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Chem 194 - Analytical Chemistry C3 > QUALITY ASSURANCE IN THE ANALYTICAL CHEMISTRY LABORATORY > Flashcards

QUALITY ASSURANCE IN THE ANALYTICAL CHEMISTRY LABORATORY Flashcards

1
Q

is Defined as the degree to which a set
of inherent characteristics fulfill requirements.

A

Quality

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2
Q

describes the overall measures that a
laboratory uses to ensure the quality of its operations.

A

Quality Assurance

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3
Q

QA includes

A

 A quality systems
 Suitable laboratory environment
 Educated, Trained and skilled staff
 Equipment suitably maintained and calibrated
 Documented and validated methods.
 Traceability and measurement uncertainty
 Proficiency testing
 Requirements for reagents, standards, reference
materials

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4
Q

Three of the most important components of laboratory
QA are:

A

QC
method validation
equipment maintenance

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5
Q

is an integrated system of management and
technical activities within an organization that ensures
overall activities meet the defined standard or quality

A

QA

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6
Q

The QA program is defined in a documented
laboratory quality system which consists of:

A
  • QA Manual
  • QC processes
  • written management and technical
    procedures
  • work instructions
  • records
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7
Q

to ensure quality of
analytical data produced by the laboratory
and to demonstrate the competence of
the lab

A

QC processes

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8
Q

Contains the quality policies and
objectives

A

QA Manual

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9
Q

The most widely recognized and used QA
protocols and standards in chemical testing:

A

ISO/ IEC 17025:2005 (International
organization for standardization/ International
Electrotechnical Commission)

ISO 9001:2000

OECD Principles of Good Lab Practice
(organization for economic cooperation and
development)

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10
Q

Standard which addresses the technical
competence of laboratories to carry out
specific tests and calibrations and is used by
lab accreditation bodies worldwide

A

ISO/ IEC 17025:2005 (International
organization for standardization/ International
Electrotechnical Commission)

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11
Q

The standards which relates primarily to
quality management, for facilities carrying out
production, or providing services, including
chemical analysis

A

ISO 9001:2000

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12
Q

International standard that contains all the
requirements that testing and calibration
laboratories have to meet if they wish to
operate a quality system

A

ISO/ IEC 17025:2005 (International
organization for standardization/ International
Electrotechnical Commission)

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13
Q

Guidelines concerned with the organizational
processes and conditions under which
laboratory studies related to certain regulatory
work are carried out

A

OECD Principles of Good Lab Practice

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14
Q

ISO/ IEC 17025 : 2005 MANAGEMENT
Requirements:

A
  1. Organization
  2. Management system
  3. Document control
  4. review of requests, tenders and contracts
  5. Sub-contracting of tests and calibrations
  6. Purchasing services and supplies
  7. Service to the customer
  8. Complaints
  9. Control of non-conforming tests
  10. Improvement
  11. Corrective action
  12. Preventive Action
  13. Control of Records
  14. Internal audits
  15. Managements reviews
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15
Q

ISO/ IEC 17025 : 2005 TECHNICAL
Requirements:

A
  1. General
     2. Personnel
     3. Accommodation and environmental
    condition
     4. Test and calibration method validation
     5. Equipment
     6. Measurement traceability
     7. Sampling
     8. Handling of test and calibration items
     9. Assuring the quality of test and calibration
    results
     10. Reporting of results
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16
Q

set of practice in the
chemical laboratory that controls the
laboratory activities and conditions that affect
the accuracy of analytical data

A

GLP ( limited sense)

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17
Q

set of
requirements covering the organization of test
facilities and conditions to ensure the
generation of high quality and reliable test data
for specific objectives

A

GLP principles ( expanded sense)

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18
Q

Component of GLP

A

QA Program
Laboratory Conditions
Test samples
Test measurements
Record management

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19
Q

Component of GLP that ensures consistent quality of data

A

QA Program

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20
Q

To preserve the identity and integrity of the
samples

A

Test samples

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21
Q

To ensure that an acceptable test method
will produce the expected performance

A

Test measurements

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22
Q

To ensure that laboratory conditions are
optimized to obtain the desired
performance of the test method

A

Laboratory Conditions

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23
Q

To enable retrieval of undistorted
information whenever required

A

Record management

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24
Q

GLP includes:

A
  • implementing standard operating
    procedures
  • Proper maintenance and calibration of
    equipment
  • Correct practices of laboratory personnel in
    performing analytical work
  • Efficient management of laboratory records
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25
Q

Ensures that the defined characteristics of
the method as required are met. The defined method
characteristics are also known as data quality objectives (DQOs)

A

Method of QA

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26
Q

are critical goals for accuracy, precision, sensitivity,
and selectivity of analytical data to be satisfied so as to
achieved analysis goals.

A

data quality objectives (DQOs)

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27
Q

Minimum requirements for Method of QA

A

Accuracy
Precision
Sensitivity
Selectivity

28
Q

degree of agreement of measurements
with an acceptable reference value or degree of
acceptable method bias. Bias ( sometimes called
recovery) is the systematic error of the measuring
system

A

Accuracy

29
Q

degree of spread of results ( degree of
differences in individual test results, expressed as
standard deviation, relative standard deviation or RSD).

A

Precision

30
Q

is defined by detection limits:

A

Sensitivity

31
Q

the measured concentration at which there is a stated probability ( 95% or 99%) that an analyte is present. MDL is defined as 3x standard deviation (of method blank runs).

A

Method detection limit (MDL)-

32
Q

the lowest concentration level that can be determined to be statistically different from the blank; the lowest analyte concentration required to be present to ensure an analytical response that will exceed the MDL.

A

Reliable detection limit (RDL)

33
Q

the level above
which quantitative results maybe obtained with
a specified degree of confidence. Confidence in
the apparent analyte concentration increases as
the analyte signal increases above the MDL.

A

Limit of quantitation (LOQ)

34
Q

Formula for LOQ

A

LOQ = 3.33 x MDL = 10 x s ( 99% CL)

35
Q

susceptibility of the method to
interferences. This maybe determined by
recovery of spiked samples

A

Selectivity

36
Q

A method QA program will:

A

Start with → DQOs

Involve → Method selection , documentation and validation

End with → Evaluation

Continue with → QC monitoring and instrument
maintenance Re-validation/ re-evaluation Improvement

37
Q

Method of QA program covers:

A

 Method Selection
 Method Validation
 Sampling
 Equipment
 Quality Control
 Traceability
 Measurement Uncertainty
 Proficiency Testing

38
Q

Factors to consider when selecting a method:

A
    1. Limit of detection
    1. precision
    1. Bias/Recovery
    1. Accuracy
    1. Selectivity
    1. Equipment required
    1. Sample size
    1. Time
    1. Cost
    1. Safety
39
Q

Checks need to be carried out to ensure that the
performance characteristics of a method are understood and to demonstrate that the method is scientifically sound under the conditions in which it is to be applied.
These checks are collectively known as

A

Validation

40
Q

Analytical procedures must be well documented before validation is performed. Documentation includes:

A
  1. Title of test method
  2. Scope and application
  3. Sample matrices
  4. Method detection level
  5. Interferences
  6. Safety considerations
  7. Sample collection, preservation, transport,
    storage
  8. Apparatus, equipment, and supplies
  9. Reagents, standards, reference materials
  10. actual test procedure:
    - Calibration
    - Standardization
    - Sample preparation
    - Calculations
  11. Specific QC practices
  12. Acceptance criteria
  13. Tables, flowcharts, validation data
  14. Estimation of measurement uncertainty
  15. References
41
Q

The inclusion of particular validation parameters
in a validation protocol depends on the
application, the test samples, the goal of the
method, and domestic or international guidelines
and regulations, as applicable. These include:

A
  1. Selectivity and specificity ( description of
    the measurand)
  2. Measurement range
  3. Calibration and traceability
  4. Bias
  5. Linearity
  6. Limit of detection/ LOQ
  7. Precision
  8. Ruggedness
42
Q

Ways of performing validation of an analytical
method:

A
  1. Collaborative Validation
  2. Internal Validation
43
Q

a method is validated in a laboratory before
use to prove that the method performs
adequately

A

Internal Validation

44
Q

Requires participation of a number
of lab.
Requires the use of a common sample
of known concentration of the analyte.
Results are evaluated for the
collaborative mean value of the analyte. Assessment of the accuracy, precision,
ruggedness and detection limits of the
method

A

Collaborative Validation

45
Q

Components of internal validation of methods:

A

Characterization of instrument calibration and
working range
Determination of sensitivity ( detection limits)
Determination of bias ( systematic error)
Determination of precision ( random error)
Assessment of ruggedness ( for lab-developed
methods and non-standard methods)

46
Q

is incorporated in
the routine analysis to maintain the
performance of the method. It is also an evaluation program incorporated
into routine and lab activities that assesses the
accuracy and precision of measurements.

A

Quality Control

47
Q

What are the three Quality Control Samples?

A
  1. Laboratory instrument QC Samples
  2. Laboratory method QC Samples
  3. Field QC Samples
48
Q

to measure and control the instrument calibrations
or instrument performance.

A

Laboratory instrument QC Samples

49
Q

solutions with certified concentration of analytes
used to verify the accuracy of the calibration
curve.

A

Lab Instrument Control Standard

50
Q

one of the standard
solutions used in making the calibration curve
that verifies the stability of a calibration curve
over time

A

Verification Standard

51
Q

solution to check for
instrument contamination and background levels.

A

Instrument Blank

52
Q

assesses the precision of the
test procedure

A

Lab sample replicate

53
Q

The three Laboratory instrument QC Samples

A

Lab Instrument Control Standard
Verification Standard
Instrument Blank

54
Q

Three Lab method QC Samples

A

Method blank
Lab sample replicate
Method analyte spike

55
Q

What are the Method analyte spike

A

Blank spike
Matrix spike
Sample spike

56
Q

measures the recovery of a
method

A

. Method analyte spike

57
Q

measures method contamination
background

A

Method blank

58
Q

analyte spiked on clean
matrix to assess losses or contribution due
to the matrix

A

Matrix spike

59
Q

analyte spiked on samples
to assess the losses or contribution due to
other components or characteristics of the
sample

A

Sample spike

60
Q

analyte spiked on a
method blank

A

Blank spike

61
Q

Naturally- occurring materials or synthetic materials with known concentrations of analytes (obtained through collaborative studies) certified by recognized certifying bodies (such as NIST, IAEA) used to assess the bias of the method; comes with Certificate of Analysis.

A

Certified Reference Materials

62
Q

Three field QC samples

A

Field Blank
Field Analyte spike
Field Replicate Samples

63
Q

measures recovery between
time of sampling and time of analysis

A

Field Analyte spike

64
Q

measures contamination from
sampling activities

A

Field Blank

65
Q

Corrective action on failed QC includes:

A
  • investigation when QC failure
  • correction of the cause of failure
  • institution of preventive measures to preclude the recurrence of failure
  • Investigation of QC failure can be started by identification
    of the trend in the QC chart.
66
Q

The ______ and ______ of analytical
measurement is the formal procedure of laboratory quality control. But _______ is the final stage of a management system of quality assurance

A

control of bias, random error
quality control

67
Q

susceptibility of the method to
interferences. This maybe determined by
recovery of spiked samples

A

Selectivity

Chem 194 - Analytical Chemistry C3 (27 decks)

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