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ANALYTICAL CHEMISTRY C3 > Quality Assurance in the Analytical Chemistry Laboratory > Flashcards

Quality Assurance in the Analytical Chemistry Laboratory Flashcards

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1
Q

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

A

quality

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2
Q

does not only depend on the application of well-researched and/or developed and/or validated methods.

A

quality in chemical analysis

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3
Q

results have to be accompanied by concurrent proof that the measurements are really and truly correct

A

quality analytical results

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4
Q

is obtained by the application of a well-planned program of Quality Assurance(QA) to analytical measurements

A

proof

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5
Q

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

A

quality assurance

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6
Q

Quality assurance 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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7
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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8
Q

is a definitive program for laboratory operation that specifies the measures required to produce defensible data of known precision and accuracy

A

QA in chemical analyses

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9
Q

Three of the most important components of laboratory QA are

A

QC
method validation
equipment maintenance

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10
Q

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

A

QA manual
QC process
written management and technical procedures
work instructions
records

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11
Q

most widely recognized and used quality assurance 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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12
Q

An international 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

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13
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

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14
Q

An international standard 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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15
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 GLP

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16
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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17
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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18
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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19
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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20
Q

components of GLP

A

QA program
Laboratory Conditions
Test Samples
Test Measurements
Record Management

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21
Q

To ensure consistent quality of data

A

QA program

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22
Q

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

A

Laboratory conditions

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23
Q

To preserve the identity and integrity of the samples

A

test samples

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24
Q

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

A

test measurements

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25
Q

to enable retrieval of undistorted information whenever required

A

record management

26
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

27
Q

Method QA ensures that the defined characteristics of the method as required are met. The defined method characteristics are also known as

A

data quality objectives

28
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 (DQO)

29
Q

– degree of agreement of measurements with an acceptable reference value or degree of acceptable method bias.

A

accuracy

30
Q

bias is sometimes called what

A

recovery

31
Q

) is the systematic error of the measuring system

A

bias

32
Q

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

A

Precision

33
Q

Sensitivity is defined by detection limits such as

A

Method detection limit
Reliable detection limit
Limit of quantitation

34
Q

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

A

Method detection limit (MDL)

35
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

36
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)

37
Q

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

A

Selectivity

38
Q

are also defined to set Acceptance Criteria for QC
measurements

A

DQOs

39
Q

Method of QA program covers

A

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

40
Q

Factors to consider when selecting a method

A
  1. Limit of detection
  2. precision
  3. Bias/Recovery
  4. Accuracy
  5. Selectivity
  6. Equipment required
  7. Sample size
  8. Time
  9. Cost
  10. Safety
41
Q

Analytical procedures must be well-documented before validation is performed, which includes

A
  1. Title of test method
    1. Scope and application
    2. Sample matrices
    3. Method detection level
    4. Interferences
    5. Safety considerations
    6. Sample collection, preservation, transport, storage
    7. Apparatus, equipment, and supplies
    8. Reagents, standards, reference materials
  2. actual test procedure:
    Calibration
    Standardization
    Sample preparation
    Calculations
    1. Specific QC practices
    2. Acceptance criteria
    3. Tables, flowcharts, validation data
    4. Estimation of measurement uncertainty
    5. References
42
Q

ways of performing validation of an analytical method

A

collaborative validation
internal validation

43
Q
  • a method is validated in a laboratory before use to prove that the method performs adequately
    - Whatever is the source of the method whether it is a standard method, a published method or a lab-developed method, the method must be internally validated before use in the lab.
    -Validation can be done with the use of spiked samples, certified reference materials or comparing the performance of a method with a reference method whose performance has been well established.
A

internal validation

44
Q

Components of internal validation 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

45
Q

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

A

Lab Instrument Control Standard

46
Q

to measure and control the instrument calibrations or instrument performance.

A

Laboratory instrument QC Samples

47
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

48
Q

solution to check for instrument contamination and background levels

A

instrument blank

49
Q

to measure and control complete method performance

A

Lab method QC Samples

50
Q

– measures method contamination background

A

methdo blank

51
Q

assesses the precision of the test procedure

A

lab sample replicates

52
Q

measures the recovery of a method

A

method analyte blank

53
Q

analyte spiked on a method blank

A

bank spike

54
Q

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

A

matrix spike

55
Q

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

A

sample spike

56
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

57
Q

Field QC smaples

A

field blank
field analyte spike
field replicate sample

58
Q

measures contamination from sampling activities

A

field blank

59
Q

measures recovery between time of sampling and time of analysis

A

field analyte spike

60
Q

measures precision

A

field replicate sample

ANALYTICAL CHEMISTRY C3 (21 decks)

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