test 1 2023 Flashcards
There are many guidelines to instruct users of analytical chemistry on how to
implement and maintain quality assurance in the laboratory.
What is the guideline to the QMS that is used by accredited laboratories of
analytical chemistry?
ISO 17025 is the guideline under ISO 9001, which addresses the quality management
of laboratories who are working with all areas of analytical chemistry
What are the two guidelines that are used to instruct the accredited
laboratories on how to perform the method validation?
The International Council for Harmonisation ICH guide Q2(R1) and the Eurachem
guide ‘The Fitness for Purpose of Analytical Methods’
- With the method of flame atomic absorption spectrometry was obtained the data set
that is shown in the table below. The purpose was to determine the concentration of
magnesium in the sample of drinking water and report on the result with the correct
number of significant digits and correct level of uncertainty of measurement.
Description [Mg2+] (mg/kg) Abs (AU)
10
1
1
1
8
1 Blank 0.0000 -0.0019
2 Blank 0.0000 -0.0007
3 Blank 0.0000 -0.0014
4 Blank 0.0000 -0.0018
5 Blank 0.0000 -0.0111
6 Blank 0.0000 -0.0085
7 Blank 0.0000 -0.0077
8 Blank 0.0000 -0.0039
9 Blank 0.0000 0.0000
10 Blank 0.0000 0.0002
11 Standard 1 0.5011 0.0482
12 Standard 2 0.9822 0.0988
13 Standard 3 2.1020 0.2246
14 Standard 4 4.9935 0.4891
15 Standard 5 10.0110 0.7355
16 Sample 0.3331
3A. With the data given in the table above, calculate the LOQ when the regression
line of calibration is given by the following equation:
Abs = (0.07857 ± 0.0067) ∙ kg ∙ g
−1
∙ [Mg2+] + (0.007 ± 0.020)
where the ‘± values’ indicate two standard deviations.
s0 = 0.003998
10*s0 = 0.039983
LOQ = 0.508872 mg/kg
~ 0.51 mg/kg
use the calculator to look forthe standard deviation by using the stat fauntion,then use the formula for LOQ the b is absorbane value mentioned
DEFINE the foLLOwing terms of VIM3
2C. Explain the definitions of the following concepts that are defined in
VIM3:
2C(a). Measurement method
2
1
2
10
1
6
2.5
measurement method
method of measurement generic description of a logical organization of operations
used in a measurement
2C(b). Resolution
4.14
resolution
smallest change in a quantity being measured that causes a perceptible change in the
corresponding indication
2C(c). Limit of detection
4.18
detection limit
limit of detection
measured quantity value, obtained by a given
measurement procedure, for which the probability of falsely claiming the absence of
a component in a material is , given a probability of falsely claiming
its presence
2C(d). Measurement standard
5.1
measurement standard
realization of the definition of a given quantity, with stated quantity value and
associated measurement uncertainty, used as a reference
1
1
1
7
2C(e). Certified reference material
5.14
certified reference material
CRM
reference material, accompanied by documentation
issued by an authoritative body and
providing one or more specified property values
with associated uncertainties and traceabilities,
using valid procedures
2C(f). Quantity value
1.19
quantity value
value of a quantity value
number and reference together expressing magnitude of a quantity
2C(g). Uncertainty budget
2.33
uncertainty budget
statement of a measurement uncertainty, of the components of that measurement
uncertainty, and of their calculation and combination
National and International organisations are especially important to the dissemination
of quality assurance in general. Explain abbreviations and describe the role the
following five international organisations have in Quality Assurance (QA):
5A. ILAC
International Laboratory Accreditation Cooperation
for accreditation bodies operating in
accordance with ISO/IEC 17011 and involved in the assessment and accreditation of
calibration laboratories (using ISO/IEC 17025),testing laboratories (using ISO/IEC 17025
ISO
International Organization for Standardization, develops and publish
International Standards ege.g. ISO 9001
* ISO standards are recognised worldwide as the prime source of quality in the
industry
EURACHEM
Europeann Analytical Chemistry
a network of organisations in Europe having the objective of establishing
a system for the international traceability of chemical measurements and the
promotion of good quality practices.
FDA
Food and Drug Administration
National regulatory body of food and drug safety in USA.Publishes guidelines of quality
assurance.
BIPM
Bureau International de Poids et Mesures
This is the organisation that defines and keeps the values of the fundamental
constants of physics and many constants and methods derived thereof.
In the QM is added a short description of the quality policy, which is an important
document to the laboratory profile.
6A. Explain how the quality policy contributes to the overall efforts of the laboratory
to secure QA and QC
Everybody in the organisation must know about the laboratory quality policy and
have ease of access to it. The quality policy translates the strategy into tangible
operations within the organisation, which make the employees understand their exact
role and how their work influences the products of the final products. With a good
level of understanding of the processes within the organisation, it is easy for the
employee how to contribute most effectively to achieve the goals of quality.
Explain in detail the contents of the quality policy
The quality policy is a document that explains intended activities of employees to take
place in an organisation, in order to ensure the best possible quality of products or
services. The quality policy should explain in plain words how each employee is
responsible for the quality of products or services. From the quality policy, each
employee must be able to see how their work influences the quality of products and
services.
The quality policy should be aligned with the overall strategy of the organisation, and
it should be reviewed and maintained by top management. A well-written quality
policy is a quality policy that is able to transfer the intents into tangible activities in
the organisation.
Describe the obligations of the top management with respect to devising the
quality policy
- Is appropriate to the organisation
- Includes a commitment to requirements and continual improvement
- Provides a basis for establishing quality objectives
- Is communicated and understood within the organisation
- Is periodically reviewed for suitability
