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MEDL-210 MB > Module 6: Intro to Quality Control > Flashcards

Module 6: Intro to Quality Control Flashcards

1
Q

TQM

A

Total quality management

overall management of all quality processes and outcomes with the goal of long term customer satisfaction

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2
Q

QM

A

quality management

includes stages QS, QA, QC with a focus on financial impact of quality activities

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3
Q

QS

A

quality system

comprehensive and coordinated efforts to maintain and improve lab processes to meet quality goals

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4
Q

QA

A

quality assurance
planned and systematic activities to provide confidence that an organization fulfills quality requirement
QA monitors QC data and looks for opportunities to improve processes

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5
Q

QC

A

quality control

includes regular operational activities that ensure high quality test results

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6
Q

Intent of QC

A

identify and prevent issues

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7
Q

Statistical QC

A

monitors the performance of analytical methods by analyzing samples with known concentrations of analytes (ex. controls)
compare observed values with known values

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8
Q

Non Statistical QC

A

procedures to maintain and improve the performance of analytical systems

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9
Q

examples of nonstatistical QC

A

production and monitoring of high quality water for procedures
regular calibration of equipment, glassware, pipets, procedures
ensuring stability of power supply
monitoring temp of baths, fridge, freezer, centrifuge
performance and documentation of maintenance and troubleshooting
monitor prep and storage of reagents and standards
performance of linearity checks

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10
Q

Analytical system

A

procedure, reagents, calibrators, instrument

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11
Q

preventative maintenance

A

done to prevent development of problems

chemical buildup, corrosion, worn/damaged parts

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12
Q

calibration

A

process of analyzing known sampled of difference concentrations to make a curve

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13
Q

standard

A

material or solution of known concentration

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14
Q

3 types of error

A

pos (higher) or negative (lower)
random error
systemic

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15
Q

Error

A

difference between the true value and the measured value

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16
Q

accuracy

A

the nearness of a result to its true value

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17
Q

precision

A

the reproducibility of replicate measurements

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18
Q

Sensitivity

A

ability to measure low concentrations (minimal detection limit)

19
Q

specificity

A

ability of an analytical system to accurately measure one analyte without interference from other substances

20
Q

measures of central tendancy

A

mean, median, mode

21
Q

mean

A

average of a set of values

22
Q

median

A

the middle number in a set of data arranged in increasing numerical data
ex: 1,4,6,8,9
median = 6

23
Q

mode

A

value that occurs most frequently in a data set
ex: 1,5,3,5,6,5
mode=5

24
Q

SD or s

A

standard deviation
statistic that describes the dispersion or spread of a set of measurement about the mean of a Gaussian or normal distribution
Measurement of imprecision

25
Q

Coefficient of Variation (%CV)

A

standard deviation expressed as a percentage of the mean
another way to describe precision of a method
No units, can be used to compare the precision of other methods
CV=(s/X)100
s=standard deviation
X=mean

26
Q

the lower the %CV, the ______ the precision

A

better

27
Q

Distribution

A

the spread and shape of a frequency curve

one type is the Gaussian curve

28
Q

Gaussian distribution or curve (normal)

A

a symmetrical bell-shaped distribution whose shape is given by a specific equation in which the mean and standard deviation are variables
mean=median=mode at top of bell curve

29
Q

non Gaussian distribution

A

a distribution that does not follow a bell-shaped curve
SD would not be a valid statistic
mean does not equal median does not equal mode

30
Q

Control

A

known concentration
measured values are compared to a range of acceptable values
fall within range = assumed method is working properly
fall outside range = may indicate problem with the analytical system

31
Q

control materials

A

ready to use liquid form or lyophilized/freeze-dried to be reconstituted with water or diluent
matrix similar to pt sample

32
Q

single analyte control

A

control only contains one analyte at a known concentration

33
Q

multi-analyte / multi-controls

A

contains a number of analytes at known concentration

34
Q

Analytical run

A

interval in which performance/precision and accuracy of the measuring system can be expected to remain stable
a set time or a set # of samples
Run may never exceed 24 hrs and must contain both controls and pt samples

35
Q

Control limits

A

defined limits or ranges of expected results that if exceeded, warn of an error in the system

36
Q

obtaining control limits

A

each lab makes their own limits
mean and SD are calculated from data collected by running control sample under standard operating conditions (at least 1 month)
Minimum of 20 observations to establish a minimum estimate

37
Q

+/- 1 SD

A

about 68% of values will fall within this range

38
Q

+/- 2 SD

A

about 95% of values will fall within this range

39
Q

+/- 3 SD

A

about 99% of values will fall within this range

40
Q

Control chart

A

graphical method
plot control values to the expected results/ control limit
Levey-jennings chart
left y axis= control result
x axis= time (days or run #)
horizontal lines for the mean, +/- 1SD, +/- 2SD, +/- 3SD (written on right y axis)
chart should be big enough for +/- 4SD

41
Q

Levey-jennings chart labeling (6)

A 
name of the test
name, level and lot# of control material
units of measurement
analytical system
mean and SD
time period covered by chart
42
Q

if qc data is outside of +/-2 SD on levey Jennings chart

A

circle plot of graph in red and then trouble shoot (and document troubleshooting)

43
Q

Troubleshooting (FIRED)

A

F: figure out what is going on (check for errors/flags, other controls ran on that instrument, recent maintenance, reagent and calibration logs)
I: Isolate the cause (RITE)
R: Resolve the issue (correct issues)
E: evaluate the resolution (repeating controls, if control is good, repeat all pt samples from failed run)
D: Document all steps and outcomes

44
Q

Troubleshooting: Isolate the cause (RITE)

A

R: Reagents (new, expired, incorrectly prepared/stored, calibrators, diluents, washes)
I: instrument (dirty, damaged, new components, bubbles, leaks, precipitates, unstable temp or power supply)
T: technologist (error loading controls, operation, technique, fail to comply with maintenance/calibration schedule)
E: environment (room temp, humidity, power, fumes)

MEDL-210 MB (13 decks)

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