Quality Assurance Principles

3- Involvement of People
Presented By:
Malak Nabil Badawy

DEFINING QUALITY
Good Appearance?
High Price?
The Best?
Particular Specification?
Not necessarily, but always:
Fitness for Purpose
Meets Customer Requirements

THE NATURE OF QUALITY

Meeting Customers and the Organization's
Needs
Integral Part of the Business
Assuring Quality Systematically
Prevention Culture
Right First Time
Continuous Improvement

QUALITY TERMINOLOGY
Quality Control

= Inspection/ Correction

Quality Assurance = Prevention

Quality Management = Enhance
Customer Satisfaction and Continual
Improvement

Quality Assurance
Is a wide range concept covering all
matters that individually or collectively
influence the quality of a product.

It is the totality of the arrangements made

with object of ensuring that products are
of the quality required for their intended
use.
QA = QC + GMP/ other Quality Systems

ISO
(International Organization for Standardization)
It work in favor of customer Its focus is on product
Quality ISO consists more Business operations Optional

GMP
(Good Manufacturing Practice)
It works in favor of Manufacturer Its focus is on
Manufacturing GMP consists of more technical
operations Mandatory

- If you have GMP 20 30 % more work needed to get

ISO
- If you have ISO 65 75 % more work needed to get
GMP

That work and required more work will be the great

effort of the QUALITY ASSURANCE

THE PRINCIPLES OF ISO

9001: 2000
Customer Focused Organization
Leadership
Involvement of People
Process Approach
System Approach to Management
Continual Improvement
Factual Approach to Decision Making
Mutually Beneficial Supplier Relationships

3- Involvement of People

People at all levels are the

essence of an organization and
their full involvement enables
their abilities to be used for the
organizations benefit.

5 Ms of Quality
Man
Material
Machinery
Manuals/ Methodology
Motivation

QA

1.
2.
3.
4.
5.

Activities

Technology transfer
Validation
Documentation
Assuring quality of products
Quality improvement plans

Quality Assurance Levels

1234-

System Level
Organizational Level
Professional Level
User Level

1- System Level:
Legislation
Inspectorate
Accreditation and Certification
National Standards and Guidelines

2- Organizational Level
Quality Management Systems and Audits
Benchmarking, Monitoring and
Performance Indicators
Improvement Measures and Processes

3- Professional Level
Professional profiles / mew professionals /
new roles
Improvement structures
Accreditation, registration
Communication and information sharing

4- User Level
Informed consent and shared decision
making
Choice
Client satisfaction
Information
Role of informal and non-formal care

Involving People Benefits:

Motivated, committed and involved people
within the organization
Innovation and creativity in furthering the
organizations objectives
People being accountable for their own
performance
People eager to participate in and
contribute to continual improvement.

Involving people leads to:

People understanding the importance of
their contribution and role in the
organization
People identifying constraints to their
performance
People accepting ownership of problems
and their responsibility for solving them
People evaluating their performance
against their personal goals and objectives

And
People actively seeking opportunities to
enhance their competence, knowledge and
experience
People freely sharing knowledge and
experience
People openly discussing problems and issues.