Transcript

Quality Management & Productivity

Meryem ŞAHİN TÜTÜNCÜ Page 1 Hacettepe University Dept. of Chemical Engineering

Quality Management & Productivity

Meryem ŞAHİN TÜTÜNCÜ Page 2 Hacettepe University Dept. of Chemical Engineering

Quality Management & Productivity

Meryem ŞAHİN TÜTÜNCÜ Page 3 Hacettepe University Dept. of Chemical Engineering

CHAPTER 1

What is Quality?

Conformance to specifications (British Defense Industries Quality Assurance Panel)

Conformance to requirements (Philip Crosby)

Fitness for purpose or use (Juran)

A predictable degree of uniformity and dependability, at low cost and suited to the

market (Edward Deming)

Synonymous with customer needs and expectations (R J Mortiboys)

Meeting the (stated) requirements of the customer- now and in the future (Mike

Robinson)

The total composite product and service characteristics of marketing, engineering,

manufacturing and maintenance through which the product and service in use will

meet the expectations by the customer (Armand Feigenbaum)

“The degree to which a system, component, or process meets

specified requirements, and customer or users needs or expectations” (IEEE)

The totality of features and characteristics of a product or service that bears on its

ability to satisfy stated or implied needs” (ISO 8402)

Degree to which a set of inherent characteristics fulfils requirements (ISO

9000:2015)

Different Views

User-based: better performance, more features

Manufacturing-based: conformance to standards, making it right the first time

Product-based: specific and measurable attributes of the product

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Meaning of Quality

Of the many meanings of the word “quality,” two are of critical importance to managing for

quality:

1. “Quality” means those features of products which meet customer needs and thereby

provide customer satisfaction. In this sense, the meaning of quality is oriented to income.

The purpose of such higher quality is to provide greater customer satisfaction and, one

hopes, to increase income.

However, providing more and/or better quality features usually requires an investment and

hence usually involves increases in costs. Higher quality in this sense usually “costs more.”

2. “Quality” means freedom from deficiencies—freedom from errors that require doing

work over again (rework) or that result in field failures, customer dissatisfaction, customer

claims, and so on. In this sense, the meaning of quality is oriented to costs, and higher

quality usually “costs less.”

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Meaning of Quality: Producer’s Perspective

Quality of Conformance

Making sure a product or service is produced according to design

if new tires do not conform to specifications, they wobble (tereddüt

etmek/bocalamak)

if a hotel room is not clean when a guest checks in, the hotel is not

functioning according to specifications of its design

Meaning of Quality: Consumer’s Perspective

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

Meaning of Quality: A Final Perspective

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

Consumer’s perspective: «PRICE»

Producer’s perspective : «COST»

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

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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

Perceptions

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

Dimensions of Quality: 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?

Courtesy

How are customers treated by employees?

Are catalogue phone operators nice and are their voices pleasant?

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Consistency

Is the same level of service provided to each customer each time?

Is your newspaper delivered on time every morning?

Accessibility and convenience

How easy is it to obtain service?

Does a service representative answer you calls quickly?

Accuracy

Is the service performed right every time?

Is your bank or credit card statement correct every month?

Responsiveness

How well does the company react to unusual situations?

How well is a telephone operator able to respond to a customer’s questions?

Quality in different areas of society

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History of Quality Methodology

Reach back into antiquity, especially into China, India, Greece and the Roman Empire : skilled

crafstmanship.

Industrial Revolution (18th century): need for more consistent products that are mass-

produced and needed to be interchangeable. Rise of inspection after manufacturing

completed and separate quality departments.

Science of modern quality methodology started by R. A. Fisher perfected scientific shortcuts

for shifting through mountains of data to spot key cause-effect relationships to speed up

development of crop growing methods.

Statistical methods at Bell Laboratories: W. A. Shewhart transformed Fisher’s methods into

quality control discipline for factories (inspired W.E. Deming and J. M. Juran); Control Charts

developed by W. A. Shewhart; Acceptance sampling methodology developed by H. F. Dodge

and H. G. Romig

World War II: Acceptance of statistical quality-control concepts in manufacturing industries

(more sophisticated weapons demanded more careful production and reliability); The

American Society for Quality Control formed (1946).

Quality in Japan: W.E. Deming invited to Japan to give lectures; G. Taguchi developed

“Taguchi method” for scientific design of experiments; The Japanese Union of Scientists and

Engineers (JUSE) established “Deming Price” (1951); The Quality Control Circle concept is

introduced by K. Ishikawa (1960).

Quality awareness in U.S. manufacturing industry during 1980s: “Total Quality

Management”; Quality control started to be used as a mangement tool.

Malcolm Baldrige National Quality Award (1987)

International Standard Organization’s (ISO) 9000 series of standards: in 1980s Western

Europe began to use; interest increase in US industry in 1990s; Became widely accepted

today: necessary requirement to world-wide distribution of product and a significant

competitive advantage.

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Quality Gurus

Walter Shewart

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

After the war, began teaching statistical quality control to Japanese

companies

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

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CHAPTER 2

Quality Management Components

Quality Planning

It identifies the standards and determines how to satisfy those standards

It lays out the roles and responsibilities, resources, procedures, and processes

to be utilized for quality control and quality assurance

Quality Assurance

It is the review to ensure aligning with the quality standards. An assessment

will be provided here

Planned and systematic quality activities

Provide the confidence that the standards will be met

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Quality Control

It addresses the assessment conducted during Quality Assurance for

corrective actions

Measure specific results to determine that they match the standards

Use of Statistical Process Control (SPC) : a methodology for monitoring a

process to identify special causes of variation and signal the need to take

corrective action when appropriate

SPC relies on control charts

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Deming’s 14 Principles

1. “Create Constancy of Purpose”

Define the problems of today and the future

Allocate resources for long-term planning

Allocate resources for research and education

Constantly improve design of product and service

2. “Adopt A New Philosophy”

Quality costs less not more

Superstitious learning

The call for major change

Stop looking at your competition and look at your customer instead

3. “Cease Dependence On Inspection For Quality”

Quality does not come from inspection

Mass inspection is unreliable, costly, and ineffective

Inspectors fail to agree with each other

Inspection should be used to collect data for process control

4. “End Proactive Awarding Of Business Based On PriceAlone”

Price alone has no meaning

Change focus from lowest inital cost to lowest cost

Work toward a single source and long term relationship

Establish a mutual confidence and aid between purchaser and vendor

5. “Improve Every Process Constantly / Forever”

Quality starts qith the intend of management

Teamwork in design is fundamental

Forever continue to reduce waste and continue to improve

Putting out fires is not improvement of the process

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Deming’s 14 Principles

6. “Institute Training”

Management must provide the setting where workers can be succesful

Management must remove the inhibitors to good work

Management needs an appreciation of variation

This is management’s new role

7. “Adopt And Institute Leadership”

Remove barriers to pride of workmanship

Know the work they supervise

Know the difference between special and common cause of variation

8. “Drive Out Fear”

The common denominator of fear

Fear of knowledge

Performance appraisals

Management by fear or numbers

9. “Break Barriers Between Staff Areas”

Know your internal suppliers and customers

Promote team work

10. “Eliminate Slogans, Exhortations And Targets”

They generate frustration and resentment

Use posters that explain what management is doing to improve the work

environment

11. “Eliminate Numerical Quotas”

They impede quality

They reduce production

The person’s job becomes meeting a quota

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Deming’s 14 Principles

12. “Remove Barriers That Rob Pride Of Workmanship”

Performance appraisal systems

Production rates

Financial management systems

Allow people to take pride in their workmanship

13. “Institute Programs For Education And Self Improvement”

Commitment to lifelong employment

Work with higher education needs

Develop team building skills

14. “Put Everybody In The Company To Work For This Transformation”

Struggle over the 14 points

Take pride in new philosophy

Include the critical mass of people in the change

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Deming Wheel: PDCA Cycle

Total Quality Management (TQM)

Started in the early 1980s, Deming/Juran philosophy as the focal point

The primary focus is on process improvement

Most of the variation in a process is due to the system and not the individual

Teamwork is an integral part of a quality management organization

Customer satisfaction is a primary organizational goal

Organizational transformation must occur in order to implement quality

management

Fear must be removed from organizations

Higher quality costs less not more but it requires an investment in training

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Key Principles of TQM

Devotion to customer satisfaction

Continuous decrease in undesirable variation

KAIZEN: continuous improvement

Teamwork

System and technology development for competition

Planning for future

Supplier improvement and participation

Leadership

Communication and mutual respect

Continuous education

Measurement and statistics

Employee involvement and empowerment

Scientific approach to problem solving

Principles of TQM

Customer-oriented Leadership Strategic planning Employee responsibility Continuous improvement Cooperation Statistical methods Training and education

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TQM Organization

Lean

Cross-functional teams

Leadership

Facilitation / support

Employee involvement and empowerment

TQM and…

… Partnering

a relationship between a company and its supplier based on mutual quality

standards

… Customers

system must measure customer satisfaction

… Information Technology

infrastructure of hardware, networks, and software necessary to support a

quality program

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

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Quality Attributes in Service

Benchmark

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

achieve

Timeliness

how quickly a service is provided

Seven Concepts of TQM

1. Continuous Improvement

2. Six Sigma

3. Employee Empowerment

4. Benchmarking

5. Just-in-time (JIT)

6. Taguchi Concepts

7. Knowledge of TQM Tools

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1. Continuous Improvement

Represents continual improvement of all processes

Involves all operations and work centers including suppliers and customers

People, Equipment, Materials, Procedures

Continuous Improvement Philosophy

1. KAIZEN (KAI:Değişim/Gelişim ZEN:Daha İyiye): Japanese term for continuous

improvement. step-by-step improvement of business processes.

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

3. Benchmarking : what do top performers do?

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2. Six Sigma

Two meanings

1. Statistical definition of a process that is 99.9997% capable, 3.4 defects

per million opportunities (DPMO)

2. A program designed to reduce defects, lower costs, and improve customer

satisfaction

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Six Sigma Management

1. Define: The problem to be solved needs to be defined along with the costs,

benefits of the project, and the impact on the customer.

2. Measure: Definitions for each Critical-To-Quality (CTQ) characteristic must be

developed. In addition, the measurement procedure must be verified so that it is

consistent over repeated measurements.

3. Analyze: The root causes why defects can occur need to be determined along

with the variables in the process that cause the defects to occur. Data are

collected to determine the underlying value for each process variable, often using

control charts.

4. Improve: The importance of each process variable on the CTQ characteristic are

studied using designed experiments. The objective is to determine the best level

for each variable that can be maintained in the long run.

5. Control: The objective is to maintain the gains that have been made with a

revised process in the long term by avoiding potential problems that can occur

when a process is changed.

Black Belts and Green Belts

Black Belt

– project leader

Master Black Belt

– a teacher and mentor for Black Belts

Green Belts

– project team members

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Six Sigma: DMAIC

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3. Employee Empowerment

Getting employees involved in product and process improvements

85% of quality problems are due to process and material

Techniques

Build communication networks that include employees

Develop open, supportive supervisors

Move responsibility to employees

Build a high-morale organization

Create formal team structures

3. Benchmarking

Selecting best practices to use as a standard for performance

1. Determine what to benchmark

2. Form a benchmark team

3. Identify benchmarking partners

4. Collect and analyze benchmarking information

5. Take action to match or exceed the benchmark

4. Just-in-Time (JIT)

JIT cuts the cost of quality

JIT improves quality

Better quality means less inventory and better, easier-to-employ JIT system

‘Pull’ system of production scheduling including supply management

Production only when signaled

Allows reduced inventory levels

Inventory costs money and hides process and material problems

Encourages improved process and product quality

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6.Taguchi’s Contribution

In the early 1980s, Prof. Genechi Taguchi introduced his approach to using

experimental design for;

1. Designing products or processes so that they are robust to environmental

conditions.

2. Designing/developing products so that they are robust to component variation.

3. Minimizing variation around a target value.

By robust, we mean that the product or process performs consistently on target and

is relatively insensitive to factors that are difficult to control.

3 stages in a product’s (or process’s) development:

1. System design: uses scientific and engineering principles to determine the basic

configuration.

2. Parameter design: specific values for the system parameters are determined.

3. Tolerance design: determine the best tolerances for the parameters.

Recommends: statistical experimental design methods have to be use for quality

improvement, particularly during parameter and tolerance design phases.

Key component: reduce the variability around the target (nominal) value.

Taguchi Concepts

Engineering and experimental design methods to improve product and process

design

Identify key component and process variables affecting product variation

Taguchi Concepts

Quality robustness

Quality loss function

Target-oriented quality

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Quality Robustness

Ability to produce products uniformly in adverse manufacturing and environmental

conditions

Remove the effects of adverse conditions

Small variations in materials and process do not destroy product quality

Quality Loss Function

Shows that costs increase as the product moves away from what the customer wants

Costs include customer dissatisfaction, warranty

and service, internal

scrap and repair, and costs to society

Traditional conformance specifications are too simplistic

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7.Use of Simple Scientific Tools for TQM

1. Pareto analysis

2. Flowcharts

3. Check sheets

4. Histograms

5. Scatter diagrams

6. Control charts

7. Fishbone diagram

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CHAPTER 3

What is the meaning of Process?

A process is a set of activities that interact to achieve a result.

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The Process Approach in ISO 9001:2015

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Quality Improvement Tools

Everyone participates

Go round robin and only one person speaks at a time

No discussion of ideas

There is no such thing as a dumb idea

Pass when necessary

Use “BIG” yellow sticky notes and write only 1 idea per sticky note

One person assigned as scribe

For a complicated issue, the session could last 30-45 minutes…or longer!

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Flow Diagrams

Build a common understanding of a whole process

Develop process thinking

Improve a process

Standardize a process

Investigate the Root Causes

Understand the root causes of a problem BEFORE you put a “solution” into place

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Cause & Effect Diagrams

Identify and display many different possible causes for a problem

See the relationships between the many causes

Helps determine which data to collect

How To Construct Cause & Effect Diagrams

Clearly define the focused problem

Use brainstorming to identify possible causes

Sort causes into reasonable clusters (no less than 3, not more than 6)

Label the clusters (consider people, policies, procedures, materials if you have not

already identified labels)

Develop and arrange bones in each cluster

Check the logical validity of each causal chain

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The 7 Basic Quality Tools for Process Improvement

Histogram: The most commonly used graph for showing frequency distributions, or how

often each different value in a set of data occurs.

Pareto chart: Shows on a bar graph which factors are more significant.

Control charts: Graphs used to study how a process changes over time.

Cause-and-effect diagram (also called Ishikawa or fishbone chart): Identifies many possible

causes for an effect or problem and sorts ideas into useful categories.

Check sheet: A structured, prepared form for collecting and analyzing data; a generic tool

that can be adapted for a wide variety of purposes.

Scatter diagram: Graphs pairs of numerical data, one variable on each axis, to look for a

relationship.

Stratification: A technique that separates data gathered from a variety of sources so that

patterns can be seen (some lists replace “stratification” with “flowchart” or “run chart”).

** Excerpted from Nancy R. Tague’s The Quality Toolbox, Second Edition, ASQ Quality Press,

2005, page 15.

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Histogram

The most commonly used graph for showing frequency distributions, or how often each

different value in a set of data occurs.

Pareto Chart

Chart consistencies of most frequent defects

Used to locate Major sources of problems

Able to use with Count and Categorical Data

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Control Charts

Used to determine if variation is chance or assignable cause

Good for measuring control of variation

Control needed before Change

More appropriately applied to process rather than product

A control chart is a presentation of data in which the control values are plotted

against time

Control charts have a central line, upper and lower warning limits, and upper and

lower action limits

Immediate visualisation of problems

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Two Types of Control Charts

When to Take Action?

One point plots outside the Action Limits

Two consecutive points plots between the Warning and Action Limits

Eight consecutive points plot on one side of the Center Line

Six points plots steadily increasing or decreasing

When an unusual or nonrandom pattern is observed

Cause-and-Effect Diagram

A tool that identifies process elements (causes) that might effect an outcome

Check Sheet

An organized method of recording data

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CHAPTER 4

Quality & Productivity

Quality Control

Significance Quality Control

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Methods of Quality Control

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Productivity

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Quality & Productivity

Computing Product Yield for Multistage Processes

Quality–Productivity Ratio

productivity index that includes productivity and quality costs

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CHAPTER 5

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

1. Prevention costs - reducing the potential for defects

2. Appraisal costs - evaluating products, parts, and services

3. Internal failure - producing defective parts or service before delivery

4. External costs - defects discovered after delivery

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Prevention Cost

Quality planning costs

costs of developing and implementing quality management program

Product-design costs

costs of designing products with quality characteristics

Process costs

costs expended to make sure productive process conforms to quality

specifications

Training costs

costs of developing and putting on quality training programs for employees

and management

Information costs

costs of acquiring and maintaining data related to quality, and

development of reports on quality performance

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Appraisal Costs

Inspection and testing

costs of testing and inspecting materials, parts, and product at various stages

and at the end of a process

Test equipment costs

costs of maintaining equipment used in testing quality characteristics of

products

Operator costs

costs of time spent by operators to gar data for testing product quality, to

make equipment adjustments to maintain quality, and to stop work to assess

quality

Internal Failure Costs

Scrap costs

costs of poor-quality products that must be discarded, including labor,

material, and indirect costs

Rework costs

costs of fixing defective products to conform to quality specifications

Process failure costs

costs of determining why production process is producing poor-quality

products

Process downtime costs

costs of shutting down productive process to fix problem

Price-downgrading costs

costs of discounting poor-quality products—that is, selling products as

“seconds”

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External Failure Costs

Customer complaint costs

costs of investigating and satisfactorily responding to a customer complaint

resulting from a poor-quality product

Product return costs

costs of handling and replacing poor-quality products returned by customer

Warranty claims costs

costs of complying with product warranties

Product liability costs

litigation costs resulting from product liability and customer injury

Lost sales costs

costs incurred because customers are dissatisfied with poor quality products

and do not make additional purchases

Measuring and Reporting Quality Costs

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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Quality–Cost Relationship

Cost of quality

Difference between price of nonconformance and conformance

Cost of doing things wrong

20 to 35% of revenues

Cost of doing things right

3 to 4% of revenues

Profitability

In the long run, quality is free

Quality-Related Costs

Prevention costs

activities to keep unacceptable products from being generated and to keep

track of the process

Appraisal costs

activities to maintain control of the system

Correction costs

activities to correct conditions out of control, including errors

Prevention Costs

Quality planning and engineering

New products review

Product/process design

Process control

Burn-in

Training

Quality data acquisition and analysis

Quality Management & Productivity

Meryem ŞAHİN TÜTÜNCÜ Page 55 Hacettepe University Dept. of Chemical Engineering

Appraisal Costs

Inspection and test of incoming material

Product inspection and test

Materials and services consumed

Maintaining accuracy of test equipment

Correction Costs

1. Internal Failure Costs

Scrap

Rework

Retest

Failure analysis

Downtime

Yield losses

Downgrading (off-specing)

2. External Failure Costs

Complaint adjustment

Returned product/material

Warranty charges

Liability costs

Indirect costs

Quality Management & Productivity

Meryem ŞAHİN TÜTÜNCÜ Page 56 Hacettepe University Dept. of Chemical Engineering

CHAPTER 6

Quality Awards and Quality Standards

Malcolm Baldrige Award

Created in 1987 to stimulate growth of quality management in the United States

Categories;

Leadership

Information and analysis

Strategic planning

Human resource

Focus

Process management

Business results

Customer and market focus

Other Awards for Quality

National individual awards

Armand V. Feigenbaum Medal

Deming Medal

E. Jack Lancaster Medal

Edwards Medal

Shewart Medal

Ishikawa Medal

International awards

European Quality Award

Canadian Quality Award

Australian Business Excellence Award

Deming Prize from Japan

Quality Management & Productivity

Meryem ŞAHİN TÜTÜNCÜ Page 57 Hacettepe University Dept. of Chemical Engineering

EFQM Quality Awards - EFQM Excellence Model

EFQM (European Foundation for Quality Management)

The EFQM Excellence Model© consists of nine criteria and these are grouped into two broad areas: Enablers - how we do things. Results - outcomes which we target, measure and achieve.

The EFQM Excellence Model© reflects the the way in which successful organisations can develop a winning formula to achieve competitive advantage. Each of the nine boxes shown above has a high level definition and the EFQM Excellence Model© includes thirty two sub-criterion elements which pose questions to be considered when assessing the performance of applicant organisations. Weighting

The percentages shown in the diagram are the weightings used by Midlands Excellence when scoring applications. At the heart of the EFQM Excellence Model© and the process of self assessment lies the logic known as RADAR which has four elements - Results, Approach, Deployment, Assessment & Review.

Quality Management & Productivity

Meryem ŞAHİN TÜTÜNCÜ Page 58 Hacettepe University Dept. of Chemical Engineering

RADAR LOGIC

RADAR logic says that an organisation needs to: Determine the Results it is aiming for as part of its policy and strategy making process.

These Results cover the financial and operational performance of the organisation

together with perceptions of its stakeholders.

Plan and develop an integrated set of sound Approaches to deliver the required

results both now and in the future.

Deploy the approaches in a systematic way to ensure full implementation.

Assess & Review the approaches by monitoring and analysing the results achieved

through ongoing learning activities. The application of RADAR logic helps organisations identify, prioritise, plan and implement improvements where needed:

RADAR LOGIC CYCLE

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Meryem ŞAHİN TÜTÜNCÜ Page 59 Hacettepe University Dept. of Chemical Engineering

EFQM EXCELLENCE MODEL© SUB-CRITERION DEFINITIONS

Quality Management & Productivity

Meryem ŞAHİN TÜTÜNCÜ Page 60 Hacettepe University Dept. of Chemical Engineering

Quality Management & Productivity

Meryem ŞAHİN TÜTÜNCÜ Page 61 Hacettepe University Dept. of Chemical Engineering

Quality Management & Productivity

Meryem ŞAHİN TÜTÜNCÜ Page 62 Hacettepe University Dept. of Chemical Engineering

Overview of ISO 9001 and ISO 14001

ISO 9001 and ISO 14001 are among ISO's most well known standards ever.

They are implemented by more than a million organizations in some 175

countries.

ISO 9001 helps organizations to implement quality management.

ISO 14001 helps organizations to implement environmental management.

ISO 9001 and ISO 14001 are generic standards. Generic means that the same

standards can be applied:

to any organization, large or small, whatever its product or service,

in any sector of activity, and

Whether it is a business enterprise, a public administration, or a

government department.

Generic also signifies that

no matter what the organization's scope of activity

if it wants to establish a quality management system, ISO 9001 gives the

essential features

or if it wants to establish an environmental management system, ISO

14001 gives the essential features.

Management system means what the organization does to manage its processes, or

activities in order that

its products or services meet the organization’s objectives, such as

satisfying the customer's quality requirements,

complying to regulations, or

meeting environmental objectives

To be really efficient and effective, the organization can manage its way

of doing things by systemizing it.

Everyone is clear about who is responsible for doing what, when, how,

why and where.

Management system standards provide the organization with an

international, state-of-the-art model to follow.

Large organizations, or ones with complicated processes, could not

function well without management systems.

Companies in such fields as aerospace, automobiles, defense, or health

care devices have been operating management systems for years.

Quality Management & Productivity

Meryem ŞAHİN TÜTÜNCÜ Page 63 Hacettepe University Dept. of Chemical Engineering

The ISO 9001 and ISO 14001 management system standards now make these

successful practices available for all organizations.

Both ISO 9001 and ISO 14001 concern the way an organization goes about its

work.

They are not product standards.

They are not service standards.

They are process standards.

They can be used by Product manufacturer and service providers.

Processes affect final products or services.

ISO 9001 gives the requirements for what the organization must do to

manage processes affecting quality of its products and services.

ISO 14001 gives the requirements for what the organization must do to

manage processes affecting the impact of its activities on the

environnent.

Quality Management

Quality refers to all those features of a product (or service) which are required by

the customer.

Quality management means what the organization does to

ensure that its products or services satisfy the customer's quality requirements

comply with any regulations applicable to those products or services.

Quality management also means what the organization does to

enhance customer satisfaction, and

achieve continual improvement of its performance.

Environmental management

This means what the organization

does to:

minimize harmful effects on the environment caused by its activities,

to conform to applicable regulatory requirements, and to

achieve continual improvement of its environmental performance.

Quality Management & Productivity

Meryem ŞAHİN TÜTÜNCÜ Page 64 Hacettepe University Dept. of Chemical Engineering

Certification and registration

Certification is known in some countries as registration.

It means that an independent, external body has audited an organization's

management system and verified that it conforms to the requirements specified

in the standard (ISO 9001 or ISO 14001).

ISO does not carry out certification and does not issue or approve certificates

Accreditation

Accreditation is like certification of the certification body.

It means the formal approval by a specialized body - an accreditation body - that

a certification body is competent to carry out ISO 9001 or ISO 14001 certification

in specified business sectors.

Certificates issued by accredited certification bodies - and known as accredited

certificates - may be perceived on the market as having increased credibility.

ISO does not carry out or approve accreditations.

Certification not a requirement

Certification is not a requirement of ISO 9001 or ISO 14001.

The organization can implement and benefit from an ISO 9001 or ISO 14001

system without having it certified.

The organization can implement them for the internal benefits without spending

money on a certification programme.

Certification is a business decision

Certification is a decision to be taken for business reasons:

if it is a contractual, regulatory, or market requirement,

If it meets customer preferences

it is part of a risk management programme, or

if it will motivate staff by setting a clear goal.

Quality Management & Productivity

Meryem ŞAHİN TÜTÜNCÜ Page 65 Hacettepe University Dept. of Chemical Engineering

Benefits of ISO 9001 and ISO 14001

International, expert consensus on state-of-the-art practices for quality and

environmental management

Common language for dealing with customers and suppliers worldwide

Increase efficiency and effectiveness

Model for continual improvement

Model for satisfying customers and other stakeholders

Build quality into products and services from design onwards

Address environmental concerns of customers and public, and comply with

government regulations

Integrate with global economy

Sustainable business

Unifying base for industry sectors

Qualify suppliers for global supply chains

Technical support for regulations

Transfer of good practice to developing countries

Tools for new economic players

Regional integration

Facilitate rise of services

Quality Management & Productivity

Meryem ŞAHİN TÜTÜNCÜ Page 66 Hacettepe University Dept. of Chemical Engineering

ISO 9001:2015

What is a quality management system?

A quality management system is a way of defining how an organization can meet the

requirements of its customers and other stakeholders affected by its work

ISO 9001 is based on the idea of continual improvement

It doesn’t specify what the objectives relating to “quality” or “meeting customer

needs” should be, but requires organizations to define these objectives themselves

and continually improve their processes in order to reach them

Who is ISO 9001 for?

ISO 9001 is suitable for organizations of all types, sizes and sectors.

In fact, one of the key improvements of the newly revised ISO 9001:2015 was to

make it more applicable and accessible to all types of enterprises.

Smaller companies that do not have staff dedicated to quality can still enjoy the

benefits of implementing the standard – ISO has many resources to assist them.

What benefits will it bring to my business or organization?

Assess the overall context of your organization to define who is affected by your

work and what they expect from you. This will enable you to clearly state your

objectives and identify new business opportunities.

Put your customers first, making sure you consistently meet their needs and

enhance their satisfaction. This can lead to repeat custom, new clients and increased

business for your organization.

ISO 9001: benefits

Work in a more efficient way as all your processes will be aligned and understood by

everyone in the business or organization. This increases productivity and efficiency,

bringing internal costs down.

Meet the necessary statutory and regulatory requirements.

Expand into new markets, as some sectors and clients require ISO 9001 before doing

business.

Identify and address the risks associated with your organization

Quality Management & Productivity

Meryem ŞAHİN TÜTÜNCÜ Page 67 Hacettepe University Dept. of Chemical Engineering

Why was ISO 9001 revised?

All ISO standards are reviewed and revised regularly to make sure they remain

relevant to the marketplace.

ISO 9001 has been updated to take into account the different challenges that

businesses now face.

For example, increased globalization has changed the way we do business and

organizations often operate more complex supply chains, and there are increased

expectations from customers.

ISO 9001 needs to reflect these changes in order to remain relevant.

How do I get started with ISO 9001:2015?

Key tips

Tip 1 – Define your objectives. Why do you want to implement the standard?

Tip 2 – Ensure senior management is on board. It is crucial that everyone is supportive

of the initiative and its objectives.

Tip 3 – Identify your organization’s key processes for meeting your objectives and

customers’ needs. Within each of these processes, ensure you understand your

customers’ requirements and can guarantee that these are met. This will form the basis

of your quality management system.

Other standards in the 9000 family

There are many other standards in the ISO 9000 series that can help you reap the full

benefits of a quality management system and put customer satisfaction at the heart of

your business.

ISO 9000 contains detailed explanations of the seven quality management principles

with tips on how to ensure these are reflected in the way you work. It also contains many

of the terms and definitions used in ISO 9001.

ISO 9004 provides guidance on how to achieve sustained success with your quality

management system.

ISO 19011 gives guidance for performing both internal and external audits to ISO 9001.

This will help ensure your quality management system delivers on promise and will

prepare you for an external audit, should you decide to seek third-party certification.

Quality Management & Productivity

Meryem ŞAHİN TÜTÜNCÜ Page 68 Hacettepe University Dept. of Chemical Engineering

Thank you …


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