MOHAMED YOUSSEF ABDELAZIM FADDA

NO.52

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 Report 1
1-1- What is meant by Quality? Discuss briefly why it is very important to develop
communities and to increase productivity of societies by applying quality concepts.

Quality needs to be defined in terms of characteristics. For example, for a mechanical

or electronic product these are performance, reliability, safety and appearance for a
food product they will include taste, nutritional properties, texture.

It is very important to develop communities and to increase productivity of societies

by applying quality concepts because if we applied the quality concepts will use fully
manpower and energy and decrease the waste of time and chose optimum solution for any
problem.

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1-2- What is meant by fixing product specifications? Give examples.

A specification is the minimum requirement according to which a producer or service

provider makes and delivers the product and service to the customer. In setting
specification limits, the following should be considered:

*The user’s and/or customer’s needs *Requirements relating to product safety and
health hazards In designing the product, the capacity of processes and machines should
be kept in mind. It is also necessary to maintain a balance between cost and value
realization. The clearer the specification, the better the possibility of creating and
delivering quality products.

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1-3- Show how the Preparing product design is related to quality management.

to achieve the quality management of product, the designer should be have enough
informations about product and it’s functions. The overall design of any product is
made up of many individual characteristics. For example these may be:

Dimensions, such as length, diameter, thickness or area

Physical properties, such as weight, volume or strength

Electrical properties, such as resistance, voltage or current

Appearance, such as finish and color

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 1-4- What is meant by Total Quality Management? Show how quality concepts can lead to
better quality within Egyptian Industrial Communities.

TQM is a philosophy which applies equally to all parts of the organization. If we use
quality concepts in Egyptian Industrial Communities we can lead to better quality of
production and service by use fully manpower and energy and decrease the waste of time
and choose optimal solution for any problem.

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1-5- What is the relationship between standards and Total Quality Management.

The International Organization for Standardization (ISO) is a worldwide federation of

national ISO standards are documented quality systems used as the basis for adoption
of uniform quality systems norms for international exchange of goods and services.

British and ISO Standards on TQM BS 7850-1:1992 •Total quality management. Guide to
management principles.

BS 7850-2:1994, ISO 9004-4:1993 •Total quality management. Guidelines for quality

improvement

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1-6- What are the main measures of quality within Marine Industrial Sectors?

he supply department : is in charge of purchasing the necessary materials and

equipment, the design department: it must be responsible for the basic design and
the detail design as well as the completion drawings and the concerned information.
The production department: in charge of equipment manufacturing, and marina operations
The quality control department : will have a close look at everything installed .

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1-8- What is meant by quality elements? Discuss with the aid of necessary figures the
simple process within fundamental concept of TQM.

1- Leadership –Top management vision, planning and support. 2 -Employee involvement

–All employees assume responsibility for the quality of their work. 3 -Product/Process
Excellence –Involves the process for continuous improvement. 4- Continuous
Improvement A concept that recognizes that quality is updating process there is a need
for new updates always for improving quality.

5 - Design quality :

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‫‪Specific characteristics of a product that determine its value in the marketplace.‬‬

‫‪6 - Conformance quality: The degree to which a product meets its design specifications.‬‬

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‫‪1-9- Draw a sketch to define what is meant by changing role of the process owner‬‬

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 1-10- Show with the aid of sketches the traditional Change TQM &

Organizational Cultural approach within Total Quality Management schemes.

1-11- Perceived quality is governed by the gap between customers’ expectations and their
perceptions of the product or service.

Discuss this statement in views of poor and good quality actions.

Draw a sketch to define the importance of perceived quality.

Perceived quality is governed by the gap between customers‟ expectations and their
perceptions of the product or service

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1-12- Compare with the aid of necessary sketches between Technical Quality versus
Functional Quality

Technical Quality versus Functional Quality

Technical quality — the core element of the good or service.

Functional quality — customer perception of how the good functions or the service is
delivered

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1-13- Implementation of quality can be faced by critics and obstacles. Discuss this
statement in detail with the aid of sketches.

Implementing TQM
1-Successful Implementation of TQM

requires total integration of TQM into day-to-day operations.

2-Causes of TQM Implementation Failures

Lack of focus on strategic planning and core competencies.

Obsolete, outdated organizational cultures.

Obstacles to Implementing TQM

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Lack of a company-wide definition of quality.

Lack of a formalized strategic plan for change.

Lack of a customer focus.

Poor inter-organizational communication.

Lack of real employee empowerment.

Lack of employee trust in senior management.

View of the quality program as a quick fix.

Drive for short-term financial results.

Politics and turf issues.

Report 2
2-1- What is quality management all about? How did one can get TQM? Draw sketches to
define what does Total Quality Management encompass?

The quality management all about :

Try to manage all aspects of the organization in order to excel in all dimensions
that are important to “customers” Two aspects of quality:

Features: more features that meet customer needs = higher quality

Freedom from trouble: fewer defects = higher quality

History How did one can get TQM?

• Deming and Juran outlined the principles of Quality Management. • Tai-ichi Ohno
applies them in Toyota Motors Corp.

• Japan has its National Quality Award (1951).

• U.S. and European firms begin to implement Quality Management programs (1980’s).

• U.S. establishes the Malcolm Baldridge National Quality Award (1987).

• Today, quality is an imperative for any business

What does Total Quality Management encompass ? TQM is a management philosophy:

• continuous improvement

• leadership development

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‫‪• partnership development‬‬

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‫‪2-2- Developing quality specifications within TQM Schemes can lead to better, discuss‬‬
‫‪with the aid of necessary sketches this statement within scheme of TQM.‬‬

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 2-3- Show with the aid of necessary sketches how six sigma concept can deal within TQM?

A philosophy and set of methods companies use to eliminate defects in their products and
processes
•Seeks to reduce variation in the processes that lead to product defects

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•The name “six sigma” refers to the variation that exists within plus or minus six standard
deviations of the process outputs

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 2-4- Show with the aid of necessary sketches how six sigma concept can improve TQM
within industrial sectors.

By : • Optimize KPOVs & test the KPIVs • Redesign process, set pacemaker • 5S, Cell design,
MRS • Visual controls Value Stream Plan

2-5- Show how the PDCA concept can improve TQM

decisions?

PDCA: Plan-do-check-act as defined by Deming.

Benchmarking: what do top performers do?

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 2-7- Mention briefly the different tools used for continuous improvement in TQM

2-8- A bank has installed waiting service, show how can reduce waiting time? Draw
all necessary charts and diagrams.

Taking lunches on three different shifts 1. Ask all employees to leave messages when leaving
desks 2. Compiling a directory where next to personnel’s name appears her/his title

2-9- How can we monitor quality? How do we define the output measures in TQM
Process?

By observing variation in output measures!

1- Assignable variation: we can assess the cause 2-Common variation: variation that may not be
possible to correct (random variation, random noise)
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2-10- When is a product good enough? With the aid of necessary figures show how the
process Which is being more accurate? Which process is being more consistent.

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 Report 3
WHAT IS MEANT BY QUALITY CONSUMER’S PERSPECTIVE? WHAT IS DIMENSIONS OF
QUALITY? SKETCH THE QUALITY MEANING.

Quality of Conformance
Making sure a product or service is produced according to design

Fitness for use: how well product or service does what it is supposed to. Quality of
design: designing quality characteristics into a product or service

Dimensions of Quality

Manufactured Products

Performance :
basic operating characteristics of a product; how well a car is handled or its gas
mileage.

Features
“extra” items added to basic features, such as a stereo CD or a leather interior in
a car.

Reliability
probability that a product will operate properly within an expected time frame; that
is, a TV will work without repair for about seven years

Conformance
degree to which a product meets pre–established standards,

Durability
how long product lasts before replacement.

Serviceability
ease of getting repairs, speed of repairs, courtesy and competence of repair person.

Aesthetics
how a product looks, feels, sounds, smells, or tastes.

Safety
assurance that customer will not suffer injury or harm from a product; an especially
important consideration for automobiles.

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Perceptions subjective perceptions based on brand name, advertising, and the
like
Service

Time and Timeliness

How long must a customer wait for service, and is it completed on time? Is an
overnight package delivered overnight?

Completeness:
Is everything customer asked for provided? Is a mail order from a catalogue
company complete when delivered?
WHAT IS MEANT BY PRODUCER’S PERSPECTIVE APPLIED WITHIN TQM?

Quality of Conformance Making sure a product or service is produced according to

design

WHAT IS MEANT BY A FINAL PERSPECTIVE?

Consumer’s and producer’s perspectives depend on each other.

Consumer’s perspective: PRICE

Producer’s perspective: COST

Consumer’s view must dominate

WHAT IS MEANT BY TQM? DRAW A SKETCH TO DEFINE THE PRINCIPLES OF TQM? Total
Quality Management Commitment to quality throughout organization

Principles of TQM

Customer-oriented

Leadership Strategic planning

Employee responsibility

Continuous improvement

Cooperation Statistical methods

Training and education

WHAT ARE THE QUALITY GURUS? DISCUSS BRIEFLY THE IMPORTANT RESULTS OF THE
DIFFERENT GURUS. DRAW THE DEMING WHEEL: PDCA CYCLE.

Walter Shewart

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In 1920s, developed control charts Introduced the term “quality assurance”

W. Edwards Deming

Developed courses during World War II to teach statistical

quality-control techniques to engineers and executives of companies that were

military suppliers

Joseph M. Juran

Followed Deming to Japan in 1954 Focused on strategic quality planning

Armand V. Feigenbaum

In 1951, introduced concepts of total quality control and continuous quality

improvement.

Philip Crosby

In 1979, emphasized that costs of poor quality far outweigh the cost of preventing
poor quality In 1984, defined absolutes of quality management—conformance to
requirements, prevention, and “zero defects”

Kaoru Ishikawa

Promoted use of quality circles Developed “fishbone” diagram Emphasized importance

of internal customer

Deming’s 14 Points
 Create constancy of purpose
 Adopt philosophy of prevention
 Cease mass inspection
 Select a few suppliers based on quality
 Constantly improve system and workers
 Institute worker training
 Instill leadership among supervisors
 Eliminate fear among employees
 Eliminate barriers between departments
 Eliminate slogans
 Remove numerical quotas
 Enhance worker pride
 Institute vigorous training and education programs
 Develop a commitment from top management to implement above 13 points

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 SHOW HOW QUALITY IMPROVEMENT CAN AFFECT QUALITY OF PRODUCTION IN
SHIPYARDS? DRAW THE QUALITY CIRCLE DIAGRAM AND COMMENT ON ITS MAIN
COMPONENTS.

WHAT IS MEANT BY STRATEGIC IMPLICATIONS OF TQM? SKETCH THE DAIMC MAP.

DISCUSS BRIEFLY THE MAIN COMPONENTS.

Strategic Implications of TQM

1. Strong leadership
2. Goals, vision, or mission
3. Operational plans and
policies
4. Mechanism for feedback

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 Report 4
4-1-Discuss briefly what is meant by TQM in Service Companies?

 Principles of TQM apply equally well to services and manufacturing.

 Services and manufacturing companies have similar inputs but different
processes and outputs.
 Services tend to be labor intensive
 Service defects are not always easy to measure because service output is not
usually a tangible item

4-2-What are the Quality Attributes in Service?

 Benchmark

“best” level of quality achievement one company or companies seek to achieve

 Timeliness

how quickly a service is provided

4-3-Why measure performance in TQM? When and why do performance measures fail?
Discuss the Importance of Measure of Performance. Why do organizations choose
accounting data as measures of performance? Why accounting measures of
performance are not adequate?

Objectives for for-profit organizations:

*Measure changes to stake holder’s wealth; put in simple terms, the value of a
firm.

*Reward an employee for contributing to increase in firm value

The performance measurement concept indicates that employees can increase the value
of the firm by

• Increasing the size of a firm’s future cash flows,

• By accelerating the receipt of those cash flows, or

• By making them more certain or less risky.

Why do performance measures fail?

• Root cause: complexity - details, details, details

• Staff who collect data get frustrated.

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 • Follow: What has to be done" (WHTBD).

Discuss the Importance of Measure of Performance

Let us now examine how real world firms measure performance and we will, later, find
out whether these measures conform to the concepts we just discussed.

Most organization measure performance using accounting measures – Net profits, gross
margin, ROA, ROE, etc.

Why do organizations choose accounting data as measures of performance?

• Accounting profits and returns can be measured on a timely basis relatively

precisely and objectively. • Because they are timely, precise, and objective,
employees would react positively.

• The short term measures keep employees on check.

Why accounting measures of performance are not adequate?

• Accounting measures are lagged indicators.

• Dependent on the choice of measurement method.

4-4-Discuss briefly the effect of changing in Business Environment on TQM?

Performance Measurements for the new era

• In the global, technology-driven, decentralized environment, measuring

• Financial performance, while important, is not adequate.

• Even if less than precise, other measures of performance are required.

• These measures should be capable of measuring multiple attributes of an

organization.

4-5-Show how the Lead indicators are value drivers? What are the lag indicators?

• Many non-financial indicators can serve as lead indicators in certain settings.

• Common examples are:

• Market share, backlog (book-to-bill ratio), new product introductions, new product
development lead times, product quality, customer satisfaction, employee morale,
personnel development, inventory turnover, bad debt ratio, or safety

Lag Indicators

In contrast to lead indicators, lag indicators are measures that point to earlier
plans and their execution.

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 Financial performances are lag indicators.

Many times, financial performances are too late to affect future products and
services.

Therefore, we need multiple measures that include both financial and nonfinancial
measures.

4-6-Show how Comprehensive Performance Measures can be addressed.

1. Financial performance

2. Customer satisfaction

3. Internal business process developments and

4. Allow an organization to learn and grow.

4-7-Sketch a diagram to denote the Customer-based measures.

4-8-What is meant by Internal Business Process Measures? Draw a diagram to denote the
main elements.

Identify the critical internal processes for which the organization must excel in
implementing its strategy.

• IBP dimension enable the business unit to

• deliver the value propositions that will attract and retain customers in targeted
market segments, and • satisfy shareholder expectations regarding financial returns.

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 4-9-What are the main Cost of Quality? Show how Measuring and Reporting Quality Costs
can be carried out. What are the main Cost of Quality? Cost of Achieving Good
Quality

 Prevention costs costs incurred during product design

 Appraisal costs costs of measuring, testing, and analyzing Cost of Poor
Quality
 Internal failure costs include scrap, rework, process failure, downtime, and
price reductions
 External failure costs include complaints, returns, warranty claims,
liability, and lost sales

Measuring and Reporting

 Index numbers ratios that measure quality costs against a base value
 labor index ratio of quality cost to labor hours
 cost index ratio of quality cost to manufacturing cost
 sales index ratio of quality cost to sales
 production index ratio of quality cost to units of final product

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Page 22
 Report 5
5-1- Discuss briefly the relationship between Quality Management and productivity within
a shipyard.

Productivity : ratio of output to input

Yield : a measure of productivity

5-2- What are the principle items in a Product Cost? 5-3- Show how computing the
product yield for multistage processesproduct yield for multistage processes

Where:

Kd=direct manufacturing cost per unit

I=input

Kr=rework cost per unit

R=reworked units

Y=yield

Computing product Yield for multistage processes

Where:

I=input of items to the production process that will result in finished products

Gi=good-quality,work-in-process products at stage i

5-4- What is meant by Quality–Productivity Ratio, “QPR”?

QPR:productivity index that includes productivity and quality costs.

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 5-5- What are the different quality awards? Satisfaction Index (ACSI)?

Baldrige Award:

 Created in 1987 to stimulate growth of quality management in the united

states.
 Categories:

5-6- What is the American Customer

Leadership

Information and analysis

Strategic planning

Human resource

Focus

Process management

Business results

Customer and market focus

National individual awards

 Deming medal
 Edwards Medal
 Shewart Medal

5-7- What is the main assets in Six Sigma?

A process for developing and delivering near perfect product and services
Measure of how much a process deviates from perfection

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 5-8- Sketch the different components in Six Sigma: DMAIC Process.

5-9- Show how the ISO 9000 can be implemented

Asset of procedures and policies for international quality certification of suppliers

Standards :
Iso 9000:2000
 Quality management systems _ fundamentals and vocabulary
 Defines fundamental terms and definitions used ind iso 9000 family

5-10- Show how the ISO 9001 can be implemented.

Many overseas companies will not do business with a supplier unless it has iso 9000 certification
Iso 9000 accreditation
Iso registrars
Atotal commitment to quality is required throughout an organization

Report 6
6-1- Discuss what are the main Seven Quality Tools? The Seven Tools Histograms,
Pareto Charts,

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 Cause and Effect Diagrams,

Run Charts,

Scatter Diagrams,

Flow Charts,

Control Charts

6-2- What are the Ishikawa’s Basic Tools of

Quality? Give example of flow
charts.

Kaoru Ishikawa developed seven basic visual

tools of quality so that the average person
could analyze and interpret data.

These tools have been used worldwide by companies, managers of all levels and
employees. Example ; Process Flow Chart for Finding the Best Way Home
Construct a process flow chart by making the
best decisions in finding the best route home.
Refer to the prior notes on flowcharts.
Remember: Define and analyze the process, build
a step-by step picture of the process, and define
areas of improvement in the process.

6-3- What are the Run Charts? Give examples.

Run Charts Defined Run charts are used to

analyze processes according to time or order.
Creating a Run Chart Gathering Data Some

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type of process or operation must be available to take measurements for analysis.
Organizing Data Data must be divided into two sets of values X and Y. X values
represent time and values of Y represent the measurements taken from the
manufacturing process or operation. Charting Data Plot the Y values versus the
X values. Interpreting Data Interpret the data and draw any conclusions that
will be beneficial to the process or operation. An Example of Using a Run Chart
An organization’s desire is to have their product arrive to their customers on
time, but they have noticed that it doesn’t take the same amount of time each day of
the week. They decided to monitor the amount of time it takes to deliver their
product over the next few weeks.

6-4- What are the New seven tools?

Affinity Diagrams

Relations Diagrams

Tree Diagrams

Matrix Diagrams

Arrow Diagrams

Process Decision Program Charts

Matrix Data Analysis

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 6-5- What are the Relation Between New Seven Q.C. Tools and Basic Seven Q.C. Tools?
Draw figures to show the Benefits of Incorporating New Seven Q.C. Tools.

Relation Between New Seven Q.C. Tools and Basic Seven Q.C. Tools

Benefits of Incorporating New Seven Q.C. Tools

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Page 29
6-6- Show with the aid of sketches what is meant by Affinity Diagram, a Relation Diagram
and Completing a Tree Diagram, Matrix Diagram, an arrow Diagram, PDPC Diagram

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appropriate symbol: Efficacy: O=good, Δ =satisfactory, X=none Practicability:
O=good, Δ =satisfactory, X=none

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PDPC : process decisions program charts

6-7- Draw a table denoting the main items in a Matrix Data Analysis.

Matrix Data Analysis

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 6-8- What are Keys to Successfully Using the New Seven tools? Discuss the different stages
applied

Mental Attitudes

-Keen awareness to the actual problem -Eagerness to solve problem

-Be highly motivated for the challenge Four Specific Keys

•Understand the problem •Select the right tool for the job

•Obtain appropriate verbal data

•Interpret analytical results

Understand the problem

 Stage 1 - problem is unclear and not obvious what exact issue should be
addressed
 Stage 2 - problem is obvious, but causes unknown explore causes and single out
valid ones
 Stage 3 - problem and causes are known required action is unknown strategies
and plan must be developed

Selecting Right tool for the Job

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 Stage 1 - Collect verbal information on events (Affinity Diagram)
 Stage 2 - Choose tool to identify causes (Relations Diagram / Matrix Diagram)
 Stage 3 - List strategies and activities (Tree Diagram / Relations Diagram)
Plan actual activities (Arrow Diagram / PDPC Chart)

 6-9- Discuss briefly how the Interpreting Analytical can have good quality impacts and
Results

 Information must be obtained for accomplishing objectives from:

 Completed diagrams; or
 Process of completing diagrams
 Analyze actual information obtained:
 Prepare summarized report with findings, conclusions, and processes used
 Check if necessary data has been obtained, if not
 Discover the cause and take appropriate action

Report 7

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 7-1- What is a Sentinel Event? Draw sketches to show what is meant by the Swiss cheese
model of how defenses, barriers, and safeguards may be penetrated by an
accident trajectory.

Sentinel Event: A sentinel event is an unexpected occurrence involving death or

serious physical or psychological injury, or the risk thereof. Serious injury
specifically includes loss of limb or function. The phrase, "or the risk thereof"
includes any process variation for which a recurrence would carry a significant
chance of a serious adverse outcome. Such events are called "sentinel" because they
signal th e need for immediate investigation and response.

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 7-2- Discuss with the aid of all sketches the Preconditions for Unsafe Acts, State different
Categories of Unsafe Supervision.

Types of Unsafe Acts

Categories of Unsafe Supervision

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 7-3- What is RCA applied within TQM Schemes? Mention briefly the different associated
RCA Principles. Show how the fishbone diagram can be implemented in TQM with
RCA.

Root cause analysis (RCA) is a class of problem solving methods aimed at identifying
the root causes of problems or events.

The practice of RCA is predicated on the belief that problems are best solved by
attempting to correct or eliminate root causes, as opposed to merely addressing the
immediately obvious symptoms. By directing corrective measures at root causes, it is
hoped that the likelihood of problem recurrence will be minimized. However, it is
recognized that complete prevention of recurrence by a single intervention is not
always possible. Thus, RCA is often considered to be an iterative process, and is
frequently viewed as a tool of continuous improvement.

Safety-based RCA descends from the fields of accident investigation and occupational
safety and health. Root causes tend to be viewed as failed or missing safety
barriers, unrecognized risks or hazards, or inadequate safety engineering.

General principles of root cause analysis

Aiming corrective measures at root causes is more effective than merely treating
the symptoms of a problem. • To be effective, RCA must be performed systematically,
and conclusions must be backed up by evidence. •There is usually more than one root
cause for any given problem.

General process for performing RCA

 Define the problem.

 Gather data/evidence.
 Identify problems that contributed to problem (Causal Factors).
 Find root causes for each Causal Factor.
 Develop solution recommendations.
 Implement the solutions.

7-4- Show how it took 57 separate steps to get a defect administered to a welded joint in
a workshop. Draw the flow Chart.

How is a fishbone diagram constructed?

1. Draw the fishbone diagram.

2. List the problem/issue to be studied in the "head of the fish".

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 3. Label each ""bone" of the "fish". The major categories typically utilized are:
The 4 M’s: Methods, Machines, Materials, Manpower The 4 P’s: Place, Procedure,
People, Policies The 4 S’s: Surroundings, Suppliers, Systems, Skills 4. Use an
idea-generating technique (e.g., brainstorming) to identify the factors within each
category that may be affecting the problem/issue and/or effect being studied. The
team should ask... "What are the machine issues affecting/causing...“

5. Repeat this procedure with each factor under the category to produce sub-factors.
Continue asking, "Why is this happening?" and put additional segments each factor and
subsequently under each sub-factor. Continue until you no longer get useful
information as you ask, "Why is that happening?"

6. Analyze the results of the fishbone after team members agree that an adequate
amount of detail has been provided under each major category. Do this by looking for
those items that appear in more than one category. These become the 'most likely
causes".

7. For those items identified as the "most likely causes", the team should reach
consensus on listing those items in priority order with the first item being the most
probable" cause.

Flowcharting is a very useful tool –who knew that it took 57 separate steps to get a
defect administered to a welded joint in a workshop.

7-5- Give an example of a quality improvement activity/project that shipyards have been
involved. Describe its development, goal, implementation, evaluation of success.

The practice of RCA is predicated on the belief that problems are best solved by
attempting to correct or eliminate root causes, as opposed to merely addressing the
immediately obvious symptoms. By directing corrective measures at root causes, it is
hoped that the likelihood of problem recurrence will be minimized. However, it is
recognized that complete prevention of recurrence by a single intervention is not
always possible. Thus, RCA is often considered to be an iterative process, and is
frequently viewed as a tool of continuous improvement.

7-6- List the activities in which residents actively participate to learn and apply the
principles of quality improvement, and identify those who oversee these activities.

Affinity Diagrams

Relations Diagrams

Tree Diagrams

Matrix Diagrams

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 Arrow Diagrams

Process Decision Program Charts

Matrix Data Analysis

7-7- Give an example of a quality improvement activity/project that residents have been
involved with during the past year or are currently. Describe its development,
goal, implementation, evaluation of success.

How does the program ensure that residents provide and document continuity of care?

the Y values versus the X values. Interpreting Data Interpret the data and draw
any conclusions that will be beneficial to the process or operation. An Example of
Using a Run Chart An organization’s desire is to have their product arrive to
their customers on time, but they have noticed that it doesn’t take the same amount
of time each day of the week. They decided to monitor the amount of time it takes to
deliver their product over the next few weeks.

Page 39
 Report 8
8-1-what are the audit based ISO norms?

This international standard provides guidance on auditing management system,including

the principlesof auditing,maning an audit programme and conducting management system
audits,as well as guidance on the evaluation of competenceof individuals involved in
the audit process.these audits can be conducted either internally or externally:

 The internal audits are conducted with the purpose of reviewing the quality
system and internal objectives
 The external audits are conducted either by stakeholders or other parts that
have interest in the organization,or by an external and independent auditing
organization

8-2-Draw efQm diagram,what are the main requirements of audit within efqm?

8-3-What are the requirements of EFQM audit-what types of quality managements

models are being used within comman assessment-framework(CAF)?

Main objectives

To introduce public administration into the culture of excellence and the principles
of TQM;

To guide them progressively to a mature PDCA (PLAN,DO,CHECK,ACT)cycle;

To facilitate the self-assessment of public organization in order to obtain a

diagnosis and a definition of improvement actions;

To act a bridge across the various models used in quality,both between public sector
organizations main results

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Identification of strength and weaknesses and of improvements areas and relative
improvement actions

Objective evaluation throughout scoring systems

8-5-What are the main basics of internal auditing and Quality?

The main emphasis was that internal auditors needed to question where they wanted to
be on the value chain. The main source of competitiveness was the knowledge their
internal auditors acquired of risk, control, strategy objectives and processes.

The key skill areas included industry based training, global practices, knowledge
management, E‐commerce and Internet technologies, soft skills and the basics of
audit. The educational issues raised were that the educators needed to redevelop the
curriculum, and train the internal auditors in globalisation skills (Gibbins, 1999).
Training skills also need to include communication skills, facilitation skills, ris

It remains management’s privilege and opportunity to either accept or reject the

internal auditor’s recommendations on what control procedures should be.

8-6-Why is quality assurance and improvement program necessary?

In an effort to provide health care of optimal quality, providers traditionally

assess or measure performance and then assure that it conforms to standards.

In cases where performance fails to conform, providers attempt to modify or improve

physician behavior. The analytic scope of this traditional paradigm may not be broad
enough to allow modern health care organizations to provide optimal care.

At a theoretical and practical level, many conceptual limitations inherent in the

traditional approach are addressed in modern industrial quality science. A
fundamental principle of industrial quality control is the recognition, analysis, and
elimination of variation.

8-7-What does quality assurance and improvement program include?

All patients admitted to five patient care units (one medical intensive care unit,
two surgical intensive care units, and two medical general care units) in one
academic tertiary care hospital were studied between February and July 1993. The main
outcome measures used were adverse drug events (ADEs) and IRs. Consensus voting was
used by senior hospital administrators, nursing leaders, and staff nurses to
determine whether an adverse drug event should have been reported and would have been
reported.

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 8-8-What is quality assessment?

Objectives for for-profit organizations:

*Measure changes to stake holder’s wealth; put in simple terms, the value of a firm.

*Reward an employee for contributing to increase in firm value

The performance measurement concept indicates that employees can increase the value
of the firm by

• Increasing the size of a firm’s future cash flows,

• By accelerating the receipt of those cash flows, or

• By making them more certain or less risky.

8-9-Which organization should obtain QAs?

Let us now examine how real world firms measure performance and we will, later, find
out whether these measures conform to the concepts we just discussed.

Most organization measure performance using accounting measures – Net profits, gross
margin, ROA, ROE, etc.

8-10-If an organization has not yet established a quality assurance and improvement
program ,how can it start the process?

• Accounting profits and returns can be measured on a timely basis relatively

precisely and objectively.

• Because they are timely, precise, and objective, employees would react positively.

• The short term measures keep employees on check.

8-11-what are appropriate external QA approaches?

Regardless of an organization “s industry or the internal audit

activity”scomplexity or size,there are two approved approaches for external QAs.

8-12-what are the selection criteria for external QA providers?

At a minimum, the QAprovider should use a methodology that includes compliance with
the standards,definition of internal auditing and the code of ethics as the benchmark
for quality.

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 8-13-what are the respercussions of not acquiring an external QA?

If the internal audit activity does not acquire the external assessment at least
every five years,it is forbiddento use the proessional practice of internal
Auditing,in its internal audit charter or reports

8-14-How do peer reviews fit into the QA process?

External quality assessments or self assessments can be conducted through peer

reviews instead of utilizing an external service providers.

8-15-what if theresults of an external QA are negative?

The organization should create an action plan that specifically addresses each
opportunity for improvement cited in the assessment. The CAE must disclose
nonconformance and the impact with senior management and the board.

8-16-what is the next step to process if the result of an external QA are positive?

Once the QA has been completed;the CAE must communicate results to the senior
management and the board

8-17-what QA resources are available?

The IIA provides free samples, models,and other resources,based on quality assessment
successful practices.

Report 9

Page 43
 9.1- Show how Deriving objectives can be fulfilled. Show how can we fulfil all
requirements and stay in business? Show how Adjusting objectives can be fulfilled.

Adjusting objectives

• Customers : let our customers find the faults

• Suppliers : Delay paying invoices until they threaten legal proceedings

• Employees : Delay pay rise until next year and only pay those we want to keep if
they hand in their notice

• Society : Don’t comply with certain regulations until we are compelled to do so

• Investors : Pay smaller dividend and pay bonus to directors instead

9.2- Show how Redefining objectives can lead to better quality assessments.

• Design, produce and market a range of new products that meet defined customer
needs by Dec 2016 in a way that:

• Captures 30% of the market (Suppliers/Investors)

• Delivers a 7% profit (Investors/Employees)

• Consumes 25% fewer resources than the product it replaces (Society/Investors)

• Is free of defects and occupational injuries and illnesses from the start
(Employees) • Reduces emissions to atmosphere by 30% (Society)

• Creates employment in the local community (Society)

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 9.3- What is meant by Reputation? Why Quality comes first principle in Western Countries
and Japan? When the same principle would apply in Egypt?

Reputations are hard to win and easy to loose

Providing fault free products that possess the features customers want World
leader

• Providing products that possess most of the features customers want but which might
be faulty

Average player

• Providing faulty products that don’t possess the features customers want but
appear as if they do

Rogue trader

Quality first principle in USA

Henry Ford 1910

For Henry Ford, quality was the number one priority in manufacturing his cars. He
felt that if one of his cars broke down on a customer, that he was personally to
blame. “It was our duty to see that his machine was put into shape again at the
earliest possible moment”. 80 years later Ford declares as one of its guiding
principles in Q101, that Quality comes first

Alfred P Sloan 1925

We have elected, as a large corporation, to build quality products sold at fair

prices …however we must admit that such a policy throws the added responsibility
upon our sales departments to get the cost of quality plus a profit on quality

Newport News Shipbuilding circa 1940

We will build good ships here; at a profit if we can, at a loss if we must, but
always good ships

Quality first principle in Japan

It’s an attitude of mind

It’s a fundamental management concept

It’s not a big issue because it’s acknowledged by all people in all levels of
the company.

Quality first principle in Japan today

Page 45
 It’s an attitude of mind

• It’s a fundamental management concept

It’s not a big issue because it’s acknowledged by all people in all levels of the
company

Egypt !!

9.4- Show how Making quality the first priority is about a way of thinking, it’s a principle
that one can choose to adopt but ignoring it when making choices may have
undesirable consequences.

• You are put under pressure to deliver a product to a customer knowing that all the
product requirements have not been fulfilled

• You run out of the approved material and can’t get a delivery in time to honour
your commitment to your customer but you do have an untested alternative

Putting quality first or cost first

• You are notified about a batch of defective product of relatively low value and
decide to scrap the lot. Then you are notified of another batch, and then another
batch, the value now runs into thousands.

• You find that a subordinate manager is rewarding production teams for record runs
related to volume/waste/delay and during the run quality (inch safety) is not
considered

Summary of Points

Quality first is about fulfilling expectations.

• Prioritizing the quality of any one variable to the detriment of others may lead to
undesirable consequences

• Satisfying customers in the short term is not profitable in the long term if you
are selling them product that will ultimately do them harm

• Quality first is about achieving the objective in a way that satisfies the
constraints

• Not putting quality first is knowingly producing work that is substandard and
charging the same price as if it were work of an acceptable standard

• Making quality the first priority is about a way of thinking and getting everyone
to think this way creates a competitive advantage

Page 46
 9.5- Discuss briefly There is an implication that if an organization is certificated to ISO
9001, it must have made a commitment to make quality the first priority. Give
examples from shipyards.

There is an implication that if an organization is certificated to ISO 9001, it must

have made a commitment to make quality the first priority

examples :

How well the auditor finds and communicates areas of improvement. While ISO auditors
may not provide consulting to the clients they audit, there is the potential for
auditors to point out areas of improvement. Many auditors simply rely on submitting
reports that indicate compliance or non-compliance with the appropriate section of
the standard; however, to most executives, this is like speaking a foreign language.
Auditors that can clearly identify and communicate areas of improvement in language
and terms executive management understands facilitate action on improvement
initiatives by the companies they audit. When management doesn't understand why they
were non-compliant and the business implications associated with non-compliance, they
simply ignore the reports and focus on what they do understan

Report 10
10.1- Show with the aid of sketches what are the different Audit Types and
Classifications?

First-Party Audit Quality auditor in your organization

audits your quality system.

Second-Party Atudit Quality auditor from your source of

funds audits your quality system

Third-Party Audit MBNQA audit team audits your

Page 47
organization’s quality system

Policy Audit compares written policies and procedures

with standards and specifications

Practice Audit compares actual practices with established

Procedures

Product Audit compares performance of a product or

service with its specifications.

10.2- What is meant by Quality System Audit?

Primary references for quality system auditing are:

ANSI/ASQC Q1-1986, American National Standard

Generic Guidelines for Auditing Quality Systems.

ANSI/ASQC Q10011-1-1994, American National

Standard Guidelines for Auditing Quality Systems

10.3- State the different steps involved in Performing a Quality or Operations Audit.

Initiation

Planning

Implementation

Reporting

Page 48
 10.4- Discuss briefly the International efforts in fields of quality auditing.

7 members opted to be the members of the research project –

Bangladesh, China, India, Malaysia, Pakistan, Philippines and Yemen, with

India chosen as the team leader.
The model for the 7th Research Project, to be completed in 4 phases

The phase I of the project - compiling prevalent audit quality management practices,
both in private and public sector auditing.

In phase II, Draft Audit quality management guidelines - prepared based on the
findings from

phase I.

Presentation of Interim Report to Governing Board at in December 2004

10.5- Mention briefly the methodology involved and carried out in audit quality
management in SAI.

The team carried out a wide search of the best practices for audit quality management
in

SAIs

Private sector auditing firms

Publications of professional Institute

Compilation of best practices documented separately

Page 49
During the phase III in 2005, audit quality management guidelines were to be piloted
in a few SAIs,.

In phase IV during 2006, the lessons from phase III are being reviewed & a final
document would be prepared & presented to 36th Governing Board & the 10th Assembly of
ASOSAI in September 2006.

10.6- Discuss briefly what is meant by AQMS Guidelines.

The team identified policies, practices and guidance relating to the management
processes that are present in SAIs:

a) Leadership and Direction

b) Human Resource Management

c) Audit Performance

d) Client and Stakeholder Relations

e) Continuous Improvement

These policies, practices and guidance are contained in the six chapters which
constitute these guidelines.

Compliance with the guidelines would provide reasonable assurance that the SAI
conducts its audits to ensure high quality & meet stakeholders’ expectations.

The guidelines have been designed for ensuring compliance with auditing standards, in
particular the INTOSAI auditing standards, applicable legislative requirements and
the office policies of the ASOSAI members.

10.7- Why do we need the quality? Show how could the Quality Audit be implemented.

Page 50
Quality has been defined as the totality of features and characteristics of a product
or service that bear on its ability to satisfy stated or implied needs

In public audit, quality management involves a system composed of an organisation,

the Supreme Audit Institution (SAI), its people – the auditors – and the audit
process, all working together to produce outputs that fulfill the requirements of its
stakeholders and the general public.

Each component of the ‘Audit Quality Management System’ (AQMS) – structure, people
and process aims towards customer satisfaction (in the context of the SAI, its
clients and stakeholders), which is always the bottom line of any organisation

10.8- What is Quality Management Principle?

The ‘quality management principle’ is the conceptual underpinning of AQMS.

It is a comprehensive and fundamental rule or belief for leading and managing an

organization, aimed at continually improving performance over the long term by
focusing on the clients while addressing the needs of all other stakeholders

10.9- Differentiate between Quality Control, Quality Assurance, Quality Management and
Total Quality Management?

The initial understanding of quality control was compliance to specifications and the
quality control task was to identify and remove defects, achieved mainly
through some form of measurement and inspection activity.

Responsibility for quality was not with line functionaries, but was vested with
separate staff departments

Quality Assurance

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Quality Assurance is understood as planned or systematic actions necessary to provide
adequate confidence that a product or service will satisfy given requirements for
quality

Quality Management

Quality Management System (QMS) is a broader concept which comprises the

organizational structure, procedures, processes and resources needed to implement
quality management.

Total Quality Management

‘Total Quality Management’ (TQM) is a total, organization wide effort – through

full involvement of the entire workforce and a focus on continuous improvement –
that organizations use to achieve clients satisfaction.

10.10- What are the relationships between Quality Control in the Audit Process?

Quality control is operational techniques and activities during audit processes of

planning, execution and reporting.

Quality control is a process in the course of which an SAI intends to fulfil quality
requirements

10.11- What are the relationships between Auditing Quality and Quality Management?

Audit Quality Management System

Continuous Improvement

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Internal Audit

Internal Quality Assurance Review

Peer Review

Lessons learned

Other inputs to Continuous Improvement

Monitoring progress and assessing impact

10.12- Define what differences are between Internal Audit & Internal Quality Assurance
Review?

Internal Audit assesses whether operating systems within SAI function efficiently as
per established policies & procedures

Internal Quality Assurance Review assesses whether individual engagements are

performed in terms of applicable standards, policies & guidance

Report 11
11.1- What codes that cover Quality Auditing?

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 Definition of audit
An audit is a systematic, independent and documented process
for obtaining audit evidence and evaluating it objectively to
determine the extent to which the audit criteria are fulfilled

from “ISO 19011: 2011 – Guidelines for auditing management

systems”

Such an activity can assume different features (objectives, internal

vs external auditors, …)

Common trait of the different types of auditing is the purpose of

check and review in order to improve

The results include a summary of the objectives, reason for

conducting review, individuals involved (including external advice),

11.2- What is meant by IT Auditing?

Two different approaches

Oriented to centralized services: evaluation of the quality of the IT (information technology)

processes relied on the internal clients for their opinion

Oriented to evaluate compliance towards production IT standards in the decentralised production

processes

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 11.3- What are the Audit based ISO norms?

ISO 19011:2011
This International Standard provides guidance on auditing management systems, including the
principles of auditing, managing an audit programme and conducting management system audits,
as well as guidance on the evaluation of competence of individuals involved in the audit process,
including the person managing the audit programme, auditors and audit teams..

11.4. Draw EFQM Diagram?

A system for the evaluation of the quality of the organisation according to the EFQM Excellence
Model (European Foundation for Quality Management). On the basis of these audits
improvements of the process and the results can be proposed.

The EFQM model may be applied by an organization as an exercise of self-assessment, made by

an internal team; or in case the organization wants to apply to the European Excellence Award. It
can be applied to the whole organization, or to a small part like a single Department

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 11.7- What types of Quality management models are being used within Common
Assessment - Framework (CAF)?

Result of the co-operation among the EU Ministers responsible for Public Administration (last
edition 2013) Free tool, inspired by TQM and EFQM excellence model, aimed at supporting
European public-sector organisations in using quality management techniques to improve their
performance.
The model is based on the premise that excellent results in organisational performance,
citizens/customers, people and society are achieved through leadership driving strategy and
planning, people, partnerships, resources and processes.
It represents a holistic approach to organisation performance analysis.

Main objectives
To introduce public administrations into the culture of excellence and the principles of TQM;
To guide them progressively to a mature PDCA (PLAN, DO, CHECK, ACT) cycle;
To facilitate the self-assessment of a public organisation in order to obtain a diagnosis and a
definition of improvement actions;
To act as a bridge across the various models used in quality, both in public and private sectors;
5. To facilitate bench learning between public sector organisations.

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 11.8- What are the main principles of Internal Auditing?

Independent
Objective
Assurance and consulting activity
Adds value
Improves operations
Helps accomplish objectives

Brings a systematic
and disciplined approach
to evaluate and improve
the effectiveness
of the
Governance,
Risk Management,
& Control

11.10- Why is a quality assurance and improvement program necessary?

As an organization grows, its operations undergo refinement, and its internal processes change
and evolve, its quality monitoring process must keep pace

11.11- What does a quality assurance and improvement program include?

The required elements of the program are periodic internal and external quality assessments,
ongoing internal monitoring, and assurance that the internal audit activity is complying with the
Standards, the definition of internal auditing and the Code of Ethics. (Standards 1300 & 1310)

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 11.12- What is a quality assessment?

A quality assessment, or QA, evaluates compliance with the Standards, the definition of internal
auditing, the Code of Ethics, the internal audit & audit committee charters, the organization’s
governance, risk and control assessment, and the use of successful practices

11.13- Which organizations should obtain QAs?

All internal audit departments, even those outsourced or co-sourced, must undergo internal &
external quality assessments.

11.14- If an organization has not yet established a Quality Assurance and Improvement
Program, how can it start the process?

A good first-step is to assess the level of compliance with the definition of internal auditing, the
Standards and the Code of Ethics.
Practice Advisory 1300-1

11.15- How do internal and external QAs differ?

Internal Assessments comprise ongoing internal evaluations of the internal audit activity,
coupled with periodic self-assessments and/or reviews.
Practice Advisory 1311-1

. External Assessments require an outside team of independent reviewers to evaluate compliance

with the Standards, the definition of internal auditing, the Code of Ethics, the use of successful
practices and the efficiency and effectiveness of the internal audit activity.
Practice Advisory 1312-1&

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 11.16- What are the benefits of an independent external QA?

. It allows the internal auditors to state that their activities are conducted “in accordance with the
International Standards for the Professional Practice of Internal Auditing

11.17- When must an internal audit shop have an external QA?

It is mandatory that every internal audit

activity have an external quality assessment at least every five years to be in compliance with the
Standards (Standard 1312)

11.18- How is an external QA conducted?

. There are various acceptable methods of performing external QAs. One typical methodology
includes advanced preparation, on-site activities, and the reporting process.

11.19- What are appropriate external QA approaches?

. Regardless of an organization’s industry or the internal audit activity’s complexity or size, there
are two approved approaches for external QAs.
Practice Advisory 1312-1 External Assessments
Practice Advisory 1312-2 Self Assessment with Independent Validation

11.20- What are the selection criteria for external QA providers?

. At a minimum, the QA provider should use a methodology that includes compliance with the
Standards, definition of internal auditing and the Code of Ethics as the benchmark for quality.

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 11.21- How do peer reviews fit into the QA process?

If the internal audit activity does not acquire the external assessment at least every five years, it
is forbidden to use the phrase, “conforms with the International Standards for the Professional
Practice of Internal Auditing,” in its internal audit charter or reports.
Practice Advisory 1321-1

11.22- What if the results of an external QA are negative?

External quality assessments or self assessments can be conducted through peer reviews instead
of utilizing an external service providers

11.23- What is the next step to the process if the results of an external QA are positive?

The organization should create an action plan that specifically addresses each opportunity for
improvement cited in the assessment. The CAE must disclose nonconformance and the impact
with Senior Management and the board. (Standard 1322)

11.24- What QA resources are available?

Once the QA has been completed; the CAE must communicate the results to the senior
management and the board. (Standard 1320)

11.25- What are the repercussions of not acquiring an external QA?

A. The IIA provides free samples, models, and other resources, based on quality assessment
successful practices. Visit the QA section of www.theiia.org to access and/or download these
valuable tools

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 Report 12

12.1- What is a quality audit?

Objective assessment, performed at defined intervals and at sufficient frequency, of a company’s quality
system to operate against a given criteria
Systematic
Independent
Documented

12.2- Draw a sketch for the Audit Program Definition.

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12.3- Draw a sketch for the Essential program elements

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 Authority for the audit
program

Establishing the audit program

 objectives & extent
 responsibilities PLAN
 resources
 procedures

Implementing the audit program Competence and evaluation

 scheduling of auditors
Improving the audit  evaluating auditors
ACT DO
program  selecting audit team
 directing audit activities
 maintaining records Audit activities

Monitoring and reviewing the audit

program
 monitor and reviewing
 identifying needs for corrective and CHECK
preventive actions
 Identifying opportunities for
improvement

12.4- Why do we need auditing?

How many companies perform audits just because “you have to”?
Best guess – at least 75% of medical device manufacturers

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 12.5- What are the main steps involved in carrying out successful audit?

Step 1 - Comply
Conforming to requirements; to conform, submit, or adapt (as to a regulation or to another's wishes) as
required or requested
Regulatory / standard compliance
Do we have the systems and procedures we are supposed to have and do they meet the regulatory /
standard requirements?

Step 2 - Effective
Producing or capable of producing an intended result
Collection of and review of objective evidence
Do we follow our procedures and maintain the required records

Step 3 – Efficient
Acting or producing effectively with a minimum of waste, expense, or unnecessary effort
Exhibiting a high ratio of output to input
Eliminate / reduce redundancy between systems
Are our systems working in the best interest of our business / customer

12.6- What are the differences of preventive costs?

Think preventive costs

Internal audits are the “downstream” assessment
FDA / ISO / customers are the “upstream” assessment

12.7- How the Auditor can score?

Quantify Efforts vs. Benefits

How much time / resources you are spending on auditing
How you do it
What the outcomes are
What is being done with the outcomes
Effort (<) (=) (>) Benefit?

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12.8- Who is the Auditor?
Dedicated internal auditors
“Part-time” internal auditors
Auditors from sister or parent company
Outsource auditing
Combination of above

If using a third party

Schedule enough time
Continue to conduct internal audits with employees

12.9- What is the Audit frequency?

Series of internal audits addressing all quality subsystems and interactions?

Complies, may be effective, not efficient
One comprehensive audit?
Complies, may not be effective, but efficient
Combination of both of the above!

12.10- What are the Auditor qualifications?

The success of the auditing program depends significantly upon the selection of the right people for the
task
Understanding of the business operating structure
Inputs / Outputs of various systems
Interactions of departments
Rotation throughout various job functions upon hire (even with prior experience

12.11- What is meant by Auditor Effectiveness?

Do not measure an efficient auditor by the number of observations recorded / not recorded
The ability to identify noncompliances and provide recommendations on ways to improve the process
should be viewed as a positive

Right personnel from cross-functional groups

Document training
Perform audits on a regular basis

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Responsibility becomes part of job description
Must be taken seriously by employee and manager
Part of performance review

12.12- What is meant by Selling to management?

Compliance is a regulatory requirement for our industry!

Make it work for you, not against you

Efficient auditing can identify redundancies in systems

To eliminate or reduce is an obvious cost savings
For example, redundant manual system and electronic system to avoid validation of electronic system

Efficient auditing can identify those areas where the company has added more requirements than needed
from both a regulatory and business perspective
Complicated system uses resources and is prone to error (i.e., non-compliance)
Too many records being completed, more signatures than necessary

12.13- What is meant by Communicating results?

Good auditing cannot be reflected in a poorly documented report

Issue TIMELY
Write to your “customer”
Write for impact
Make the report talk
Recognize their priorities
Lead (don’t lose) the “custome

12.14- What is meant by Act on results?

Requires management support to fix root cause of identified non-compliances

Not all observations will require a corrective action
Correction or other remediation may be appropriate
Triage / prioritize based on risk
Safety
Regulatory
Quality
Business
Re-evaluate during management review
Risks may change

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12.15- Draw a sketch for Act on results.

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