Quality Control Flashcards
Method is easily repeated
Practicability
Maintain accuracy and precision
Reliability
Daily monitoring of accuracy and precision
Intralab/Interlab QC
Proficiency testing (Reference lab)
Long-term accuracy
Difference of >2: not in agreement w/ other lab
Interlab/External QC
Available for a min. of 1 yr
QC materials
Graphic representation of the acceptable limits of variation
Shewhart Levey-Jennings Chart
V-mask
Earliest indication of systematic errors (trend)
Cumulative Sum Graph (CUSUM)
SD of 2 groups of data
F-test
Means of 2 groups of data
T-test
Improper product manufacturing
Unpurified analyte
Altered protein
Matrix effect
Degree of flatness or sharpness
Kurtosis
Control rules + Control chart
Multirule Shewhart procedure
Westgard: at least 40 samples
Test method
Westgard: preferably 100 samples
Reference method
Tripod:
Program development
Assessment and monitoring
Quality improvement
Quality Assurance