Unit No.

QUALITY
MANAGEMENT
Definition
Gurus of TQM
 The Americans who went to Japan
 W Edwards Deming placed great importance and
responsibility on management, at both the individual
and company level, believing management to be
responsible for 94% of quality problems.

 His 14 point plan is a complete philosophy of

management, that can be applied to small or large
organizations in the public, private or service sectors:

1. Create constancy of purpose for improvement of product and service.

Allocate resources to provide for long range needs rather than only
short term profitability.
2. Adopt the new philosophy. We can no longer live with commonly
accepted levels of delays, mistakes, defective materials, and
defective workmanship.
3. Cease dependency on mass inspection to achieve quality. Quality is
achieved by building quality into the product in the first place.
4. End the practice of awarding business on the basis of price tag alone.
 The aim is to minimize total cost, not merely initial cost. Establish long
term relationship with suppliers to develop loyalty and trust.

5. Improve constantly and forever every process for planning, production,

and service. It is management’s job to work continually on improving
total system.

6. Institute training on the job for all, including management, to make

better use of every employee. New skills are required to keep up with
changes in products and processes.

7. Adopt and institute leadership aimed at helping people do a better job.

Management must ensure that immediate action taken on issues that
are detrimental to quality.

8. Drive out fear so that everybody may work effectively and more
productively for the company.

9. Break down barriers between departments and staff areas. Everyone

must work together to tackle problems that may be encountered with
10.Eliminate slogans and exhortations for the work force as they
create adversarial relationships. Also, bulk of the causes of low
quality & productivity belong to the system and lie beyond the power
of the work force.

11.Eliminate arbitrary numerical targets for the workforce and

management. Substitute aids and helpful leadership in order to
achieve continual improvement.

12.Remove barriers that rob people of pride of workmanship. This

includes the annual appraisal of performance and Management by
Objective.

13.Encourage education. Institute a vigorous program of education and

self-improvement for everyone

14.Clearly define top management’s permanent commitment to ever

improving quality and productivity. Put everybody in the company to
work to accomplish the transformation. Support is not enough,
action is required.
 Deming also encouraged a systematic approach to problem solving
and promoted the widely known Plan, Do, Check, Act (PDCA) cycle.

 The PDCA cycle is also known as the Deming cycle, although it was
developed by a colleague of Deming, Dr. Shewhart.
 Dr Joseph M Juran developed the quality trilogy – quality planning,
quality control and quality improvement.

 Good quality management requires quality actions to be planned out,

improved and controlled.

 The process achieves control at one level of quality performance,

then plans are made to improve the performance on a project by
project basis, using tools and techniques such as Pareto analysis.

 This activity eventually achieves breakthrough to an improved level,

which is again controlled, to prevent any deterioration.
Juran’s ten steps to quality improvement are:

 Build awareness of the need and opportunity for

improvement
 Set goals for improvement
 Organise to reach the goals
 Provide training
 Carry out projects to solve problems
 Report progress
 Give recognition
 Communicate results
 Keep score of improvements achieved
 Maintain momentum
Armand V Feigenbaum

He was the originator of “total quality control”, often

referred to as total quality.

Quote: “Quality is everybody’s job, but because it is

everybody’s job, it can become nobody’s job without the
proper leadership and organization.”

He proposed three steps to quality:

 Quality leadership
 Modern quality technology
 Organizational commitment
Dr. Kaoru Ishikawa

 Known as father of Japanese quality control effort.

 Established concept of Company Wide Quality Control (CWQC)
– participation from the top to the bottom of an organization
and from the start to the finish of the product life cycle.
 Started Quality Circles – bottom up approach – members from
within the department and solve problems on a continuous
basis.
 The fishbone diagram is also called Ishikawa diagram in his
honor.
He promoted the use of Quality Circles to
(1) Support improvement
(2) Respect human relations in the workplace
(3) Increase job satisfaction
(4) More fully recognize employee capabilities and utilize their
ideas

Seven Basic Tools of Quality

Pareto Analysis Which are the big problems?
Cause and Effect Diagram What causes the problems?
Stratification / Classification How is the data made up?
Check Sheets How often it occurs or is done?
Histograms What do overall variations look like?
What are the relationships between
Scatter Charts
factors?
Process Control Charts Which variations to control and how?
Dr. Genichi Taguchi

 The Taguchi method of quality control is an approach to

engineering that emphasizes the roles of research and
development (R&D).
 Genichi Taguchi, considers design to be more important
than the manufacturing process in quality control,
seeking to eliminate variances in production before they
can occur.
 Companies such as Toyota, Ford, Boeing, and Xerox have
adopted this method.
TQM Framework

Total Quality Management (TQM)

 is a management framework  based on the belief that
 an organization can build long-term success
 by having all its members, from low-level workers to its
highest ranking executives
 focus on improving quality and, thus, delivering
customer satisfaction.
 Historical Review of Quality Management

 In 1924, W.A Shewhart of Bell Telephone Laboratories developed

a statistical chart of the control of product variables.
 This chart is considered to be the beginning of statistical quality
control.

 H.F. Dodge and H.G Roming, both of Bell Telephone Laboratories,

developed the area of acceptance sampling as a substitute of
100 per cent inspection.

 Recognition of the value of statistical quality control became

apparent by 1942.

 In 1946, the American Society for quality control was formed.

Recently the name was changed into American Society for
Quality (ASQ).
Evolution of Total Quality Management

 In 1950’s W. Edwards Deming emphasized about the

management’s responsibility to achieve quality.

 In 1960’s the first quality control circle were formed for

the purpose of quality improvement.

 In the late 1980’s the automotive industry began to

emphasize statistical process control.

 After 1990’s the ISO became the model for a quality

management system worldwide.
Evolution of Total Quality Management

 1900: Quality was controlled by the operator.

 1925: With more advanced assembly line and mass

production, quality became the responsibility of a
foreman.

 1950: There came a separate inspection department,

which was responsible for quality.

 1970: Use of Statistical quality control tools for

controlling quality became popular.

 1985: Concept of Total Quality control introduced.

 Benefits of TQM-1
1) Strengthened competitive position
2) Adaptability to changing or emerging market conditions
and to environmental and other government regulations
3) Higher productivity
4) Enhanced market image
5) Elimination of defects and waste
6) Reduced costs and better cost management
7) Higher profitability
 Benefits of TQM-2
8) Improved customer focus and satisfaction
9) Increased customer loyalty and retention
10) Increased job security
11) Improved employee morale
12) Enhanced shareholder and stakeholder value
13) Improved and innovative processes
 Unit-2 Statistical Process Control A) Pareto Diagram / Pareto Analysis
 A Pareto chart is a bar graph.

 Pareto diagram  The lengths of the bars represent frequency or cost (time or money), and
are arranged with longest bars on the left and the shortest to the right.
 Process flow diagram
 In this way the chart visually depicts which situations are more significant.
 Cause and- effect diagram

 Histograms

 Scatter diagrams
 Statistical fundamentals
 Control charts for variables
 Control charts for attributes

Problem: System Weight is over specified limit

When to Use Pareto Diagram / Pareto Analysis

 When analyzing data about the frequency of problems or causes in  Trying to reduce weight on every feature would take large
a process amounts of time and be ineffective.

 When there are many problems or causes and you want to focus on  Use Pareto Analysis to identify to most important features to
the most significant concentrate on.
 When analyzing broad causes by looking at their specific
components .
Step 1
- Order components from heaviest to least in terms of percentage.
Step 2-8
- Calculate the cumulative percentage.

No. C o mponent % of Weight C u m. %

1 Battery 18 18
2 Base 16.2 34.2
3 Wheel Assembly 14.4 48.6
4 Cylinders 12.9 61.5
5 Motor 11.7 73.2
6 Pump 9 82.2
7 Handle 7.2 89.4
8 Fluid 3.8 93.2
9 Valves 2.7 95.9
10 Hose 1.8 97.7
11 Fittings 1.4 99.1
12 Reservoir 0.9 100

Conclusion B) Process Flow Diagram /Flow Chart

To effectively reduce weight the key features to analyze are:

– Battery
– Base Basic Flow Chart
– Wheel Assembly
– Cylinders
– Motor

Detailed Flow Chart

 Introduction When To Use A Flowchart ?
 A flowchart is a picture of the separate steps of a process in sequential
order.  To develop understanding of how a process is done

 To study a processfor improvement

 It is a tool that can be adapted for a wide variety of purposes, and can be
used to describe various processes, such as a manufacturing process, an  To communicate to others how a process is done
administrative or service process, or a project plan.  When better communication is needed between people involved
with the same process
 It is a common process analysis tool.
 To document a process
 Elements that may be included in a f lowchart are a sequence of actions,
materials or services entering or leaving the process (inputs and outputs),  When planning a project
decisions that must be made, people who become involved, time involv ed
at each step, and/or process measurements.

Commonly Used Symbols In Detailed Flowcharts

Flowchart Basic Procedure
Symbols Information
One step i n the pr oc ess. The s tep is written i nside the box.
1) Define the process to be diagrammed. Write its title at the top of Usually, only one arrow goes out of the box.
the work surface.
2) Discuss and decide on the boundaries of your process: Where or Direction of flow from one step or decision to another.
when does the process start? Where or when does it end? Discuss
and decide on the level of detail to be included in the diagram. Decision bas ed on a questi on. T he q ues tion is written in the
diamond. More than one arrow goes out of the diamond, eac h
3) Brainstorm the activities that take place. Write each on a card or one s howi ng the dir ection the process takes for a given ans wer
sticky note. to the question. (Often the answers are "yes" and "no.")

4) Arrange the activitiesin proper sequence.

Delay or wait
5) When all activities are included and everyone agrees that the
sequence iscorrect, draw arrowsto show the flow of the process.
Link to another page or another flowc hart . The same s ymbol on
6) Review the flowchart with others involved in the process (workers, the other page indicates that the flow continues there.
supervisors, suppliers, customers) to see if they agree that the
process isdrawn accurately Input or output
 Commonly Used Symbols In Detailed Flowcharts

Symbols Information

Document

Alternate symbols for start and end points

C) Cause and - Effect Diagram/ Fishbone Diagram Introduction

 A cause and effect diagram examines why something happened or

might happen by organizing potential causes into smaller
categories.

 It can also be useful for showing relationships between contributing

factors.

 One of the Seven Basic Tools of Quality, it is often referred to as a

fishbone diagram or Ishikawa diagram.

 The completed diagram ends up looking like a fish's skeleton with

the fish head to the right of the diagram and the bones branching
off behind it to the left.
 Example-Manufacturing Industry Creating Cause and Effect Diagrams

 Identify the problem

 Def ine the process or issue to be examined.

 Brainstorm
 Discuss all possible causes and group them into categories.

 Draw the backbone

 Once the topic is identified, draw a straight, horizontal line (this is called
the spine or backbone) on the page, and on the right side, draw a
Methods / Machines / Materials / Measurements / rectangle at the end.
Environment / Manpower  Write a brief description of the problem in the rectangle.

Creating Cause and Effect Diagrams

 Add causes and effects
 Causes are added with lines branching off from the main backbone at an
angle.
 Write the description of the cause at the end of the branch.
 These are usually one of the main categories discussed above.
 Details related to the cause or effect may be added as sub-categories
branching off further from the main branch.
 Continue to add branches and a cause or effect until all factors have
been documented.
 The end result should resemble a f ish skeleton.

 Analyze
 Once the diagram has been completed, analy ze the information as it
has been organized in order to come to a solution and create action
items.
 Check Sheets / Defect Concentration Diagram Check Sheet Procedure

1. Decide what ev ent or problem will be observ ed. Dev elop operational
def initions.

2. Decide when data will be collected and f or how long.

3. Design the f orm.

4. Set it up so that data can be recorded simply by making check marks

or X's or similar sy mbols and so that data do not hav e to be recopied
f or analy sis.

5. Label all spaces on the f orm.

• A check sheet is a structured, prepared form for collecting and
analyzing data. 6. Test the check sheet for a short trial period to be sure it collects the
appropriate data and is easy to use.
• This is a generic data collection and analysis tool that can be
7. Each time the targeted ev ent or problem occurs, record data on the
adapted for a wide variety of purposes. check sheet.

Histogram
 What is a Histogram ? Example
Age Data
 A histogram is a plot that lets you discover, and show, the 36 25 38 46 55 68 72 55 36 38
underlying frequency distribution (shape) of a set 67 45 22 48 91 46 52 61 58 55
of continuous data.
Construct a Histogram
 This allows the inspection of the data for its underlying  Largest value = 91
distribution (e.g., normal distribution), outliers, skewness,  Smallest value = 22
etc.  Range of values = (91-22) = 69
 Determine the number of intervals required.

Choosing The Correct Bin Width

 You need to make sure that the bins are not too small or too large.
 Types of Histogram

Scatter Diagram Example

No. of Student Marks obtained
(out of 100)
12 40-50
10 50-60
8 60-70
7 70-80
5 80-90
2 90-100
 Draw this graph with two variables. The first variable is independent and the
second variable depends on the first.
 This diagram is used to find the correlation between these two variables, how
they are related.  From the shape of the curve, clearly,
only a fewer number of students get
 After determining the correlation, you can then predict the behavior of the high marks.
dependent variable based on the measure of the independent variable.
 A scatter chart is useful when one variable is measurable and the other is not.  This implies a negative correlation
between the two variables
 Types of Pattern Types of Pattern
Low Degree of P ositive Correlation Low Degree of Negative Correlation
P erfect P ositive Correlation P erfect Negative Correlation

High Degree of Positive Correlation High Degree of Negative Correlation

No Correlation

Statistical Fundamentals -Introduction

1. In business, decisions need to be taken based on data.

2. Statistical thinking guides decision making based on the analysis of
data.
3. Many companies have a lot of data but don't knowto turn their data
into useful and actionable information.
4. However, companies that make the best use of their available data
achieve a competitive advantage by optimizing their operations and
making superior decisions.
 Statistical Fundamentals -Introduction Statistical Fundamentals
5. It is allthe more imperative for quality
professionals to examine the best
practices in statics for quality
engineering to improve the
performance of their current system.
6. To focus on continual improvement, 9. Statistics are tools that help in analyzing data, making summaries,
companies must make a shift from drawing inferences and generalizing from the data.
control-oriented management to
statistical quality control. 10. Statistics are highly crucial in the field of quality.

7. They must emphasize statistics rather 11. Learning how to develop different statistical charts and statistical
techniques is crucial.
than application.
12. However, learning how to apply those techniques in a way that will
8. They must collect data and make document and stimulate continual improvement of the organization is
faster decisions based on data even more important.

• Statistical thinking is a skill that is displayed by the ability to Process Variation

make decisions based on data.
• All processes display variation.
• Such thinking is based on three concepts as shown in the
figure below: • There is some variation that can be controlled and others that
cannot be controlled.
• If the variation is too high, the process parts will not fit in
properly, the product will be defective, and the company's
reputation for quality will be at stake if corrective actions are
not taken.

Fundamentals of Statistics for Quality Improvement

• There are two types of variations that occur commonly viz.
Process Stability
random and nonrandom variation.  When a process performs consistently over time, then the process is
considered to be stable or in control.
 Process stability refers to the steadiness of the process with regard to
critical process characteristics such as the average value of a key
dimension or the variation in that key dimension.
 The process stability is determined by using process charts.
 Process charts are charts that signal the process personnel when a
nonrandom variation occurs in a process.

Sampling Methods Planning For Inspection

• Data are gathered in samples to ensure the stability of the process. • T he type of sampling
• Sampling methods are preferred and are better established because • T he personnel who will sample
they are cost-effective, less intrusive, fast, and their destructive • T he persons for the use in-process inspection sample size
testing features. • T he critical attributes to be inspected
– Random Sampling: Randomization ensures independence • T he location for the inspection
among observations.
– Systematic Samples: Systematic samples according to time or
according to sequence
– Sampling by Rational Subgroup: a group of data that is
logically homogenous; variation within the data can provide a
measure for setting limits on the standard variation between
subgroups.
 Process Control Charts Control Chart
 The control chart is a graph used to study how a process changes over time.
 "A control chart is a statistical tool used to distinguish between
 Data are plotted in time order.
variation in a process resulting from common causes and variation
resulting from special causes.  A control chart always has a central line for the average, an upper line for the
upper control limit, and a lower line for the lower control limit.
 These lines are determined from historical data.
 It presents a graphic display of process stability or instability over
time."  By comparing current data to these lines, you can draw conclusions about
whether the process is in control or out of control, affected by special causes of
variation.

Use A Control Chart………when Types of Control Charts

 When controlling ongoing processes by finding and correcting
problems as they occur. 1 .Control Charts for Variables
 When predicting the expected range of outcomes from a process.  Variable data are data that can be measured on a continuous
 When determining whether a process is stable (in statistical scale such as a thermometer, a weighing scale, or a tape rule.
control).
2 . Control Charts for Attributes
 When analyzing patterns of process variation from special causes
(non-routine events) or common causes (built into the process).  Attribute data are data that are counted, for example, as good
 When determining whether your quality improvement project or defective, as possessing or not possessing a particular
should aim to prevent specific problems or to make fundamental characteristic.
changes to the process.
 Control Charts for Variables
X- bar chart
 The mean or average change in process over time from subgroup
values.
 The control limits on the X-Bar brings the sample’s mean and
center into consideration.

R - chart
 The range of the process over the time from subgroups values.
 This monitors the spread of the process over the time.

X-Bar Chart & R-Bar Chart

 Example
 In a manufacturing industry the
plate thickness is one of the
important CTQ (Critical To
Quality) factor

 In Analyze phase collected 20 sets

of plate thickness samples with a
subgroup size of 4.

In the above example n=4

 Process Out of Control
The various reasons for the process being out of control may be

(i) Faulty tools

(ii) Sudden significant change in properties of new materials in a
new consignment
(iii) Breakdown of lubrication system
(iv) Faults in timing of speed mechanisms etc.
 Possible Alternatives
(a) R e-evaluate the specifications.
Whether the tight tolerances are actually needed or they
can be relaxed without affecting quality.

(b) If relaxation in specifications is not allowed

Then a more accurate process is required to be selected.

(c) If both the above alternatives are not acceptable

Then 100% inspection is carried out to trace out the
defectives.

Control Charts for Attributes

 In manufacturing, sometime it is required to control burns,

cracks, voids, dents, scratches, missing and wrong components,
rust etc.
 We inspect products only as good or bad but not how much good
or how much bad.

 These products are inspected with GO and NOT GO gauges.

 Again under this type also, our aim is to tell that whether
product confirms or does not confirm to the specified values.

 Quality characteristics expressed in this way are known as

attributes.
 Types of Attribute Charts Attribute Chart to Use for Defects or Defectives

There are four types of Attribute Charts

 p Charts (proportion charts)

 np Charts
 C Charts
 u Charts

Attribute Charts for Defective Items (P-Chart)

Type of What Kind
What Gets
Attribute of Sample Type of Data Used
Displayed?
Chart Size?  Maximum Percent
Defective is -7%
% of Samples in
Constant or happens/ does not
P which something  Total Number of Samples
Varying size happen
happens Inspected is – 20.
# times something happens/ does not
NP Constant size
happens happen
has a condition On graph paper.
#
OR
C times t otal something Constant size  Make abscissa (X – axis)
has more than one
happens for samples number
condition
1, 2, 3, up to 20.
has a condition
% of total in which Constant or OR  Make ordinate (Y-aixs)
U
something happens Varying size has more than one as percent defective so
condition as to accommodate 7%.
 What is np Chart ?
 The np chart is for the number of defective items in a sample.

 This chart shows the number of nonconforming.

 The number of defective, np, chart shows the number of defective

items in samples rather than the fraction of defective items.
 It requires that the sample size remainsconstant.
 CL - 10.88 % LCL- 1.54 % UCL- 20.22%

NP Chart-2020
272 25
P bar = 2500 = 0.1088
21
NP bar = 0.1088 × 100 = 10.88 % 20
20

16

Defective Item
15 14

12 12 12
11 11 11 11 11 11
= 10.88 – 3 10.88(1 − 0.1088) 10
10 10 10 10 10
9 9
= 1.54
7
6 6 6 6

= 10.88 + 3 10.88(1 − 0.1088)

= 20.22 0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
Sample No.

ത = 112 /100 × 25 = 112 = 0.0448

𝑃
2500

UCL np = 4.5 + 3 4.5 1 − 0.0448

= 10.71

LCL np = 4.5 – 3 4.5 1− 0.0448

= - 1.71
 C-Chart
 A c-chart is a type of control chart used to monitor the
total number of nonconformities when measuring
subgroups at regular intervals from a process.

 Each point on the chart represents the total number of

nonconformities in a subgroup.

u-Chart
 When the sample size varies due to some reason, such as
machinery, raw material, workers, etc., the u-chart is constructed
to monitor the number of defects per unit.

 The procedure for drawing the u-chart for variable sample size is
similar to the c-chart with constant size.

 The primary difference between the c-chart and u-chart is that

instead of plotting the number of defects per sample, we plot the
number of defects per item/unit and monitor them.
 Method No.1
Example
Twenty samples of carpets are inspected for varying sample size and the
number of defects in each sample is noted in the following table:

Since the number of defects is given for varying sample size, we

use the u-chart.
2 Approaches/Methods to solve this problem

Method No.2

 We observe that the point corresponding to sample 13 lies

outside the upper control limit.

 Therefore, the process is not under statistical control with

respect to the number of defects per carpet.
 Difference Between U and C Charts

 The main difference between U and C charts is the vertical

scale.
 U charts show the number of nonconformities per single unit
on the y-axis.
 C charts show the number of nonconformities per sample,
which can include more than one unit on the y-axis.

Summery of Chart Formula

 Unit 3 Content
 The PDCA Cycle
Continuous Process Improvement  Kaizen
Tools and Techniques  Benching Marking
 Failure Mode and Effect Analysis
 Taguchi’s Loss Functions

Continuous Process Improvement Impact / Benefits of

Continuous Improvement Process
 By definition, Continuous process improvement (CPI) is the act of
implementing improvements to a product, service or process.
 Increased productivity
 The key here is continuous – CPI isn’t a one-time initiative.
 Improved quality
 Don’t just optimize a certain process once  Lowered costs
 Once you succeed with a process improvemen t initiative, you need to  Decreased delivery times
periodic ally look b ack and see wh ether ther e are any ch anges you
could make.  Improved employee satisfaction/morale
 Reduced employee turnover rate
 Think, adopting new hardware, software, methodology, etc.
 The PDCA Cycle
When to use the PDCA cycle ?
Use the PDCA cycle when:
 Starting a new improvement project
 Developing a new or improved design of a process, product, or service
 Defining a repetitive work process
 Planning d ata collection and an alysis in ord er to verify and prioritiz e
problems or root causes
 Implementing any change
 Working toward continuous improvement

PDCA Procedure
1. Plan: Recognize an opportunity and plan a change.
2. Do: Test the change. Carry out a small-scale study.
3. Check: Review the test, an alyze th e results, and identif y wh at you’ve
learned.
4. Act: Take action based on what you learned in the study step.
 If the chang e did not work, go through the cycl e again with a
different plan.
 If you were succ essful, incorpor ate wh at you l earn ed fro m th e tes t
into wider changes.
 Use wh at you learn ed to plan new improvements, b eginning th e
cycle again.
 Kaizen Kaizen Process
 Kaizen is a lean manufacturing tool that improves quality,
productivity, safety, and workplace culture. 1. Identify a problem or opportunity

 Kaizen focuses on applying small, daily changes that result 2. Analyze the process
in major improvements over time. 3. Develop an optimal solution
4. Implement the solution
 Kaizen first surfaced during the effort to rebuild Japan
after World War II. 5. Study the results and adjust
6. Standardize the solution
 At the time, several U.S. business consultants collaborated
with Japanese companies to improve manufacturing.

 The collaboration resulted in the development of several

new management techniques, one of which was Kaizen.
 Advantages of Kaizen
 Less waste – Inventory is usedmore efficiently asare employee skills.
 People are more satisfied – They have a direct impact onthe way things are done.
 Improved commitment – Team members have more of a stake in their job and are more
inclined to commit to doing a good job.
 Improved retention – Satisfied and engagedpeople are more likely to stay.
 Improved competitiveness – Increases in efficiency tend tocontribute to lower costs and
higher quality products.
 Improved consumer satisfaction – Coming from higher quality products with fewer faults.
 Improved problem solving – Looking at processes from a solutions perspective allows
employees to solve problems continuously.
 Improved teams – Workingtogether to solve problems helpsbuild and strengthen existing
teams.
 Limitations of Kaizen
 It distorts/misrepresented the entire management system. Benchmarking
 Difficult for businesses to go back to previous systems.

 Employees might be unwilling to change the system that they have

 A proce ss of comparing age ncies’ operati ons and performa nce agai nst
been used to. recognized standards a nd im provi ng t hose operati ons to enhance t he
effectiveness.
 Training staff to adapt to new changes could be expensive and very
demanding.  Benchmarki ng is t he pr ocess of c ompari ng som ethi ng or some one with
best practice.
 If employees do not play their part in adopting these changes, the
amount of time and resources spent will go to waste.  The pr ocess of identifyi ng, underst anding and a dapti ng out sta ndi ng
practices from other orga nizati ons to help an orga nization im prove
performance.

Benchmarking Barriers Misconceptions for Benchmarking

 Lack of action
 Benchmarking leads to rating and ranking o f performance
 Not involving the appropriate people
 Parti cipation in b ench mar king is r evealing trad e s ecrets that would
 Not understanding that learning can happen even without inventing it. lead to compromising
 Lack of understanding the internal processes  competitive advantage
 Weak leadership  Bench marking leads to explic it cause- eff ect rel ationships with b est
 Inability to see opportunity to improve practices

 Organisation not promoting entrepreneurial behaviors, innovation or  It is a one-time programme

risk taking  It is a reactive tool
 Failure to see need for change  Benchmarking is just copying others
Requirements for A Successful Benchmarking Model

 A clear understanding of benchmarking requirements.

 Identification of benchmarking team.

 Use of effective project planning tools and techniques.

 The mod el has to create a set of exp ectations r egarding th e
information; ho w it is to be g ath er ed, r eported and used to r eview
and adjust progress of activity.

 Identification and analysis of gaps.

 Feed back provision to take action and recycle.

Types of Benchmarking
1) Process Benchmarking

 This is all about b etter understanding your process es, co mparing

perfor manc e ag ainst internal and external b enchmar ks, and finding
ways to optimise and improve your processes.

 The idea is that, by understanding how top perfor mers complete a

process, you can find ways to make your own processes mo re efficient,
 Intern al b enchmar king: comp arison of pr actic es and perfo rmance faster and more effective.
between teams, individuals or groups within an organization.

 Extern al bench marking : compar ison of organizational perfo rmance

to industry peers or across industries.
2) Performance Benchmarking 3) Strategic Benchmarking

 This involves collec ting information on how well you’r e doing in  This compar es strategies, business approaches and business mod els
ter ms of outcomes (which could mean an ything fro m revenu e in order to strengthen your own str at egic planning and deter min e
growth to customer satisf action) and comp aring thes e outcomes your strategic priorities.
internally or externally.
 The id ea is to understand wh at str ategies underpin successful
 This can also ref er to function al p erfor manc e bench marking, such compani es (or teams or business units) and then compare thes e
as bench mar king th e p erfor manc e of th e HR team or th e Mar keting strategies with your o wn to iden tify ways you can b e mor e
team. competitive.

Failure Modes & Effects Analysis (FMEA)

Introduction:-
 FMEA is a systematic method by which potential failures of a product or
process design are identified, analyzed and documented.

 Once identified, the effects of these failures on perfor mance and safety are
recognized, and appropriate actions are taken to eliminate or minimize the
effects of these failures.

 An FMEA is a crucial reliability tool that helps avoid costs incurred from
product failure and liability.
 Use of FMEA
 The F MEA process is an on-going, bottom-up approach typically
utilised in three areas of product realization and use, namely design,
manufacturing and service.  Throughout the entire design process but is especially important during the
concept development phase to minimise cost of design changes.
 A design FMEA exa mines potential product failures and the effects of
these failures to the end user  Testing

 Manufacturing or process FMEA examines the variables that can affect  Each design revision or update.
the quality of a process.

 Service FMEA is to prevent the misuse or misrepresentation of the tools

and materials used in servicing a product.

Application of FMEA
The main elements of the FMEA are Example:- Table Lamp
 The Failure Mode that describes the way in which a design fails to perform
as intended or according to specification. Step 1: Identify components and associated functions

 The Effect or the impact on the customer resulting from the failure mode;
and the cause(s) or means by which an element of the design resulted in a  P art Description - P art Function
failure mode.  Light bulb - P rovides x ± y lux of illumination
 P lug - 2 wire electrical plug
 Cord - Conducts power from outlet to lamp
Step 2: Identify failure modes
Step 3: Identify effects of the failure modes
1) Com plete Failures 5) Incorrect Operation
2) Intermittent Failures 6) Premature Operation  For each failure mode identified, the consequences or effects on product,
3) Partial Failures 7) Failure To Cease Functioning At property and people are listed.
4) Failures Over Time Allotted Time
8) Failure To Function At Allotted Time  These effects are best described as seen though the eyes of the customer.

Example:
P art Description Failure Mode
Cord Short circuit
Open circuit
Insulation failure

Step 4: Determine severity of the failure mode Step 5: Identify cause(s) of the failure mode
 The severity or criticality rating ind icates how signif icant of an impact the effect
is on the customer.  For each mode of failure, causes are identified.

 Severity can range from insignificant to risk of fatality.  These causes can be design deficiencies that result in performance
 Dependin g on the FM EA method employ ed, severity is usually given e ither a failures, or induce manufacturing errors.
numeric rating or a coded rating.

 The advan tage of a numeric rating is the ability to be ab le to calcu late the Ris k
Priority Number (RPN)
 Step 6: Determine probability of occurrence Step 7: Identify controls
 Identify the controls that are currently in place that either prevent or detect the
 This step involves determining or estimating the probability that a given cause of the failure mode.
cause or failure mode will occur.

Step 8: Determine effectiveness of current controls Step 9: Calculate Risk Priority Number (RPN)

 The RP N is an optional step that can be used to help priorities failure modes
for action.

 It is calculated for each failure mode by multiplying the numerical ratings of

the severity, probability of occurrence and the probability of detection
(effectiveness of detection controls) (RP N=S x O x D).
Step 10: Determine actions to reduce risk of failure mode
 Traditional Definition
 Quality say s that a pr oduct is either g ood or bad, depend ing on whether it is
within the specification range (between the lower and upper specification limits).

 In this approach, the specification limits are more importan t than the target

Taguchi’s loss Functions value. But, is the pro duct as good as it can be, or shou ld be, just because it is
within specification.

Taguchi’s Definition
• Taguchi did not accept the above traditional definition of quality.
• He defines the ‘ quality’ as deviation from on-target performance.
• When a product moves from its target value then it will cause the loss even
if the product lies or not within the specification limits .
 Taguchi’s loss Functions Taguchi’s Quadratic Quality Loss Function
• Taguchi states that any deviation fro m the desired target value or
According to the Taguchi, the loss due to the per for mance variation is
specification results in a monetary loss to society.
proportional to the square of the deviation the perfor mance characteristics fro m
its nominal value.
• Taguchi method is based on the hypothesis that the smaller the variation
with respect to said target value (goal), the better the product quality.
L (y) = k (y-m) ²
• In general there is practically no difference between a product that is just
where, y = objective characteristic or attribute
within the limits of specification and a product that is just outside of these.
L = loss associated with y
• The difference turns out to be much greater in ter ms o f quality, when
comparing a product that has the target specification (objective) in relation m = specification target value
to a product that is near one of the specification limits. k = constant called quality loss coefficient
depending upon target and specification limit

Taguchi’s 3 Concepts
(1) Quality should be designed into the product and not inspected
into it.
 Taguchi believed that better way to improve quality was to design and built it
into the product.

 Quality improvement starts at very beginning from the design stages of a

product or process which continues through the production phase.
 He proposed an “ off-line” strategy for developing the quality improvement in
place of an atte mpt to inspect the quality into a product on the production
line.
 2) Quality should be best achieved by minimizing the (3) The cost of quality should be measured as a function
deviation from a target. of deviation from the standard and the losses should
be measured system-wide.

 Concept calls for measuring deviation from a given design parameter in

 Quality is directly related to the deviation of design parameter from
terms of the overall life cycle cost of the products.
the target value, not to conformance to some fixed specifications.
 These costs would include the cost of scrap, rework, inspection, warranty
service calls and product replacement.

 These costs provide the guidance regarding the major para meters to be
controlled

Taguchi’s 3 Stage Process To The Robust Design Systems Design

 System design is the conceptualization and synthesis of a product or process
(1) Systems Design to be used.

(2) Parameter Design  New ideas, concepts and knowledge in the areas of science and technology
are utilized by the design team to determine the right combination of
(3) Tolerance Design materials, parts, processes and design factors that will satisfy functional and
economical specifications.
 Parameter Design Tolerance Design
 It occurs when the tolerances for the products or process are established
 P arameter design is related to finding the appropriate design factor to minimize the sum o f the manufacturing and lifetime costs of the
levels to make the system less sensitive to variations in uncontrollable product or process.
noise factors, i.e., to make the system robust.
 In the tolerance design stage, tolerances of factors that have the largest
 In this way the product perfor ms better, r educing the loss to the influence on variation are adjusted only if a fter the parameter design
customer. stage, the target values of quality have not yet been achieved.

 Most engineers tend to associate quality with better tolerances, but

tightening the tolerances increases the cost of the product or process
because it requires better materials, components, or machinery to achieve
the tighter tolerances

Different Types of Quality Loss Function

1. Nominal-the-best (NTB) - the no minal value is best because it is the one that
satisfies the customer’s need.The characteristic value away on either side of
the target is undesirable, such as air pressure in vehicle tires or location of
gauges on the instrument panel.

2. Smaller-the-better (STB ) – a s maller value is better and higher values are

undesirable, such as vehicle emissions or fuel consumption (dollar per
distance).

3. Larger-the-better (LTB) – a larger value is better and smaller values are

undesirable, such as gas mileage (distance per gallon).
Nominal-the-best (NTB) Smaller-the-better (STB)

Larger-the-better (LTB)
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Six Sigma

Unit 4
 Six Sig ma is usually related to the magic nu mber of 3.4 de fects per
million opportunities.

 P eople often view Six Sig ma as yet another rigorous statistical quality

Standard Method of Improvement control mechanism.

 P ioneered at Motorola in the mid-1980s, Six Sig ma was initially targeted

to quantify the defects occurred during manufa cturing processes, and to
reduce those defects to a very small level.

 Motorola claimed to have saved several million dollars.

 Another very popular success was at GE. Six Sig ma contributed over
Origin of Six Sigma
US $ 300 million to GE's 1997 operating income.
 Six Sigma originated at Motorola in the early 1980s, in response to
 Today Six Sigma is delivering business excellence, higher customer achieving 10X reduction in product-failure levels in 5 years.
satisfaction, and superior profits by dramatically improving every
process in an enterprise, whether financial, operational or production.  Engineer Bill S mith invented Six Sig ma, but died o f a heart attack in the
Motorola cafeteria in 1993, never knowing the scope of the craze and
 Six Sigma has beco me a darling of a wide spectrumo f industries, fro m controversy he had touched off.
health care to insurance to telecommunications to software.
 Six Sig ma is based on various quality manage ment theories (e.g.
Deming's 14 point for manage ment, Juran's 10 steps on achieving
quality).

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 Six Sigma is a business-driven, multi-dimensional structured approach for −

Features of Six Sigma  Improving P rocesses
 Lowering Defects
 Six Sig ma's ai m is to eliminate waste and inefficiency, thereby increasing  Reducing process variability
customer satisfaction by delivering what the customer is expecting.  Reducing costs
 Increasing customer satisfaction
 Six Sig ma follows a structured methodology, and has de fined roles for  Increased profits
the participants.
 The word Sigma is a statistical term that measures how far a given process
 Six Sigma is a data driven methodology, and requires accurate data
deviates from perfection.
collection for the processes being analyzed.
 Six Sigma is about putting results on Financial Statements.  The central idea behind Six Sigma: I f you can measure how many "de fects"
you have in a process, you c an systematically figure out how to eliminate
them and get as close to "zero de fects" as possible and specifically it means a
failure rate of 3.4 parts per million or 99.9997% perfect.

Key Concepts of Six Sigma Myths about Six Sigma

At its core, Six Sigma revolves around a few key concepts.  Six Sigma is only concerned with reducing defects.
1) Critical to Q uality − Attributes most important to the customer.  Six Sigma is a process for production or engineering.
2) Def ect − Failing to deliver what the customer wants.  Six Sigma cannot be applied to engineering activities.
3) Process Capability − What your process can deliver.  Six Sigma uses difficult-to-understand statistics.
4) Variation − What the customer sees and feels.  Six Sigma is just training.
5) Stable Operations − Ensuring consistent, predictable processes to
improve what the customer sees and feels.
6) Design f or Six Sigma − Designing to meet customer ne eds and
process capability. Six Sigma f ocuses firs t on reducing process varia tio n
and then on improving the process capability.

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Benefits of Six Sigma Methodologies of Six Sigma

1) Six Sigma offers six major benefits that attract companies
DMAIC DMADV
2) Generates sustained success
3) Sets a performance goal for everyone
4) Enhances value to customers
5) Accelerates the rate of improvement
6) P romotes learning and cross-pollination
7) Executes strategic change

DMAIC Process DMADV Process

 Define - Selecting and planning the project.

 Measure - Gathering data on the current level of effectiveness of the process.
 Analyze - Mapping/understanding the process and discovering forms of waste.
 Improve - Utilizing collaborative problem solving to remove non-value-added
elements.
 Control - Standardizing, monitoring, and managing process effectiveness

VOC-Voice of the Customer / CTQ-Critical to Quality

VOB-Voice of Business / VOP-Voice of People

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Difference between DMAIC & DMADV

When should we use DMAIC & DMADV?

 DMAIC is used, when the problem you want to solve is for a process that is
already existing but not meeting the expected levels of performance.

 DMAIC is used when you want to correct an existing process that has not
been performing up to the expectations.

 DMADV is used when you want to set up/design a whole new process, that
should be meeting the desired level of performance from the beginning.

 DMADV may also be used when there is a need to redesign an existing

product or process, rather than constantly correcting the process.

CTQ-Critical to Quality

Key Six Sigma Techniques in use

The Six Sigma Tools
 Cause and Effect Analysis
 Flow Chart
 Pareto Chart
 Histogram
 Check Sheet
 Scatter Plot
 Control Chart

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Six Sigma Levels

Quality Function Deployment (QFD)

 Many s uccessful or ganizati ons gather and int egrat e the Voice of the
Customer (VOC) into the design and manufacture of their products.
 The a ver age cons umer t oday has a m ultitude of options av ailable t o select
from for similar products and services.  They activ ely desi gn quality and cust om er percei ved val ue int o their
products and services.
 Most consum ers mak e their selecti on based upon a general perce pti on of
quality or value.  Thes e companies ar e utilizi ng a struct ur ed pr ocess to defi ne their
customer’s wants and needs and transfor ming them i nto specific
 In order to r emai n c om petitive , organizations m ust determi ne w hat is dri ving
pr oduct designs and proc ess plans to pr oduc e pr oducts that satisfy the
the consumer’s perception of value or quality in a product or service. customer’s needs.
 They must defi ne w hic h char acteristics of the pr oducts such as reli ability,
 The pr ocess or tool they ar e usi ng is called Quality F uncti on Depl oym ent
styling or performance form the customer’s perception of quality and value.
(QFD).

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Benefits Of Quality Function Deployment (QFD)

9. It facilitates identifi cation of the cau ses of customer complaint s
1. A sy stematic w ay of obtaining information and presenting it. and makes it easier to takes prompt remedial action.

2. S horter product dev elopment cy cle. 10. It is a useful tool for improv ing product Q uality.
3. C onsiderably reduced start-up costs. 11. It is a useful tool for competitiv e analy sis of product quality.
4. F ew er engineering changes.
12. It is stabilizes quality.
5. Reduced chance of ov ernights during design process.
13. It cuts dow n on rejects and rew ork at the production site.
6. A n env ironment of team w ork.
14. It decreases claims substantially.
7. C onsensus decision.
15. M arketing benefits are obtained by identify ing sales point.
8. E v ery thing is preserv ed in w riting.

House of Quality Steps

4) Develop importance ratings. It refers to using
1) Identify what customer wants. the customer’s importance ratings and weights
from the relationships in the matrix to compute
2) Identify how the product will satisfy the our importance ratings.
customer. It refers to identifying specific
product characteristics, features or 5) Evaluate competing products or services. The
attributes and showing how they will question to be answered here is: How well do
competing products meet customer wants?
satisfy customer wants This activity is completely based on research.
3) Identify relationships between how’s. A
6) Determine the desirable technical attributes. In
couple of questions, that are to be this step, our performance and the
answered here: How do our how’s tie competitor’s performance are determined and
together? What is the relationship compared.
between our two or more how’s?

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7 Steps of Developing HOQ

 Thin Crust Pizza
 Meat lovers 1) Identify customer w ants.
 Oven Baked 2) Identify how the good/serv ice w ill satisfy customer w ants.
 Greek Style
3) Relate customer w ants to product how 's.
Types  Triple Meat Pizza
4) Identify relationship betw een the firm's how 's.
 Pineapple And Chicken
of  Muffled Pizza 5) Dev elop importance ratings.
Pizza  Supreme Pizza
6) E v aluate competing products.
 Chicago Style Pizza
 Buffalo Chicken 7) Determine the desirable technical attributes , y our performance,
and the competitor's performance against these attributes.
 Deep Dish Pizza

1) Identify customer wants.

- Good texture 3) Relate customer w ants to product how ’s.
- Generous portions
- Tastes good  In this step we have to relate the customer requirements and the technical
- Low price specifications provided by the company manager.
- Appetizing appearance
 How well what we do meets the customer’s wants (relationship matrix).
2) Identify how the good/service will satisfy customer wants
 Ratings for high, medium and low relationships have been shown in the diagram.
 Colour
 Tensile yield strength
 Tensile Ultimate strength
KE Y
 Weight
 Size(Diameter) High Relationship (5)
 Thickness M edium Relationship (3)
 Avg. Hedonic scale rating
 Cost per Pizza Low Relationship (1)
 Density of topping

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4) Identify relationship betw een the firm's how 's. 5) Develop Importance Ratings
 This is basically the roof of the house. CUSTOMER ‘WANTS’ IMPORTANCE RATING

 This includes relationship betw een the things w e can do. Tastes Good 5
 It giv es the relationships among the C ompany ’s how 's.
Low Price 4

Appetizing Appearance 3
Key..
Good Texture 2

Generous Portions 1

6) Evaluate Competing Products

C U S TOMER ‘WA NTS ’ COMPANY ALPHA COMPANY BETA COMPANY CHARLIE

Tastes G ood Fair Good Good

Low P rice Good Poor Poor

A ppetizing A ppearance Poor Fair Good

G ood Texture Good Fair Good

G enerous P ortions Good Good Poor

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7) Determine the desirable technical attributes, y our performance and

the competitor's performance against these attributes.

Process Capability

Unit-4
Process:-

 A s equenc e of i nter dependent pr oc edur es, oper ati ons or s teps that
consume resources and convert the inputs into outputs.

 Each operati on or s tep adds to the next to ac hieve a g oal or desired

result.

Process Capability  In every process, there exists a certain amount of variation.

 Variation in a pr oc es s c annot be eli minated, but it c an be measur ed,

monitored, reduced and controlled.

 Example of making a c up of c offee, we can i dentify the i nputs, steps,

equipment and output of the process.

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Process Capability:- (Cp) Cp Formula

 Process Capability (Cp) is a statistical measurement of a process’s ability Cp=USL–LSL6×σ Where,

to produce parts within specified limits on a consistent basis.  USL is the upper specification limit
 LSL is the lower specification limit and
 σ is the standard deviation.

Question 1: Calculate Cp whose USL, LSL and σ are 10, 6 and 3 respectively?
Solution:
From the equation, it is given that
USL = 10, LSL = 6 and σ = 3
Formula for Cp is,
Cp = USL−LSL6×σ = 10−66×3 = 0.222

Process Capability Index (Cpk) Cpk Formula

 It is a statistical tool, to measure the ability of a process to produce output within
customer's specification limits. A person may perfor m wi th mi ni mum vari ati on, but he c an be away from his targ et
towar ds one of the s pecifi cation li mits that i ndic ates the Cpk will be l ower, but C p
 In simple words, it meas ures producer's capability to produce a product within will be high.
customer's tolerance range.

 Cpk is used to estimate how close you are to a given target and how consistent you Cpk=min(USL− mean3σ,mean− LSL3σ)
are to around your average performance.

 Cpk gives you the best-case scenario for the existing process. Where,

 It can also estimate future process performance, assuming performance is σ is a standard deviation,
consistent over time.
USL is the upper specification limit,
 Cpk is a standard index to state the capability of one process, the higher the Cpk
LSL is the lower specification limit.
value the better the process is.

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Question 1: Food served at a restaurant should be between 39°C and 49°C when it is
Cp = (USL – LSL) / 6 sigma
delivered to the customer. The process used to keep the food at the c orrect temperature
has a process standard deviation of 2°C and the mean value for these temperatures is
40. What is the process capability index of the process?
Cp<1 means the process variation exceeds
Solution: specification, and a significant number of defects are
USL (Upper Specification Limit) =49°C LSL (Lower Specification Limit) =39°C
Standard Deviation =2°C Mean = 40
being made.

Cpk is given by,

Cp=1 means that the process is just meeting
Cpk=min( USL−mean 3σ ,me an−LS L3σ )
specifications. A minimum of .3% defects will be made
Solution of part 1: (USL – Mean)/ 3σ = (49-40)/3 ×2 = 9/6 = 1.5 and more if the process is not centered.

Solution of part 2: (Mean – LSL)/ 3σ = (40-39)/3 ×2 = 1/6 = 0.166

Cp>1 means that the process variation is less than the
Cpk = min (part 1, part 2) Cpk = min (1.5, 0.166)
Since the mininum value is 0.166, specification, however, defects might be made if the
The process capability index, Cpk is 0.166. process is not centered on the target value.

Relationship Between Cp and Cpk Difference between Cp & CpK

Cp CpK
 Cp is the simplest indicator of a
process capability.  Cpk gives a better picture.
 Cp is also known as the “process  Cpk is known as “process
potential index”. capability index” or “process
performance index”.
 Cp index does not take into
consideration the plac ement of  Cpk considers the centering of the
process with respect to the given process distribution.
limits or the specification width.
 Cpk provides both form and
 Cp will give a description of form location.

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RAM Approach
 Reliability, Availability, and Maintainability (RAM or RMA) are system
design attributes that have significant impacts on the sustainment or total Life
Cycle Costs (LCC) of a developed system.

 The RAM attributes impact the ability to perform the intended mission and
affect overall mission success.

Definition Reliability
Reliability is the probability of a product/equipment/process/system
 The standard de finition of RELIAB ILITY is the probability of zero perfor ming its intended function for a stated period of time under certain
failures over a defined time interval (or mission). specified conditions.

 AVAILAB ILITY is defined as the percentage of time a system is  Reliab ility is a probability based concept. The numerical value of reliability is
considered ready to use when tasked. between 0 and 1.

 The functional performance of the pro duct to meet certain stipulation s. Prod uct
 MAINTAINABILITY is a measure o f the ease and rapidity with which a
design w ill u sually ensure develo pment of a product that meets or exceeds the
system or equipment can be restored to operational status following a
stipulated requirements.
failure.
 Reliability implies successful operation over a certain period of time.

 Operating or env ironmental cond itions un der whic h pro duct use ta ke s p lace are
specified.

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Reliability Reliability
 Productio n department using the equ ipment, main tenance department, the equ ipment
 Achieving total reliability is very costly and so the users in the industries manufacturer and the de sig ner of the equipment are fed with th is data f or necessary
often have to co mpromise and aim for the low chance o f failure of the actions to improve reliability.
equipment.
 Pareto analy sis is used to segregate critical comp onents/parts w hich fail too
 Equivalent emphasis is placed on early return back o f the equipment a fter frequently or wh ich have greater impact on the availability of the eq uipment . T his is
repair of any breakdown. also called 80 : 20 analy sis, where 20 % of the parts account for 80 % of the failures.

 It involves enormous amount of data collection, data analysis to find out the
mode of failure and various stresses on the equipment.

Maintainability Maintainability

 Maintainability is the measure of the ability of an ite m to be retained in or

restored to a specified condition when maintenance is perfor med by personnel
having specified skill levels using prescribed procedures and resources at each
prescribed level of maintenance and repair.

 Maintainability depends on the product design and the technical level of repair
personnel, the repair process, and the repair facilities.

 Maintainability is a probability measure that a product will be maintained or

restored to the specified function for a specified period of time at any specific
level of repair conditions.

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Maintainability Availability

To obtain satisfactory maintainability the following factors must be considered:  Availability is a the probability that a system is not failed or undergoing a
repair action when it needs to be used.

(a) The equipment or machine could fail at some time or other.  Availability is the probability that a system will be available to preform its
(b) The positioning of maintenance displays, check points, gauges, meters and function when called upon.

the position of one assembly with respect to others.  The mathematical formula for Availability is as follows:
(c) The limitations imposed by the human frame. P ercentage of availability =
(Total elapsed time – Sum of downtime) / Total elapsed time
(d) The environment in which maintenance or repairs will be carried out.
(e) The design of test equipment.
(f) The presentation of information in the maintenance and repair manual.

MTBF, or Mean Time Between Failures

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MTBF, or Mean Time Between Failures MT T R-Mean Time T o Repair

For example, let’s say you have a 10 i dentical pumps at your facility. The pumps
operated for 100 hours each over the course of a year, totaling 1,000. The pumps
failed 16 times in total over that year.

MTBF = (10 pumps x 100 operational hours each) ÷ 16 failures

MTBF = 1,000 operational hours ÷ 16 failures

MTBF = 1,000 ÷ 16

MTBF = 62.5 hours

MTTR-Mean Time To Repair Mean Time to Failure (MTTF)

 It measure the average time needed to determine the cause of and fix failed
equipment.  MTTF is the ave rage time that an ite m will function be fore it fails. It is the
me an life time of the ite m.
 It gives a snapshot of how quickly the maintenance team can respond to and repair
unplanned breakdowns.
 MTTF= T/N whe re T = Total time and
Examples:-
One of your assets may have broken down six different times during production in the N = Numbe r of units unde r te st.
last year. The total number of time it took to repair the asset across all six failures was
44 hours.

MTTR = 44 hours ÷ 6 breakdowns

MTTR = 44 ÷ 6
MTTR = 7.33 hours

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Example : Suppose 10 de vice s are tested for 500 hours. During the te st 2
failure s occur. Calculate MTBF & MTTF

The e stimate of the MTBF is:

MTBF= (10*500)/2 = 2,500 hours / failure .

Whe re as for MTTF

MTTF= (10*500)/10 = 500 hours / failure .

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 Unit 5
Information Technology
in Quality Management

 Introduction to I.T.
 History
 Computers & Quality Function
 The Internet And Other Electronic Communication
 Information Quality Issues
 Technology Of Future

IT Means

 Information technology is the product of fusion of information

science and technology, information science comprises of
set of practices and related disciplinary studies, which is
concerned with the transmission, organization, storage,
retrieval and use of information.

 Technology is the branch of knowledge that deals with

industrial arts, applied science and engineering.
IT Means

 Information technology is a combination of computer and

telecommunications technologies, which has made possible
to help the people at work, in education and at home.

 Thus, it is all about the application of varieties of electronics

to the information organization.

Quality Management

 Quality management is the act of overseeing all activities and tasks

that must be accomplished to maintain a desired level of
excellence.

 This includes the determination of a quality policy, creating and

implementing quality planning and assurance, and quality control
and quality improvement.
Advantages of Computer in QM

1) Response time is greatly reduced

2) Very large data are stored for information and decision-
making
3) Accuracy of information is considerably improved, thereby
improving the quality of the decision
4) Problems are handled more easily by using various operation
research models
5) The cost involved in the decision-making process is reduced
6) More secrecy is observed as compared to manual file system
Advantages of Computer in QM

7) Ability to take quick decision improves considerably as the time for

retrieval of information is very fast;
8) Paper work is reduced to the minimum as all the information is
stored in the computer itself;
9) Lots of information are stored for future reference;
10) Chances of leakage of classified information are reduced;
11) Accuracy in manipulation is increased very much; and
12) Time spent in various decision-making activities is reduced to a
minimum.
 Components of Information Technology

a. Processor, memory and input/output channels

b. Micro, mini and large scale computers
c. Mass storage technologies
d. Data communication, networking and distributed processing
e. Data entry, display responds technology
f. Software

Impact of IT on Quality
Management

 Improving costumer and supplier relationship

 Increasing process control
 Facilitating teamwork
 Facilitating inter-departmental information flow
 Improving design process and skills
 Applying preventive maintenance
 Measuring quality costs
 Improving the decision process in quality departments
Quality Management

Advantages of Computer in
Quality Management

1) 100% testing and inspection

 (Computer Aided Inspection (CAI) & Computer Aided
Testing (CAT)

2) Inspection integrated with manufacturing process

 As soon as the product is manufactured it is tested
immediately by the computerized process without moving it
to some other location.
 This helps in reducing the overall time required for
manufacturing the product.
 Advantages of Computer in
Quality Management

3) Use of non-contact sensors

 Non-contact sensors operated by the computer are kept
along the production line and they can check the product
very quickly in the fraction of seconds.

4) Computerized feedback control system

 The data collected by the non-contact sensors is sent as
the feedback to the computerized control systems.

Electronic Communication

 Electronic communication can be defined as, the

communication which uses electronic media to transmit the
information or message using computers, e-mail, telephone,
video calling, FAX machine, etc.

 This type of communication can be developed by sharing

data like images, graphics, sound, pictures, maps, software,
and many things.
 Types of Electronic
Communication

E-Mail
 E-Mail or electronic mail is the most used type of electronic
communication.

 By using this communication, one can send a message to another

person through a mail immediately.

 For that, we need to create an account to send an e-mail, media

files, photos, documents, etc.

 This type of communication has replaced many conventional types

of communication due to many benefits.

Types of Electronic
Communication

Messaging
 This type of communication allows people to interact with others
who are far away from us.

 This is possible only due to technology as well as usage of the

internet.

 There are different types of messengers are available like Skype,

Windows Live, Gmail, etc.

 These messengers help in chatting or sending messages to our

beloved ones or friends.
 Types of Electronic
Communication
Blogging
 Blogging is the most preferable communication method.
 This is a type of online journaling, which can be updated
daily, or many times a day.
 It covers all the information or a particular topic.
 By using such blogs, one can share, follow, or even post
comments.
 This kind of communication is extremely suitable.
 This is the reason why people utilize blogs very often.
 Additionally, by using the internet, people can access, read
& follow it worldwide.

Types of Electronic
Communication
Video Chat

 This type of communication can be done by adding

web cameras for video calling application.
 By using this application, one can communicate with
others and also they can observe with whom they are
speaking.
 The webcam can be connected to the computer
externally and also we need to use applications like
Skype, Hangouts, etc.
 We can communicate with more than one person at a
time by using the feature like business conference
feature.
 Also, we can share PPTs, data sheets online.
 Types of Electronic
Communication

Social Networking

 Social media is one kind of communication

between people, which is used with their general
advantage otherwise for relationships.

 In this, mostly Facebook, as well as LinkedIn,

give places for people to work together,
sometimes in real-time.

 There is a Micro-blogging service namely Twitter,

which allows the short message of more than
140 characters to be transmitted to a huge
audience.

Types of Electronic
Communication
Telex
 This is a significant device for current
electronic communication.

 This system uses a tele printer to

communicate from one position to
another using a machine.

 It includes mainly two parts like

keyboard transmitter as well as a
receiver.
 Types of Electronic
Communication
Fax
 The Fax machine is a kind of communications and
use of this is increasing gradually to trans mit
materials which are visual like illustrations,
diagrams, picture, etc. Here, this machine can be
connected using a telephonic.

 The transmitted document can be fed throughout the machine, after that it
is scanned electronically & signals are broadcasted to the end of receiver
wherever an equal document copy is replicated on a plain paper sheet
using the receiving machine.

Types of Electronic
Communication
Multimedia

 The multimedia mainly includes a

photo, graphics, voice, music,
animation, and message.
 Whenever all these media are
located jointly otherwise computer
screen then becomes multimedia.
 This can be used efficiently for marketing and advertising campaigns.
 This type of communication is extremely powerful.
 Types of Electronic
Communication

Information Quality

 Information quality (IQ) is the quality of the content

of information systems.

 It is often defined as: "The fitness for use of the information

provided.“

 Information quality is a measure of the value which

the information provides to the user of that information.

 Quality of information can vary among users and among uses

of the information.
 Point to consider-Information
Quality

 Reasonably accurate
 Must be relevant
 Must be up to date
 Needs to be complete
 Has to be well presented
 Not too much or too little detail

Characteristics of Good Quality Information

Importance of Information Quality

 Improve business performance (financial,operations,marketing)

 Inform decisions about all aspects of business.
 Understand the fast-moving business environment.
 Understand customer needs, wants and behavior = customer
intelligence managers.
 Knowledge management.

Process for Improving Information Quality

 Issues of Information
Quality

A) Too Much Information

 Large volumes of information available and store make it

difficult to access for the right information at the right time.
 Excess time is required to extract and summarize those
needed information accordingly.

Issues of Information Quality

B) Security and privacy requirements

 Despite the easy access to information, conflict may occur
regardless of requirements for security, privacy, and
confidentiality.

 Limited access to the organization’s information might affect

the workers’ performance as they cannot access the needed
information at the needed time.

 The open access might lead to uncontrolled used of

information as well as will harm the organizations’ asset.
Issues of Information Quality

C) Lack of computing resources

 The information communication technology (ICT) infrastructure
such as computer, network or databases storage is insufficient.

D) Inadequate information management

 The weaknesses arising from poor or inadequate information
management are commonly noticeable in the failures of
company workers to respond to intelligence in a timely way.

Examples of Information Quality

 Recommendations for Information Quality

 Analyze information needs; develop regular, frequently

extracted subsets of relevant information.
 Develop consistent policies and procedures for secure
information.
 Develop technology upgrade policies so consumers know
when to expect more resources.

 Hired authorize or expertise staff in order to search and

acquire the valuable and useful information needed.

Broad Cross-functional
Perspective of IT Quality Issues

 Provide discipline and rigor to address quality improvements.

 Define top quality goals and measures.

 Drive consistent, agreed-to quality measures and corresponding

management systems.
 Identify and prioritize IT quality issues from an end-to-end
perspective.

 Serve as a focal point for an extended IT quality network

comprised of end users and providers.
Broad Cross-functional Perspective of IT
Quality Issues

 Assign issues to owners for resolution, drive root cause analysis,

and track results.

 Promote knowledge sharing of best practices relative to quality

management in IT.

 Drive preventive defect activities so that quality does not become

an afterthought.

Key Aspects of IT quality function

Size : How large should the quality function be?

Structure : How should the function be organized?
Scope : What should be the focus?
Roles and responsibilities: Who should be responsible for what?
Sk ills : What kind of talent and capabilities are needed?
Measures : How should performance be tracked?
IT & Quality Function

Case Study (Health Care)

 Barcode Medication Scanning

 Accurate Clinical Documentation
 Improved Communications Between Doctors
 High-Risk Monitoring and Decision Support
 High-Risk Monitoring and Decision Support
Summery

 Health information technologies are critical in improving patient

care, safety, and the overall quality of our healthcare systems.

 Whether it is advanced decision support, reducing human error,

or improving coordination between providers, there is no doubt
that information technology is making the world of healthcare
better every day.

 As our world continues to change, relying more and more on

tech every day, advances in artificial intelligence and information
technology will only continue to impact how we receive care and
think about clinical settings.
 12/11/2020

Unit 6
Quality Management System

Quality Management System

 A quality management system (QMS) is defined as a formalized
system that documents processes, procedures, and responsibilities
for achieving quality policies and objectives.

 A QMS helps coordinate and direct an organization’s activities to

meet customer and regulatory requirements and improve its
effectiveness and efficiency on a continuous basis.

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ISO Means
• ISO (International Organization for Standardization) is an
independent, non-governmental, international organization that
develops standards to ensure the quality, safety, and efficiency
of products, services, and systems.

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Some of The Benefits of ISO To Your Organisation

 Provides efficient management process

 Sets out areas of responsibility across the organisation
 Communicates a positive message to staff and customers
 Identifies and encourages more efficient and time saving processes
 Highlights deficiencies
 Reduces your costs
 Provides continuous assessment and improvement
 Marketing opportunities

Some of The Benefits To Your Customers

 Improved quality and service

 Delivery on time
 Right first time attitude
 Fewer returned products and complaints
 Independent audit demonstrates commitment to quality

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ISO 9000 series

 The phrase “ISO 9000 family” or “ISO 9000 series” refers to a group of quality
management standards which are process standard (not product
standards).

1) ISO 9000
 Quality management systems – Fundamentals and vocabulary referenced
in all ISO 9000 Standards.
 It explains the basics of quality management systems and provides
definitions for the terminology used in the 9000 series.
 It does not contain any requirements therefore, an organization cannot be
ISO 9000 certified.

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2) ISO 9001:2015

 Quality management systems – Requirements, contains the

requirements an organization must comply with to become ISO 9001
certified.

 It is NOT a standard for products.

 It does not define product quality.

 This is a process-based standard: you use it to control your

processes, then your end product should meet the desired results.

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3) ISO 9002:2016
 Guidelines for the application of ISO 9001:2015
 This standard provides examples of possible steps that an organization
can take to meet the requirements.
 It is a model for quality assurance in production, installation, and
servicing.
 It has covered almost all the concepts of ISO 9001, but does not
include the creation of new products.
 It was directly related with the contract manufacturing.

Difference between ISO 9001 and ISO 9002

 ISO 9001 is a model for quality assurance in design, development,
production, installation while ISO 9002 is a model for quality
assurance in production, installation and servicing.

 Therefore, ISO 9001 sets out the requirements for an organization

where the business processes range from design and development,
to production, installation and servicing and ISO 9002 is appropriate
for organizations where they do not concern on designing and
developing the products, as it does not include the design control
requirements of ISO 9001.

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4) ISO 9004:2018

 Managing for the sustained success of an organization,

provides guidelines for sustaining QMS success through evaluation
and performance improvement.
 Guidance to achieve sustained success”, gives guidelines for
enhancing an organization’s ability to achieve sustained success.

What is IATF 16949 ?

 IATF 16949 is a global Quality Management System Standard for the Automotive industry.

 The IATF 16949 standard provides info rmatio n and too ls for companies and organizatio ns
who wish to ensure that the ir products constantly meet customer requirements which
quality and client satisfaction are regularly upgraded

 IATF 16949:2016 incorpo rates the structure and re quirements of the ISO 9001:2015 quality
manageme nt system standard with additional automotive c ustomer-spec ific
requirements.

 It w as deve loped by the International A utomotive Task Fo rce (IATF), with suppo rt from AIAG
(Automotive Industry Action Group)

 This standard requires certification by a 3rd party auditor (Registrar/CB/Certification Body).

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Some Key Areas of Focus

 Continuous Improvement
 Defect Prevention
 Reducing Waste
 Product Safety
 Risk Management
 Contingency Planning
 Requirements for Embedded Software
 Change and Warranty Management
 Management of Sub-tier Suppliers

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Benefits of IATF 16949:2016 Certification

 Increases production efficiency and reduces error rates.
 Ensures necessary production quality for the automotive industry.
 Creates a responsible corporate status.
 Enables a company to enter and remain in automotive supplier chain.
 Qualify to supply the automotive industry.

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ISO 9000 Clauses

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IS0 9000 Requirements

1. Management Responsibility
 The quality policy shall be defined, documented, understood, implemented
and maintained.
 Responsibilities and authorities for all personnel specifying, achieving and
monitoring quality shall be defined.
 In-house verification resources shall be defined, trained and funded.
 A designated management person sees that the Q91 program is implemented
and maintained.

2. Quality System
 Procedures shall be prepared.
 Procedures shall be implemented.

3. Contract Review/ Purchase Orders Review

 Incoming contracts (and purchase orders) shall be reviewed to see
whether the requirements are adequately defined, agree with the bid
and can be supplied.

4. Design Control
 The design project shall be planned.
 Design input parameters shall be defined.
 Design output, including crucial product characteristics shall be
documented.
 Design output shall be verified to meet input requirements.
 Design changes shall be controlled.

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5. Document Control
 Generation of documents shall be controlled.
 Distribution of documents shall be controlled.
 Changes to documents shall be controlled.

6. Purchasing
 Potential subcontractors and sub-suppliers shall be evaluated for their ability
to provide stated requirements.
 Requirements shall be clearly defined in contracting data.
 Effectiveness of the subcontractor's quality assurance system shall be
assessed.

7. Customer-Supplied Material
 Any customer-supplied material shall be protected against loss or damage.

8. Product Identification & Tractability

 The products shall be identified and traceable by item, batch or lot during all
stages of production, delivery and installation.

9. Process Control

 Production (and installation) processes shall be defined and planned.

 Production shall be carried out under controlled conditions: documented
instructions, in-process controls, approval of processes and equipment, and
criteria for workmanship.
 Special processes that cannot be verified after the fact shall be monitored
and controlled throughout the processes.

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10. Inspection and Testing

 Incoming materials shall be inspected or verified before use.
 In-process inspection and testing shall be performed.
 Final inspection and testing shall be performed prior to release of finished product.
 Records of inspection and test shall be kept.

11. Inspection/Measuring/Test Equipment

 Equipment used to demonstrate conformance shall be controlled, calibrated and
maintained.
 Identify measurements to be made.
 Identify affected instruments.
 Calibrate instruments (procedures and status indicators).
 Periodically check calibration.
 Control environmental conditions in metrology lab.
 Where test hardware or software is used, it shall be checked before use and rechecked
during use.

12. Inspection and Test Status

 Status of inspections and tests shall be maintained for items as they progress throug h various
processing steps.
 Records shall show who released conforming product.

13. Control of Nonconforming Product

 Nonconforming product shall be controlled to prevent inadvertent use or installation.
 Review and disposition of nonconforming product shall be formalized.

14. Corrective Action

 Problem causes shall be identified.
 Specific problems and their causes shall be corrected.
 Effectiveness of corrective actions shall be assessed.

15. Handling, Storage, Packaging & Delivery

 Procedures for handling, storage, packaging and deliver y shall be developed & maintained.
 Handling controls shall prevent damage and deterioration.
 Secure storage shall be provided. Product in stock shall be checked for deterioration.
 Packing, preservation and marking processes shall be controlled.
 Quality of the product after final inspection shall be maintained. This mig ht include deliver y
controls.

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16. Quality Records

 Quality records shall be identified, collected, indexed, filed, stored, maintained and
dispositioned.

17. Internal Quality Audits

 Audits shall be planned and performed.
 Results of audits shall be communicated to management.
 Any deficiencies found shall be corrected.

18. Training
 Training needs shall be identified.
 Training shall be provided.
 Some tasks may require qualified individuals.
 Records of training shall be maintained.

19. Servicing
 Servicing activities shall be performed to written procedures.
 Servicing activities shall meet requirements.

20. Statistical Techniques

 Statistical techniques shall be identified.
 Statistical techniques shall be used to verify acceptability of process capability and
product characteristics.

Implementing QMS
1) Engage top management to
▸ Agree on why to implement a QMS
▸ Determine the context of the organization, strategic objectives and
business processes
▸ Determine customer and interested parties’ needs and expectations
▸ Understand the quality management principles described in ISO 9000
▸ Review the implication of risk-based thinking
▸ Describe the scope of the QMS
▸ Define the policy
▸ Determine quality objectives

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2) Identify Key Processes

▸ Identify the processes needed to deliver products and services

▸ Understand ISO 9001 requirements
▸ Determine the risks and opportunities applicable to the processes

3) Plan your QMS

▸ Identify the gaps in the existing system compared to QMS requirements
▸ Identify the process controls needed
▸ Define the working environment needed
▸ Define the skills and facilities needed

4) Document your QMS

 Document the processes, activities and controls needed
 Prepare the documented information (procedures and records)
required by the standard and according to your needs
 Ensure the QMS conforms to ISO 9001 requirements

5) Implement your QMS

 Manage the processes
 Control monitoring and measuring equipment
 Train employees
 Verify effective operation of processes

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6) Manage your QMS

 Monitor and measure performance
 Audit process effectiveness
 Focus on customer satisfaction
 Manage system and operational change
 Perform management review

7) Improve your QMS

 Seek third-party certification/registration of the QMS
 Strive for improvement with reference to ISO 9004
 Consider implementing business excellence models in company
operations

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Internal Audit
 To review and evaluate the reliability and soundness of its internal control system;
 To ascertain the degree of compliance with established standards, policies and
procedures;
 To minimize losses and maximize profits;
 To ascertain whether the information generated in an organization is accurate
and reliable;
 To ascertain the level of integrity of the data provided to management;
 To provide informed advice and feedback to management on next steps and
growth opportunities;
 To seek opportunities for improvement in the existing systems.

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ISO 9000 Registration Steps

 Get Top Management Commitment.

 Train Personnel.
 Prepare Quality Policy Manual.
 Prepare Operating Procedures.
 Hold Internal Audit.
 Select Registrar.
 Go Through Registration Process.
 Obtain ISO 9000 Registration.

Registration Process
 Apply for registration and audits

 Agree to audit process etc. with registrar

 Hold pre-assessment audit

 Take any needed corrective action

 Have ISO 9000 registration audit

 Take any needed corrective action

 Re-audit as needed

 Take any needed corrective action

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