UNIT IV TQM TOOLS & TECHNIQUES II

Quality circles – Quality Function Deployment (QFD) – Taguchi quality loss function – TPM – Concepts, improvement needs – Cost of Quality – Performance measures.

Quality CircleWhat is quality circle?

A group of employees who perform similar duties and meet at periodic intervals, often with management, to discuss work-related issues and to offer suggestions and ideas for improvements, as in production methods orquality control,calledquality circle.

Therefore quality circle is nothing but a small group of employees who come together to discuss with the management issues related to either quality control or improvement in production methods form a Quality Control Circle (QCC). These employees usually work in the same areas, and voluntarily meet on a regular basis to identify, analyze and solve their problems.

Key Characteristics of quality circle: 1. A circle, usually consisting of 6-8 members, from the same section. 2. Membership of a Quality Circle is voluntary. 3. Circle members should meet regularly, ideally once a week, in particular place also in

particular time. 4. Circle members select a name for their circle in the first meeting and elect a leader to

conduct the meetings. 5. Members are specially trained in problem solving and analysis techniques in order to play

their role effectively. 6. Circle works on a systematic basis to identify and solve work - related problems for

improving quality and productivity not just discussing them. 7. The management must ensure that solutions are implemented quickly once they have been

accepted 8. The management must give appropriate and proper recognition to solution

Why Quality Circle: It is said that 95% of the problems in workshops can be solved through quality control tools. The Japanese have experienced this! The quality control tools useful for QCCs are Pareto Diagrams, Cause-and-Effect Diagrams, Stratification, Check Sheets, Histograms, Scatter Diagrams, Graphs and Control Charts. Also, logical thinking and experience are a must for solving problems. Therefore the main objectives of QC are: 1. To improve quality and productivity.2. To reduce the cost of products or services by waste reduction, safety, effective

utilization of resources, avoiding unnecessary errors and defects. 3. To identify and solve work-related problems and interfere with production as a team.

4. To tap the creative intelligence of people working in the org. and make full use of human resources.

5. To improve communication within the organization. 6. To improve employees loyalty and commitment to the organization and its goals. Promoting

Morale of employees) 7. To build a happy, bright, meaningful work environment. 8. To satisfy the human needs of recognition, achievement and self development

The benefits of introducing a quality control circle program in the work place are many.

1. Heightened quality awareness reveals faults in the system that might obstruct good practices.

2. It improves the quality of your firm’s products and services, thereby increasing the value of your brand, and securing your customers’ confidence. The quality of customer relationship management can be further enhanced by using help desk software from the likes of pro software.

3. The people who are part of the quality control circle will feel a sense of ownership for the project.4. Higher yields and lower rejection rates also result in enhanced job satisfaction for workers,

which in turn drives them to contribute more. 5. A quality control circle program also brings about improved two-way communication between the

staff and the management. 6. Finally, the financial benefits will certainly exceed the costs of implementing the program.7. A study revealed that some companies improved their savings ten fold!

Basic Organizational Structure of QC:

A quality circle should have an appropriate organizational structure for its effective and efficient performance. The structure may vary from one org. to another, but it is useful to have basic framework as a model:

In a typical organization, the structure of a QC may consist of the following elements: 1. Steering committee - Gen. manager / works manager, rep. from top management, rep. of

human resource development and a rep. of employees’ union. 2. Coordinator: an administrative officer/ personnel officer from middle level

management.3. Facilitator: senior supervisory officer / foreman. A facilitator may manage up to 10

circles. A facilitator is usually from one of the three departments - quality control, production or training.

4. Circle Leader: circle leaders may be from the lowest level of supervisors. A circle leader organizes and conducts circle activities.

5. Circle members: line and / or staff workers ( circle members should attend all meetings as far as possible, offer suggestions and ideas, participate actively in group processes, and attain training seriously.

How to implement quality circle: 1. Firstly, the management is informed about the quality control circle process that is being

planned. 2. A committee is formed, and key persons such as a coordinator and in-house coach are

selected. 3. The scope is defined, and areas of application identified. 4. First-line supervisors in the identified areas are given QCC presentations. It is

important to make these impressive, and valuable tips on the subject are available. 5. This is followed up with extensive training for coordinators and middle management

on the process and their roles. 6. Employees are invited to become members of a circle, and trained suitably once they sign

up. Thus, a circle is formed and begins work. These may give rise to other circles. 7. Problems are discussed and solved in a systematic manner in the QCCs. It is very

important that solutions are implemented as quickly as possible, to maintain the momentum.

Usually QCC programs must operate in all sections of the company i.e., in the offices, service operations and manufacturing. But remember, while the size of the company is not important to a program's success, the following factors certainly are:

1. Voluntary participation. 2. Management support. 3. Employee empowerment. 4. Training programs. 5. Team work. 6. Problem solving skills.

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QUALITY FUNCTION DEPLOYMENT

(1) What is Quality Function Deployment(QFD)? Explain its uses. Quality Function Deployment is a planning tool used to fulfill customer expectations. Quality Function Deployment focuses on customer expectations or requirements, often

referred to as voice of the customer.QFD TEAM :

There are two types of teams namely

1. Team for designing a new product

2. Team for improving an existing product

BENEFITS OF QFD :

1. Improves Customer satisfaction Creates focus on customer requirements Uses competitive information effectively Prioritizes resources Identifies items that can be acted upon

2. Reduces Implementation Time Decreases midstream design changes Limits post introduction problems Avoids future development redundancies

Promotes Team Work

Based on consensus Creates communication Identifies actions

3. Provides Documentation Documents rationale for design Adds structure to the information Adapts to changes (a living document)

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4. What is House of Quality? Explain how it is constructed.

HOUSE OF QUALITY :

i

Interrelationship

Between

Technical Descriptors

Technical Descriptors

(Voice of the organization)

Relationship between

Requirements and

Descriptors

Priortized

Technical Descriptors

Cus

tom

er R

equi

rem

ents

(Voi

ce o

f the

cus

tom

er)

Prio

ritiz

ed

Cus

tom

er R

equi

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ents

6

THE STEPS IN BUILDING A HOUSE OF QUALITY ARE :

1. List Customer Requirements (WHAT’s)2. List Technical Descriptors (HOW’s)3. Develop a Relationship Matrix Between WHAT’s and HOW’s4. Develop an Inter-relationship Matrix between HOW’s

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5. Competitive Assessmentsa. Customer Competitive Assessmentsb. Technical Competitive Assessments

6. Develop Prioritized Customer Requirements7. Develop Prioritized Technical Descriptors

TAGUCHI’S QUALITY LOSS FUNCTION

(5) What is Taguchi’s Loss Function?

TAGUCHI’S QUALITY LOSS FUNCTION

INTRODUCTION

Taguchi Methods is a statistical methods developed largely by GENICHI TAGUCHI to improve quality of manufactured goods.

The philosophy of off-line quality control.

Innovations in the design of experiments.

Taguchi Loss Function Definition

Taguchi defines Quality as “the loss imparted by the product to society from the time the product is shipped.”

LOSS = Cost to operate, Failure to function, maintenance and repair cost, customer satisfaction, poor design.

Product to be produced “being within specification”

Taguchi’s Vs Traditional Approach

Taguchi’s Quadratic Quality Loss Function

Quality Loss Occurs when a product’s deviates from target or nominal value.

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Deviation Grows, then Loss increases.

Taguchi’s U-shaped loss Function Curve.

Taguchi’s U-shaped loss Function Curve.

Formula to find Taguchi’s Loss FnTaguchi uses Quadratic Equation to determine loss Curve

L (x) = k (x-N)²

Where L (x) = Loss Function,

k = C/d² = Constant of proportionality, where C – Loss associated with sp limit

d - Deviation of specification from target value

x = Quality Features of selected product,

N = Nominal Value of the product and

(x-N) = Tolerance

Problem

A part dimension on a power tool is specified as 32.25±0.25.Company records show±0.25 exceeded & 75% of the returned fo replacement. Cost of replacement is Rs.12,500.Determine k & QLF.

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Solution : Expected Cost of repair

C = 0.75(12500) = Rs 9,375

k = C/d²= 9375/(90.25)² = Rs 1,50,000

QLF =L (x) 1,50,00(x-N)

Taguchi’s Quality Loss Function concept combines cost, target and variation in one metric with specifications being of secondary importance.

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Taguchi has defined quality as the loss imparted to society from the time a product is shipped. Societal losses include failure to meet customer requirements, failure to meet ideal performance and harmful side effects.

CUSTOMERS PERCEIVE QUALITY AS MEETING THE TARGET RATHER THAN JUST MEETING THE SPECIFICATIONS.

There are three common quality loss functions

1. Nominal - the - best.

2. Smaller - the - better.

3. Larger - the - better.

NOMINAL – THE – BEST :

Although Taguchi developed so many loss functions, many situations are approximated by the quadratic function which is called the Nominal – the – best type.

The quadratic function is shown in figure. In this situation, the loss occurs as soon as the

performance characteristic, y, departs from the target τ.

At τ, the loss is Rs. 0.

At LSL (or) USL, the loss is Rs. A.

The quadratic loss function is described by the equation L = k (y - τ) 2.

Loss

(Rs)

USL

A

τ + ∆

LSL

Performance Characteristic

Quadratic Loss Function

L

0τ - ∆

Y

τ

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Where,

L = cost incurred as quality deviates from the target.

y = Performance characteristic

τ = target

k = Quality loss coefficient.

The loss coefficient is determined by setting ∆ = (y – τ), the deviation from the target. When ∆ is the USL (or) LSL, the loss to the customer of repairing (or) discarding the product is Rs. A.

Thus,

K = A / (y – τ)2 = A / ∆2 .

SMALLER – THE – BETTER :

The following figure shows the smaller – the – better concepts.

The target value for smaller – the – better is 0. There are no negative values for the performance characteristic.

The radiation leakage from a microwave appliance, the response time for a computer, pollution from an automobile, out of round for a hole etc. are the performance characteristics for this concept.

LARGER – THE – BETTER :

The following figure shows the concept of the Larger – the – better.

TOTAL PRODUCTIVE MAINTENANCE (TPM)

Loss

(Rs)

A

Performance Characteristic

Smaller-the-better

L

0 y

y

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(6) Define TPM(Total Productive Maintenance). Explain in detail TPM steps.

Total Productive Maintenance (TPM) is defined as keeping the running plant and equipment at its highest productive level with the co-operation of all areas of the organization.

Predictive and Preventive maintenance are essential to building a foundation for a successful TPM environment. Predictive Maintenance is the process of using data and statistical tools to determine when a piece of equipment will fail. Preventive Maintenance is

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the process of periodically performing activities such as lubrication on the equipment to keep it running.

OBJECTIVES OF TPM :

1. To maintain and improve equipment capacity.

2. To maintain equipment for life.

3. To use support from all areas of the operation.

4. To encourage input from all employees.

5. To use teams for continuous improvement.

TPM PHILOSOPHY – CONCEPT OF TPM :

Total Productive Maintenance (TPM) is an extension of the Total Quality Management (TQM) philosophy to the maintenance function.

TPM has the following steps:

1. Management should learn the new philosophy of TPM.

2. Management should promote the new philosophy of TPM.

3. Training should be funded and developed for everyone in the organization.

4. Areas of needed improvement should be identified.

Loss measurements to identify improvement needs are

Down time losses Reduced speed losses Poor quality losses

5. Performance goals should be formulated.

6. An implementation plan should be developed.

7. Autonomous worth groups should be established.

2 MARKS1.What is a QFD?

1. Quality Function Deployment is a planning tool used to fulfill customer expectations.

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2. It is a disciplined approach to product design, engineering, and production and provides in-depth evaluation of a product.

2.. What are the benefits of QFD?1. Customer driven2. Reduces implementation time3. Promotes teamwork4. Provides documentation

3. What are the steps required to construct an affinity diagram?1. Phrase the objective2. Record all responses3. Group the responses4. Organize groups in an affinity diagram

4.What are the goals of TPM?The overall goals of Total Productive Maintenance, which is anextension of TQM are

1. Maintaining and improving equipment capacity2. Maintaining equipment for life3. Using support from all areas of the operation4. Encouraging input from all employees5. Using teams for continuous improvement

5. Give the seven basic steps to get an organization started toward TPM?1. Management learns the new philosophy2. Management promotes the new philosophy3. Training is funded and developed for everyone in the organization4. Areas of needed improvement are identified5. Performance goals are formulated6. An implementation plan is developed7. Autonomous work groups are established

6. What are the major loss areas?1. Planned downtime2. Unplanned downtime3. Idling and minor stoppages4. Slow-downs5. Process nonconformities6. Scrap

7.Define TPM?1. T : Total = All encompassing by maintenance and production individuals working

together.2. P : Productive = Production of goods and services that meet or exceed customer’s

expectations.3. M : Maintenance = Keeping equipment and plant in as good as or better than original

condition at all times.

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8.Define quality cost.Quality cost is defined as the cost associated with the non-achievement of product/service quality as defined by the requirements established by the organisation and its contracts with customers and society.

9.List the categories of quality costs.The categories of quality cost are

1. Cost of prevention2. Cost of appraisal3. Cost of internal failures and4. Cost of external failures.

10.What is meant by cost of prevention?Prevention costs are the costs that are incurred on preventing a quality problem from arising.

11.List the elements of cost of prevention.The elements of cost of prevention are

1. Cost of quality planning2. Cost of documenting3. Process control cost4. Cost of training5. Costs associated with preventing recurring defects.

12.What is cost appraisal?Appraisal costs are the cost that are incurred in assessing that the products/services conform to the requirements

13. What are the cost of appraisal?The cost of appraisal are

1. Cost of receiving test and equipment2. Cost of Laboratory acceptance testing3. Cost of installation testing4. Cost of installation and commissioning5. Cost of maintenance and calibration of testing and inspecting equipments.

14. What is meant by cost of internal failures?The costs associated with defective products, components and materials that fail to meet quality requirements and result in manufacturing losses are called as costs of internal failures. These costs are linked to correcting mistakes before delivery of the product

15. List the components cost of internal failures.The cost of internal failures are

1. Cost associate with scrap and rejects.2. Cost of repair and rework.3. Cost of design changes.4. Cost of trouble shooting5. Cost of reinspection and retesting., etc;

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16. What is meant by cost of external failures?It consist of the cost which are generated because of defective products being shipped to customers. These cost are associated with the adjustments of malfunctions after delivery of the product.

17.Give the sub-elements of Preventive cost category?1. Marketing/Customer/User2. Product/Service/Design development3. Purchasing4. Operations/5. Quality Administration6. Other Prevention Costs

18. Give the sub-elements of Appraisal cost category?1. Purchasing appraisal cost2. Operations appraisal cost3. External appraisal cost4. Review of test and application data5. Miscellaneous quality evaluations

19. Give the sub-elements of Internal failure cost category?1. Product or Service Design costs (Internal)2. Purchasing failure costs3. Operations failure costs

20. Give the sub-elements of External failure cost category?1. Complaint investigations of customer or user service2. Returned goods3. Retrofit and recall costs4. Warranty claims5. Liability costs6. Penalties7. Customer or user goodwill8. Lost sales9. Other external failure costs

21. Give the typical cost bases?1. Labor2. Production3. Unit4. Sales

22. How will you determine the optimum cost?1. Make comparison with other organizations2. Optimize the individual categories3. Analyze the relationships among the cost categories

QUESTION BANK

UNIT IV : TQM TOOLS AND TECHNIQUES-II

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Quality Circles - Quality Function Development (QFD) - Taguchi quality loss function - TPM - Concepts, improvement needs - Performance measures.

PART - A1. Define is Quality Circle?2. What is the philosophy of Quality Circle?3. List out attributes of Quality Circle.4. Draw the diagram for the objectives of Quality Circle.5. Draw the diagram for the structure of Quality Circle.6. Define the role of coordinator of Quality Circle.7. Define the role of steering committee of Quality Circle.8. Define the role of leader of Quality Circle.9. Define the role of facilitator of Quality Circle.10. List out the various processes involved in Quality Circle operation.11. What is a QFD?12. When is QFD used?13. Define QFD Team.14. What are the objectives of QFD?15. List out various sources of capturing the customer expectations.16. What is House of quality?17. Draw parts of house of quality?18. Define Taguchi methods.19. Define Taguchi loss function.20. Why we need of loss functions?21. Define the philosophy of the manufacturer in22. Define TPM?23. What are the objectives benefits of TPM?24. What is difference between Taguchi’s approach and traditional approach?

TopicsQuality Circles-Quality Function Development (QFD) - Taguchi quality loss function

PART - B1. Write about House of Quality tool and how is useful for implementing QFD with a neat

diagram.2. Explain the steps to construct QFD, 4 phases of QFD? (16M)3. Briefly explain the steps involved in QFD? (16M)

TopicsTPM - Concepts, improvement needs - Performance measures.

PART - B1. What are goals of TPM, Explain the losses of TPM? (8M)2. Discuss the significance of TPM? (8M)

UNIVERSITY QUESTIONSPart-A(2 Marks)

1. What are the functions of Quality circle? (Dec 2013)

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2. What is Taguchi quality loss function (TQLF)? (Jun 2013)3. What is meant by “House of quality”? (Jun 2011)4. What are the benefits of QFD? (Dec 2010)5. Sketch the structure of quality circle? (Dec 2011)6. What is the difference between Taguchi’s approach, traditional approach? (Dec 2010)7. Indicate different parameters used for Quality performance measurement? (Dec 2011)

Part-B

3. With suitable example, explain various stages of building a House of quality matrix? (16M) (Jun 2009, Dec 2012)

4. Explain the Taguchi’s quadratic quality loss function, How it differs from traditional approach of quality loss cost? (16M) (Dec 2011)

5. Write short notes on i) QFD (8M) ii) Quality circle (4M)

iii) Performance measure of TQM (4M)

6. What are goals of TPM, Explain the losses of TPM? (Dec 2011)7. What is Quality circle? Explain the structure, elements of quality circle? (16M) (Dec

2012, Jun 2013)8. Explain the pillars of TPM and its benefits? (16M) (Jun 2011)

CONCEPT QUESTIONS1. Describe the roles and responsibilities of quality circle members of Software Company

and Manufacturing company.2. Describe in detail the concept of TPM in Software development company.3. Develop the QFD house of quality for the services provided by the library of

university/college.4. Construct the house of quality for Mobile and Ball point pen manufacturing company.

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UNIT-V : QUALITY SYSTEMS

UNIT V – QUALITY SYSTEMS

ISO 9000 STANDARDSNeed for ISO 9000- ISO 9001-2008 Quality System – Elements, Documentation, Qualityauditing- QS 9000 – ISO 14000 – Concepts, Requirements and Benefits – Case studiesof TQM implementation in manufacturing and service sectors including IT.

(1) Give an overview and evolution of of IS 9000 series of standards .The International Organization of Standardization (ISO) was founded in

1946 in Geneva, Switzerland. The development of International Standards is to facilitate the exchange of goods and services worldwide. ISO consists of more than 90 country members.

The ISO Technical Committee (TC) developed a series of International Standards for Quality Systems, which were first published in 1987. The standards (ISO 9000,9001, and 9004) were intended to be advisory and developed for use in two-party contractual situations and internal auditing.

These standards were adoted by European Community and have been accepted worldwide with emphasis on quality and economic competetiveness.

The fourth edition of ISO 9001 was released in the year 2008 and it replaces the third edition (ISO9001 : 2000), which have been amended to clarify the points in the text and also to enhance the compatibility with ISO 14001 : 2004.

Most countries have adopted ISO 9000 series as their national standards.

(2) Explain briefly the scope and purpose of ISO 9000 Series standards.

The ISO 9000 series Stadnards is generic in scope. By design, the series can be tailored to fit any organization ‘s needs. Whether it is large or small, a manufaturerer or a service organization. It can be applied to construction, engineering, health care, legal, and other professional services as well as the manufacturing of anything from nuts and bolts to spacecraft. Its purpose is to unify quality terms and defi nitions used by industrialized nations and use those terms to demonstrate the supplier’s capability of controlling the processes.

In very simplified terms , the standards require an organization to say what it is doing to ensure quality, then do what it says,and, finally document or prove that it has done what it said.

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(3) Briefly describe the ISO 9000 Series of Standards.

ISO 9000: 2005 - Quality Management Systems (QMS) – Fundamentals and Vocabulary discusses the fundamental concepts related to QMS and provides the terminology used in the other two standards.

ISO 9001 : 2008 – Quality Management Systems (QMS) – Requirements is the standards used registration by demonstrating conformity of the QMS to customers, regulatory and organization’s own requirements.

ISO 9004 : 2000- Quality Management Systems (qms) – GUIDELINES FOR PERFORMANCE IMPROVEMENT provides guidelines that an organization can use to establish a QMS focused on improving performance.

ISO 9000

ISO 9001

ISO 9002

ISO 9003

ISO 9001Design, Development, Production, Installation & Servicing

ISO 9002Production, Installation & Servicing

ISO 9003Inspection & Testing

ISO 9004

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

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)4.1 Management Responsibility

Adequate resources for the verification activities Need for trained personnel Work and verification activities including audits A Management Representative to be identified Review the Quality System performance and customer complaints

periodically4.2 Quality System4.3 Contract review4.4 Design Control4.5 Documents Control4.6 Purchasing4.7 Purchaser – Supplied Product4.8 Product Identification and Traceability4.9 Process Control4.10 Inspection and Testing4.11 Inspection Measuring and Test Equipment4.12 Inspection and Test Status4.13 Control of Non – Conforming Product4.14 Corrective Action4.15 Handling, Storage, Packaging and Delivery4.16 Quality Records4.17 Internal Quality Audits4.18 Training4.19 Servicing4.20 Statistical TechniquesCLAUSES (ELEMENTS) OF ISO 9000 (During the year 2000)

1. Scope2. Normative Reference3. Terms and Definitions4. Quality Management System (QMS)

4.1 General Requirements4.2 Documentation

5. Management Responsibility5.1 Management Commitment5.2 Customer Focus5.3 Quality Policy5.4 Planning5.5 Responsibility, Authority and Communication5.6 Management Review

6. Resource Management6.1 Provision of Resources6.2 Human Resources6.3 Infrastructure6.4 Work Environment

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7. Product Realization7.1 Planning of Product Realization7.2 Customer related processes7.3 Design and Development7.4 Purchasing7.5 Production and Service Provision7.6 Control of Monitoring and Measuring devices

8. Monitoring and Measurement8.1 General8.2 Monitoring and Measurement8.3 Control of Non-Conforming Product8.4 Analysis of Data8.5 Improvement

(4) Discuss in detail the steps that are necessary to implement a Quality Management System.

IMPLEMENTATION OF QUALITY MANAGEMENT SYSTEM :

1. Top Management Commitment2. Appoint the Management Representative3. Awareness4. Appoint an Implementation Team5. Training6. Time Schedule7. Select Element Owners8. Review the Present System9. Write the Documents10. Install the New System11. Internal Audit12. Management Review13. Pre-assessment14. Registration

PITFALLS OF SUCCESSFUL IMPLEMENTATION :

1. Using a generic documentation program or another organization’s documentation program

2. Over-documentation or documentation that is too complex3. Using External Consultants without involvement4. Neglecting to obtain top management’s involvement5. Developing a system that does not represent what actually occurs

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DOCUMENTATION

In every organization, the quality system must be documented properly. The documentation of the system can be seen as a hierarchical format as shown.

1

POLICY

2

PROCEDURE

3

PRACTICE

4

PROOF

(5) What are Quality Audits? Explain in detail the types of audits.

Quality Audit

Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.

Types of audit

3 types

o Process audits

o Product audits

o System audits

Process audits

• Evaluation of the content and effectiveness of specific processes and work activities

• To confirm the process parameters and improve capability of the process

• To ensure the realization of process quality characteristics

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• To ensure improvement of process control during service provision

• Product audits

-To identify opportunities for improvement to establish the quality level of units before final inspection and testing

-To establish the capability of the inspection function

-To determine the usefulness of inspection/tests

• Audits are distinguished by the party requesting:

• 1st party audit (internal audits) – the auditee audits its own quality system according to a quality standard.

• 2nd part audits (supplier audits) – the customer audits the supplier’s quality system

• 3rd party audits – these are external certification audits by an independent institution in order to certify the quality system

Products audits

Investigation of products conformance to specified characteristics

-To obtain additional neutral assessment of product’s level of quality

-To obtain additional assurance that specified quality requirements are met

System audits

• Evaluation all the elements of the quaity system in order to:-

• Verify usefulness, suitability and effectiveness

• Verify adequate documentation

• Verify compliance with requirements

• Determine weak points

Purpose of audits

• Registration / certification audit

• Verify that the organization's QMS meet the requirements of ISO 9001 : 2000

Internal audit

• Identify opportunities for improvement• Maintain ISO 9001 certification

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(6) What are the objevtives of Internal audit?

Objectives of the Internal audit

• To verify conformance to applicable standards

• To verify conformance to documented procedures

• To verify effectiveness of the processes in the system

• To identify opportunities to improve the system

• Creating and environment for successful audits (1)

(7) Discuss in detail the purpose of Quality Auditing.

QUALITY AUDITING

The term Audit refers to a regular examination and checking of accounts or financial records, settlement or adjustment of accounts.

It also refers to checking, inspection and examination of Production Processes.

PURPOSE OF QUALITY AUDIT :

To establish the adequacy of the system. To determine the effectiveness of the system. To afford opportunities for system analysis. To help in problem solving. To make decision making easier etc.

TYPES OF QUALITY AUDIT :

1. First – Party Audit.2. Second – Party Audit.3. Third – Party Audit.

Quality audit can also be classified on the basis of the area taken into account for the audit such as

System Audit. Process Audit. Product Audit. Adequacy Audit. Compliance Audit.

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(8) Discuss the evolution of ISO 14000, the Environmental Management Systems (EMS).

ISO 14000 – ENVIRONMENTAL MANAGEMENT SYSTEM (EMS)

The overall aim of the Environmental Management systems is to provide protection to the environment and to prevent pollution.

The success of ISO 9000 along with increased emphasis on Environmental issues were instrumental in ISO’s decision to develop Environmental Management Standards.

In 1991, ISO formed the Strategic Advisory Group on the Environment (SAGE) which led to the formation of Technical Committee (TC) 207 in 1992.

Mission of TC207 is to develop standards for an Environmental Management System (EMS) which was identified as ISO 14000.

TC 207 has Established six sub-committees1. Environmental Management System (EMS)2. Environmental Auditing (EA)3. Environmental labeling (EL)4. Environmental Performance Evaluation (EPE)5. Life-Cycle Assessment (LCA)6. Terms & Definitions

Environmental Management System (EMS) :

EMS has two Evaluation Standards. They are

1. Organization Evaluation Standards 2. Product Evaluation StandardsREQUIREMENT OF ISO 14001

There are six elements

1. GENERAL REQUIREMENTS

EMS should include policy, planning implementation & operation, checking & corrective action, management review.

2. ENVIRONMENTAL POLICY (Should be based on mission)

The policy must be relevant to the organization’s nature. Management’s Commitment (for continual improvement & preventing pollution). Should be a framework (for Environmental objectives & Targets). Must be Documented, Implemented, & Maintained.

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3. PLANNING

Environmental Aspects Legal & other Requirements Objectives & Targets Environmental Management Programs

4. IMPLEMENTATION & OPERATION Structure & Responsibility Training, Awareness & Competency Communication EMS Documentation Document Control Operational Control Emergency Preparedness & Response

5. CHECKING & CORRECTIVE ACTION Monitoring & Measuring Nonconformance & Corrective & Preventive action Records EMS Audit

6. MANAGENMENT REVIEW Review of objectives & targets Review of Environmental performance against legal & other requirement Effectiveness of EMS elements Evaluation of the continuation of the policy

(9) Discuss in detail ISO 14000 series standards , its scope, concepts and steps in its implementation.

ISO 14000: Environmental   Standards

ISO 14000

The International Organization for Standards published its Quality Management System (ISO9000) in 1987.  ISO9000 became an instant world wide success.

In 1991, ISO formed Strategic Advisory Group on the Environment (SAGE). The purpose of formation of this group was world wide increase in emphasis of management of environmental issues a part of quality management systems. This group proposed the formation of Technical Committee to develop standards that deal with environmental management system. This technical committee, TC 207 developed the standards called ISO14000.

The EMS is part of a comprehensive management system that addresses with the overall business activities, including its products and services, affect the environment.

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ISO14000 Series Standards

ISO14000 is a generic standard. When we state the term generic, we mean that- like ISO9000-it is not an industry specific standard.

The series is divided into two separate areas-the organization evaluation standards  and the product evaluation standards. The first deals with Environmental Management System (EMS), Environmental Auditing (EA), and Environmental Performance Evaluation (EPE), whereas later deals with Environmental Aspects in Product Standards (EAPS), Environmental Labeling (EL), and Life-Cycle Assessment (LCA).

See following figures to understand the division of standards as mentioned above:

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 Concepts of ISO 14001:2004 Standards

In this post we will particularly discuss ISO 14001:2004 because this standards is the heart of all the environmental standards. This standard provides organizations with the elements of for an

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environmental systems, which can be integrated into other management systems to help achieve environmental and economic goals.

This standard provide guidelines for registration and/or self-declaration of the organization’s environmental management systems. This standard is written in a manner that it can be applicable to all types and sizes of organizations. This standard is also capable to accommodate diverse geographical, cultural, and social conditions.

The demonstration of successful implementation of the system can be used to assure other parties that an appropriate EMS is in place. The basic approach to Environmental System can be understood with the help of following diagram:

Environmental Management System Model

ISO 14001:2004 works as follows:

As stated earlier in this post that ISO14000 is generic in nature. It does not  intend to specify the level of environmental performance of an organization. If that had been the case, ISO would have written it according to the specific activity of each business.

However, ISO has developed many other environmental standards that  deal with specific environmental standards. These standards are beyond the scope of ISO14001:2004 standards at the moment.

ISO14001:2004 provide a framework to the organizations so that they could communicate about EMS matters with the other stakeholders including customers, environmental regulators, the public and so forth.

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It also provides framework to the organizations-irrespective of their current level of environmental maturity-to remain committed for environmental management and its continual improvement as well.

(10) What are the benefits of EMS?

BENEFITS OF ENVIRONMENTAL MANAGEMENT SYSTEM :

GLOBAL BENEFITS Facilitate trade & remove trade barrier Improve environmental performance of planet earth Build consensus that there is a need for environmental management and a common

terminology for EMS

ORGANIZATIONAL BENEFITS Assuring customers of a commitment to environmental management Meeting customer requirement Improve public relation Increase investor satisfaction Market share increase Conserving input material & energy Better industry/government relation Low cost insurance, easy attainment of permits & authorization

2marks1. Give the ISO 9000 Series of Standards?

1. ISO 9000, “Quality Management and Quality Assurance Standards Guidelines for Selection and Use”.

2. ISO 9001, “Quality Systems – Model for Quality Assurance in Design, Development, Production, Installation & Servicing”.

3. ISO 9002, “Quality Systems – “Model for Quality Assurance in Production, Installation & Servicing”.

4. ISO 9003, “Quality Systems – “Model for Quality Assurance in Final Inspection and Test”.

5. ISO 9004-1, “Quality Management and Quality System Elements – Guidelines”.

2. What is the need for ISO 9000?ISO 9000 is needed to unify the quality terms and definitions used by industrialized nations and use terms to demonstrate a supplier’s capability of controlling its processes.

3. Give some other quality systems?The quality systems are

1. QS-90002. QS-90003. TE-90004. AS9000

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4. Enumerate the steps necessary to implement the Quality Management System?The steps necessary to implement the Quality Management System are

1. Senior management commitment2. Appoint the management representative3. Awareness4. Appoint an implementation team5. Training6. Time schedule7. Select element owners8. Review the present system9. Write the documents10. Install the new system11. Internal audit12. Management review13. Pre assessment14. Registration.

5.What are the three sections of QS-9000?The three sections of QS-9000 are

1. Common requirements, which include the exact text of ISO 9001 and the addition of automotive/heavy trucking requirements.

2. Additional requirements covering production part approval process, continuous improvement and manufacturing capabilities.

3. Customer-specific requirements.

6. Give the objectives of the internal audit?The objectives of the internal audit

1. Determine the actual performance conforms to the documented quality systems.2. Initiate corrective action activities in response to deficiencies.3. Follow up on noncompliance items of previous audits.4. Provide continued improvement in the system through feedback to management.5. Cause the auditee to think about the process, thereby creating possible improvements.

7. What are the requirements of ISO 14001?The requirements of ISO 14001 are

1. General requirements2. Environmental policy3. Planning4. Implementation and operation5. Checking and corrective action6. Management review

8. What are the benefits of ISO 14000?The benefits of ISO 14000 are

1. Globala) Facilitate trade and remove trade barriersb) Improve environmental performance of planet earthc) Build consensus that there is a need for environment management and a common

terminology for EMS.2. Organizational

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9. What are the four elements for the checking & corrective action of ISO14001?

1. Monitoring and measuring2. Nonconformance and corrective and preventative action3. Records4. EMS audit

10. What are the seven elements for the implementation & operations of ISO 14001?1. Structure and responsibility2. Training, awareness and competency3. Communication4. EMS documentation5. Documentation control6. Operational control7. Emergency preparedness and response

11. What are the four elements for the planning of ISO 14001?1. Environmental aspects2. Legal and other requirements3. Objectives and targets4. Environmental Management Programs

12. Give the types of Organizational Evaluation Standards?1. Environmental Management System2. Environmental Auditing3. Environmental Performance Evaluation

13. Give the types of Product Evaluation Standards?1. Environmental Aspects in Product Standards2. Environmental Labeling3. Life-Cycle Assessment

14. Define Quality Audits?Quality Audits examine the elements of a quality management system in order to evaluate how well these elements comply with quality system requirements.

15. Give the usage of an effective recognition and reward system?1. Serves as a continual reminder that the organization regards quality and productivity as

important.2. Offers the organization a visible technique to thank high achievers for outstanding

performance.3. Provides employees a specific goal to work toward. It motivates them to improve the

process.4. Boosts morale in the work environment by creating a healthy sense of competition among

individuals and teams seeking recognition.

16. What are the typical measurements frequently asked by managers and teams?1. Human Resource2. Customers3. Production

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4. Research & Development5. Suppliers6. Marketing/Sales7. Administration

17.Explain the ISO/QS 9000 elements?1. Management responsibility2. The Quality system3. Contract review4. Design control5. Document and data control6. Purchasing7. Control of customer-supplied product8. Product identification and traceability9. Process control10. Inspection and testing11. Control of inspection, measuring and test equipment12. Inspection and test status

18.What are the benefits of ISO?1. Fewer on-site audit by customers.2. Increased market share.3. Improved quality, both internally and externally.4. Improve product and service quality levels from suppliers.5. Greater awareness of quality by employees.6. A documented formal systems.7. Reduced operating costs.

19. Give the ISO 9001 requirements?1. Scope2. Normative Reference3. Terms and Definitions4. Quality Management System5. Management Responsibility6. Resource Management7. Product Realizatio20

20. What are the methods of actual audit?1. Examination of documents2. Observation of activities3. Interviews

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QUESTION BANK

UNIT V : QUALITY SYSTEMS

Need for ISO 9000 - ISO 9001-2008 Quality System - Elements, Documentation, Quality Auditing - QS 9000 - ISO 14000 - Concepts, Requirements and Benefits - TQM Implementation in manufacturing and service sectors.TopicsNeed for ISO 9000 - ISO 9001-2008 Quality System - Elements, Documentation, Quality Auditing - QS 9000

PART - A1. Define Quality systems.2. What are the functions of Quality Systems.3. List out various standards of ISO family.4. What are the reasons are considered for implementing a Quality system.5. List out objectives of ISO 9000 Quality System.6. Differentiate between ISO 9000 and QS 9000?7. What are the benefits of ISO-9000 certification?8. What are the types of audit systems?9. What are organization standards, product standards?10. What is the concept of EMS?11. Draw the documentation pyramid?12. What is third party audit?13. Name the ISO9000 series?14. State benefits of documentation?15. What are the elements of quality system?16. Define quality audit?17. Name the ISO series of standards?18. Draw the documentation pyramid?

PART - B1. What are the reasons for implementing of Quality system.(4M)2. What are the objectives of ISO 9000 Quality system. (4M)3. What is QS9000? State its significance? (4M)4. What are the benefits of ISO-9000 certification? (8M)5. Explain the major clauses of QS9000 standard? (8M)

Discuss the benefits of ISO 9000 certification? (8M)

6. Discuss the need for standardization procedures of quality assurance, Explain the requirements of documentation? (16M)

7. Discuss various elements of ISO 9000:2008 quality system? (16M)8. i) Explain the benefits of EMS? (8M)

ii) Discuss the quality auditing in detail? (8M)TopicsISO 14000 - Concepts, Requirements and Benefits

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PART - B1. List down the main elements of ISO-14000? (8M)2. What are benefits of ISO:14000 Certification? (8M)3. What are the needs of documentation in quality management system? (8M)4. Discuss in detail the elements of ISO 14000 and its benefits? (16M)

TopicsTQM Implementation in manufacturing and service sectors.

1. Write a brief notes on Quality auditing in QMS? (4M)2. Discuss various elements of QMS?(8M)\3. Explain the need for documentation and the documents to be prepared for QMS? (16M)

UNIVERSITY QUESTIONSPart-A(2 Marks)

1. What is internal quality audit, external quality audit? (Jun 2012)2. What are organization standards, product standards? (Dec 2010, Jun 2013)3. What is the concept of EMS? (Dec 2011, Jun 2013)4. Differentiate between ISO 9000,QS 9000? (Jun 2010)5. Define the term “Quality Loss Function”? (Dec 2011)6. List down the main elements of ISO-14000? (Jun 2012)7. Define quality audit? (Dec 2011)

Part-B1. i) What is QS9000? State its significance? (8M) (Dec 2010)

ii) What are benefits of ISO:14000 Certification? (8M) (Dec 2011, Dec 2010)2. i) Explain the major clauses of QS9000 standard? (8M) (Jun 2013)

ii)Discuss the benefits of ISO 9000 certification? (8M) (Jun 2013)3. i) Discuss the need for standardization procedures of quality assurance, Explain the

requirements of documentation? (16M) (Jun 2012)ii) Explain the term quality cost? (6M) (Jun 2012)

4. i) Explain the benefits of EMS? (8M) (Dec 2010)ii) Discuss the quality auditing in detail? (8M) (Dec 2010)

5. Discuss in detail the elements of ISO 14000, What are benefits of ISO 14000? (16M)6. Explain the need for documentation and the documents to be prepared for QMS? (16M)

(Dec 20107. i) What are the needs of documentation in quality management system? (4M)

ii)Write a brief notes on Quality auditing in QMS? (4M) (Dec 2010)iii)Discuss various elements of QMS?(8M)

8. Differentiate ISO 9000 and QS 9000. (8M) (Dec 2012)9. Differentiate 9000:14000 (16M) ( Dec 2012)

CONCEPT QUESTIONS1. Describe about quality auditing in your software company.2. Describe about documentation needed in your software company.3. Discuss the benefits of environmental management system in the software.

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