Quality Assurance Principles3- 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 organization’s benefit.

5 M’s of Quality

Man

Material

Machinery

Manuals/ Methodology

Motivation

QA Activities

1. Technology transfer

2. Validation

3. Documentation

4. Assuring quality of products

5. Quality improvement plans

Quality Assurance Levels

1- System Level

2- Organizational Level

3- Professional Level

4- 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 organization’s 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

• People actively seeking opportunities to enhance their competence, knowledge and experience

• People freely sharing knowledge and experience

• People openly discussing problems and issues.

And…