Quality Assurance

Question 1

It is one of several graphical tools typically used in quality control analysis to understand how a process changes over time.

Answer 1

Statistical Process Control (SPC) Chart

Question 2

It describes all steps taken during the analysis, including how the sample is processed in the laboratory.

Answer 2

Standard Operations Procedure (SOP)

Question 3

It is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs and products that emit radiation.

Answer 3

Food and Drug Administration (FDA)

Question 4

It gives formal recognition of competence to carry out the production of reference materials based on third-party assessment and following international standards.

Answer 4

Reference Material Producer (RMP) Accreditation

Question 5

It is headquartered in Geneva, Switzerland, and is the organization that prepares and publishes international standards for all electrical, electronic, and related technologies.

Answer 5

International Electromechanical Commission (IEC)

Question 6

7’S

Answer 6

Sort
Set in Order
Shine

Sustain
Safety
Spirit

Question 7

DEFINE ACRONYMS: ISO

Answer 7

International Organization for Standardization

Question 8

DEFINE ACRONYMS: IEC

Answer 8

International Electrotechnical Commission

Question 9

DEFINE ACRONYMS: ITU

Answer 9

International Telecommunication Union

Question 10

DEFINE ACRONYMS: EPA

Answer 10

Environmental Protection Agency

Question 11

DEFINE ACRONYMS: FDA

Answer 11

Food and Drug Administration

Question 12

The process of comparing an instrument’s accuracy to known standards

Answer 12

Calibration

Question 13

It is a process that evaluates the competencies of an individual in a particular field or profession.

Answer 13

Certification

Question 14

An overarching system within your Quality Assurance Management Systems

Answer 14

Tool Calibration and Control System

Question 15

Is a unique nine-digit identifier for business es, which is required for the FDA registration process

Answer 15

DUNS number

Question 16

The DUNS number is issued by _______, a US-based company

Answer 16

Dun & Bradstreet

Question 17

A 5-digit company identification number assigned by the FDA to the manufacturer or distributor of OTC drugs.

Answer 17

Labeler Code / NDC Labeler Code

Question 18

It is a process that evaluates the quality of an educational institution, program, or degree.

Answer 18

Accreditation

Question 19

Identified the practices necessary to bring a system into statistical Control

Answer 19

Quality Assurance Program

Question 20

The _____ in the analytical approach is maintained by quality assurance program, whose objective is to control systematic and random sources of error

Answer 20

Feedback loop

Question 21

_____ drug product s that are considered safe and effective by the FDA and yet can be purchased without a prescription

Answer 21

Over-the-counter or OTC

Question 22

______ is a procedure by which an authorative body gives formal recognition of technical competence for specific tests/measurements based on third party assessment and following international standards.

Answer 22

Laboratory Accreditation