THE CONCEPT OF QUALITY ASSURANCE

QUALITY

Quality is never an accident,

it is always the result of high

intention, sincere effort,

intelligent direction and

skillful execution. It represents

the wise choice of many

alternatives.

In manufacturing, a measure of excellence or a state of being free from defects, deficiencies and significant variations. It is brought about by strict and consistent commitment to certain standards that achieve uniformity of a product in order to satisfy specific customer or user requirements.

ISO (International Standard Organization) defines quality as “The totality of features and characteristics of a product or service that bears its ability to satisfy stated or implied needs."

Example:

If an automobile company finds a defect in one of their cars and makes a product recall, customer reliability and therefore production will decrease because trust will be lost in the car's quality.

QUALITY ASSURANCE

Quality Assurance “(QA) is a way of preventing mistakes or defects in manufactured products and avoiding problems when delivering solutions or services to customers”.

The planned and systematic activities implemented in a quality system so that quality requirements for a product or service will be fulfilled.

QA is applied to physical products in pre-production to verify what will be made meets specifications and requirements, and during manufacturing production runs by validating lot samples meet specified quality controlsThe maintenance of a desired level of quality in a service or product, especially by means of attention to every stage of the process of delivery or production.

QA is also applied to software to verify that features and functionality meet business objectives, and that code is relatively bug free prior to shipping or releasing new software products and versions.Quality Assurance is any systematic process of checking to see whether a product or service being developed is meeting specified requirements.

QUALITY ASSURANCE AND SOFTWARE DEVELOPMENT

HISTORY AND INITIAL EFFORTS • During the time of the First World War, manufacturing

processes typically became more complex with larger numbers of workers being supervised.

• This period saw the widespread introduction of mass production and piece work, which created problems as workmen could now earn more money by the production of extra products, which in turn occasionally led to poor quality workmanship being passed on to the assembly lines.

• To counter bad workmanship, full-time inspectors were introduced to identify, quarantine and ideally correct product quality failures.

WORLD WAR 2 AND FURTHER PROGRESS

• Rebuilt of most manufacturing capabilities.

• “General Douglas MacArthur” supervise the re-building of Japan.

• W. Edwards Deming and Joseph Juran involved in the development of modern concept of Quality.

JOBS/DUTIES OF QUALITY ASSURANCE MANAGER

Quality assurance managers work with other staff within

organizations to determine and establish procedures and quality standards and to monitor these

against agreed targets.

FUNCTION OF QUALITY ASSURANCE

• Covers everything from raw materials and GMP verification through finished-product release

• HACCP is part of QA (Hazard Analysis & Critical Control Points)

COSTUMER EXPECTATIONS

This is where quality programs begin. • Marketing has defined the

customer expectations.• Product development has

created a product that meets those expectations.

• Engineering has designed a process to make the desired product.

• Now, all QA must do is design a control system that verifies that everything is working as designed

INSTALLATION OF QA PLAN• Organization of department Make use of supervisors

• Amount and quality of training affects finished product quality

Every line employee should be trained

Verify job is being done correctly

• Automation of process changes types and quantities of analyses needed

Speed of testing What level of accuracy is necessary Maintenance and calibration of lab

equipment Training of technicians Verification of accuracy and

variation of technicians