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By Loh Wan Leng

1-Jul-2010, Rev 0

1
Quality Control
1. What is Quality Control?
2. What is Statistical Process Control (SPC)?
3. Why use SPC?
4. Benefit of SPC
5. Type of Statistical Control Chart.
6. Type of Variable Control Chart
7. Type of Attribute Control Chart
8. Which control chart to use?

Quality Assurance
1. What is Quality Assurance?
2. What is acceptance sampling?
3. Why use acceptance sampling?
4. How/When to use acceptance sampling?
5. Acceptance sampling explained

Quality System and Tool


1. TQM
2. ISO 9001:2008
3. Seven Quality Tool
2
What is Quality Control?

Control:
An evaluation to indicate needed corrective responses; the act of
guiding a process in which variability is attributable to a constant
system of chance causes.

Quality control:
The observation techniques and activities used to fulfill
requirements for quality
e.g on-line inspection, use of control-chart

Quote from ASQ website

3
What is Statistical Process Control (SPC)?

•A method of monitoring processes and process variation. The


purpose is to identify causes for process variations and resolve
them. Process variables may include rework, scrap, inconsistent raw
materials, and downtime on equipment.

•Invented by Dr. Walter A. Shewhart at Bell Telephone Labs around


1920’s

•Measures performance of a process

•Statistical technique used to ensure process is making product to


standard

•Involves collecting, organising & interpreting data

•All process are subject to variability


Natural causes: Random variations
Assignable causes: Correctable problems Machine wear,
unskilled workers, poor material
4
SPC in summary:

•It is a way of:

presenting data on a chart

determining if your process have a trend

determining if your process are stable

determining the capability of your process

•It is also a way of thinking

5
Why use SPC?

•Provides a formal method to detect trends.

•Provides Credibility and Rigor at minimum cost.

•Balances False Alarms and Failures to Detect.

•Accepted Industry Standard with long history.

Control Charts are similar to the circuitry in your home’s smoke


detector.

6
Benefit of SPC

•Increases product consistency

•Improves product quality

•Decreases scrap and rework defects

•Increases production output

7
Type of Statistical Control Chart.

Variable Control Charts

• Deal with items that can be measured .


• Examples
1) Weight
2) Height
3) Speed
4) Volume

Attribute Control Charts

• Control charts that factor in the quality attributes of a process


to determine if the process is performing in or out of control.

8
Type of Common Variable Control Chart use in Quality.

X-Bar chart
• Deals with a average value in a process.

R chart
• Takes into count the range of the values

9
Example of Variable Control Chart – Xbar Chart

A machining factory produces slip-ring. The diameter of the


slip-ring is set at 5.00cm. When sampling the batches, quality
inspector collected the following data:

OBSERVATIONS (SLIP- RING DIAMETER, CM)


SAMPLE k 1 2 3 4 5 x R
1 5.02 5.01 4.94 4.99 4.96 4.98 0.08
2 5.01 5.03 5.07 4.95 4.96 5.00 0.12
3 4.99 5.00 4.93 4.92 4.99 4.97 0.08
4 5.03 4.91 5.01 4.98 4.89 4.96 0.14
5 4.95 4.92 5.03 5.05 5.01 4.99 0.13
6 4.97 5.06 5.06 4.96 5.03 5.01 0.10
7 5.05 5.01 5.10 4.96 4.99 5.02 0.14
8 5.09 5.10 5.00 4.99 5.08 5.05 0.11
9 5.14 5.10 4.99 5.08 5.09 5.08 0.15
10 5.01 4.98 5.08 5.07 4.99 5.03 0.10
50.09 1.15
10
Example of Variable Control Chart – Xbar Chart

= ∑x 50.09
x= = = 5.01 cm
k 10

UCL = x= + A2R = 5.01 + (0.58)(0.115) = 5.08

LCL = x= - A2R = 5.01 - (0.58)(0.115) = 4.94

where
x = average of sample means

Retrieve factor value A2

11
Example of Variable Control Chart – Xbar Chart

5.10 –

5.08 –
UCL = 5.08
5.06 –

5.04 –

5.02 –
x= = 5.01
Mean

5.00 –

4.98 –

4.96 –
LCL = 4.94
4.94 –

4.92 –
| | | | | | | | | |
1 2 3 4 5 6 7 8 9 10
Sample number

12
Example of Variable Control Chart – R chart

∑R 1.15 UCL = D4R = 2.11(0.115) = 0.243


R= = = 0.115
k 10 LCL = D3R = 0(0.115) = 0

where
R = range of each sample
k = number of samples

Retrieve factor value D3 and D4

13
Example of Variable Control Chart – R chart

0.28 –
0.24 –
UCL = 0.243
0.20 –
Range

0.16 – R = 0.115
0.12 –
0.08 –
0.04 – LCL = 0
0– | | | | | | | | | |
1 2 3 4 5 6 7 8 9 10
Sample number

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Quality Control
Determining Control Limits for x-bar and R-Charts

SAMPLE SIZE FACTOR FOR x-CHART FACTORS FOR R-CHART


n A2 D3 D4

2 1.88 0.00 3.27


3 1.02 0.00 2.57
4 0.73 0.00 2.28
5 0.58 0.00 2.11
6 0.48 0.00 2.00
7 0.42 0.08 1.92
8 0.37 0.14 1.86
9 0.44 0.18 1.82
10 0.11 0.22 1.78
11 0.99 0.26 1.74
12 0.77 0.28 1.72
13 0.55 0.31 1.69
14 0.44 0.33 1.67
15 0.22 0.35 1.65
16 0.11 0.36 1.64
17 0.00 0.38 1.62
18 0.99 0.39 1.61
19 0.99 0.40 1.61
20 0.88 0.41 1.59

Back to X-bar Back to R Chart


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Type of Common Attribute Control Chart use in Quality.

P chart
• A chart of the percent defective in each sample set with
unequal sample sizes.

C chart
• A chart of the number of defects per unit in each sample set.

U chart
• A chart of the average number of defects in each sample set.

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Example of Attribute Control Chart – P chart

A garment factory produces jean. The product should be free of


defects, meaning no tear, loose thread and etc. Sampling the
batches, quality inspector collected the following data:

NUMBER OF PROPORTION
SAMPLE DEFECTIVES DEFECTIVE
1 6 .06
2 0 .00
3 4 .04
: : :
: : :
20 18 .18
200

20 samples of 100 pairs of jeans

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Example of Attribute Control Chart – P chart

total defectives
p = total sample observations = 200 / 20(100) = 0.10

p(1 - p) 0.10(1 - 0.10)


UCL = p + 3 = 0.10 + 3
n 100
UCL = 0.190

p(1 - p) 0.10(1 - 0.10)


LCL = p - 3 = 0.10 - 3
n 100
LCL = 0.010

z = number of standard deviations from process average


p = sample proportion defective; an estimate of process average

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Example of Attribute Control Chart – P chart
0.20

0.18 UCL = 0.190

0.16

0.14
Proportiondefective

0.12
p = 0.10
0.10

0.08

0.06

0.04

0.02 LCL = 0.010

2 4 6 8 10 12 14 16 18 20
Sample number

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Example of Attribute Control Chart – C chart
A new hotel had completed. The hotel room need to be
inspected before ready for opening. The quality inspector
collected the following data:

Number of defects in 15 sample rooms


NUMBER
OF
SAMPLE DEFECTS
190
1 12 c= = 12.67
15
2 8
UCL = c + zσc
3 16
= 12.67 + 3 12.67
: : = 23.35
: : LCL = c + zσc
15 15 = 12.67 - 3 12.67
190 = 1.99
where
c = number of defects per sample

20
Example of Attribute Control Chart – C chart

24
UCL = 23.35
21

18
Number of defects

c = 12.67

15

12

3 LCL = 1.99

2 4 6 8 10 12 14 16
Sample number

21
Example of Attribute Control Chart – U chart
A transcription company wants to assess its accuracy. An
analyst samples transcribed documents and counts the number
of errors. Because the number of pages in each document
differs, comparing the number of errors across documents is
misleading. Instead, the analyst compares the average errors
per page.

Number of defects in 27 documents


NO. OF NO OF AVE. ERROR
PAGES DEFECTIVES PER PAGEu = ∑c 219
= = 0.243
∑n 901
32 7 .21
26 6 .23 UCL = u + 3
u
n
49 9 .19 0.243
= 0.243 + 3 = 0.5275
27
. . .
u
. . . LCL = u − 3
n

_ _ . 0.243
= 0.243 −3 = − 0.0416 OR 0
27
901 219
22
Quality Control
Example of Attribute Control Chart – U chart

23
Which Control Chart to use?
%
Variable No Defective or Defects
Data? Defects?

Yes %
Defective
No Constant Constant
Rational
I & MR chart Sample Sample
Subgroups?
Size? Size?

No No
Yes Yes Yes

p-chart u-chart
Yes Easy to
Subgroup
Compute
Size >8?
sigma?
np- or p-chart c- or u-chart
No Yes
No
Attribute charts require larger sample sizes 50
to 100 parts in a sample
X-bar & R chart X-bar & S chart
Variable charts require smaller samples 2 to 10
parts in a sample

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What is Quality Assurance?

Assurance:
The act of giving confidence, the state of being certain or the
act of making certain.

Quality assurance:
The planned and systematic activities implemented in a quality
system so that quality requirements for a product or service will
be fulfilled.

Quote from ASQ website

25
What is acceptance sampling?

• Acceptance Sampling

 A form of inspection that is used to determine whether or


not goods are coherent with a set standard of quality.

 A Statistical quality control technique, where a random


sample is taken from a lot, and upon the results of the
sample taken the lot will either be rejected or accepted.

 To determine the quality level of an incoming shipment or,


at the end production.

 To ensure that the quality level is within the level that has
been predetermined

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Quality Assurance
What is acceptance sampling?

• The decision to accept or reject the shipment is based on the


following set standards:

 Lot size = N
 Sample size = n
 Acceptance number = c
 Defective items = d
 If d <= c, accept lot
 If d > c, reject lot

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Why use acceptance sampling?

• To avoid problems with 100% inspection


 Inspection of product is very expensive,

 When product must be destroyed to test.

 Inspection of product is very time consuming.

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How/When use acceptance sampling?

• Determine how many units, n, to sample from an lot.

• Determine maximum number of defective items, d, that can be


found before the lot is rejected.

• Determine the acceptance level to know the acceptance


number, c.

• If d <= c, accept lot.

• If d > c, reject lot.

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How/When use acceptance sampling?

• At any point in production.

• The output of one stage is the input of the next.

30
How/When use acceptance sampling?

• Sampling at the Input stage


 Prevents goods that don’t meet standards from entering
into the process.

 This saves rework time and money.

• Sampling at the Output stage


 Can reduce the risk of bad quality being passed on from the
process to a consumer

 This can prevent the loss of prestige, customers, and


money

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Quality Assurance
How/When use acceptance sampling?

• Sampling at the Process stage


 Can help adjust the process and reduce the amount of poor
quality in production.

 Helps to determine the source of bad production and


enables return for reprocessing before any further costs
may be incurred.

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Quality Assurance
Acceptance sampling explained

• Acceptable Quality levels(AQL) -


Number of defect percentage allowed in a lot which can still be
considered accepted(Type I error).

• Lot Tolerance Percent Defective(LTPD) -


Amount of defects that will come with a lot of goods(Type II
error).

• Sampling Plan -
Forms after n and c values have been found.

• Producers risk -
Risk associated with a lot of acceptable quality rejected.

• Consumers risk -
Receive shipment, assume good quality, actually bad quality.

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Quality Assurance
Acceptance sampling explained

• Alpha (α) –
Type I error(producers risk).

• Beta (ß) -
Type II error(consumers risk)

• N-
Sample size taken for your sampling plan.

• C-
Where rejections would occur when defects exceeded this
percent

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Quality Assurance
Acceptance sampling explained

• Operating characteristics curve(OC) -


A graph, displaying standards at which shipments would be accepted.

P(Accept Whole Shipment)


Probability is not 100%: Risk of
100% keeping bad shipment or
returning good one.
Keep whole
shipment
Return whole
shipment

0%
0 1 2 3 4 5 6 7 8 9 10
Cut-Off % Defective in Lot

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Quality Assurance
Acceptance sampling explained

• Two classifications of acceptance plans

 Attributes(“go no-go”)

 Variables

36
Quality Assurance
Acceptance sampling explained

• Attributes(“go no-go”) -
Defectives-product acceptability across range
Defects-number of defects per unit

• Variable(continuous) -
Usually measured by mean and standard deviation

 Remember
You are not measuring the quality of the lot, but, you are to
sentence the lot to either reject or accept it

37
Quality Assurance
Acceptance sampling explained

• ANSI/ASQC Z1.4. Sampling Procedures and Tables for


Inspection by Attributes
(Replaced MIL-STD-105E, Sampling Procedures and Tables for
Inspection by Attributes )

38
Quality Assurance
Acceptance sampling explained

ANSI/ASQC Z1.4. Sampling Procedures and Tables for


Inspection by Attributes

• Acceptance sampling system for inspection by attributes. It is


indexed in terms of acceptance quality level (AQL).

• Aim - to induce a supplier to maintain a process average at


least as good as the specified acceptance AQL, whilst at the
same time providing an upper limit for the risk to the consumer
of accepting the occasional poor lot.

• Applicable to end products, raw materials, operations,


maintenance operations, administrative procedures.

39
Quality Assurance
Acceptance sampling explained

ANSI/ASQC Z1.4. Sampling Procedures and Tables for


Inspection by Attributes

• Intended to be used for a continuing series of lots, which will


allow the application of switching rules. The rules provide:

 protection to the consumer should a deterioration in quality


be detected.

 an incentive to the supplier to reduce inspection costs


should consistently good quality be achieved.

• Can also be used for inspection of lots in isolation.

40
Quality Assurance
Acceptance sampling explained

ANSI/ASQC Z1.4. Sampling Procedures and Tables for


Inspection by Attributes

• Normal inspection -
Use of a sampling plan with acceptance criteria devised to
secure the producer a high probability of acceptance when the
process average of the lot is better than the AQL. Used when
there is no reason to suspect the process
average differs from an acceptable level.

• Tightened inspection –
Use of a sampling plan with an acceptance criteria that is
tighter than that for the corresponding plan for normal
inspection. Invoked when the inspection results of consecutive
lots indicate that the process average might be poorer than the
AQL.

41
Quality Assurance
Acceptance sampling explained

ANSI/ASQC Z1.4. Sampling Procedures and Tables for


Inspection by Attributes

• AQL values shall not exceed 10% nonconforming.

• When the quality level is expressed as number of


nonconformities per 100 items, AQL values up to 1000
nonconformities per 100 items may be used.

• Sampling:
 Sample selection must be drawn from the lot by simple
random sampling.

 When double or random sampling is to be used, each


subsequent sample shall be selected from the remainder of
the same lot.

42
Quality Assurance
Acceptance sampling explained

ANSI/ASQC Z1.4. Sampling Procedures and Tables for


Inspection by Attributes

• 4 special inspection levels - S1, S2, S3, S4.

• 3 general inspection levels - I, II, III.

• Special inspection levels used when sample size must be kept


small and larger sampling risks can be tolerated.

• Level II will be used unless another inspection level is specified.

• Level I is used when less discrimination is required, Level III


when greater discrimination is required.

43
Quality Assurance
Acceptance sampling explained

ANSI/ASQC Z1.4. Sampling Procedures and Tables for


Inspection by Attributes
Sample Size Code Letter Chart
General Inspection Levels
Lot or batch size I II III
2 8 A A B
9 15 A B C
16 25 B C D

26 50 C D E
51 90 C E F
91 150 D F G

151 280 E G H
281 500 F H J
501 1,200 G J K

1,201 3,200 H K L
3,201 10,000 J L M
10,001 35,000 K M N

35,001 150,000 L N P
150,001 500,000 M P Q
500,001 and Over N Q R

44
Quality Assurance
Acceptance sampling explained

ANSI/ASQC Z1.4. Sampling Procedures and Tables for


Inspection by Attributes

Single Sampling Plan


A cceptable Q uality Level C hart
Acceptable quality levels ( norm al inspection )

S am p le 0.010 0.015 0.025 0.040 0.065 0.10 0.15 0.25 0.40 0.65 1.0 1.5 2.5 4.0 6.5 10 15
S iz e

Code S am p le Ac Rc Ac Rc Ac Rc Ac Rc Ac Rc Ac Rc Ac Rc Ac Rc Ac Rc Ac Rc Ac Rc Ac Rc Ac Rc Ac Rc Ac Rc Ac Rc Ac Rc
L etter S iz e

A 2 0 1

B 3 0 1 1 2

C 5 0 1 1 2 2 3

D 8 0 1 1 2 2 3 3 4

E 13 0 1 1 2 2 3 3 4 5 6

F 20 0 1 1 2 2 3 3 4 5 6 7 8

G 32 0 1 1 2 2 3 3 4 5 6 7 8 10 11

H 50 0 1 1 2 2 3 3 4 5 6 7 8 10 11 14 15

J 80 0 1 1 2 2 3 3 4 5 6 7 8 10 11 14 15 21 22

K 125 0 1 1 2 2 3 3 4 5 6 7 8 10 11 14 15 21 22

L 200 0 1 1 2 2 3 3 4 5 6 7 8 10 11 14 15 21 22

M 315 0 1 1 2 2 3 3 4 5 6 7 8 10 11 14 15 21 22

N 500 0 1 1 2 2 3 3 4 5 6 7 8 10 11 14 15 21 22

P 800 0 1 1 2 2 3 3 4 5 6 7 8 10 11 14 15 21 22

Q 1 ,2 5 0 0 1 1 2 2 3 3 4 5 6 7 8 10 11 14 15 21 22

R 2 ,0 0 0 1 2 2 3 3 4 5 6 7 8 10 11 14 15 21 22

45
Quality Assurance
Acceptance sampling explained

ANSI/ASQC Z1.4. Sampling Procedures and Tables for


Inspection by Attributes

Double Sampling Plans


Normal Inspection

Code Sample Cumu. AQL


Sample
letter Size Samples 1.5 2.5 4 6.5 10
Acc Re Acc Re Acc Re Acc Re Acc Re
G First 20 20 0 2 0 3 1 3 2 5 3 6
G Second 20 40 1 2 3 4 4 5 6 7 9 10
H First 32 32 0 3 1 3 2 5 3 6 5 9
H Second 32 64 3 4 4 5 6 7 9 10 12 13
J First 50 50 1 3 2 5 3 6 5 9 7 11
J Second 50 100 4 5 6 7 9 10 12 13 18 19

46
Quality Assurance
Acceptance sampling explained

ANSI/ASQC Z1.4. Sampling Procedures and Tables for


Inspection by Attributes

• Example
A lot containing 210 units is to be inspected using General
Inspection Level II to a 2.5% AQL. Single sampling is to be
used.

Find the lot size (Slide 44)


The sample size code is G

The sampling plan for sample size code letter G is (Slide 45)
32 and we accept the lot if 2 or lower not acceptable items
are found. We reject the lot if 3 or more not acceptable
items are found.

47
Quality Assurance
Acceptance sampling explained

MIL-STD-1235C, Single and Multi-Level Continuous Sampling


Procedures and Tables for Inspection by Attributes

Introduction

The first of the continuous sampling plans, CSP-1, was


introduced by Dodge in 1943. After CSP-1 several other
alternatives such as CSP-2, CSP-3, CSP-M and CSP-C has
been developed. CSP-1 is the simplest and probably most
used Continuous Sampling Plan. It is presented in numerous
quality management textbooks and also in MIL-STD-1235C

48
Quality Assurance
Acceptance sampling explained

MIL-STD-1235C, Single and Multi-Level Continuous Sampling


Procedures and Tables for Inspection by Attributes

 The Continuous Sampling Plan CSP-1 is for application to


continuous production meaning that each unit is inspected
as it is produced.

 Application of this sampling methods is for product flowing


in assembly-line fashion.

 The sampling plan also requires a homogeneous production


system.

49
Quality Assurance
Acceptance sampling explained

MIL-STD-1235C, Single and Multi-Level Continuous Sampling


Procedures and Tables for Inspection by Attributes

 All units must be made in accordance with the same


specification under stable conditions of production (in
statistical control).

 Any interruption in the production process, like the change


of material source, change of tooling, or stopping of
production, is assumed to terminate a production run
homogeneous conditions.

50
Quality Assurance
Acceptance sampling explained

MIL-STD-1235C, Single and Multi-Level Continuous Sampling


Procedures and Tables for Inspection by Attributes

The operating procedure of the CSP-1 plan as stated by Dodge


is as follows :

a) At the outset , inspect 100% of the units consecutively as


produced and continue such inspection until i units in
succession are found clear of defects.

b) When i units in succession are found clear of defects,


discontinue 100% inspection, and inspect only a fraction f
of the units, selecting individual units one at a time from
the flow of product, in such a manner as to ensure an
unbiased sample.

51
Quality Assurance
Acceptance sampling explained

MIL-STD-1235C, Single and Multi-Level Continuous Sampling


Procedures and Tables for Inspection by Attributes

c) If a sample unit is found defective, revert immediately to a


100% inspection of succeeding units and continue until again i
units in succession are clear of defects, as in step (a).

d) Correct or replace with good units, all defective units found.


Thus, the CSP-1 plans are characterised by two parameters i
and f.

The i and f value can be find in the standard.

52
Quality Assurance
Acceptance sampling explained

MIL-STD-1235C, Single and Multi-Level Continuous Sampling


Procedures and Tables for Inspection by Attributes

Inspection 100%

i consecutive No
acceptable
unit

Yes

Inspect fraction f of
the unit

Yes Defect found No


in sample

53
Quality Assurance
Acceptance sampling explained

MIL-STD-1235C, Single and Multi-Level Continuous Sampling


Procedures and Tables for Inspection by Attributes

The condition that must exist before the sampling plans may be
used are:
 Moving product.

 Ample space, equipment and manpower at or near the site


of inspection to permit rapid 100% inspection when
required.

 Relatively easy and quick inspection.

 A process which is producing, or is capable of producing


material whose quality is stable.

 The inspection is non-destructive.

54
Quality Assurance
Acceptance sampling explained

MIL-STD-1235C, Single and Multi-Level Continuous Sampling


Procedures and Tables for Inspection by Attributes

Current practice in Times Printers as follow:

1. Continuous inspection 100% of first 36 bundles.

2. If no defects are found, randomly sample 1 bundle out of 2


bundles.

3. Whenever a defect is found, correct the flaw and repeat


step 1.

55
Quality System & Tools
Total Quality Management (or TQM)

TQM is a business philosophy - a way of doing business coined


by W. Edwards Deming. It describes ways to managing
people and business processes to ensure complete customer
satisfaction at every stage.

TQM is often associated with the phrase - "doing the right


things right, first time". This revision note summarises the main
features of TQM.

TQM recognises that all businesses require "processes" that


enable customer requirements to be met. TQM focuses on the
ways in which these processes can be managed - with two key
objectives:

1. 100% customer satisfaction

2. Zero defects

56
Quality System & Tools
Total Quality Management (or TQM)

A core concept in implementing TQM is Deming’s 14 points, a


set of management practices to help companies increase their
quality and productivity:

1. Create constancy of purpose for improving products and


services.

2. Adopt the new philosophy.

3. Cease dependence on inspection to achieve quality.

4. End the practice of awarding business on price alone;


instead, minimize total cost by working with a single
supplier.

5. Improve constantly and forever every process for planning,


production and service.

6. Institute training on the job.


57
Quality System & Tools
Total Quality Management (or TQM)

7. Adopt and institute leadership.

8. Drive out fear.

9. Break down barriers between staff areas.

10. Eliminate slogans, exhortations and targets for the workforce.

11. Eliminate numerical quotas for the workforce and numerical


goals for management.

12. Remove barriers that rob people of pride of workmanship, and


eliminate the annual rating or merit system.

13. Institute a vigorous program of education and self-improvement


for everyone.

14. Put everybody in the company to work accomplishing the


transformation.
58
Quality System & Tools
Total Quality Management (or TQM)

Main Principles of TQM

The main principles that underlie TQM are summarised below:


Prevention Prevention is better than cure. In the long run, it is
cheaper to stop products defects than trying to find them

 Zero defects: The ultimate aim is no (zero) defects - or


exceptionally low defect levels if a product or service is
complicated

 Getting things right first time: Better not to produce at all


than produce something defective

 Quality involves everyone: Quality is not just the concern of


the production or operations department - it involves everyone,
including marketing, finance and human resources

59
Quality System & Tools
Total Quality Management (or TQM)

Main Principles of TQM (Cont’n)

 Continuous improvement: Businesses should always be


looking for ways to improve processes to help quality

 Employee involvement: Those involved in production and


operations have a vital role to play in spotting improvement
opportunities for quality and in identifying quality problems

60
Quality System & Tools
TQM Wheel

61
Quality System & Tools
ISO 9001 : 2008

ISO 9000 is a family of standards for quality management


systems. ISO 9000 is maintained by ISO, the International
Organization for Standardization and is administered by
accreditation and certification bodies. The rules are updated, as
the requirements motivate changes over time. Some of the
requirements in ISO 9001:2008 (which is one of the standards
in the ISO 9000 family) include

• a set of procedures that cover all key processes in the business;


• monitoring processes to ensure they are effective;
• keeping adequate records;
• checking output for defects, with appropriate and corrective
action where necessary;
• regularly reviewing individual processes and the quality system
itself for effectiveness; and
• facilitating continual improvement

62
Quality System & Tools
ISO 9001 : 2008

A company or organization that has been independently audited


and certified to be in conformance with ISO 9001 may publicly
state that it is "ISO 9001 certified" or "ISO 9001 registered".
Certification to an ISO 9001 standard does not guarantee any
quality of end products and services; rather, it certifies that
formalized business processes are being applied.

63
Quality System & Tools
ISO 9001 : 2008

ISO 9001:2000, the requirement standard, includes the


following main sections:

• Quality Management System

• Management Responsibility

• Resource Management

• Product Realization

• Measurement Analysis and Improvement

64
Quality System & Tools
Seven Basic Tool of Quality

The Seven Basic Tools of Quality is a designation given to a


fixed set of graphical techniques identified as being most helpful
in troubleshooting issues related to quality.

They are called basic because they are suitable for people with
little formal training in statistics and because they can be used
to solve the vast majority of quality-related issues.

65
Quality System & Tools
Seven Basic Tool of Quality

The tools are:

1. The cause-and-effect (Ishikawa diagram or fishbone


chart): Identifies many possible causes for an effect or
problem and sorts ideas into useful categories.

2. The check sheet: A structured, prepared form for collecting


and analyzing data; a generic tool that can be adapted for a
wide variety of purposes.

3. The control chart: Graphs used to study how a process


changes over time.

4. The histogram: The most commonly used graph for showing


frequency distributions, or how often each different value in a
set of data occurs.

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The tools are: (Cont’n)

5. The Pareto chart: Shows on a bar graph which factors


are more significant.

6. The scatter diagram: Graphs pairs of numerical data,


one variable on each axis, to look for a relationship.

7. Stratification (alternately flow chart or run chart): A


technique that separates data gathered from a variety of
sources so that patterns can be seen

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1. The cause-and-effect (Ishikawa diagram or fishbone


chart):

Appearance Responsiveness
equipment time
personnel
facility

accuracy Poor Service


One on one
courtesy service
dependability

Attention Reliability

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Constructing a Cause and Effect Diagram

• First, clearly identify and define the problem or effect for which
the causes must be identified. Place the problem or effect at
the right or the head of the diagram.

• Identify all the broad areas of the problem.

• Write in all the detailed possible causes in each of the broad


areas.

• Each cause identified should be looked upon for further more


specific causes.

• View the diagram and evaluate the main causes.

• Set goals and take action on the main causes.

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2. The check sheet:

• Simplifies data collection or analysis.

• Arrange data automatically so that they can be used easily at


later stage.

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Generate the check sheet:

1. Decide what event or problem will be observed. Develop


operational definitions.

2. Decide when data will be collected and for how long.

3. Design the form. Set it up so that data can be recorded simply


by making check marks or Xs or similar symbols and so that
data do not have to be recopied for analysis.

4. Label all spaces on the form.

5. Test the check sheet for a short trial period to be sure it collects
the appropriate data and is easy to use.

6. Each time the targeted event or problem occurs, record data on


the check sheet.

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3. The control chart:

• Helps in reducing the process variability


• Performance monitoring over time
• Out-of-control and a particular trend is immediately known
• Helps in deciding the quality of out coming samples of a lot

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Steps Used in Developing Process Control Charts:

1. Identify critical operations in the process where inspection


might be needed.

2. Identify critical product characteristics.

3. Determine whether the critical product characteristic is a


variable or an attribute.

4. Select the appropriate process control chart.

5. Establish the control limits and use the chart to monitor and
improve.

6. Update the limits.

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4. The histogram:
Histogram
70 65

# times ordered
60
50
40 33
30
20
12
8
10
0 0 1
0
1 2 3 4 5 6 7

Slices of Pizza

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Creating a Histogram

1. Collect data and sort it into categories.

2. Then label the data as the independent set or the dependent


set.

3. The characteristic you grouped the data by would be the


independent variable.

4. The frequency of that set would be the dependent variable.

5. Each mark on either axis should be in equal increments.

6. For each category, find the related frequency and make the
horizontal marks to show that frequency.

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5. The Pareto chart:

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Constructing a Pareto Chart:

1. First, information must be selected based on types or


classifications of defects that occur as a result of a process.

2. The data must be collected and classified into categories.

3. Then a histogram or frequency chart is constructed showing the


number of occurrences.

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6. The scatter diagram:

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Constructing a Scatter Diagram:

1. First, collect two pieces of data and create a summary table of


the data.

2. Draw a diagram labeling the horizontal and vertical axes.

3. It is common that the “cause” variable be labeled on the X axis


and the “effect” variable be labeled on the Y axis.

4. Plot the data pairs on the diagram.

5. Interpret the scatter diagram for direction and strength.

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• Stratification (alternately flow chart or run chart):

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• Creating a Flow Chart:

1. First, familiarize the participants with the flow chart symbols.

2. Draw the process flow chart and fill it out in detail about each
element.

3. Analyze the flow chart. Determine which steps add value and
which don’t in the process of simplifying the work.

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• Stratification (alternately flow chart or run chart):

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Creating a Run Chart:

• Gathering Data - Some type of process or operation must be


available to take measurements for analysis.

• Organizing Data - Data must be divided into two sets of


values X and Y. X values represent time and values of Y
represent the measurements taken from the manufacturing
process or operation.

• Charting Data - Plot the Y values versus the X values.

• Interpreting Data - Interpret the data and draw any


conclusions that will be beneficial to the process or operation.

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