Certified Quality Engineer

Preparation

Eng. / Ahmed Basyouni

1
 PART 1
Basics Concepts of Quality

Section 1
Introduction

Eng. / Ahmed Basyouni

2
QUALITY Synonyms?

First class
Excellence

superior

Best of all
Zero defect

???????
QUALITY can Mean

Safety Reliability Durability

Sensitivity Free of defect Accuracy

Integrity Simplicity Serviceability

?????
QUALITY pioneers
Conforming Standards Fitness for use Performance
Levitt (1972) Juran et al. (1974)

Value Added Value conformance to requirements

Feigenbaum (1951) Deromy Crosby (1979)

conformance to Specific
customer needs Integrity ?????
Reeves and Bednar, (1994) ASQ
 What is Quality?
• Feigenbaum (1951) and Abbott (1955) defined quality as ‘value’,
• Levitt (1972) as ‘conformance to specifications’,
• Juran et al. (1974) as ‘fitness for use’,
• Crosby (1979) as ‘conformance to requirements’,

• Reeves and Bednar, (1994) as ‘the extent to which a product or service

meets and/or exceeds a customer’s expectations’ which reflects a shift
in focus to customer satisfaction.
 What is Quality
• One of the most famous meanings of the word Quality is:
Those features of products or services which meet customer needs
and thereby provide customer satisfaction.
SO, Quality practically means Exceeding customer needs &
expectation
 Customers & Their Expectations
He is the person who make use of the process output and/ or affected by it
regardless he is internal / external customer
•External customer: expects realization of their demands verses prices they
pay.
•Stake holders: expects benefits & long term investment.

• Employees: expect job stability& reasonable fair.

•Society: expect safe & non environmental polluted products.
Interested Parties : any person / org. Affecting , Affected by or
percieved that he is affected by the Organization
‫‪The word (QUALITY) never comes alone‬‬

‫رقابة الجودة‬ ‫ضمان الجودة‬ ‫مبادىء الجودة‬ ‫أبعاد الجودة‬

‫‪QC‬‬ ‫‪QA‬‬ ‫‪Q. Principals‬‬ ‫‪Q. Dimensions‬‬

‫شهادات الجودة‬ ‫البنية التحتية للجودة‬

‫مراجعات الجودة‬
‫‪Q. Certificates‬‬ ‫‪National Quality‬‬ ‫‪Q. Audits‬‬
‫‪Infra structure‬‬

‫تحسين الجودة‬ ‫تخطيط الجودة‬ ‫نظام إدارة الجودة‬

‫إدارة الجودة الشاملة‬
‫‪Q. Improvements‬‬ ‫‪Q. Planning‬‬ ‫‪QMS‬‬ ‫‪TQM‬‬
 PART 1
Quality Basic Concepts

Section 2
Quality Infrastructure

10
Quality Infra Structure

11
 In any country / Organization:
The National Quality infra structure expresses the level of
confidence in its activities
( 5 ) components
1- Standardization
2- Conformity assessment ( Testing – Certification )
3-Accreditation
4-Metrology
5- Market Surveillance
In any country / Organization:
The National Quality infra structure expresses
the level of confidence in its activities
( 5 ) components
1- Standardization
2- Conformity assessment ( Testing – Certification )
3-Accreditation
4-Metrology
5- Market Surveillance
What is a Standard?

14
A World Built on Standards
Standards in Everyday
Life

Examples of standards
in everyday life

16
Standards

in

Our

daily

life
Standards

in

Our

daily

life
 STANDARDS
• Technical & Legal document

• Set through consensus of extremely technical experts committees,

• Approved by a recognized body,

• Driven by the Market / customer needs

• Referenced to scientific facts

• Supported by verified & trusted results

• Periodically updated
 Definition of a Standard (cont)
• The overall general and technical specifications that shape performance
and safety requirements for the product ) service or Management system(

•Minimum acceptable QUALITY level to verify customer )satisfaction &

protection)

• Law (Legislation) that governing relation between 2 parties ( producer /

consumer - Exporter / Importer - Service provider / Service beneficiary(

• Technical Barrier to Trade ( TBT )

20
Level of Standardization

• International standardization,( ISO – IEC – CODEX – ITU -…)

• Regional, and ( EN – GSO – ARSO - ….)
• National.( EOS – SASO – SSMO – ESMA – BSI – ANSI – AFNOR …)

• Standards consortia
• Company Standard Private Standard
Characteristics of a Standard

22
 The Characteristics of a Standard
• Voluntary and market driven – every interested party can participate in the
making of a standard and provide comments when a standard is submitted
to public consultation.

• The decision to develop new standards is driven by market needs/requests.

• Approved by a recognized body – a recognized standards body such as

CEN, CENELEC, ISO, IEC or a national standards body has approved the
document and that the document has gone through the necessary
procedures, public consultations, etc.
23
 The Characteristics of a Standard(cont)

• Consensus based – all standards are subject to dialogue in order to

establish general agreement characterized by the absence of sustained
opposition to substantial issues by any important part of the concerned
interests ,
• and by a process that involves seeking to take into account the views of
all parties concerned,
• and to reconcile any conflicting arguments (definition of consensus
from EN 45020).
• Afterwards, to get it approved, it goes through a formal vote procedure.

24
Benifits of Standards

25
Standardization and trade

• Standardization is a key factor of trade policy.

• It contributes to the removal of technical barriers to trade (TBT)

• increases market access and international trade, and enhances

cooperation at the international level.

• The use of standards can help LEBANIES industry and SMEs to

access global markets
 The Value of Standards to Consumers

• Standards have a direct value to the consumer, although few consumers

are aware of the extent that standards affect their daily lives.

• Standards ensure safety, security, in the everyday lives of consumers.

• Standards ensure Compatibility & common rules for any product

27
The Value of Standards to Manufacturers & Exporters

•Lowering costs through minimizing errors, redundancies

and increasing productivity.
•Efficiency.
•Mitigating Risks.
•Consistency.
•Customer Confidence.
•Uniformity.
•Eliminate Trade Borders.
•Universal Vendor Requirements. 28
How are Standards Developed and Structured?

29
 Who Makes Standards?

• Standardization is open to any competent one.

• Standards are developed in technical committees and their sub-

committees as well as in working groups.

• The easiest way to find out and to get involved in standardization is to

contact your National Standardization Organization.

30
 How are Standards Made?

• Drafting a standard goes through a certain process from a draft standard

to the phase of a Public Enquiry, balloting, publishing and finally, the
implementation of a standard.

• Revising a standard is also part of the lifecycle of a standard.

• A Technical Committee makes sure that a standard is up-to-date.

31
 Interpretation of standards

• All standards are voluntary unless there is an

agreement of a private nature or there is an order of a
legislative body.

• Copyright of standards : NSB is source to obtain

standards and information on standards. NBS
sometimes use a publishing house to sell standards.
 Consensus
• All formal standards therefore incorporate the views
and expertise of a very wide range of interests from
– consumers,

– academia,

– special interest groups,

– government,

– business and industry.

 National Standard Body
• Facilitators of standards work.

• Coordinate activities related to standardization and

communication to stakeholders and participants and
members of standards committee.

• Consensus building.

• Controlling & Documenting all processes in the

development process.

• Standards bodies are not involved in developing the

technical contents of the standards.
Level of Standardization

• National,
• Regional, and
• International standardization.

• Standards consortia
• Company Standard
National, international and private standards

‫ أحمد بسيونى‬/‫م‬
 The ISO definition of "standard"
 Document, established by consensus and approved by
a recognized body,

 that provides, for common and repeated use, rules,

guidelines or characteristics for activities or their
results,

 aimed at the achievement of the optimum degree of

order in a given context
 1- STANDARDS ISSUING
New Work Item
1
CD
2 ALL
3 WORLD
DIS (1-2-…)
4 COUNT-
RIES
FDIS 5
6
IS
38
STANDARDS
CONTENTS:
• Specifications ( General – Technical)
Mechanical – Electrical – Chemical - ….
• Limits ( Tolerance ) ( +/- LSL- USL – ( < - >
1- Test Method
• Performance Tests 2- Equipments
3- Steps
• Safety Tests 4- Repeatability
5- Special Condition
• SAMPLING
39
National Quality Infra Structure

( 5 ) components
1- Standardization
2- Conformity assessment (Testing , Inspection – Certification )
3-Accreditation
4-Metrology ( Measurement – Calibration )

5- Market Surveillance
 Cost of Poor Quality(COPQ)
Cost of internal Failure include:
- Raw Material
- Energy
- Labor
- Packaging
- Storage
- Time
- Over processing
 Cost of Poor Quality(COPQ)
Cost of External Failure include:
- Transportation ( 3/4 times )
- Packaging removal
- Retesting / Re-inspection
- Repair / Recycle
- Insurance Certificates
- Market share losses

1:10:100:????
 Cost of Quality(COQ)
Cost of Quality:
- Standards
- Raw materials
- Maintenance
- Training
- Work environment
- Calibration
1:10:100:????
 Conformity Assessment

Conformity assessment involves a set of processes that show that a :

• product,

• service

• or a system
meets the requirements of a standard.

44
 Conformity Assessment

Undergoing C.A has a number of benefits:

•It provides consumers and other stakeholders with added
confidence.

•It gives a company a competitive edge by documenting

that it meets the requirements of a standard.

•It ensures that health, safety and Env. conditions are met.

•It reduces technical barriers to trade and opens markets by

making it easier to export and import products.

45
 Declarations of Conformity

• It is often possible for a company to declare that they meet

certain requirements by self declaration of conformity.

• However, in some areas it is required that a third party

(certification organization) test and verify that a product,
service etc.

• follow the criteria in a standard for it to be allowed to use a

mark of conformity.

46
 Declarations of Conformity

• In both cases the company is liable for the claim that they
meet certain requirements and are therefore subject to
liability legislation.

• Third party certification organizations must be given formal

recognition by an authoritative party (accreditation body)
that they are competent to carry out certain certification tasks
in order to be allowed to certify.

47
2-Conformity Assessment (Certification )
Certification Bodies shall be :
-Impartial

- Expert

-Notified ( Authorized )

-Accredited

48
 2-Conformity Assessment (Certification )
Main objective of (CB )

-Objective &Trusted proof of conforming standards

-Certification Bodies includes (CB ) :

1- Product Certification Bodies P.C.B (ISO 17065 )

2- Management Certification Bodies M.S.C.B (ISO 17021 )
3- Inspection Bodies I.C.B ( ISO 17020 )
4- Individuals Ind.C.B ( ISO 17024 )
49
5- Testing & Calibration Laboratories Lab.( ISO 17025)
2-Conformity Assessment (Certification )

Laboratories are the main tool to perform

Conformity Assessment through doing :

1- Performance Tests
2- Safety Tests

According to relevant STANDARD

50
Standards & Conformity Assessment

ISO 17021
ISO 17025 ISO 17020
ISO 17024
ISO 15189
ISO 17065

Inspection Conformity
Laboratories Bodies Bodies

• Product,
• Calibration • Product • Process Service
• Medical • Process • Mgmt Sys
• Personnel
• Test • Service
National Quality Infra Structure

( 5 ) components
1- Standardization
2- Conformity assessment ( Testing – Certification )

3-Accreditation
4-Metrology ( Measurement – Calibration )
5- Market Surveillance
 3- Accreditation

•According to International Accreditation Forum (IAF) and the

International Laboratory Accreditation Cooperation (ILAC),

•accreditation is defined as "the independent evaluation of

conformity assessment bodies against recognized standards to
ensure their impartiality and competence."

53
 3- Accreditation

•According to International Accreditation Forum (IAF) and the

International Laboratory Accreditation Cooperation (ILAC),

•accreditation is defined as "the independent evaluation of

conformity assessment bodies against recognized standards to
ensure their impartiality and competence."

54
May 16, 2024
 IAF ILAC

Accreditation Body
Certification Body

Certification Bodies , LABAs

Business
(people, management systems, organizations, products , etc)

Confidence Trust Assurance

May 16, 2024 55
3-Accreditation

Accreditation is a means of

• determining
• recognizing “competence”
• promoting

56
3- Accreditation
STANDARDS & ACCREDITATION

•ISO 17011 is the reference standard to certify

accreditation bodies

57
Egac ‫المجلس الوطنى لالعتماد‬

ISO 17011
SAC

DAC

TUNAC

TURKAC

May 16, 2024 58

National Quality Infra Structure
( 5 ) components
1- Standardization
2- Conformity assessment (Testing –Certification)
3-Accreditation
4-Metrology ( Measurement – Calibration )
5- Market Surveillance
 4- Metrology

Measurement:
Comparison between Quantity ( Length , Mass , Speed ,
Volt , Torque …) & reference unit of the measuring device.

Calibration
Comparison between Device under test with a reference
device

60
 Testing

• The most common form of conformity assessment.

• It can include other activities like measurement and calibration.

• provides the basis for other forms – for example, it is the main
technique used in product certification.
• The general requirements for laboratories or other organizations to be
considered competent to carry out testing, calibration and sampling
are specified in the joint International Standard ISO/IEC 17025.

61
 ‫‪4- Metrology‬‬
‫‪Values:‬‬
‫األسمية ‪1- Nominal‬‬
‫‪2- Measured‬‬ ‫المقاسة‬
‫‪3- Actual‬‬ ‫الفعلية = القيمة المقاسة ‪ )-(+‬الخطأ‬
‫‪4- True 3‬‬ ‫‪- Actual‬القيمة الحقيقية‬

‫‪62‬‬
 Accuracy – Precision

••
••• •••
••

ACCURATE & NOT ACCURATE –PRECISE

PRECISE
•
•
•
•
•
•

• • •
•
NOT ACCURATE – NOT PRECISE ACCURATE – NOT PRECISE 63
Calibration Certificate

1- Error ( + or - x)

2- Uncertainty ( +/- y)
4- Metrology

Calibration

1- Industrial

2- Scientific

3- Legal

65
 4- Metrology
Calibration
•Periodic
•Traceability

Verification
• Daily
•Per shift

Intermediate check
66
 4- METEROLOGY
STANDARDS & METEROLOGY

•ISO 17025 is the reference standard to certify Laboratories.

•Tests are performed according to standardized

test methods

•Calibration are performed according to standardized calibration

methods

67
National Quality Infra Structure
( 5 ) components
1- Standardization
2- Conformity assessment (Testing –
Certification)
3-Accreditation
4-Metrology ( Measurement – Calibration )
5- Market Surveillance
 5- Market Surveillance

•The main tool of subsequent control

•Assuring that goods & products still conforming standards as they were
produced

•Protect good products from poor product competition

• Conformity Ass. of Random samples from markets

•CE & Quality Marks

69
CE-marking
• The letters "CE" are the abbreviation
of the French wording "Conformité
Européenne" which means "European
Conformity".

• It consists of the CE logo and the four-

digit identification number of the
notified body involved in the
conformity assessment procedure.

70
 National Quality Infra Structure
absence or weakness of any component leads to
disasters

MARKET
SURVILLANCE

STANDARDS
s.

Metrology

ACCREDITATION
Con. As
 PART 1
Quality Basic Concepts

Section 3
Quality Principals

72
 ‫‪The word (QUALITY) never comes alone‬‬

‫رقابة الجودة‬ ‫ضمان الجودة‬ ‫البنية التحتية للجودة‬ ‫أبعاد الجودة‬

‫‪QC‬‬ ‫‪QA‬‬ ‫‪Q. Infrastructure‬‬ ‫‪Q. Dimensions‬‬

‫شهادات الجودة‬
‫مبادىء للجودة‬
‫مراجعات الجودة‬
‫‪Q. Certificates‬‬ ‫‪Quality Principals‬‬ ‫‪Q. Audits‬‬

‫تحسين الجودة‬ ‫تخطيط الجودة‬ ‫نظام إدارة الجودة‬

‫إدارة الجودة الشاملة‬
‫‪Q. Improvements‬‬ ‫‪Q. Planning‬‬ ‫‪QMS‬‬ ‫‪TQM‬‬
Quality Principles 2015

1.Customer
2. Leadership
Focus

3. Engagement 4. Process 5. Improvement

Of People Approach

6. Evidenced-
Based 7. Relationship
decision Management
making
74 74
 XX- Management System

Satisfying
Customers

Protecting
Environment
OUTCOME

Mitigating
INTERSTED Hazards & Risks
PARTIES
REQ.
Improve Energy
Performance
May 16, 2024
 ?What is a process

- A series of activities

- implemented on a set of inputs

- Under a set of controls

- To obtain Measurable outputs

- Accompanied with Bi - Products

Process
Controls

Inputs Activities Outputs

Manufacturing Process:
Controls

R. Materials Activities Product

Service Process:
Controls

Data Activities Document

Managerial Process:
Controls

Information Activities Decision

PROCESS APPROACH

Controls

Main O/Ps
Inputs Activities Highest Quality

( N.C & Bi) products

Affecting Environment & health
 Storage
Actives:

Inputs:

Controls :

Outputs :

Bi - Products:
 ‫‪PDCA Cycle‬‬
‫نموذج ديمنج‬

‫‪PLAN‬‬
‫دراسة‬ ‫دراسة‬
‫‪DO‬‬ ‫مدى‬
‫احتياجات‬ ‫رضاء‬
‫‪CHECK‬‬
‫العميل‬
‫العميل‬ ‫‪ACT‬‬
Process Levels

MAJOR

SUB

Activities
84
 Process are multi- stages

Air Condition

Main
Compressor Body Capillary process

Sub-
Cutting Forming Assembly Painting
process

Final Activities
Sand plaster Smoothing Primer Coat
coating
 The SIPOC Model
Inputs Process Outputs

Suppliers Customers

Steps

Inform Loop
 COPIS Model

Outputs Process Inputs

Customers Suppliers

Steps How does Six Sigma Work?

The Voice of the Customer (VOC) is aggressively sought and rigorously
evaluated and used to determine needed outputs and hence the optimal
process configuration needed to yield those outputs and their necessary
inputs for which the best suppliers are identified and allied with.

From Concept to Market: the Voice of the Customer

Source

Input

Process

Output

Customer
 PART 1
Quality Basic Concepts

Section 4
Quality Dimensions

89
 ‫‪The word (QUALITY) never comes alone‬‬
‫البنية التحتية للجودة‬ ‫مبادىء الجودة‬
‫رقابة الجودة‬ ‫ضمان الجودة‬
‫‪National Quality‬‬ ‫‪Q. Principals‬‬
‫‪QC‬‬ ‫‪QA‬‬
‫‪Infra structure‬‬

‫شهادات الجودة‬ ‫‪Quality Dimensions‬‬ ‫مراجعات الجودة‬

‫‪Q. Certificates‬‬ ‫‪Q. Audits‬‬
‫أبعاد الجودة‬

‫تحسين الجودة‬ ‫تخطيط الجودة‬ ‫نظام إدارة الجودة‬

‫إدارة الجودة الشاملة‬
‫‪Q. Improvements‬‬ ‫‪Q. Planning‬‬ ‫‪QMS‬‬ ‫‪TQM‬‬
Quality Dimensions :
* Performance
* conforming Standards
* Reliability
*Durability
*Serviceability
*Safety
*Added features & Aesthetics
* Perceived quality
 PART 2
Quality Leadership

Section 1
Quality Philosophy

92
Quality Gurus
 Quality Gurus &their philosophies
• https://www.youtube.com/watch?v=7Pjniu1_Pdw
 Quality Gurus
• Edward Deming
• He is best known for his "14 Points for Management," which
outline the key principles of quality management, and his
emphasis on the importance of statistical process control and
continuous improvement.
Process Approach
Statistical Process Control
 Quality Gurus
Joseph Jurans
Trilogy of quality management:
quality planning,
quality control,
and quality improvement.
He is also credited with introducing the Pareto principle in the
quality field, which states that 80% of the effects come from 20%
of the causes
Trilogy of Management
Fitness for use
 Quality Gurus
Philip Crosby
• the importance of prevention over inspection to achieve "zero defects,"
• Four Absolutes of Quality:
1- conformance to requirements.
2- prevention.
3- zero defects.
4- The measurement of quality is the price of non-conformance. "quality is free,"

the cost of preventing defects is always lower than the cost of dealing with
defects after they occur.
Zero Defect
 Quality Gurus
Karero Iskikawa
• the importance of involving all employees in the quality
management process.
• the concept of "total quality control," involving all employees in
the quality control process
• using data and statistical analysis to drive continuous
improvement.

Quality Circles – Cause &Effect – Root Cause Analysis

 Quality Gurus
Taiiche Ohono
• the father of the TPS,
• maximizing efficiency
• minimizing waste.
• "just-in-time",
• "kanban" system.
TPS
JIT
Kanban System
 PART 2
Quality Management &Leadership

Section 2
Quality Control / Assurance

101
 ‫‪The word (QUALITY) never comes alone‬‬
‫البنية التحتية للجودة‬ ‫مبادىء الجودة‬
‫أبعاد الجودة‬ ‫ضمان الجودة‬
‫‪National Quality‬‬ ‫‪Q. Principals‬‬
‫‪Q. Dimensions‬‬ ‫‪QA‬‬
‫‪Infra structure‬‬

‫شهادات الجودة‬ ‫‪QC/QA‬‬ ‫مراجعات الجودة‬

‫‪Q. Certificates‬‬ ‫‪Q. Audits‬‬
‫ضبط ‪ /‬توكيد الجودة‬

‫تحسين الجودة‬ ‫تخطيط الجودة‬ ‫نظام إدارة الجودة‬

‫إدارة الجودة الشاملة‬
‫‪Q. Improvements‬‬ ‫‪Q. Planning‬‬ ‫‪QMS‬‬ ‫‪TQM‬‬
 Quality Control
Quality Assurance

103
QUALITY CONTROL

- 2 Dimensions
* Segregation( Isolation ) between conforming & non-

conforming (N.C)
* Root Cause Analysis & counter measures to
minimize ( eliminate ) N.C

- Applied at certain & critical activities of any process

Disadvantages of Q.C
- Detected N.C products Consumes :
* Raw materials
* Energy
* Labor costs
* inspection &Testing costs
* Aging of Machines & production lines
* Time
* Costs of reworking / recycling
QUALITY ASSURANCE
* Historically after Q.C era
* Eliminates Disadvantages of Q.C Process
* Applied at all process stages:
- inputs
- Activities
- Controls ( whenever it is applicable )
- Outputs ( final product ) { after sale service }
(Q.C/Q.A) must be applied throughout all production processes :

Raw materials Storage

Sampling Industrial processing Packaging

Inspection & testing Final storage

107
The main objective of Q. Assurance is to assure that the products
throughout the whole production processes are :
* meeting Specifications ( general & technical ).
* Free of defects.
* Non conforming ( Outputs & Products ) are
under full control .
* Fulfilling QUALITY &SAFETY requirements.

108
 QC/QA must applied to all Processes
Factory Main Processes
Procurement Storage Production
Sampling Testing Packaging

QC/QA

Factory Supportive Processes

Maintenance OH&S IT
HR TRAINING ------------
Raw Materials Storage Process
Controls
Std. – Temp. – Humd. – Maintenance – FIFO – FEFO – Safety- ….

Inputs
Activities
•Cust. Req. *Inspection
•People * Registration
•Tools * Coding Output(s)
•Equipments * Arrangement Items free of
•Raw Materials * Safety stock
* Release defects
•Design * Resupply
• Energy * …….
•……
Bi- Products
NC. items – wastes –En . Consumption - …
Final Product Storage Process
Controls
Std. – Temp. – Humidity – Maintenance – FIFO – FEFO – Safety- ….

Inputs
Activities
•Cust. Req. *Inspection
•People * Registration
•Tools * Coding Output(s)
•Equipments * Arrangement Items free of
•Raw Materials * Safety stock
* Release defects
•Design * Resupply
• Energy * …….
•……
Bi- Products. items – w
astes –En . Consumption - …
Maintenance Process
Controls
Std. – Temp. – Humidity – Maintenance – FIFO – FEFO – Safety- ….

Inputs
Activities
•Cust. Req. *Inspection
•People * Registration
•Tools * Coding Output(s)
•Equipments * Arrangement Items free of
•Raw Materials * Safety stock
* Release defects
•Design * Resupply
• Energy * …….
•……
Bi- Products
NC. items – wastes –En . Consumption - …
Procurement Process
Controls
Std. – Temp. – Humidity – Maintenance – FIFO – FEFO – Safety- ….

Inputs
Activities
•Cust. Req. *Inspection
•People * Registration
•Tools * Coding Output(s)
•Equipments * Arrangement Items free of
•Raw Materials * Safety stock
* Release defects
•Design * Resupply
• Energy * …….
•……
Bi- Products
NC. items – wastes –En . Consumption - …
externally provided processes
Controls
Std. – Temp. – Humidity – Maintenance – FIFO – FEFO – Safety- ….

Inputs
Activities
•Cust. Req. *Inspection
•People * Registration
•Tools * Coding Output(s)
•Equipments * Arrangement Items free of
•Raw Materials * Safety stock
* Release defects
•Design * Resupply
• Energy * …….
•……
Bi- Products
NC. items – wastes –En . Consumption - …
Internal Audit processes
Controls
Std. – Temp. – Humidity – Maintenance – FIFO – FEFO – Safety- ….

Inputs
Activities
•Cust. Req. *Inspection
•People * Registration
•Tools * Coding Output(s)
•Equipments * Arrangement Items free of
•Raw Materials * Safety stock
* Release defects
•Design * Resupply
• Energy * …….
•……
Bi- Products
NC. items – wastes –En . Consumption - …
Training Process
Controls
Std. – Temp. – Humidity – Maintenance – FIFO – FEFO – Safety- ….

Inputs
Activities
•Cust. Req. *Inspection
•People * Registration
•Tools * Coding Output(s)
•Equipments * Arrangement Items free of
•Raw Materials * Safety stock
* Release defects
•Design * Resupply
• Energy * …….
•……
Bi- Products
NC. items – wastes –En . Consumption - …
Quality control of procurement& services
Quality control of Design
Quality control of measuring resources
Quality control of Non conforming outputs
 PART 2
Quality Management &Leadership

Section 3
Quality Management System

121
 ‫‪The word (QUALITY) never comes alone‬‬
‫البنية التحتية للجودة‬ ‫مبادىء الجودة‬
‫أبعاد الجودة‬ ‫ضمان الجودة‬
‫‪National Quality‬‬ ‫‪Q. Principals‬‬
‫‪Q. Dimensions‬‬ ‫‪QA‬‬
‫‪Infra structure‬‬

‫شهادات الجودة‬
‫نظام إدارة الجودة‬
‫مراجعات الجودة‬
‫‪Q. Certificates‬‬ ‫‪QMS‬‬ ‫‪Q. Audits‬‬
‫‪ISO 9001‬‬

‫رقابة الجودة‬ ‫تخطيط الجودة‬ ‫تحسين الجودة‬

‫إدارة الجودة الشاملة‬
‫‪Q.C‬‬ ‫‪Q. Planning‬‬ ‫‪Q. Improvements‬‬
‫‪TQM‬‬
ISO

International

Organization

Standardization
 WE HAVE THREE KEY WORDS

Quality

MANAGEMENT

SYSTEM

We Have To Have a Common Understanding of each

 What Does the word MANAGEMENT Mean?

•Series of Activities

• Aims to Get ideal use of Available Resources

•to Fulfill the Planned Objectives at all levels

May 16, 2024 125

 1-VISION 2-POLICY 3-PLANNING

6-RESOURCES 5-ACTION PLANS 4-OBJECTIVES

AVAILABILITY

8- Communication
7- Roles ,Resp.&
,
9- Follow up
Authorities Channels & KPI S

12- Mgm. Review 11- Corr.& Preventive

10- Ass. &Review
For Improvement Actions
May 16, 2024 126
Resources

- Tangible

- Non- tangible
What are the available resources?

Utilities FINANCE HR

Warehouses P. Lines
Energy Resources
Facilities Infrastructure

Equipments NETS N. Tangible Resources

Time-Talents -…
May 16, 2024 128
 Planned Objective
Duration FOLLOW UP
Resources
# Activity Responsibility KPI,S Reasons
Required
from to YES NO

May 16, 2024 129

 Quality Management
• What is meant by (Quality Management )?

• A system to make sure that a product or service meets standards

of excellence, and that the process by which the product or
service is created is efficient and effective as well.
 Quality - Management System

Satisfying
Customers

Protecting
Environment
Exceeding Interested
OUTCOME
Parties
Interested Satisfaction
Mitigating
Parties Hazards & Risks
Requirements

May 16, 2024

Approach ‫منهجية‬
System means :

• Set of Documented Approaches (Work Instructions) / SOP ,S

• Describe
• Explain
• Clarify

• HOW a set of interrelated processes are Performed

• To achieve a specified product ( service ) of certain Specification

• System must :
• Self Running
• Standardized
System means :
The Perfect Approaches Specifies:
• Who
• What
• When
• HOW
• Why

Perfect Approach Shall be:

• Written
• Revised Extremely Experts
• Approved
• Referenced
• Updated
 Approach

Who

What

When

How

Why
May 16, 2024
Standardized Operating Procedures (SOP,S ) 135
 ) ‫ما المعنى الحقيقى لتعبير ( نظام إدارة الجودة‬
What is meant by ( QMS )?

is a collection of business processes and procedures which aims

to ensure that the quality of products or services meets - or
exceeds - customer expectations.

: ‫ التى‬SOP,S(( ‫* هو مجموع المنهجيات الموثقة‬

‫ تصف‬-
May 16, 2024 ‫ تشرح‬-136
 Section 3
Common in all
Management System Standards

May 16, 2024 137

Common in all Management System Standards
1- HLS ( Annex SL - 10 MAIN CLAUSES)
2- Risk based thinking
3- Process Approach (PDCA - SIPOC)
4- Language
5- Consistent with Business Strategy
6- Documented Information
May 16, 2024 138
 Risk
Risk = The effect of Uncertainty on targets

• In future
• Unknown
• Probable to occur OR not
• Has positive or Negative effect
 PROCESS APPROACH

Controls

M. O/Ps
Inputs Activities H. Quality

Bi - products
N.C o/p - negatively Affecting Environment & health- En. Performance
Should be eliminated ( mitigated )
140
 PROCESS CONCEPTS

May 16, 2024 141

• Management system consists of a number of key processes and
supportive processes

• each process (key or supportive) consists of several sub-processes

• Each sub-process consist of activities

• activities are performed by qualified personnel & other resources.

• System determines targets (Objectives) for each activity / process /

personnel to be achieved

• The main Objective of QMS is to improve its processes

Performance.
May 16, 2024 142
- All Management systems are built on the applying many principles.

- The most important principal is called (Process Approach(

- (Process Approach(is applied to all activities throughout the all

organizations.

May 16, 2024

 Process :
• Series of applied activities performed upon some inputs under the
control of some controls to achieve measurable outputs

• The output of a process become an input of another process within

the organization

May 16, 2024

 Annex SL Common Structure

1. Scope
6. Planning

2. Normative references
7. Support

3. Terms and definition

8. Operation

4. Context of the 9. Performance

organisation
evaluation

5. Leadership 10. Improvement

May 16, 2024 145
 Contents of this International Standard
• In all International Standard, the following verbal forms are
used:

‒ "shall" indicates a requirement;‫يجب‬

‒ "should" indicates a recommendation;‫ينبغى‬

‒ "may" indicates a permission; ‫يجوز‬

‒ "can" indicates a possibility or a capability.‫يمكن‬

May 16, 2024
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