Wk 1 - Introduction to Quality Control

Question 1

the combination of attributes or characteristics of a product which, when compared to a standard, serves as a basis for measuring the uniformity of the product and determines its degree of acceptability

Answer 1

Quality

Answer 2

Control

Answer 3

Quality Control

Answer 4

Quality Assurance

Question 5

QA vs QC

Quality Assurance

Question 6

QA vs QC

Quality Control

Answer 7

Quality Control System

Question 8

What are the benefits of establishing a Quality Control System?

Answer 9

Benchmarking

Question 10

TQM

Answer 10

Total Quality Management

Question 11

What are the primary elements of TQM?

Answer 11

• Customer focused
• Total employee involvement
• Process-centered
• Integrated system
• Strategic and Systematic
• Continual improvement
• Fact-based decision making
• Communications

Question 12

quality assessment with an attached judgment that the evaluated unit is good enough to have the right to exist in a particular system.

Answer 12

Accreditaton

Question 13

Accreditation is usually given for a limited amount of time and is renewed and repeated in a cyclical process. For how many years is accreditation valid?

Answer 13

4 to 10 years

Question 14

A voluntary, non-treaty federation of standards setting bodies of some 130 countries, promoting the development of standardization and related activities to facilitate international trade in goods and services, and cooperation on economic, intellectual, scientific, and technological aspects

ISO

Answer 14

The International Organization for Standardization (ISO)

Question 15

When and where was ISO first founded?

Answer 15

Geneva (1946-1947) as a UN agency

Question 16

a public statement by a certified auditor that an organization lives up to the ISO standards.

Answer 16

ISO certification

Question 17

What aspects of organization of quality control should be defined by a manufacturing firms?

Answer 17

• functions and responsibilities
• effective coordination
• all activities perforomed towards the production of the product (highest std, lowest cost)

Question 18

Common divisions of a Manufacturing firm

Answer 18

1. Finance
2. Production
3. Quality Assurance and Control
4. Marketing (but may be optional in 3rd party contract)

Question 19

Manufacturing process must be done in compliance with?

cGMP

Answer 19

Current Good Manufacturing Practice

(Administrative Order No. 220, s. 1974)

Answer 20

Quality control department

Question 21

What are the control functions?

Answer 21

• Analysis Function
• Monitor Function
• Record Review and Release Function
• Audit Function