
vocabulary, can mean a physical object, or services, or software. In fact, according to ISO in 2004,
"service sectors now account by far for the highest number of ISO 9001:2000 certificates - about
31% of the total" - source: the ISO Survey 2004
Advantages
1) Create a more efficient, effective operation
2) Increase customer satisfaction and retention
3) Reduce audits
4) Enhance marketing
5) Improve employee motivation, awareness, and morale
6) Promote international trade
XI. Quality Parameters and Specific Dimensions of Quality
a. Quality Parameters is the standards or expectations that must be met by a certain

product or service provided to the customers.
1. Quality of Design: It is the extent to which the design meets or satisfies the
customer’s needs and expectations, and also the regulatory requirements
2. Quality of Conformance: It is the extent to which the product or service conforms to
the design standard
3. Quality of Use: It is the extent to which the user is able to secure continuity of use of
the product or service (safe, easy to use, reliable, low cost)
b. Service Quality Dimension is the characteristics that a service must possess to satisfy
the needs of the customers
1. Tangible: It refers to the cleanliness of the facility where the product is being
manufactured
2. Time and Timeliness: It refers to the customer’s waiting time or on-time completion
3. Completeness: It refers to the deliverance of complete service to the customer
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4. Courtesy: It refers to the treatment of employees to their customers (Politeness,

respect, consideration, friendliness)
5. Accessibility and Convenience: It refers to the ease of obtaining service
6. Accuracy: It refers to the correct and precise performance of an employee
7. Responsiveness: It refers to the reaction to special circumstances or requests
c. Product Quality Dimension refers to the characteristics that a product should possess
in order to satisfy the needs of the people
1. Performance: It refers to how well the product performs when in use

2. Features: It refers to the characteristics of a product that supplements and sometimes
enhances its basic functions (internet on smart phones, eraser of a pencil)
3. Reliability: It refers to the probability that a product will fail within a specified period of
time
4. Conformance: It refers to the degree to which the design or operating characteristics
of a product meet pre-established standards
5. Durability: It refers to the amount of use a product can sustain before it physically
deteriorates to the point where replacement is preferable or repair
6. Serviceability: It refers to the speed, courtesy, competence and ease of repair for a
certain product
7. Aesthetics: It refers to the looks, feel, taste, smell and sound of a product
8. Perceived Quality: It refers to impact of brand name, company image and advertising
XII. Total Quality Management
a. Quality
➢ In manufacturing, a measure of excellence or a state of
being free from defects, deficiencies and significant
variations.
➢ It is brought about by strict and consistent commitment
to certain standards that achieve uniformity of a product
in order to satisfy specific customer or user
requirements.
b.Quality Management
➢ Ensures that an organization, product or service is consistent.
➢ Is focused not only on product and service quality, but also on the means to achieve it.
➢ Uses quality assurance and control of processes as well as products to achieve more
consistent quality.
➢ Meeting specifications at the lowest possible cost as well as delivering the value that a
customer derives from a product.
c. Components of Quality Management

➢ Quality Planning
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❖ The first step of quality management is planning. You need to take the time to
identify your goals and what you want your baseline to be. You should determine
what your quality standards are, the requirements necessary to meet these
standards, and what procedures will be used to check that these criteria are being
met. In this planning stage, you will want to consider:
▪ What your stakeholder’s expectations and priorities are, if applicable
▪ What your company’s definition of success is
▪ What legal standards or requirements are in place that must be abided by
▪ Who will handle each role in the quality management process (supervision,
testing, etc.)
▪ How often processes will be evaluated for improvement
➢ Quality Assurance
❖ While quality control involves inspecting the actual products or services in the field,
quality assurance is reviewing the delivery process of services or the quality
management manufacturing of goods. By inspecting your goods or services at the
source, you can catch mistakes before they reach the customer. You can also fine
tune your processes to prevent errors in the future. When reviewing your product
or service during this stage of quality control management, you will want to follow
these steps:
▪ Confirm that everything is operating as it was agreed upon during the
quality planning stage
▪ Measure how effective your pre-determined processes are and confirm that
all compliance needs are being met
▪ Take note of any lessons learned
▪ Identify areas where there is an opportunity for a smoother process
❖ To be effective, quality assurance must be completed regularly through
independent audits. For the best results, have the audit completed by a third-party
that is not financially or emotionally invested in the outcome.
➢ Quality Control
❖ Once you have a plan in place, quality control comes into play. This is the process
of physically inspecting and testing what you laid out in the planning stage to make
sure it is obtainable. You need to confirm that all the standards you have put into
place are met, and you need to identify any mishaps or errors that need to be
corrected. The sooner you can catch these errors, the better. As such, you should
be paying attention to all aspects of the product, including both the materials used
and the process of putting them together.
❖ Once the inspection data has been collected, it should be displayed in a way that
makes it easy to analyze. You can create histograms, run charts, or cause and
effect displays, and then easily share them through your document management
software to make sure everyone has access to them.
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➢ Quality Improvement
❖ Finally, after completing the quality control process, you need to thoroughly review
your findings and come up with a way to improve your methods going forward.
Quality control management is fruitless if you are not willing to make changes when
they are necessary. The desire for continual improvement is the goal for every
successful company. So, gather all your data, re-evaluate both the processes and
the product—always keeping compliance in mind—and then begin the quality
control management process again. With each cycle, you will end up with a better
product, happier customers, and more profit in your pocket.
d. The TQM Approach

• Total Quality Management is a management approach that originated in the 1950s
and has steadily become more popular since the early 1980s.
• Is a description of the culture, attitude and organization of a company that strives to
provide customers with products and services that satisfy their needs.
• The culture requires quality in all aspects of the company’s operations, with processes
being done right the first time and defects and waste eradicated from operations.
• Is a method by which management and employees can become involved in the
continuous improvement of the production of goods and services.
• It is a combination of quality and management tools aimed at increasing business and
reducing losses due to wasteful practices.
e. Generic Strategy Model for Implementing TQM Systems

• Top management learns about and decides to commit to TQM. TQM is identified as
one of the organization’s strategies.
• The organization assesses current culture, customer satisfaction, and quality
management systems.
• Top management identifies core values and principles to be used, and communicates
them.
• A TQM master plan is developed on the basis of steps 1, 2, and 3.
• The organization identifies and prioritizes customer demands and aligns products and
services to meet those demands.
• Management maps the critical processes through which the organization meets its
customers’ needs.
• Management oversees the formation of teams for process improvement efforts.
• The momentum of the TQM effort is managed by the steering committee.
• Managers contribute individually to the effort through hoshin planning, training,
coaching, or other methods.
• Daily process management and standardization take place.
• Progress is evaluated and the plan is revised as needed.
• Constant employee awareness and feedback on status are provided and a
reward/recognition process is established.
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f. Statistical Process Control

• Is a method of quality control which employs statistical methods to monitor and control
a process.
• Helps to ensure that the process operates efficiently, producing more specification-
conforming products with less waste (rework or scrap)
• Key tools used in SPC include run charts, control charts, a focus on continuous
improvement, and the design of experiments
• SPC must be practiced in 2 phases:
o First phase is the initial establishment of the process.
o Second phase is the regular production use of the process.
▪ a decision of the period to be examined must be made, depending upon the change
in 5M&E conditions (Man, Machine, Material, Method, Movement, Environment) and
wear rate of parts used in the manufacturing process (machine parts, jigs, and fixtures)
g. Taguchi Methods
• Are statistical methods, or sometimes called robust design methods developed by
Genichi Taguchi
• Helps to improve the quality of manufactured goods, and more recently also applied
to engineering,biotechnology, marketing and advertising.
• Taguchi's work includes three principal contributions to statistics:
o A specific loss function
o The philosophy of off-line quality control; and
o Innovations in the design of experiments.
h. Quality Function Deployment

• Is a method developed in Japan beginning in 1966 to help transform the voice of the
customer into engineering characteristics for a product.
• Yoji Akao, the original developer, described QFD as a "method to transform qualitative
user demands into quantitative parameters, to deploy the functions forming quality,
and to deploy methods for achieving the design quality into subsystems and
component parts, and ultimately to specific elements of the manufacturing process.“
• QFD is applied Ain a wide variety of services, consumer products, and military needs.
Supplemental Information:
▪ http://www.businessdictionary.com/definition/quality.html
▪ http://ispatguru.com/components-of-product-quality-management/
▪ https://info.docxellent.com/blog/main-components-quality-management
▪ https://www.parallelprojecttraining.com/forums/topic/describe-the-four-main-
components-of-a-quality-management-process/
▪ https://www.isixsigma.com/methodology/total-quality-management-tqm/introduction-and-
implementation-total-quality-management-tqm/
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▪ http://asq.org/learn-about-quality/total-quality-managezent/overview/implementing-
tqm.html
▪ https://www.brighthubpm.com/monitoring-projects/73621-three-different-approaches-in-
total-quality-management/
▪ https://managementhelp.org/quality/total-quality-management.htm
▪ http://asq.org/learn-about-quality/total-quality-management/overview/overview.html
▪ https://www.thebalancesmb.com/total-quality-management-tqm-2221200
▪ https://en.wikipedia.org/wiki/Quality_management
▪ https://www.linkedin.com/pulse/article-identifying-appropriate-quality-parameters-
products-moosa
▪ www.vodppl.upm.edu.my/uploads/docs/OM2E_Chapter09.ppt
Activities/Assessments:
:
1-4.) Enumerate the Components of Quality Management
5.) It is a measure of excellence or a state of being free from defects, deficiencies and significant
variations.
6.) It is a method developed in Japan beginning in 1966 to help transform the voice of the
customer into engineering characteristics for a product.
7.) What helps to ensure that the process operates efficiently, producing more specification-
conforming products with less waste (rework or scrap)
8.) It is a group of workers who do the same or similar work, who meet regularly to identify, analyze
and solve work-related problems
9.) What helps to improve the quality of manufactured goods, and more recently also applied to
engineering,biotechnology, marketing and advertising.
10.) What are the keywords in the picture in quality improvement?
TOPIC 2: CONTROL OF QUALITY

Overview:
Business success may simply be the extent to which your organization can produce a
higher-quality product or service than your competitors are able to do at a competitive price. When
quality is the key to a company’s success, quality management systems allow organizations to
keep up with and meet current quality levels, meet the consumer’s requirement for quality, retain
employees through competitive compensation programs, and keep up with the latest technology
• Elaborate and Adapt Planning for quality
• Determine Process Flowchart

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• Evaluate Just-In-Time (JIT) Management
• Determine System Design and Contents
• Differentiate System Documentation, Implementation and Assessments
Course Materials:
I. Planning For Quality
In the systematic planning or detailed examination of any process, whether that be an

administrative service delivery, manufacturing, or managerial activity, it is necessary to record the
series of events and activities, stages and decisions, in a form that can be easily understood and
communicated to all. If improvements are to be made, the facts relating to the existing method
must be recorded first. The statements defining the process should lead to its understanding and
will provide the basis of any critical examination necessary for the development of improvements.
It is essential therefore that the descriptions of processes are accurate, clear and concise.
The usual method of recording facts is to write them down, but this is not suitable for
recording the complicated processes that exist in any organization, particularly when an exact
record is required of a long process, and its written description would cover several pages
requiring careful study to elicit every detail. To overcome this difficulty, certain methods of
recording have been developed, and the most powerful of these is flowcharting. This method of
describing a process owes much to computer programming, where the technique is used to
arrange the sequence of steps required for the operation of the program. It has a much wider
application, however, than computing.
II. Process Flowchart
a. What is a process flowchart?
A flowchart is a picture of the separate steps of a process in sequential order. It is a

common process analysis tool and one of the seven basic quality tools.
Elements that may be included in a flowchart are: a sequence of actions, materials or
services entering or leaving the process (inputs and outputs), decisions that must be made,
people who become involved, time involved at each step and/or process measurements.
A flowchart is a generic tool that can be adapted for a wide variety of purposes, and can
be used to describe various processes, such as. a manufacturing process, an administrative or
service process, or a project plan.
b. When to use a flowchart?

• To develop understanding of how a process is done.
• To study a process for improvement.
• To communicate to others how a process is done
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• When better communication is needed between people involved with the same process.
• To document a process.
• When planning a project
c. Flowchart Basic Procedures
1) Discuss and decide on the boundaries of your process: Where or when does the process
start? Where or when does it end?
2) Discuss and decide on the level of detail to be included in the diagram.
3) Brainstorm the activities that take place. Write each on a card or sticky note.
4) Arrange the activities in proper sequence.
5) When all activities are included, and everyone agrees that the sequence is correct, draw
arrows to show the flow of the process.
6) Review the flowchart with others involved in the process (workers, supervisors, suppliers,
customers) to see if they agree that the process is drawn accurately.
d. Commonly Used Symbols in Detailed Flowcharts
➢ One step in the process; the step is written inside the box. Usually, only
one arrow goes out of the
➢ Direction of flow from one step or decision to another
➢ Decision based on a question. The question is written in the diamond.

More than one arrow goes outof the diamond, each one showing the
direction the process takes for a given answer to the question. (Often the
answers are “ yes” and “ no.”)
➢ Delay or wait
➢ Link to another page or another flowchart. The same symbol on the other
page indicates that the flow continues there.
➢ Input or Output
➢ Document
➢ Alternate symbols for Start and End points

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Example of Flowcharting in Use — Improving a travel Procedure
The flowchart for the improved process is

shown above. The proposal reduced the total
administrative effort per travel request (or per travel
arrangement, because the travel request was
eliminated) from 23 minutes to 5 minutes.
It is surprisingly difficult to draw flowcharts for

even the simplest processes, particularly managerial
ones, and following the first attempt it is useful to ask whether:
• The facts have been correctly recorded.
• Any oversimplifying assumptions have been made.
• All the factors concerning the process have been recorded.
III. JUST-IN-TIME (JIT) Management
JIT, like many modern management concepts, is credited to the Japanese, who developed
and began to use it in the late 1950s. It took approximately 20 years for JIT methods to reach
Western hard goods industries and a further ten years before businesses realized the generality
of the concepts.
JIT is a program directed towards ensuring that the right quantities are purchased or
produced at the right time, and that there is no waste.
It is essentially:
• A series of operating concepts that allows systematic identification of operational
problems.
• A series of technology-based tools for correcting problems following their identification.
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An important outcome of JIT is a disciplined program for improving productivity and

reducing waste. This program leads to cost-effective production or operation and delivery of only
the required goods or services, in the correct quantity, at the right time and place. This is achieved
with the minimum amount of resources – facilities, equipment, materials, and people. The
successful operation of JIT is dependent upon a balance between the suppliers’ flexibility and the
users’ stability, and of course requires total management and employee commitment and
teamwork.
a. Aims of JIT
The fundamental aims of JIT are to produce or operate to meet the requirements of the
customer exactly, without waste, immediately on demand. In some manufacturing companies JIT
has been introduced as ‘continuous flow production’, which describes very well the objective of
achieving conversion of purchased material or service receipt to delivery, i.e. from supplier to
customer. If this extends into the supplier and customer chains, all operating with JIT a perfectly
continuous flow of material, information or service will be achieved. JIT may be used in non-
manufacturing, in administration areas, for example, by using external standards as reference
points.
The JIT concepts identify operational problems by tracking the following:

• Material movements – when material stops, diverts or turns backwards, these always
correlate with an aberration in the ‘process’.
• Material accumulations – these are there as a buffer for problems, excessive variability,
etc., like water covering up ‘rocks’.
• Process flexibility – an absolute necessity for flexible operation and design.
• Value-added efforts – where much of what is done does not add value, the customer will
not pay for it.
b. Operation of JIT
The tools to carry out the monitoring required are familiar quality and operations
management methods, such as:
• Flowcharting.
• Process study and analysis.
• Preventive maintenance.
• Plant layout methods.
• Standardized design.
• Statistical process control.
• Value analysis and value engineering.
But some techniques are more directly associated with the operation of JIT systems:
• Batch or lot size reduction.
• Flexible workforce.
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• Kanban or cards with material visibility.

• Mistake-proofing.
• Pull-scheduling.
• Set-up time reduction.
• Standardized containers.
There is clear evidence that JIT has been an important component of business success
in the Far East and that it is used by Japanese companies operating in the West. Many European
and American companies that have adopted JIT have made spectacular improvements in
performance. These include:
• Increased flexibility (particularly of the workforce).
• Reduction in stock and work-in-progress, and the space it occupies.
• Simplification of products and processes.
IV. System Design and Contents
a. Quality Management System
The International Organization for Standardization (ISO) 9001:2000 series is a standard

for methods by which a system can be implemented to ensure that the specified customer
requirements for a certain product or services are met. A quality system may be defined as an
assembly of components, such as the management responsibilities, process, and resources.
The activities are generally composed of processing, communicating, and controlling.

These activities should be documented in the form of a quality manual.The system should follow
the “Plan, Do, Check, Act” cycle, through documentation, implementation, audit and review.
There are a lot of Quality Management Systems since there are different products and
services offered by any human, firm, or organization. Different profession caters to different
audiences through different products given or services rendered, which then requires a certain
Quality Management System that would fit in line with their work. I would be discussing on a
Process-Based Quality Management System.
Product
Realization
Management
Resource
Analysis and
Management
Improvement
Management
Responsibility
Figure 1. Process-Based Quality Management System

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b. Product Realization
Contains of all the product-related tools for a Process-Based Quality Management

System. It includes the raw materials of a product or service, and the desired outcome and quality
of the said product or service.
1. Customer-Related Processes. Pertains to the desired outcome of the customer.

Includes what features they needed or wanted to an offered service or product.
2. Design and Development. The team assigned to one’s esign and development of a
product or service, must now conform to the needs of the customer. Each needs of the
customer must be satisfied in order to produce a quality product or service.
3. Purchasing. It refers to buying of the raw materials in order to produce such product or
services. It is the procurement method of one’s company on its raw materials. One must
know or trust a seller to ensure that the goods delivered are conformed within your
specifications.
4. Production and Service Delivery Processes. The manufacturing process of the product
is included here. On how the product is presented and delivered is also a factor, in order
to produce or serve such quality.
5. Monitoring and Measurement Devices. Allows the company to ensure all products
produced are equal in all ways, through using monitoring and measurement devices.
c. Measurement, Analysis and Improvement
This section of the summary pertains to the inside processes of the manufacturing
industry. A good QMS means that there is some room for improvement.
1. Measurement and Monitoring. This pertains to the Customer Satisfaction, Employee

Satisfaction, Constant Surveying in order to monitor if the QMS being implemented now
is working just fine. It can also serve as a basis for “Employee of the Month” and serve as
a motivation for employees to give their best in every way.
2. Control of Non-conforming Products. It refers to whether to correct and adjust,

reassign; and rejection of Non-conforming resources and raw materials. This is to control
the raw materials before using and incorporating them into the product.
3. Analysis of Data. The gathered results from the Measurement and Monitoring under this
section shall be subject to analyzation, identify the strengths, weaknesses, and
opportunities. This is to formulate the solution to aim for a better result, thus improving it.
4. Improvement. It eliminates or reduces the identified weakness from the analysis of data.
It may include controlling what gets in and out of your manufacturing industry.
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d. Management Responsibility
This includes the responsibilities and functions of the managerial department of your
industry. This includes how the Human resources managers accept or conduct interview to people
who want to apply for a job offered.
1. Management Review. It refers to recalling the results and analyzed data. It refers to
reviewing the current QMS being implemented and then making changes for its
improvement.
2. Quality Manual. It refers to the journal which contains all the rules and guidelines for a
proper procedure of all the processes happening inside the company. All employees
should have read its entirety and may consult it from time to time.
3. Quality Policy. Define and publish its quality policy, which forms one element of the
corporate policy. It sets the rules and standards to be complied by the employees.
4. Customer Needs. Focus on customer needs and specify them as defined requirements
for the organization. Basic standard to be followed and complied. All customer needs must
be satisfied, and all managerial staff shall make sure of it.
5. Control of Documents and Records. Documentation needs to be legible, revision

controlled, readily identifiable and maintained in an orderly manner. Records demonstrate
conformance to requirements and effective operation of the QMS.
e. Resource Management
Refers to the human and raw materials that completes the vital part of the company.
1. Infrastructure and Work Environment. The work environment must be safe, orderly and
clean. A clean environment reflects as to what the people and the whole company looks
like to its customers.
2. Human Resources. This refers to the working labor force of the company. It is the most
vital part of the company. They should all be taken care off with great benefits presented
by the company to them. They should be safe and given enough rests and breaks.
3. Provision of Resources. It refers to the quality of the resources. The raw materials must
be already conformed with the set standards to avoid tampering or make changes which
will have additional cost to the whole manufacturing process.
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V. System Documentation, Implementation and Assessments
a. System Documentation
A quality system is the method used to ensure that the quality of a product or service is
maintained in the system which includes system documentation. The system documentation can
be viewed as a hierarchy containing four levels.
Figure 1: The Documentation Pyramid
The four levels are Policy, Procedures, Work Instructions or Practices, and Records or proofs.
➢ Policy- This is the first tier of documentation, the policy manual. This is the document that
defines what needs to be done and why is it needed to be done. A quality policy should
be written so it is clear, easy to understand, and precise and practical. Quality intentions
should be short, simple and the definition of the organization’s real quality goals. Another
way to look at policy manual is to think of it like the commandments of the system.
➢ Procedures – The second tier of the documentation is quality procedures. These

procedures define how the specific tasks should be performed; who will perform the task
and when will the task should be done. They must indicate the strategies that will be used
to ensure the quality of the overall system. Procedures must be detailed and every
member of the organization should understand.
➢ Work Instructions – Work instructions are usually department, machine, task, or product
oriented on how a job must be done. A work instruction is the most detailed of the
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hierarchy. A work instruction may be in the form of detailed drawing, recipe, routing sheet,
video or simple a sample for comparison.
The writing of a work instruction is best carried out by the person who is doing the task.
Because this person knows the process and problems encountered in that way he can
write it more specifically and more precisely.
➢ Records – this are a way of documenting that the policies, procedures, and work
instructions have been followed. Records may be form that are filled out, a stamp of
approval on a product, or a signature and date on some type of document, such as routing
sheet. Records are used to provide traceability of actions taken on a specific product or
batch of products. They provide data for corrective actions and a way of recalling products
if needed.
b. System Implementation
TQM Implementation Principle- TQM WILL NOT BE IMPLEMENTED IF AN ORGANIZATION

IS NOT READY FOR TQM. EMPLOYEES NEED TO REALIZE THE NEED FOR CHANGE IN
ORDER TO IMPLEMENT TQM. TQM IMPLEMENTATION SHOULD BE DELAYED UNTIL THE
ORGANIZATION IS IN A STATE IN WHICH TQM IS LIKELY TO SUCCEED.
Implementation Process
1) Assess the organization’s current reality. Relevant preconditions have to do with the
organization’s history, its current needs, precipitating events leading to TQM.
2) If the organization has a track record of effective responsiveness to the environment, and
if it has been able to successfully change the way it operates when needed, TQM will be
easier to implement. An organization should be basically healthy before beginning TQM.
3) A certain level of stress is probably desirable to initiate TQM. People need to feel a need
for a change. A crisis, if it is not too disabling, can also help create a sense of urgency
which can mobilize people to act. After a crisis, a leader may intervene strategically by
articulating a new vision of the future to help the organization deal with it. A plan to
implement TQM may be such a strategic decision.
4) Finally, action vehicles are needed and mechanisms or structures to enable the change
to occur and become institutionalized.
c. System Assessment
System assessments include assessing the overall performance of the company by the
use of the system documentations and system implementation. Assessment is the overall
studying of behavior, performance and success of every individual who worked on the problems
of the company. With assessment the owners will also know what adjustments is needed to be
done and how should they respond to even bigger problems that will come to them.
30
▪ Department of Trade and Industry. (n.d.). Quality Management Systems. Retrieved from
https://www.businessballs.com/dtiresources/quality_management_systems_QMS.pdf
▪ Oakland, J. (2004). Oakland on Quality Management. Elsevier Butterworth-Heinemann.
▪ Quality Management System. (n.d.). Designing a Quality Management System. Retrieved
from http://qualitymanagementsystem.com/total-quality-management/designing-a-
quality-management-system/
▪ Quality Management System. (n.d.). How to Create a Quality Management Plan.
Retrieved from http://qualitymanagementsystem.com/total-quality-management/how-to-
create-a-quality-management-plan/
▪ https://totalqualitymanagement.wordpress.com/2009/02/27/documentation-of-
quality-management-system/
▪ https://www.slideshare.net/ZubairNoorMemon/quality-management-system-
44356883
▪ https://www.nibusinessinfo.co.uk/content/how-implement-quality-management-
system
▪ https://www.isixsigma.com/methodology/total-quality-management-
tqm/introduction-and-implementation-total-quality-management-tqm
1) What is the four system documentation hierarchy? Discuss each..

2) What hierarchy must be presented the most detailed and why?
3) What is the most simple but most important hierarchy and why?
4) What is the process of doing the things in the system documentation? Elaborate each.
5) What is the final step after documentation and implementation and how is it being done?
TOPIC 3: TQM TOOLS AND THE IMPROVEMENT CYCLE
Overview:
In manufacturing, a measure of excellence or a state of being free from defects,

deficiencies and significant variations. It is brought about by strict and consistent commitment to
certain standards that achieve uniformity of a product in order to satisfy specific customer or user
• Discuss the Measurement of Quality
• Determine the Cost of quality

31
• Distinguish between the Tools and techniques for quality improvement
• Explain Statistical process control
• Differentiate the Quality improvement techniques in service industries
• Explore the Specific techniques for design, reliability, maintenance and process
improvement
Course Materials:
I. Measuring Quality
The measurement of Quality, whether Product or Process, requires the collection and
analysis of information, usually stated in terms of measurements and metrics. Measurements are
made primarily to gain control of a project, and therefore be able to manage it. They are also used
to evaluate how close or far we are from the objectives set in the plan in terms of completion,
quality, compliance to requirements, etc.
Metrics are used to attain two goals, knowledge and change (or achievement):
• Knowledge goals: they are expressed by the use of verbs like evaluate, predict, monitor.
You want to better understand your development process. For example, you may want to
assess product quality, obtain data to predict testing effort, monitor test coverage, or track
requirements changes.
• Change or achievement goals: these are expressed by the use of verbs such as increase,
reduce, improve, or achieve. You are usually interested in seeing how things change or
improve over time, from an iteration to another, from a project to another.
Metrics for both goals are used for measuring Process and Product Quality.
All metrics require criteria to identify and to determine the degree or level at which of
acceptable quality is attained. The level of acceptable quality is negotiable and variable, and
needs to be determined and agreed upon early in the development lifecycle For example, in the
early iterations, a high number of application defects are acceptable, but not architectural ones.
In late iterations, only aesthetic defects are acceptable in the application.
The acceptance criteria may be stated in many ways and may include more than one
measure. Common acceptance criteria may include the following measures:
1. Defect counts and / or trends, such as the number of defects identified, fixed, or that
remain open (not fixed).
32
2. Test coverage, such as the percentage of code, or use cases planned or implemented
and executed (by a test). Test coverage is usually used in conjunction with the defect
criteria identified above).
3. Performance, such as a the time required for a specified action (use case, operation, or
other event) to occur. This is criteria is commonly used for Performance testing, Failover
and recovery testing, or other tests in which time criticality is essential.
4. Compliance. This criteria indicates the degree to which an artifact or process activity / step
must meet an agreed upon standard or guideline.
5. Acceptability or satisfaction. This criteria is usually used with subjective measures, such
as usability or aesthetics.
a. Measuring Product Quality
Stating the requirements in a clear, concise, and testable fashion is only part of achieving
product quality. It is also necessary to identify the measures and criteria that will be used to identify
the desired level of quality and determine if it has been achieved. Measures describe the method
used to capture the data used to assess quality, while criteria defines the level or point at which
the product has achieved acceptable (or unacceptable) quality.
Measuring the product quality of an executable artifact is achieved using one or more
measurement techniques, such as
• reviews / walkthroughs
• inspection
• execution
Different metrics are used, dependent upon the nature the quality goal of the measure.
For example, in reviews, walkthroughs, and inspections, the primary goal is to focus on the
function and reliability quality dimensions. Defects, coverage, and compliance are the primary
metrics used when these measurement techniques are used. Execution however, may focus on
function, reliability, or performance. Therefore defects, coverage, and performance are the
primary metrics used. Other measures and metrics will vary based upon the nature of the
requirement.
b. Measuring Process Quality
The measurement of Process Quality is achieved by collecting both knowledge and

achievement measures.
• The degree of adherence to the standards, guidelines, and implementation of an
accepted process.
• Status / state of current process implementation to planned implementation.
• The quality of the artifacts produced (using product quality measures described
above).
Measuring process quality is achieved using one or more measurement techniques, such as:
33
• progress - such as use cases demonstrated or milestones completed

• variance - differences between planned and actual schedules, budgets, staffing
requirements, etc.
• product quality measures and metrics (as described in Measuring Product Quality
section above)
II. Cost of Quality
Cost of quality (COQ) is defined as a methodology that allows an organization to determine

the extent to which its resources are used for activities that prevent poor quality, that appraise the
quality of the organization’s products or services, and that result from internal and external
failures. Having such information allows an organization to determine the potential savings to be
gained by implementing process improvements.
a. What Is Cost of Poor Quality (COPQ)?
Cost of poor quality (COPQ) is defined as the costs associated with providing poor quality
products or services. There are three categories:
1. Appraisal costs are costs incurred to determine the degree of conformance to quality
requirements.
2. Internal failure costs are costs associated with defects found before the customer receives
the product or service.
3. External failure costs are costs associated with defects found after the customer receives
the product or service.
Quality-related activities that incur costs may be divided into prevention costs, appraisal
costs, and internal and external failure costs.
a.1. Appraisal Costs. Appraisal costs are associated with measuring and monitoring
activities related to quality. These costs are associated with the suppliers’ and customers’
evaluation of purchased materials, processes, products, and services to ensure that they conform
to specifications. They could include:
• Verification: Checking of incoming material, process setup, and products against

agreed specifications
• Quality audits: Confirmation that the quality system is functioning correctly
• Supplier rating: Assessment and approval of suppliers of products and services.
a.2. Internal failure costs. Internal failure costs are incurred to remedy defects discovered
before the product or service is delivered to the customer. These costs occur when the results of
work fail to reach design quality standards and are detected before they are transferred to the
customer. They could include:
34
• Waste: Performance of unnecessary work or holding of stock as a result of errors, poor

organization, or communication
• Scrap: Defective product or material that cannot be repaired, used, or sold
• Rework or rectification: Correction of defective material or errors
• Failure analysis: Activity required to establish the causes of internal product or service
failure
a.3. External failure costs. External failure costs are incurred to remedy defects discovered
by customers. These costs occur when products or services that fail to reach design quality
standards are not detected until after transfer to the customer. They could include:
• Repairs and servicing: Of both returned products and those in the field
• Warranty claims: Failed products that are replaced or services that are re-performed
under a guarantee
• Complaints: All work and costs associated with handling and servicing customers’
complaints
• Returns: Handling and investigation of rejected or recalled products, including
transport costs
b. Prevention Costs
Prevention costs are incurred to prevent or avoid quality problems. These costs are
associated with the design, implementation, and maintenance of the quality management system.
They are planned and incurred before actual operation, and they could include:
1. Product or service requirements: Establishment of specifications for incoming materials,

processes, finished products, and services
2. Quality planning: Creation of plans for quality, reliability, operations, production, and
inspection
3. Quality assurance: Creation and maintenance of the quality system
4. Training: Development, preparation, and maintenance of programs
c. Cost of Quality and Organizational Objectives
The costs of doing a quality job, conducting quality improvements, and achieving goals
must be carefully managed so that the long-term effect of quality on the organization is a desirable
one.
These costs must be a true measure of the quality effort, and they are best determined
from an analysis of the costs of quality. Such an analysis provides a method of assessing the
effectiveness of the management of quality and a means of determining problem areas,
opportunities, savings, and action priorities.
35
Cost of quality is also an important communication tool. Philip Crosby demonstrated what
a powerful tool it could be to raise awareness of the importance of quality. He referred to the
measure as the "price of nonconformance" and argued that organizations choose to pay for poor
quality.
Many organizations will have true quality-related costs as high as 15-20% of sales
revenue, some going as high as 40% of total operations. A general rule of thumb is that costs of
poor quality in a thriving company will be about 10-15% of operations. Effective quality
improvement programs can reduce this substantially, thus making a direct contribution to profits.
The quality cost system, once established, should become dynamic and have a positive
impact on the achievement of the organization’s mission, goals, and objectives.
III. Tools and Techniques for Quality Improvement
FDA's quality system regulation (QSR) and ISO 9001 encourage device manufacturers to
incorporate continuous quality improvement processes as a part of their quality systems. While
companies have adopted different methods to control design and manufacturing outcomes, the
intent is always the same: quality improvement.
Hitoshi Kume, a recipient of the 1989 Deming Prize for use of quality principles, defines
problems as "undesirable results of a job." Quality improvement efforts work best when problems
are addressed systematically using a consistent and analytic approach; the methodology
shouldn't change just because the problem changes. Keeping the steps to problem-solving simple
allows workers to learn the process and how to use the tools effectively.
Easy to implement and follow up, the most commonly used and well-known quality
process is the plan/do/check/act (PDCA) cycle (Figure 1). Other processes are a takeoff of this
method, much in the way that computers today are takeoffs of the original IBM system. The PDCA
cycle promotes continuous improvement and should thus be visualized as a spiral instead of a
closed circle.
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Figure 1. The most common process for quality improvement is the plan/do/check/act cycle
outlined above. The cycle promotes continuous improvement and should be thought of as a
spiral, not a circle.
Another popular quality improvement process is the six-step PROFIT model in which the
acronym stands for:
P = Problem definition.
R = Root cause identification and analysis.
O = Optimal solution based on root cause(s).
F = Finalize how the corrective action will be implemented.
I = Implement the plan.
T = Track the effectiveness of the implementation and verify that the desired results are
met.
If the desired results are not met, the cycle is repeated. Both the PDCA and the PROFIT
models can be used for problem solving as well as for continuous quality improvement. In
companies that follow total quality principles, whichever model is chosen should be used
consistently in every department or function in which quality improvement teams are working.
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a. Seven Basic Tools
Once the basic problem-solving or quality improvement process is understood, the

addition of quality tools can make the process proceed more quickly and systematically. Seven
simple tools can be used by any professional to ease the quality improvement process: flowcharts,
check sheets, Pareto diagrams, cause and effect diagrams, histograms, scatter diagrams, and
control charts. (Some books describe a graph instead of a flowchart as one of the seven tools.)
The concept behind the seven basic tools came from Kaoru Ishikawa, a renowned quality
expert from Japan. According to Ishikawa, 95% of quality-related problems can be resolved with
these basic tools. The key to successful problem resolution is the ability to identify the problem,
use the appropriate tools based on the nature of the problem, and communicate the solution
quickly to others. Inexperienced personnel might do best by starting with the Pareto chart and the
cause and effect diagram before tackling the use of the other tools. Those two tools are used
most widely by quality improvement teams.
1. FLOWCHARTS
Flowcharts describe a process in as much detail as possible by graphically displaying the

steps in proper sequence. A good flowchart should show all process steps under analysis by the
quality improvement team, identify critical process points for control, suggest areas for further
improvement, and help explain and solve a problem.
The flowchart in Figure 2 illustrates a simple production process in which parts are
received, inspected, and sent to subassembly operations and painting. After completing this loop,
the parts can be shipped as subassemblies after passing a final test or they can complete a
second cycle consisting of final assembly, inspection and testing, painting, final testing, and
shipping.
Flowcharts can be simple, such as the one featured in Figure 2, or they can be made up
of numerous boxes, symbols, and if/then directional steps. In more complex versions, flowcharts
indicate the process steps in the appropriate sequence, the conditions in those steps, and the
related constraints by using elements such as arrows, yes/no choices, or if/then statements.
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Figure 2. A basic production process flowchart displays several paths a part can travel from the
time it hits the receiving dock to final shipping.
2. CHECK SHEETS
Figure 3. Because it clearly organizes data, a check sheet is the easiest way to track information.
Check sheets help organize data by category. They show how many times each particular
value occurs, and their information is increasingly helpful as more data are collected. More than
50 observations should be available to be charted for this tool to be really useful. Check sheets
minimize clerical work since the operator merely adds a mark to the tally on the prepared sheet
rather than writing out a figure (Figure 3). By showing the frequency of a particular defect (e.g., in
a molded part) and how often it occurs in a specific location, check sheets help operators spot
problems. The check sheet example shows a list of molded part defects on a production line
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covering a week's time. One can easily see where to set priorities based on results shown on this
check sheet. Assuming the production flow is the same on each day, the part with the largest
number of defects carries the highest priority for correction.
3. PARETO DIAGRAMS
The Pareto diagram is named after Vilfredo Pareto, a 19th-century Italian economist who
postulated that a large share of wealth is owned by a small percentage of the population. This
basic principle translates well into quality problems—most quality problems result from a small
number of causes. Quality experts often refer to the principle as the 80-20 rule; that is, 80% of
problems are caused by 20% of the potential sources.
A Pareto diagram puts data in a hierarchical order (Figure 4), which allows the most
significant problems to be corrected first. The Pareto analysis technique is used primarily to
identify and evaluate nonconformities, although it can summarize all types of data. It is perhaps
the diagram most often used in management presentations.
Figure 4. By rearranging random data, a Pareto diagram identifies and ranks nonconformities in
the quality process in descending order.
To create a Pareto diagram, the operator collects random data, regroups the categories
in order of frequency, and creates a bar graph based on the results.
3. CAUSE AND EFFECT DIAGRAMS
The cause and effect diagram is sometimes called an Ishikawa diagram after its inventor.
It is also known as a fish bone diagram because of its shape. A cause and effect diagram
describes a relationship between variables. The undesirable outcome is shown as effect, and
related causes are shown as leading to, or potentially leading to, the said effect. This popular tool
has one severe limitation, however, in that users can overlook important, complex interactions
between causes. Thus, if a problem is caused by a combination of factors, it is difficult to use this
tool to depict and solve it.
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A fish bone diagram displays all contributing factors and their relationships to the outcome
to identify areas where data should be collected and analyzed. The major areas of potential
causes are shown as the main bones, e.g., materials, methods, people, measurement, machines,
and design (Figure 5). Later, the subareas are depicted. Thorough analysis of each cause can
eliminate causes one by one, and the most probable root cause can be selected for corrective
action. Quantitative information can also be used to prioritize means for improvement, whether it
be to machine, design, or operator.
Figure 5. Fish bone diagrams display the various possible causes of the final effect. Further
analysis can prioritize them.
4. HISTOGRAMS
The histogram plots data in a frequency distribution table. What distinguishes the
histogram from a check sheet is that its data are grouped into rows so that the identity of individual
values is lost. Commonly used to present quality improvement data, histograms work best with
small amounts of data that vary considerably. When used in process capability studies,
histograms can display specification limits to show what portion of the data does not meet the
specifications.
After the raw data are collected, they are grouped in value and frequency and plotted in a
graphical form (Figure 6). A histogram's shape shows the nature of the distribution of the data, as
well as central tendency (average) and variability. Specification limits can be used to display the
capability of the process.
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Figure 6. A histogram is an easy way to see the distribution of the data, its average, and
variability.
5. SCATTER DIAGRAMS
A scatter diagram shows how two variables are related and is thus used to test for cause
and effect relationships. It cannot prove that one variable causes the change in the other, only
that a relationship exists and how strong it is. In a scatter diagram, the horizontal (x) axis
represents the measurement values of one variable, and the vertical (y) axis represents the
measurements of the second variable. Figure 7 shows part clearance values on the x-axis and
the corresponding quantitative measurement values on the y-axis.
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Figure 7. The plotted data points in a scatter diagram show the relationship between two
variables.
6. CONTROL CHARTS
A control chart displays statistically determined upper and lower limits drawn on either
side of a process average. This chart shows if the collected data are within upper and lower limits
previously determined through statistical calculations of raw data from earlier trials.
The construction of a control chart is based on statistical principles and statistical

distributions, particularly the normal distribution. When used in conjunction with a manufacturing
process, such charts can indicate trends and signal when a process is out of control. The center
line of a control chart represents an estimate of the process mean; the upper and lower critical
limits are also indicated. The process results are monitored over time and should remain within
the control limits; if they do not, an investigation is conducted for the causes and corrective action
taken. A control chart helps determine variability so it can be reduced as much as is economically
justifiable.
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In preparing a control chart, the mean upper control limit (UCL) and lower control limit
(LCL) of an approved process and its data are calculated. A blank control chart with mean UCL
and LCL with no data points is created; data points are added as they are statistically calculated
from the raw data.
Figure 8. Data points that fall outside the upper and lower control limits lead to investigation and
correction of the process.
Figure 8 is based on 25 samples or subgroups. For each sample, which in this case
consisted of five rods, measurements are taken of a quality characteristic (in this example, length).
These data are then grouped in table form (as shown in the figure) and the average and range
from each subgroup are calculated, as are the grand average and average of all ranges. These
figures are used to calculate UCL and LCL. For the control chart in the example, the formula is ±
A2R, where A2 is a constant determined by the table of constants for variable control charts. The
constant is based on the subgroup sample size, which is five in this example.
Many people in the medical device manufacturing industry are undoubtedly familiar with
many of these tools and know their application, advantages, and limitations. However,
manufacturers must ensure that these tools are in place and being used to their full advantage as
part of their quality system procedures. Flowcharts and check sheets are most valuable in
identifying problems, whereas cause and effect diagrams, histograms, scatter diagrams, and
control charts are used for problem analysis. Pareto diagrams are effective for both areas. By
properly using these tools, the problem-solving process can be more efficient and more effective.
Those manufacturers who have mastered the seven basic tools described here may wish to
further refine their quality improvement processes.
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IV. Statistical Process Control
a. Introduction to Statistical Process Control (SPC)
Statistical Process Control (SPC) is not new to industry. In 1924, a man at Bell Laboratories
developed the control chart and the concept that a process could be in statistical control. His
name was William A. Shewart. He eventually published a book titled “Statistical Method from the
Viewpoint of Quality Control” (1939). The SPC process gained wide usage during World War II
by the military in the munitions and weapons facilities.
The demand for product had forced them to look for a better and more efficient way to monitor
product quality without compromising safety. SPC filled that need. The use of SPC techniques in
America faded following the war. It was then picked up by the Japanese manufacturing companies
where it is still used today. In the 1970s, SPC started to gain acceptance again due to American
industry feeling pressure from high quality products being imported from Japan. Today, SPC is a
widely used quality tool throughout many industries.
b. What is Statistical Process Control (SPC)
SPC is method of measuring and controlling quality by monitoring the manufacturing

process. Quality data is collected in the form of product or process measurements or readings
from various machines or instrumentation. The data is collected and used to evaluate, monitor
and control a process. SPC is an effective method to drive continuous improvement. By
monitoring and controlling a process, we can assure that it operates at its fullest potential. One of
the most comprehensive and valuable resources of information regarding SPC is the manual
published by the Automotive Industry Action Group (AIAG).
c. Why Use Statistical Process Control (SPC)
Manufacturing companies today are facing ever increasing competition. At the same time
raw material costs continue to increase. These are factors that companies, for the most part,
cannot control. Therefore companies must concentrate on what they can control: their processes.
Companies must strive for continuous improvement in quality, efficiency and cost reduction. Many
companies still rely only on inspection after production to detect quality issues. The SPC process
is implemented to move a company from detection based to prevention based quality controls.
By monitoring the performance of a process in real time the operator can detect trends or changes
in the process before they result in non-conforming product and scrap.
d. How to Use Statistical Process Control (SPC)
Before implementing SPC or any new quality system, the manufacturing process should
be evaluated to determine the main areas of waste. Some examples of manufacturing process
waste are rework, scrap and excessive inspection time. It would be most beneficial to apply the
SPC tools to these areas first. During SPC, not all dimensions are monitored due to the expense,
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time and production delays that would incur. Prior to SPC implementation the key or critical
characteristics of the design or process should be identified by a Cross Functional Team (CFT)
during a print review or Design Failure Mode and Effects Analysis (DFMEA) exercise. Data would
then be collected and monitored on these key or critical characteristics.
e. Collecting and Recording Data
SPC data is collected in the form of measurements of a product dimension / feature or

process instrumentation readings. The data is then recorded and tracked on various types of
control charts, based on the type of data being collected. It is important that the correct type of
chart is used gain value and obtain useful information. The data can be in the form of continuous
variable data or attribute data. The data can also be collected and recorded as individual values
or an average of a group of readings. Some general guidelines and examples are listed below.
This list is not all inclusive and supplied only as a reference.
Variable data
• Individual – Moving Range chart: to be used if your data is individual values
• Xbar – R chart: to be used if you are recording data in sub-groups of 8 or less
• Xbar – S chart: to be used if your sub-group size is greater than 8
Attribute data
• P chart – For recording the number of defective parts in a group of parts
• U chart – For recording the number of defects in each part
V. Quality Improvement Techniques in Service Industries
Service industries have some unique features that mean some of the normal tools of
process improvement are more appropriate than others, says contributor Abhishek Soni. Here
are four techniques you should consider using to improve processes in the service industry.
The service sector of the economy has grown by leaps and bounds over the last two
decades. Today it constitutes 62% of the world’s total GDP and employs 40% of global labour
force. As industry grows so does its complexity especially in a sector which produces intangible
goods and deals with perceptions of the customer.
The following set of features are unique to most services:
1. Intangibility: services are intangible in nature and they cannot be seen, felt or touched
2. Inseparability : services are produced and consumed simultaneously
3. Perishability: services must be consumed when they are offered and they cannot be stored
for future sale.
4. Variability: Quality of service may vary depending upon who provides it and also on when,
where and how service is rendered.
5. Government, Healthcare, Financial Services, Telecommunications, Consulting,
Information Technology, Education are a few examples of service sector industries.
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These unique features of services pose specific challenges. Service operations are often
labour intensive and hence susceptible to variations. These variations are complex to manage
and can lead to customer dissatisfaction. Additionally, the same services can be offered via
multiple platforms (e.g. banking services are being offered via platforms such as Internet banking,
telebanking or at bank branch) and it becomes a big challenge to deliver consistent quality of
service across all platforms.
Demand planning is another big challenge in services environment. Services are dynamic
and perishable in nature and this can often lead to instances of idle capacity or opportunity loss.
Compared to traditional manufacturing processes, processes in service industry are less visible
and hence it is more difficult to identify waste in a service process. Further, the quality in service
environment is an experience and not just a measurement against specification so defect
definition can tricky.
To overcome these challenges, as in other industries, the service industry needs to

innovate and continuously improve its processes.
Here are four suggested process improvement techniques for service industries.
Technique #1: Develop a Process Manual
A process manual is a set of instructions/directions to carry out day to day operations. It

is one of the most cost effective ways of achieving a certain degree of process standardization.
Although it does not reduce human involvement, it prevents service providers from digressing
from prescribed process steps while delivering services.
Expected benefits:
• It increases consistency in service outcome as all service providers refer to same
process manual
• It acts as a quick reference guide to handle exceptions and questions.
• It assists in transitioning process from one resource to another
Technique #2: Automate Processes
Service processes are people intensive tasks and hence there is high probability that
variations would be infused in the processes during service delivery. Across the service sector,
various organizations have achieved process standardization in certain areas to a large extent by
deploying process automation solutions. Certain examples of process automation are ATMs
(Automatic Teller machine), Self checking kiosks, IVR (Interactive Voice Response).
Expected benefits:
• It reduces people involvement during service delivery
• It increases productivity of service delivery process
• It standardizes the service delivery process
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• It eliminates variations infused in the process at the service provider level
Technique #3: Reduce Failure Demand
Service organizations experience two types of demands: failure demand and value
demand. Value demand is the demand for a service from customer when they want something
whereas failure demand is a demand caused by a failure to do something correctly for the
customer. Failure demand is thus a demand that only exists because the initial demand was not
satisfied properly. For example; in call centers large proportion of calls received are either
enquires pertaining to request made earlier or requests to correct earlier work that was not done
properly. These calls do not deliver value to the customer and they consume the existing capacity
of the call center.
Failure demand represents a common type of waste in service organizations. Service

organizations must identify the proportion of failure demand in total demand received. Further
they need to conduct root cause analysis for the failure demand and take steps to reduce the
occurrence of failure demand. For example, in a call center which receives numerous failure
demands, organization needs to analyze the reason why the customers are calling and should try
to curtail the volume of failure demand instead of focusing on reducing cost per call answered.
Expected benefits:
• It reduces wastes and increases the efficiency of service delivery process
• It increases customer satisfaction as more value per transaction/interaction is
delivered.
• It frees up capacity for new services
Technique #4: Conduct a Service Blueprinting exercise
Service blueprinting is a customer focused approach to service innovation and

improvement. Service blueprinting is an exercise of mapping out the service journey. It includes
identifying key target customer segment, processes that constitute the service and graphically
depicting sequence of user actions, service responses and touch points or interfaces that enables
the service relationship.
The typical steps of service process improvement using blueprinting technique are:
1. Choose a service which needs to be blueprinted.

2. Determine the goal of blueprinting exercise.
3. Identify the focal customer segment that are supposed to experience the service
4. Identify other stakeholders of the service.
5. Conduct blueprinting exercise
a. Map the service from the customer perspective
b. Map the actions of contact employees (both onstage and backstage)
c. Link the contact activities to the required support functions
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d. Add evidence of service for every customer action.

6. Note insights and action items throughout the process
Expected benefits:
• Illustrates the customer’s role and demonstrates where the customer experiences
value
• Assists in identifying failure points and opportunities for service improvement
• Provides a common point of discussion for new service development
• Provides a customer-focused basis for developing metrics to track service
performance
VI. Specific Techniques for Design, Reliability, Maintenance and Process Improvement
A. Tools for Improving Maintenance strategies and failure analysis processes
1. Reliability Centred Maintenance. RCM
Reliability Centred Maintenance is defined by John Moubray as "a process used to

determine what must be done to ensure that the physical asset continues to fulfil its intended
functions in its present operating context" (1993, pg.7). RCM was born from the airline industry in
the US in the early 70's in response to the statutory maintenance requirements that had to be
applied to larger aircraft such as Boeings 747. It was determined that the cost of applying the
standards to these aircraft would make them uneconomical to operate (Smith and Hinchcliffe,
2004). The basis of RCM is to ensure equipment maintains its function and the process requires
that the following seven questions be answered (Moubray, 1993).
1. What is the function of the equipment and what are the required performance
standards?
2. In what ways can it fail to perform its function?
3. What could cause each functional failure?
4. What happens when the failure occurs?
5. In what way does the failure matter?
6. What can be done to prevent the failure?
7. What has to be done if the failure can't be prevented?
Smith and Mobley (2008) highlight the following types of asset management strategies
that may be developed from an RCM process.
1. Condition based tasks. E.g. Oil is sampled from a transformer and the results of the
analysis determine if further maintenance is required.
2. Scheduled restoration. E.g. A Sheave bank running in a corrosive environment that
requires overhaul at fixed intervals.
3. Scheduled Discard. E.g. The replacement of oil in a combustion engine.
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4. Failure finding task. E.g. Calibration of instrumentation. The fault may not be discovered
until the calibration is done.
5. One-time change. Typically a one off redesign.
RCM in its purest form is a resource hungry process that should only be applied to the
most critical of assets. The results from the process if performed properly and coupled with
assessment of historical failures will produce efficient and effective maintenance strategies, but
this will be at the expense of a significant amount of time for plant staff and the project analyst.
a. Failure Modes and Effects Analysis. FMEA.
Fig 1. FMEA flowchart.

A Failure Mode and Effects Analysis is an integral part of the RCM process and deals with
questions 2, 3 and 4 of the 7 RCM questions listed above. Teng and Ho (1996) define FMEA as
a technique that identifies the potential failure modes of a device or product, determines the
effects of these failures and assesses the criticality of the failure. The Teng and Ho model is
shown in figure 1.
An FMEA completed on DC machines in an Australian Steel mill revealed the following

most likely causes of DC machine failure to be:
1. Contamination of motor by Dust, Dirt fumes etc.

2. Inadequate maintenance practices. (Internal and contract)
3. Inadequate brush tension
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4. Over tensioning of belts or shaft misalignment.

5. Overheating due to ineffective ventilation
6. Neutral axis and compounding issues.
7. Overloading.
8. Inadequate lubrication (Too much or not enough).
9. Incorrect or ineffective protection devices.
These findings were used to improve the existing PM's with excellent results. Over a 3
year period there was a 70% reduction in DC motors that failed in service.
b. Planned Maintenance Optimisation. PMO
Planned Maintenance Optimisation is a process where existing PM inspections and failure

history are used to form the basis of a new set of strategies. This can provide a similar output to
classical RCM in far less time. As unknown failure modes are not addressed in the first instance
the process allows for input of potential failure modes after the initial assessment. This process
couples the PMO top down approach with the RCM bottom up approach and in many cases will
be the best option for mature businesses with existing PM systems and access to failure history.
New businesses with no existing systems or failure history will need to apply more classical
methods such as a RCM or a knowledge based process.
c. Event trees and Fault trees.
Fig 2. Example of an event tree.

Event and fault trees are not aimed at determining root cause, but are meant to determine
the probability of an event occurring. From the probability rating you can then determine which
parts of a system require attention.
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Fig 3. Example of a fault tree.
d. Problem solving tools.
d.1. RCA.
Smith and Mobley (2008, pg., 79) define Root Cause Analysis as "The systematic
evaluation of problems to find the basic causes that, when corrected, prevent or significantly
reduce the likelihood of recurrence."
Latino (2006, pg., 3) promotes the steps to "Root Cause Analysis" as being:
1. Identification of the actual problem.
2. Identify the cause and effects that combine to cause the undesirable event.
3. Data collection to support the cause and effect relationship.
4. Identification of physical, human and latent (System) causes that are associated with the
undesirable event.
5. Development of corrective actions to prevent the re-occurrence of the problem.
6. Communication of the lessons learned to relevant areas in the organisation.
Latino discusses many other forms of problem analysis, which he classifies as

"shallow analysis" because not all of the steps are completed as listed above. Figure 4.
compares suggested shallow analysis processes with RCA to highlight the differences.
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Fig. 4. Comparison of RCA to "shallow analysis" processes.
d.2. 5-Why analysis.
The 5 why process is an integral part of "Kaizen" in the Toyota Production System, (Liker,
2004) and the Lean manufacturing philosophy. The process is based on the assumption that if
you ask "why" five times to a specific issue you will determine the root cause of the problem.
Actions are then to be put in place to eliminate the root cause.
Latino and Latino (2006) suggest that the 5 "why's" should been changed to "how could",
as "why" can imply that there is only one answer. "How could" suggests that there could be
numerous reasons as to why the problem occurred. Latino and Latino also suggest that the 5-
why approach is often used by people in isolation and is rarely backed up with evidence. This
could lead to answers that do not address the root causes.
d.3. Practical Problem Solving (PPS)
Practical Problem solving is an extension of the 5 why process in that it adds steps to
either side of this process. The process is defined by Liker (2004) as follows:
1. Initial problem perception.
2. Clarify the Problem.
3. Locate the point of cause of the problem.
4. Use 5 why to find the root cause from the direct causes.
5. Determine countermeasures to eliminate the problem.
6. Evaluate whether the countermeasures were effective.
7. Standardise the process.
PPS is used on a daily basis in businesses that apply LEAN manufacturing philosophies.
It is a simple process that delivers actions that lead to continuous improvement in all aspects of
manufacturing.
d.4. Cause and effect diagrams. (Ishikawa)
The cause and effect diagram was developed in the 60's and was the brainchild of Kaoru
Ishikawa. The diagram is fundamentally a brainstorming tool that clusters possible causes of a
problem into broad headings. These causes are then assessed to determine the most likely
53
causes of the problem so solutions can be developed. The cause and effect diagram is useful to
determine "what could" have caused a problem. This tool can be considered as "shallow analysis"
and should not be seen as a complete tool for use on complex problems.
Fig 5. Cause and effect diagram.
d.5. SCRA.
SCRA (Symptom, Cause, Remedy, Action.) The system contains four steps for
improvement and introduces a number of tools that can be used through each step of the process
as detailed below:
• Symptom. Define the problem, Measure the problem, prove the need, set the goal.
Tools that can be used: Run charts, surveys, interviews, flow charts, paretos, check
sheets, histograms, box plots.
• Cause. Collect the data, analyse it, define and test possible causes, determine the key
root causes, determine the improvement avaliable.
Tools that can be used: Check sheets, histogram, cause and effect diagram, 5 why's,
Brainstorm etc.
• Remedy. Formulate and evaluate solutions and choose the best solution.
Tools that can be used: Brainstorming, cause and effect, driver tree, FMEA, force field
analysis, evaluation matrix, cost benefit analysis etc.
• Action. Plan, Do, Check, Adjust and hold the gains made.
Tools that can be used: Action plan, implementation monitoring chart, KPI's, checklists,
SOP's, control charts, audits etc.
The SCRA methodology is a conglomerate of a number of different but well-known

improvement tools collated under a single heading.
d.6. Six Sigma.
Six Sigma is a set of practices that was developed by Motorola in the 80's and is closely
linked to the TQM philosophy of involving all in the process of reducing variation and eliminating
54
defects (Arnheiter E.D & Maleyeff J, 2005). The Six Sigma process steps are called "DMAIC"
and in relation to equipment reliability could be applied to maintenance in the following ways:
1. Define. Select and define appropriate projects that align with the needs of the business.
This may be determining what equipment requires strategy re-development based on poor
reliability.
2. Measure process variables, such as the MTBF and re-occurring failure modes of a piece
of equipment.
3. Analyse the data gathered using graphical techniques to understand the causes of the
failures.
4. Improve the assets reliability by applying continuous improvement techniques such
RCM and RCA.
5. Control the improvements by implementing a good work management system and
embedding follow up reporting in the system (Smith & Mobley 2008; Senapati, 2004).
Like SCRA, the six-sigma process utilises different tools, of which, many have been included in
this review
d.6. Pareto analysis.
The Pareto principal, also known as the 80/20 rule, highlights that some things are more
important than others (Latino and Latino, 2006). In relation to maintenance, an example of the
rule could state: "80% of plant downtime applies to 20% of the installed equipment". The
significance of the 80/20 rule is that if the top 20% of losses can be identified and then eliminated
improvements will be made in the shortest timeframe. This is an extremely powerful tool and
arguably the most common method used to determine where improvements need to be focussed.
It is a must in the toolkit of Maintenance Reliability professionals.
d.7. Failure reporting.
Formal failure reports are the traditional way of presenting investigations into failures and
are generally an after- the-event communication exercise more than a tool to determine the failure
cause. Typical headings are used within these reports are:
1. Project Title
2. Equipment hierarchical location.
3. Work order no.
4. Problem Statement.
5. Potential costs associated with the issue.
6. Observations.
7. Process followed. This includes collating data and analysing it to diagnose the cause of
the problem.
8. Findings.
9. Are existing strategies in place to address the findings?
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10. Conclusion.
11. Actions.
12. Information for further reference.
Read:
▪ https://sceweb.uhcl.edu/helm/RationalUnifiedProcess/process/workflow/manageme/co_
meqlty.htm
▪ https://asq.org/quality-resources/cost-of-
quality#:~:text=Cost%20of%20quality%20(COQ)%20is,from%20internal%20and%20ext
ernal%20failures.
▪ https://www.mddionline.com/design-engineering/seven-basic-tools-can-improve-quality
▪ https://www.processexcellencenetwork.com/innovation/articles/four-key-process-
improvement-techniques-for-servic
Watch:
• The Seven basic quality tools
https://www.youtube.com/watch?v=7Kc1reo8NU0
• Process Improvement: Six Sigma & Kaizen Methodologies

https://www.youtube.com/watch?v=ilDAYBR5sQU
Instructions: Answer the following questions on a different sheet of paper based on your
personal experience and understanding. Use your own words in explaining and strictly
avoid plagiarism. Minimum of 15 sentences per question.
1. Elaborate the similarities and differences of each tool used for quality improvement.
2. What are the reason/s behind the cost of poor quality and how does a company avoid this
cost?
3. Among the different Tools and Techniques for Quality Improvement, which do you think is
best and applicable in most cases and why?
4. Why is it important to adapt and improve maintenance strategy in a company/business?
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TOPIC 4: CONFORMANCE AND NON-CONFORMANCE TO QUALITY

STANDARDS
Overview:
Conformance is how well something, such as a product, service or a system, meets a

specified standard. While non-conformance means that something went wrong. It could be in a
product, service, process, and the result does not meet the specifications or requirements in some
way
Nonconformity can be found at any level of an organization’s operations from quality
control and manufacturing to personnel procedures. If Non-conformance persists, it can lead to
the company’s overall demise, as these standards are in place to ensure everyone is playing by
the same rules.
• Define Quality of design
• Discover Quality of conformance to design
• Implement the Control of non-conforming products
• Distinguish between Corrective and preventive action
Course Materials:
Creation of any product involves two major stages – intellectual creation and physical
creation. During intellectual creation a product is conceived in the mind and a design is created
and after that it is physically produced.
The term quality involves two complementary aspects, quality of design and quality of
conformance. So, good quality can be attained only when both of them are controlled
satisfactorily. Quality is designed into a product as much as it is built in during its production or
service processes.
I. Quality of design
Quality of design is the quality which the producer or supplier is intending to offer to the
customer. When the producer is making the quality of design of the product, he should take into
consideration the customer's requirements in order to satisfy them with fitness for use of the
product.
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If the quality of design does not reflect the customer's requirements, the product which the
producer offers him would not probably satisfy the customer, even if it does sufficiently conform
to the design. Quality of design is usually indicated by completeness and correctness of
specifications, drawings, catalogues, etc. and is measured with fitness for use.
II. Quality of conformance
Quality of conformance is the level of the quality of product actually produced and
delivered through the production or service process of the organization as per the specifications
or design. When the quality of a product entirely conforms to the specification (design), the quality
of conformance is deemed excellent.
Specifications are targets and tolerances determined by the designer of a product. Targets
are the ideal values for which production is expected to strive; tolerances are acceptable
deviations from these ideal values recognizing that it is difficult to meet the exact targets all the
time due to variability in material, machine, men and process.
For example, if an engineering component manufacturer specifies the diameter of a steel

pin as 2.525 + 0.005 mm, the value 2.525 is the target value and + 0.005 is the tolerance. In a
similar way, in case of an Airline service, if on time arrival of a flight is specified as within 15
minutes of scheduled time, the target is scheduled time and tolerance is + 15 minutes.
The measure most commonly used for expressing the quality of conformance is fraction
defective. A fraction of defect of 0 % implies that the quality of a product wholly conforms to the
quality of design. Even if the quality of a design is very good and quality of conformance is poor,
the product cannot give the intended service and is classified as poor quality product.
For example, in case of a service product like maintenance of law and order by
governmental agencies, the quality of design is reflected in the relevant acts and rules, whereas
quality of conformance depends upon the extent to which these acts and rules are complied by
the enforcement agencies. In spite of having excellent rules and regulations, the quality of law
and order of society cannot be rated as good, if these rules and regulations are not adhered to
properly.
Fitness for use (quality of design) and conformance to specification (quality of

conformance) provide the fundamental basis for managing the processes to produce quality
products. Good quality can be attained only when both, quality of design and quality of
conformance are good.
III. Control of non-conforming products
A. What is ISO Control of Nonconforming Process Outputs, Products and Services? Control
of Nonconforming Process Outputs, Products, and Services occurs when outputs
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from the business do not confirm with ISO 9001 guidelines. In this case, these
products and outputs must be identified and corrected.
The ISO 9001 standards are very helpful to organizations that strive to stay organized
and in full control of their business. With all of the specific clauses and requirements that exist
within the system, some of the main ideas can get lost under all of the big words they are written
with.
If you agree that some of the ISO 9001 guidelines are not as clear as you would like them to be,
there is no need to worry. Keep reading this quick explanation of Control of Nonconforming
Process Outputs, Products and Services to get a better understanding of some of the details
that were left out.
ISO 9001:2015 ISO 9001:2008 Summary of Changes
8.7 Control Of 8.3 Control Of This clause now includes as a new

Nonconforming Nonconforming requirement, the terms ‘process outputs’
Process Product and ‘services’ as well as products. It should
Outputs, be noted that there is no need to maintain a
Products And documented procedure but your
Services organization may still chose to operate one.
B. ISO Control of Nonconforming Process Outputs, Products, and Services Explained
The term “nonconformity” when it comes to ISO 9001 guidelines refers to the event of one
or more requirements being broken or ignored within an organization. There are several clauses
with individual sections within ISO 9001 that highlight specific areas of a company in order
to keep everything organized and running smoothly.
Some of these areas that are specified within the guidelines are process outputs,
products, and services.
For the most straight forward and general explanation of what this clause means, it is
basically the violation of rules and regulations within any of these specific categories.
From the moment that a nonconforming process or output is noticed within the company,
there is a series of steps that must be followed in order to come up with a solution for the issue
and prevent it from happening again.
This is where the Control part comes in within the Control of Nonconforming Process
Outputs, Products, And Services clause.
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While nonconformity cannot always be avoided because mistakes do happen within a

company, the most important thing to keep in mind about this process is that the issue must be
immediately handled when it presents itself.
In other words, the event of a nonconformity itself within an organization is not the end of
the world, but it will have more dire consequences if the nonconformity is not properly identified,
addressed, corrected, and prevented in the future.
Take a look at the list below to learn about the basics of ISO Control of Nonconformity.
ISO Control Of Nonconformity:
1. Identify the nonconformity
2. Record the nonconformity
3. Control the nonconformity
The three basic steps when it comes to Controlling nonconformity are identifying the
problem or violation, recording it, and taking the appropriate action to put a stop to it.
In order to be able to properly deal with the issue that is at hand, the nonconformity must
first be identified. This process will include determining which specific ISO 9001 requirement
has been broken to move on to the next step of solving the problem.
Recording the nonconformity will be done by filling out a document called a Non-
Conformance Report, or NCR. The NCR should be a very detailed report that clearly states
what the violation was and how it can be fixed.
The control of the nonconformity must include a specific outline of the actions that will be
taken in order to correct the nonconformity as well as control it during future business
operations.
While the prompt correction of a nonconformity is needed within any organization, the
maintenance of this process is key. Without following up on the specific issue after it has been
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handled, the nonconformity is more likely to happen again, which would defeat the entire
purpose of correcting it in the first place.
C. How To Handle Nonconforming Products and Outputs
When a product or output does not fit into the guidelines and requirements that are
outlined by ISO 9001, it is considered to be a nonconforming product or output.
The term product refers to anything that is designed and developed by the organization
for purchase and distribution to their customer base. Output, on the other hand, refers to the
result of a process that does not fit into the requirements that are outlined by ISO 9001.
In either case, the issue of nonconformity must be quickly identified, corrected, and
prevented in the future in order for the operations of the business to continue running smoothly.
Since the requirements of ISO must be strictly adhered to in order to maintain the quality
standards of a business, any product or service that does not fit into these processes will need
to be eliminated.
In the event that a product is not compliant with ISO 9001, it will not be able to be
distributed to customers of the business, and must quickly be stopped before any mistakes of
that nature occur.
Take a look at the list below to find an explanation of the process that goes into handling
nonconforming products.
Handling Nonconforming Products:

1. Documented procedure should indicate the plan of action for controlling products
2. Nonconforming product is identified and separated from other conforming products
3. Nonconforming product must be reviewed and approved before release
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4. Details of nonconformity must be documented

5. If nonconformity is identified after delivery, separate actions taken
6. Re-processed nonconforming products should be re-validated before release
When it comes to controlling and handling products that do not conform to ISO 9001
guidelines, there is a specific procedure that must be carefully followed to ensure that the wrong
product is not given out to consumers.
First and foremost, the organization should already have a documented procedure that
indicates the method they will use or plan of action that will be taken in order to control the
products in question.
Following along with these guidelines that have already been put into place, the product
that does not conform to the requirements must be immediately identified and separated from
the other conforming products.
Upon the removal of the product that does not qualify under ISO 9001 guidelines, the
organization will ensure that it does not get mixed up with the quality products that are on their
way to be distributed to the masses.
Once the product has been effectively identified and removed from the others, it must be
properly reviewed and approved before it can be released. The release of a nonconforming
product can be made under concession by an authorized person. Any release of this kind
should be properly documented after it has been completed.
The other details of the nonconformity must also be documented in detail. This should
include the exact non-conforming characteristics that were identified, as well as the procedures
that were followed in order to get rid of it and prevent it from happening in the future.
From the documentation of the nonconforming product, all company personnel should
be able to understand the nature of the event, why the product did not conform to the specified
standards, and what was done to eliminate the issue.
In the event that a nonconforming product is identified after it has already been
distributed or delivered, there will be a separate set of actions that must be taken to solve the
problem at hand. These actions will depend on the severity of the nonconformity, and will be
determined by the discretion of the company leaders.
When a nonconforming product has been identified and a plan of action has been
established to solve the problem, it can either be permanently removed or possibly altered in
order to fit the guidelines and be considered a qualifying product.
When any nonconforming product is reprocessed, it must go through a revalidation

process by someone of proper authority in order to be approved for release.
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As you can see, the process of identifying and controlling products, services, and
outputs, serves to keep an organization alert about what is coming and going from the business.
With the help of these detailed standards, companies are able to ensure that they are meeting
their goals without compromising quality.
D. Corrective and preventive action
1. What is meant by preventive action?
In a management system, a preventive action (PA) definition could be: “the activities taken
by the organization to eliminate the cause of a potential process nonconformity.” In other words,
preventive action is taken to fix the cause of a process problem before it can happen. If you are
identifying potential problems that could happen in a process, assessing what could cause these
problems, and taking action to prevent the problem from occurring before it happens, then you
are taking preventive action.
2. What is an example of corrective action?
First, what is corrective action? Corrective action (CA) is the activities taken to eliminate
the cause of a process nonconformity. Corrective action is the activity of reacting to a process
problem, getting it under control through containment actions, and then taking the action needed
to stop it from happening again. Earlier versions of ISO 9001 made the distinction that CA will
prevent recurrence of a problem, but PA will prevent the occurrence of the problem.
In other words, corrective actions take steps to fix the cause of a problem after the problem
has occurred, whereas preventive actions notice the problem before it occurs and takes steps to
fix the cause of the problem before it happens. Here is a simple corrective action and preventive
action (CAPA) example:
Corrective action – I hurt myself on the corner of a table, find that the cause is that the
table has sharp corners, and take action to make the table have rounded corners so that
no one else gets hurt. This includes the actions to change the design so that future tables
made will have rounded corners.
Preventive action – I notice that the corners of a table could cut someone (even though
no one has been injured), then find that the cause is the sharp corners, and take action to
round the corners and change the future design to have round corners.
This is an example that uses a product problem, where CAPA in the management
system normally involves process problems, but with this example it is easy to see the
difference between preventive actions and corrective actions. In short, corrective actions are
reactive to a problem after it happens, where preventive actions are proactive to a potential
problem before it can happen.
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3. Why does ISO 9001 require corrective action and not preventive action?
The previous version of ISO 9001 included requirements for a corrective action process
and a preventive action process as part of quality management. The steps involved in both were
essentially the same, but the action that triggered the process was different; corrective action
reacted to a problem that occurred, where preventive action was initiated by the identification of
a potential problem. There was often confusion about this when implementing earlier versions of
ISO 9001; some people only used their preventive action process a few times, as it is a complex
process and takes time away from reacting through corrective actions. Still other people
interpreted any action during the corrective action process to prevent a recurrence to be
preventive action.
So, now the most recent release of the Quality Management System (QMS) standard, ISO
9001:2015, doesn’t require preventive action any longer. In some ways, this prevents the
confusion mentioned above, but in other ways, ISO has indicated that the complex process that
was previously involved in PA is unnecessary, and there are other parts of the standard that,
when used properly, can effectively provide good preventive actions. Now preventive action is
replaced by other parts of the standard, including:
• Risk-based thinking – This new requirement asks that you identify areas that could affect
the QMS where you are uncertain of the outcome. This way of thinking entails identifying
this uncertainty, or risk, and determining if you need to take action to prevent bad
outcomes or to capitalize on positive outcomes; these are risks and opportunities
(essentially positive risk).
• Improvement – Any improvement activities that you take to make the processes of your
QMS better are preventive actions. The focus of the new requirements is for each
company to find good ways that work for them to improve processes, rather than having
the complicated preventive action system in place from previous versions of the ISO 9001
standard. If you have something as simple as a suggestion program that identifies how to
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make processes better and implements those changes, this could be an action to prevent
a problem.
It should be noted that some other standards based on the ISO 9001 standard, including
ISO 13485 and IATF 16949, still require preventive actions. In both of these standards, the
preventive action process is still intended to be the systematic process to address identified
potential issues, rather than the improvement activities mentioned above.
4. How do you do corrective and preventive action?
The systematic process for CAPA has not really changed in the ISO 9001:2015 standard,
and it is essentially the same in all of the ISO management system standards. Corrective actions
are about improving behavior or performance of the process, and this hasn’t changed. In general,
you need to:
a. Identify the process problem – Define what the problem actually is.
b. Identify how big the problem is – What is the scope of the problem?
c. Take action to contain the problem – How can we stop the problem while we fix the root
cause?
d. Identify the root cause of the problem – What is the base of the problem, not just the
surface manifestation?
e. Come up with a plan to fix the root cause – What do you need to change to eliminate the
root cause? Make sure the planned changes will not cause further problems.
f. Put your plan in place – Do what you have planned.
g. Check that your plan worked – Make sure your plan was effective.
Many companies will have a corrective action form that follows this process, or a modified
process, to capture the information and ensure that you do not forget any steps. Having a good
systematic process is important to find and fix the root of the problem for large, systemic issues
within your organization. If you only treat the symptom, then the problem will come back. The goal
of corrective actions is to correct the root of the problem, so the failure does not recur.
5. What should a corrective action plan include?
When you have identified the root cause of the problem, it is time to create a corrective
action plan to eliminate it. The corrective action plan is about addressing the root cause of the
problem, not simply correcting the symptom that has been found; correction may be part of the
containment actions. For instance, adding in additional inspection may contain the process
problem in the short term, but the corrective actions will stop the problem from occurring again.
Some things to think about when preparing your corrective action plan include:
• Fully assessing the root cause – Have we fully assessed the root cause, or could there be
a further underlying cause to what has been identified?
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• Identify the steps needed – What are the steps needed to eliminate the root cause from
the process?
• Assess schedule & cost – What is the timeline of implementation? What are the cost and
return on investment? Are there other alternatives that need to be assessed? Is this plan
feasible?
• Plan for assessment along the way – As you work through your plan, do you need to make
changes? Assessing if the plan is working as you proceed can help to ensure that your
final assessment for effectiveness will give authentic results.
• Plan for assessment of effectiveness – Before starting on the plan, how will we know the
changes actually worked? Will a key performance indicator improve? Will we have to wait
for several months to ensure the problem doesn’t come back (which would mean we didn’t
address the root cause)?
As you can see, the corrective action plan is essentially equivalent to any other project
plan you would create in your organization. It is important to set expectations for how long the
plan will take, what resources will be required, and when you will be completely done with the
corrective action. It is an important note that the ISO standards include a statement that the
corrective actions taken should be appropriate to the significance of the effects presented by the
nonconformities; so, it is not expected that you will spend an exceptional amount of time and
money to address a small problem. Remember this when you assess the feasibility of the plan.
6. What is a preventive action plan?
A preventive action plan, created for preventive actions, needs to include all of the same
things that a corrective action plan does, as outlined above. If you are taking action to remove an
identified risk, this should also be treated like a project, with the same adequate oversight and
budgeting of resources.
It is, of course, important to note that even a CA plan includes elements to prevent the
problem from happening in the future. The distinction of the PA plan is that it is implemented
proactively for a potential problem, rather than as a reaction to an existing problem.
7. Why is corrective action important?
When dealing with a systemic problem, one that is not due to a one-time mistake, but
rather is caused because of something in the system, you can lose a lot of time and money by
ignoring it. This is why corrective action is important. If people are performing unnecessary
activities to continually fix problems that occur, or need to be constantly vigilant to catch problems
that happen all the time before they go further, then you can save a lot of resources by taking the
necessary actions to stop the problems from happening again. The CA process is part of the
Quality Management System to save you time and money.
It is important to note that one of the issues with the corrective action process is that it is
difficult to use for small, non-systemic problems where a root cause is not able to be found. For
66
this reason, the new ISO 9001:2015 standard (and others related to it, such as ISO 14001:2015
and ISO 45001:2018) has added into the requirements a decision after you have corrected the
problem.
Once you have fixed the problem that was found, you can determine the need to take
action to eliminate the root cause of the nonconformity. If you determine this is not needed, such
as for a one-time issue that shows no signs of recurrence, you can stop the corrective action
process without going further. You will still want to follow up to ensure the problem does not recur
and, if it does prove to be systemic, change your decision and take further actions.
8. How do you implement corrective action?
Implementing corrective action is as simple as following the plan you have identified.
Perform each step you have identified, ensure it is completed satisfactorily, and assess that
changes have not introduced new risks that you need to further address. Once again, thinking of
your CA plan as a project plan can help you to understand how implementation should proceed.
For implementation of a complex plan, you may want to use a Gantt chart to organize all
of the activities, who will be doing them, and by when. This type of tool can also indicate which
activities can occur in parallel, and which need to wait until other actions have taken place. Even
if you choose another method to track your implementation, it is important to ensure that actions
are identified with resources, timelines, and how complete they are.
9. How do you write a corrective action report?
As with any other report in an organization, the corrective action report can take whatever
form is adequate in your company. Larger companies, with many people in top management, may
want formalized reports for big corrective actions – as they would for any project. These reports
may include executive summaries, detailed outcomes and expenses incurred, and evidence for
effective closure. Others may simply include a completed CAPA form as the report.
There are some requirements for records to be kept in the ISO management system
standards, and this should be included as part of your report as a minimum. The ISO management
system standards, such as ISO 9001:2015 or ISO 14001:2015, require that the following be kept
as CA records:
• The nature of nonconformities you have taken corrective actions for

• The actions taken in the corrective actions
• The results of the corrective actions, which would include the effectiveness
Remember that the process is there to help you to save resources by removing larger
systemic problems from your organization, rather than being a burden to your company. Make
sure you implement a CAPA system that will work for you; not one that is just there for show.
Removing problems can be one of the best ways to make your organization better.
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Read:
• http://www.openlearningworld.com/books/Quality%20by%20Design/Quality%20by%20D
esign/Quality%20of%20Design%20and%20Quality%20of%20Conformance.html
• https://www.iso-9001-checklist.co.uk/8.7-control-of-nonconforming-process-outputs-
products-and-services.htm#:~:text=of%20this%20section.-
,What%20is%20ISO%20Control%20of%20Nonconforming%20Process%20Outputs%2C
%20Products%20and,must%20be%20identified%20and%20corrected.
• https://advisera.com/9001academy/blog/2020/06/22/complete-guide-to-corrective-action-
vs-preventive-action/
Watch:
• Quality by Design
https://www.youtube.com/watch?v=yn0_6N07_E4
• Quality of design and conformance

https://www.youtube.com/watch?v=XecJ-aLfpN0
• CAPA | Corrective Action Preventive Action | non conformance - corrective and preventive
action
https://www.youtube.com/watch?v=3lSntuzt2dY
1. What is the major difference between corrective and preventive action and why are they
both important in product design?
2. What is the significance of conformance to quality standard? What are the repercussions
of non conformance on the other hand?
3. In doing your research/thesis, how do you think the school/ECE department would assess
the conformance of your output including prototype or system you created?
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TOPIC 5: QUALITY ORGANIZATION WITHIN AN ORGANIZATION
Overview:
An organization is a group of people who together work to achieve a common goal. In

order to work together efficiently, the group must find the best way to organize the work that needs
to be done in order to meet the goals of the organization.
Quality Organization
Establishing a quality procedure is a comprehensive business project that requires the

participation of all employees. Therefore, it is necessary to define a "quality organization" that fits
into and hinges on the existing organization.
A quality manager (sometimes called a quality adviser or a quality director depending on

the company's size) must be designated. He or she will manage the quality actions taken in the
company. Depending on how big the organization is, the quality manager may be assisted by a
team called the quality unit (or the quality department). That said, the quality procedure must not
be solely the responsibility of the quality manager and his or her unit but rather should be a team
effort.
A quality committee that is headed by management and includes the quality manager as
well as company managers must be created so that results in terms of quality can be made known
and so that the entire company is involved in the improvement of these results. The quality
committee must be cleverly structured along with the management committee to make sure that
the important decisions are not only made in management committee meetings.
Each department or office is responsible for implementing the quality directives at their
level. With the involvement of the quality manager, a quality correspondent will ideally be named
at each one of these levels so as to show a strong commitment to the company's quality
department.
• Understand people and the organizational structure
• Define Responsibilities and performance management
• Distinguish the relationship between the quality organization and top management
• Recognize culture change through teamwork for quality improvement
• Determine how to Implement teamwork for quality improvement.

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Course Materials:
I. Organizational Structure
An organizational structure is a system that outlines how certain activities are directed in
order to achieve the goals of an organization. These activities can include rules, roles, and
responsibilities.
The organizational structure also determines how information flows between levels within
the company. For example, in a centralized structure, decisions flow from the top down, while in
a decentralized structure, decision-making power is distributed among various levels of the
organization. Having an organizational structure in place allows companies to remain efficient and
focused.
Organizational structure aligns and relates parts of an organization, so it can achieve its
maximum performance. The structure chosen affects an organization's success in carrying out its
strategy and objectives.
a. Understanding Organizational Structures
Businesses of all shapes and sizes use organizational structures heavily. They define a
specific hierarchy within an organization. A successful organizational structure defines each
employee's job and how it fits within the overall system. Put simply, the organizational structure
lays out who does what so the company can meet its objectives.
This structuring provides a company with a visual representation of how it is shaped and
how it can best move forward in achieving its goals. Organizational structures are normally
illustrated in some sort of chart or diagram like a pyramid, where the most powerful members of
the organization sit at the top, while those with the least amount of power are at the bottom.
Not having a formal structure in place may prove difficult for certain organizations. For
instance, employees may have difficulty knowing to whom they should report. That can lead to
uncertainty as to who is responsible for what in the organization.
Having a structure in place can help with efficiency and provide clarity for everyone at
every level. That also means each and every department can be more productive, as they are
likely to be more focused on energy and time.
b. Centralized Versus Decentralized Organizational Structures
An organizational structure is either centralized or decentralized. Traditionally,

organizations have been structured with centralized leadership and a defined chain of command.
The military is an organization famous for its highly centralized structure, with a long and specific
hierarchy of superiors and subordinates.
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There has been a rise in decentralized organizations, as is the case with many technology
startups. This allows companies to remain fast, agile, and adaptable, with almost every employee
receiving a high level of personal agency.
c. Problems created by a misaligned organizational structure
Rapid reorganization of business units, divisions or functions can lead to ineffective,

misaligned organizational structures that do not support the business. Poorly conceived
reorganizations may create significant problems, including the following:
Structural gaps in roles, work processes, accountabilities and critical information flows can
occur when companies eliminate middle management levels without eliminating the work, forcing
employees to take on additional responsibilities.
Diminished capacity, capability and agility issues can arise when a) lower-level employees
who step in when middle management is eliminated are ill-equipped to perform the required duties
and b) when higher-level executives must take on more tactical responsibilities, minimizing the
value of their leadership skills.
Disorganization and improper staffing can affect a company's cost structure, cash flow
and ability to deliver goods or services. Agile organizations can rapidly deploy people to address
shifting business needs. With resources cut to the bone, however, most organizations' staff
members can focus only on their immediate responsibilities, leaving little time, energy or desire
to work outside their current job scope. Ultimately, diminished capacity and lagging response
times affect an organization's ability to remain competitive.
Declining workforce engagement can reduce retention, decrease customer loyalty and
limit organizational performance and stakeholder value.
d. The importance of aligning the structure with the business strategy
The key to profitable performance is the extent to which four business elements are
aligned:
• Leadership. The individuals responsible for developing and deploying the strategy and
monitoring results.
• Organization. The structure, processes and operations by which the strategy is deployed.
• Jobs. The necessary roles and responsibilities.
• People. The experience, skills and competencies needed to execute the strategy.
An understanding of the interdependencies of these business elements and the need for
them to adapt to change quickly and strategically are essential for success in the high-
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performance organization. When these four elements are in sync, outstanding performance is
more likely.
The organizational design process is the pivotal connector between the business of the
organization (e.g., top-level leadership and organizational strategy and goals) and forms of HR
support (e.g., workflow process design, selection, development and compensation). Strategy
must continually drive structure and people decisions, and the structure and design must reflect
and enable effective leadership.
Achieving alignment and sustaining organizational capacity requires time and critical
thinking. Organizations must identify outcomes the new structure or process is intended to
produce. This typically requires recalibrating the following:
• Which work is mission-critical, can be scaled back or should be eliminated.

• Existing role requirements, while identifying necessary new or modified roles.
• Key metrics and accountabilities.
• Critical information flows.
• Decision-making authority by organization level.
e. Types of Organizational Structures
1. Functional Structure. Four types of common organizational structures are implemented in

the real world. The first and most common is a functional structure. This is also referred
to as a bureaucratic organizational structure and breaks up a company based on the
specialization of its workforce. Most small-to-medium-sized businesses implement a
functional structure. Dividing the firm into departments consisting of marketing, sales, and
operations is the act of using a bureaucratic organizational structure.
2. Divisional or Multidivisional Structure. The second type is common among large

companies with many business units. Called the divisional or multidivisional structure, a
company that uses this method structures its leadership team based on the products,
projects, or subsidiaries they operate. A good example of this structure is Johnson &
Johnson. With thousands of products and lines of business, the company structures itself
so each business unit operates as its own company with its own president.
3. Flatarchy Structure. Flatarchy, a newer structure, is the third type and is used among many
startups. As the name alludes, it flattens the hierarchy and chain of command and gives
its employees a lot of autonomy. Companies that use this type of structure have a high
speed of implementation.
4. Matrix Structure. The fourth and final organizational structure is a matrix structure. It is
also the most confusing and the least used. This structure matrixes employees across
different superiors, divisions, or departments. An employee working for a matrixed
company, for example, may have duties in both sales and customer service.
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f. Management Levels: An Overview
Most organizations have three management levels:

1. Low-level managers;
2. Middle-level managers; and
3. Top-level managers.
These managers are classified in a hierarchy of authority, and perform different tasks. In
many organizations, the number of managers in every level resembles a pyramid. Below, you’ll
find the specifications of each level’s different responsibilities and their likely job titles.
1. Top-level managers
The board of directors, president, vice-president, and CEO are all examples of top-level
managers. These managers are responsible for controlling and overseeing the entire
organization. They develop goals, strategic plans, company policies, and make decisions on the
direction of the business. In addition, top-level managers play a significant role in the mobilization
of outside resources. Top-level managers are accountable to the shareholders and general public.
2. Middle-level managers
General managers, branch managers, and department managers are all examples of
middle-level managers. They are accountable to the top management for their department’s
function. Middle-level managers devote more time to organizational and directional functions than
top-level managers. Their roles can be emphasized as:
• Executing organizational plans in conformance with the company’s policies and the
objectives of the top management;
• Defining and discussing information and policies from top management to lower
management; and most importantly
• Inspiring and providing guidance to low-level managers towards better performance.
Some of their functions are as follows:
• Designing and implementing effective group and intergroup work and information systems;
• Defining and monitoring group-level performance indicators;
• Diagnosing and resolving problems within and among work groups;
• Designing and implementing reward systems supporting cooperative behavior.
3. Low-level managers
Supervisors, section leads, and foremen are examples of low-level management titles.
These managers focus on controlling and directing. Low-level managers usually have the
responsibility of:
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• Assigning employees tasks;

• Guiding and supervising employees on day-to-day activities;
• Ensuring the quality and quantity of production;
• Making recommendations and suggestions; and
• Upchanneling employee problems.
Also referred to as first-level managers, low-level managers are role models for
employees. These managers provide:
• Basic supervision;
• Motivation;
• Career planning;
• Performance feedback; and
• Staff supervision.
II. Responsibilities and Performance Management
a. What Is Performance Management?
Performance management is a corporate management tool that helps managers monitor

and evaluate employees' work. Performance management's goal is to create an environment
where people can perform to the best of their abilities to produce the highest-quality work most
efficiently and effectively.
A formal performance-management program helps managers and employees see eye-to-

eye about expectations, goals, and career progress, including how individuals' work aligns with
the company's overall vision. Generally speaking, performance management views individuals in
the context of the broader workplace system. In theory, you seek the absolute performance
standard, though that is considered unattainable.
b. How Performance Management Works
Performance-management programs use traditional tools such as creating and measuring

goals, objectives, and milestones. They also aim to define what effective performance looks like
and develop processes to measure performance. However, instead of using the traditional
paradigm of year-end reviews, performance management turns every interaction with an
employee into an occasion to learn.
Managers can use performance management tools to adjust workflow, recommend new
courses of action, and make other decisions that will help employees achieve their objectives. In
turn, this helps the company reach its goals and perform optimally. For example, the manager of
a sales department gives her staff target revenue volumes that they must reach within a set
period. In a performance management system, along with the numbers, the manager would offer
guidance gauged to help the salespeople succeed.
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c. Why Performance Management Matters
Focusing on continuous accountability creates a healthier, more transparent work

environment, and emphasis on regular meetings can improve overall communications. Because
performance management establishes concrete rules, everyone has a clearer understanding of
the expectations. When expectations are clear, the workplace is less stressful. Employees are
not trying to impress a manager by doing some random task, and managers aren't worried about
how to tell employees that they are not performing well. If the system is working, they probably
know it already.
d. Types of Performance-Management Programs
Although performance-management software packages exist, templates are generally

customized for a specific company. Effective performance-management programs, however,
contain certain universal elements, such as the following:
• Aligning employees' activities with the company's mission and goals. Employees
should understand how their goals contribute to the company's overall achievements.
• Developing specific job-performance outcomes. What goods or services does my job
produce? What effect should my work have on the company? How should I interact with
clients, colleagues, and supervisors? What procedures does my job entail?
• Creating measurable performance-based expectations. Employees should give input
into how success is measured. Expectations include results—the goods and services an
employee produces; actions—the processes an employee uses to make a product or
perform a service; and behaviors—the demeanor and values an employee demonstrates
at work.
• Defining job-development plans. Supervisors and employees together should define a
job's duties. Employees should have a say in what types of new things they learn and how
they can use their knowledge to the company's benefit.
• Meeting regularly. Instead of waiting for an annual appraisal, managers and employees
should engage actively year-round to evaluate progress.
III. Quality Improvement
a. What is quality improvement?
Quality improvement refers to the combined and unceasing efforts of everybody in a

company to make everything about it, especially its production process, better. It is a systematic
approach to the elimination or reduction of rework, waste, and losses in the production process.
Put simply, quality improvement (QI) refers to methods to improve the production process.
It requires getting rid of or changing parts of the process that do not function optimally.
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In manufacturing, for example, the term nearly always refers to the production process.
However, management can target any part of a company or organization for QI. There are several
different methods for quality improvement. They cover people-based improvement, process
improvement, and product improvement.
QI is part of quality management. It exists alongside quality control, quality assurance,

and quality planning. Below is an explanation of the four parts that make up quality management:
• Quality control or QC is a system in manufacturing for maintaining standards. Inspectors

examine the final product to make sure it meets standards and specifications. When the
company provides a service, the inspector checks the end results.
• Quality assurance or QA is a program for the systematic monitoring of different aspects of
production. We also use QA for projects and services. QC occurs after the finished product
is completed, while QA happens before.
• Quality improvement or QI focuses on improving the production process. However, the
target could be any part of an organization.
Quality Assurance vs. Quality Improvement

Quality Assurance Quality Improvement
Individual focused Systems focused
Perfection myth Fallibility recognized
Solo practitioners Teamwork
Peer review ignored Peer review valued
Errors seen as opportunities for
Errors punished
learning
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b. The Model for Improvement
The Model for Improvement (MFI) is the most commonly used QI approach in health care
and one you will want to teach your practices. The MFI was developed by the Institute for
Healthcare Improvement (IHI) in 1996 and published in The Improvement Guide: A Practical
Approach to Enhancing Organizational Performance (1996).
The MFI uses a rapid cycle process called Plan Do Study Act (PDSA) cycles to test the
effects of small changes, make them, and ultimately spread the effective changes through the
practice or organization (see Figure 4.1). The MFI begins by asking three simple questions:
• What are we trying to accomplish?

• How will we know that a change is an improvement?
• What changes can we make that will result in improvement?
Quality improvement teams then introduce and test changes designed to achieve the
improvement aims using successive PDSA cycles until they arrive on a change they believe will
produce the desired results and is ready for implementation and spread.
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Use of the Model for Improvement
To use the MFI, first you will need to help your practices identify their “aims” or goals for
improvement. Often this will require you to listen “between the lines” and simplify the discussion
for the practice. Large and lofty goals are excellent for inspiration and rallying troops, but the
actual work of improvement can be mundane and tedious and involve small changes, tested, and
then spread, in sequence until the goal is attained.
Because the MFI and PDSA processes have been the primary approach to practice
improvement over the past 10 years, you may also encounter practices that have been
“overexposed” to the approach. They will need to be skilled in navigating their reactions to
processes they may have used with limited success in the past. While there can be barriers to
getting a practice to use the MFI and PDSA cycles in their improvement work, it is a “habit” that
is very helpful for practices to develop. Without some type of systematic approach, improvement
work can become chaotic, ineffective, and unlikely to produce the outcomes desired.
In addition to the MFI and PDSA cycles, there are a wide variety of QI tools that you will
find helpful in your work with practices. Some of these are covered in subsequent modules and
include workflow mapping, audit and feedback, benchmarking, academic detailing, and best
practices research.
Read:
• https://www.investopedia.com/terms/o/organizational-
structure.asp#:~:text=An%20organizational%20structure%20is%20a,between%20levels
%20within%20the%20company.
• https://www.shrm.org/resourcesandtools/tools-and-
samples/toolkits/pages/understandingorganizationalstructures.aspx
• https://www.investopedia.com/terms/p/performance-
management.asp#:~:text=Performance%20management%20is%20a%20corporate,moni
tor%20and%20evaluate%20employees'%20work.&text=A%20formal%20performance%
2Dmanagement%20program,with%20the%20company's%20overall%20vision.
• https://courses.lumenlearning.com/boundless-management/chapter/management-levels-
and-types/
• https://marketbusinessnews.com/financial-glossary/quality-
improvement/#:~:text=Quality%20improvement%20refers%20to%20the,losses%20in%2
0the%20production%20process.
• https://www.ahrq.gov/ncepcr/tools/pf-handbook/mod4.html
Watch:
• Types of Organizational Structures

https://www.youtube.com/watch?v=Vbcpr1TS9NM
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• HR Basics: Performance Management

https://www.youtube.com/watch?v=SyOZ_4rWWiY
• Management in Organizations: Top, Middle & Low Level Managers

https://www.youtube.com/watch?v=iB334D7-jOY
• Introduction to Quality Improvement

https://www.youtube.com/watch?v=f-FbIA3ezBw
1. Why do we need to have a structure in the organization?

2. What is the significance of performance management in a company? How does it help?
3. Why is there a need to improve the quality of a product and a service?
4. As a student, how would you recommend to have a quality improvement in education
especially in this time of pandemic that online classes are necessary?
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TOPIC 6: CONTROL OF QUALITY RECORDS

Overview:
Keeping and managing records is part of everyone’s daily work, usually using the facilities
of modern technology. But although individuals keep these records, they are not solely for
individual use. They form part of the organization’s information resource and are a corporate
asset. An organization receives and processes tremendous amount of information day in and day
out but not all of them are records. A record is invariably linked to an organization’s official
business and maintained as evidence. Accordingly, “records” can be defined as any recorded
information or data in any physical format or media created or received by an organization during
its course of official business and kept as evidence of polices, decisions, procedures, functions,
activities and transactions. For example, a driving license application will be kept as a record by
the Transport Department of the Government as evidence of its business.
Documents It is the form that will be used to gather data. It is created to use as evidenced
of data.
Records It is an object containing information which serves to preserve or perpetuate
knowledge of events, facts or ideas. It is the memory bank of an organization.
In order to serve as evidence, a record should be complete and must possess the following
three elements -
• Content – this refers to the information or ideas the record contains;
• Context – this refers to the information about the circumstances in which the record is
created, transmitted, maintained and used (e.g. who created it, when, to whom it was sent,
why); and
• Structure – this means the physical and logical format of the record, and the way parts
of the record relate to each other (e.g. the structure of an e-mail record covers its header,
body, attachments and corresponding reply).
• Differentiate between the types of records
• Elaborate the importance of records management.
• Expound the purpose compilation and indexing of quality records
• Storage and maintenance of quality records
• Procedures related to quality records
• Authentication of quality records

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Course Materials:
I. WHAT IS QUALITY RECORDS?
A subset of records that demonstrates conformance to requirements and the effective

operation of the quality system. Quality records are those records important enough to be
specifically identified as such in System Level Procedures or Work instructions. It must be
readable, identifiable (it states its purpose) and retrievable. In addition it is recommend every form
include a date and employees identification.
All records must be legible, permanent, and non-erasable. It shall be maintained in a

manner that they are readily retrievable and contained in a suitable environment to prevent
damage or deterioration.
Types of Records
1. Active Records Records which are still actively being used by an office. These records
will be located in a handy place within the office since they are used frequently.
2. Inactive Records Records that do not have to be readily available but which must be
kept for legal or historical purposes as defined in the Records Retention Schedule.
3. Obsolete Records Records no longer needed or which have been superseded by more
current editions of the same series.
II. WHY IS RECORDS MANAGEMENT IMPORTANT?
Records management is important because it supports an organization to -

1. Make decisions based on evidence;
2. Meet operational, legal and regulatory requirements;
3. Be open and accountable;
4. Enhance operational efficiency and effectiveness; and
5. Maintain organization or collective memory.
Records management benefits:

1. Uniformity of filing system
2. Standardization and control in the creation and revision of forms
3. Proper filing facility and storage area
4. Systematic and orderly transfer of inactive records
5. Ease of record’s retrieval
6. Compliance to statutory and regulatory requirements.
III. COMPILATIONS AND INDEXING OF QUALITY RECORDS
A record keeping system is the tool to manage records. It is a manual or automated

information system having the necessary functionality that enables it to carry out and support the
various records management processes such as collection, organization and classification of
records to facilitate their retrieval, distribution, use, disposal or preservation. When designing and
implementing a recordkeeping system, an organization should ensure that it can meet the
organization’s records management policy, requirements, practices, guidelines and procedures.
To serve its purpose, a recordkeeping system should have the following characteristics –
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• Reliability: It should be capable of continuous and regular operation in

accordance with established guidelines and procedures;  
• Integrity: Access and security measures should be in place to prevent
unauthorized access, destruction, alteration or removal of records;
• Compliance: It should be managed to comply with all requirements arising from
the legal and regulatory environment and business, and expectations in which
the organization operates;
• Comprehensiveness: It should be able to manage records in any formats
captured from different activities and transactions of the organization; and
• Systematic: It should be able to capture, maintain and manage records
systematically.
To facilitate a wide range of records management activities, including identification,
capturing and retrieval of records, security and access control as well as disposal, records should
be systematically organized according to records classification schemes (also called file plans),
which are plans for logical arrangement of records according to one or more of the following:
business functions, activities and contents of the records.
In general, a records classification scheme includes a coding system expressed in

symbols (e.g. alphabetical, numerical or alpha-numerical) to show the logical relationship
amongst the records. A records classification scheme should allow modifications such as addition
of new records series/groups to cater for changing circumstances.
In view of their important role in records management, records classification schemes

should be approved and reviewed by a senior staff in the organization having regard to the
following principles.
• Whether business records are separated from administrative records;

• Whether the scheme is systematic, logical, consistent and scalable to facilitate accurate
and complete documentation of policies, procedures and decisions for the efficient
carrying out of the organization’s functions, activities and transactions;
• Whether the scheme can be used easily and the file titles are clear and unique (e.g. avoid
the use of “general”/“miscellaneous”) to facilitate accurate capturing and ready retrieval of
records; and
• Whether the scheme facilitates segregation of vital records for protection and
establishment of records retention and disposal schedules to satisfy retention
requirements stipulated by legislation (e.g. Personal Data (Privacy) Ordinance) and to
separate records which need to be kept for a long period (e.g. those on policy) from those
which need to be kept briefly (e.g. routine correspondence).
IV. STORAGE AND MAINTENANCE OF QUALITY RECORDS
A. Storing Quality Records

Records soon grow into a mass of paper and occupy valuable floor space. To overcome this
problem you may choose to microfilm the records but keep them in the same location or archive
them in some remote location. In both cases you need to control the process and the conditions
of storage. With paper archives you will need to maintain records of what is where and if the
archive is under the control of another group inside or outside the organization, you will need
adequate controls to prevent loss of identity and inadvertent destruction
A.1 Using a paper system

It is important to consider the following when using a paper system for records.
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• Permanence—paper records must last for as long as needed. This should be ensured by
binding pages together, or using a bound book (log register). Pages should be numbered
for easy access, and permanent ink used.
• Accessibility—paper systems should be designed so that information can be easily
retrieved whenever needed.
• Security— documents and records must be kept in a secure place. Security considerations
include maintaining patient confidentiality. Care should be taken to keep documents safe
from any environmental hazards such as spills. Consider how records can be protected in
the event of fires, floods, or other possibilities.
• Traceability—it should be possible to trace a sample throughout all the records. All records
should be signed, dated, and reviewed to ensure that this traceability throughout the
records has been maintained.
A.2. Using an Electronic System

Electronic systems have essentially the same requirements as paper systems. However,
the methods for meeting these requirements will be different when using computers. The following
are factors to consider.
• Permanence—backup systems in case the main system fails are essential. Additionally,
regular maintenance of the computer system will help to reduce system failures and loss
of data.
• Security—it is sometimes more difficult to assure confidentiality with a computer system,
as many people may have access to the data.
• Traceability—electronic record systems should be designed in a way that allows for tracing
the specimen throughout the entire process in the laboratory. Six months after performing
an examination, it should be possible to look at the records and determine who collected
the specimen and who ran the test.
A.3. Maintenance of Quality Records
The standard requires records to be maintained. There are three types of maintenance
regarding records.
• Keeping records up to date
• Keeping the information in the records up to date
• Keeping the records in good condition
Maintenance includes filing, collection and storage issues. Your filing system provides a
means for records to be readily retrievable. Maintaining the files means keeping the files up-to-
date, placed in the proper location and not allowing alterations to completed records. For example:
asking the Human Resources department for a specific training record. The human resources
person checks the employee file and does not find the record. The person checks the pile of
unfilled records and after 20 minutes has not found the requested record. This situation indicates
inadequate maintenance of records. The file was not in the proper location. Another common
maintenance issue is keeping shop floor records clean. A simple solution is to use a clear-view
protective cover
V. PROCEDURES RELATED TO QUALITY RECORDS
Records have a life cycle. They are generated during which time they acquire an identity
and are then assigned for storage for a prescribed period. During use and storage they need to
be protected from inadvertent or malicious destruction and as they may be required to support
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current activities or investigations, they need to be brought out of storage quickly. When their
usefulness has lapsed, a decision is made as to whether to retain them further or to destroy them.
Readily retrievable means that records can be obtained on demand within a reasonable
period (hours not days or weeks) Readily identifiable means that the identity can be discerned at
a glance. Although the requirement implies a single procedure, several may be necessary
because there are several unconnected tasks to perform. A procedure cannot in fact ensure a
result. It may prescribe a course of action which if followed may lead to the correct result, but it is
the process that ensures the result not the procedure.
a. Legibility of records
Unlike prescriptive documents, records may contain handwritten elements and therefore
it is important that the handwriting is legible. If this becomes a problem, you either improve
discipline or consider electronic data capture. Records also become soiled in a workshop
environment so may need to be protected to remain legible. With electronically captured data,
legibility is often
not a problem. However, photographs and other scanned images may not transfer as well as the
original and lose detail so care has to be taken in selecting appropriate equipment for this task
b. Identification of records
Whatever the records, they should carry some identification in order that you can
determine what they are, what kind of information they record and what they relate to. A simple
way of doing this is to give each record a reference number and a name or title in a prominent
location on the record.
Records can take various forms – reports containing narrative, computer data, and forms
containing data in boxes, graphs, tables, lists and many others. Where forms are used to collect
data, they should carry a form number and name as their identification. When completed they
should carry a serial number to give each a separate identity. Records should also be traceable
to the product or service they represent and this can be achieved either within the reference
number or separately, provided that the chance of mistaken identity is eliminated. The standard
does not require records to be identifiable to the product involved but unless you do make such
provision you will not be able to access the pertinent records or demonstrate conformance to
specified requirements.
c. Retrieving records
You need to ensure that the records are accessible to those who will need to use them.
This applies not only to current records but also to those in the archive and any ‘insurance copies’
you may have stored away. A balance has to be attained between security of the records and
their accessibility. You may need to consider those who work outside normal working hours and
those rare occasions when the troubleshooters are working late, perhaps away from base with
their only contact via a computer link. In providing for record retrieval you need to consider two
aspects. You need to enable authorized retrieval of records and prohibit unauthorized retrieval. If
records are held in a locked room or filing cabinet, you need to nominate certain persons as key
holders and ensure that these people can be contacted in an emergency. Your procedures should
define how you provide and prohibit access to the records.
With electronically held records, password protection will accomplish this objective
provided that you control the enabling and disabling of passwords in the records database. For
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this reason it is advisable to install a personnel termination/movement process that ensures

passwords are disabled or keys returned on departure of staff from their current post.
Remember these records are not personal property or the property of a particular
department. They belong to the organization and are a record of the organization’s performance.
Such records should not be stored in personal files. The filing system you create should therefore
be integrated with the organization’s main filing system and the file location should either be
specified in the procedure that defines the record or in a general filing procedure.
If you operate a computerized record system, filing will be somewhat different although
the principles are the same as for paper records. Computerized records need to be located in
named directories for ease of retrieval and the locations identified in the procedures.
d. Protection of Records
The protection of records applies when records are in use and in storage and covers such
conditions as destruction, deletion, corruption, change, loss and deterioration arising from wilful
or inadvertent action.
On the subject of loss, you will need to consider loss by fire, theft, and unauthorized
removal. If using computers you will also need to consider loss through computer viruses and
unauthorized access, deletion or the corruption of files.
It is always risky to keep only one copy of a document. If computer generated, you can
easily take another copy provided you always save it, but if manually generated, its loss can be
very costly. It is therefore prudent to produce additional copies of critical records as an insurance
against inadvertent loss. These ‘insurance copies’ should be stored in a remote location under
the control of the same authority that controls the original records. Insurance copies of computer
disks should also be kept in case of problems with the hard disk or file server. Data back-up at
defined periods should be conducted and the backed-up data stored securely at a different
location than the original data.
Records, especially those used in workshop environments can become soiled and
therefore provisions should be made to protect them against attack by lubricants, dust, oil and
other materials which may render them unusable. Plastic wallets can provide adequate protection
whilst records remain in use.
e. Retention of Records
It is important that records are not destroyed before their useful life is over. There are several
factors to consider when determining the retention time for records.
• The duration of the contract – some records are only of value whilst the contract is in force.
• The life of the product – access to the records will probably not be needed for some
considerable time, possibly long after the contract has closed. On defence contracts the
contractor has to keep records for up to 20 years and for product liability purposes, in the
worst-case situation (taking account of appeals) you could be asked to produce records
up to 17 years after you made the product.
• The period between management system assessments – assessors may wish to see
evidence that corrective actions from the last assessment were taken. If the period of
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assessment is three years and you dispose of the evidence after 2 years, you will have
some difficulty in convincing the assessor that you corrected the deficiency.
f. Disposition of Records
Disposition in this context means the disposal of records once their useful life has ended.
The requirement should not be confused with that on the retention of records. Retention times are
one thing and disposal procedures quite another.
As stated previously, records are the property of the organization and not personal
property so their destruction should be controlled. Controls should ensure that records are not
destroyed without prior authorization and, depending on the medium on which data are recorded
and the security classification of the data, you may also need to specify the method of disposal.
The management would not be pleased to read details in the national press of the organization’s
performance, collected from a waste disposal site by a zealous newspaper reporter – a problem
often reported as encountered by government departments!
g. Validation of Records
The standard does not specifically require records to be authenticated, certified or

validated other than product verification records. A set of results without being endorsed with the
signature of the person who captured them or other authentication lacks credibility. Facts that
have been obtained by whatever means should be certified for three reasons:
• They provide a means of tracing the result to the originator in the event of problems.
• They indicate that the provider believes them to be correct.
• They enable you to verify whether the originator was appropriately qualified. They give the
results credibility.
If the records are generated by computer and retained in computerized form, a means
needs to be provided for the results to be authenticated. This can be accomplished through
appropriate process controls by installing provisions for automated data recording or preventing
unauthorized access.
VI. AUTHENTICATION OF QUALITY RECORDS
What is Authentication?
Authentication (from Greek: authentikos, "real, genuine”) is the act of confirming the truth
of an attribute of a single piece of data (a datum) claimed true by an entity. In contrast with
identification which refers to the act of stating or otherwise indicating a claim purportedly attesting
to a person or thing's identity, authentication is the process of actually confirming that identity.
In recent years the rapid spread of electronic records and communication systems has
presented significant changes and challenges to many disciplines. The increasing growth of
computer communications has made new opportunities possible and raised subsequent issues
such as:
• data security
• accountability
• reliability
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• authenticity
• privacy
• authentication
• encryption
The diplomatic understanding of authenticity is that a document is authentic when it is

what it claims to be. When a record follows the body of rules established for recording acts and
also contains all the elements required by the socio-juridical system in which it exists (i.e., it is
complete), the record is assumed to be reliable. Reliability is another important concept that, along
with authenticity in diplomatics, indicates the trustworthiness and authority of the content of the
record. When a record is what it purports to be, the record is genuine.
Types of Authentication:
1. The first type of authentication is accepting proof of identity given by a credible person
who has first-hand evidence that the identity is genuine. When authentication is required
of art or physical objects, this proof could be a friend, family member or colleague attesting
to the item's provenance, perhaps by having witnessed the item in its creator's possession.
2. The second type of authentication is comparing the attributes of the object itself to what is
known about objects of that origin.
3. The third type of authentication relies on documentation or other external affirmations.
The ways in which someone may be authenticated fall into three categories, based on
what are known as the factors of authentication:
• something the user knows
• something the user has
• something the user is
Each authentication factor covers a range of elements used to authenticate or verify a

person's identity prior to being granted access, approving a transaction request, signing a
document or other work product, granting authority to others, and establishing a chain of
authority.Security research has determined that for a positive authentication, elements from at
least two, and preferably all three, factors should be verified. The three factors (classes) and some
of elements of each factor are:
• the knowledge factors: Something the user knows (e.g., a password, Partial Password,
pass phrase, or personal identification number (PIN),challenge response (the user must
answer a question, or pattern), Security question
• the ownership factors: Something the user has (e.g., wrist band, ID card, security token,
cell phone with built-in hardware token, software token, or cell phone holding a software
token)
• the inherence factors: Something the user is or does (e.g., fingerprint, retinal pattern, DNA
sequence (there are assorted definitions of what is sufficient), signature, face, voice,
unique bio-electric signals, or other biometric identifier).
Descriptions of Emergent Themes Relating to Proving Authenticity
• Supporting litigation: Authenticity is needed for supporting litigation, lawsuits, court cases,
or other legal and judicial actions in court. e.g., “Authentication of records is necessary to
introduce any document or record into evidence at a trial or motion. We were asked to do
so during a trial recently.”
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• Proving/verifying: Authenticity is needed for proving or verifying. e.g., “The situation was
to prove that I was not the person who posted a scurrilous message to an Internet
discussion group . . .”
• Authenticating/validating: Authenticity is needed for authenticating or validating that

records are not fake or counterfeit. e.g., “Establishing the authenticity of records is vital in
my business since most of the valuable records have been counterfeited.”
• Preserving/digitizing: Authenticity is needed for converting or digitizing data into different

formats. e.g., “We are currently faced with the issue of reformatting electronic media such
as videotapes. Deciding on the conversion of cancelled check records from paper to
microform.”
• Controlling the version: Authenticity is needed for deciding between the original version or
a copy, or differentiating between multiple copies in a situation where there are more than
two different versions. e.g., “Some times there are 6 copies of the same letter. Of course
each is corrected and changed from the earlier on. Then the last is the actual authentic
letter which is so after editing and was the one sent to the person or prospect. This is the
authentic [one] and sometimes requires time in figuring out which is the real finished one.”
• Ensuring accuracy: Authenticity is needed for ensuring accuracy or correctness. e.g., “It
is necessary to make sure that what is filed is the most accurate and up to date information
possible. . . . I have found that often times the system people require the paper files to
ensure the data entered into computer is accurate.”
• Ensuring quality: Authenticity is needed for ensuring quality control. e.g., “Required to
document the authenticity of records gathered for quality of products and services.”
• Meeting contractual obligations: Authenticity is needed for meeting contracts or

contractual compliance. e.g., “Contract in hand was the original, official copy
Descriptions of Emergent Themes Relating to Judging Authenticity
• Signature: a record is authentic by seeing any forms of signature, including hand-written

signature and digital signature.
• Authentication symbols: a record is authentic by seeing any forms of authentication

symbols including seals, certification, watermarks, letterhead, date, mailing, e-mail, and
all kinds of metadata, except signature*.
• Adherence to information management policy, guidelines, and procedures: a record is

authentic by referring to policy or guidelines, or to a procedure manual, etc. within the
organization. e.g., “Yes, by providing the written policy and procedures showing a
standard method of creating the record. . . .”
• Authority of source: a record is authentic by referring to the authority and originality of the
source of information. e.g., “what it is; where it came from; what its content is. . . .”
• Physical condition: a record is authentic by referring to physical conditions and

characteristics such as age of paper, printing condition, physical appearances, etc.
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Comparison with other sources: Respondents judge if a record is authentic by comparing

the original with copies or other sources. e.g., “verify it in more than one source”
• Unalterability/unchangability: a record is authentic by seeing that no changes have been

made in the item. e.g., “determination of originality of item, mainly checking for illegal
photocopies. Is this an original or a copy?”
• No criteria: unable to judge if a record is authentic because there are no established

criteria yet. e.g., “No organized criteria . . . No way to do that.” * There is considerable
ambiguity in the overlap between “signature (esp. digital signature)” and “authentication
symbols (esp. seals),” probably because a digital signature exhibits the characteristics of
both a signature and a seal. They are broken into two categories here because there is a
high incidence of the term “signature” in the survey responses.
Descriptions of Emergent Themes Relating to Defining Authenticity
• Authority of source: Authenticity is associated with authoritativeness of source and

context. e.g., “I define authenticity as being able to be certain that records have been
created by the person they say they are, when they say they are containing true (or
perceived to be true) information as related to their context.”
• Accuracy assurance: Authenticity is associated with assuring accuracy or correctness.

e.g., “Maintain written standards of process which are followed without deviation. The
standards should follow industry guidelines (if such exist).”
• Originality/genuineness: Authenticity is to be original and genuine. e.g., “It is the original

record created (and copies) at the time of the activity (whatever it may be) and presented
as being the facts, conditions, purpose, truth, etc.”
• Quality assurance: Authenticity is associated with assuring quality. e.g., “I work with a
large construction company developing its own document control database which I have
used for 3 years; I believe that because we get the paper document within a brief amount
of time after it is logged in to the database that lends to the authenticity of those records.”
• Unalterability/unchangability: Authenticity is associated with ensuring that no changes are

made to the item. e.g., “Any data object in which not a single bit of the binary content has
been modified. . . .”
• Validity/reliability: Authenticity is to be valid or reliable. e.g., “When a document is what it

claims to be and is from whom it says it is. Authenticity goes hand in hand with reliability.
. . .”
• Verification*: Authenticity is to be verified or proved. e.g., “An authentic document or

record is one which is intrinsically able to be proved that it is what it purports to be.” * Two
themes, “authority of source” and “validity/reliability,” are closely related in their meaning.
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Watch:
• What is RECORDS MANAGEMENT? What does RECORDS MANAGEMENT mean?

https://www.youtube.com/watch?v=4XvhtcT0We8
• Records Management 101: Policy and responsibility

https://www.youtube.com/watch?v=TtCr5ygjxSE
• Records Management An Introduction to Filing Rules and Indexing

https://www.youtube.com/watch?v=zRw0wjL6OUM
• Basics of Records Management

https://www.youtube.com/watch?v=9diFIqpf6n8
Read:
• http://www.nationalarchives.gov.uk/documents/information-management/rm-code-
guide2.pdf
• http://www.slideshare.net/princekurt11/document-and-records-control-records-
management
• http://pqm-online.com/assets/files/lib/books/holye2.pdf
• https://extranet.who.int/lqsi/sites/default/files/attachedfiles/LQMS%2016-
7%20Document%20storage.pdf
• https://books.google.com.ph/books?isbn=1856176843
• https://en.wikipedia.org/wiki/Authentication
• http://americanarchivist.org/doi/pdf/10.17723/aarc.64.2.yrw0584547775404
5. As an engineering student subjected to a lot of examinations and assignments from
freshmen to senior years of study, how do you keep a quality record of all your lessons
from time to time? How important is quality in keeping your lessons? Also discuss your
own ways on how you store and maintain those records.
6. Compare your answer to at least two of your friends/classmates taking up the same
program course and reflect what are the differences and your key takeaways from each
other.
7. Other than school, what other matters in your personal daily life does quality of records
would be applicable? Discuss the specific scenario/s and relate how you perform
compilations and indexing of quality records.
8. Consider yourself to become a business owner of a startup after graduation. Why do you
think quality record would benefit you as a young entrepreneur? How significant is it for
your company’s success?
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TOPIC 7 - INTERNAL QUALITY AUDITS
Overview
Quality audit is the process of systematic examination of a quality system carried out by
an internal or external quality auditor or an audit team. It is an important part of an organization's
quality management system and is a key element in the ISO quality system standard, ISO 9001.
Quality audits are typically performed at predefined time intervals and ensure that the
institution has clearly defined internal system monitoring procedures linked to effective action.
This can help determine if the organization complies with the defined quality system processes
and can involve procedural or results-based assessment criteria.
With the upgrade of the ISO9000 series of standards from the 1994 to 2008 series, the
focus of the audits has shifted from purely procedural adherence towards measurement of the
actual effectiveness of the Quality Management System (QMS) and the results that have been
achieved through the implementation of a QMS.
Audits are an essential management tool to be used for verifying objective evidence of
processes, to assess how successfully processes have been implemented, for judging the
effectiveness of achieving any defined target levels, to provide evidence concerning reduction
and elimination of problem areas. For the benefit of the organization, quality auditing should not
only report non-conformances and corrective actions, but also highlight areas of good practice. In
this way other departments may share information and amend their working practices as a result,
also contributing to continual improvement.
Learning Objectives
• Differentiate the types of audits
• Elaborate the audit considerations
• Understand the benefits of Quality Audits
• Identify Auditing Activities for Defining Objectives, Scope, and Criteria
• Learn the importance of Industry Certification through Auditing
• Distinguish between Performance Audits vs. Compliance and Conformance Audits
• Appreciate and adapt the Four Phases of an Audit Cycle
• Determine how to follow-Up Audits

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Course Materials
I. The Three Different Types of Audits
ISO 19011:2018 defines an audit as a "systematic, independent and documented process

for obtaining audit evidence [records, statements of fact or other information which are relevant
and verifiable] and evaluating it objectively to determine the extent to which the audit criteria [a
set of policies, procedures or requirements] are fulfilled." There are three main types of audits:
a. Process audit: This type of audit verifies that processes are working within established
limits. It evaluates an operation or method against predetermined instructions or standards
to measure conformance to these standards and the effectiveness of the instructions. A
process audit may:
• Check conformance to defined requirements such as time, accuracy, temperature,
pressure, composition, responsiveness, amperage, and component mixture.
• Examine the resources (equipment, materials, people) applied to transform the inputs
into outputs, the environment, the methods (procedures, instructions) followed, and
the measures collected to determine process performance.
• Check the adequacy and effectiveness of the process controls established by
procedures, work instructions, flowcharts, and training and process specifications.
b. Product audit: This type of audit is an examination of a particular product or service, such
as hardware, processed material, or software, to evaluate whether it conforms to
requirements (i.e., specifications, performance standards, and customer requirements).
c. System audit: An audit conducted on a management system. It can be described as a

documented activity performed to verify, by examination and evaluation of objective
evidence, that applicable elements of the system are appropriate and effective and have
been developed, documented, and implemented in accordance and in conjunction with
specified requirements.
• A quality management system audit evaluates an existing quality management
program to determine its conformance to company policies, contract commitments,
and regulatory requirements.
• Similarly, an environmental system audit examines an environmental management
system, a food safety system audit examines a food safety management system, and
safety system audits examine the safety management system.
II. Audit Considerations
Other methods, such as a desk or document review audit, may be employed

independently or in support of the three general types of audits.
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Some audits are named according to their purpose or scope. The scope of a department
or function audit is a particular department or function. The purpose of a management audit relates
to management interests, such as assessment of area performance or efficiency.
An audit may also be classified as internal or external, depending on the interrelationships

among participants.
1. Internal audits are performed by employees of your organization.

2. External audits are performed by an outside agent. Internal audits are often referred
to as first-party audits, while external audits can be either second-party or third-party.
a. A first-party audit is performed within an organization to measure its strengths and

weaknesses against its own procedures or methods and/or against external
standards adopted by (voluntary) or imposed on (mandatory) the organization. A
first-party audit is an internal audit conducted by auditors who are employed by the
organization being audited but who have no vested interest in the audit results of
the area being audited.
b. A second-party audit is an external audit performed on a supplier by a customer or

by a contracted organization on behalf of a customer. A contract is in place, and
the goods or services are being, or will be, delivered. Second-party audits are
subject to the rules of contract law, as they are providing contractual direction from
the customer to the supplier. Second-party audits tend to be more formal than first-
party audits because audit results could influence the customer’s purchasing
decisions.
c. A third-party audit is performed by an audit organization independent of the

customer-supplier relationship and is free of any conflict of interest. Independence
of the audit organization is a key component of a third-party audit. Third-party
audits may result in certification, registration, recognition, an award, license
approval, a citation, a fine, or a penalty issued by the third-party
III. Benefits of Quality Audits
The benefits of quality audits are numerous. At a minimum level, for companies that have
no choice but to open themselves to audits by government bodies like the FDA, the audit ensures
that quality standards set by law are being met and the company can remain open for business
— provided it passes the audit, of course.
Customers benefit from quality in audits in that they can rest assured that the products or
services they buy will meet the quality levels the company promises. In the business-to-business
(B2B) sector, customers may insist on quality audits as part of a contract.
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Finally, the company itself benefits from the audit. Customers are more satisfied, returns
and complaints decrease and employee morale should improve. In addition to increased sales
from satisfied customers, there are direct long-term cost-savings because less time and money
is spent replacing or fixing inferior products and services.
IV. Auditing Activities for Defining Objectives, Scope, and Criteria

The auditing activities clause is a major one of ISO 19011. The auditing activities can
also be called process steps or actions. The auditing activities are the step-by-step methods
for preparing, performing, reporting, and following up on the audit. In this column, I will discuss
one of the most important preparation or planning activities. Before there can be a system or
process audit, the audit objectives, scope, and criteria must be defined. All other audit
activities will center around what has been decided in this step. This is the ‘why do the audit’
and ‘what needs to be audited’ step.
ISO 19011, clause 6.2.2 for defining audit objectives, scope and criteria starts out
stating that every individual audit should be based on documented objectives, scope and
criteria. Important points are that all individual audits must have documented objectives,
scope, and purpose. Audit objectives, scope and criteria should be specific to each individual
audit and should not be generic statements that would apply to all process or system audits.
If definitions are too general, they provide very little guidance and could cause confusion and
result in inefficient use of resources. The second point in this paragraph of clause 6.2.2 is that
the objectives, scope, and criteria definitions must be documented. An organization can
consider any means or mediums for documenting the information. Considerations include
cost, efficiency or speed, and effectiveness of the medium in distributing, disseminating, or
communicating the information to others involved in the process.
There are several example audit objectives included the standard. The example
audit objectives are:
a. Determine the extent of conformity of the system or process to the defined criteria. This is
a typical objective for quality and environmental management system audits. An
interesting and important word in this phrase is the word extent. How does an auditor
determine the extent of conformity? Can the auditor issue an audit score? A score or
grade could determine the extent or degree of conformity as-well-as establishing a
minimum score or grade to pass the audit. Or should the auditor determine if the
organization conforms to the criteria based on number of major findings (such as zero)?
Audit organizations may practice either of the above methods depending on their situation
such as type of industry, 1st 2nd or 3rd Party audit, government oversight, regulated
organization and so on.
b. Evaluate capability of the management system to ensure compliance to statutory,

regulatory, and contractual requirements. When would determining organizational
capability be important? Perhaps when selecting a supplier or evaluating readiness for a
regulatory audit or inspection.
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c. Evaluate the effectiveness in meeting management system objectives. This example

objective goes beyond simple conformance or compliance that many don’t fully
understand. Plus, it could have different meanings for 1st, 2nd and 3rd party audit
organizations as, well as regulated versus non-regulated. An important point is that an
audit with this type of audit objective is only going to be as good as the management
system objectives. For example, an organization may have exceeded its objective to
reduce the number of label defects. But this may be a result of reduced usage of the label
and not a result of actions by management. The other important aspect for this audit
objective is for the auditor(s) and auditee organization to understand what an effective
process looks like. How do you know a process is effective? The ISO 9000 vocabulary
standard provides some help by defining the word effectiveness (see definition at the end
of this article).
d. The last example audit objective is for the auditor to identify areas for potential
improvement of the management system. This objective could add value to the
organization and is very worthwhile. In our competitive world in both the public and private
sectors, organizations want to improve, make things better. This is another audit objective
that can add value, but more needs to be understood about improvement. Many equated
improvement with maintaining, repairing, redoing activities. Improvement happens when
the organization is more valuable as a result of the improvement actions such as being
more efficient, having greater capacity, adding innovative designs, services or products,
and capital improvements.
Some organizations use the phrase audit purpose and audit objective interchangeably.
ISO 19011, clause 6.2.2 describes the audit scope as the extent and boundaries of the
audit. This is explained as the: 1) physical location (such as address, plot, floor, area), 2)
organization units (such as department or branch), 3) activities and processes (such as marketing,
sawing, underwriting, product line), and 4) the time period to be covered. What would a scope
statement for your organization look like? This helps the auditor to prepare and keeps him/her
focused. In general, auditors should always stay within the scope. Staying within the scope is
good practice and avoids accusations of an auditor being on a witch hunt. However, when would
it be acceptable for auditors to deviate from the agreed scope? When there are observations that
could result in possible personal injury, illegal acts, unethical actions, or potential loss of property
(such as a fire hazard).
We have not discussed the audit criteria yet. Defining the audit criteria is part of the ‘what
needs to be audited’ step. The audit criteria term stands for everything that an auditor can audit
against. An auditor can audit against any rules, procedures, objectives, goals, contracts, laws,
codes of conduct, good practices and so on.
Who should define the audit objectives, scope, and audit criteria? The audit client should
define the audit objectives. The scope and criteria should be defined between the audit client and
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audit team leader. This means that either the client, audit team leader or both should be
responsible for defining the scope and criteria. The ISO 19011 does not include the audit program
manager in this process. My experience has been that the audit program manager is also involved
in the process for determining the audit criteria but this is not mentioned in ISO 19011. How this
is managed in your organization, should be stipulated in your audit program procedures.
Defining the audit objectives, scope and criteria is the key for determining all the remaining
audit process steps for planning, performing, reporting and follow-up. This step provides the basis
for the individual audit. Doing a poor job here will directly affect the audit effectiveness and
efficiency.
Overall, the audit activities for defining the audit objectives, scope and criteria should be
consistent with your audit program objectives, scope, criteria and procedures. The ISO 19011
standard provides guidance to help you develop your organization audit program procedures that
support your organization’s objectives.
V. Industry Certification Through Auditing
Companies in certain high-risk categories—such as toys, pressure vessels, elevators, gas

appliances, and electrical and medical devices—wanting to do business in Europe must comply
with Conformité Europeënne Mark (CE Mark) requirements. One way for organizations to comply
is to have their management system certified by a third-party audit organization to management
system requirement criteria (such as ISO 9001).
Customers may suggest or require that their suppliers conform to ISO 9001, ISO 14001,
or safety criteria, and federal regulations and requirements may also apply. A third-party audit
normally results in the issuance of a certificate stating that the auditee organization management
system complies with the requirements of a pertinent standard or regulation.
Third-party audits for system certification should be performed by organizations that have
been evaluated and accredited by an established accreditation board, such as the ANSI-ASQ
National Accreditation Board (ANAB).
VI. Performance Audits vs. Compliance and Conformance Audits
Value-added assessments, management audits, added value auditing, and continual

improvement assessment are terms used to describe an audit purpose beyond compliance and
conformance. The purpose of these audits relates to organization performance. Audits that
determine compliance and conformance are not focused on good or poor performance, yet.
Performance is an important concern for most organizations.
A key difference between compliance audits, conformance audits, and improvement

audits is the collection of evidence related to organization performance versus evidence to verify
conformance or compliance to a standard or procedure. An organization may conform to its
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procedures for taking orders, but if every order is subsequently changed two or three times,
management may have cause for concern and want to rectify the inefficiency.
VII. Four Phases of an Audit Cycle
a. Audit planning and preparation: Audit preparation consists of planning everything that is
done in advance by interested parties, such as the auditor, the lead auditor, the client, and
the audit program manager, to ensure that the audit complies with the client’s objective.
This stage of an audit begins with the decision to conduct the audit and ends when the
audit itself begins.
b. Audit execution: The execution phase of an audit is often called the fieldwork. It is the
data-gathering portion of the audit and covers the time period from arrival at the audit
location up to the exit meeting. It consists of multiple activities including on-site audit
management, meeting with the auditee, understanding the process and system controls
and verifying that these controls work, communicating among team members, and
communicating with the auditee.
c. Audit reporting: The purpose of the audit report is to communicate the results of the
investigation. The report should provide correct and clear data that will be effective as a
management aid in addressing important organizational issues. The audit process may
end when the report is issued by the lead auditor or after follow-up actions are completed.
d. Audit follow-up and closure: According to ISO 19011, clause 6.6, "The audit is completed
when all the planned audit activities have been carried out, or otherwise agreed with the
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audit client." Clause 6.7 of ISO 19011 continues by stating that verification of follow-up
actions may be part of a subsequent audit.
Note: Requests for correcting nonconformities or findings within audits are very common.
• Corrective action is action taken to eliminate the causes of an existing nonconformity,

defect, or other undesirable situation in order to prevent recurrence (reactive). Corrective
action is about eliminating the causes of problems and not just following a series of
problem-solving steps.
• Preventive action is action taken to eliminate the causes of a potential nonconformity,
defect, or other undesirable situation in order to prevent occurrence (proactive).
• Follow-Up Audits
A product, process, or system audit may have findings that require correction and
corrective action. Since most corrective actions cannot be performed at the time of the audit, the
audit program manager may require a follow-up audit to verify that corrections were made and
corrective actions were taken. Due to the high cost of a single-purpose follow-up audit, it is
normally combined with the next scheduled audit of the area. However, this decision should be
based on the importance and risk of the finding.
An organization may also conduct follow-up audits to verify preventive actions were taken
as a result of performance issues that may be reported as opportunities for improvement. Other
times organizations may forward identified performance issues to management for follow-up.
Watch:
• ISO Internal Quality Audit (IQA) Explained

https://www.youtube.com/watch?v=fckZK6l678E
• What is audit quality and how do you measure it?

https://www.youtube.com/watch?v=qEqJEEWq0Sk
• What is QUALITY AUDIT? What does QUALITY AUDIT mean?

https://www.youtube.com/watch?v=oX3TS4kotx4
Read:
• https://en.wikipedia.org/wiki/Quality_audit
• https://bizfluent.com/about-6387350-define-quality-assurance-audit.html
• https://www.qualitywbt.com/auditing-activities-for-defining-objectives-scope-and-criteria
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1. Looking at the perspective of your professor, how would you explain how a student is
being “audited” on his class performance? Site specific and realistic examples/scenarios
relevant to the above discussion.
2. In your personal daily life, how do you perform quality audit? Site specific and realistic
examples/scenarios relevant to the above discussion.
3. Explain the relationship of internal and external audits based from your own
understanding. Elaborate their significance to each other.
TOPIC 8: Quality and Business Process Re-engineering
Overview:
Business Process Reengineering involves the radical redesign of core business

processes to achieve dramatic improvements in productivity, cycle times and quality. In Business
Process Reengineering, companies start with a blank sheet of paper and rethink existing
processes to deliver more value to the customer.
They typically adopt a new value system that places increased emphasis on customer
needs. Companies reduce organizational layers and eliminate unproductive activities in two key
areas. First, they redesign functional organizations into cross-functional teams. Second, they use
technology to improve data dissemination and decision making.
• Understand the Basic Concepts of Business Process Reengineering
• Determine How Business Process Reengineering works:
• Verify the Relationship of Business Process Reengineering (BPR) and Total Quality
Management (TQM)
• Identify the Business Process Reengineering Steps and the Risk of Failure
• Adapt the Quality Circle Concepts

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Course Materials:
I. Business Process Reengineering Concepts
How Business Process Reengineering works:
Business Process Reengineering is a dramatic change initiative that contains five major
steps that managers should take:
• Refocus company values on customer needs

• Redesign core processes, often using information technology to enable improvements
• Reorganize a business into cross-functional teams with end-to-end responsibility for a
process
• Rethink basic organizational and people issues
• Improve business processes across the organization
Companies use Business Process Reengineering to:
1. Reduce costs and cycle times. Business Process Reengineering reduces costs and cycle
times by eliminating unproductive activities and the employees who perform them.
Reorganization by teams decreases the need for management layers, accelerates
information flows and eliminates the errors and rework caused by multiple handoffs.
2. Improve quality. Business Process Reengineering improves quality by reducing the
fragmentation of work and establishing clear ownership of processes. Workers gain
responsibility for their output and can measure their performance based on prompt
feedback.
II. Business Process Reengineering (BPR) and Total Quality Management (TQM)
Total Quality Management and BPR share a cross-functional relationship. Quality

specialists tend to focus on incremental change and gradual improvement of processes, while
proponents of reengineering often seek radical redesign and drastic improvement of processes.
Quality management, often referred to as TQM or continuous improvement, means programs and
initiatives, which emphasize incremental improvement in work processes, and outputs over an
open-ended period of time. In contrast, reengineering, also known as business process redesign
or process innovation, refers to prudent initiatives intended to achieve radically redesigned and
improved work processes in a specific time frame. In contrast to continuous improvement, BPR
relies on a different school of thought. The extreme difference between continuous process
improvement and business process reengineering lies in where you start from and also the
magnitude and rate of resulting changes. In course of time, many derivatives of radical,
breakthrough improvement and continuous improvement have emerged to address the difficulties
of implementing major changes in corporations. Leadership is really important for effective BPR
deployment, and successful leaders use leadership styles to suit the particular situation and
perform their tasks, giving due importance to both people and work. Business process is
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essentially value engineering applied to the system to bring forth, and sustain the product with an
emphasis on information flow. By mapping the functions of the business process, low value
functions can be identified and eliminated, thus reducing cost. Alternatively, a new and less costly
process, which implements the function of the current process can be developed to replace the
present one.
The role of executive leadership or top management in business process reengineering

cannot be disregarded. They should provide the needed resources to the team, demonstrate their
active support for the project, set the stage for reengineering by determining core business
processes, and by defining the project scope and objectives. The management should also take
care to provide adequate funding, set new standards as well as encourage others to be open to
innovative approaches. Many reengineering projects fail to be completed or do not achieve
bottom-line business results. For this reason alone, business process reengineering 'success
factors' has become an important area of study. Success factors are a collection of lessons learnt
from previous projects. It is useful to think of your team structure in 3 levels: stakeholders, core
team, and extended team.
The stakeholders are key business leaders ultimately accountable for the success of the
project. Their role is to provide high-level guidance to the team, help remove barriers, and provide
funding. The core team is the group responsible for the design and implementation of the solution.
Your extended team includes other people in the organization contributing to the project on an
as-needed basis. These extended-team members include subject-matter experts. A well-rounded
team includes a mix of people and skills. Such a team may include individuals who thoroughly
understand the current process, who actively use the process and also work closely with
customers, technical experts, and consultants, if necessary. But the main criterion is that the
entire team should work together for the project to succeed.
III. Business Process Reengineering Steps
Step #1: Identity and Communicating the Need for Change
If you’re a small startup, this can be a piece of cake. You realize that your product has a
high user drop-off rate, send off a text to your co-founder, and suggest a direction to pivot.
For a corporation, however, it can be a lot harder. There will always be individuals who
are happy with things as they are, both from the side of management and employees. The first
might be afraid that it might be a sunk investment, the later for their job security.
So, you’ll need to convince them why making the change is essential for the company. If
the company is not doing well, this shouldn’t be too hard.
In some cases, however, the issue is with the company not doing as well as it could be.
Meaning, you should do your research. Which processes might not be working? Is your
competition doing better than you in some regards? Worse?
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Once you have all the information, you’ll need to come up with a very comprehensive plan,
involving leaders from different departments. The management will have to play the role of
salespeople: conveying the grand vision of change, showing how it’ll affect even the lowest-
ranked employee positively.
Risk of Failure: Not Getting Buy-In From The Company
• If you fail to do this, however, your business process reengineering efforts might be
destined to fail long before they even start.
• Business Process Re-Engineering can seriously impact everyone in the company, and
sometimes this can appear to be a negative change for some. Some employees might,
for example, think you’ll let them all go if you find a better way to function (which is a
real possibility).
• In such cases, even if the management is on board, the initiative might fail because
the employees aren’t engaged.
• Usually, it’s possible to get the employees buy-in by motivating them or showing them
different views they weren’t aware of. Sometimes, however, the lack of employee
engagement might be because of a bad workplace culture – something that might
need to be dealt with before starting any BPR initiatives.
Step #2: Put Together a Team of Experts
As with any other project, business process reengineering needs a team of highly skilled,
motivated people who will carry out the needed steps.
In most cases, the team consists of:
a. Senior Manager. When it comes to making a major change, you need the
supervision of someone who can call the shots. If a BPR team doesn’t have
someone from the senior management, they’ll have to get in touch with them for
every minor change.
b. Operational Manager. As a given, you’ll need someone who knows the ins-and-
outs of the process – and that’s where the operational manager comes in. They’ve
worked with the process(es) and can contribute with their vast knowledge.
c. Reengineering Experts. Finally, you’ll need the right engineers. Reengineering
processes might need expertise from a number of different fields, anything from IT
to manufacturing. While it usually varies case by case, the right change might be
anything – hardware, software, workflows, etc.
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Risk of Failure: Not Putting The Right Team Together
• There are a lot of different ways to mess this one up.
• If the team consists of individuals with a similar viewpoint and agenda, for example,
they might not be able to properly diagnose the problems/solutions.
• Or, the team might involve too many or too few people. In the first case, the decision
making might be slowed down due to conflicting viewpoints. In the later, there might
not be enough experts in certain fields to create adequate solutions.
• It’s hard to put all that down as a framework, as it depends on the project itself. There
is one thing, however, that benefits every BPR team: having a team full of people who
are enthusiastic (and yet unbiased), positive and passionate about making a
difference.
Step #3: Find the Inefficient Processes and Define Key Performance Indicators (KPI)
Once you have the team ready and about to kick-off the initiative, you’ll need to define the
right KPIs. You don’t want to adapt to a new process and THEN realize that you didn’t keep some
expenses in mind – the idea of BPR is to optimize, not the other way around.
While KPIs usually vary depending on what process you’re optimizing, the following can
be very typical:
Manufacturing
• Cycle Time – The time spent from the beginning to the end of a process
• Changeover Time – Time needed to switch the line from making one product to the
next
• Defect Rate – Percentage of products manufactured defective
• Inventory Turnover – How long it takes for the manufacturing line to turn inventory into
products
• Planned VS Emergency Maintenance – The ratio of the times planned maintenance
and emergency maintenance happen
IT
• Mean Time to Repair – Average time needed to repair the system / software / app after
an emergency
• Support Ticket Closure rate – Number of support tickets closed by the support team
divided by the number opened
• Application Dev. – The time needed to fully develop a new application from scratch
• Cycle Time – The time needed to get the network back up after a security breach
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Once you have the exact KPIs defined, you’ll need to go after the individual processes.
The easiest way to do this is to do business process mapping. While it can be hard to analyze
processes as a concept, it’s a lot easier if you have everything written down step by step.
This is where the operational manager comes in handy – they make it marginally easier
to define and analyze the processes.
Usually, there are 2 ways to map out processes:
1. Process Flowcharts – the most basic way to work with processes is through flowcharts.
Grab a pen and paper and write down the processes step by step.
2. Business Process Management Software – if you’re more tech-savvy, using software for
process analysis can make everything a lot easier. You can use Tallyfy, for example, to
digitize your processes, set deadlines, etc. Simply using such software might end up
optimizing the said processes as it allows for easier collaboration between the employees.
Risk of Failure: Inability to Properly Analyze Processes
• Or, to put it more succinctly – impatience. It’s uncommon for someone to try business
process reengineering if they profits are soaring and the projections are looking great.
• BPR is usually called for when things aren’t going all that well and businesses need drastic
changes. So, it can be very tempting to hurry things up and skip through the analysis
process and start carrying out the changes.
• The thing is, though, the business analysis needs to be done properly, not rushed through
to get to the more exciting parts.
• There are always time and money pressures in the business world, and it’s the
responsibility of the senior management to resist the temptation and make sure the proper
procedure is carried out. Problem areas need to be identified, key goals need to be set
and business objectives need to be defined and this takes time.
• Ideally, each stage requires input from groups from around the business to ensure that a
full picture is being formed, with feedback and ideas being taken into consideration from
a diverse range of sources. The next step is to identify and prioritize the improvements
that are needed and those areas and processes that need to be scrapped.
• Any business that doesn’t take this analysis seriously will be going into those next steps
blind and will find that their BPR efforts will fail.
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Step #4: Reengineer the Processes and Compare KPIs
Finally, once you’re done with all the analysis and planning, you can start implementing
the solutions and changes on a small scale.
Once you get to this point, there’s not much to add – what you have to do now is keep
putting your theories into practice and seeing how the KPIs hold up.
If the KPIs show that the new solution works better, you can start slowly scaling the
solution, putting it into action within more and more company processes.
If not, you go back to the drawing board and start chalking up new potential solutions.
IV. Quality Circle
a. Definition
Conceptually Quality Circles can be described as a small group of employees of the same
work area, doing similar work that meets voluntarily and regularly to identify, analyse and resolve
work related problems. This small group with every member of the circle participating to the full
carries on the activities, utilising problem solving techniques to achieve control or improvement in
the work area and also help self and mutual development in the process.
b. Concept of Quality Circle
The concept of the Quality Circle is based on “respect for the human individual” as against
the traditional assumption based on suspicion and mistrust between management and its
em-ployees. Quality circles built mutual trust and create greater understanding between the
manage-ment and the workers. Cooperation and not confrontation is the key element in its
operation. Quality Circles aims at building people, developing them, arousing genuine interest
and dedication to their work to improve quality, productivity, cost reduction etc.
Thus we can say that a quality circle is a group of 5 to 8 employees performing similar
work, who volunteer themselves to meet regularly, to identify the cause of their on-the-job
problems, employ advanced problem-solving techniques to reach solutions and implement them.
The concept is based on the premise that the people who do a job everyday know more
about it than anyone else and hence their voluntary involvement is the best way to solve their
work related problems. The Quality Circle concept provides an opportunity to the circle members
to use their wis-dom, creativity and experience in bringing about improvements in the work they
are engaged in by converting the challenging problems into opportunities and it contributes to the
develop-ment of the employees and in turn benefits the organisation as well. The concept
encourages the sense of belongingness in circle members and they feel that they have an
important role to play in the organisation.
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c. Characteristics of Effective Quality Circles:
1. The atmosphere should be informal, comfortable and relaxed. The members should feel
involved and interested.
2. Everyone should participate.
3. The objectives should be clear to the members.
4. The members should listen to each other.
5. The group should feel comfortable even when there are disagreements.
6. The decisions should generally be taken by a kind of consensus and voting should be
minimum.
7. When an action is required to be taken, clear assignments should be made and ac-cepted
by all the members.
8. The leader should not dominate the group. The main idea should not be as to who controls
but how to get the job done.
9. Until a final solution is found and results are attained feedback is necessary.
d. Objectives of Quality Circles:
Some of the broad objectives of the Quality Circle are:
(i) To improve quality, productivity, safety and cost reduction.
(ii) To give chance to the employees to use their wisdom and creativity.
(iii) To encourage team spirit, cohesive culture among different levels and sections of the
employees.
(iv) To promote self and mutual development including leadership quality,
(v) To fulfill the self-esteem and motivational needs of employees.
Watch:
• Business Process Reengineering with Application
https://www.youtube.com/watch?v=IZHqAo4QryE
• Davenport's Business Process Reengineering 5-Step Model
https://www.youtube.com/watch?v=sQebM_Q_AXo
Read:
• Reengineering Work: Don’t Automate, Obliterate
https://hbr.org/1990/07/reengineering-work-dont-automate-obliterate
• Quality Circles After the Fad
https://hbr.org/1985/01/quality-circles-after-the-fad
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• https://www.bain.com/insights/management-tools-business-process-reengineering/
• https://www.heflo.com/blog/bpm/business-process-reengineering-examples/
• https://tallyfy.com/business-process-reengineering/
• https://www.omnex.com/members/standards/bpr/business_process_reengineering.aspx
• https://www.businessmanagementideas.com/management/quality-circles/quality-circles-
q-c-meaning-objectives-and-benefits/6302
1. Do you think that the redevelopment of business processes is necessary to stay ahead of
the competition? Defend your answer.
2. Does reengineering relate in your projects/thesis making and implementation? Cite

realistic example/s based from your experience from planning onwards. Emphasize the
reason/s and how you performed reengineering along the way.
3. What do you think are the important attributes/characteristics of stakeholders involved

during the reengineering process?
4. How essential is a quality circle in a company’s success? What do you think is their major
role in a business?
TOPIC 9: TRAINING FOR TOTAL QUALITY MANAGEMENT
Overview:
Today's work environment requires employees to be skilled in performing complex tasks

in an efficient, cost-effective, and safe manner. Training (a performance improvement tool) is
needed when employees are not performing up to a certain standard or at an expected level of
performance. The difference between actual the actual level of job performance and the expected
level of job performance indicates a need for training. The identification of training needs is the
first step in a uniform method of instructional design.
A successful training needs analysis will identify those who need training and what kind of
training is needed. It is counter-productive to offer training to individuals who do not need it or to
offer the wrong kind of training. A Training Needs Analysis helps to put the training resources to
good use.
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• Differentiate the Types of Needs Analyses
• Understand the Purpose of Training Needs Assessment
• Identify Five Steps of Training Needs Assessment
• Develop a Training Program Design
• Verify Measuring Effectiveness
• Appreciate and Adapt Career Development Programs and Succession Planning
• Recognize the Importance of Training Follow-up
Course Materials:
I. Introduction
TNA is a systematic process that applies work analysis techniques and procedures to
identify and specify training requirements that have been linked to deficiencies in individual, team,
or organization performance to develop learning objectives to address the identified deficiencies.
These evidence-based objectives in turn guide design, delivery, and evaluation of training
to close the gaps in underlying knowledge, skills, abilities, or other characteristics (KSAOs) or
competencies that are related to the identified performance deficiencies. Although there is no
strong consensus on specific TNA procedures (Rossett, 1987) and there are many TNA resources
offering slightly different approaches, most processes include the same basic steps, starting with
an initiating or triggering event that requires a TNA to be considered and using work analysis
techniques to determine training requirements.
II. Types of Needs Analyses
Many needs assessments are available for use in different employment contexts. Sources
that can help you determine which needs analysis is appropriate for your situation are described
below.
a. Organizational Analysis. An analysis of the business needs or other reasons the training
is desired. An analysis of the organization%27s strategies, goals, and objectives. What is
the organization overall trying to accomplish? The important questions being answered by
this analysis are who decided that training should be conducted, why a training program
is seen as the recommended solution to a business problem, what the history of the
organization has been with regard to employee training and other management
interventions.
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b. Person Analysis. Analysis dealing with potential participants and instructors involved in
the process. The important questions being answered by this analysis are who will receive
the training and their level of existing knowledge on the subject, what their learning style
is, and who will conduct the training. Do the employees have required skills? Are there
changes to policies, procedures, software, or equipment that require or necessitate
training?
c. Work analysis / Task Analysis. Analysis of the tasks being performed. This is an analysis
of the job and the requirements for performing the work. Also known as a task analysis or
job analysis, this analysis seeks to specify the main duties and skill level required. This
helps ensure that the training which is developed will include relevant links to the content
of the job.
d. Performance Analysis. Are the employees performing up to the established standard? If
performance is below expectations, can training help to improve this performance? Is
there a Performance Gap?
e. Content Analysis. Analysis of documents, laws, procedures used on the job. This analysis
answers questions about what knowledge or information is used on this job. This
information comes from manuals, documents, or regulations. It is important that the
content of the training does not conflict or contradict job requirements. An experienced
worker can assist (as a subject matter expert) in determining the appropriate content.
f. Training Suitability Analysis. Analysis of whether training is the desired solution. Training
is one of several solutions to employment problems. However, it may not always be the
best solution. It is important to determine if training will be effective in its usage.
g. Cost-Benefit Analysis. Analysis of the return on investment (ROI) of training. Effective
training results in a return of value to the organization that is greater than the initial
investment to produce or administer the training.
III. Why do we need a Training Needs Assessment?
First, identify dissatisfaction with the current situation and desire for change as similarities
among the requests. Each request implies that a gap or discrepancy exists between what is and
what could be or should be. A learning or performance gap between the current and desired
condition is called a need. TNA aims at the following situations.
• Solving a current problem
• Avoiding a past or current problem
• Creating or taking advantage of a future opportunity
• Providing learning, development or growth
The purpose of TNA is to answer some familiar questions: why, who, how, what, and
when. The following are descriptions of the questions and what analysis can be done to answer
them.
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IV. Five Steps of Training Needs Assessment
The processes of Training Needs Assessment can be divided into five steps: i) identify
problem and needs; ii) determine design of needs assessment; iii) collect data; iv) analyze data;
and v) provide feedback.
V. Design of a Training Program
When developing your training plan, there are a number of considerations. Training is
something that should be planned and developed in advance.
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The considerations for developing a training program are as follows:
a. Needs assessment and learning objectives. This part of the framework development asks
you to consider what kind of training is needed in your organization. Once you have
determined the training needed, you can set learning objectives to measure at the end of
the training.
b. Consideration of learning styles. Making sure to teach to a variety of learning styles is
important to development of training programs.
c. Delivery mode. What is the best way to get your message across? Is web-based training
more appropriate, or should mentoring be used? Can vestibule training be used for a
portion of the training while job shadowing be used for some of the training, too? Most
training programs will include a variety of delivery methods.
d. Budget. How much money do you have to spend on this training?
e. Delivery style. Will the training be self-paced or instructor led? What kinds of discussions
and interactivity can be developed in conjunction with this training?
f. Audience. Who will be part of this training? Do you have a mix of roles, such as accounting
people and marketing people? What are the job responsibilities of these individuals, and
how can you make the training relevant to their individual jobs?
g. Content. What needs to be taught? How will you sequence the information?
h. Timelines. How long will it take to develop the training? Is there a deadline for training to
be completed?
i. Communication. How will employees know the training is available to them?
j. Measuring effectiveness of training. How will you know if your training worked? What ways
will you use to measure this?
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VI. Measuring Effectiveness
After we have completed the training, we want to make sure our training objectives were
met. One model to measure effectiveness of training is the Kirkpatrick model,Donald Kirkpatrick,
Evaluating Training Programs, 3rd ed. (San Francisco: Berrett-Koehler, 2006). developed in the
1950s. His model has four levels:
1. Reaction: How did the participants react to the training program?

2. Learning: To what extent did participants improve knowledge and skills?
3. Behavior: Did behavior change as a result of the training?
4. Results: What benefits to the organization resulted from the training?
Each of Kirkpatrick’s levels can be assessed using a variety of methods. We will discuss
those next.
Kirkpatrick’s Four Levels of Training Evaluation
Review the performance of the employees who received the training, and if possible
review the performance of those who did not receive the training. For example, in your orientation
training, if one of the learning objectives was to be able to request time off using the company
intranet, and several employees who attended the training come back and ask for clarification on
how to perform this task, it may mean the training didn’t work as well as you might have thought.
In this case, it is important to go back and review the learning objectives and content of your
training to ensure it can be more effective in the future.
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Many trainers also ask people to take informal, anonymous surveys after the training to
gauge the training. These types of surveys can be developed quickly and easily through websites
such as SurveyMonkey. Another option is to require a quiz at the end of the training to see how
well the employees understand what you were trying to teach them. The quiz should be developed
based on the learning objective you set for the training. For example, if a learning objective was
to be able to follow OSHA standards, then a quiz might be developed specifically related to those
standards. There are a number of online tools, some free, to develop quizzes and send them to
people attending your training.
VII. Career Development Programs and Succession Planning
Another important aspect to training is career development programs. A career

development program is a process developed to help people manage their career, learn new
things, and take steps to improve personally and professionally. Think of it as a training program
of sorts, but for individuals. Sometimes career development programs are called professional
development plans.
Career development programs are necessary in today’s organizations for a variety of

reasons. First, with a maturing baby-boom population, newer employees must be trained to take
those jobs once baby boomers retire. Second, if an employee knows a particular path to career
development is in place, this can increase motivation. A career development plan usually includes
a list of short- and long-term goals that employees have pertaining to their current and future jobs
and a planned sequence of formal and informal training and experiences needed to help them
reach the goals. As this chapter has discussed, the organization can and should be instrumental
in defining what types of training, both in-house and external, can be used to help develop
employees.
To help develop this type of program, managers can consider a few components: Martha
Heller, “Six Tips for Effective Employee Development Programs,” CIO Magazine.
a. Talk to employees. Although this may seem obvious, it doesn’t always happen. Talking
with employees about their goals and what they hope to achieve can be a good first step
in developing a formal career development program.
b. Create specific requirements for career development. Allow employees to see that if they
do A, B, and C, they will be eligible for promotion. For example, to become a supervisor,
maybe three years of experience, management training, and communication training are
required. Perhaps an employee might be required to prove themselves in certain areas,
such as “maintain and exceed sales quota for eight quarters” to be a sales manager. In
other words, in career development there should be a clear process for the employees to
develop themselves within the organization.
c. Use cross-training and job rotation. Cross-training is a method by which employees can
gain management experience, even if for short periods of time. For example, when a
manager is out of the office, putting an employee “in charge” can help the employee learn
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skills and abilities needed to perform that function appropriately. Through the use of job
rotation, which involves a systematic movement of employees from job to job within an
organization, employees can gain a variety of experiences to prepare them for upward
movement in the organization.
d. Utilize mentors. Mentorship can be a great way for employees to understand what it takes
to develop one’s career to the next level. A formal mentorship program in place with willing
mentees can add value to your career development program.
VIII. Training Follow-up
Follow-up is essential in all training situations as it provides participants with further

support and skill development. Also, follow-up improves existing trainings as well as future training
plans. The lecturers get a feedback on what the participants actually learned during the training,
whereas the participants have the opportunity to reflect on their learning a second time.
a. Advantages and Disadvantages
Advantages Disadvantages
• Determining the learning outcomes of • Requires time and resources
the training investment
• Assessing the results and reinforcing • Participants may not be willing to
the key points contribute to the follow-up after the
• Providing the learners time to reflect on training
their learning • Difficult to set up when people meet
• Getting useful feedback which only once and have no further
supports future trainings connection to each other
• Determining what kind of retraining is • Difficulties to capture a comprehensive
needed follow-up when it is only possible by
mail
b. What Is Follow-up on Trainings?
Successful training events always integrate follow-up to provide further support, skill
development, and continuous improvement to promote new practise.
Trainers responsible for the training plans will benefit from this discussion of the need for
a connexion between new learning and a process of ongoing learning and feedback. This is
important especially for further development of solid teaching practise and approaches to
supervision (KNAPP-PHILO 2007). Whereas evaluation of the training course takes place during
the training itself, follow-up on trainings comes after the training and is often combined with quality
control assessment (see figure).
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c. Important Dimensions of a Training Follow-up (Adapted from RAE 2004)
An effective follow-up phase includes several dimensions:
1. Determining what the participants have learned during the course

2. Giving the learners time to reflect on their learning prior to their completion of the
post-training personal action plan
3. Getting useful feedback in an organised manner to help with future training
planning
4. Ensuring trainees and learners follow up their training with relevant actions to
apply, improve, develop and reinforce learning attained.
d. Benefits of Follow-up on Trainings

• Further measure effectiveness of training
• Long-term evaluation: Measure change in behaviour, knowledge and attitudes
• Quality control: Make sure that participants are implementing correctly
• Solicit additional feedback on training
• Provision additional training
• Answers questions and clarifies original lessons
• Gives more specific advice and more relevant demonstrations
• Follow-up on action plan
• Check benchmarks and milestones in action plan
As mentioned before, it is very useful for learners, trainers and future training planning to
implement a follow-up. However, it is not always easy to conduct a follow-up, especially when
participants and trainers meet only once for a training course and then go back to their work in
different contexts (maybe even in different countries). Even if the follow-up is done only by mail
or over the internet, it can be difficult to motivate the learners to contribute to a reliable follow-up.
Under these circumstances, you have to make sure that you invest enough time and resources
in implementing an appropriate evaluation during the training course, but still give participants the
opportunity to make use of a follow-up if they wish to do so.
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Watch:
• Identify Training Needs
https://www.youtube.com/watch?v=Y14R-brmFqA
• 6 steps to conducting a training needs analysis and assessment
https://www.youtube.com/watch?v=-CSEtFSngLc
Read:
• https://hr-survey.com/Determining_Training_Needs.htm
• https://www.jica.go.jp/project/cambodia/0601331/pdf/english/3_TNA_01.pdf
• https://open.lib.umn.edu/humanresourcemanagement/chapter/8-4-designing-a-training-
program/
• http://www.cio.com/article/29169/Six_Tips_for_Effective_Career_Development_Program
s.
• https://sswm.info/train-trainers/post-training-activities/training-follow-up
1. How would you compare the differences between training, compared that to taking formal
classes? How about the difference of a training versus seminar?
2. Being a fresh graduate soon, how essential is training for a newbie like you in the industry?
Do you think it is fair to subject a fresh graduate directly to a workload?
3. For a certain employee who has been in a certain company for more than 10 years
already, is training still necessary? Why?
4. How important is training for your personal career development as an engineer?
TOPIC 10: TQM APPLICATION TO ELECTRONICS ENGINEERING FIELDS
Overview:
Effective engineering managers look for constant improvement. Controlling costs,

schedules, and production plans are all essential to managing a project well and finishing within
or under budget. Controlling that which can be controlled, and responding quickly and efficiently,
to those things that do not go according to plan, are all within the purview of an engineering
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manager. As an ECE practitioner, it is important to develop necessary management skills which

will put an engineer to an advantage aside from having strong technical skills.
• Understand the Nature and scope of practice of Electronics Engineering and Electronics
Technician Profession in accordance to RA 9292
• Appreciate the Significance of Project Management and it’s Benefits to the Field of
Engineering in General
• Learn the Information Technology Infrastructure Library (ITIL) Fundamentals and its
Relevance to the ECE Profession
Course Materials:
I. Nature and scope of practice of Electronics Engineering and Electronics Technician

Profession in accordance to RA 9292
According to the Electronics Engineering Law of 2004 also known as Republic Act 9292,
An act providing for a more responsive and comprehensive regulation for the registration,
licensing and practice of professional electronics engineers, electronics engineers and electronics
technicians, repealing Republic Act No. 5734, otherwise known as the “Electronics and
Communications Engineering Act of the Philippines” and for other purposes, enacted on April 17,
2004, Section 5 states the:
Nature and Scope of Practice of Electronics Engineering and Electronics Technician

Professions:
(1) The scope and nature of practice of the Electronics Engineer shall embrace and consist
of any work or activity relating to the application of engineering sciences and/or principles
to the investigation, analysis, synthesis, planning, design, specification, research and
development, provision, procurement, marketing and sales, manufacture and production,
construction and installation, tests/measurements/control, operation, repair, servicing,
technical support and maintenance of electronic components, devices, products,
apparatus, instruments, equipment, systems, networks, operations and processes in the
fields of electronics, including communications and/or telecommunications, information
and communications technology (ICT), computers and their networking and
hardware/firmware/software development and applications, broadcast/broadcasting,
cable and wireless television, consumer and industrial electronics,
electrooptics/photonics/opto-electronics, electro-magnetics, avionics, aerospace,
navigational and military applications, medical electronics, robotics, cybernetics,
biometrics and all other related and convergent fields; it also includes the 4 administration,
management, supervision and regulatory aspects of such works and activities; similarly
included are those teaching and training activities which develop the ability to use
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electronic engineering fundamentals and related advanced knowledge in electronics

engineering, including lecturing and teaching of technical and professional subjects given
in the electronics engineering and electronics technician curriculum and licensure
examinations.
(2) The scope and nature of practice of the Professional Electronics Engineer shall embrace
and consist of all of the above plus the sole authority to provide consulting services as
defined in this Act and to sign and seal electronics plans, drawings, permit applications,
specifications, reports and other technical documents prepared by himself/herself and/or
under his direct supervision.
(3) The scope and nature of practice of the Electronics Technician profession shall embrace
and consist of any non-engineering work or activity relating to the installation, construction,
operation, control, tests and measurements, diagnosis, repair and maintenance,
manufacture and production, sales and marketing of any electronic component/s,
device/s, products, apparatus, instruments, equipment, system/s, network/s, operations
and processes located on land, watercraft, aircraft, industrial plants or commercial
establishments, including the teaching and training of technical and professional subjects
given in the electronics technician curriculum and licensure examinations.
II. PROJECT MANAGEMENT
If you are like most people, you are “pretty sure” you know what projects are, and you
“think” you know what project management is (and what a project manager does), but there’s
always a varying amount of uncertainty in those perceptions. So, let’s start off by clarifying some
key concepts. Project management is simply the process of managing projects (and you thought
this was going to be difficult). While this definition is not particularly helpful, it does illustrate three
key points:
■ Project management is not “brain surgery.” Yes, it covers a vast array of subjects, processes,
skills, and tools, but the key fundamentals of project management are straightforward and are
consistent across industries.
■ to better understand project management, we need to understand what a project is. The nature
of a project provides insights into the scope and challenges of project management.
■ to better understand project management, we need to understand what is implied by the term
managing and how this compares against traditional business management
According to the Project Management Institute, project management is “the application

of knowledge, skills, tools and techniques to project activities to meet project requirements.”
a. What is a Project?
A project is a unique endeavor to produce a set of deliverables within clearly specified

time, cost and quality constraints (Westland, 2006). Projects are different from standard business
operational activities as they:
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a.) Are unique in nature. They do not involve repetitive processes. Every project undertaken
is different from the last, whereas operational activities often involve undertaking repetitive
(identical) processes.
b.) Have a defined timescale. Projects have a clearly specified start and end date within
which the deliverables must be produced to meet a specified customer requirement.
c.) Have an approved budget. Projects are allocated a level of financial expenditure within
which the deliverables are produced, to meet a specified customer requirement.
d.) Have limited resources. At the start of a project an agreed amount of labor, equipment
and materials is allocated to the project.
e.) Involve an element of risk. Projects entail a level of uncertainty and therefore carry
business risk.
f.) Achieve beneficial change. The purpose of a project is typically to improve an
organization through the implementation of business change.
b. Characteristics of a Clearly Defined Project
In order for a project to be useful, effective and achieving its full objective, it must be clearly
defined. Clearly defined projects share the following SMART criteria:
1. Specific. Being specific includes detailing out the project’s structure, goals, benefits,
milestones and costs. All these requires careful planning and inputs from the project
team members involved and if necessary the external consultants or experts.
2. Measurable. A clearly defined project must be measurable in terms of its benefits and
achievements. This should not only be in terms of monetary benefits but also other
tangible and intangible benefits derived from the project’s execution. A clear and
precise plan devised during the project’s planning stage will enable objective
measurements be executed to analyze the project’s achievements and if any
shortcomings.
3. Achievable A project will only be meaningful if it is achievable. Being too ambitious in

planning for the project will not be helpful and may result in the project being
unachievable. This may also lead to the project team morale being affected. All these
unhealthy things may lead to the project’s costs being overrun and timing of the
deliverables being significantly affected.
4. Relevant. The project needs to bring relevant benefits to the entity concerned. This
may be in the form of reducing its overall production costs, increasing its operational
efficiency or other specific purposes relevant to the entity. If it fails to address this, the
project will not be beneficial to the entity and will ultimately result in a waste of
resources to the entity and its stakeholders.
119
5. Time bound. The final ingredient to ensure that becomes clearly defined is that it
should be time bound. It means that the project should come with a time frame for its
completion including its planning, development, execution, fine tuning before its full
run instead of taking forever to be completed. Any adjustments to this time table should
be clearly justified by the parties involved bearing in mind the costs involved in the
project’s execution, opportunity costs and finance costs related to the project.
c. Project Management Components
SKILLS TOOLS
PROCESSESES
Figure 1. The Project Management Components (Westland, 2006)
1.) SKILLS. Specialist knowledge, skills and experience are required to reduce the level of
risk within a project and thereby enhance its likelihood of success.
2.) TOOLS. Various types of tools are used by project managers to improve their chances of
success. Examples include document templates, registers, planning software, modeling
software, audit checklists and review forms.
3.) PROCESSES. Various processes and techniques are required to monitor and control
time, cost, quality and scope on projects. Examples include time management, cost
management, quality management, change management, risk management and issue
management.
d. The Project Life Cycle
Project Life Cycle is a sequence of activities which are bind together to achieve the goal
or target. It is also a responsibility of the project Manager to arrange the resources which are
required for the completion of the Project. The whole requirement of the Project is to produce in
the first phase of the specific product. At the end stage of the project it issue quality, delivery and
completeness. Project Life Cycle in Consist of four of phases which are helpful for the completion
of project and give the specific output. In the Project Life Cycle each Phase has their specific goal.
1.) Initiation
The first phase of a project is the initiation phase. During this phase a business
problem or opportunity is identified and a business case providing various solution options
120
is defined. Next, a feasibility study is conducted to investigate whether each option

addresses the business problem and a final recommended solution is then put forward.
Once the recommended solution is approved, a project is initiated to deliver the approved
solution. Terms of reference are completed outlining the objectives, scope and structure
of the new project and a project manager is appointed. The project manager begins
recruiting a project team and establishes a project office environment. Approval is then
sought to move into the detailed planning phase.
2.) Planning
In the Second Phase of a Project Life Cycle all the planning is done which is
required for the Project achieve the target goal. In this planning phase all the task are
assigned to particular team member according to his caliber. As the Planning of the work
is done before it’s starting, so all the process running smoothly and complete at a fix time.
Once the scope of the project has been defined in the terms of reference, the project
enters the detailed planning phase. This involves creating a:
• Project plan - outlining the activities, tasks, dependencies and timeframes;

• Resource plan - listing the labor, equipment and materials required;
• Financial plan - identifying the labor, equipment and materials costs;
• Quality plan - providing quality targets, assurance and control measures;
• Risk plan - highlighting potential risks and actions to be taken to mitigate those risks;
• Acceptance plan - listing the criteria to be met to gain customer acceptance;
• Communications plan - describing the information needed to inform stakeholders;
• Procurement plan - identifying products to be sourced from external suppliers.
At this point the project will have been planned in detail and is ready to be executed.
3.) Execution
This phase involves implementing the plans created during the project planning phase.
While each plan is being executed, a series of management processes are undertaken to
monitor and control the deliverables being output by the project. This includes identifying
change, risks and issues, reviewing deliverable quality and measuring each deliverables
121
produced against the acceptance criteria. Once all of the deliverables have been produced
and the customer has accepted the final solution, the project is ready for closure.
4.) Project closure
Project closure involves releasing the final deliverables to the customer, handing over
project documentation to the business, terminating supplier contracts, releasing project
resources and communicating the closure of the project to all stakeholders. The last remaining
step is to undertake a post-implementation review to quantify the level of project success and
identify any lessons learnt for future projects.
e. PROJECT MANAGEMENT RISKS
Complex projects are always fraught with a variety of risks ranging from scope risk to cost
overruns. One of the main duties of a project manager is to manage these risks and prevent them
from ruining the project.
Major risks involved in a Project
1. Scope Risk
This risk includes changes in scope caused by the following factors:
▪ Scope creep – the project grows in complexity as clients add to the requirements and
developers start gold plating.
▪ Integration issues
▪ Hardware & Software defects
▪ Change in dependencies
2. Scheduling Risk
There are a number of reasons why the project might not proceed in the way you
scheduled. These include unexpected delays at an external vendor, natural factors, errors in
estimation and delays in acquisition of parts. For instance, the test team cannot begin the work
until the developers finish their milestone deliverables and a delay in those can cause cascading
delays.
To reduce scheduling risks use tools such as a Work Breakdown Structure (WBS) and RACI
matrix (Responsibilities, Accountabilities, Consulting and Information) and Gantt charts to help
you in scheduling.
3. Resource Risk
This risk mainly arises from outsourcing and personnel related issues. A big project might
involve dozens or even hundreds of employees and it is essential to manage the attrition issues
and leaving of key personnel. Bringing in a new worker at a later stage in the project can
significantly slow down the project.
122
Another source of the risk includes lack of availability of funds. This could happen if you are relying
on an external source of funding (such as a client who pays per milestone) and the client suddenly
faces a cash crunch.
4. Technology Risk
This risk includes delays arising out of software & hardware defects or the failure of an
underlying service or a platform. For instance, halfway through the project you might realize the
cloud service provider you are using doesn’t satisfy your performance benchmarks. Apart from
this, there could be issues in the platform used to build your software or a software update of a
critical tool that no longer supports some of your functions.
III. Information Technology Infrastructure Library (ITIL) Fundamentals

ITIL offers a systematic approach to the delivery of quality of IT services. It provides a
detailed description of most of the important processes for an IT organization and includes
information about procedures, task, roles and responsibilities. The broad coverage of ITIL also
provides a helpful reference guide for many years
a. The ITIL Service Lifecycle
The entire framework of ITIL is divided into five broad components/categories:
• ITIL Service Strategy
• ITIL Service Design
• ITIL Service Transition
• ITIL Service Operation
• ITIL Continual Service Improvement
b. Service Strategy Process

The Service Strategy process is concerned with the development of service concepts in
preparation for the selection of services to be provided.
• Service Portfolio Management Process: The Service Portfolio Management process is
concerned with management of services that concern information in the Service Portfolio.
Service Portfolio Management organizes the process by which services are identified,
described, evaluated, selected, and chartered.
• Demand Management Process:
The Demand Management process is concerned with understanding and
influencing customer demand. Demand Management models demand in terms of:
• Financial Management Process:
IT Financial Management provides a means of understanding and managing costs
and opportunities associated with services in financial terms.
c. Service Design
The Service Design lifecycle phase is about the design of services and all supporting
elements for introduction into the live environment.
123
The ‘Four Ps of Service Design’ represent areas which should be taken into consideration when
designing a service. They are:
1. People
2. Processes
3. Products
4. Partners
Processes under Service Design are as follows:
• Service Catalog Management

Service Catalog Management involves management and control of the Service
Catalog which contains information about services currently available to customers for
use.
• Service Level Management
Service Level Management is the process charged with securing and managing
agreements between customers and the service provider regarding the levels of
performance (utility) and levels of reliability (warranty) associated with specific services.
• Availability Management
The Availability Management process is concerned with management and
achievement of agreed-upon availability requirements as established in Service Level
Agreements. In ITIL, availability is defined as the ability of a system, service, or
configuration item to perform its function when required.
• Capacity Management
Capacity Management is concerned with ensuring that cost-effective capacity
exists at all times which meets or exceeds the needs of the business as established in
Service Level Agreements. In ITIL, capacity is defined as the maximum throughput a
service, system, or device can handle. Capacity Management is divided into three major
activities:
• Supplier Management
Supplier Management is the process charged with obtaining value for money from
third-party suppliers. Supplier Management plays a very similar role to that of Service
Level Management, but with respect to external suppliers rather than internal suppliers.
• IT Security Management
focuses on protection of five basic qualities of information assets:
o Confidentiality – Assurance that the asset is only available to appropriate parties
o Integrity -- Assurance that the asset has not been modified by unauthorized
parties
o Availability -- Assurance that the asset may be utilized when required
o Authenticity -- Assurance that the transactions and the identities of parties to
transactions are genuine
o Non-Repudiation -- Assurance that transactions,
• Service Continuity Management
124
The IT Service Continuity Management process (ITSCM) is ensures that the IT

Service Provider can always provide the minimum, agreed-upon levels of service. IT
Service Continuity Management uses techniques such as:
o Business Impact Analysis (BIA)-that identifies Vital Business Functions and
their dependencies
o Management of Risk (MOR).
d. Service Transition
The objective of the Service Transition process is to build and deploy IT services by also
making sure that changes to services and Service Management processes are carried out in a
coordinated way.
• Service Asset and Configuration Management

The objective is to maintain information about Configuration Items required
to deliver an IT service, including their relationship.
• Change Management
The objective of this process activity is to control the lifecycle of all the
changes. The primary objective of Change Management is to enable beneficial
changes to be made with minimum disruption to IT services.
Change Types:
▪ Standard Changes-Routine Changes that follow an established
procedure & do not disrupt It services
▪ Emergency Changes-Crucial to an organization and have to be
implemented immediately.
• Release and Deployment Management
The objective of this process is to plan, schedule and control the movement
of releases to test and live environments. The primary goal of this management
activity is to ensure that the integrity of the live environment is protected and that
the correct components are released.
• Knowledge Management
The objective is to gather, analyze, store and share knowledge and
information within an organiza The primary purpose of Knowledge Management is
to improve efficiency by reducing the need to rediscover knowledge.
e. Service Operation
The objective of the Service Operation make sure that IT services are delivered effectively
and efficiently. This includes fulfilling user requests, resolving service failures, fixing problems, as
well as carrying out routine operational tasks.
Processes
• Event Management- The objective is to make sure CIs and services are constantly
monitored, and to filter and categorize Events in order to decide on appropriate
actions.
125
• Incident Management- The objective is to manage the lifecycle of all Incidents. The
primary objective of Incident Management is to return the IT service to users as
quickly as possible.
• Request Fulfilment- The objective is to fulfill Service Requests, which in most cases
are minor Changes (e.g. requests to change a password) or requests for
information.
• Access Management- The objective is to grant authorized users the right to use a service,
while preventing access to unauthorized users. The Access Management processes
essentially execute policies defined in Information Security Management. Access
Management is something also referred to as Rights Management or Identity
Management.
• Problem Management- The process objective is to manage the lifecycle of all Problems.
The primary objectives of Problem Management are to prevent Incidents from happening,
and to minimize the impact of incidents that cannot be prevented. Proactive Problem
Management analyzes Incident Records, and uses data collected by other IT Service
Management processes to identify trends or significant Problems.
Function
• Service Desk- serve as FIRST Point of Contact (FPOC)
• Technical Management- Technical Management provides technical expertise and
support for management of the IT infrastructure.The objective of this is to make
sure that IT services are delivered effectively and efficiently.
• IT Operations Management- The objective is to monitor and control the IT services
and their underlying infrastructure. The process objective of IT Operations Control
is to execute day-to-day routine tasks related to the operation of infrastructure
components and applications. This includes job scheduling, backup and restore
activities, print and output management, and routine maintenance.
• Application Management- Application Management is responsible for managing
applications throughout their lifecycle.Management is something also referred to as
Rights Management or Identity Management.
f. Continual Service Improvement (CSI)

The objective of this is to use methods from quality management to learn from past
successes and failures. The Continual Service Improvement process aims to continually improve
the effectiveness and efficiency of IT processes and services in line with the concept of continual
improvement adopted in ISO 2000.
CSI offers a mechanism for the IT organization to measure and improve service levels,
the technology, efficiency and effectiveness of processes used in the overall management of
services.
Main Processes of CSI

o Service Review- The objective of Service Review is to review business services
and infrastructure services on a regular basis. The aim of this process is to improve
126
service quality where necessary, and to identify more economical ways of

providing a service where possible.
o Process Evaluation- The objective here is to evaluate processes on a regular
basis. This includes identifying areas where the targeted process metrics are not
reached, and holding regular benchmarking, audits, maturity assessments and
reviews.
o CSI Initiatives- The objective of CSI initiatives is to define specific initiatives aimed
at improving services and processes, based on the results of service reviews and
process evaluations. The resulting initiatives are either internal initiatives, pursued
by the service provider on his/her own behalf, or initiatives which require the
customer’s cooperation.
o Monitoring of CSI Initiatives- The objective is to verify if improvement initiatives
are proceeding according to plan, and to introduce corrective measures where
necessary.
Watch:
• Introduction to Project Management (2020)
https://www.youtube.com/watch?v=rBSCvPYGnTc
• Project Management Simplified: Learn The Fundamentals of PMI's Framework ✓
https://www.youtube.com/watch?v=ZKOL-rZ79gs
• ITIL 4 Foundation | ITIL 4 Foundation Training | What Is ITIL V4? | ITIL Certification |
Simplilearn
https://www.youtube.com/watch?v=CMRd6poZ8d4
Read:
• R.A. 9292. (Apr. 17, 2004). Retrieved from Inc.:
http://www.lawphil.net/statutes/repacts/ra2004/ra_9292_2004.html
• ITIL Overview. (Feb. 13, 2013). Retrieved from https://www.simplilearn.com/itil-key-
concepts-and-summary-article
• ITIL. (May 9, 2011). Retrieved from https://itil2014.wordpress.com/tag/service-
operation/
• Bernard, Pierre, 2011, Foundations of ITIL (USA: Van Harren Publishing)
• Horine, G. M. (2009). Absolute Beginner's Guide to Project Management. Indianapolis:
Que Publishing.
• Vidal, K. (2015, October 28). The Business. Retrieved January 17, 2017, from Tools and
Techniques for Risk Management: http://thebusiness.duedil.com/tools-and-techniques-
for-risk-management-8036/
• Westland, J. (2006). The Project Management Life Cycle. London: Kogan Page Limited.
• Williams, M. (2008). The Principles of Project Management. Collingwood, Australia:
SitePoint Pty. Ltd. .
127
1. What are the other related trainings to the ECE field and why do you think it is significant
to your career as future practitioner?
2. After graduation, what is your perspective about the career difference between being an
academician and an industry practitioner?
3. After 5 years of your graduation, how do you see yourself in terms of career progress?
How about after 10 years of gradudation?
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1

COMPILER: Engr. CHRISTIAN P. ENOVAL

Republic of the Philippines

B. Course Learning Outcomes

At the end of the course, the student should be able to

• Basic concepts and foundations of total quality management

• Quality organization within an organization

IV. Course Study Guide

It is a self-paced material; hence, please be guided to -

Engr. CHRISTIAN P. ENOVAL Dr. BEN B. ANDRES

Recommending Approval: Approved:

Engr. GEOFFREY T. SALVADOR Dr. REMEDIOS G. ADO

Table of Contents Page

Basic concepts and foundations of total quality management 6

Key steps in the control of quality 20

TQM tools and the improvement cycle 30

Conformance and non-conformance to quality standards 56

Quality organization within an organization 68

Control of quality records 79

Internal quality audits 90

Quality and business process re-engineering 98

Training for total quality management 106

TQM application to electronics engineering fields 115

TOPIC 1: BASIC CONCEPTS AND FOUNDATIONS OF TOTAL

In manufacturing, a measure of excellence or a state of being free from defects,

Quality of something can be determined by comparing a set of inherent characteristic with

• Elaborate the Components of quality

• Explain the TQM approach

• Explore about Innovation, design and improvement

• Product quality characteristics and service quality characteristics

• Quality parameters and specific dimensions of quality

“getting what you pay for” – Student

II. QUALITY FROM THE CUSTOMER’S PERSPECTIVE

III. DIMENSIONS OF QUALITY FOR MANUFACTURED PRODUCTS

1. Performance: The basic operating characteristics of a product

IV. DIMENSIONS OF QUALITY FOR SERVICES

V. QUALITY FROM THE PRODUCER’S PERSPECTIVE

An important consideration from the customer’s perspective of product quality is product

VI. FINAL PERSPECTIVE ON QUALITY

• Institute a programme of education and self-improvement.

c. Quality Assurance: It is part of quality management focused on providing confidence that

Goal of quality assurance

▪ Prevention costs ▪ Appraisal costs

A commonly used control device called a ‘’’programmable logic controller’’, or a PLC, is

VII. The Determinants of Quality

VIII. Quality of design

➢ Service after delivery

6-Sigma refers to a quality improvement and business strategy concept started by

The ISO 14000environmental management standards exist to help organizations

XI. ISO 9000

• Monitoring manufacturing processes to ensure they are producing quality product;

A company or organization that has been independently audited and certified to be in

XI. Quality Parameters and Specific Dimensions of Quality

a. Quality Parameters is the standards or expectations that must be met by a certain

4. Courtesy: It refers to the treatment of employees to their customers (Politeness,

1. Performance: It refers to how well the product performs when in use

XII. Total Quality Management

c. Components of Quality Management

d. The TQM Approach

e. Generic Strategy Model for Implementing TQM Systems