I.D.

Number _____________________________ Desk No _____________

Faculty of Science, Engineering and Computing

Postgraduate Regulations

January Examinations 2019/2020

Level 7

MODULE: CH7010: Statistics and Quality Systems

DURATION: 2 hours

Instructions to Candidates

This paper contains six questions in TWO sections: Sections A and B

Answer FOUR questions only.
Answer TWO questions from each section
All questions carry equal marks

ANSWER EACH SECTION IN A SEPARATE ANSWER BOOK

THIS PAPER MUST BE HANDED IN AT THE END OF THIS EXAMINATION

CANDIDATES ARE PERMITTED TO BRING ONE APPROVED

CALCULATOR INTO THIS EXAMINATION: from either Casio FX83 or FX85
series (with any suffix), FX115MS, FX570ES or FX991ES

Invigilators are under instruction to remove any other calculators

Stationery Answer Booklets x 2

Attached

Number of Pages: 1 – 6
Statistical Formulae and Tables Pages: 7 – 11
 SECTION A

Answer TWO questions from this section

1. Answer ALL parts of this question

(a) Discuss any FOUR of the steps involved in the Analytical Process
Model with an appropriate example in each case.
(12 marks)

(b) Precision and accuracy have very specific meanings from an analytical
perspective. What are they and how do they differ?
(4 marks)

(c) Describe what is meant by “integrity” and “representative”, with respect

to sampling.

(4 marks)

Continued…

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2. Answer ALL parts of this question

(a) The ICH Guidelines for Validating Analytical Procedures covers six
main areas. Describe what these are and what is being assessed in
each.
(12 marks)

(b) What is Measurement Uncertainty and why is it evaluated as part of the

validation process?
(4 marks)

(c) For what reasons are validations carried out?

(4 marks)

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 Continued…
3. Answer ALL parts of this question

(a) Define each of the following acronyms; QM, QA, QC, and QR, and
discuss how they fit into the overall Quality System of a company.
(12 marks)

(b) Discuss the difference between a process deviation and an out-of-

specification (i.e. test failure) result?
(4 marks)

(c) Describe the difference between Instructions and Records with respect
to Quality Control.
(4 marks)

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 Continued…
SECTION B

Answer TWO questions from this section

4. Answer ALL parts of this question

There is the suspicion that Vitamin A has degraded in a laboratory standard.

The initial concentration of Vitamin A in the fresh standard was 100.1 mg
Vitamin A / L. Replicate measurements of the Vitamin A concentration in the
laboratory standard by LC-UV gave the following concentrations; 101.1, 95.0,
110.3, 99.0, 110.2 and 94.0 mg / L.

(a) Determine statistically if there is an outlier in the results reported.

(5 marks)

(b) Assess if there is statistical evidence that Vitamin A is degrading in the

laboratory standard.
(5 marks)

(c) The analysis of Vitamin A was also carried out by LC-MS which gave
the following concentrations; 98.2, 99.5, 102.3, 98.6, 110.2 and 94.0
mg / L. Discuss the data obtained by both LC-MS and LC-UV methods
in terms of their trueness and precision.
(10 marks)

4
 Continued…
5. Answer ALL parts of this question

The same mercury sample has been determined several times by two
laboratories and the results are contained in the table below.

Laboratory A Laboratory B
(% Hg) (% Hg)
5.6 6.5
5.7 5.8
5.5 6.0
6.0 5.7
5.8 5.8
5.6 6.3
5.9 6.0
5.5 6.0
5.7
6.2

(a) Compare the precision of the two laboratories.

(5 marks)

(b) Demonstrate statistically whether the values obtained by the two

laboratories differ significantly.
(10 marks)

(c) Explain how to identify if there is a systematic error in the quantification

of mercury carried out by either of the laboratories.
(5 marks)

Continued…

5
6. Answer ALL parts of this question

A forensic scientist has been taking samples of grass from a crime scene. The
samples were taken with increasing distance from a yellow patch of grass
over different months. During this study, the arsenic in grass was quantified
with inductively coupled plasma-mass spectrometry (ICP-MS) after minor
sample treatment.

(a) Discuss the effect of the different factors studied on the concentration
of arsenic in grass with the 2-way ANOVA treatment provided below
AND explain which data would be needed to carry out the assessment
with a 1-way ANOVA treatment instead.
(10 marks)

Distance (m)
Sampling month 1m 2m 3m 4m
January 38 38 36 34
February 35 34 34 30
March 30 28 25 25

Anova: Two-Factor Without Replication done at α 0.05

SUMMARY Count Sum Average Variance
January 4 146 36.5 3.666667
February 4 133 33.25 4.916667
March 4 108 27 6

1m 3 103 34.33333 16.33333

2m 3 100 33.33333 25.33333
3m 3 95 31.66667 34.33333
4m 3 89 29.66667 20.33333

ANOVA
Source of Variation SS df MS F P-value F crit
Rows 186.5 2 93.25 90.72973 3.28E-05 5.143253
Columns 37.58333333 3 12.52778 12.18919 0.005792 4.757063
Error 6.166666667 6 1.027778

Total 230.25 11

(b) ICP-MS is a technique where the signal of the analyte may become
reduced when the sample matrix has other abundant elements.
Discuss which method you would choose for the calibration, either: (i)
external calibration OR (ii) standard additions AND explain how to
carry out the calibration and quantification with that chosen strategy.
(10 marks)

END OF EXAMINATION PAPER

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Statistical Formulae and Tables

 ( x - x)2
s=
n-1

 s 
x t 
 n 

t=|(x-µ) √n /s |

t= xd√n /sd

7
 |r | √(n-2)
t=
√(1-r2)

sy x
sslope 
 x 
2
i x
i

 i
x 2

sintercept  s y i

  x  x
x 2
(a)
n i
i

   residuals  2 
sy x   
 n  2 

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