QUALITY ASSURANCE FOR THE BIOSCIENCES
MID-TERM EXAM
Note for instructors: This exam is from an online course. You may want to cover this
material in short answer, case studies, long answers etc…Answers are provided below.
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Question Match up the duties with the responsible department
Answer Match Question Items
Answer Items
B. - A. Research &
Development
D. - B. Production
A. Test samples of the product and the materials that
go into making the product
B. Investigate a potential product with commercial
value
C. - C. Quality Assurance C. Ensure all documents are accurate, complete and
available
A. - D. Quality Control
D. Make product by following documented procedures
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Question What is the mission of "bio.org"?
Answer a. bio.org is the world's largest biotechnology organization, providing advocacy,
business development and communications services for its members
b. bio.org is a biotechnology educational institution that assists biotechnology
professors with curriculum.
c. bio.org is a biotechnology student assistance program.
d. bio.org is a biotechnology techniques website. You can find protocols relating to
biotechnology here.
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Question The exact organization of a Biotechnology company is the same, no matter what type
of biotechnology company it is.
Answer
True
False
The exact organization of a Biotechnology company depends on what type of
company it is: whether it is marking a product or service, agricultural, medical,
environmental, forensics or research products.
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Question The Quality Control Department decides whether or not to approve the final product
for release to the customers.
Answer
True
Incorrect
Feedback
False
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Feedback
It is the responsibility of the QA dept to decide whether or not to approve the
final product for release to the customers.
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Question The Quality dept is a very private department. In order to achieve impartiality in
results they do not work closely with other departments.
Answer
True
False
Quality works VERY closely with ALL depts throughout the company.
Incorrect Feedback
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Question Scale up problems are solved by the Research & Development Dept
Answer
True
False
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Question Quality is easily defined one way. Everyone views quality in the same way.
Answer
True
False
Quality has many connotations. If you ask 20 people to define quality you will
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get 20 different definitions!
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Question Quality is determined by the company (the maker of the product)
Answer
True
False
Quality is a customer determination
Incorrect Feedback
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Question Quality is based on customer perception - actual or even perceived!
Answer
True
False
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Question A successful company has a clear vision statement. A vision statement is
Answer
a. a description of where they came from
b. how they see themselves right now
c. how they see themselves in the future
d. a short statement on the company philosophy
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Question The following is true about a mission statement
Answer a. The mission statement a lengthy description of where they see themselves in the
future.
b. The mission statement should be short and complete.
c. The mission statement is developed to support the organization's vision.
d. b & c only
e. a & c only
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Question The following is true about variation in processes:
Answer a. Variation is rarely present in a process.
b. Variation is never present in a process.
c. Variation is present in any process.
d. Variation is no big deal in any process, so it's presence isn't relevant.
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Question Specification are provided by the customer.
Answer
True
False
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Question A product's process is considered in tolerance when the specification are met within
the tolerance limits provided by the customer.
Answer
True
False
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Question Productivity is the same as Quality.
Answer
True
False
Productivity looks at best utilizing available resources, quality just focuses on
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effectiveness while meeting customer needs.
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Question The practice of Quality and Quality Principles is a new concept, brought about by a
competitive market.
Answer
True
False
Modern quality principles have evolved over a long period of time - starting
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over 10,000 years ago!
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Question Match up the following Quality tasks with their purpose
Answer
Question
Match
Answer Items
Items
a. - a. Inspection a. Highly defined, close examination of a product.
b. - b. Audit
b. Determination of adherence to the established quality
standards.
c. - c.
c. Determination of adherence to following day-to-day
Surveillance established procedures.
d. - d. Prevention d. Highly defined, close examination of a process.
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Question Statistical Process Control (SPC) can be used to help a company meet the following
goals:
Answer
a. Reduce variability from product to product
b.
c.
d.
e.
Increase Profits
Create products that will meet customer needs and expectations
All of these
a & b only
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Question The following is true about a major defect:
Answer a. Will result in a hazardous condition for person using product.
b. Will result in reduced usability of the product.
c. May not result in a decrease in the effectiveness of the product.
d. All of these apply.
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Question The following apply to Total Quality Management (TQM)
Answer a. Management approach that involves the input of management only.
b. Management approach that relies on all members of the company to participate.
c. A short-term problem solving approach that can be used to get a company out of
a bad situation.
d. In order for the Total Quality Management approach to be success, it must be
adhered to strictly and never change.
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Question Match up the Quality Standard with the Methodology
Answer
Question
Match
Answer Items
Items
B. - A. cGMP
A. Rigorous process improvement methodologies.
D. - B. ISO9000 B. Involuntary, enforced by the FDA.
A. - C. Six Sigma C. Production focuses on removing waste from production
processes.
C. - D. Lean
D. Voluntary system, enforced by private auditor hired by the
company.
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Question Quality Control has a limited function in a company, it is responsible for testing or
sampling in compliance as determined by Quality Assurance.
Answer
True
False
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Question Match up the Founder of Quality with their philosophy and contribution.
Answer Match Question Items
Answer Items
B. - A. Fredrick
Taylor
C. - B. Dr. W.
Deming
D. - C. Dr. Armand
Feigenbaum
A. - D. Dr. Joseph
Juran
A. Three universal processes for managing quality: Quality
Planning, Quality Control, Quality Improvement.
B. Used motion studies to simply the manufacturing process
for the workers. Required no worker input.
C. Quality improvement through better management.
Encouraged a cooperative atmosphere between workers and
management.
D. Founder of Total Quality Control - an extensive
company-wide customer-based improvement system.
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Question In Juran's fitness for use definition of quality, there are four components of product
fitness. Match up the Component of product fitness with its main function.
Answer Match Question Items
Answer Items
B. - A. Quality of Design
A. - B. Quality of
Conformance
D. - C. Availability
C. - D. Field Service
A. How well processes are adhering to specifications.
B. How to determine the specifications for
manufacturing.
C. Interacting with the customer using the product.
D. Determining how fast the product can be
delivered to a customer.
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Question Maslow's Hierarchy of Needs has nothing to do with how connected an employee feels
with a company
Answer
True
False
The further up the hierarchy an employee goes, the more connected they feel
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to that company.
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Question What is NIST?
Answer a. National Institute of Standards is a non-regulatory federal agency
b. National Institute of Standards is a highly regulated federal agency, which is a
branch of the FDA.
c. Network of Investigators working for Standardization is a non-profit group
working towards quality system standardization.
d. Network of Investigators working for Standardization is a for profit company
working towards quality system standardization.
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Question A quality system is the totality of the procedures and processes that together ensure a
quality product.
Answer
True
False
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Question A quality system is a guarantee of a products quality.
Answer
True
False
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Question All Quality Management Systems are voluntary.
Answer
True
False
Incorrect Feedback cGMP is mandatory for pharmaceutical companies, for example.
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Question ISO9000 is enforced by the FDA
Answer
True
False
This is a voluntary system, it is enforced by ISO, and an auditing body that
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company hires for certification.
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Question ISO9000:2008 standards are based on the following principles:
Answer a. They are customer focused.
b. They use a factual approach to decision making.
c. Encompasses the involvement of everyone in the company
d. All of these
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Question The types of documents required for ISO9001 certification
Answer
a. Quality Policy and Objectives
b.
c.
d.
e.
Quality Manual
Documented procedures and records
All of these
b & c only
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Question The purpose of all Quality Management Systems is to
Answer
a. Outline what you are going to do in your QMS
b. Follow their QMS as outlined
c. Keep records and documentation that they are following a QMS
d. All of the above
Incorrect Feedback "do what you say, say what you do, and be able to prove it!"
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Question The Quality Management System that must be used in an Academic Research Lab is
Answer
a. cGMP
b.
c.
d.
e.
ISO9001
GLP
Any of these can be used in an Academic Research lab.
None of these. The QMS in Academic labs is informal.
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Question The following is true about cGMP
Answer
a. This is an informal voluntary system provided by the government to assist
drug manufacturers.
b. Although this system is formal, it is entirely voluntary.
c. This is a formal system that outlines step-by-step how a company is to
manufacture pharmaceuticals. A bad drug can cause death, so it's important to
keep strict adherence to these regulations.
d. Although this system is formal, it provides flexible guidelines to allow each
manufacturer to decide individually how to best implement the necessary
quality controls.
Incorrect
GMP guidelines are NOT prescriptive instructions, they are GUIDELINES!
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Question The following is false about implementing change in different workplaces
Answer
a. Change in an academic research lab is welcome. This is the basis for
scientific progress!
b. Change in a Pharmaceutical company is highly controlled and monitored.
This is part of the cGMP regulations.
c. Change in an ISO9000 certified company is no big deal. This is a voluntary
system, so if the manufacture wants to change something, they can!
d. All of these are true.
Although ISO9000 is a voluntary system, it is important to tightly regulate and
monitor changes. Change is highly controlled and implemented changes are
monitored.
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Question Match up the ISO standard with it's appropriate description
Answer Match Question Items
Answer Items
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C. - A. ISO
9000:2008
A. Addresses environmental management.
D. - B. ISO
9001:2008
B. - C. ISO
9004:2008
A. - D. ISO 14000
E. - E. ISO/IEC
17025:2005
F. - F. ISO
15378:2006
B. Guidelines for performance improvement (beyond the
standard).
C. Provides information about the concepts and vocabulary
used in the standards
D. Provides the requirements that must be met in order to
achieve certification
E. General requirements for testing and calibration labs
F. Requirements for a quality management system that
applies to packaging pharmaceutical products
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Question The following is true about ISO 9000 certification
Answer a. It is a quick and easy process, it just costs a lot of money to hire an auditor.
b. This is a long and arduous process because you have to deal with the bureaucracy
of the FDA.
c. This is an expensive process who's length depends on the current quality
management state of the company. It typically takes thousands of man hours to
complete.
d. You can purchase the ISO 9000 certification logo on-line. There are no
requirements to using it, it's rather expensive though.
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Question Since ISO is a voluntary system, why would a company go to great lengths to achieve
compliance? What motivates companies to adopt these stringent quality standards.
Answer
Developing a quality product.
Building reputation with potential customers and other companies.
Saving money by removing inefficient processes and keeping the efficient
processes well tuned.
All of these
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Question The following is true about Deming's philosophy in Quality Management
Answer a. Involve every employee in the quality plan.
b.
c.
d.
e.
Develop a statistical approach to inspection.
Remove adversarial relationship with management and employees.
All of these (a, b, & c)
b & c only
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Question Six Sigma is a quality management principle that focuses on removing waste from
production processes.
Answer
True
False
Six Sigma is a methodology strategy that deal with product and system failures.
Incorrect
Define-Measure-Analyze-Improve-Control
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Question In a bio-sciences company that prepares reagents for research purposes only, which
departments participate in a voluntary quality management system
Answer
a. Quality Assurance
b.
c.
d.
e.
f.
Quality Control
Research and Development
Shipping and Receiving
all of these
a & b only
Every department participates in a QMS, regardless if the system is
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voluntary or involuntary.
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Question Which departments are bound by cGMP regulations in a pharmaceutical company that
manufactures drugs.
Answer
a. Quality Assurance
b.
c.
d.
e.
f.
g.
Production
Research & Development
Shipping & Receiving
all of these
a only
a & b only
Every department participates in the quality management system! This is
particularly important by cGMP companies that are regularly audited by the
FDA.
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Question Inspections, audits and surveillance will rarely uncover nonconforming products.
Answer
True
Incorrect
Feedback
False