quality systems

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7/23/2015 1 MODULE - I QUALITY SYSTEMS M.SURESH ASSISTANT PROFESSOR/EEE KONGU ENGINEERING COLLEGE PERUNDURAI – 638 052 Email id: [email protected] Mobile:+91-9578951073 7/23/2015 1 MODULE - I OUTLINE Introduction to Total Quality Management Definition of Quality Dimensions of Quality Quality Planning Quality Costs Basic concepts of Total Quality Management Historical Review Need for ISO 9000 and Other Quality Systems ISO 9000:2008 Quality System- Elements Implementation of Quality System Documentation Quality Auditing Introduction to TS 16949, QS 9000 ISO 14000, ISO 18000 ISO 20000, ISO 22000 7/23/2015 2

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Page 1: Quality Systems

7/23/2015

1

MODULE - I QUALITY SYSTEMS

M.SURESH

ASSISTANT PROFESSOR/EEE

KONGU ENGINEERING COLLEGE

PERUNDURAI – 638 052

Email id: [email protected]

Mobile:+91-9578951073

7/23/2015 1

MODULE - I OUTLINE

Introduction to Total Quality Management

Definition of Quality

Dimensions of Quality

Quality Planning

Quality Costs

Basic concepts of Total Quality Management

Historical Review

Need for ISO 9000 and Other Quality Systems

ISO 9000:2008 Quality System- Elements

Implementation of Quality System

Documentation

Quality Auditing

Introduction to TS 16949, QS 9000

ISO 14000, ISO 18000

ISO 20000, ISO 22000

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INTRODUCTION TO TOTAL QUALITY MANAGEMENT

Made up of whole

Degree of excellence a product or service provides

Act , art or manner of handling, controlling, directing , etc.

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TQM-Art of managing the whole

to achieve excellence

Definition of TQM:

It is defined as

both a philosophy

and set of guiding

principles that

represent the foundation of a continuously improving

organization.7/23/2015 4

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SIX BASIC CONCEPTS OF TQM

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1.Commitment and Involvement

2.Focus on customer (internally and externally)

3.Effective involvement and utilization of entire work force.

4.Continuous improvement (Business and Production)

5.Treating suppliers as partners

6.Establish performance measures for the processes

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1: Deming 2: Juran 3: Feigenbaum 4 :Ishikawa 5: Crosby 6: Shewhart

6 GURUS OF 6 GURUS OF

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DEFINITION OF QUALITY

QUALITY Excellent product or service that fulfills or exceeds our expectations

Quality can be quantified as follows:

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Q= Quality

P= Performance

Q=P/E

E= Expectations

If Q>1,Customer has a good feeling about the product or service

DEFINITION OF QUALITY IN ISO 9000:2000

It is defined as the degree to which a set of inherent characteristics fulfills requirements.

Degree - poor , good and excellent(quality)

Inherent – permanent characteristic

Characteristics – qualitative or quantitative

Requirement – need or expectation

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DIMENSIONS OF QUALITY---------------------------------------------------------------------------------------------------------------- ---------------------------------------------

Dimension Meaning and Example----------------------------------------------------------------------------------------------------------------1. Performance Primary product characteristics, such as the brightness of the

picture2.Features Secondary characteristics, added features, such as

remote control3.Conformance Meeting specifications or industry standards, workmanship4.Reliability Consistency of performance over time, average time of the

unit to fail5.Durability Useful life, includes repair6.Service Resolution of problems and complaints, ease of repair7.Response Human – to – human interface, such as the courtesy of the

dealer8.Aesthetics Sensory characteristics, such as exterior finish9.Reputation Past performance and other intangibles, such as being ranked

first

--------------------------------------------------------------------------------------------

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QUALITY PLANNING

The following are the important steps for quality planning.

Establishing quality goals

Identifying customers

Discovering customer needs

Developing product features

Developing process features

Establishing process controls and transferring to operations

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IMPORTANT POINTS TO BE NOTED WHILE QUALITY PLANNING

Business, having larger market share and better quality, earn returns much higher than their competitors.

Quality and Market share each has a strong separate relationship to profitably.

Planning for product quality must be based on meeting customer needs, not just meeting product specifications.

For same products ,we need to plan for perfection. For other products, we need to plan for value.

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QUALITY PLANNING ROAD MAP

It can be applied to the following:

1. Supervisory and worker level(self-control & triple role concept)

2. Functional level(marketing)

3. Multifunctional systems(MIS,HR)

4. Major programmes

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JURAN’S QP ROAD MAP

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QP MAPPING

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QUALITY COSTSFalls into two categories…..

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QU

ALI

TY C

OST

SCost of conformance

(Cost of achieving good quality)

Cost of non - conformance

(Cost associated with poor quality)

CATEGORIES OF QUALITY COSTS

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COST OF GOOD QUALITYPREVENTION COSTS: Planned cost by an organization

– to ensure no errors are made at

any of the various stages during the

delivering process of that product or

service to the customer

Delivery process - design,

development, production and shipping

Prevention Costs - training ,

Continuous improvement efforts, quality administration, process control, market research, field testing and preventive maintenance.7/23/2015 17

COST OF GOOD QUALITYAPPRAISAL COSTS: Cost of verifying , checking or evaluating

a product or service at various stages during the delivery process of that product or service

to the customer.

Appraisal Costs- receiving or incoming inspection , internal product audit , inspection activities , inventory counts , quality administration salaries , supplier evaluation and audit reports

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COST OF POOR QUALITY

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Cost incurred by the company because

the product or service did

not meet the requirements

the product had to be

fixed or replaced

the service had to be repeated

INTERNAL FAILURES COSTS-failures that are found before the product or service reaches the customer

-Internal failure costs include:

Scrap

Rework

Extra inventory

Process failure

Process downtime

Process-downgrading7/23/2015 20

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EXTERNAL FAILURES COSTS- Occurs when the customer finds the failure

- Do not include any customer’s personal costs

- External failure costs include:

Customer complaint costs

Customer follow up and field services

Product return costs

Warranty claims

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HIDDEN QUALITY OF COSTS(QOC)

Customer dissatisfaction costs

Lost reputation costs

Customer incurred costs

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TOTAL COST OF QUALITY

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Prevention + Appraisal + Internal failures + External

failures

Actual cost of a product or service

What reduced cost would be if there were no possibility of

service,failures or defects in their manufacture

ANALYSIS OF QUALITY COSTSThere are three curves

1. Failure costs (FC=0 if product is 100% good or

FC=infinity if product is 100% defective)

2. Costs of appraisal + prevention (100%defective , cost=0 and rises if perfection isapproached)

3. The sum of curves 1 & 2 (Total cost of qualityper good unit of product)

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Economics of Quality of conformance

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ANALYSIS TECHNIQUES FOR QUALITY COSTS

Two common techniques:

Trend Analysis

Pareto Analysis

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TREND ANALYSISPresent level Vs. Past levels

It provides information for:

-long range planning

-instigation and assessment

of quality improvement

programs

Taken as Quarterly reports

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TREND ANALYSIS

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PARETO ANALYSIS

Item values are

located as bars in

descending order

Left – items

(substantial amount

of the total)-vital few

Right – small amount

of total-trivial many

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BAR CHARTS AND PIE CHARTS

To compare similar item of a competing organization

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HISTORICAL REVIEW

• Stone Age- Man used Sharp

Tools to earn his livelihood

• Middle age - Skilled craftsman

built Pyramids in Egypt and the

Craftsman trained family members

as Apprentices.

•Industry revolution – concept of

specialization of labor was introduced.

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HISTORICAL REVIEW1924 - Statistical quality control

chart– developed by W.A.Shewhart

in Bell Laboratories.

1942 – H.F.Dodge and H.G.Romig

– Quality of acceptance instead of 100% inspection

- US industry managers failed to understand its value

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HISTORICAL REVIEW1946 – American Society for Quality Council was formed (recent name - ASQ)

1950 –W.Edwards Deming and Joseph .M.Juran gave lectures on Statistical methods to Japanese Engineers

1960s – first Quality circle was formed

In 1970s – US industries started practicing these concepts

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HISTORICAL REVIEWIn middle of 1980 – Concepts of

TQM were published

In late 1980s – Statistical process control was emphasized

MALCOM BALDRIGE NATIONAL QUALITY AWARD – to measure TQM – First award

Genichi and Taguchi – Concept of parameter and tolerance design –Design of Experiments(DOE) as important quality tool

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HISTORICAL REVIEW

Japanese – DEMING AWARD – HIGHEST at global level

In 1996 – Saturn Automobile ranked first in customer satisfaction

ISO 9000 – worldwide model for a quality system

ISO 14000 - worldwide model for environmental management systems & continues with new standards.......

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NEED FOR ISO 9000 AND OTHER QUALITY SYSTEMS

What is a standard?

- document that provides requirements,specifications, guidelines or characteristics thatcan be used consistently to ensure that materials,products, processes and services are fit for theirpurpose.

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NEED FOR A QUALITY SYSTEM

An organisation’s role –To satisfy the customer’s

needs – proper utilization of resources

and ideas with cost reduction in mind

QUALITY MONITORING SYSTEM

- sets standards of quality

Customer needs – Good Quality product at a

lower cost

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ISO - International Organization for Standardization ISO, is an international standard-

setting body composed ofrepresentatives from various nationalstandards organizations.

Founded on 23 February 1947, theorganization promotes worldwideproprietary, industrial and commercialstandards.

Head Quarters - Geneva, Switzerlandand as of 2013 works in 164 countries

Over 19 500 International Standardsare published

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POPULAR STANDARDS

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STANDARDS IN ACTION

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STANDARDS IN ACTION

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ISO 9000 STANDARDSISO 9001

Design, Development, Production, Installation & Servicing

ISO 9002

Production, Installation & Servicing

ISO 9003

Inspection & Testing

ISO 9004

Provides guidelines on the technical, administrative and human factors affecting the product or services.

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OBJECTIVES OF ISO 9000 STANDARDS

Each organization should: Achieve and sustain the quality of the

product or service produced so as to meet implied needs continuously.

Provide confidence to its own managementthat the intended quality is being achieved.

Provide confidence to the purchasers that theintended quality is being or will be achievedin the delivered product or service provided.

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BENEFITS OF ISO 9000 STANDARDS Achievement of international standard of quality.

Value for money.

Customer satisfaction.

Higher productivity.

Increased profitability

Improved corporate image

Access to global market

Growth of the organization

Higher morale of employees

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CLAUSES (ELEMENTS) OF ISO 9000 (During the year 1987)

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CLAUSES (ELEMENTS) OF ISO 9000:2008 (During the year 2000)

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IMPLEMENTATION OF QUALITY SYSTEM ISO 9000:2008

Requirements:

1.Top management Commitment

2. Appoint a Management Representative

3. Awareness

4. Appoint an Implementation team

5. Training

6. Time Schedule

7. Select Element Owners

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IMPLEMENTATION OF QUALITY SYSTEM ISO 9000:2008

Requirements:

8. Review the Present System

9. Preparation of the Document

10. Install the New system

11. Internal Audit

12. Management Review

13. Pre – Registration

14. Registration

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MODULE - I OUTLINE Introduction to Total Quality Management

Definition of Quality

Dimensions of Quality

Quality Planning

Quality Costs

Basic concepts of Total Quality Management

Historical Review

Need for ISO 9000 and Other Quality Systems

ISO 9000:2008 Quality System- Elements

Implementation of Quality System

Documentation

Quality Auditing

Introduction to TS 16949, QS 9000

ISO 14000, ISO 18000

ISO 20000, ISO 22000

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“Whatever you Do , Document it.Whatever you

Document , Do it.Demonstrate ”

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DOCUMENT PYRAMID

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POLICY

PROCEDURES

WORK INSTRUCTIONS

RECORDS

.................Why , What

........Who , When , Where

.........How

....Evidence

QUALITY SYSTEM AUDITING

“A systematic and independentexamination to determine whetherquality activities and related resultscomply with planned arrangementsand whether these arrangements areimplemented effectively and aresuitable to achieve the objectives”

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OBJECTIVES OF AUDIT1. To determine the effectiveness of

the quality system implemented inachieving quality objectives.

2. To provide an opportunity toimprove the quality systems.

3. To meet regularity and/orstatutory requirements.

4. To provide an evidence foreffectiveness of the quality systemimplementation for certification

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STAGES OF AUDIT

1.Planning and Preparation for the audit

2.Execution of the Audit plan

3.Reporting the audit results

4.Corrective actions and follow up

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How to conduct an audit?According to Quality manual,

Opening meeting

Gathering information

Record observations and non conformances

Evaluate the significance of non conformances

Assess the compliance to the requirements

Prepare the document for findings

Closing meeting and review

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TYPES OF AUDITS

QUALITY AUDITS

INTERNAL AUDIT

FIRST PARTY AUDIT

EXTERNAL AUDIT

SECOND PARTY AUDIT

THIRD PARTY AUDIT

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TYPES OF AUDITS

• Independent self assessment system looking at its own activities for continuous improvement

• Can be carried out within a particular area or function within an organization

FIRST PARTY AUDIT

• Supplier quality assurance audits

• To ensure the purchasing organisations , level of confidence and suppliers capabilities

SECOND PARTY AUDIT

• Conducted by recognized certifying agency or a statutory body

• Certificate of Quality Assurance will be issued

THIRD PARTY AUDIT

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TYPES OF AUDITS(BASED ON THE AREA OF COVERAGE OF AUDIT)

System audit – to evaluate and ensure the quality ofthe supplied products

Process audit – to inspect the processes involved

Product audit – Conducted before delivery of theproduct to check specifications and customer needs

Compliance audit – to establish the extent to whichthe documented system is implemented andfollowed by the employees

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