INTRODUCTION TO QUALITY AND ITS IMPORTANCE

INTRODUCTION TO QUALITY AND ITS IMPORTANCE

•       There are so many definitions for Quality.

•       Quality is…..

–      Based on judgments by an individual or organisation

–      Fitness for purpose

–      Corresponds to a rating

–      Based on acceptable performance

–      Meeting goals

–      Meeting requirements

What is Quality Assurance?

•       What is Quality?

Quality is the ability of your product to be able to satisfy your users

•       What is Quality Assurance?

Quality Assurance is the process that demonstrates your product is able to satisfy your users

What is the Aim of QA?

•       When good Quality Assurance is implemented there should be improvement in usability and performance and lessening rates of defects

QUALITY TERMINOLOGY

•       Quality Control   =   Correction

•       Quality Assurance = Prevention

•       Quality Management = Enhance  Customer Satisfaction and Continual Improvement

WHAT DOES QA GIVE?

–      Quality’ means measure of excellence or state of being free from defects or significant variations.

–      But ‘quality assurance’ needs documented standards and best practices to be meaningful

–      ‘Quality’ & ‘Best Practice’ can be considered in terms of being ‘Fit for Purpose’

WHAT IS QUALITY CONTROL?

•       Quality Control (QC) is the implementation of regular testing procedures against your definitions of quality and more specifically the refinement of these procedures

–      Formal use of testing

–      Acting on the results of your tests

–      Requires planning, structured tests, good documentation

–      Relates to output - Quality Circle

–      Standards - ISO 9000 & BS5750

•          however there is currently no such  standard for Web sites

QUALITY RELATIONSHIPS

Quality Management

â

Quality Assurance

â

GMP

â

Quality Control

FACTORS IN DRUG QUALITY ASSURANCE

DRUG PRODUCT QUALITY

–      IMPORT & EXPORT CONTROL

–      PACKAGING

–      LABELLING & PRODUCT INFORMATION

–      QC & ANALYSIS

–      TRANSPORT DISTRIBUTION DISPENSING & USE

–      STORAGE

–      MANUFACURING PROCESSES & PROCEDURES

–      RAW MATERIALS

–      HUMAN RESOURCES- PROFESSIONALS

–      LEGISLATIVE FRAMEWORK –REGULATIONS

Quality Assurance: Essential at All Stages

PRINCIPLES OF QUALITY ASSURANCE

• Customer focus

• Leadership

• Involvement of people

• Process approach

• System approach to management

• Continual improvement

• Factual approach to decision making

• Mutually beneficial supplier relationship

COMPONENTS OF QUALITY ASSURANCE

• STRUCTURE EVALUATION

• PROCESS EVALUATION

• OUTCOME EVALUATION

MODELS OF QUALITYASSURANCE

1.       System Model

2.       Input

3.       Throughput

4.       Output

5.       Feedback

QUALITY ASSURANCE MODEL

 

PLAN, DO, STUDY, ACT CYCLE

LEVELS OF EVALUATION OF QUALITY OF CARE

National Level

Trust or organization level

Local Level

APPROACHES OF QUALITY IMPROVEMENT

General Approaches

• Credentialing

• Licensure

• Accreditation

• Certification

• Charter

• Academic Degrees

Specific Approaches

• Peer Review Committees (Staff Review Committees)

• Standard as a device for quality assurance