Name:
Department &/or Function:
Date:
Score: ____________/32
1. What is cGMP?
A:
2. Which of the following is not true for the “Quality” of a medical device every
time it is manufactured (select all that apply):
must be fit for its intended use
must be within specification
must satisfy customer expectations
must be safe to use
None of the above
3. Top Management is responsible for providing (select all that apply):
Buildings with the right environment
Machines and equipment suitable for the purpose
Qualified Personnel
Quality Department
Procedures
Training
4. The principal documents used during the manufacturing of a medical device
include (select all that apply):
Standard Operating Procedures
Work Instructions
Financial documents
Manufacturing records
Customer agreements
5. Status label control is a method to control the movement of materials…
from the moment the material arrives onto the company premises to the
point at which the finished goods leave the company premises..
from the time at which the product is manufactured until the point at which
the finished goods leave the company premises..
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6. A high standard of personal hygiene in manufacturing areas is one of the
most important ways of preventing the contamination of a product.
True
False
7. Protective clothing is used to (select all that apply):
Protect the product
Protect the operator
Avoid touching the clothes
Avoid particles contamination
8. Cleaning fluids must always be used in the correct dilution and within their
shelf-life.
True
False
9. Housekeeping & cleaning materials are not useful for Medical device
companies.
True
False
10. Only the equipment and materials needed for the work being performed
should be held in the production area at that time.
True
False
11. Protective clothing is not required for maintenance employees when working
in the production area.
True
False
12. Quality Systems Regulations include some of the following topics (select all
that apply):
Documentation
Facility maintenance
Record keeping
Strategic planning
Sales standards
Process controls
Distribution
Marketing
13. What is the purpose of cGMP?
To ensure that safe and effective devices are designed and produced
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To ensure that safe devices are designed and marketed
To ensure corporate responsibility and accountability to patient safety
14. Good housekeeping is important because (select all that apply):
It helps to prevent accidents
It looks nicer
It helps to prevent dust accumulation
Makes it easier to clean the floors
15. Handwritten entries on documentation must (select all that apply):
Be in ink
Be readable
Be accurate
Be written at the time of operation
Be corrected using correction fluid
16. The status of incoming materials is obvious so it does not need to be
documented, labeled, or stored by status.
True
False
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