‫‪1‬‬

‫بسم ہللا الرمحن‬

‫الرحمی‬
2 QUALITY CONTROL &
QUALITY ASSURANCE

GROUP NO.1

MAERIA AAMER SABAH ROLL NO. 09

Submitted to -------------
Issued on wed. Oct 2nd
Due date Tue. Oct 3rd
Submitted on Tue. Oct 3rd
3 BASIC DEFINITIONS
QUALITY
• Standard of something
• Degree of excellence of something

QUALITY POLICY
• Overall intentions
• Directions of an organization related to product quality

QUALITY ASSURANCE
• Implementations of different procedure
• OR
• Set of activities
• Ensure proper performance of a method
• Proactive process
• Ensures the quality of product processes
4 QUALITY CONTROL
 Ensure the quality of products
 Reactive process
 Identify defects in the actual product produced.

QUALITY SYSTEM
 Combinations of ;
o Organizational structure
o Procedures
o Processes
o Resources
 To implement the quality management
 ORGANIZATIONAL STRUCTURE
5

 Responsibilities
 Authorities
 Relationships
 All these maintains performance of an organization

PROCEDURES
 A specified way to perform an activity

PROCESS
 set of resources
 Set of activities
 Transform inputs into outputs
 QUALITY MANAGEMENT
6  People in organization set up quality criteria

QUALITY AUDIT
 Verifies quality processes
 Verifies result meets to standard

PROCESS VALIDATION
 Analysis of the data obtained from product or design

PROCESS QUALIFICATION
 Qualification of manufacturing and production process
 Confirms that they are able to operate at certain standards
7 7 TOOLS OF QUALITY CONTROL
I. Cause and effect diagram
II. Check sheet
III. Control chart
IV. Histogram
V. Pareto chart
VI. Scatter plot
VII. Stratification
8 CAUSE AND EFFECT DIAGRAM
 Problems have causes
 Causes have effects
 Effects cause defects in product

Equipment Process People

Problem

Material Environment Management

Cause Effect
9 QUANTITATIVE CHECK SHEET OF DEFECTS
CHECK SHEET IN A JUICE COMPANY
Mon Tue Wed Thurs Fri sat Total
Quantify defects by types Defects type
Quantify defects by location Bottles 2 / / / 2 1 5
Quantify defects by instrumental broke
cause Cap lost 3 1 1 / / / 4
Missed / / / 1 / / 1
DATA label
Dirt 7 5 2 4 3 / 21
Wrong 1 / / / 5 7 13
order
QUALITATIVE QUANTITATIVE Damage 3 4 2 3 2 / 14
while
packaging
Total 16 10 5 8 12 8 58
10 CONTROL CHART
 Determine the process is in state of
9 Series 1
control
Consist of 8
UCL
I. Statistical quantities 7

II. Mean of sample 6

CL
III. Center line of mean of statistics 5

IV. Standard deviation or variance 4

V. Upper and lower control limits 3

2
LCL
1

0
10 20 30 40 50 60 70 80 90 100 110 120 130 140
11 HISTOGRAM
 Graphical representation of a numerical data
 Used to estimate to probability distribution of continuous variable

Histogram
6

0
Category 1 Category 2 Category 3 Category 4

Series 1 Series 2 Series 3

12 PARETO CHART
Bars and lines are used 4.5 Pareto chart
Bars shows the individual value
4
Line shows commutative total
3.5

2.5

1.5

0.5

0
Category 1 Category 2 Category 3 Category 4

Column2 Linear (Column2)

13 SCATTER PLOT
 Use Cartesian coordinates
 Two variables are used

Y-Values
7

0
0 1 2 3 4 5 6 7 8
14 STRATIFICATION
 Expressed in the form of boxes
 Method of sampling in a population

GROUP 1 GROUP 2
River water River animals

SAMPL
E

GROUP 4 GROUP 3
River plants River sediments
15 7 TOOLS FOR QUALITY ASSURANCE
I. Affinity diagram
II. Process decision program chart
III. Interrelationship diagraphs
IV. Tree diagram
V. Prioritization matrix
VI. Matrix diagram/matrix based charts
VII. Network diagram
16
AFFINITY DIAGRAMS
 Japanese anthropologist developed this method named Jiro kawakita. That’s why this method is
also called as KJ Method
 Organize large amount of ideas into meaningful groups

1 level
Identify the area of concern
st

label

2 nd
level
Summaries set of group 2nd level
label label

Single Single Single

Captured during single point
point point point
17 PROCESS DECISION PROGRAM
CHARTS
 Identify important steps to reach a goal.

Control Plans not

Require audit prior
to process
plans completed
SIGN OFF

Require metrology
Metrology Gauges not ready prior to training
SIGN OFF

Operator Operators not

Require supervisor
SIGN OFF
training identified
18 INTERRELATIONSHIP DIAGRAPHS
 Visual display between cause and effect relationship.
 Multiple variables, Complex problems, Desired outcomes.

Promised
Excessive over
dates
scheduling of
patient
Inadequate
High systems
turnover of
nurses

Inadequate
training of
new nurses
Inconsistent use
if different labs
19 TREE DIAGRAMS
 Systematic diagrams
 Used to break down broad categories into finer and finer levels of details

Types of mixtures
1st 2nd
3rd level
level level
solid

Solid liquid

Gas
solid
Mixtures Liquid
liquid
Gas
solid

Gas Liquid

Gas
20 PRIORITIZATION MATRICES
 Provides the mechanism for ranking the relative importance of ideas and issues

Important but not

urgent Important and
urgent
Decide when
Do it now
you will do it

Urgent but not

not important nor important
urgent Delegate to
Do it later somebody
else
21 MATRIX DIAGRAM/MATRIX BASED CHARTS
 Illustrate the relationship among different factors

Key;
R; Reasonable Person Person Person Person
I; Inform A B C D
A; Accountable
C; Consult Task A A I R
Task B R A
Task C C R A
Task D C A R
Task E I R A
22
COMPONENTS OF QUALITY
ASSURANCE
Management

Training

Standard operating procedures

Equipment maintenance and calibration

Sampling

Reporting results
23 VALIDATION
 To make sure that specific procedure will produce desired product.

PHASES OF VALIDATION
 Design qualification
 Installation qualification
 Operational qualification
 Performance qualification
 Maintenance qualification
 Component qualification
 DESIGN QUALIFICATION

24

 Initial step
 Review the design’s quality

INSTALLATION QUALIFICATION
 Proper installation of the instrument in selected environment
 Check if environment is suitable for operation

OPERATIONAL QUALIFICATION
 Determine the proper functioning of the system
 Operation is going well
25 PERFORMANCE QUALIFICATION
 Performance is on right track
 Expected performance Matches the real performance in real world

Relationship;

Design Instrumental
qualification qualification

Operational Performance
qualification qualification

Maintenance Component
qualification qualification
26

SIX SIGMA
 Methodology of eliminating defects
 Continuous improving methodology
 Eliminates defects from products process and services
 Professionals of six sigma are KEY STAKEHOLDERS.
27 PRINCIPLES
 Focus on customers
 Identify and understand how work gets alone
 Manage improve and smooth the process flow
 Manage by fact and reduce variation or make zero defect

IMPORTANCE OF SIX SIGMA

 Companies reduce defects
 Improve quality of business processes
 Defines specific goals
 Defines objective of project
28 SIX SIGMA

Basic processes of six sigma are DMIC and DMAICT

Define Measure Analyze

opportunity performances opportunity

Improve Transfer best

Control performance
performance practice
29
ISO
international standards organization

 Non-governmental organization.
 163 members of ISO.
 Sets the standards for the quality of product

STANDARDS
 Documents that provides
• Requirements
• Specifications
• Guidelines
• Characteristics
30 BENEFITS OF ISO
 Suitable for both large and small organization
 Better internal management
 Less wastage
 Increase in efficiency, productivity and profit
 Improved customer retention and acquisition.
 Consisted outcomes, measured and monitored
 Globally recognized standards

DEVELOPMENT OF STANDARDS
 Through consensus process
 Experts from all over the world develop standard
31 MONITORING
 Regular observations of process.
 Recording of all procedure.
 Involves giving feedback for improvement of work.
 The gathered information is then reported which is used to improve the process.

PURPOSE
 Plan project and implementation.
 Ensure the right path.
 Determine that inputs are well utilized.
 Identify problems and find solutions.
 Ensure the completion of right work on right time
32 PERIODICAL TRAININGS
 Process for providing required skills to employee.
 Important for doing their job effectively, skillfully and quantitatively.
 Training is given by experts or professional.
 Must held on every level every year.
 Improve quality of work
 Quality review process
33

1
• Self assessment

2
• Service detail

3
• Notifications

4
• Informing representative
5
• Site visit schedule
6
• Quality review
7
• Quality review report
34 CALIBRATION
 Measuring the actual measurement of the instrument
 Determine the error in the graduations

Purpose
 Evaluate the accuracy in measurement
 Reduce error
 Traceability of the measurement

Significance
 Reduce risks of error
 Bring accuracy in calculations
35 TYPES OF CALIBRATION

 INSTRUMENTAL CALIBRATION
Finding the errors in measurement of various instruments
For-example calibration of glassware
 TEMPERATURE CALIBRATION
Finding the errors in measurement of thermal equipment
For-example thermometer
 EQUIPMENT CALIBRATION
Finding the errors in measurement of various equipments
For-example weighing balance
36

 MECHANICAL CALIBRATION
Find errors in the measurements of mass, torque, force and vibration elements
For-example screw drivers, scales.
 ELECTRICAL CALIBRATION
Finding the errors in the measurements of voltage current frequency and resistance
For-example clamp meter, loop testers.
37

The
end