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Design of Experiments

Total questions: 10

Worksheet time: 3mins

Name
Class
Date
1.

QbD full form

a)

Quality by Design

b)

Quantity by Design

2.

Key elements of QbD

a)

QTTP

b)

CQA

c)

Design Space

d)

All the above

3.

Which ICH guideline focus on Quality Risk Management

a)

ICH Q8

b)

ICH Q9

c)

ICH Q10

d)

ICH Q7

4.

Which strategy SAVE TIME to get QUALITY PRODUCT

a)

OFAT

b)

DOE

5.

How is a low level variable coded?

a)

+1

b)

0

c)

-1

6.

What is the quantitative casual diagram used to identify possible failures in a system/process

a)

Quantitative diagram

b)

Fish bone diagram

c)

Tree root diagram

7.

Operating space is a subset of design space

a)

True

b)

False

8.

Which of the following is the correct ORDER

a)

Design Space --) CQA---) Risk Assessment ----)DoE ---) QTTP

b)

DoE ---) ----) Design Space ---) QTTP --) CQA---) Risk Assessment

c)

QTTP --) CQA---) Risk Assessment ----)DoE ---) Design Space

9.

DoE is one of the tools of QbD

a)

True

b)

False

10.

When to use Response Surface Methodology [RSM]?

a)

P < 0.05 for curvature

b)

P >0.05 for curvature

c)

P=0.05 for curvature