Quality Assurance Flashcards
It is one of several graphical tools typically used in quality control analysis to understand how a process changes over time.
Statistical Process Control (SPC) Chart
It describes all steps taken during the analysis, including how the sample is processed in the laboratory.
Standard Operations Procedure (SOP)
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.
Food and Drug Administration (FDA)
It gives formal recognition of competence to carry out the production of reference materials based on third-party assessment and following international standards.
Reference Material Producer (RMP) Accreditation
It is headquartered in Geneva, Switzerland, and is the organization that prepares and publishes international standards for all electrical, electronic, and related technologies.
International Electromechanical Commission (IEC)
7’S
Sort
Set in Order
Shine
Sustain
Safety
Spirit
DEFINE ACRONYMS: ISO
International Organization for Standardization
DEFINE ACRONYMS: IEC
International Electrotechnical Commission
DEFINE ACRONYMS: ITU
International Telecommunication Union
DEFINE ACRONYMS: EPA
Environmental Protection Agency
DEFINE ACRONYMS: FDA
Food and Drug Administration
The process of comparing an instrument’s accuracy to known standards
Calibration
It is a process that evaluates the competencies of an individual in a particular field or profession.
Certification
An overarching system within your Quality Assurance Management Systems
Tool Calibration and Control System
Is a unique nine-digit identifier for business es, which is required for the FDA registration process
DUNS number
The DUNS number is issued by _______, a US-based company
Dun & Bradstreet
A 5-digit company identification number assigned by the FDA to the manufacturer or distributor of OTC drugs.
Labeler Code / NDC Labeler Code
It is a process that evaluates the quality of an educational institution, program, or degree.
Accreditation
Identified the practices necessary to bring a system into statistical Control
Quality Assurance Program
The _____ in the analytical approach is maintained by quality assurance program, whose objective is to control systematic and random sources of error
Feedback loop
_____ drug product s that are considered safe and effective by the FDA and yet can be purchased without a prescription
Over-the-counter or OTC
______ 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.
Laboratory Accreditation
