DEPARTMENT OF BIOTECHNOLOGY€¦ · BT6601 Total Quality Management for Biotechnologists Dept. of Biotechnology 2018-2019 2 DEPARTMENT OF BIOTECHNOLOGY COURSE DETAILS Faculty Name

Dept. of Biotechnology 2018-2019 BT6601 Total Quality Management for Biotechnologists

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DEPARTMENT OF BIOTECHNOLOGY

Faculty Name : Dr. D. Yuvaraj

Faculty Code : HTS 981

Subject Name : Total Quality Management for Biotechnologists

Subject Code : BT6601

Year & Semester : III & VI


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DEPARTMENT OF BIOTECHNOLOGY COURSE DETAILS

Faculty Name : Dr. D. Yuvaraj Faculty Code : HTS 1396

Subject Name : TQM Subject Code : BT6601

Department: Biotechnology Year & Semester : III & VI

COURSE OUTCOMES

On completion of this course, the students will be able to

CO No Course Outcomes Knowledge Level

C313.1 Understand the basic concepts of total quality management principles and their

importance in biotech industries K1

C313.2 Discussabout the customer orientation and continuous improvement, supplier selection

and management and practice 5S principles

K2

C313.3 Explain six sigma concept methodology and applications of traditional and modern TQM

tools

K2

C313.4 Describe of advanced TQM tools and techniques in various levels of management K2

C313.5 Understand and implement quality system of ISO auditing in biotechnology industries

with good leadership skills

K2

Mapping of Course Outcomes with Program Outcomes and Program Specific Outcomes

BT6602 PO1 PO2 PO3 PO4 PO5 PO6 PO7 PO8 PO9 PO10 PO11 PO12 PSO1 PSO2 PSO3

PSO4

C313.1 2 - 1 - - - 3 3 - - - 2 - - - -

C313.2 2 - 1 - - 3 3 - - - - 2 - - - -

C313.3 - 2 - - - 3 - - - - 2 1 - - - 3

C313.4 - 2 - - - 3 - - - - 2 1 - - - 3

C313.5 2 - - - - 3 - 2 - - 2 1 - - - 3

BT6602 PO1 PO2 PO3 PO4 PO5 PO6 PO7 PO8 PO9 PO10 PO11 PO12 PSO1 PSO2 PSO3

PSO4

C313 2 2 1 - - 3 3 2 - - 2 3 - - - 3

Mapping Relevancy: 1: Slight (Low) 2: Moderate (Medium) 3 Substantial (High) - : No correlation

K1 – Remember; K2 – Understand; K3 – Apply; K4 – Analyze; K5 – Evaluate; K6 - Create


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UNIT I – INTRODUCTION

Part A

1. Define Quality. (May 2012, May 2015 & 2017)

1. Fitness for intended use. (Joseph Juran). 2. Conformance to specifications. (Philip Crosby). 3. The

totality of features of a product or service that bears on its ability to satisfy a stated or implied need.

2. Define Total Quality Management. (Dec 2011, Nov 2013, May 2015)

1. The art of managing the total organization to achieve excellence in all spheres of activity (Besterfield). 2. The integration of all functions and processes within an organization in order to achieve the continuous

improvement of the quality of goods and services (Omachonu).

3. Mention the basic features of TQM. (June 2013)

1. Management commitment, 2. Focus on customer (both external and internal), 3. Employee

involvement & empowerment, 4. Continuous improvement, 5. Treating suppliers as partners, and

6. Establish performance measures for processes.

4. What are the major benefits of TQM? (Dec 2011 & 2014, May 2016)

Improved quality, higher productivity, employee participation, teamwork, working relationships, customer satisfaction, employee satisfaction, communication, profitability, market share, and stock price performance.

5. What are some major obstacles to TQM implementation? (May 2012)

Lack of management commitment, Inability to change organizational culture, Improper planning, Lack of continuous training and education, Paying inadequate attention to internal and external customers, Inadequate use of empowerment and teamwork, Lack of employee involvement, Emphasis on short-term results, etc.

6. Mention the four pillars of TQM?

Customer satisfaction, continuous improvement, Quality leadership and systems approach.

7. What is Deming’s system of profound knowledge?

Deming advocated that all managers need to have a System of Profound Knowledge, consisting of:

Appreciation of a system: understanding the overall processes involving suppliers, producers, and

customers (or recipients) of goods and services (explained below);

Knowledge of variation: the range and causes of variation in quality, and use of statistical sampling in

measurements;

Theory of knowledge: the concepts explaining knowledge and the limits of what can be known.

Knowledge of psychology: concepts of human nature.

8. What is Zero Defect?

Zero Defects is a management tool aimed at the reduction of defects through prevention. It is directed at

motivating people to prevent mistakes by developing a constant, conscious desire to do their job right the

first time.

9. What is quality planning?

Systematic process that translates quality policy into measurable objectives and requirements, and lays

down a sequence of steps for realizing them within a specified timeframe.

10. What is quality habit? (May 2011)

Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction

and skillful execution; it represents the wise choice of many alternatives.

11. What are the seven deadly diseases?

Lack of constancy of purpose, Emphasis on short-term profits, Evaluation of performance, Mobility of

management, Management by use only of visible figures, with little or no consideration of figures that

are unknown or unknowable, Excessive Medical Costs, Excessive costs of liability.

12. What is quality according to Juran? (Dec 2012)

Juran defines quality as fitness for use in terms of design, conformance, availability, safety and field use.

13. How can quality be quantified?

Quality is mostly subjective but it can be quantified in terms of perceived expectations of the customers

and the actual performance delivered by the product. Q = P / E.


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14. What is quality control?

Quality control (QC) is a procedure or set of procedures intended to ensure that a manufactured product

or performed service adheres to a defined set of quality criteria or meets the requirements of the client

or customer.

15. What are the four absolutes of quality?

(1) Quality means conformance to requirements, not elegance. (2) Quality is achieved by prevention,

not appraisal. (3) The performance standard is zero defects, not acceptable quality levels. Quality is

free. (4) Quality is measured by the price of non-conformance, not indexes.

16. Explain Crosby’s quality vaccine?

There are three main segments in the quality vaccine - determination, education and implementation. 17. What is TQM triangle?

The essence of the total quality management concept is a triangle, each corner being a key point; the

focus on the customer, Continuous improvement, and teamwork.

18. Mention the names of some major contributors to the quality movement.

Edwards Deming, Joseph M. Juran, Philip Crosby, Feigenbaum, Ishikawa, Taguchi, Shingo, Walter

Shewhart, etc.

19. What is Deming Cycle?

P-D-S-A (Plan-Do-Study-Act) cycle of continuous improvement.

20. What are the measure dimensions of service quality? (Nov 2013, June 2013)

Service duration, Timeliness, Completeness, Consistency, Convenience, Accuracy, Courtesy, etc.

21. What are the elements of TQM? (Dec 2014)

Ethics, Integrity, Trust, Training, Teamwork, Leadership, Recognition and Communication.

22. What do you understand by the term cost of quality? (May 2016 & 2017)

Quality costs are defined as costs associated with non-achievement of product/service quality. In simple

terms, quality cost is the cost of poor products/services. All costs associated with poor quality and their

corrections are integrated into one system to enhance the quality management function.

23. What is meant by ‘Cost of quality’?

Quality costs are defined as costs associated with non-achievement of product/service quality. In simple

terms, quality cost is the cost of poor products/services. All costs associated with poor quality and its

correction is integrated into one system to enhance the quality management function.

24. What are the four categories of quality costs?

1. Prevention costs, 2. Appraisal costs, 3. Internal failure costs and 4. External failure costs.

25. What are internal failure costs?

These are costs required to identify, repair, replace, or dispose off defective products/services prior to

delivery to the customer.

Part B

1. Explain the dimensions of quality? (Nov 2011, Dec 2014)

2. Explain the contributions of Crosby to TQM.

3. Write notes on quality cost. (Dec 2006)

4. State and explain the barriers to TQM implementation in an organization. (Dec 2014,May 2017)

5. State the need and importance of maintaining quality in an organization?

6. Explain the contributions of Deming to TQM. (Nov 2013, Dec 2014, May 2015)

7. Explain the basic concepts of TQM? (Nov 2013)

8. Explain the evolution of TQM.

9. Explain the concepts of TQM principles. (June 2009)

10. Explain the dimensions of product quality.

11. Elaborate on TQM frame work and importance of each element. (May 2015)

12. Discuss Juran’s principles of quality management. (May 2016)

13. Explain Deming’s 14 point philosophy for quality improvement. (May 2016)

14. Explain the dimensions of service quality. (May 2017)


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UNIT II – TQM PRINCIPLES

PART A

1. Why should suppliers be treated as partners?

Costs due to inferior materials/components from suppliers increase costs in the later stages of production.

Suppliers themselves are part of the whole system and hence should be treated as long-term partners.

2. What is the ‘Juran Trilogy’ (‘Quality Trilogy’)? (Dec 2011)

The Juran Trilogy (Quality Trilogy) consists of three inter-related processes – quality planning, quality control, and quality improvement – for managing quality.

4. What are the Japanese 5S principles? (Dec 2011) The 5S’s stand for five Japanese words: Seiri, Seiton, Seiso, Seiketsu, and Shitsuke. In English, they mean Sort, Arrange, Clean up, Systematize and Discipline respectively.

5. What are the various quality statements?

The quality statements include the vision statement, mission statement, and quality policy statement.

6. What is a Vision statement?

A short Declaration of what an organization aspires to be in the future. It is an ideal state that an

organization continually strives to achieve. It is timeless, inspirational, and becomes deeply shared

within the organization.

7. What is a Mission statement?

The mission statement answers the following questions: who we are, who are our customers, what we

do, and how we do it. The mission provides the guide map, milestones for achieving the vision.

8. Distinguish between ‘internal customer’ and ‘external customer’.

An external customer exists outside the organization and can be defined in many ways – user, buyer and

influencer. He generally falls into one of three categories: current, prospective, or lost customer. Every

function within the organization – engineering, production, order processing, etc. – has an internal

customer. Every person in a process is considered a customer of the preceding operation. For example,

Manufacturing is a customer for Purchasing, and Dispatching is a customer for Packaging.

9. What is importance of customer retention? (Dec 2014)

It costs a company six times more to sell a product to a new customer than it does to sell to an existing

one. Loyal customers generate more revenue, and are also cheaper to maintain. Customer loyalty

facilitates cross-selling/up-selling of a company’s other products/services, and also acts as an effective

barrier to the entry of competition.

10. Mention some benefits of implementing 5S principles.

5S increases productivity, eliminates waste, reduces inventory, creates a pleasant workplace, improves

safety, and increases the overall efficiency and effectiveness of people and machines.

11. Explain Kaizen. (Dec 2011)

Kaizen, which is a Japanese word that means gradual and orderly continuous improvement, is a

philosophy that covers all business activities and everyone in an organization. In the kaizen philosophy,

improvement in all areas of business – cost, meeting delivery schedules, employee safety and skill

development, supplier relations, new product development, and productivity – serve to improve the

quality of the firm. Thus, any activity directed toward improvement falls under the kaizen umbrella.

12. Explain Supplier Rating. (May 2015)

Supplier rating system (often called a scorecard system) is usually based on quality, delivery, and

service; however, some customers have added other categories, such as lead time, product support,

technology, etc.

13. Define the tools required to implement Kaizen in a manufacturing system. (May 2016)

Plan-Do-Study-Act: PDSA Cycle – First, plan carefully what is to be done. Next carry out the plan (do it). Third, study the results – Did the plan work as intended or were the results different? Finally, act an improved plan and repeat the cycle.

5S – The five S’s for workplace organizations, which are five Japanese words that mean proper

arrangement (Seiko), orderliness (Seiton), personal cleanliness (Seiketso), cleanup (Seiso) and discipline

(Shitsuke).


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14. What is Supplier Partnering? (Dec 2014)

Partnering is a relationship between two or more parties based upon trust, dedication to Common goal.

15. Give any four tips for rating a supplier. (May 2016)

Rate supplier based on quality, delivery and service where quality is given high weightage. In few

cases, product technology and cost can also be included in rating scale

Prepare reports periodically and keep a regular and formal review of a process

Check whether the supplier has a stable management system and agrees to the management

philosophy of the organization

Check for the sincerity of the supplier in implementing the contract provisions and tracking the

customer satisfaction and credibility

16. What is meant by customer retention? (May 2017) Customer retention is the process of retaining the existing customers. Customer retention represents the activities that produce the necessary customer satisfaction that creates customer loyalty.

17. What are the various stage in supplier selection and evaluation?

1. Survey stage, 2. Enquiry stage,

3. Negotiation and selection stage,

4. Experience stage

18. What are the types of sourcing?

1. Sole sourcing, 2. Multiple sourcing,

3. Single sourcing

19. Why does customer rate supplier?

The customer rates supplier in order to:

1. Obtain an overall rating of supplier performance,

2. Ensure complete communication with supplier,

3. Provide each supplier about the details of problems for corrective action and

4. Maintain and improve partnering relationship

20. What are the steps involved in strategic planning process?

1. Customer needs, 2. Customer positioning,

3. Predict the future,

4. Gap analysis,

5. Closing the gap,

6. Alignment and

7. Implementation

PART B

1. What do you mean by customer satisfaction? Explain a customer satisfaction model. (June 2011)

2. Explain all the elements in 5’S principle and also the implementation procedure of 5’S in a

manufacturing company. (Dec 2007, 2011 & 2014 Nov 2013)

3. What are the steps involved in continuous improvement process. (Dec 2011)

4. Write short notes on customer perception of quality (Dec 2010, May 2015 & 2017)

5. Write in detail about Customer complaints (Dec 10, May 2015 & 2017)

6. Name and discuss the different approaches for continuous process improvement. (May 2017)

7. Write short note on: Supplier partnership, Partnering

8. Write short note on supplier selection, supplier rating.

9. What are the different quality statements? Explain their importance in an organization

10. Write notes on customer focus and customer orientation.

11. Write in detail about the following: (i) PDCA Cycle (ii) 5S (May 2016)

12. Design a customer satisfaction questionnaire to evaluate the level of customer satisfaction in the

following industries: (i) Pharmaceutical industry (ii) Biomedical equipment. (May 2016)


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UNIT III – TQM TOOLS AND TECHNIQUES I

Part A

1. List the seven tools of quality. (Dec 2013, May 2015, 2016 & 2017)

1. Check sheets, 2. Histograms, 3. Cause and effect diagrams, 4. Pareto diagrams, 5. Stratification

analysis, 6. Scatter diagrams, and 7. Control charts.

2. What is check sheet?

A check sheet or tally sheet is a form for systematic data gathering and registering to get a clear view of

the facts. A check sheet is used to indicate the frequency of a certain occurrence.

3. Write down the difference between a defect and defective.

An item is said to be defective if it fails to conform to the specifications in any of the characteristics. Each

characteristic that does not meet the specifications is called defect. For example, if a casting contains

undesirable hard sports, below holes, etc., the casting is defective and the hard spots, below holes, etc.,

are the defects.

4. What is six sigma? (Dec 2009)

Six sigma is similar to Zero Defects (ZD), is a philosophical benchmark or standard of excellence

proposed by Philip Crosby. Six sigma strives for perfection. It allows for only 3.4 defects per million

opportunities (or 99.99966 percent accuracy).

5. What is histogram?

A histogram is a bar chart / diagram showing a distribution of variable quantities or characteristics. It is

graphical display of the frequency distribution of numerical data.

6. What is process capability? (May 2011)

Process capability analyses the relationship between two aspects of process like on design specification.

If the specification limit is greater than control limits the process is capable of meeting specification and

if it exceeds is not capable of meeting specifications.

7. What are the various types of histogram?

1. Bell-shaped. 2. Double-peaked.3. Plateau. 4. Comb. 5. Skewed. 6. Truncated.7. Isolated peak

and 8.Edged peak.

8. What is cause and effect diagram?

The cause and effect diagram or Fishbone diagram is a graphical-tabular chart to list and analyze the

potential causes of a given problem.

9. Under what situations, one can use cause and effect diagram?

The cause and effect diagram has unlimited application in research manufacturing, marketing, office

operations, services, etc.

10. What are the measure benefits of six sigma? (Dec 2012)

In addition to a focus on defect, six sigma seeks to improve all aspects of operation. The key matrices include cycle time, process variation and yield.

11. What is Pareto diagram?

A pareto diagram is a diagnostic tool commonly used for separating the vital few causes that account for

a dominant share of quality loss.

12. Differentiate between producer’s risk and consumer’s risk.

Producer’s risk: It is the probability of rejecting a good lot which otherwise would have been accepted.

Consumer’s risk: It is the probability of accepting a defective lot which otherwise would have been

rejected.

13. What are the purposes of pareto principle.

Pareto analysis can be used in a wide range of situations, where one need to priorities problems based

on its relative importance.

14. When do you use the scatter diagram?

The purpose of the scatter diagram is to display what happens to one variable when another variable is

changed.

15. What is scatter diagram? (Dec 2014)

The scatter diagram is a simple graphical device to depict the relationship between two variables.


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16. What is control chart? What are the types of control charts?

A control chart is a graph that displays data taken over time and the variation of this data. Control charts for variables – for measurable data such as time, length, temperature, weight, pressure

Control charts for characteristics- for quantifiable data such as number of defects, typing errors in a

report.

17. What is stratification?

Stratification is a method of analysis of data by grouping it in different ways.

18. When do you use control chart?

The purpose of control chart is to identify when the process has gone out of statistical control, thus

signaling the need for some corrective action to be taken.

19. Define statistics applications of statistical techniques?

Statistics is defined as the science that deals with the collection, tabulation, analysis, interpretation and

presentation of quantitative data.

20. What is Risk Prioritization Number? (May 2012) It is a number used to prioritize the risk of failure in Failure Mode and Effect Analysis. It ranges from 1 to 1000 and it’s the multiplication of severity, detection and occurrence.

21. What are the benefits of benchmarking? (May 2016)

Creating a culture that values continuous improvement to achieve excellence

Sharing the best practices between benchmarking partners

Prioritizing the areas that need improvement

Enhancing creativity by devaluing the not-invented-here syndrome

Increasing sensitivity to changes in the external environment

Shifting the corporate mind-set from relative complacency to a strong sense of urgency for ongoing

improvement

Focusing resources through performance target set with employee unit

22. What does DMAIC convey in Six sigma? (May 2016)

There are five fundamental phases or stages in applying the six-sigma approach for improving

performance in a process: Define Measure, Analyze, Improve, and Control (DMAIC). DMAIC provides

a breakthrough strategy and disciplined methods of using rigorous data gathering and statistically based

analysis to identify sources of errors and ways of eliminating them. These form an improvement cycle

similar to Deming’s Plan, Do, Check, Act (PDCA), to deliver the strategies of process design/redesign,

management and improvement, leading to bottom line achievements.

23. What are the three types of benchmarking? (May 2017)

There are three types of benchmarking namely, 1. Internal benchmarking,

2. Competitive benchmarking and

3. Functional benchmarking

24. What are the reasons for benchmarking? (May 2015)

A good benchmarking review will allow you to determine how well each aspect of your business is

faring, discover areas where you need to improve, and develop a plan for achieving those improvements.

Before you can decide where you are going, you need to know where you are now - and benchmarking

can help you do this.

25. What is matrix diagram?

A matrix diagram is a tool that is used to systematically organize information that must be compared

on a variety of characteristics in order to make a comparison, selection or choice. A matrix diagram

sometimes referred as quality table, is the starting point in building the house of quality.

26. What is an arrow diagram?

An arrow diagram, also known as the activity network is a graphical description of the sequential steps

that must be completed before a project can be completed. The PERT (Program Evaluation and Review

Technique) and CPM (Critical Path Method) charts are the best known arrow diagrams. It is a planning

tool that determines the critical path of a process or a project.


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Part B

1. Explain tools for quality of TQM. (May 2010, Dec 2012)

2. Explain six sigma concepts with example. (June 2013, Dec 2014, May 2015, 2016 &2017)

3. Explain the cause and effect diagram (or) fishbone diagram. (Dec 2014)

4. Explain bench marking and its steps. (Nov 2013)

5. Compare the variable charts and Attribute charts.

6. Explain new seven TQM tools. (May 2008, Dec 2011)

7. Explain PCPC with an example.

8. Explain the failure mode and effect analysis. (May 2015)

9. What are the stages of FMEA? Explain in detail. (May 2017)

10. Detail check sheets, Pareto chart, and Cause & Effect diagram. (Nov 2013)

11. Prepare a FMEA work Sheet for a failure of your choice (May 2015)

12. What is Tree diagram? How is it useful for quality management? (Dec 2014)

13. What is Critical success factor? How is it important in benchmarking?

14. With an example, illustrate how benchmarking can help a system to improve both efficiency and

effectiveness of a system.


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UNIT IV – TQM TOOLS AND TECHNIQUES II

Part A

1. What is quality circle? And its significance (Nov 2013, Dec 2014, May 2017)

QC is a group activity practiced at regular intervals which focuses on quality practices. The significance is rise organizational morale, inspire effective team work, promote job involvement,

create problem solving capacity by themselves, improve communication with the organization etc.

2. What is the structure of Quality Circle?

Executive committee, steering committee, facilitators, QC leader, Deputy Leader, members 5-8%.

3. What are the three stages shown on a Product Life Characteristics Curve?

The curve consists of three distinct stages: Early failure (‘infant mortality’ or ‘debug’), useful life

(‘normal failure’ or ‘chance’) and wear out (‘old age’) failure. The curve shows that the failure rates are

higher at the early and end stages of a product’s life and relatively low in between the two extremes.

4. What is the usefulness of the Product Life Characteristics Curve?

Knowing the product life characteristics curve for a particular product helps engineers predict failure

behavior and take suitable decisions.

5. What is the essential feature of Total Productive Maintenance (TPM)? (Nov 2013) TPM is keeping plant and equipment at their highest productive level through cooperation of all areas of the enterprise. TPM brings maintenance into focus as a necessary and vital part of the business. It is not regarded as a non-profit activity. Down time for maintenance is scheduled as an integral part of the manufacturing process.

6. What are the overall goals of TPM? (Dec 2008)

The overall goals of TPM are: Maintaining and improving equipment capacity, Maintaining equipment

for life, Using support from all areas of operation, Encouraging inputs from all employees, Using teams

for continuous improvement.

7. What is meant by house of quality?

It is the first area in QFD process, it is used to translate VOC in to design requirement in order to ensure

that all engineering decisions have the basis to meet the customer needs.

8. What are the steps used to build house of quality?

To identify customer needs, technical features, relate both, conduct evaluation of competing products,

determine which characteristics to display in production process.

9. What are the three categories of losses identified in TPM?

(A) Losses that impede equipment efficiency (B) Losses that impede human work efficiency and

(C) Losses that impede effective use of production resources.

10. What are the eight pillars of TPM?

The eight pillars of TPM are: [1] 5S,

[2] Jishu Hozen (Autonomous Maintenance),

[3] KobetsuKaizen (KK),

[4] Planned Maintenance (PM),

[5] Quality Maintenance (QM),

[6] Training,

[7] Office TPM, and [8] Safety, Health and Environment.

11. What is Office TPM?

Office TPM is aimed at improving quality, productivity and efficiency in the administrative functions

and identifying and eliminating losses.

12. What is Business Process Reengineering (BPR)?

The fundamental rethinking and radical redesign of business processes to improve performance

dramatically in terms of measures like cost, quality, service, and speed.

13. What is Taguchi’s Loss function? (May 2012 & 2015) The essence of the loss function concept is that whenever a product deviates from its target performance


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it generates a loss to society. This loss is minimum when performance is right on target, but it grows gradually as one deviates from the target.

14. Give Taguchi’s definition of quality.

“Loss imparted to society by a product during its life cycle”, i.e. the costs incurred in the production

process as well as the costs encountered during use by the customer.

15. What is voice of customer?

It is the requirements of the customers in a product and the requirements are described by them in their

own words.

16. What are the performance measures of TQM?

Customer orientation, value based operations, performance compatibility, teamwork, development

monitoring.

17. What is QFD?

Quality function development may be defined as a system for translating consumer requirements into

appropriate requirements at every stage, from research through product design and development, to

manufacture, distribution, installation and marketing, sales and service.

18. What is Poka Yoke?

Poka Yoke is Mistake proofing. Humans tend to make mistakes. Designing the product with the ability

to alarm or inform the humans that their handling is wrong.

19. What is the use of prioritization Matrices? (Dec 2014)

Helps prioritize complex or unclear issues when there are multiple criteria for determining importance

Provides a quick and easy, yet consistent, method for evaluating options

Takes some of the emotion out of the process

Quantifies the decision with numeric rankings

Is adaptable for many priority-setting needs (projects, services, personal, etc.)

When used with a group of people, it facilitates reaching agreement on priorities and key issues

20. What performance measures would you suggest for airline passenger service? (Dec 2014)

The suggested Performance measures are : Getting to and from the airport, ease of access Public

transport options, efficiency and price, Taxi availability and prices, Availability of luggage trolley,

Terminal comfort, ambiance and general design and appearance, Seating facilities through terminal,

Immigration-queuing time and system for departure and arrival, Waiting time at security screening.

21. State the concept of quality loss function. (May 2017)

The loss imparted by the product to the society from the time the product is shipped. This loss includes loss to operate, failure to function, maintenance and repair costs, customer dissatisfaction,

injuries caused by poor design etc.

22. What are the Different Parameters used for quality performance measures? (May 2015)

Human resource: Employee turnover number, Employee satisfaction index, Training cost per employee. Customers: Number of complaints from customers, Warranty data, Dealer satisfaction

Production: Inventory, Amount of scraps / rework, Machine down time

R&D: New product time to market, Design change orders, Cost estimating errors

Suppliers: On-time delivery, Service rating, Quality performance

Marketing or sales: Sales expense to revenue, new product sales to total sales, new customers.

Administration: Revenue per employee, Billing accuracy, Cost of poor quality.

23. What are Quality Circles (QC)?

QC is a small team of people (around 8 to 10) coming from the same work area/department who

voluntarily meet on a regular basis (about an hour every week) to identify, investigate, analyze and solve

work-related problems. QC can be viewed from three angles: (i) as a form of participative management,

(ii) as a HRD technique, and (iii) as a problem-solving technique.

24. What are the roles assigned to people in Quality Circles?

The QC organization has a four-tier structure consisting of Members, Leaders, Facilitators, and Steering

Committee.

25. Mention some major objectives of Quality Circle projects.

1. Improve quality and productivity. 2. Cost reduction.


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3. Effective utilization of resources.

4. Avoid unnecessary errors, defects.

5. Solve work-related problems that interfere with production, etc.

26. Explain the quality circle forum of India. (May 2016)

Quality Circle Forum of India functions as a common forum for discussion and dissemination of

information related to Quality Circle and other quality concepts as part of TQM and assist both

individuals and organizations to launch and operate Quality Circles integrated with TQM. The mission

is to impart training, knowledge and practice of Quality concepts and philosophy with special attention

to Quality Circles in the organizations and enable people of our nation to face challenges and achieve

success in this fierce competitive world, to disseminate, share and keep abreast in the knowledge of

Quality concepts and to create Total Quality People.

PART B

1. Explain about Taguchi’s Quality Loss Function. (June 2013, Dec 2014, May 2012)

2. Highlight the benefits of QFD. (May 2012)

3. Briefly explain the steps involved in QFD (Nov 2012 & 2013)

4. Explain each section of the basic structures of house of quality. (May 2010, June 2013)

5. Discuss objectives of quality function deployment.

6. Explain about TQM philosophy. (Dec 2011 & 2012)

7. What are quality circles? Explain the structure of quality circles with its relative merits.

8. Explain the types and the analysis techniques of cost of quality. (June 2013)

9. With an example, draw QFD chart and explain. (Nov 2013, Dec 2014,May 2015)

10. Explain in detail performance measures used in industries. (Dec 2014)

11. Explain the Pillars of TPM and its benefits (May 2015)

12. Write down a methodology for QFD for the design and development of hot and cold beverages from a

vending machine. (May 2016)

13. What are the concepts of TPM, What are the methods for improvement and how would you measure the

performance? (May 2016)

14. Explain the Quality Function Deployment with suitable example. What are the advantages and

disadvantages of QFD? (May 2017)

15. Explain the types of Total Productive Maintenance techniques. (May 2017)


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UNIT V – QUALITY SYSTEMS

Part A

1. What are the general requirements of quality management system? (Dec 2011) The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.

2. What are ISO 9000 quality standards? (June 2007, Nov 2013, Dec 2014) ISO 9000 are a set of quality standards aimed at promoting the growth of international trade by facilitating harmonious interactions between suppliers and customers located in diverse locations globally. It is a quality management system [QMS] to ensure quality of products and services.

3. Define Quality Management Systems?

Quality management systems are the organizational structures, responsibilities, processes, procedures,

and resources used for implementing quality.

4. Give any five elements of ISO 9000.

[1] Management responsibility, [2] Quality system, [3] Contract review, [4] Design control, [5] Document

control, [6] Purchasing, [7] Purchaser supplied product, [8] Product identification and traceability, [9]

Process control, [10] Inspection & testing

5. Define quality system audit. (May 2010)

Quality system audits is a systematic, independent examination to determine whether quality activities

and results comply with planned arrangements, whether these arrangements are implemented effectively,

and whether these are suitable to achieve objectives.

6. What are the different types of audit?

First party audit (internal),

Second party audit (by customer), and

Third party audit (by independent agency).

Another classification: System audit, Process audit, Product audit, Adequacy audit, and Compliance

audit.

7. Draw the documentation pyramid. (Dec 2011)

8. What are the different types of documents found in ISO 9000?

1) Quality Policy Manual (What? Why?) 2) Quality System Procedures (Who? When? Where?)

3) Work Instructions (How?) 4) Records, formats, forms (Evidence)

9. What are the eight quality principles underlying ISO 9000: 2000?

[1] Customer focus, [2] Leadership, [3] Involvement of people, [4] Process approach, [5] System

approach to management, [6] Continuous improvement, [7] Decisions based on facts, and

[8] Mutually beneficial supplier relationships.


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10. What are the different stages in conducting quality audit?

1. Audit planning – schedules, personnel, notifications, checklist. 2. Performance – opening meetings, audit process, noting of non-conformities.

3. Reporting – Observations, suggestions for corrective action 4. Follow-up – implementation of corrective action.

11. What are the quality function needs served by the computer?

[1] Data collection, [2] data analysis and reporting, [3] statistical analysis, [4] process control, [5] test

and inspection, and [6] system design

12. What are the documentation requirements of quality management systems?

The quality management system documentation shall include

a) documented statements of a quality policy and quality objectives,

b) a quality manual

c) documented procedures and records required by this International Standard, and d) documents, including records, determined by the organization to be necessary to ensure the effective

planning, operation and control of its processes.

13. What is quality manual?

The organization shall establish and maintain a quality manual that includes

a) the scope of the quality management system, including details of and justification for any exclusions

b) the documented procedures established for the quality management system, or reference to them, and

c) a description of the interaction between the processes of the quality management system.

14. Explain the management’s responsibility for ISO.

Top management shall provide evidence of its commitment to the development and implementation of

the quality management system and continually improving its effectiveness by a) communicating to the

organization the importance of meeting customer as well as statutory and regulatory requirements, b)

establishing the quality policy, c) ensuring that quality objectives are established, d) conducting

management reviews, and e) ensuring the availability of resources.

15. What is the need for ISO standards?

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.

16. What is third party audit? (Dec 2010)

The third party certification audit is carried out much in the same way as first party and second party

quality system assessments and audits. However, the big difference is that an independent accredited

auditing body carries out the assessment and audit, as opposed to carrying it out by the organization

themselves.

17. Give the objectives of internal audit.

a) Determine the actual performance conforms to the documented quality systems.

b) Initiate corrective action activities in response to deficiencies.

c) Follow up on noncompliance items of previous audits.

d) Provide continued improvement in the system through feedback to management.

18. What is Environment Management Systems Standards? (Dec 2014)

An EMS meeting the requirements of ISO 14001:2004 is a management tool enabling an organization of any size or type to:

1. Identify and control the environmental impact of its activities, products or services, and to

2. Improve its environmental performance continually, and to

3. Implement a systematic approach to setting environmental objectives and targets, to achieving

these and to demonstrating that they have been achieved.

19. What are the benefits of ISO 14001?

• Facilitate trade and remove trade barriers

• improve environmental performance of planet earth • Build consensus that there is a need for environment management and a common terminology for

EMS.


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20. What is QS 9000 and who have developed the system? (June 2013, May 2017) QS 9000 is an extension of ISO 9000 and is only for automotive industries, this was developed by three big industries like Ford, Chrysler and General Motors in 1994.

21. List the various clauses of ISO 9000-2000 standard

Scope, Normative reference, Terms and condition, General requirement, Documentation requirement,

Management responsibility, management commitment, customer focus, quality policy, planning,

responsibility, Authority and communication, Management review

23. What is motivation?

Scott defines motivation is the process of stimulating people to accomplish desired goals.

24. What is meant by empowerment? (Dec 2012)

Empowerment means entrusting people with authority and responsibility

25. Distinguish between Reward and Recognition. (Dec 2010)

Creating incentives for suppliers is one way to ensure that they remain committed to a quality

improvement strategy. Incentives may be in the form of a preferred supplier category with its rewards.

Recognition may be in the form of publication of outstanding contributions in the customer’s newsletter,

a letter of commendation, or a plaque.

26. Why is teamwork a fundamental element of total quality? (May 2016)

Teamwork enables various parts of the organization to work together in meeting customer needs, promote equality among individuals, encourage a positive attitude and trust, provide unique perspective on work, spontaneous thought, and creativity and develop a greater sense of responsibility for achieving goals and performing tasks.

27. What are the Benefits of Team Work? (May 2015)

1. Improved solutions to quality problems. 2. Improved ownership of solutions.

3. Improved communications.

4. Improved integration.

28. Mention the characteristic of a leader

Customer first, value people, build supplier partnership, empower people, demonstrate involvement,

strive for excellence, explain and deploy policy, improve communication, promote team work,

benchmark continuously, establish system, encourage collaboration.

29. What are the general benefits of employee involvement? (May 2017) Employee involvement increases the employee commitment to their organizational and departmental

objectives. It improves the quality and productivity at all levels of an organization.

PART B

1. Explain the elements of ISO 9000 standards. (Dec 2012,2013 & 2014)

2. Discuss about implementation of ISO 9000. (Dec 2012)

3. Explain documentation in quality standard. (May 2011, Dec 2014 & 2015)

4. Explain Quality Audits in detail. (Dec 2011, May 2015 & 2017)

5. Explain ISO 14000 environmental standards. (Nov 2013, May 2015)

6. Explain the benefits of ISO 9000. (June 2013, Dec 2014)

7. Explain in detail about Environment Management Systems and the benefits of EMS. (May 2012)

8. Discuss about implementation requirements of ISO standards to IT industries. (May 2012)

9. Explain the different types of Teams, List the characteristics of successful team and explain the various

steps involved in developing a team (Dec 2012 & 2014, Nov 2013)

10. Write about the system of recognition and reward followed in an organization. (Dec 2011)

11. Explain in detail the concept of employee involvement and employee empowerment. (May 2015)

12. Define motivation and explain any two theories of motivation. (May 2015)

13. Discuss the need for standardization procedures for quality assurance. Explain the requirements of ISO

system of documentation. (May 2016)

14. Differentiate between ISO 9000 and QS14000. List the benefits that a firm would enjoy by implementing

these series of quality documentation processes. (May 2016)

15. What are the characteristics of empowered employee? And also discuss the benefits of empowered environment. (May 2017)

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