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Analytical Chemistry > Quality Assurance > Flashcards

Quality Assurance Flashcards

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1
Q

How to consider an analysis to be under statistical control?

A
  1. free of bias
  2. characterized by well-defined confidence intervals
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2
Q

Define the goal of quality assurance program (3)

A
  1. identifies the practices necessary to bring a system into statistical control
  2. allows us to determine if the system remains in statistical control
  3. suggests a course of corrective action if the system falls out of statistical control
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3
Q

Components of quality assurance (2)

A
  1. Quality control
  2. Quality assesment
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4
Q

Define quality control

A

encompasses all activities that bring an analysis into statistical control

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5
Q

totality of characteristics of an entity that bear on its ability to satisfy stated and implied needs

A

quality

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6
Q

organizational structure, procedures, processes, and resources needed to implement quality management

A

quality system

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7
Q

all activities of the overall management function that determine the quality policy, objectives and responsibilities, and implement them by means such as quality planning, quality control, quality assurance, and quality improvement within the quality
system

A

quality management

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8
Q

ISO meaning

A

International Organization for Standardization

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9
Q

develops standards and guides to encourage good practice in accreditation and certification

A

ISO

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10
Q

ISO does not carry out _____ and does not issue or approve certificates

A

certification/accreditation

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11
Q

It means that an independent, external body has audited an organization’s management system and verified that it conforms to the requirements specified in the standard

A

Certification (registration)

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12
Q

It means the formal approval by a specialized body that a certification body is competent to carry out ISO

A

Accreditation

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13
Q

Certificates issued by specialized bodies may be perceived on the market as having increased credibility (not required for companies)

A

Accredited certificates

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14
Q

ISO certification for “general requirements for the competence of testing and calibration laboratories”

A

ISO 17025:2017

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15
Q

ISO certification for “quality management system”

A

ISO 9001:2015

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16
Q

ISO certification for “environmental management system”

A

ISO 14001:2021

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17
Q

ISO certification for “Occupational Health and Safety” to protect employees and visitors from work-related accidents and diseases

A

ISO 45001:2018

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18
Q

ISO certification for “managing psychosocial risks at work” (psychological health and safety)

A

ISO 45003:2021

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19
Q

ISO certification for “information security management system”

A

ISO 27001:2013

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20
Q

ISO certification for “food safety management system”

A

ISO 22000:2018

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21
Q

HACCP meaning and goal

A

Hazard Analysis Critical Control Point
- a system which identifies, evaluates and controls hazards which are significant for food safety
- ensure safety than detect

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22
Q

HACCP method whereas all the potential hazards are identified before there is a problem

A

systematic

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23
Q

HACCP method whereas it concentrates the control effort at the stages where the risk is potentially the highest

A

efficient

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24
Q

HACCP method whereas the processes can be controlled immediately by the food business

A

on the spot

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25
Q

Differentiate GLP and GMP

A

Good Laboratory Practices (GLP)
- describe the general laboratory operations that we must follow in any analysis

Good Measurement Practices (GMP)
- describe those operations specific to a technique

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26
Q

provide instructions for maintaining, calibrating, and using equipment and instrumentation.

A

Good Measurement Practices

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27
Q

involves the principle of waste elimination through workplace organization

A

Good housekeeping (5S)

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28
Q

provide a methodology for organizing, cleaning, developing, and sustaining a productive work environment.

A

5S Pillars

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29
Q

Keep only necessary items in the workplace (5S)

A

Sort - Seiri

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30
Q

Arrange items to promote efficient workflow (5S)

A

Set in Order - Seiton

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31
Q

Clean the work area so it is neat and tidy (5S)

A

Shine - Seiso

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32
Q

Set standards for a consistently organized workplace (5S)

A

Standardize - Seiketsu

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33
Q

Maintain and review standards (5S)

A

Sustain - Shitsuk

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34
Q

written procedure which states what steps will be taken and how they will be carried out are the bulwark of quality assurance

A

Standard Operating Procedure (SOP)

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35
Q

most detailed of the written quality control
directives

A

Protocol for a Specific Purpose (PSP)W

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36
Q

What set of written instructions must be followed step by step?

A

Protocol for a Specific Purpose (PSP)

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37
Q

process of collecting data to show that analytical procedures are operating within specified limits verifying that final results meet use objectives

A

Quality Assessment

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38
Q

List all the components and subcomponents of quality assessment

A
  1. Internal method of quality assessment
    - prescriptive approach (specification and method validation)
    - performance-based approach
  2. External method of quality assessment
    - proficiency testing
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39
Q

general approaches to developing a
quality assurance program

A

internal method of quality assessment

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40
Q

prescribe an exact method of quality assessment and a way of applying quality control

A

prescriptive approach

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41
Q

use any form of quality assessment, provided an acceptable level of statistical control can be demonstrated (use of control charts)

A

performance-based approach

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42
Q

provides a system to gauge how good the numbers need to be and what precautions are required in the analytical procedure

A

specification

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43
Q

Sampling requirement (2)

A
  1. representative
  2. preserved
44
Q

says that the concentration exceeds the legal limit when, in fact, the concentration is below the limit

A

False Positive

45
Q

says that the concentration is below the limit when it is actually above the limit

A

False Negative

46
Q

numerical parameters that are usually employed for comparing analytical methods in terms of predictive ability and detection capabilities

A

figures of merit

47
Q

process of proving that an analytical method is acceptable for its intended purpose

A

method validation

48
Q

closeness of the obtained value to the true value for the sample; most difficult parameter to validate

A

accuracy

49
Q

Ways to demonstrate accuracy

A
  1. analysis of a standard reference material
  2. comparison with results using another method known to be accurate
  3. spike recovery studies
50
Q

analyze a blank sample spiked with a known addition of analyte (matrix must be the same as your unknown; use standard addition if can’t)

A

fortification/spike recovery

51
Q

known quantity of analyte added to a sample to test whether the response to a sample is the same as that expected from a calibration curve

A

spike

52
Q

Must be performed when dealing large numbers of samples and replicates to ensure that the instrument continues to work properly

A

calibration checks

53
Q

How to perform calibration checks?

A

analyze solutions formulated to contain known concentration of analyte

54
Q

Describe performance test samples or quality control samples or blind samples

A
  1. samples of known composition are provided to the analyst as unknowns
  2. results are then compared with the known values, usually by a quality assurance manager
55
Q

a sample containing all components except analyte, and it is taken through all steps of the analytical procedure

A

method blank

56
Q

similar to a method blank, but it has not been subjected to all sample preparation procedures.

A

reagent blank

57
Q

similar to a method blank, but it has been exposed to the site of sampling

A

field blank

58
Q

an analyte-free sample carried from the laboratory to the sampling site and back to the laboratory without being opened.

A

trip blank

59
Q

measures how well replicate measurements agree with one another

A

precision (standard deviation)

60
Q

To gauge precision, perform analysis using (2)

A
  1. replicate samples
  2. replicate portions of same sample
61
Q

Explain instrument precision and how reproducibility is observed.

A

Precision of different steps of the analysis
- observed when same quantity of one sample is repeatedly introduced into an instrument

62
Q

Statistical considerations dictate that _____ measurements should be made for each evaluation step in instrument precision

A

at least seven measurements

63
Q

evaluated by analyzing aliquots of a homogeneous material several times by one person on one day with the same equipment.

A

intra-assay precision

64
Q

within lab reproducibility whereas an assay is performed with the same method on identical test items in the same laboratory by different people on different days

A

ruggedness or intermediate precision

65
Q

measures the repeatability whereas aliquots of the same sample are analyzed by different people in different laboratories

A

interlaboratory precision

66
Q

Differentiate repeatability and reproducibility

A

repeatability
- describes the precision of within-run replicates

reproducibility
- describes the precision of between-run replicates

67
Q

Using different pieces of glassware and different batches of indicator test the ____

A

reproducibility

68
Q

interval between the upper and lower concentration (amounts) of analyte

A

range

69
Q

interval over which the method provides results with an acceptable uncertainty

A

working range

70
Q

concentration range over which calibration curve is linear

A

linear range

71
Q

concentration range over which there is measurable response.

define the lower and upper limit

A

dynamic range

lower limit - detection limit
upper limit - deviation of 5% from linearity

72
Q

measures how well a calibration curve follows a straight line

A

linearity

73
Q

Describe the concentration in detection limit (2)

A
  1. the concentration that gives twice the peak-to-peak noise of a series of background signal measurements
  2. the concentration that gives a signal equal to three times the standard deviation of the background above the mean background
74
Q

Differentiate Instrument and Method Detection Limit

A
  1. Instrument Detection Limit
    - obtained by replicate measurements (n ≥ 7) of aliquots from one sample
  2. Method Detection Limit
    - obtained by preparing n ≥ 7 individual samples and analyzing each one once
75
Q

Differentiate Lower Limit of Detection and Lower Limit of Quantitation

A

LLD - 3 times greater than the noise
LLQ - 10 times greater than the noise

76
Q

concentration below which regulations say that a given analyte is reported as “not detected”

A

reporting limit

77
Q

___ is equivalent to the slope of calibration curve

A

(calibration) sensitivity

78
Q

A method must have _____ to be measured

A

a detection limit lower than the concentrations

79
Q

being able to distinguish analyte from other species in the sample (avoiding interference)

A

specificity/ selectivity

80
Q

An analytical method is specific if ____

A

its signal depends only on the analyte

81
Q

defines a method’s selectivity for an interferent relative to the analyte

A

selectivity coefficient

82
Q

a measure of its capacity to remain unaffected by small, but deliberate variations in method parameters

A

robustness/ruggedness

83
Q

Describe ruggedness test. How to access the ruggedness?

A

involves making deliberate changes to the method and investigating the subsequent effect on performance

e.g. if a simple change in the temperature will greatly affect the result, then it is rugged.

84
Q

arises from a host of uncontrollable variables that affect the chemistry of the system being analyzed

A

chemical noise

85
Q

noise that is associated with each component of an instrument

A

instrumental noise

86
Q

caused by the thermal agitation of electrons or other charge carriers in resistors, capacitors, radiation transducers, electrochemical cells and other resistive elements in an instrument

A

thermal noise (Johnson Noise)

87
Q

attributable to the quantized nature of charge carriers and photons

A

shot noise

88
Q

At low signal levels, noise arises from random variation in the ____ or _____

A

small number of photons reaching a detector

the small number of electrons and holes generated in a semiconductor

89
Q

characterized as having a magnitude that is inversely proportional to the frequency of the signal being observed

A

flicker noise

90
Q

Flicker noise becomes significant at frequencies ____

A

lower than about 100 Hz

91
Q

common measurement of noise (2)

A

root-mean-square (rms)
signal-to-noise ratio

92
Q

_____ can improve the quality of data

A

signal averaging

93
Q

ratio of the mean to the standard deviation of numerous measurements or the reciprocal of the relative standard deviation

A

signal-to-noise ratio

94
Q

The effect of noise on the relative error of a measurement becomes greater and greater as the ____ in magnitude. How to minimize it?

A

quantity being measured decreases

increase the signal-to-noise ratio

95
Q

will use previous performance/experience to gauge or to know if still under statistical control

A

performance-based approach

96
Q

principal tool for performance-based quality assessment

A

control chart

97
Q

Control charts are used to monitor: (3)

A
  1. performance on blanks
  2. calibration checks
  3. spiked samples
98
Q

Goal of control charts (3)

A
  1. see if results are stable over time
  2. compare work of different employees
  3. monitor sensitivity if a laboratory encounters a wide variety of matrixes
99
Q

Differentiate property and precision control chart

A

Property Control Chart
- single measurements or the means for several replicate readings are recorded

Precision Control Chart
- ranges or standard deviations are recorded

100
Q

To construct the property control chart, we analyze a minimum of ____ while the system is under statistical control and the ____ is the average of these n samples

A

7–15 samples
Center Line (CL) of the control chart

101
Q

The ____ in the original control chart, the easier it is to detect when an analysis is beginning to drift out of statistical control.

A

more samples (30 or more samples)

102
Q

shows how the precision of an analysis changes over time

A

Precision Control Chart

103
Q

To construct the control chart, we analyze a minimum of ____ while the system is under statistical control.

A

15–20 samples

104
Q

The purpose of a control chart is to _____.

A

determine if an analysis is in a state of statistical control

105
Q

Using a control chart, an analysis is no longer under statistical control if: (6)

A
  1. any single point exceeds either the UCL or the LCL.
  2. two out of three consecutive points are between the UWL and the UCL or between the LWL and the LCL.
  3. seven consecutive results are completely above or completely below the center line.
  4. six consecutive results increase (or decrease) in value.
  5. 14 consecutive results alternate up and down in value.
  6. there is any obvious nonrandom pattern to the results

Analytical Chemistry (12 decks)

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