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Quality Engineering Best Practice

Dr. Attia Gomaa


Industrial Engineering Professor & Consultant
Mechanical Eng. Department Shoubra Faculty of Eng. - Benha University
& Engineering and Science Services - American University in Cairo
Facebook: Attia Gomaa & Group: Quality Management Dr. Attia Gomaa
TQM Practice Dr. Attia
Quality Engineering BestSeptember 2016Gomaa - 2016 1
Quality Engineering Best Practice
Contents:

Part I: Quality Management


Quality Definitions
Quality Management
Quality Management System (QMS)
Total Quality Management (TQM)
Cost of Quality
ISO 9001:2015
Key Performance Indicators (KPIs)

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Quality Engineering Best Practice
Contents:
Part II: Quality Control Tools
Quality Control Tools
Case Studies
Part III: Continuous Improvement Approaches
KAIZEN Approach
Lean Approach
Six Sigma Approach
Lean-Six Sigma Approach
Lean Six Sigma Supply Chain
Case Studies

Grading Policy:
Class work: 10%, Project: 30% , Final Exam: 60%

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Rules of the Course:

This is an Open Discussion Course:

Share Knowledge
Share Experiences Team Approach

Share Best Practices

Share Questions

Remember You cant do it alone!

Let us be a teamwork.
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Quality Management
What is Quality?
What is Quality Management?

What is Quality Management System (QMS)?

What is Total Quality Management (TQM)?

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What is Quality?
3) The degree of customer satisfaction

Quality

2) Free from Defects 1) Achieve Features


(Zero defect) (Specs / Scope of work)

A degree of excellence (Oxford Dictionary)

Quality means that a product should meet its specification


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Achieving a 99% level of quality

means

accepting a 1% error rate

Result:
In Egypt a 1% error rate would mean everyday
1% failure
14.4 minutes without water or electricity
(0.01 * 24 hours/day * 60 minutes)

Two bad landings at Cairo airport


(0.01 * 200)

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What is Quality?
The degree of customer satisfaction.
The degree to which a product or service meets specified requirements.
The totality of features and characteristics of a product or service that bear on its
ability to satisfy stated or implied needs. ISO 8402 / ISO 9000
Dimensions of Quality (5 Fit)

Fit to Use Improvement

Fit to Customer
Fit to Standard
Fit to Time
Fit to Price

There is a positive link between quality and productivity.


Quality is a journey, not a destination.
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Who are the customers?
Customers are all those affected by our work (product,
service or process):
External Customers
Internal Customers

Customers Types:

Customers

Short term Long term


Customers customers

--
--- --- ---- --- ---

Voice of the customer Critical Parameters


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Customer Satisfaction:

Time Scope of
work

Price

Quantity Quality

Customer satisfaction is a marketing term that measures how


products or services supplied by a company meet a
customers expectation.
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Customer Satisfaction
Customer Expectations

Company Operations Customer Satisfaction


(Processes)

American Customer Satisfaction Index (ACSI):


Measures customer satisfaction
Established in 1994
Web site: www.acsi.org
Examples (in 2003):
Amazon.com scored 88 (highest in service)
Dell scored of 78 (highest in computer industry)
Cadillac scored 87 (highest in car industry)
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Effects of poor Quality Low customer satisfaction
Low productivity, sales & profit
Low morale of workforce
More re-work, material & labor costs
High inspection costs
Delay in shipping
Higher inventory costs
Greater waste of material

Effect of Quality Improvement:


Improve Quality (Product/Service)

Increase Productivity (less rejects, faster job)

Lower Costs and Higher Profit

Improve customer satisfaction


Business Growth & Competitive
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Perspectives on Service Quality

Product-Based:
Quality is precise and measurable

User-Based:
Quality lies in the eyes of the user

Manufacturing-Based:
Quality is conformance to the firms developed
specifications

Value-Based:
Quality is a trade-off between price and value

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What is Reliability?

Probability of zero failure during standard time according to


standard working conditions.

R(t)

0
time

Reliability is a dynamic aspect of Quality.


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What is Quality Management (QM) ?

QM is a systematic approach for Quality planning,


control and improvement to improve the quality
features at low cost.
4 Pillars of Quality Management:
Juran Trilogy:
Quality Planning Three aspects of quality
managerial systems:
Quality Quality planning

Defining Quality control


Quality Quality
Improvement Control Quality improvement

Quality management should be separate from production / project


management to ensure independence.
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Quality Management

Systematic approach to achieve certain quality at low cost.


Systematic approach to improve the product quality at low cost.
Systematic Approach For Long Term Continuous Improvements.

Jurans Quality Trilogy


Quality Planning Quality Control Quality Improvement
Establish quality goals Prove the process can Seek to optimise the
Identify customer needs produce under process via tools of
Translate needs into our operating conditions diagnosis
language Transfer process to
Develop a product for operation
these needs
Optimise product
features for these needs

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What is Quality Management (QM) ?
QM is a systematic approach for Quality planning, control and
improvement to improve the quality features at low cost.

Quality Management Cycle (10 Steps):


1) Status Analysis
10) Close out
Reporting 2) Decomented
Information

9) Quality Improvement
Recommenaditions 3) Quality Policy
& Objectives
Continuous
Improvement
8) Quality Control 4) Quality
(KPIs) Plans

5) Quality
7) Weekly
Orgnization
Inspection Report
6) Execution &
Inspection
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Quality Management System (QMS):
QMS is a set of policies, processes and procedures required for quality
planning, control and improvement to meet the customer requirements.

Quality Policy
Customer
Requirements Customer
Quality Assurance Satisfaction

Quality Planning Quality Control

Quality Improvement

ISO 9000 defines a QMS as:


Management system to direct and control an
organization with regard to quality
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Quality Management Activities

Quality Assurance Organization Level (ISO 9001)


Establish organisational procedures and standards for quality.

Quality Planning Product / Project Level


Select applicable procedures and standards for a particular project and
modify these as required.

Quality Control Process Level


Ensure that procedures and standards are followed by the project
development team.

Quality Assurance is a systematic approach to ensure the costumer quality.

Quality management should be separate from project management to ensure


independence.
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Quality Management System (QMS):

Quality Assurance (ISO 9001)


Quality
Quality Planning
Policy
Quality Control
Inspection Quality
Plan

Information Target Quality


(Measurable)

Quality assurance standards, codes, plans, regulations, ..


Quality control inspection, testing, analysis
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Quality Management System (QMS):
Whole-System Process Approach to Quality

Improvement
Quality
Policy
Top Objectives

Planning
Middle
Control
Operational

Inspection
Feedback
Site / Workshop

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Quality Management System (QMS):
Whole-System Process Approach to Quality

Improvement
Quality
Policy
Quality
Auditing Assurance Objectives
(Internal / External)
Quality Planning Planning
Control
(KPIs)
Quality Control
(Checklist / Standard Forms)

Feedback Inspection & Testing


(Inspection or QA/QC Forms or ITP Checklist)

(QA/QC) Quality Assurance/Quality Control (Inspection and Test Plan) checklist


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Objective Levels:
Benchmarking
(Best of the best practice for continuous improvements
Internal / External)

Vision / Policy
(Strategic Objectives 3 to 10 years)

Goals SMART:
(Long term 2 to 3 years) Specific
Measurable
Applicable
Reliable
Targets Time frame
(Short term month to year)
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Quality Policy (QP):
describes the organization approach to quality
One Page Quality Management Roadmap.
It should be understood to all level of organization.

Quality Quality
Objectives Guidelines / Rules
Quality
Standards

Customer Satisfaction Quality Culture


Continuous Improvement All Staff Responsibility
etc. ISO 9001:2008 Staff Training

Technical Standards Leaders & Teamwork


etc.

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Quality Policy Evaluation

Company Name /
1 Fields

2 Quality Objectives

3 Quality Standards

4 Guidelines / Rules

Top Management
5 Commitment

Conclusion:

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For Example;

Quality Policy
ABC Steel Company is committed to ensure customer satisfaction and
minimize rejects. The company achieves this goal by establishing,
documenting, implementing and maintaining an effective and efficient
Quality Management System that meets the requirements of ISO
9001:2008. Quality improvement is a continuous process and it is
primary responsibility of management. All Staff must consistently
strive for a six sigma target.

General Manager Quality Manager

------ --------

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For Example;

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Project Quality Plan (PQP) (Project Quality Management Plan)
It is a project-specific quality plan that describes the activities, standards, tools and
processes necessary to achieve quality in the delivery of a project.
The purpose of the Quality Management Plan is to describe how quality will be
managed throughout the lifecycle of the project.
A Project Quality Plan Checklist:
1. Work Breakdown Structure (WBS)
2. Checkpoints
3. Responsible
4. Schedule
5. Reference
6. Remark
For example; A Project Quality Plan Checklist:
Project Description: A Gas Pipeline 24" Client: --- Contractor: --- Start: --- Finish: ---
WBS Checkpoints Responsible Schedule Reference Remark
Design Design Control
Procurement Procurement Control
Construction Construction Control, etc.
Testing
Finishing

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Project Quality Plan
Project:

Client: Start Date: Finish Date:

Project Duration; Month


# Main Activities Responsibility
1 2 3 4
1
2
3
4

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QA/QC Check List (Checklist / Standard Forms for each process)
Quality Assurance / Quality Control checklist is used to ensure the quality of a
product / process. It defines set of tasks & inspections to be performed in
different stages of the product/process.
QA / QC Checklist for ----- Process: (Leader / Engineer)
Phase Item Limits Status Responsibility
Check

Before
Process

During
Process

After
Process

Comments:

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QA/QC Check List:
Quality Assurance / Quality Control checklist is used to ensure the quality of a
product / process. It defines set of tasks & inspections to be performed in
different stages of the product/process.
QA / QC Checklist for Arc Welding Process: (Leader / Engineer)
Phase Item Limits Status Responsibility
Check Metal Sheets (type, size, defects, etc)
Check Welding Electrode (type, grade, humidity, etc)
Before Check Welding Machine & Tools
Welding
Check Welding Conditions (angle, amp, temp., area)
Check Process (cleaning, area, safety, etc.)
Check Welding Procedure
During
Welding Check Welding Positions
Check Worker Efficiency (skills, safety, etc)
Visual Inspection (profile, size, surface defects, etc)
After Inspect Welding Quality
Welding Final Inspection
Quality Documentation

Comments:

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Assignment 1: Quality Management System

Company Overview
Quality Policy
For each project / product:
Work breakdown structure (WBS)
Project quality plan (PQP)
For each process / activity:
QA/QC check list for each process
Inspection and test plan
Actual inspection report
Process quality control

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What is Total Quality Management
(TQM)?
Total = Total View
= Everyone is involved in
= Everything

TQM is a management approach for long term continuous


improvement.

TQM means quality in all aspects of organization.

TQM = Quality System & System Quality


TQM = Quality Management & Management Quality
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TQM is a management system for a customer focused organization that

involves all employees in continual improvement of all aspects of the organization.

Continuous
4 Pillars of TQM: Improvement

CUSTOMER
FOCUS

Scientific Leadership &


Approach Teamwork

TQM is the integration of all functions and processes within an organization in order
to achieve continuous improvement of the quality of goods and services.

The goal is customer satisfaction.


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Problem-solving process
Deming Wheel, 1950
Plan-Do-Check-Act (PDCA) Circle

Improvement Identify problem


recommendations and develop plan
for improvement.

Assess the plan; Implement the


is it working? plan on a test
basis.

To improve any process we need to know where we are and where we want to be.
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Deming Improvement cycle - (Plan Do Check - Act )

(4)

(1) (3)

(2)

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For example; Management process

Improvement
Planning

Execution
Control

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For example; Inventory process

Inventory Inventory
Improvement Planning

Inventory
Preparation
Inventory
Control

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Quality Management System (QMS)

Quality Policy
Quality Policy

Plan Planning

Do Implementation

Check Measurement &


Evaluation
Act Management
Review
Improve Continual
Improvement
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Safety Management System (SMS)

Safety Policy
Safety Policy

Plan Planning

Do Implementation

Check Measurement &


Evaluation
Act Management
Review
Improve Continual
Improvement
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Total Quality Management
Goal of TQM:
Do the right things right the first time, every time.

Total Customer
Performance

Satisfaction

Plan
Act Do
Check
Continuous
Improvement

PDCA Cycle repeated to create ccontinuous improvement


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TQM Total View Integration

Empowerment TQM+
6 Sigma
TQM
HRM
Lean
QA QMS
Quality
Teams
L6S
ISO 9001
QC
SPC
TPM SCM
Quality
Inspection/ Quality Plan JIT
ERP
Blame Testing Circles MRP
orientated CRM
MRP II

Reactive Proactive
(What Happened Analysis) (What If Analysis?)

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Main Terms:
ITP Inspection and Test Plan
SPC Statistical Process Control
L6S Lean Six Sigma
HRM Human Resource Management
JIT Just In Time
TQC Total Quality Control
TQM Total Quality Management
TPS Toyota Production System
TPM Total Productive Maintenance
SCM Supply Chain Management
MRP Material Requirement Planning
MRP II Resource Requirement Planning
ERP Enterprise Resource Planning
CRM Customer Relationship Management

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Evolution of Quality Management
Long Term Continuous Improvement
Product Quality: Business
Motorola
Statistical Process
Reengineering
Quality Six Sigma
Control Total
Quality
Management Lean
Resource Toyota Six Sigma
Productivity: Production
Ford Lean
System Six Sigma
Production Lean
System Supply Chain
JIT Supply
Chain
Information MRP, ERP
Technology: MRP II CRM

1960 1970 1980 1990 2000+


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Long Term Continuous Improvements
Global Leaders in their fields

Dr. Joseph M. Juran Walter Shewhart


W. Edwards Deming
Father of Quality Father of Statistical
Father of Quality Control Quality Control
management
(1900 1994) (19-- 19--)
(1904 2008)

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Quality Leaders (Gurus):
1. Walter Shewart
In 1924, developed control charts
Introduced the term quality assurance
2. W. Edwards Deming
Developed courses during World War II to teach statistical quality-control techniques
to engineers and executives of companies that were military suppliers
After the war, began teaching statistical quality control to Japanese companies
3. Joseph M. Juran
Followed Deming to Japan in 1954
Focused on strategic quality planning
4. Armand V. Feigenbaum
In 1951, introduced concepts of total quality control and
continuous quality improvement
5. Philip Crosby
In 1979, emphasized that costs of poor quality far outweigh the cost
of preventing poor quality
In 1984, defined absolutes of quality managementconformance to
requirements, prevention, and zero defects
6. Kaoru Ishikawa
Promoted use of quality circles
Developed fishbone diagram
Emphasized importance of internal customer
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Cost of Quality:
Cost of Good Quality:
- Prevention costs (P):
costs of design, quality planning, etc.
- Appraisal costs (A):
costs of inspection, testing , etc.

Cost of Poor Quality (COPQ) (F):


- Internal failure costs:
costs of scrap, rework, process failure, etc.
- External failure costs:
P
costs of returns, claims, lost sales, etc.
A

F
Balance

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Prevention Costs

Quality planning costs:


Costs of developing and implementing quality management program
Product-design costs:
Costs of designing products with quality characteristics
Process costs:
Costs expended to make sure productive process conforms to quality
specifications
Training costs:
Costs of developing and putting on quality training programs for
employees and management
Information costs:
Costs of acquiring and maintaining data related to quality, and
development of reports on quality performance

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Appraisal Costs:

Inspection and testing


costs of testing and inspecting materials, parts, and product at
various stages and at end of process

Test equipment costs


costs of maintaining equipment used in testing quality
characteristics of products

Operator costs
costs of time spent by operators to gar data for testing product
quality, to make equipment adjustments to maintain quality, and to
stop work to assess quality

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Internal Failure Costs:

Scrap costs
costs of poor-quality products that must be discarded, including labor,
material, and indirect costs
Rework costs
costs of fixing defective products to conform to quality specifications
Process failure costs
costs of determining why production process is producing poor-
quality products
Process downtime costs
costs of shutting down productive process to fix problem
Price-downgrading costs
costs of discounting poor-quality productsthat is, selling products as
seconds

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External Failure Costs:

Customer complaint costs


costs of investigating and satisfactorily responding to a customer
complaint resulting from a poor-quality product
Product return costs
costs of handling and replacing poor-quality products returned by
customer
Warranty claims costs
costs of complying with product warranties
Product liability costs
litigation costs resulting from product liability and customer injury
Lost sales costs
costs incurred because customers are dissatisfied with poor quality
products and do not make additional purchases

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Typical Quality Cost Ratios

Source: A. V. Feigenbaum, Total Quality Control, 3rd ed. (New York: McGraw-Hill, 1983), p. 112; and
Joseph M. Juran and F. M. Gryna, Quality Planning and Analysis (New York: McGraw-Hill, 1970), p. 60.

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Cost of Quality (COQ)

The equation Cost of Quality (COQ) allows to quantify the impact of


POOR quality. It is used as a monitoring tool to track costs for
inspection, internal errors, external errors, and prevention. As the
prevention efforts are increased, the costs for inspection, internal
failures and external failures drop.

E: External Failure Costs


I: Internal Failure Costs
A: Appraisal Costs
P: Prevention Costs
S: Sales

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Measuring and Reporting Quality Costs
Index numbers
ratios that measure quality costs against a base value

Labor index
ratio of quality cost to labor hours

Cost index
ratio of quality cost to manufacturing cost

Sales index
ratio of quality cost to sales

Production index
ratio of quality cost to units of final product

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QualityCost Relationship

Cost of quality
Difference between price of nonconformance and
conformance

Cost of doing things wrong


20 to 35% of revenues

Cost of doing things right


3 to 4% of revenues

Profitability
In the long run, quality is free

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Juran, J.M., Planning for Quality

Minimal Cost 0f Quality Curve

Total quality
Costs
Costs per Failure Costs
good unit Internal + External
of
Product

Minimal Cost of Quality


Prevention & Appraisal
Costs

100% Defect Rate 100%


Defective Good
Optimal Conformance
Level
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Quality Assurance (QA) & ISO 9000

QA is a structured approach for prevention,


through planned and systematic activities i.e.
a quality management system.

What is ISO?
International Organization for Standardization

ISO 9000 International Standard for QMS

ISO 9001 is a series of standards describing the


requirements for establishing and maintaining
a QMS in an organization
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Management System Standards (MSS)

ISO 9001 gives the requirements for what the organization


must do for the quality management system.

ISO 14001 gives the requirements for what the organization


must do the environment management system.
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Revisions of ISO 9001
Third revision
Last revision named as
named as
ISO 9001:2008
ISO 9001:2015
Second revision
named as 2008
ISO 9001:2000
First revision 2000
Clarify
named as points & ISO
14001:2004
ISO 9001:1994

1994
Originally TQM
released as
ISO 9001:1987
ISO 9001 is the only standard in the ISO 9000
1987 family that can be used for certification

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A short overview of ISO 9001 in the world

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ISO 9001:2008 Clauses

0. Introduction -0
1. Scope -1
2. Normative Reference -2
3. Terms and Definitions -3

4. Quality Management System -4


5. Management Responsibility -5
6. Resource Management -6
7. Product Realization -7
8. Measurement, Analysis & Improvement -8

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Principles of ISO 9001:2008
8 QUALITY MANAGEMENT PRICINIPLES
1- Customer-focus
8- Mutually beneficial
supplier relationship 2- Leadership

7- Factual 8 QUALITY 3- Involvement of


Approach to MANAGEMENT People
Management PRINCIPLES

6- Continual 4- Process Approach


Improvement
5- System approach to
management
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ISO 9001:2015
Timeline to Revision Release and Client Transition

2015 2016 2017 2018

September 2015
Published International Standard

September 2015 start of 3 years


transition period to September 2018

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ISO 9001:2015 Clauses
0. Introduction -0
1. Scope -1
2. Normative Reference -2
3. Terms and Definitions -3

4. Context of the Organization -4


5. Leadership -5
6. Planning for the QMS -6
7. Support / -7
8. Operation -8
9. Performance Evaluation -9
10. Improvement -10

High Level Structure (HLS)


that brings a common framework to all management systems.
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Principles of ISO 9001:2015
7 QUALITY MANAGEMENT PRICINIPLES
1- Customer-focus

2- Leadership

7- Relationship 7 QUALITY 3- Engagement of


Management MANAGEMENT People
PRINCIPLES

6- Evidence-based
Decision Making 4- Process Approach

5- Improvement

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1- Standard Clauses
ISO 9001:2008 ISO 9001:2015
0. Introduction 0. Introduction
1. Scope 1. Scope
2. Normative Reference 2. Normative Reference
3. Terms and Definitions 3. Terms and Definitions

4. Quality Management System 4. Context of the Organization


5. Management Responsibility 5. Leadership
6. Planning for the Q M S
6. Resource Management 7. Support
7. Product Realization 8. Operation
8. Measurement, Analysis & 9. Performance Evaluation
Improvement 10. Improvement
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2- Quality Management Principles
ISO 9001:2008 ISO 9001:2015
1. Customer Focus 1. Customer Focus
2. Leadership 2. Leadership
3. Involvement of People 3. Engagement of People
4. Process Approach 4. Process Approach
5. System Approach to
Management 5. Improvement
6. Continual Improvement
7. Factual Approach to 6. Evidence-based Decision
Decision Making Making
8. Mutually Beneficial 7. Relationship
Supplier Relationships Management.

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3- Terminology Changes

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4- Key Changes:
1. Increased emphasis on Achieving Value for the organisation and its customers

2. Increased emphasis on understanding and control of Risk to the organisation

3. Reduced emphasis on Documentation

4. No stated requirement for Documented Procedures

5. No reference to a Quality Manual.

6. No requirement for a Management Representative

7. No formal requirement for Preventive Action

8. Outsourcing is now External Provision

9. Enhanced Leadership Requirements

10. Organisational Context responsiveness to changing Business Environment

11. No exclusions, only Not Applicable clauses!

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ISO 9001:2015 Clauses
0. Introduction -0
1. Scope -1
2. Normative Reference -2
3. Terms and Definitions -3
4. Context of the organization -4
4.1. Understanding the organization and -1-4
its context
4.2. Understanding the needs and
-2-4
expectations of interested parties
4.3. Determining the scope of the quality -3-4
management system -4-4
4.4. Quality management system and its
processes
5. Leadership -5
5.1. Leadership and commitment
-1-5
5.2. Policy
5.3. Organizational roles, responsibilities -2-5
and authorities -3-5

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6. Planning -6
6.1. Actions to address risks and -1-6
opportunities

6.2. Quality objectives and planning to
-2-6
achieve them
-3-6
6.3 Planning of changes
7. Support / -7
7.1. Resources -1-7
7.2. Competence -2-7
7.3. Awareness -3-7
7.4. Communication -4-7
7.5. Documented information -5-7
8. Operation -8
8.1. Operational planning and control
-1-8
8.2 Requirements for products and services
8.3 Design and development of products and
-2-8
services -3-8
8.4 Control of externally provided products and -4-8
services
8.5 Production and service provision -5-8
8.6 Release of products and services
-6-8
8.7 Control of nonconforming outputs
-7-8
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9. Performance evaluation -9
9.1. Monitoring, measurement, analysis & -1-9
evaluation
-2-9
9.2. Internal audit
-3-9
9.3. Management review

10. Improvement -10


10.1. General -1-9
10.2. Non conformity and corrective action -2-9
10.3. Continual Improvement -3-9

Annex A - (informative)
Clarification of new structure, terminology ) (- ) (
and concepts

Annex B - (informative) ) (- ) (
Quality management principles
Annex C - (informative)
) (- ) (
The ISO 10000 portfolio of quality
management standards 10000

TQM Quality Engineering Best Practice Dr. Attia Gomaa - 2016 73


SUPPORTING STANDARDS:

ISO 10005 Guidelines for Quality Plans

ISO 10006 Guidelines for Project Management

ISO 10007 Guidelines for Configuration Mgt

ISO 10012 Measurement Management System

ISO 10013 Documentation

ISO/TR 10014 Economics Of Quality

ISO/TR 10015 Training

ISO/TR 10017 Statistics

ISO 19011 Auditing

ISO 10002 Complaint handling

ISO 10003 External Dispute Resolution System


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How to implement ISO 9001? Dr. Attia Gomaa
(Quality Management System) 2016
1. Top Management Commitment
2. Quality Policy & Objectives
3. Awareness Programs
4. Quality Teams Building
5. Training Plans
6. GAP Assessment
7. Documentation Development
8. Auditing Teams Building
9. Auditing Plan
10. Internal Auditing
11. Management Review Meeting Continuous
12. Simulation Visit Improvement

13. Corrective & Preventive Actions


14. External Auditing
15. Certification
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List of documents required by ISO 9001:2015
Mandatory records required by ISO 9001:2015
# Documents Clause
1 Scope of the QMS 3.4
2 Quality policy 5.2
3 Quality objectives 6.2
4 Criteria for evaluation and selection of suppliers 8.4.1
Mandatory records required by ISO 9001:2015
# Records Clause
1 Monitoring and measuring equipment calibration records* 7.1.5.1
2 Records of training, skills, experience and qualifications 7.2
3 Product/service requirements review records 8.2.3.2
4 Record about design and development outputs review* 8.3.2
5 Records about design and development inputs* 8.3.3
6 Records of design and development controls* 8.3.4
* are only mandatory in cases when the relevant clause is not excluded)

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List of documents required by ISO 9001:2015
Mandatory records required by ISO 9001:2015
# Records Clause
7 Records of design and development outputs * 8.3.5
8 Design and development changes records* 8.3.6
9 Characteristics of product to be produced and service 8.5.1
10 Records about customer property 8.5.3
11 Production/service provision change control records 8.5.6
12 Record of conformity of product/service with acceptance criteria 8.6
13 Record of nonconforming outputs 8.7.2
14 Monitoring and measurement results 9.1.1
15 Internal audit program 9.2
16 Results of internal audits 9.2
17 Results of the management review 9.3
18 Results of corrective actions 10.1
* are only mandatory in cases when the relevant clause is not excluded)

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Non-mandatory Documents:

# Documents / Records Clause


1 Procedure for determining context of the organization and 4.1, 4.2
interested parties
2 Procedure for addressing risks and opportunities 6.1
3 Procedure for competence, training and awareness 7.1.2, 7.2, 7.3
4 Procedure for equipment maintenance and measuring equipment 7.1.5
5 Procedure for document and record control 7.5
6 Sales procedure 8.2
7 Procedure for design and development 8.3
8 Procedure for production and service provision 8.5
9 Warehousing procedure 8.5.4
10 Procedure for management of nonconformities and corrective 8.7 ,10.2
actions
11 Procedure for monitoring customer satisfaction 9.1.2
12 Procedure for internal audit 9.2
13 Procedure for management review 9.3

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Baldrige Award: http://www.quality.nist.gov/

Created in 1987 to stimulate growth of quality management in United States

The integrated framework of the Baldrige Award criteria

Source: 2004 Criteria for Performance Excellence, U.S. Dept. of Commerce, Baldrige National Quality
Program, National Institute of Standards and Technology, Gaithersburg, MD 20899. (www.quality.nist.gov)
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Other Awards for Quality

National individual awards:


Armand V. Feigenbaum Medal
Deming Medal
E. Jack Lancaster Medal
Edwards Medal
Shewart Medal
Ishikawa Medal

International awards http://www.efqm.org/model_awards/eqa/intro.asp


European Quality Award
Canadian Quality Award
Australian Business Excellence Award
Deming Prize from Japans
http://www.deming.org/demingprize/

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Performance Evaluation - (ISO 9001:2015 Clause #9)

Key Performance Indicators (KPI)


(Balanced Scorecard)

Stephen Covey

KPIs as key decision-making tools


KPIs measure the performance of certain areas of a business.

Control = Monitor + Compare + Analysis + Corrective Action

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Performance Indicators:
Balance Between:
Actual Target

Actual Target
Performance Performance

Actual Variance Analysis


Target

Continuous Improvement

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Key Performance Indicators (KPIs) for each managerial level

Top Management
Facility Managers Top

Middle Management Middle


XX Managers

Operational Level
XXX disciplines Operational

Work order Level


XXXX Crews Site

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Bad Normal Good Excellent
Key Performance Indicators (KPIs)
35
How to minimize this GAP?
30
25
GAP
20
15 Target
10 Actual
5
0
-5 1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35
-10
-15
Months

1) Scope of Work: 2) Period: 3) Status Analysis

5) Actual Performance 6) Indicators 4) Target Performance


(Where you are?) (Where you want to be?)

7) GAP (+ / -) (Graph)
KPIs must be SMART:
- Specific
8) Analysis (Strength / Weakness) - Measurable
One Page - Applicable
Management - Reliable
9) Improvement Recommendations
- Time Based
10) Improvement Plan
(Activity, Schedule, Budget, Responsibility)

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What are key performance indicators?

1) Critical success
indicators

6) Continuous 2) Relevant to your


improvement strategies / goals

KPIs
5) Total view 3) Quantifiable
(integration) measurements

4) Readable &
standardized

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Brainstorming; For examples:

Company Departments

Market & Sales Financial


.

Operation
..

Company Maintenance
Planning

Safety
Human Resource

Procurement IT
Inventory

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Brainstorming; For examples:

Market & Sales Department


Resources Outputs

Performance % Market Share

Labor Productivity Customer


KPIs Satisfaction

Lead Response Time Overdue %

Cost Variance Number of new


customers

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Brainstorming; For examples:

Financial Department
Resources Outputs

Total cost Total revenue

Unit cost Unit price


KPIs
Cost Variance Profit ratio

Inventory Turnover
Value added

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Brainstorming; For examples:

Operation Department
Resources Outputs

Performance % Operation rate

Labor Productivity Unplanned %


KPIs
Material Utilization Overdue %

Cost Variance
Quality %

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Brainstorming; For examples:

Maintenance Department
Resources Outputs

Customer
Performance % Satisfaction

Labor Productivity Unplanned %


KPIs
Material Utilization Overdue %

Cost Variance
Availability %

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Safety & Health Department:

Safety & Health Indicators


Health Indicators Safety Indicators

1,000,000
1 ( C ) ( ) ( )

10
( ) ( )

30 KPIs
( ) 1

:
( ) 100
( ) 10
1500
= 150,000
= 10

=
% (10/150000)*1000000 ( ) 30
= 66.7

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Brainstorming; For examples:

Safety Department
Resources Outputs

Accident
Performance % Frequency Rate

Safety Training Accident


Hours
KPIs Severity Rate

Number of Safety Injury


Inspections Frequency Rate

Cost Variance Minor Injury


Frequency Rate

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Safety Performance Indicators
Accidents Frequency Rate = (# Accidents) x 1,000,000
(Accident / 1,000,000 hours) Employee hours worked

Accidents Severity Rate = (# Total days lost) x 1,000,000


(Lost hours / 1,000,000 hours) Employee hours worked

Injury Frequency Rate = (# injuries) x 1,000,000


(Injury / 1,000,000 hours) Employee hours worked

Minor Injury Frequency Rate = (# minor injuries) x 1,000,000


(Minor Injury / 1,000,000 hours) Employee hours worked
(First aid = minor injury)

Near-miss Frequency Rate = (# Near-misses) x 1,000,000


(Near-miss / 1,000,000 hours) Employee hours worked
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Case Study:
Safety Information (2014):
Average Number of Workers = 3000 man
Average Working Conditions = 2000 hour/year/man
Total Number of Accidents = 150 accidents
Total Number of Injuries = 240 injury
Total Lost Time Accidents = 600 man-day
Total Number of Minor Injuries= 900 injury
Total Number of Near-Miss = 1200 near-miss
Employee hours worked = 3000 man * 2000 hours = 6,000,000 man-hours
Accident Frequency Rate = (# Accidents) x 1,000,000 / Employee hours worked
= 150 *1000000 / 6,000,000 = 25 (Accident / 1,000,000 hours)
Injury Frequency Rate = (# Injuries) x 1,000,000 / Employee hours worked
= 240 *1000000 / 6,000,000 = 40 (Injury / 1,000,000 hours)
(Lost Time Injury = LTI = 40 )

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Brainstorming; For examples:

IT Department
Resources Outputs

Customer
Performance % Satisfaction

Labor Productivity Unplanned %


KPIs
Material Utilization Overdue %

Cost Variance
Availability %

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Brainstorming; For examples:

Inventory Department
Resources Outputs

KPIs

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Brainstorming; For examples:

Procurement Department
Resources Outputs

KPIs

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Brainstorming; For examples:

Human Resource Department


Resources Outputs

KPIs

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Brainstorming; For examples:

Planning Department
Resources Outputs

KPIs

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Key Performance Indicators (KPI)
(Balanced Scorecard)
For example;

Company Integration Management:

Financial Market
Process (Outputs)
Manpower

KPIs for each Discipline

KPI Report for Top Management


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Strategic Objectives (3 to 5) years
(Small vision statement for each discipline)

For example;

Financial Improve the Profitability

Market Grow the Market Share

Process Enhance the Process Efficiency

Manpower Develop the Workforce

If you cant measure it, you cant manage it; Peter Drucker
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How to measure the strategic objectives?
Cause / Effect Relationship; for example

Profitability Sales Revenue


Financial

Market # of
Market Share Customers

Quality Performance
Process Rate Rate

Labor Safety
Manpower Productivity (Near-Miss Rate)

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Calculations of KPIs; for example:
Perspective Key Indicators Equation Raw Data Responsibility

Revenue = Total Incomes


Financial
Department = (RevenueTotal Cost)/
Profit Ratio
Total cost
= Sales Quantity/ Standard Data Sheet
Market Share
Market Market Quantity
Department # of Data Forms
= Total Customers
Customers
= Net Quantity / Information Collection
Quality Rate
Process Total Quantity
Department Performance = Net Quantity /
Rate Total Working hours
Labor = Total Quantity/
Human Productivity man-hours
Resource
Department Near-Miss = Total Near-Miss /
Rate Actual working hours

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KPIs Analysis; for example:

Actual Target
Perspective Key Indicators Unit Benchmark
2015 2016

Finance Sales Revenue M$ 70 80 100

Profitability % 21 24 30

Customer Market Share % 14 16 20

# Customer # 90 80 100

Process Quality Rate % 95 94 98

Performance Rate U/h 85 80 100

Manpower Labor Productivity U/m-h 7 8 10

Near-Miss Rate # 14 15 12

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KPIs Analysis; for example:

Actual Target Benchmark


Indicator
Perspective Key Indicators Unit 2015 2016
Evaluation
(x/10) (8/10) (10/10)

Finance Sales Revenue M$ 70 80 100 (7/10)

Profitability % 21 24 30 (7/10)

Customer Market Share % 14 16 20 (7/10)

# Customer # 90 80 100 (9/10)

Process Quality Rate % 95 94 98 (8.5/10)

Performance Rate U/h 85 80 100 (8.5/10)

Manpower Labor Productivity U/m-h 7 8 10 (7/10)

Near-Miss Rate # 14 15 12 (8.5/10)

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Star Diagram Revenue Profitability
Benchmarking

Target
# Near-Miss
Market
Share
Actual

#
Labor
Customer
Productivity

Performance Rate Quality Rate

Company Index = Current Area / Benchmark Area 50%


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KPIs Report; for example:
Above At Below Far Below
Perspective Key Indicators
Target Target Target Target

Finance Sales Revenue X

Profitability X

Customer Market Share X

# Customer X

Process Quality Rate X

Performance Rate X

Manpower Labor Productivity X

Near-Miss Rate X

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For example:
KPIs Report

Sales Revenue Market %

Unit Cost Labor Productivity

Recommendations:

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For example:
KPIs Report
KPI A B C

Recommendations:

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Case Study: The production information for cast iron manufacturing is as follows:
Department Item Unit Actual 2014 Actual 2015

Sales Sales Quantity ton 350 380


Department
Unit Price LE/ton 4857 5000

Net Production Quantity Tons 310 330


Process
Production Material Weight Tons 510 560
Department
Production Time hour 300 320

Financial Unit Material Cost LE/ton 1930 1939


Department
Unit Cost LE/ton 3967 4000
Targets (Benchmarking or planned ) KPIs:
Indicator Equation Unit Targets
Profit Ratio (Unit Price Unit Cost) / Unit Cost % 20 to 30

Value Added Factor Unit Price / Unit Material Cost Factor 2.4 to 2.6

Production Rate Net Production Quantity / Production Time Ton/hr 1.1 to 1.2

Material Yield Net Production Weight / Production Material Weight % 70 to 80


Based on this information, discuss the key performance indicators & improvement recommendations.
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Actual Actual Bench
Item Unit
2014 2015 marking
Profit Ratio % 22% 25% 20 30%
Value Added Factor Factor 2.51 2.57 2.40 2.60
Production Rate Ton/hour 1.033 1.031 1.100 1.200
Material Yield % 60.7 58.9 70.0 80.0
Profit Ratio 10 8.4 9 8 10
Value Added Factor 10 9.1 9.7 8 10
Production Rate 10 6.66 6.62 8 10
Material Yield 10 6.14 5.78 8 10
Profit Ratio Value added Production Rate Material Yield
Actual 30 10 2.6 10 1.2 10 80 10
2015 25 x= 9 2.57 x=9.7 1.1 8 70 8
20 8 2.4 8 1.031 x=6.62 58.9 x= 5.78

Profit Ratio Value added Production Rate Material Yield


Actual 30 10 2.6 10 1.2 10 80 10
2014 22 x= 8.4 2.51 x=9.1 1.1 8 70 8
20 8 2.4 8 1.033 x=6.66 60.7 x=6.14

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1) Profit Ratio 10 Actual 2015
Actual 2014

4) Material 2) Value
Yield Added
0
10 8 8 10

10
3) Production Rate
TQM Quality Engineering Best Practice Dr. Attia Gomaa - 2016 113
Current Situation Analysis
Company: xxxx Product: yyyy

Main Indicators (2015):


Sales quantity: 380 ton Unit Price : 5,000 LE/ton Profit Ratio: 25 %

Losses Weakness Points:


--- %
Total 1 - Production Rate (1.031 <1.10)
Performance--- 2- Material Yield (58.9 < 70%)
%

Recommendations:
To increase the production rate ; reduce
Strength Points: the time losses
To improve the material yield; reduce the
1 - Profit ratio (25 > 20%)
material scrape
2 Value Added (2.57 > 2.4 %) To improve the overall performance,
achieve motivation programs

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Case Study: The production information for cast iron manufacturing is as follows:
Department Item Unit Actual 2014 Actual 2015
Market Plan ton 450 450
Sales
Sales Quantity ton 400 420
Department
Unit Price LE/ton 5000 5100

Net Production Quantity Tons 330 430


Process
Production Material Weight Tons 560 700
Department
Average Labors Man 10 14

Financial Total Material Cost 1000 LE 600 800


Department Total Cost 1000 LE 1300 1700
Targets (Benchmarking or planned ) KPIs:
Indicator Equation Unit Targets
Sales Revenue Unit Price* Sales Quantity M.LE 1.9 to 2.1

Market Ratio Sales Quantity / Market Plan % 85 to 95

Unit Cost Total Cost / Net Production Quantity LE / unit 3800 to 3500

Labor Productivity Net Production Quantity / Average Labor Ton / man 34 to 36


Based on this information, discuss the key performance indicators & improvement recommendations.
TQM Quality Engineering Best Practice Dr. Attia Gomaa - 2016 115
Actual 2014 Sales Revenue 10

Labor
Productivity Market Ratio
10 8 8 10

10
Unit Cost
Benchmarking KPIs or Targets: Sacle A2014 Scale (10) Evaluation
Sales Revenue (1.9 to 2.1) M.LE 8-10 2.0 9 +
Market Ratio (85 to 95) % 8-10 88.9 8.8 +
Unit Cost (3800 to 3500) LE/unit 8-10 3939 6.8 -
Labor Productivity (34 to 36) ton/man 8-10 33 7.0 -

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Actual 2015 Sales Revenue 10

Labor
Productivity Market Ratio
10 8 8 10

10
Unit Cost
Benchmarking KPIs or Targets: Sacle A2015 Scale (10) Evaluation
Sales Revenue (1.9 to 2.1) M.LE 8-10
Market Ratio (85 to 95) % 8-10
Unit Cost (3800 to 3500) LE/unit 8-10
Labor Productivity (34 to 36) ton/man 8-10

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Current Situation Analysis
Company: xxxx Product: yyyy

Main Indicators (2015):


Sales quantity: 420 ton Unit Price : 5,100 LE/ton Profit Ratio: -- %

Losses Weakness Points:


--- %
Total
Performance---
%

Recommendations:
Strength Points:


TQM Quality Engineering Best Practice Dr. Attia Gomaa - 2016 118
What is the balanced scorecard?
An Integrated Approach to Performance Management

Developed by Dr. Robert Kaplan and David Norton in 1992.


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Quality Control Tools

TQM Quality Engineering Best Practice Dr. Attia Gomaa - 2016 120
Quality Control System
Before During After

Inputs Process Outputs

Acceptance Process Acceptance


sampling control sampling
Random Random
sample sample

Continuous
Improvement

Technical Technical
Standard Standard
or 3% Must be customized or 3%

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Variance Analysis:
What is mean (average)? n

It is the arithmetic average


x i
x i 1
n

x x
What is Standard deviation (Sigma)? 2
That is a measure of dispersion around i
the mean. n 1
X
X
X XX
X X X X
XX XX
X XXX
XX
X
X
Degree of
= 1.4 variation = 0.7
TQM Quality Engineering Best Practice Dr. Attia Gomaa - 2016 122
Coefficient of Variation (V%)

V % = 100 * Standard deviation / Mean

( V% < 3% Excellent )
For Example:
Criticality: Medium
Level Excellent Good Fair Poor
V% < 10% 10-15% 15-20% > 20%
2007

Criticality: High
Level Excellent Very Good Good Fair Poor
V% < 3% 3-4% 4-5% 5-6% > 6%

Default

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Discuss the variance analysis:
40, 55, 75, 95, 95

n
xi x
2

i 1 2380
s 595 24.39
n 1 5 1
By calculator:
V % = (Standard deviation / Mean) * 100 Mean = 72
= (24.39 / 72 )*100 = 33.88 % (Poor) Standard deviation = 24.39
Range = Max Min = 95-40=55 V% = 33.88%
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Example: Variance Analysis
Process Data:
9 10 11 12 10 13 11 10 12 9
7 9 11 10 8 9 11 9 10 8
10 8 10 9 11 10 10 12 11 10

Frequency:
Value 7 8 9 10 11 12 13
Frequency 1 3 6 10 6 3 1

Count 30.0 Normal Distribution Test:


Sum 300.0 = 1.36
Average (X\) 10.0
Standard Deviation () 1.4
Coefficient of Variation (CV) 13.6
Maximum Value 13.0
Minimum Value 7.0
Range 6.0
Average
Mode 10.0 = X\ = 10

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TQM Quality Engineering Best Practice Dr. Attia Gomaa - 2016 126
TQM Quality Engineering Best Practice Dr. Attia Gomaa - 2016 127
Mean & Standard Deviation

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Discuss the following figures:
Normal distribution curves
Same mean; but different standard dev.
a) 3=0.5
Standard dev. 3 < 2 < 1
2=1
Process capability Cp3 > Cp2 > Cp1
1=2
Process 3 is better than (2 & 1)

b)
Actual Normal distribution curves
Target
Different mean; but same standard dev.
Standard dev. 2 = 1
x
Actual mean is shifted
1 2
Process is not capable

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x x
Normal Distribution: n
2
x
i
i
x i 1
Beta n n 1

Normal


Uniform

x
Standard Normal
Distribution Curve

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Normal Distribution Test:

Normal

Beta

Uniform

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Distributions Histogram Appearance Statistics
Shape
Skewed left
Long tail of histogram points left
(negative Mean < Median
(a few low values but most data on right)
skewness)
Tails of histogram are balanced
Symmetric Mean Median
(low/high values offset)
Skewed right
Long tail of histogram points right
(positive Mean > Median
(most data on left but a few high values)
skewness)
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To summarize data, you will need to determine:
Measures of central tendency: They are Mean
used to tell us how many observations Median
were recorded and how frequently each
Mode
score or category occurred.

Measures of variability: They tell you Range


about how the scores are spread out. Variance
Standard Deviation
Mean: It is the arithmetic average of all scores in a distribution
Median: It is the point at which exactly half of the scores in a distribution are
below & half are above
Mode: It is the most frequently occurring score (s)

Range is the difference between the highest score & the lowest score
Variance, mean deviation, Reflects the extent to which any score deviates from
the mean (how close or how far away)
TQM Quality Engineering Best Practice Dr. Attia Gomaa - 2016 133
Central Tendency

Statistic Formula Excel Formula


n
1
Mean
n
xi =AVERAGE(Data)
i 1

Middle value in sorted


Median =MEDIAN(Data)
array
Most frequently occurring
Mode =MODE(Data)
data value
xmin xmax =0.5*(MIN(Data)
Midrange
2 +MAX(Data))

TQM Quality Engineering Best Practice Dr. Attia Gomaa - 2016 134
Dispersion
Measures of Variation
Statistic Formula Excel Formula

Range xmax xmin =MAX(Data)-MIN(Data)


n
xi x
2
Variance (s2) i 1 =VAR(Data)
n 1

n
Standard
ix x 2
=STDEV(Data)
deviation (s) i 1
n 1

Coefficient. of s
variation (CV)
100 None
x
n
Mean absolute xi x =AVEDEV(Data)
deviation (MAD) i 1
n
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Areas Under the
Normal Curve

Example: = 1.000
= 0.0016

0.9952 0.9968 0.9984 1.000 1.0016 1.0032 1.0048


68.3%
95.4%
99.7%
TQM Quality Engineering Best Practice Dr. Attia Gomaa - 2016 136
Standard Normal
Distribution Curve

Areas Under the


Normal Curve

Sigma Standard Normal Shifted by 1.5


Performance
Level DPPM Yield % DPPM Yield %
1 317,400 68.2600 691,462 30.8538 F
2 45,600 95.4400 308,537 69.1463 D
3 2,700 99.7300 66,807 93.3193 C
4 70 99.9930 6,210 99.3790 B
5 57 99.9943 233 99.9767 A
6 2.0 99.9998 3.4 99.99966 A+
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Six Sigma Measures (Practice)
Long-Term
* Sigma is a statistical unit of Normal Distribution
measurement which reflects Shifted by 1.5 Pre-conditional
situation
process capability.

7.5 4.5

-6 -5 -4 -3 -2 -1 X +1 +2 +3 +4 +5 +6
Sigma Level PPM Yield Performance
1 691,462 31% F
2 308,537 69% D
3 66,807 93.3% C
4 6,210 99.3% B
5 233 99.98% A
6 3.4 99.9997% A+
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Sampling Inspection
QHSE
100% inspection
Quality Health Safety -
Inspect every part Environment

When the consequence of failure is critical For Example;

When its easy to do Welding Inspection


(NDT) for 100 Km:
Tends to be expensive
Water Pipeline
Oil Pipeline
Acceptance sampling Gas Pipeline
Technical
Take a sample of parts Standard QHSE?
or 3%
High? Level I
Samples must be random Medium? Level II
Low? Level III
Sampling plans

Accept or reject the entire batch Welding


Inspection%?
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Sample Size: Technical
Standard
guideline of sample sizes/frequency using or 3%

Say, 3000 parts/day, then 50 total inspections are suggested.

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Determine Sample Size (n) :
no = (Z-score) * (StdDev)/ (margin of error) Standard Normal Distribution Curve

Lot size = N (known)


n = no * N / (no+ (N-1))
Assume: (by default for normal inspection level II)
95% confidence level Z-Score = 1.96
margin of error (confidence interval) of +/- 5%.

no = (Z * / E)
For example;
Lot Size = N=1000
no = (1.96* 0.12/ 0.05) = 22
Sample size = n=30
n = 22 * 1000 / (22+ (1000-1)) = 21.6 = 22
Process = 0.12
Target sample size n 22 unit n = 30 > 22 Accepted
Check the sample size.
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What is a Process Map?

A process map is a graphical representation of the flow of a process


A detailed process map includes information that can be used to improve the
process, such as process times; quality; costs; inputs; outputs.

Symbols:
Operations
Inspection
Transportation
Delay
Storage

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Process Flow Diagram (Process Map):

Raw Cutting Welding


Materials 0% Scrap 1% Defect
Supplier 20 m2/hr 8 m/hr
- day 6.5 hr 51.5 hr

Finishing
Check Incomplete 1% Defect
5 unit/hr
Process
List 20.25 hr
Defect %
Performance
Duration
Product Description:
A welded water tank
Symbols: open on one side. Painting
1% Defect
Operations 500 4 units/hr
500 25.25 hr
Inspection

Transportation 500

Delay
Customer
Storage
(All dimensions are in mm)

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QA/QC Check List:
Quality Assurance / Quality Control checklist is used to ensure the quality of a
product / process. It defines set of tasks & inspections to be performed in
different stages of the product/process.

QA / QC Checklist for Arc Welding Process: (Leader / Engineer)


Phase Item Limits Status Responsibility
Check Metal Sheets (type, size, defects, etc)
Check Welding Electrode (type, grade, humidity, etc)
Before
Welding Check Welding Machine & Tools
Check Welding Conditions (angle, amp, temp., area)
Check Process (cleaning, area, safety, etc.)
Check Welding Procedure
During Check Welding Positions
Welding
Check Worker Efficiency (skills, safety, etc)
Visual Inspection (profile, size, surface defects, etc)
After Inspect Welding Quality
Welding Final Inspection
Quality Documentation
Comments:

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Quality Management and Productivity

Productivity
ratio of output to input

Yield: a measure of productivity


Yield = Net Outputs / Inputs

Inputs = 200 Kg Net Outputs = 188.23 Kg


Process

Yield = Net Outputs / Inputs = 188.23/200 = 94.12%


Defect = 100 94.12 = 5.88 %
= 58800 / 1000000 = 58800 PPM
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Case Study: Final Product Analysis:

Spare Parts Production System:


Total Production = 1000 units
Defective Units = 50 units
Final Product Weight = 10 kg
Total Raw Materials = 12 ton

Raw Final
Material Product

Based on this information, discuss the following:


1. Quality Analysis
2. Material Analysis
3. Sigma Levels
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Final Product Analysis:
Spare Parts Production System:
Total Production = 1000 units
Defective units = 50 units
Final Product weight = 10 kg
Total Raw Materials = 12 ton
Production Analysis:
Net Production Quantity = 1000 50 = 950 units
Final Products Weight = 950*10 = 9500 kg
Total Scrap = 12000 9500 = 2500 kg
Quality Analysis:
Defect Ratio = 50/1000 = 5.0%
Quality Yield = Quality Rate = 95%
Material Analysis:
Scrap Ratio = 2500 / 12000 = 20.8%
Material Yield = Material utilization = 79.2%
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Quality Analysis: Standard Normal Distribution Curve
Defect ratio = 5.0%
= 50000 PPM
(Goal: 2 PPM)
Quality yield = 95%
Z= (1 to 2) = 1.96 (1.98)
Sigma level = 1.96
Z Yield
1 68.27
X 95.0
2 95.45

Material Analysis:
Scrape = 20.8%
= 208000 PPM
Material yield = 79.2%
Z= (1 to 2) = 1.40
Sigma level = 1.40
Z Yield
1 68.27
X 79.2
2 95.45

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Normal Distribution Shifted by 1.5 (Practice)
Sigma Level PPM Yield Performance
1 691,462 31% F
2 308,537 69% D
3 66,807 93.3% C
4 6,210 99.3% B
5 233 99.98% A
6 3.4 99.9997% A+

Quality Analysis:
Defect ratio = 5.0% = 50000 PPM (Goal: 3.4 PPM)
Quality yield = 95%
Z= (3 to 4) = (C to B) = Sigma level = 3.28
Z Yield
3 93.3
X 95.0
4 99.3
(x-3)/(4-3) = (95.0-93.3)/(99.3-93.3) X = 3.28
Material Analysis:
Scrape = 20.8% = 208000 PPM
Material yield = 79.2%
Z= (2 to 3) = Sigma level = 2.42
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Statistical Process Control (SPC)
A methodology for monitoring a process to identify special causes
of variation and signal the need to take corrective action.

Seven QC tools; Ishikawa, 1968:


1. Graph or Flow Diagram
2. Check Sheet
3. Histogram
4. Pareto Chart (Rule 80/20), 1906
5. Scatter diagram
6. Control chart, 1924
7. Cause-and-effect diagram, 1943

Focus: Quality control


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7 Quality Control Tools 2- Check Sheet (or Defect Frequency)

1- Graph (or Flow Diagram)

4- Pareto Chart (or Sorting or Rule 80/20)

3- Histogram
5- Cause-and-effect diagram

6- Scatter diagram 7- Control chart

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Wilfredo Pareto 1848-1923
Italian Economist

1906- Pareto Optimality

80/20 rule: 80% of the wealth is controlled


by 20% of the people.

80/20 rule believed to apply much more


widely

80% of the problems may be


attributed to 20% of the causes.
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Example:
A company has the following defects while producing 10,000 units:
Total
ID Category
Defect
A Defective material 3
B Defective parts 12
C Wrong part dimensions 16
D Surface finish 3
E Machine errors 7
F Operator errors 4
G Poor design 80

Based on this information; construct the Pareto Chart &


Rule 80/20.
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Example: Pareto Chart Pareto Chart
A company has the following defects
while producing 10,000 units: Rule 80/20

Category Total %
A Defective material 3 2.4%
B Defective parts 12 9.6%
Wrong part
C 16 12.8%
dimensions
D Surface finish 3 2.4%
E Machine errors 7 5.6%
F Operator errors 4 3.2%
G Poor design 80 64.0%
Total 125 100.0%

Based on this information;


construct the Pareto Chart & 77 / 28
Rule 80/20.
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Example: Pareto Chart

Arc Welding for Gas Pipeline


Defect Frequency:
Defect Defect
#
Description Freq.
A Incomplete Joint 100
B Improper Fusion 40
C Overlap 10 Based on this information:
D Insufficient Penetration 60 a) Construct the Pareto Chart
E Pits 100
b) Discuss the Rule 80/20.
F Porosity 120
G Vertical Crack 40
H Under Bead Crack 52
I Irregular Weld 24
K Others 20

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Example: Pareto Chart Pareto Chart
Arc Welding for Gas Pipeline
Rule 80/20
Defect Frequency:
Defect Defect
# %
Description Freq.
A Incomplete Joint 100 17.8
B Improper Fusion 40 7.1
C Overlap 10 1.8
Insufficient 60 10.6
D Penetration
E Pits 100 17.7
F Porosity 120 21.2
G Vertical Crack 40 7.0
H Under Bead Crack 52 9.2
I Irregular Weld 24 4.2
K Others 20 3.5
Total 566 100 76 / 50

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Cause-and-Effect Diagram (Fishbone diagram)
A method a work group can use to identify the possible causes of a problem

A tool to identify the factors that contribute to a quality characteristic

It is used to present the priorities of root causes for a certain problem/defect.

Management system Manpower Method

Failure /
Defect /
Problem

Environmental Measurement Machine Materials

C & E analysis is used as a starting point for investigating a problem


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Cause-and-Effect Diagram or Fishbone diagram

Environmental Manpower Method


Feedback Planning
Unsafe Unsafe
condition Organization
acts
Culture
Dust & Training Standards
Dirt
Defect

Sampling Maintenance Defective

Inspection Operating
Accuracy Control conditions Type & Storage
Specs

Measurement Machine Materials

C & E analysis is used as a starting point for investigating a problem


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Fish Improvement Process

Man Machine
F Focus

I Improve Process
capability?

(effect)
S Sustain

Method Material
H Honor
(causes)

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Scatter Diagrams
Scatter Diagrams are used to study and identify the possible relationship
between the changes observed in two different sets of variables.

X1 X2 X3

Weak Positive Correlation Negative correlation Positive Correlation

X4 X5 X6

Weak Negative Correlation No Correlation Nonlinear


Correlation
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Y * Y
*
* * *
* *
* * *
* * *
* *
*
X X
Perfect Positive Correlation: Positive Correlation:
r = +1 0<r<1

Y Y
*
* *
*
* * * * *
*
* *
* * * *
* *
X X
No Correlation: Perfect Negative Correlation:
r=0 r = 1

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Example:

Input (x) Output (y)


102.5 37
100.8 30
102.6 40
101.5 32
100.8 27
101.4 35
102.4 43
99.8 23
100.8 32
101.2 30

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Process Control Chart

UCL = Process Average + 3 Standard Deviations


LCL = Process Average - 3 Standard Deviations
Walter Shewhart
Developer of
Control Charts
in 1924
X UCL

+ 3 Process Average

- 3
LCL

TIME
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Control Charts

The control chart is a statistical quality control tool used


in the monitoring variation in the characteristics of a
product or service

The control chart focuses on the time dimension and the


nature of the variability in the system.

The control chart may be used to study past performance


and/or to evaluate present conditions.

Data collected from a control chart may form the basis


for process improvement.

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SPC: Control Limits

In control Out of control


Process Process center
is stable has shifted


+3x UCL






-3x LCL

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5-30
Control Charts:
Tool to diagnose problems

Tomorrow ?
Process Parameter

Upper Specification Limit (USL)

Analysis

Lower Specification Limit (LSL)

Time Today

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Process Control Chart UCL

Normal Behavior

LCL

UCL

Possible problem, investigate

LCL

UCL

Possible problem, investigate

LCL

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How to check the control chart

UCL UCL UCL

LCL LCL LCL

UCL
UCL UCL

LCL LCL LCL

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Discuss the following process control chart:
a) All points in control area, but not normal
The points are not fluctuated around the mean
One point (1/9) is above the mean (upper side)
8/9 points are under the mean (lower side)
7 consequence points are under the mean
Unstable process & May be abnormal conditions
We need to investigate the process and define the
LCL root causes.

UCL
b) All points in control area, but not normal
The points are not fluctuated around the mean



Unstable process & May be abnormal conditions
We need to investigate the process and define the
LCL root causes.

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Type I and Type II Errors

Study Conclusion
Out of Control In Control

In Control Type I Error No Error

Truth

Out of Control No Error Type II Error

A type I error occurs when a process is thought to be out of control


when in fact it is not.
A type II error occurs when a process is thought to be in control when it
is actually out of statistical control.
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Tracking Improvements

Out of Control In Control Process Improvement


(Reduced Variation)
UCL UCL
UCL

LCL
LCL
LCL

Process not centered and Process centered Additional improvements


not stable and stable made to the process

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Two Types of Control Charts
Variable Control Charts
Deal with items that can be measured; examples:
Weight Height Speed - Volume

X chart: deals with a average value in a process


R chart: takes into count the range of the values
MA chart: take into count the moving average of a process

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.
P Chart: a chart of the percent defective in each sample set.
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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Control Charts for Attributes:
p chart fraction defective
np chart number defective
c, u charts number of defects

Defect vs. Defective


Defect a single nonconforming quality characteristic.

Defective items having one or more defects.

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Control Chart Selection

Quality Characteristic
variable attribute
defective defect
no
n>1? x and MR
constant
yes constant yes
p or sampling
sample
np unit?
no size?
n>=10 or
x and R
computer? yes no
no
yes
p-chart with c u
x and s variable sample
size

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Control Chart for Attributes (p-Chart)
A chart used for controlling the proportion of defective
services or products generated by the process.

Given: T o ta l N u m b e r o f D e fe c tiv e s
p =
T o ta l N u m b e r o f O b s e rv a tio n s

p (1- p)
sp =
n

Compute control limits:

UCL = p + 3sp
LCL = p - 3sp

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Example of Constructing a p-chart:
Sample n Defectives p Calculate the average of the
1 100 4 0.04 sample proportions:
2 100 2 0.02
55
3 100 5 0.05 p = = 0.036
4 100 3 0.03 1500
5 100 6 0.06
6 100 4 0.04 Calculate the standard deviation
7 100 3 0.03 of the sample proportion:
8 100 7 0.07
9 100 1 0.01 p (1- p)
10 100 2 0.02
sp =
n
11 100 3 0.03
12 100 2 0.02 .036(1- .036)
13 100 2 0.02
=
100
14 100 8 0.08
15 100 3 0.03
= .0188
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Calculate the control limits.
UCL = p + 3sp
.036 3(.0188)
LCL = p - 3sp
UCL = 0.0924 LCL = -0.0204 (or 0)
p

0.16

0.14
Plot the individual sample proportions and the control limits
0.12

0.1 UCL
UCL
0.08

0.06

0.04
CL
0.02

0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Sample number

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Variable Control Chart - n < 10 - Average and Range Charts

X-bar and R charts


The X- bar chart is developed from the average of each
subgroup data.
used to detect changes in the mean between subgroups.
The R- chart is developed from the ranges of each subgroup
data
used to detect changes in variation within subgroups

Centerline
shows where the process average is centered or the central tendency of
the data
Upper control limit (UCL) and Lower control limit (LCL)
describes the process spread

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Variable Control Chart - n < 10 - Average and Range Charts

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X-bar and R charts
UCLx-bar = X-D bar + A2 R-bar
LCLx-bar = X-D bar - A2 R-bar

UCLR = D4 R-bar
LCLR = D3 R-bar

Sample size X-chart R-chart


n A2 D3 D4
2 1.88 0 3.27
3 1.02 0 2.57
4 0.73 0 2.28
5 0.58 0 2.11
6 0.48 0 2.00
7 0.42 0.08 1.92
8 0.37 0.14 1.86
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Example: Control Charts for Variable Data
Slip Ring Diameter (cm)
Sample 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
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X-bar and R charts

UCLx-bar = X-D bar + A2 R-bar


= 5.009 + (0.577)(0.115) = 5.075 cm

LCLx-bar = X-D bar - A2 R-bar


= 5.009 - (0.577)(0.115) = 4.943 cm

UCLR = D4R-bar = (2.114)(0.115) = 0.243 cm

LCLR = D3R-bar = (0)(0.115) = 0 cm

n=5

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X-bar Chart
5.10
UCL
5.08
5.06
5.04
X bar

5.02
5.00 CL
4.98
4.96 LCL
4.94
0 1 2 3 4 5 6 7 8 9 10 11

Subgroup

R Chart
0.25 UCL

0.20
Range

0.15
CL

0.10

0.05
LCL
0.00
0 1 2 3 4 5 6 7 8 9 10 11
Subgroup

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Variable Control Chart - (n 10) - Average and Standard Deviation Charts

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Case Study:

The table below gives the average and standard deviation of the depth of
key way on shaft in mm. The subgroups size is 10 .

Sub
1 2 3 4 5 6 7 8 9 10
group
X\ 6.35 6.41 6.44 6.56 6.42 6.40 6.42 6.44 6.45 6.41
0.031 0.026 0.024 0.040 0.036 0.035 0.021 0.032 0.016 0.039

Based on this information, analyze and discuss


the average and Standard Deviation Chart .

X\\ = 6.43 \ = 0.03

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Process Capability Ratios
(Specification limits) / (Process control limits)
Process performance is
not necessarily centered
between the spec limits The shaded areas
This curve is the represent the
distribution of data percentage of off-spec
from the process
production

Voice of Customer

Voice of Process

The capability index is defined as:


Cp = (allowable range)/6
=T (Tolerance)/ 6 = (USL - LSL)/6 Are you capable?
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Process Capability:
It is a method of measure used to determine if the process is capable to
produce the required quality level & customer specifications or not.
Process capability is the ability of the process to meet the desired quality
LSL USL

(Not capable!) Cp < 1.0


X

Cp = 1.0
(Capable) X

(High Capable) Cp > 1.0


X
Process Capability is dynamic. LSL USL
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Process Capability: C pkVariations

(a) (b) (c)

Cpk = 1.0 Cpk = 1.33 Cpk = 2.0

LSL USL LSL USL LSL USL

(d) (e) (f)

Cpk = 1.0 Cpk = 0.60 Cpk = 0.80

LSL USL LSL USL LSL USL


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6- Process Capability:
8.40.2
UCL
USL = 8.6

(a) (b) (c)


(d) (e)

LSL = 8.2
LCL
Not Not Capable High Very
capable capable Capable Good
Cp = 1
Cp<1 Cp<1 Cp>1 Cp > 1
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Discuss the following figures:
1000.5
Process: Machining

(1) (2) (3)


(4)
Month #1 Month #2 Month #3
Month #4
USL

LSL

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(1) (2) (3)
(4)
Month #1 Month #2 Month #3
Month #4
USL

LSL
The mean is shifted; Process is not stable
Month #1 Process control limits are out specification limits
Cp <<1; (not Capable- very poor)
The mean is centered; Process is stable
Month #2 Process control limits are out specification limits
Cp <1; (not Capable- poor)
The mean is centered; Process is stable
Month #3 Process Control limits are within specification limits
Cp=1; (Capable - good)
The mean is centered; Process is stable
Month #4 Process Control limits are within specification limits
Cp>1; (High Capable very good)
Overall Continuous improvement
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Discuss the following figures:
Process: Machining 1000.5
USL = 100.5

(b)
(a) (d)

(c)

LSL = 99.5
The mean is centered; Process is stable
(a) Process Control limits are within specification limits
Cp=1; (Capable - good)
The mean is shifted to USL; Process is not stable
(b) Process control limits are out specification limits
Cp <<1; (not Capable- very poor)
The mean is shifted to LSL; Process is not stable
(c) Process control limits are out specification limits
Cp <<1; (not Capable- very poor)
The mean is centered; Process is stable
(d) Process control limits are out specification limits
Cp <1; (not Capable- poor)
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Case Study:

A metal-cutting operation has a target value of 20.01 and the


process average is 19.5 with a standard deviation of 0.3.
a) What is the process capability index?
b) How to improve the process capability?

Design Target = 20.0 USL=21.0 LSL= 19.0 Process Capability Chart


Process Mean = 19.5 = 0.3
USL=21.0
The mean is shifted to LSL:
UCL = Mean + 3 = 20.4 < USL (21.0); capable UCL = 20.4
LCL = Mean - 3 = 18.6 < LSL (19.0); not capable Target=20.0
Then; the process is not capable
Mean=19.5
Cp = (USL LSL) / 6 = 1.11 > 1; capable

Cpu = (USL Mean) / 3 = 1.67 > 1; capable


x LSL=19.0

LCL = 18.6
Cpl = (Mean-LSL) / 3 = 0.56< 1; not capable

Cpk = min. {Cp,Cpu, Cpl} = 0.56< 1; not capable Cpl = (Mean-LSL) / 3

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How to improve the process capability?

Improve the manpower skills through advanced training plan.

Improve the maintenance program.

Improve the visual Control & Workplace Organization (5-S Approach)

Improve the mistake proofing (Poka-Yoke Approach)

Improve the automatic detection (Jidoka Approach)

etc.

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Process Capability Chart
Cpu = (USL Mean) / 3

USL x

(c)
(b) Mean
(a)
Target

Mean

(d)

LSL x

Cp = (USL LSL) / 6 Cpl = (Mean-LSL) / 3

Cpk = min. {Cp,Cpu, Cpl}


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Process Capability & Six Sigma
Nominal
value
Cpk < 1 Not Capable
Cpk > 1 Capable at 3 Six sigma
Cpk > 1.33 Capable at 4
Cpk > 1.67 Capable at 5 Four sigma

Three sigma
Cpk >= 2 Capable at 6

Process
Capability &
Design For 6 Lower Upper
Sigma specification Mean specification

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Advanced Tools: Design of experiments by Taguchi method
Process Parameter Diagram:




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For example; Friction Stir Spot Welding

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Process Parameter Diagram:
Process: Friction Stir Spot Welding (FSSW)
Temperature
Humidity
Wear
Shrinkage

Material Strength
Vertical force Hardness
Tool geometries Corrosion
Shoulder angle Cost

Rotational Speed
Plunge Depth
Dwell time
Plunge rate
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Design of experiments by Taguchi method
START
1

7
END
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Taguchi method ?
Time, Effort, Cost
For example; four factors with three levels
Experiments #
Full factorial =(4)=64
Taguchi design= 4*(3-1)=8 = 9 DOF

Degrees of freedom is the number of values in the final


calculation of a statistic that are free to vary
DOF for factor=number of levels-1
DOF for all factors=DOF for all factors

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Conduct the Matrix Experiment
Factors
Run # Response y
A B C D
1 1 1 1 1
2 1 2 2 2
3 1 3 3 3
4 2 1 2 3
5 2 2 3 1
6 2 3 1 2
7 3 1 3 2
8 3 2 1 3
9 3 3 2 1

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Design of experiments by Taguchi method in Minitab

Optimization software Minitab-v16.2010

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Tensile Shear load

Factors Trail
MEAN S/N
Run# RS PD PR DT
(rpm) (mm) (mm/min) (sec) T1(KN) T2(KN) T3(KN) ratio

1 1000 0.5 10 4 5.88 5.81 6.35 6.01333 15.5623

2 1000 0.7 20 6 5.82 6.2 5.26 5.76000 15.1484

3 1000 0.9 30 8 8.13 8.5 7.43 8.02000 18.0424

4 1500 0.5 20 8 6.25 5.45 5.35 5.68333 15.0305

5 1500 0.7 30 4 6.34 5.52 6.43 6.09667 15.6392

6 1500 0.9 10 6 6.68 6.65 7.08 6.80333 16.6439

7 2000 0.5 30 6 5.26 5.18 5.79 5.41000 14.6327

8 2000 0.7 10 8 8.16 8.72 8.21 8.36333 18.4360

9 2000 0.9 20 4 9.21 9 7.79 8.66667 18.6845

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Main effects of s/n ratios of tensile shear load.
Level RS PD PR DT
1 16.25 15.08 16.88 16.63
2 15.77 16.41 16.29 15.48
3 17.25 17.79 16.10 17.17
Signal-to-noise: Larger is better
Rotational speed(rpm) plunge depth(mm)
18
Mean of S/N ratios for tensile shear load

17

16

15
1000 1500 2000 0.5 0.7 0.9
plunge rate(mm/min) Dwell time(s)
18

17

16

15
10 20 30 4 6 8
parametar levels

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Main effects of means of tensile shear load.
Level RS PD PR DT
1 6.598 5.702 7.060 6.926
2 6.194 6.740 6.703 5.991
3 7.480 7.830 6.509 7.356

Rotational speed(rpm) plunge depth(mm)


8.0
Mean of Means for tensile shear load (KN)

7.5

7.0

6.5

6.0

1000 1500 2000 0.5 0.7 0.9


plunge rate(mm/min) Dw ell time(s)
8.0

7.5

7.0

6.5

6.0

10 20 30 4 6 8
parametar levels

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Analysis of Variance (ANOVA) for tensile shear load

rotational
dwell time
speed
23%
17%

plunge rate
5%
plunge depth
55%

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Case Studies

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Case Study #1 Lot Size = N = 1000 unit
Final Product Single Sample
Customer Required: Sample Size (3%): 30 Units
Product Dimensions Target Defect 1 unit from 30
8.40.2
8.4 0.2
M/c M/c M/c M/c M/c
#
#1 #2 #3 #4 #5
Based on this information,
discuss the following:
1 8.8 8.6 8.5 8.4 8.5
1. Problem Graph
2. Sigma Level
2 8.5 8.5 8.4 8.5 8.4
3. Normal Distribution Test
4. Variance Analysis 3 8.5 8.4 8.5 8.1 8.6
5. Process Control Chart
6. Average and Range Charts 4 8.5 8.5 8.4 8.6 8.5
7. Process Capability
8. Check the Sample Size 5 8.4 8.6 8.5 8.4 8.6
9. Process Parameters Diagram
10. Conclusion 6 8.7 8.4 8.5 8.6 8.5
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1- Problem Graph: Lot Size = N = 1000 unit
Product: xxxx Final Product Single Sample
CTQ (Critical To Quality): Sample Size (3%): 30 Units
Diameter 8.4 0.2
8.40.2 Target Defect 1 unit from 30
USL = 8.6
Target = 8.4 M/c M/c M/c M/c M/c
#1 #2 #3 #4 #5
LSL = 8.2
8.8 8.6 8.5 8.4 8.5
Number of Defects = 3 units > 1
Rejected Lot size
Defect Ratio = 3/30 = 10% 8.5 8.5 8.4 8.5 8.4
35
30
30
27
8.5 8.4 8.5 8.1 8.6
25
20 8.5 8.5 8.4 8.6 8.5
15
10 8.4 8.6 8.5 8.4 8.6
5 3 1
0
Sample Size Accepted Rejected Target
8.7 8.4 8.5 8.6 8.5
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2- Sigma Level:
Sigma Standard Normal Shifted by 1.5
Performance
Level DPPM Yield % DPPM Yield %
1 317,400 68.2600 691,462 30.8538 F
2 45,600 95.4400 308,537 69.1463 D
3 2,700 99.7300 66,807 93.3193 C
4 70 99.9930 6,210 99.3790 B
5 57 99.9943 233 99.9767 A
6 2.0 99.9998 3.4 99.99966 A+
Standard Normal: Practice (Shifted by 1.5):
Defect ratio = 10% Defect ratio = 10%
= 100000 DPPM = 100000 PPM
(Goal: 2 PPM 6 Sigma level) (Goal: 3.4 PPM 6 Sigma level)
Quality yield = 90% Quality yield = 90%
Z= Sigma level = (1 to 2) = 1.79 Z= (2 to 3) = 2.86
Z Yield Z Yield
1 68.27 2 69.1463
X 90.0 X 90.0
2 95.45 3 93.3193
Performance: F Performance: D

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3- Normal Dist. Test LSL = 8.2 USL = 8.6

Class Limit Frequency


< 8.2 1
8.2- 0
8.3- 0
8.4- 8
8.5- 13
8.6- 6
> 8.6 2
Total = 30

Min. = 8.1 Max. = 8.8


Range = Max. Min. = 0.7
Mode 8.5 < Target 8.4 (Shifted)
<8.2 8.2 8.3 8.4 8.5 8.6 >8.6
(Beta Dist.)

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4- Variance Analysis:

M/c M/c M/c M/c M/c


Mean (average) = 8.497 mm = 8.5
#1 #2 #3 #4 #5
Standard deviation = 0.12172 mm
8.8 8.6 8.5 8.4 8.5
Coefficient of variance
= 100* S / M = 1.43% 8.5 8.5 8.4 8.5 8.4
(<3% Excellent)
8.5 8.4 8.5 8.1 8.6
Max. value = 8.8 mm
Min. value = 8.1 mm
8.5 8.5 8.4 8.6 8.5
Range = 0.7 mm 8.4 8.6 8.5 8.4 8.6
8.7 8.4 8.5 8.6 8.5

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5- Process Control Chart: Mean = 8.497 = 0.12172
LCL = M - 3 = 8.14 UCL = M + 3 = 8.86
(Process Evaluation)

UCL = 8.86

RCA LCL = 8.14

RCA: Root Cause Analysis

13/30 points on the mean 8/30 points above the mean


8/30 points under the mean 1/30 point is out of control (out of the LCL)
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6- Average and range (X-bar R ) charts
M/c M/c M/c M/c M/c
#1 #2 #3 #4 #5
8.8 8.6 8.5 8.4 8.5
8.5 8.5 8.4 8.5 8.4

8.5 8.4 8.5 8.1 8.6

8.5 8.5 8.4 8.6 8.5

8.4 8.6 8.5 8.4 8.6

8.7 8.4 8.5 8.6 8.5

X/ 8.56 8.50 8.46 8.43 8.51

R 0.4 0.2 0.1 0.5 0.2

X Bar Chart:
X// = 8.49 S(X/) = 0.05
UCL = 8.64
LCL = 8.34

Range Chart:
R/ = 0.28 S(R) = 0.16
UCL = 0.76
LCL = -0.2=0

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Process Capability: Product: Target = 8.4 LSL=8.2 USL= 8.6
Process: Mean = 8.497 = 0.12172
LCL = M - 3 = 8.14 UCL = M + 3 = 8.86
Product: Process:
UCL = 8.86
UCL > USL & LCL < LSL
USL=8.6 Process is not capable

Target=8.4 Mean=8.5 Target < Mean


Mean is shifted to USL

LSL=8.2 LCL = 8.14


Total Cp = (USL LSL) / 6 = (8.6-8.2)/6*0.12 = 0.4/0.72 = 0.56
Upper Cpu = (USL x`) / 3 = (8.6 8.5)/3*0.12 = 0.1 / 0.36 = 0.28
Lower Cpl = (x` -LSL) / 3 = (8.5-8.2)/3*0.12 = 0.3 / 0.36 = 0.83
Cpl > Cpu, since the process mean is shifted.
Process capability index = Lower value (Cp, Cpu, Cpl) = 0.28 <1 (not capable)
This means, the process is not capable to achieve the desired.
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8- Check the sample size

Assume: (by default for normal inspection level II)


95% confidence level Z-Score = 1.96
margin of error (confidence interval) of +/- 5% E=0.05

= 0.12
no = (1.96*0.12/ 0.05) = 22
no = (Z * / E)
n = 22 * 1000 / (22+ (1000-1))
n = no * N / (no+ (N-1)) = 21.6 = 22
Target sample size n 22 unit
n = 30 > 22 Accepted

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8- Check the sample size

Assume: (Critical Items)


99.73% confidence level Z-Score = 3.0
margin of error (confidence interval) of +/- 2%.

= 0.12
no = (3*0.12/ 0.02) = 324 units
no = (Z * / E)
n = 324 * 1000 / (324+ (1000-1))
n = no * N / (no+ (N-1)) = 245 units
Target sample size n 245 unit
n = 245 > 30 Not Accepted

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9- Process Parameter Diagram:
Ambient temperature
Process: Machining Operator skills
Vibration & dust
Final Product

8.40.2

Machine type Dimensions


Material type Surface finish
Tool type Time
Cost

Rotational speed
Feed
Depth of cut

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10- Conclusion:
Defect Analysis:
Number of Defects = 3 units > 1 Rejected Lot size
Defect Ratio = 3/30 = 10% Sigma level = 2.86 (practice)
Sample size Analysis:
n = 30 > 22 Accepted
Control Charts:
1/30 point is out of control (out of the LCL)
3 Points are rejected ( 2 Points above USL & 1 Point below LSL)
Mean is shifted to USL
Process Capability:
Process capability index <1 (not capable)
Normal Distribution Test:
Mode 8.5 < Target 8.4 (Shifted) (Beta Dist.)
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Case Study #2
Lot Size = N = 1000 unit
Final Product Single Sample = 24 units
Target Defect 1 unit from 24
30 0.2
mm Sample M/c M/c M/c M/c
# #1 #2 #3 #4
1 30.1 30.3 29.9 29.9
Based on this information,
discuss the following: 2 29.9 30.2 29.8 30.2
1. Problem Graph 3 30.0 30.1 30.0 30.0
2. Sigma Level
3. Normal Distribution Test 4 29.8 30.0 29.7 29.9
4. Variance Analysis 5 30.1 30.2 29.9 30.1
5. Process Control Chart
6. Average and Range Charts 6 29.9 30.1 29.8 29.8
7. Process Capability
8. Check the Sample Size
9. Process Parameters Diagram
10. Conclusion

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1- Problem Graph: Lot Size = N = 1000 unit

Product: xxxx Final Product Single Sample = 24 units

CTQ (Critical To Quality): Target Defect 1 unit from 24

Diameter 30 0.2 30 0.2


USL = 30.2 mm

Target = 30 Sample M/c M/c M/c M/c


LSL = 29.8 # #1 #2 #3 #4
Number of Defects = 2 units > 1 1 30.1 30.3 29.9 29.9
Rejected Lot size 2 29.9 30.2 29.8 30.2
Defect Ratio = 2/24 = 8.33%
3 30.0 30.1 30.0 30.0
24
22
4 29.8 30.0 29.7 29.9
5 30.1 30.2 29.9 30.1
6 29.9 30.1 29.8 29.8
2
1
Sample Size Accepted Rejected Target

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2- Sigma Level:
Sigma Standard Normal Shifted by 1.5
Performance
Level DPPM Yield % DPPM Yield %
1 317,400 68.2600 691,462 30.8538 F
2 45,600 95.4400 308,537 69.1463 D
3 2,700 99.7300 66,807 93.3193 C
4 70 99.9930 6,210 99.3790 B
5 57 99.9943 233 99.9767 A
6 2.0 99.9998 3.4 99.99966 A+
Standard Normal: Practice (Shifted by 1.5)
Defect ratio = 8.33% Defect ratio = 8.33%
= 83300 DPPM = 83300 DPPM
(Goal: 2 DPPM 6 Sigma level) (Goal: 3.4 PPM 6 Sigma level)
Quality yield = 91.67% Quality yield = 91.67%
Z= (1 to 2) = x = 1.861 Z= (2 to 3) = x = 2.932
Z Yield Z Yield
1 68.27 2 69.1463
x 91.67 x 91.67
2 95.45 3 93.3193
Performance: F Performance: D

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3- Normal Dist. Test LSL = 30.2 USL = 29.8

Class Limit Frequency


<29.8 1
29.8 4
29.9 6
30.0 4
30.1 5
30.2 3
>30.2 1
Total = 24

Max= 30.3 Min.= 29.7 mm


Range= 0.6 mm
Mode 29.9 < Target 30 (Shifted)
<29.8 29.8 29.9 30.0 30.1 30.2 >30.2
(Beta Dist.)

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4- Variance Analysis:

Mean (average) = 29.99 mm Sample M/c M/c M/c M/c


Standard deviation = 0.1569 mm # #1 #2 #3 #4
1 30.1 30.3 29.9 29.9
Coefficient of variance
2 29.9 30.2 29.8 30.2
= 100* S / M = 0.52%
3 30.0 30.1 30.0 30.0
(<3% Excellent)
Max. value = 30.3 mm 4 29.8 30.0 29.7 29.9

Min. value = 29.7 mm 5 30.1 30.2 29.9 30.1

Range = 0.6 mm 6 29.9 30.1 29.8 29.8

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5- Process Control Chart: Mean = 29.9 = 0.1569
LCL = M - 3 = 29.5 UCL = M + 3 = 30.4

UCL = 30.4

LCL = 29.5

Process in control

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6- Average and range (X-bar R ) charts

Sample M/c M/c M/c M/c


# #1 #2 #3 #4

1 30.1 30.3 29.9 29.9

2 29.9 30.2 29.8 30.2

3 30.0 30.1 30.0 30.0

4 29.8 30.0 29.7 29.9

5 30.1 30.2 29.9 30.1

6 29.9 30.1 29.8 29.8

X/ 29.97 30.15 29.85 29.98

R 0.3 0.3 0.3 0.4

X// 29.99 R/ 0.325


S(X/) 0.13 S(R/) 0.05
UCL 30.37 UCL 0.475
LCL 29.60 LCL 0.175

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7- Process Capability: Product: Target = 30 LSL=30.2 USL= 29.8
Process: Mean = 29.99 = 0.1569
LCL = M - 3 = 29.5 UCL = M + 3 = 30.4
Product:
Process:
UCL = 30.4 UCL > USL & LCL < LSL
USL= 30.2
Process is not capable

Target= 30 Target > Mean


Mean=29.99 Mean is shifted to LSL

LSL= 29.8
LCL = 29.5
Total Cp = (USL LSL) / 6 = (30.2 - 29.8)/6* 0.1569 = 0.43
Upper Cpu = (USL x`) / 3 = (30.2 29.99)/3* 0.1569 = 0.47
Lower Cpl = (x` -LSL) / 3 = (29.99 29.8)/3* 0.1569 = 0.39

Process capability index = Lower value (Cp, Cpu, Cpl) = 0.39 <1 (not capable)
This means, the process is not capable to achieve the desired.

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8- Check the sample size

Assume: (by default for normal inspection level II)


95% confidence level Z-Score = 1.96
margin of error (confidence interval) of +/- 5%.

= 0.1569
no = (1.96*0.1569/ 0.05) = 37.82
no = (Z * / E)
n = 37.82 * 1000 / (37.82 + (1000-1))
n = no * N / (no+ (N-1)) = 36.48 = 37 units
Target sample size n 37 units
n = 24 < 37 Not Accepted

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9- Process Parameter Diagram:
Ambient temperature
Process: Machining Operator skills
Vibration & dust
Final Product

30 0.2

Machine type Dimensions


Material type Surface finish
Tool type Time
Cost

Rotational speed
Feed
Depth of cut

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10- Conclusion:
Defect Analysis:
Number of Defects = 2 units > 1 Rejected Lot size
Defect Ratio = 8.33% Sigma level = 2.932 (D)
Mean = 0.1536 = 0.1569 V% = 0.5%(<3% Excellent)

Sample size Analysis:


n = 24 < 37 Not Accepted
Control Charts:
Process in control
Process Capability:
Process capability index <1 (not capable)
Normal Distribution Test:
Mode 29.9 < Target 30.0 (Shifted) (Beta Dist.)
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Case Study #3

Roller Bearing Manufacturing Lot Size = N = 1000 unit


Diameter 2.5 0.25 mm Single Sample
Target Defect 1 unit from 24

# M/c #1 M/c #2 M/c #3 M/c #4


Based on this information,
discuss the following:
1 2.45 2.60 2.40 2.80
1. Problem Graph
2. Sigma Level 2 2.35 2.25 2.45 2.65
3. Normal Distribution Test
4. Variance Analysis 3 2.40 2.55 2.20 2.50
5. Process Control Chart
6. Average and Range Charts 4 2.20 2.35 2.30 2.65
7. Process Capability
8. Check the Sample Size 5 2.30 2.25 2.30 2.55
9. Process Parameters Diagram
10. Conclusion 6 2.55 2.70 2.70 2.75

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1- Problem Graph:
Lot Size = N = 1000 unit
Product: Roller Bearing Manufacturing
Single Sample
CTQ (Critical To Quality):
Target Defect 1 unit from 24
Diameter 2.5 0.25 mm
Nominal diameter = 2.5 mm
# M/c #1 M/c #2 M/c #3 M/c #4
Minimum Spec = 2.25 mm
Maximum Spec = 2.75 mm 1 2.45 2.60 2.40 2.80
Number of Defects = 3 units > 1
Rejected Lot size
2 2.35 2.25 2.45 2.65
Defect Ratio = 3/24 = 12.5 %
3 2.40 2.55 2.20 2.50
24
21
4 2.20 2.35 2.30 2.65

5 2.30 2.25 2.30 2.55

3 6 2.55 2.70 2.70 2.75


1
Sample Size Accepted Rejected Target

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2- Sigma Level:
Sigma Standard Normal Shifted by 1.5
Performance
Level DPPM Yield % DPPM Yield %
1 317,400 68.2600 691,462 30.8538 F
2 45,600 95.4400 308,537 69.1463 D
3 2,700 99.7300 66,807 93.3193 C
4 70 99.9930 6,210 99.3790 B
5 57 99.9943 233 99.9767 A
6 2.0 99.9998 3.4 99.99966 A+
Standard Normal: Practice (Shifted by 1.5)
Defect ratio = 12.5% Defect ratio = 12.5%
= 125000 DPPM = 125000 DPPM
(Goal: 2 DPPM 6 Sigma level) (Goal: 3.4 PPM 6 Sigma level)
Quality yield = 87.5% Quality yield = 87.5%
Z= (1 to 2) = x = 1.7 Z= (2 to 3) = x = 2.76
Z Yield Z Yield
1 68.27 2 69.1463
x 87.5 x 87.5
2 95.45 3 93.3193
Performance: F Performance: D

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3- Normal Dist. Test
Mode = 2.30 & 2.55
Max. value = 2.8 mm
Class Limit Frequency
2.20 2 Min. value = 2.2 mm
2.25 2 Range= 0.6 mm
2.30 3
Number of intervals = 24^.5 = 4.89 = 5
2.35 2
2.40 2 Class = Range / 5 = 0.6/5 = 0.12
2.45 2
2.50 1 Class Class
Frequency Frequency
2.55 3 Limit Limit

2.60 1 2.20-2.32 7 2.20-2.32 7

2.65 2 2.33-2.45 6 2.32-2.44 4

2.70 2 2.46-2.58 4 2.44-2.56 6

2.75 1 2.59-2.71 5 2.56-2.68 3

2.80 1 2.72-2.84 2 2.68-2.80 3

Total = 24 Total = 24 2.80-2.92 1


Total = 24

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3- Normal Dist. Test LSL = 2.25 USL = 2.75

Class Limit Frequency


2.20-2.32 7
2.33-2.45 6
2.46-2.58 4
2.59-2.71 5
2.72-2.84 2
Total = 24

Mode 2.55 < Target 2.50


(Shifted & Beta Dist.)

2.20- 2.33- 2.46- 2.59- 2.72-


2.32 2.45 2.58 2.71 2.84

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4- Variance Analysis:

Mean (average) = 2.467 mm


# M/c #1 M/c #2 M/c #3 M/c #4
Standard deviation= 0.18218 mm
1 2.45 2.60 2.40 2.80
Coefficient of variance
= 100* S / M = 7.386% 2 2.35 2.25 2.45 2.65
(>6% Poor)
3 2.40 2.55 2.20 2.50
Mode = 2.55
4 2.20 2.35 2.30 2.65
Max. value = 2.8 mm
Min. value = 2.2 mm 5 2.30 2.25 2.30 2.55
Range= 0.6 mm
6 2.55 2.70 2.70 2.75

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5- Process Control Chart: Mean = 2.467 = 0.18218
LCL = M - 3 = 1.92 UCL = M + 3 = 3.01

UCL = 3.01

LCL = 1.92

2 points on the mean


12 points under the mean
10 points above the mean

Process in control

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6- Average and range (X-bar R ) charts

# M/c #1 M/c #2 M/c #3 M/c #4

1 2.45 2.60 2.40 2.80

2 2.35 2.25 2.45 2.65

3 2.40 2.55 2.20 2.50

4 2.20 2.35 2.30 2.65

5 2.30 2.25 2.30 2.55

6 2.55 2.70 2.70 2.75

X/

X// R/
S(X/) S(R/)
UCL UCL
LCL LCL

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7-Process Capability: Product: Target = 2.5 LSL=2.25 USL= 2.75
Process: Mean = 2.467 = 0.18218
LCL = M - 3 = 1.92 UCL = M + 3 = 3.01
Product:
Process:
UCL = 3.01 UCL > USL & LCL < LSL
USL=2.75
Process is not capable

Target= 2.5 Target > Mean


Mean=2.46 Mean is shifted to LSL

LSL=2.25
LCL = 1.92
Total Cp = (USL LSL) / 6 = (2.75 - 2.25) / 6* 0.18218 = 0.015
Upper Cpu = (USL x`) / 3 = (2.75 - 2.467) / 3* 0.18218 = 0.017
Lower Cpl = (x` - LSL) / 3 = (2.467 - 2.25) / 3* 0.18218 = 0.013

Process capability index = Lower value (Cp, Cpu, Cpl) = 0.013 <1 (not capable)
This means, the process is not capable to achieve the desired.

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8- Check the sample size

Assume: (by default for normal inspection level II)


95% confidence level Z-Score = 1.96
margin of error (confidence interval) of +/- 5%.

= 0.18217
no = (1.96*0.18218/ 0.05) = 50.99
no = (Z * / E)
n = 50.99 * 1000 / (50.99 + (1000-1))
n = no * N / (no+ (N-1)) = 48.5 = 49 units
Target sample size n 49 units
n = 24 < 49 Not Accepted

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9- Process Parameter Diagram:
Ambient temperature
Process: Machining Operator skills
Vibration & dust

Roller Bearing Manufacturing


Diameter 2.5 0.25 mm

Machine type Dimensions


Material type Surface finish
Tool type Time
Cost

Rotational speed
Feed
Depth of cut

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10- Conclusion:
Defect Analysis:
Number of Defects = 3 units > 1 Rejected Lot size
Defect Ratio = 12.5% Sigma level = 2.76 (D)
Mean = 2.467 = 0.18218 V% = 7.28% (>6% Poor)

Sample size Analysis:


n = 24 < 49 Not Accepted

Control Charts:
Process in control

Process Capability:
Process capability index <1 (not capable)
Normal Distribution Test:
Mode 2.55 < Target 2.50 (Shifted) (Beta Dist.)
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Case Study #4
The inspection information for a concrete process is as follows:
Critical To Quality: Concrete Strength; Target 320 Kg/cm2

Sample Pour Pour Pour Pour Pour


# #1 #2 #3 #4 #5
Based on this information,
discuss the following: 1 340 360 340 330 320
1. Problem Graph
2. Sigma Level 2 320 320 370 320 340
3. Normal Distribution Test
4. Variance Analysis 3 330 330 310 330 330
5. Process Control Chart
6. Average and Range Charts 4 330 340 350 340 350
7. Process Capability
8. Check the Sample Size
9. Process Parameters Diagram
10. Conclusion

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1- Problem Graph: Target 320 Kg/cm2
Sample # Pour #1 Pour #2 Pour #3 Pour #4 Pour #5
1 340 360 340 330 320
2 320 320 370 320 340
3 330 330 310 330 330
4 330 340 350 340 350
Accepted 4 4 3 4 4
Rejected 0 0 1 0 0
100%

75%

95%
50%

5%
25%
#1 #2 #3 #4 #5 Total
Accepted % 100 100 75 100 100 95
Rejected % 0 0 25 0 0 5
Sample ( #3 in pour #3) is rejected (310 < 320); So we need to investigate this pour to
determine the root cause. Defect Ratio = 1/20 = 5% Quality Rate = 95%
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2- Variance Analysis
Target 320 Kg/cm2 USL = 320 LSL= non limited
Mean (average) = 335 Standard deviation = 14.689
Min. value = 310 Max. value = 370 Range = 370-310 = 60
V % = 100 * Standard deviation / Mean = 100*14.689/ 335 = 4.88 % (Good)

3- Frequency Analysis & 4- Normal Distribution Test


Number of classes= SQR(n) =4.45 = 5 Class width = range/ 5 = 60/5= 12

Class limit Frequency 6


310-322 5 5
322-334 6 4
334-346 5 3
346-358 2 2
358-370 2 1
Total 20 310 322 334 346 358 370
Mean is shifted to left
LSL=320
Beta distribution
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5- Process Control Chart
Mean = 335 Standard deviation = 14.689
UCL = 335 + 3*14.689 = 379 LCL= 335 -3*14.689 = 291

UCL = 379

LCL = 291

Zero points on the mean & 9/20 points above the mean
Process is stable
11/20 points under the mean & Zero points out of control

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6- Average and range (X-bar R ) charts
Sample # Pour #1 Pour #2 Pour #3 Pour #4 Pour #5
1 340 360 340 330 320
2 320 320 370 320 340
3 330 330 310 330 330
4 330 340 350 340 350
X bar 330.00 337.50 342.50 330.00 335.00
Range 20 40 60 20 30
X-D bar = 335 R-bar = 34
Sample size X-chart R-chart
n A2 D3 D4
5 0.58 0 2.11

UCLx-bar = X-D bar + A2 R-bar = 335 + 0.58 * 34 = 354.62


LCLx-bar = X-D bar - A2 R-bar = 335 0.58 * 34 = 315.38
UCLR = D4 R-bar = 2.11 * 34 = 71.94
LCLR = D3 R-bar = 0 * 34 = 0
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6- Average and range (X-bar R ) charts
354.62

315.38
In control

71.94

In control
0

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7- Sigma Level:

Sigma Standard Normal Shifted by 1.5


Performance
Level DPPM Yield % DPPM Yield %
1 317,400 68.2600 691,462 30.8538 F
2 45,600 95.4400 308,537 69.1463 D
3 2,700 99.7300 66,807 93.3193 C
4 70 99.9930 6,210 99.3790 B
5 57 99.9943 233 99.9767 A
6 2.0 99.9998 3.4 99.99966 A+

Standard Normal: Shifted by 1.5:


Defect ratio = 5% Defect ratio = 5%
= 50000 PPM = 50000 PPM
(Goal: 2 PPM) (Goal: 3.4 PPM)
Quality yield = 95% Quality yield = 95%
Z= 1.96 Z= (3 to 4) = 3.1

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8- Process capability Process Capability Chart
UCL = 379

Mean= 335

LSL=320

LCL = 291
Cpl = (Mean-LSL) / 3

LCL = Mean - 3 = 291 < LSL )320(; not capable


Then; the process is not capable

Cpl = (Mean-LSL) / 3 = )335-320)/3*14.689

= 0.34 < 1; not capable

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9) Process Parameter Diagram:
Ambient temperature
Process: Concrete Operator skills

Concrete Strength;
Target 320 Kg/cm2

Material type Strength


Tool type Cost





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10- Conclusion
Mean is shifted to left
Beta distribution
9/20 points above the mean
11/20 points under the mean
1/20 point is rejected (out of the LSL)
3.1 sigma level
The process is not capable
We should investigate the Pour #3 & Identify RCA

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Case Study #5
A metal-cutting operation has a target value of 100.01 and the
process average is 99.5 with a standard deviation of 0.3.
a) What is the process capability index?
b) How to improve the process capability?
Design Target = 100 USL=101 LSL= 99 Process Capability Chart
Process Mean = 99.5 = 0.3
USL= 101
The mean is shifted to LSL:
UCL = Mean + 3 = 100.4 < USL (101); capable UCL = 100.4
LCL = Mean - 3 = 98.6 < LSL (99); not capable Target= 100
Then; the process is not capable
Mean= 99.5
Cp = (USL LSL) / 6 = 1.11 > 1; capable

Cpu = (USL Mean) / 3 = 1.67 > 1; capable


Rejected X LSL= 99

LCL = 98.6
Cpl = (Mean-LSL) / 3 = 0.55< 1; not capable

Cpk = min. {Cp,Cpu, Cpl} = 0.55< 1; not capable Cpl = (Mean-LSL) / 3

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How to improve the process capability?

Improve the manpower skills through advanced training plan.

Improve the maintenance program.

Improve the visual Control & Workplace Organization (5-S Approach)

Improve the mistake proofing (Poka-Yoke Approach)

Improve the automatic detection (Jidoka Approach)

etc.

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Case Study #6
A company has the following defects while producing 10,000 units:
Total
ID Category
Defect Final Product
A Machine errors 10
B Method errors 12
C Measurement errors 6 8.40.2
D Operator errors 8
E Defective material 16
F Environmental 4
G Management system errors 2
Based on this information:
1. Calculate the defect ratio
2. Analyze the sigma level
3. Construct the Pareto Chart
4. Discuss the Rule 80/20
5. Construct the cause and effect diagram
6. Conclusion

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1- Defect Ratio

N= 10,000 units

Total
ID Category
Defect
A Machine errors 10
B Method errors 12
C Measurement errors 6
D Operator errors 8
E Defective material 16
F Environmental 4
G Management errors 2
Total Defect 58

Defect ratio = 58/10000 = 1.16%


Quality Yield = 98.84 %

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2- Sigma Level:
Defect ratio = 1.16% Quality Yield = 98.84 %

Sigma Standard Normal Shifted by 1.5


Performance
Level DPPM Yield % DPPM Yield %
1 317,400 68.2600 691,462 30.8538 F
2 45,600 95.4400 308,537 69.1463 D
3 2,700 99.7300 66,807 93.3193 C
4 70 99.9930 6,210 99.3790 B
5 57 99.9943 233 99.9767 A
6 2.0 99.9998 3.4 99.99966 A+

Standard Normal: Shifted by 1.5:


Defect ratio = 1.16% Defect ratio = 1.16%
= 11600 PPM = 11600 PPM
(Goal: 2 DPPM 6 Sigma Level) (Goal: 3.4 DPPM 6 Sigma Level)
Quality yield = 98.84 % Quality yield = 98.84 %
Z= (2 to 3) = 2.86 Z= (3 to 4) = 3.91
Performance: D Performance: C

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3- Pareto Chart Rule 80/20

Sorting
ID Category Total % C%
E Defective material 16 27.6 28

B Method errors 12 20.7 48

A Machine errors 10 17.2 66

D Operator errors 8 13.8 79


Measurement
C 6 10.3 90
errors
F Environmental 4 6.9 97
Management
G 2 3.4 100
errors
Total 58 100

79 / 57
4- Rule 80/20
79% of the problems defects is controlled by 57% of the root causes.

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5- Cause-and-Effect Diagram or Fishbone diagram (Brainstorming)

Environmental Manpower Method


Feedback Planning
Unsafe Unsafe
condition Organization
acts
Culture
Dust & Training Standards
Dirt
Defect

Sampling Maintenance Defective

Inspection Operating
Accuracy Control conditions Type & Storage
Specs

Measurement Machine Materials

C & E analysis is used as a starting point for investigating a problem


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Case Study #7
A Pipeline project has the following defects while producing 10,000 welding joints:

ID Defect Description Defect Freq. Relative Weight


A Incomplete Joint 20 3
B Improper Fusion 8 3
C Overlap 12 2
D Insufficient Penetration 14 3
E Pits 22 2
F Porosity 30 3
G Vertical Crack 10 4
H Under Bead Crack 6 4
I Irregular Weld 16 1
K Others 4 1

Based on this information:


a) Briefly discuss the welding defects
a) Calculate the defect ratio
b) Analyze the sigma level
c) Construct the Pareto Chart
d) Discuss the Rule 80/20
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A Pipeline project has the following defects while producing 10,000 welding joints:

Defect Relative Relative


ID
Freq. Weight Frequency
A 20 3 60
B 8 3 24
C 12 2 24
D 14 3 42
E 22 2 44
F 30 3 90
G 10 4 40
H 6 4 24
I 16 1 16
K 4 1 4

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Case Study #8
A Pipeline project has the following defects while producing 10,000 welding joints:
Crew Crew Crew Crew Crew
ID Defect Description
#1 #2 #3 #4 #5
A Incomplete Joint 2 8 4 3 3
B Improper Fusion 2 1 2 2 1
C Overlap 3 4 2 2 1
D Insufficient Penetration 4 1 3 2 4
E Pits 5 3 4 6 4
F Porosity 6 4 5 7 8
G Vertical Crack 3 1 2 3 1
H Under Bead Crack 2 0 0 3 1
I Irregular Weld 4 0 3 5 4
K Others 1 0 2 1 0

Based on this information:


a) Problem graph (crew level)
b) Calculate the defect ratio
c) Analyze the sigma level
d) Construct the Pareto Chart
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Rule 80/20 80/60

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Case Study #9
The production process consists of the following four processes:

Process Cutting Welding Finishing Painting


Process Scrape & Defect % 3% 1% 1% 1%
Product Description:
a) What is the daily production yield (good units) for the company if A welded water tank
open on one side.

daily input is 200 units? 500


500
b) How many units must the company put into production each day
500
to achieve a daily yield of 100 good units?
c) What is the sigma level for this process?
(All dimensions are in mm)

Material Flow Diagram:


Inputs Outputs - C - W - F - P -
Process
Defect % 3% 1% 1% 1%

Scrap - - - -

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Material Flow Diagram:
200 C 194 W 192.06 F 190.14 P 188.24

3% 1% 1% 1%

6 1.94 1.92 1.9

Inputs = 200 units Net Outputs = 188.24 units


Yield = Net Outputs / Inputs = 188.24/200 = 94.12%
Net Outputs = 100 units Yield = Net Outputs / Inputs = 94.12%
Inputs = 100/0.9412 = 106.25 units
106.25 C 103.06 W 102.03 F 101.01 P 100

3% 1% 1% 1%

3.18 1.03 1.02 1.01

For standard normal distribution (Rule 68.27 - 95.45 - 99.73)


Yield = 94.12% Sigma level = (1 to 2 ) = 1.96
For shifted 1.5 sigma
Yield = 94.12% Sigma level = (3 to 4 ) = 3.1
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Case Study #10
The following table presents information for injection molding machine,
and four possible causes have been suggested: mold pressure, coolant
temperature, mold cool-down time, and mold squeeze time. Values of
each of these variables as well as the quality of the surface finish were
collected on 10 batches. Discuss the scatter diagrams.
Batch Mold Coolant Cool-down Squeeze Surface
number pressure temperature time time finish
# (x1) (x2) (x3) (x4) (Y)
1 220 102.5 14.5 0.72 37
2 200 100.8 16.0 0.91 30
3 410 102.6 15.0 0.90 40
4 350 101.5 16.2 0.68 32
5 490 100.8 16.8 0.85 27
6 360 101.4 14.8 0.76 35
7 370 102.4 14.3 0.94 43
8 330 99.8 16.5 0.71 23
9 280 100.8 15.0 0.65 32
10 400 101.2 16.6 0.96 30

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b)
a) (x3)
(x1)

(x2) d) (x4)
c)

a) Low negative correlation between the surface finish & mold pressure
b) High negative correlation the surface finish & cool-down time
c) High positive correlation the surface finish & coolant temperature
d) Low positive correlation the surface finish & squeeze time
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Case Study #11
The quality information for pipe line welding is as follows:
Week Total Number of Week Total Number of
# Joints Rejected # Joints Rejected
1 1000 120 11 1100 120
2 1100 110 12 1200 120
3 1000 100 13 1200 100
4 1200 110 14 1300 120
5 1100 105 15 1300 120
6 1000 100 16 1300 120
7 1100 100 17 1400 130
8 1000 110 18 1400 130
9 1000 120 19 1500 140
10 1100 110 20 1500 140
Based on this information, discuss the following:
1- Frequency Analysis 2- Control Chart
3- Sigma Level 4- Summary report
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Welding Process Week Production Rejected R% Comment
Production rate 1 1000 120 12.0 Max.
2 1100 110 10.0
1000 1500
3 1000 100 10.0
Joint/week 4 1200 110 9.17
Average = 1180 5 1100 105 9.55
6 1000 100 10.0
Rejected ratio
7 1100 100 9.09
8.33 12.00% 8 1000 110 11.0
Average = 9.84 % 9 1000 120 12.0
Range = 12-8.33 = 3.67 10 1100 110 10.0
11 1100 120 10.9
Standard Dev. = 0.943
12 1200 120 10.0
Quality Rate = 100 9.85 13 1200 100 8.33 Min.
= 90.15 % 14 1300 120 9.23
15 1300 120 9.23
1 S 68.27%
16 1300 120 9.23
X 90.15 17 1400 130 9.29
2 S 95.45% 18 1400 130 9.29
3 S 99. 73% 19 1500 140 9.33
20 1500 140 9.33
Sigma Level 1.81
X 1190 116.25 9.84
(without 1.5 S Shift)
S 164.012 12.13 0.943
Sigma Level 2.80 Min 1000 100 8.3
TQM Max Best1500
(with 1.5 S Shift) Quality Engineering 140
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Frequency Analysis

Frequency
Class Limit Frequency
7.8-8.5 1 20
8.5-9.2 2 15
9.2-9.9 8
10
9.9-10.6 5
5
10.6-11.3 2
11.3-12.0 2 0
Rejected %
Total = 20 9 10 11 12

Mean
x = 9.85
n

Standard deviation ( mean x ) 2


= 0.961
n 1

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X = 9.84S=0.943
UCL = x + 3 S = 12.67 LCL = x - 3 S = 7.0
Rejected % Upper Control Limit mean + 3 stdev

Mean

Lower Control Limit mean - 3 stdev

Week
Comment: All the points are within the control limits.
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Rejected %

Out of chart X+3


Fair X+2
Good X+1
Very good X
X-1
Excellent X-2
X-3

Week

Motivation Program )bonus, respect, etc(


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Case Study #12

The table below gives the average and range for tensile tests on an
improved plastic product. The subgroups size is 4.
Determine the trial control limits. If any point is out of control, assume
assignable causes and calculate the revised limits.

Sub
group 1 2 3 4 5 6 7 8 9 10 11 12

X\ 462 476 467 484 468 475 489 478 490 488 485 498

R 14 31 14 12 16 14 14 18 44 14 16 15

n=4 X-D bar = 480 R-bar = 18.5

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X-bar and R charts
n=4 X-D bar = 480 R-bar = 18.5
UCLx-bar = X-D bar + A2 R-bar = 480 + 0.73*18.5 = 493.505
LCLx-bar = X-D bar - A2 R-bar = 480 - 0.73*18.5 = 466.495
UCLR = D4 R-bar = 2.28 * 18.5 = 42.18
LCLR = D3 R-bar = 0

Sub
1 2 3 4 5 6 7 8 9 10 11 12
group

X\ 462 476 467 484 468 475 489 478 490 488 485 498
R 14 31 14 12 16 14 14 18 44 14 16 15

Sub
1 2 3 4 5 6 7 8 9 10 11 12
group

X\ 476 467 484 468 475 489 478 488 485


R 31 14 12 16 14 14 18 14 16
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X-bar and R charts
n=4 X-D bar = 478.89 R-bar = 16.56
UCLx-bar = X-D bar + A2 R-bar = 478.89 + 0.73* 16.56 = 490.98
LCLx-bar = X-D bar - A2 R-bar = 478.89 - 0.73* 16.56 = 466.80
UCLR = D4 R-bar = 2.28 * 16.56 = 37.76
LCLR = D3 R-bar = 0

Sub
1 2 3 4 5 6 7 8 9 10 11 12
group

X\ 476 467 484 468 475 489 478 488 485


R 31 14 12 16 14 14 18 14 16

Conclusion:

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Case Study #13 Photocopy Defect Analysis
1- Defect Description

Horizontal lines Vertical lines Curved lines

Rounded dot Oval dot Irregular dot

Rounded Circle Rectangular Clearness

Cleanness
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2- Root Cause
ID Defect Description Root Causes

A Horizontal lines

B Vertical lines

C Curved lines

D Rounded dot

E Oval dot

F Irregular dot

G Rounded Circle

H Rectangular

I Clearness

L Cleanness

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3- Check Sheet:
Sample #1
ID Defect Description Slides Total
A Horizontal lines 111-138-174 3
B Vertical lines 172 1
C Curved lines 0
D Rounded dot 123 1
E Oval dot 0
F Irregular dot 95-131-133-152-173-174-281-281 8
G Rounded Circle 73 1
H Rectangular 0
2-4-8-22-24-32-34-35-43-47-48-59-63-64-87-95-112-142-143-144-
I Clearness 146-167-177-186-187-188-189-211-219-240-245-246-247-250-251- 47
252-254-255-258-260-262-265-266-275-335-337-338-

L Cleanness 18-73-213-241- 4
Total 63 65
Defect Ratio 63/338 = 18.6%

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4- Check Sheet (Total Samples):
Sample Sample Sample Sample Sample Sample
ID Defect Description Total
#1 #2 #3 #4 #5 #6
A Horizontal lines 3

B Vertical lines 1

C Curved lines 0

D Rounded dot 1

E Oval dot 0

F Irregular dot 8

G Rectangular 1

H Clearness 0

I Cleanness 47

L Rounded Circle 4

Number of Defects 65

Number of Defective Pages 63


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Continuous Process Improvement (CPI) Approaches

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Continuous Process Improvement (CPI) Approaches
Quality Total Quality Long Term Continuous Strategic
Culture Management Improvement Planning

Kaizen Six Sigma Lean


Self Continuous Improve Effectiveness Improve Efficiency
Improvement (Min. Defects) (Min. Wastes)
Problem Solving Customer-Based Resource-Based
Focus on people Focus on part / process Focus on system
Quality Team (93) Variation Reduction Waste Reduction
Brainstorming Defect Prevention Cycle Time Reduction
Problem Analysis Error Prevention Inventory Reduction
Toyota, 1986 Motorola, 1986 Toyota, 1990 (TPS)
Lean Six Sigma, 2001
Lean Six Sigma Supply Chain , 2004

Change Management Teamwork Strong Leadership


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Kaizen Continuous Improvement
Philosophy that seeks to make never-
Kai Change
ending improvements to the process
Zen Better
of converting inputs into outputs.

Kaizen (), Chinese and Japanese for "change for better".

Kaizen is a tool originally used by Toyota to foster continued improvement within its
Toyota Production System (TPS).

It began as "Quality Circles," a means of factory shop floor employees solving quality
issues within a structured team framework,
using specific new tools.

It is a process based on improving Safety, Quality, and Delivery, by the elimination of


waste (MUDA) in its many forms.

It is now used around the world by many companies and has been adapted to suit their
individual needs and customs.

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Kaizen Approach
Change for Respect for
Batter / Good People

Continuous Self Continuous


Improvement Improvement

Small Continuous Human Resource


Improvement Continuous Improvement

HRM

Masaaki Imai is the Founder of Kaizen Institute


which was established in Switzerland in 1985.
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Plan-Do-Check-Act (PDCA) Circle

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Brainstorming (Focus Groups):
Problem-solving Approach
Problem: -------------------------------- Team size 93
Report Outline:
1. Problem Definition (What is a Problem?)
2. Teamwork
3. Objectives (Benchmarking, Goals or Targets)
4. Problem Identification (Graph)
5. Root Causes Analysis
6. Recommendations

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Kaizen Tools; for example:
Why-Why Technique (Root Cause Analysis); 1958
Cause-and-Effect Diagram (Fishbone diagram); 1958
5S (Visual Control - Workplace Organization); 1970
PokaYoke (Mistake-Proofing); 1970
Jidoka (Automatic Detection); 1970
etc.
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What is Root Cause Analysis (RCA)?
Root Cause Analysis is a systematic approach to get to the true root causes of
the problems.

Why-Why Technique, Invented by Sakichi Toyoda, 1958

Problem

5 Whys Method

You Can
Root Cause Control
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Cause-and-Effect Diagram (Fishbone diagram)
A method a work group can use to identify the possible causes of a problem

A tool to identify the factors that contribute to a quality characteristic

It is used to present the priorities of root causes for a certain problem/defect.

Measurement Manpower Method

Failure /
Defect /
Problem

Environmental Management Machine Materials

C & E analysis is used as a starting point for investigating a problem


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5 S, Japanese Tool, 1970
5 Pillars of Visual Control & Workplace Organization
Productivity Improvement Tool
A Systematic Approach for Visual Control & Workplace
Organization in order to improve safety, quality and productivity

1.
Sort
5. 2.
Sustain
5S Set in order

4. 3.
Standardize Shine

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5S - Visual Control - Workplace Organization
Brainstorming:
Briefly discuss how to apply 5-S tool in your office.
Before After

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5S - Visual Control - Workplace Organization
Brainstorming:
Briefly discuss how to apply 5-S tool in your store.
Before After

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Before

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After

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Why good housekeeping?

Safety Productivity

Quality Clean
Environment

Good housekeeping
promotes

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Poka-Yoke (Mistake-Proofing or Error-Proofing)
An approach for mistake-proofing processes
using automatic devices or methods to avoid Shigeo Shingo
simple human or machine error.

Work to achieve defect prevention


not defect detection

Defect warning system


Make it impossible to make mistakes A Strategy for
Initial term was baka-yoke, which means Performance
fool-proofing Excellence
Improve quality and reliability
Can eliminate both human and mechanical
errors

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Poka-Yoke (Mistake-Proofing or Error-Proofing); Examples:

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Process for Mistake Proofing

Describe Defect and Defect Rate

Determine Defect Location

Study the Process Flow

Observe the Process

Identify Errors and Determine Cause

Determine Prevention Method

Test/Re-test in Extreme Conditions

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Jidoka (Automatic detection - Self working); Examples:

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Jidoka (Automatic detection - Self working); Examples:

Vibration Alarm Temperature Alarm Laser Alarm System

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Jidoka (Automatic detection - Self working); Examples:

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What is Six Sigma?
A systematic approach to minimize defects; Defects
Near Zero Defects 3.4 PPM.
Improve Quality!
1987 Motorola
introduced Quality
Program now known
Customer Company/Supplier as Six Sigma.

The Use Of Six Sigma


By identifying factors which are critical to quality, we can:
Reduce process variation;
Improve capabilities;
Increase stability;
Work towards ZERO DEFECTS.
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LSL Target USL 1000.5
68.27% Process
Critical To Customer (CTC):
-1 +1 Target = 100
USL = 100.5 LSL = 99.5

95.45%
-2 +2

99.73%
-3 +3


Sigma
Yield Defect PDPM
Level
(Quality%) % (1000000)
-4 +4 ( z)

-5 +5
1 Sigma
2 Sigma
3 Sigma
1
2
3
68.27%
95.45%
99.73%
31.73%
4.55%
0.27%
317300
45500
2700
Strategic Objective
-6 +6
99.99966 6 Sigma 6 3.4 zero

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Sources of Process Variability
The outputs (Y) of a process is dependent upon the inputs (Xs) to the process.

Y = f (Material, Machine , Man , Method , Measurement, etc.)

Y = f(x)
Process

Root Causes: Output

x1
x3
Materials
Manpower Management
System
x2
Measurement
Machines

Money
Methods Tools
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Normal Distribution Shifted by 1.5
Sigma Level PPM Yield Performance
1 691,462 31% F
2 308,537 69% D
3 66,807 93.3% C
4 6,210 99.3% B
5 233 99.98% A
6 3.4 99.9997% A+

Brainstorming
Total Total DPPM Defects % Yield % Process
Production Defects Sigma Level
1000 25 25000 2.50% 97.50% (3 to 4) 3.70
1200 26 21600 2.16% 97.84% (3 to 4) 3.75
900 24 26666 2.67% 97.33% (3 to 4) 3.67
1100 25 22730 2.27% 97.73% (3 to 4) 3.74
1300 32
1150 50

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Sigma Capability Conversion Table
Yield % DPMO Process Sigma Level
30.85 691500 1.00
40.13 598700 1.25
50.00 500000 1.50
59.87 401300 1.75
69.15 308500 2.00
77.34 226600 2.25
84.13 158700 2.50
89.44 105600 2.75
93.32 66800 3.00
95.99 40100 3.25
97.73 22700 3.50
98.78 12200 3.75
99.38 6200 4.00
99.70 3000 4.25
99.87 1300 4.50
99.94 600 4.75
99.977 230 5.00
99.987 130 5.25
99.997 30 5.50
99.99833 16.7 5.75
99.99966 3.4 6.00
Yield Quality rate DPMO Defects Per Million Opportunities
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Example Sigma Levels

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Six Sigma Methodology
Focus on the customer (Critical To Customer)
Focus on the data (Data driven approach)
Focus on the process (Process-driven approach)
Proactive (What If Analysis)

Practical Problem Define

Statistical Problem Measure

Statistical Solution Analyze DMAIC


Practical Solution Improve

Solution Follow-up Control

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The process includes models for manufacturing, design and
administrative services

Manufacturing & Administrative

Define Measure Analyze Improve Control

DMAIC

Design For Six Sigma (DFSS)

Define Measure Analyze Design Verify

DMADV
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Six Sigma (D-M-A-I-C) Cycle (Roadmap)
Define Measure Analyze Improve Control

Project / Product Type Scope (Specs) Analysis KPIs Calculations


Process / Operation Quality (CTQ) Analysis ------------
Customer Requirements ------------- Strength Points
Main Problems / Defects Seven QC Tools Weakness Points
--------------- Root Causes Analysis ------------
Teamwork -------------- Corrective Actions
Brainstorming Recommendations
---------------
Problem / Defect List
References
----------------
Standards
Baselines
Benchmarking
Target Improvement Plans:
KPIs Selection, etc. Short term (weekly, monthly, quarter)
Medium tem (6 monthly, annual)
Information Plan Long term (2 to 5 years)
Standard Forms / Reports ---------------
--------------- Change Management Plan
Communication Plan
----------------
Information collection

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Define: Process: Machining Process
Monthly Production:
Customer Requirements: Total Production = 10,000 units
Final Product weight = Total Defects = 58 units
Defect Ration = 58/10000 = 0.58 %
Target Defect Ratio 0.2%
8.40.2
Total Raw Material weight =
Material Yield = %
Standards / Reference:
Defect List:
ID Category Teamwork
A Machine errors Quality Leader (Facilitator)
B Method errors Production Engineer
C Measurement errors Machining Crew
D Operator errors
KPIs Selection:
E Defective material Sigma Level
F Environmental Process Capability
G Management system errors Coefficient of Variation (V%)
Material Scrape (%)
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Measure: Information Plan Lot Size = N = 1000 unit

Final Product Single Sample


Sample Size (3%): 30 Units
Target Defect 1 unit from 30
8.40.2
M/c M/c M/c M/c M/c
#1 #2 #3 #4 #5
Frequency: Monthly Information
Total Production = units
Total
ID Category
Defect
A Machine errors
B Method errors
C Measurement errors
D Operator errors
E Defective material
F Environmental
G Management system errors
Total Defects
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Measure: Information Collection Lot Size = N = 1000 unit

Final Product Single Sample


Sample Size (3%): 30 Units
Target Defect 1 unit from 30
8.40.2
M/c M/c M/c M/c M/c
#1 #2 #3 #4 #5
Frequency: Monthly Information
Total Production = 10,000 units
8.8 8.6 8.5 8.4 8.5
Total 8.5 8.5 8.4 8.5 8.4
ID Category
Defect
A Machine errors 10
8.5 8.4 8.5 8.1 8.6
B Method errors 12
C Measurement errors 6
D Operator errors 8
8.5 8.5 8.4 8.6 8.5
E Defective material 16
F Environmental 4
8.4 8.6 8.5 8.4 8.6
G Management system errors 2
Total Defects 58 8.7 8.4 8.5 8.6 8.5
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Analyze #1 Lot Size = N = 1000 unit

Final Product Single Sample


Sample Size (3%): 30 Units
Target Defect 1 unit from 30
8.40.2
M/c M/c M/c M/c M/c
#1 #2 #3 #4 #5
Based on this information, discuss
the following: 8.8 8.6 8.5 8.4 8.5
1. Problem Graph
2. Sigma Level 8.5 8.5 8.4 8.5 8.4
3. Normal Distribution Test
4. Variance Analysis 8.5 8.4 8.5 8.1 8.6
5. Process Control Chart
6. Average and range charts 8.5 8.5 8.4 8.6 8.5
7. Process Capability
8. Check the sample size 8.4 8.6 8.5 8.4 8.6
9. Process Parameters
10. Conclusion 8.7 8.4 8.5 8.6 8.5
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Analyze #2
A company has the following defects while producing 10,000 units:
Total
ID Category
Defect Final Product
A Machine errors 10
B Method errors 12
C Measurement errors 6 8.40.2
D Operator errors 8
E Defective material 16
F Environmental 4
G Management system errors 2
Based on this information:
1. Calculate the defect ratio
2. Analyze the sigma level
3. Construct the Pareto Chart
4. Discuss the Rule 80/20
5. Construct the cause and effect diagram
6. Conclusion

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Control:

KPIs Calculations:
Sigma Level
Process Capability
Coefficient of Variation (V%)
Material Scrape (%)

Strength points: Weakness points:

Corrective Actions:

TQM Quality Engineering Best Practice Dr. Attia Gomaa - 2016 323
Width of landing
strip 1/2 Width
of landing
strip

25

50

If pilot always lands 100


25
within 1/2 the landing strip
width, we say that he has
Six-sigma capability. Out of Control
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Design For 6 Sigma:

500.2 mm

USL = 50.2

Mean 6 Sigma
Mean = 50.0 Target:
Mean = 50.0
6 Sigma = 0.2
Sigma = 0.2 /6 = 0.033
Inputs ??????

LSL = 49.8
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Target Design For 6 Sigma Process Cap. = 2

USL = 50.2

Target Process Control Chart


12 S = 0.40 UCL = 50.1

6 S = 0.20
Mean = 50.0 6 S = 0.2 S=0.033

LCL = 49.9

S = Process Stand. Dev.


LSL = 49.8

Design for 6 sigma,

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Six Sigma Project Participants

Green Belts

training

complete a cost-savings project ($10,000+)

Black Belts

training (more advanced)

complete cost-savings projects ($100,000+)

Master Black Belts

extensive training

complete cost-savings projects ($1,000,000+)

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What is Lean?
A systematic approach to minimize the waste in process
Lean is about understanding what is important to the customer

Lean is all about continuous 1990, Toyota,


assembly-line.
waste elimination

Eliminate the Gap!

Lean
Customer Company/Supplier
Lean: A principle driven, tool based philosophy that focuses on
eliminating waste so that all activities/steps add value
from the customers perspective.
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Lean Approach:
It based on eliminating of the main seven wasters (Non-value-Added Activities).
Overproduction

1
1 Waiting
Unnecessary
movement 7 2
7 2

WASTE

Rework 6
6 3
3 Transportation

5
5 4
4
Inventory
Over-processing

Lean = Elimination of Wastes (Muda)


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7 Basic Types of Waste (Toyota)

Overproduction producing more than what is


demanded by the customer
Inventory Storing more than the absolute
minimum needed
Transportation the unnecessary movement of
materials
Waiting waiting for the next process step
Excess processing due to poor tool or
product design
Wasted motion unnecessary reaching,
walking, looking for parts, tools, prints, etc
Defects scrap and rework

Lean = Elimination of Wastes (Muda)


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Stand in the Circle 7 Waste Analysis
MUDA (7 Wastes)

Overproduction

Transportation

Processing

Inventory

Defects
Waiting
Motion
# Observation
1
One Day Site Visit
2

3
Measure Value
4 Main Wastes
5 Information Plan (standard forms)
6
Information Collection
Sources; etc.
7

Main Comments:
1.
2.
3.
4.
5.
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Lean Methodology

Define Define
Value

Measure Measure
Value

Analyze Analyze
Process - Flow

Improve Improve
Process - Pull

Control
Process
Control

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Lean - D-M-A-I-C Cycle (Roadmap)
Define Measure Analyze Improve Control

Project Type Time Analysis KPIs


Process Cost Analysis Strength Points
Main Problems Resource Analysis Weakness Points
Teamwork Safety Analysis Corrective Actions
Brainstorming Root Causes Analysis
References Recommendations
Standards
Baselines
Benchmarking

Improvement Plans:
Short term (weekly, monthly, quarter)
Information Plan Medium tem (6 monthly, annual)
Standard Forms Long term (2 to 5 years)

Standard Period )daily, weekly, ( Change Management Plan


Information collection

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History and Philosophy of Lean
Lean production is the name given to the Toyota Production System (TPS)
Toyota Production System (TPS)
Best Quality - Lowest Cost - Shortest Lead Time
Through Eliminating Waste

Just in Time Jidoka


The right part Built in Quality
at the right time
in the right amount
Manual / Automatic
Line Stop
Continuous Flow Labor-Machine
Pull System Flexible, Capable, Efficiency
Level Production Highly Motivated Error Proofing
(Heijunka) Visual Control
People

Standardized Work
Operational Stability Robust Products & Processes
Total Productive Maintenance Supplier Involvement

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Customer
Value Stream
Value

Value Stream: The set of activities that convert


customer needs into delivered products and services.
Value stream mapping
Construct process map of the value stream
Avoid using existing maps, may be out of date or have
misconceptions
Analyse the process map
Focus on customer
Identify value-added and non-value-added activities
Calculate the value-add ratio
Reduce and eliminate wasteful steps
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Evaluation of Process Steps

Work Processes

Normal Abnormal

Value Add Non Value Add

Necessary Unnecessary

Flow Reduce Eliminate

place the value-added reduce the non-value eliminate the abnormal


processes into a natural added but necessary, and the unnecessary
sequence e.g. regulatory non- value added tasks

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Activities Classification
Value- and Non-value-Added Activities

Focus on reduction

Waste
(Non- Value Added Value Added
& not necessary)
Non- Value Added,
but necessary

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Activities Classification
Value Added
Any activity or operation performed that helps transform a product or service
from its raw state into its finished form.
Completed right the first time.
Any activity customer is prepared to pay for. Activity required to ensure that
a product or service is delivered in conformance to specification.

Non-Value Added
Any activity that doesnt help to transform a product or service into its final
form. Activity not performed right. Activity customer not willing to pay for.
This includes:
Unnecessary process steps
Movement of inventory, paperwork, etc.
Re-work, corrections, etc.
Storage between operations, batching inventory
Wait times, delay times, idle times

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Process: Spare Part Manufacturing
# Activity Time Value add Non value add
1 Work Order Preparation 1 hour 1 hour
2 Material Receipt 1 hour 1 hour
3 Material Inspect 30 min. 30 min.
4 Material Handling 30 min. 30 min.
5 Machine startup 30 min. 30 min.
6 Machining Process 1 hour 1 hour
7 Inspection 30 min. 30 min.
8 Finishing Process 1 hour 1 hour
9 Inspection 30 min. 30 min.
10 Material Handling 30 min. 30 min.
11 Work Order Close-Out 30 min. 30 min.
Total 7.5 hours 2 hours 5.5 hours
Ratio 100 % 26.7 % 73.3 %

1 2 3 4 5 7 9 10 11
6 8

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Value Stream Map Symbols 3,000 units

C/T = 30 sec

C/O = 10 min Finished


goods
3 shifts = 1 day
Inventory
Outside 2% scrap rate
Process
Sources Data box
C/T = Cycle Time
C/O = Change over or setup time

Physical pull Shipment

Supermarket
Push
Manual
Information
Flow Electronic
Information Flow
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Value Stream Mapping
Understanding concepts of cycle time and value added time lead to improvement.

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Process Plan:
Process plan defines the key steps & stages which must be takes to achieve
the target process.
Process Map
SIPOC & Measurement Instruments
Requirements Requirements Requirements

Input Boundary Output Boundary

S I P O C
Suppliers Inputs Process Outputs Customers

Measures Measures

Measures

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Process Map (SIPOC Chart)

Suppliers Inputs Process Outputs Customers

Production Work Order Products Storage


Planning Process Sheet Right Quantity Market
Department Right Quality
Drawings Customer
Raw Materials Right Time
Process map
Tools
(flow chart)
Preparation of

Quality Control
Receive Shop drawings
Submittal to
W/O & Drawings
the Engineer
Drawings Checking
for Approval
Quantity Completion of
Survey the W/o
Elements

Detailed Procurement of
Planning Resources Execution
of Works

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Kanban

Kanban is the Japanese word for card

The card is an authorization for the next


container of material to be produced

A sequence of kanbans pulls material


through the process

Many different sorts of signals are


used, but the system is still called
a kanban
Signal marker
on boxes

Part numbers
mark location

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Total Productive Maintenance, Japanese concept, 1951
TPM is a Lean tool to optimize the effectiveness of
manufacturing equipment and tooling.
TPM is a Lean tool for Quality and Productivity
TPM Goals: Zero Losses
Vision: Total life cycle ZERO breakdowns
equipment management ZERO defects
ZERO speed losses
ZERO accidents
TPM in three words,
Total All individuals in the organization working together.
Productive Production of products that meet or exceed
customers expectations.
Maintenance Keeping equipment and plant in good condition
at all times.
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Process Time Analysis
Non-Productive Time
Time Losses

Planned Quality
downtime
Speed losses
Unplanned
(t1) losses
downtime Waiting (t5)
(t2) time (t4)
(t3)

Availability Utilization Performance Quality


Ratio Efficiency
Ratio Rate

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Process Time Analysis
Total (calendar) time (T0)
A
Planned (target) time (T1) t1
R
Available time (T2) t2

U
Operating (used) time (T3) t3
PE
Net operating time or uptime (T4) t4

EP QR
Productive time (T5) t5

Non-productive time (TL)


Total time losses
A= Availability = T2/T0 R= Reliability = T2/T1

U= Utilization = T3/T2 PE= Performance Efficiency = T4/T3

QR= Quality rate = T5/T4 TEP= Total Equipment Productivity = T5/T0 > 80%
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R >= A Process Time Analysis
Total (calendar) time (T0) = 8760
A= 97% t1= 160
Planned (target) time (T1) = 8600
R=98.8% PM
t2=100
Available time (T2)=8500
CM
U
Operating (used) time (T3)=8000 t3=500
Standby
PE t4=2000
Net operating time or uptime (T4)=6000
Speed
EP QR
Productive time (T5)= 5540 t5=60
Defect
Non-productive time (TL)
Total time losses
A= Availability = T2/T0 R= Reliability = T2/T1

U= Utilization = T3/T2 PE= Performance Efficiency = T4/T3

QR= Quality rate = T5/T4 TEP= Total Equipment Productivity = T5/T0 > 80%
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Overall Equipment Effectiveness (OEE)

OEE = Availability * Performance * Quality yield

Availability Downtime loss

Performance Speed loss

Quality Yield Quality loss

(Target Zero Losses)

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Case Study
Process: Excavation Equipment: Excavator

Item Day #1 Day #2


Planned working hours 10 10
Overtime hours 2 1
Planned downtime (PM), hours 0.75 0.75
Unplanned downtime (CM), hours 0.25 0.50
Used time, hours 10 9
Planned Performance Rate, m3/hr 30 30
Actual Quantity, m3 200 180
Defect Quantity, m3 20 10
Net Quantity, m3 180 170
Based on this information, discuss briefly the equipment time analysis.

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Case Study: Current Situation Analysis: Process: Spare Parts Manufacturing
Time Number of
# Activity Top 3 Comments / Problems (Rule 80/20)
(hour) Workers
1 Product Order 1 1 Incomplete specs Lack of info. Lack of control
2 Material Order 1 1 Incomplete specs Lack of info. Lack of control
3 Waiting Materials 1 - Material shortage Delivery late Lack of control
4 Material Receiving 1 1 Material defect Unsafe Delivery late
5 Material Handling to Process A 1 1 Low speed Unsafe Heavy work load
6 Process A (standard time) 4 (3) 2 Unskilled labor High WIP Low productivity
7 Material Handling to Process B 1 1 Low speed High noise Heavy work load
8 Process B (standard time) 3 (2) 2 Unskilled labor High WIP Low productivity
9 Process B Downtime 1 1 Machine failure Lack of PM w/o Lack of info.
10 Material Handling to Process C 1 1 Low speed High Noise Heavy work load
11 Process C (standard time) 2 (2) 2 High WIP Process Defect Lack of plan
12 Defect Repair 1 1 Lack of QA/QC Time pressure Lack of control
13 Final Product Handling to Store 1 1 Low speed High noise Heavy work load
14 Final Product Inventory 1 1 Delivery late Lack of control House keeping
Total (Product Lead Time Customer wise) 20
Production: Critical Material(s): General Comments:
Production Lead Time = 14 hour Material Type: Steel - Lack of information; planning; control
Total Production Quantity= 6 units Raw Material Quantity = 1000 kg - Unsafe Conditions (Near-miss)
Defective Quantity= 1 unit Final Product Quantity = 750 kg - High Work In Process (WIP)

Based on this information; discuss the following:


1) Value added time analysis 2) Value steam mapping 3) Process flow diagram
4) Process KPIs 5) Recommendations 6) Target plan

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Current Situation Analysis:
Value Added Time Analysis
Time Target
# Activity Value Non- Value
(hour) Waste Time
Added Added
1 Product Order 1 1 0.5
2 Material Order 1 1 0.5
3 Waiting Materials 1 1 0
4 Material Receiving 1 1 0.5
5 Material Handling to Process A 1 1 0.5
6 Process A (standard time) 4 (3) 4 3
7 Material Handling to Process B 1 1 0.5
8 Process B (standard time) 3 (2) 3 2
9 Process B Downtime 1 1 0
10 Material Handling to Process C 1 1 0.5
11 Process C (standard time) 2 (2) 2 2
12 Defect Repair 1 1 0
13 Product Handling to Store 1 1 0.5
14 Final Product Inventory 1 1 0.5
Total Time 20 9 8 3 11
% 100 45 40 15 55%
For Safety Critical Items Safety Risk Wise Time Reduction 20%
Target:
Eliminate the waste time & minimize the non-value added time by 50%
TQM Quality Engineering Best Practice Dr. Attia Gomaa - 2016 353
Value Stream Mapping One Page
Management
Current State Target State

Information Flow
Supplier Customer

Abnormalities Abnormalities

Material Flow

Time Analysis

Total Lead Time: Value Added Time: Utilization: %


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Value Stream Mapping - Current State One Page (A4/A3) Management

Order Material Order Production Order Sales Order


Supplier Control Control Control Customer
1 hour 1 hour

Process Plan Shipping


1 hour

Process A Process B Process C


Receiving 1 hour 4 hours 3 hours 2 hours
1 hour
1 hour
2 workers 1 hour 2 workers 1 hour 2 workers
Final
Process B Defect Product
Waiting Downtime Repair Inventory
Materials 1 hour 1 hour
1 hour

Value
Added
Analysis 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 hours

Total Time = 20 hour Value Added= 9 hour Time Utilization= 45 %

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Value Stream Mapping - Current State Top Comments / Problems

Specs
Shortage
Specs

Order Order Order Order


Material Production Sales
Supplier Control Control Control Customer
1 hour 1 hour

Shipping
Process Plan
1 hour
WIP
Safety

Receiving 1 hour Process A Process B Process C 1 hour


4 hours 3 hours 2 hours
2 workers 1 hour 2 workers 1 hour 2 workers Final
Defect Product
Inventory
Waiting Process B Defect
Late Materials Downtime Repair
Overdue
1 hour 1 hour 1 hour
Low Failure
speed
Safety

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Process Flow Chart (Material Flow Chart): (Indoor)
Defect
Repair
1 hour
Standard Process A Process B Process C
plates 4 hour 3 hour 2 hour
2 workers 2 workers 2 workers
1 hour 1 hour
Process B
1 hour 1 hour
Symbols: Downtime
1 hour Final
Operations
1 hour Products
Inspection Product Description: Store
xxxxx
Transportation

Delay Process KPIs:


Production KPIs:
Storage
Production Lead Time = 14 hour
Total Production Quantity= 6 units
Defective Quantity= 1 unit
Process Process Process Net Production Quantity = 5 unit
Indicator Site
A B C
% Defect Ratio = 16.7 %
Capacity Utilization 45 20 15 10
Cycle Time = 3 hour/unit
Defect Ratio % 16.7 Production Rate = 0.33 unit / hour
Cycle Time hour/unit 3
Critical Material(s): Steel
Labor Productivity man-hour/unit Steel Material Quantity = 1000 kg
$/hour Steel Product Quantity = 750 kg
Process Cost Rate
Process Overhead % Steel Material yield = 75%

TQM Quality Engineering Best Practice Dr. Attia Gomaa - 2016 357
Recommendations:
# Activity Main Recommendations (Soft Skills) Very Short Term
1 Product Order Standard Information (specs)
2 Material Order Standard Information (specs)
3 Waiting Materials Inventory Control Policy
4 Material Receiving QA / QC Check list
5 Material Handling to Process A Preventive Maintenance Program
6 Process A Method of Work; QA / QC Check list, Training Plan
7 Material Handling to Process B Preventive Maintenance Program
8 Process B Method of Work; QA / QC Check list, Training Plan
9 Process B Downtime Preventive Maintenance Program
10 Material Handling to Process C Preventive Maintenance Program
11 Process C Method of Work; QA / QC Check list, Training Plan
12 Defect Repair QA / QC Check list
13 Product Handling to Store Preventive Maintenance Program
14 Final Product Inventory QA / QC Check list
Conclusion:
1. Standard Information (Specs, time rates, etc)
2. Method of Work for all process
3. Advanced Training Plan Teamwork
4. QA / QC (Quality Assurance / Quality Control) Check list for material receiving and processes
5. Preventive Maintenance Program for all equipment
6. Safety Awareness Program Improvement Plan:
7. Motivation Program Task Specs Responsibility Duration Dates Resources
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Target plan for the next period: Process: Product Manufacturing
Target Actual Number
# Activity Time Time of Top 3 Comments / Problems
(hour) (hour) Workers
1 Product Order 0.5
2 Material Order 0.5
4 Material Receiving 0.5
5 Material Handling to Process A 0.5
6 Process A (standard time) 3.0
7 Material Handling to Process B 0.5
8 Process B (standard time) 2.0
9 Material Handling to Process C 0.5
10 Process C (standard time) 2.0
11 Product Handling to Store 0.5
12 Final Product Inventory 0.5

Total 11

Production: Critical Material(s): Steel General Comments:


Production Lead Time = hour Steel Material Quantity = kg -
Total Production Quantity= units Steel Product Quantity = kg -
Defective Quantity= units Steel Scrap = kg -

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Lean Six Sigma
Lean tools and techniques are used to standardize work and remove
waste and non value-added activities.
Six Sigma tools and techniques are used to attack the variation present in
processes.

Six Sigma Vs. Lean


Six Sigma: Lean:
Remove variation from processes Remove waste, rework, inventory
Design more capable processes Improve flow, velocity
Focus on parts / process Focus on system

Integration Management & Leader & Teamwork

Lean Six Sigma Drivers


Voice of the Critical to
Reduce
Customer Quality Data
Variation
(VOC) (CTQ)

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Lean and Six Sigma
Lean = Rapid Improvement Teams focused on dramatically improving
process speed, and the elimination of the eight deadly wastes.

Define Measure Analyze Improve Control IMPROVE


Value Value Process- Process- Process EFFICIENCY
Flow Pull

Six Sigma = Breakthrough Process Improvement Teams focused on


eliminating chronic problems and reducing variation in processes.

IMPROVE
Define Measure Analyze Improve Control
Problem Problem Process Process Process EFFECTIVENESS

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What is Lean Six Sigma?

Lean Six Sigma is a Systematic Approach to Integrate the power of


Six Sigma Tools & Lean Tools which can be applied within an
organization to improve the Effectiveness and Efficiency.

DMAIC (Define-Measure-Analysis-Improve-Control)
Lean Value Value Added Time, etc.?
Analyze
Improve
Define Measure Improve Control
Process-
Value Value Value Process
Flow Efficiency
&
Control
Effectiveness
Define Measure Analyze Improve
Problem Problem Process Process Process

Six Sigma Problem Defect Ratio; etc.?

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Lean Six Sigma - D-M-A-I-C Cycle (Roadmap)
Define Measure Analyze Improve Control

Project Type Scope Analysis KPIs


Process Quality Analysis Strength Points
Main Problems Time Analysis Weakness Points
Teamwork Cost Analysis Corrective Actions
Brainstorming Resource Analysis
References Safety Analysis
Standards Root Causes Analysis
Baselines Recommendations
Benchmarking

Improvement Plans:
Short term (weekly, monthly, quarter)
Information Plan Medium tem (6 monthly, annual)
Standard Forms Long term (2 to 5 years)

Standard Period )daily, weekly, ( Change Management Plan


Information collection

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The Theory of Constraints
A systematic way to view and analyze process flows.
Key aspects of the theory of constraints (TOC) include
identifying the bottlenecks in the process and balancing the
work flows in the system.

An hour lost at a bottleneck is an hour lost for the whole shop.


Identify the system's constraints.
Exploit the constraint.
Subordinate all else to the constraint.
Elevate the constraint.
If the constraint is no longer a bottleneck, find the next constraint and
repeat the steps.
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Comparing Six Sigma, Lean, TOC

Program Six Sigma Lean Thinking Theory of Constraints

Theory Reduce Remove Manage


variation waste constraints

Application Define Identify value Identify constraint


Guidelines Measure Identify value stream Exploit constraint

Analyze Flow Subordinate constraint

Improve Pull Elevate constraint

Control Perfect Repeat cycle

Focus Problem Flow System

Focused Focused Constraints

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References

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References

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References
George, Michael. (2002). Lean Six Sigma: Combining Six Sigma Quality with Lean
Speed, New York: McGraw-Hill.
Rother, M. and Shook, J. (2003). Learning to See: Value Stream Mapping to
Create Value and Eliminate Muda, Brrookline, MA: The Lean Institute.
Pande, P, Neuman,R.P., and Cavanagh,R.R. (2000). The Six Sigma Way, New
York:McGraw Hill.
Bossert , James. ( July 2003) Lean and Six Sigma--Synergy Made in Heaven
Quality Progress.
Goldratt, Eliyahu M., (1994). The Goal: A Process of Ongoing Improvement,
second edition. Great Barrington, MA: North River Press.
Womack, James P. and Daniel T. Jones. (2003). Lean Thinking: Banish Waste
and Create Wealth in Your Corporation. New York: Simon & Schuster.
Also...you might consider:
www.6-sigma.com
www.sixsigma.co.uk
www.sixsigmasystems.com
www.isixsigma.com
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Made in Egypt -
-
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Thank you for your attention! Useful Science For
the Sake of Allah

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Copyrights of this file & More information:

Dr. Attia Gomaa


Industrial Engineering Professor & Consultant
Mechanical Eng. Department Shoubra Faculty of Eng. - Benha University
& Engineering and Science Services - American University in Cairo
attiagomaa@yahoo.com or attiagomaa@aucegypt.edu
Tel: 01222738497
TQM Quality Engineering Best Practice Dr. Attia Gomaa - 2016 370

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