Terminology
SOP is an acronym for.....
Standard Operating Procedure
How many years has ECI been in business?
54
What quality system is ECI accredited to?
ISO 17025
What does Correction Code WT stand for?
Wrong Time
TRUE or FALSE
I do not have to initial and date N/A cross outs.
False
An exact and verified copy of an original record.
How many employees work at ECI?
65
Per the training and onboarding SOP, competency evaluations are done every _________ years.
2
What is the first step of the training process?
Read and signed a "Read and Acknowledge" form for the associated procedure.
True or False:
I can leave blank spaces.
False
The completeness, consistency, accuracy, legibility, and honesty of all raw and final data throughout the life cycle of the data/project
Data Integrity
A previous ECI QM started a sports league (that is still currently active). What sport was it for?
Golf
set of guidelines for creating, maintaining, and archiving records to ensure their accuracy, integrity, and reliability
GDP
A quality system for managing and performing non-clinical health and environmental studies to ensure data integrity and reliability
GLP
"Alexander had an error with his documentation. He took a sharpie to it. What should he have done instead?"
Use a pen to correct his mistake by single line cross out of mistake, correction code, initial and date
Any data recorded on laboratory worksheets, records, memoranda, notes, or exact copies thereof, that are the result of original observations and activities of a test/study and are necessary for the reconstruction and evaluation of the report of that test/study.
Raw Data
The medical lab had a resident animal living on property, what animal was it?
Raccoon
An internal, proactive process focused on improving processes and preventing defects to consistently achieve higher quality outcomes.
Quality Assurance
What does Correction Code SF stand for?
Significant Figure Error
"Monica made a transcription error when writing the date. She used error code EE and initialled/dated the mistake."
Was this the right error code? If no, what error code should have been used?
DE, Dating error
What does the "C" in ALCOA stand for? What does it mean?
Contemporaneous – Data must be generated at the time the work is performed.
How many SQFT is ECI?
70000
What is the difference between Calibration and Validation?
-Calibration ensures instrument accuracy
-Validation confirms that the process, system, or equipment produces result that meets the specified measurement.
The process of adhering to established rules and standards to ensure products and services are safe, reliable, and meet specific quality benchmarks
Compliance
True or False:
A structured problem-solving approach to process improvement ensures that solutions are developed objectively.
True