2. Quality WHAT IS QUALITY
Degree of congruence between expectation and realization
WHO DEFINITION
Quality means meeting the predetermined requirements of users for a particular substance or service

3. Quality Control
Testing performed during food or biopharmaceutical manufacturing to verify that appropriate standards of product quality are attained
The actual organizational group (QC unit) who execute this work

4. Quality Control

5. Quality Assurance vs. Quality Control
An overall
management plan to
guarantee the
integrity of data
(The “system”)
A series of
analytical
measurements used
to assess the
quality of the
analytical data
(The “tools”)

6. True Value vs. Measured Value
The known, accepted value of a quantifiable property
Measured Value
The result of an individual’s measurement of a quantifiable property

7. Accuracy vs. Precision Accuracy
How well a measurement agrees with an accepted value
Precision
How well a series of measurements agree with each other

8. Systematic vs. Random Errors
Systematic Error
Avoidable error due to controllable variables in a measurement.
Random Errors
Unavoidable errors that are always present in any measurement. Impossible to eliminate

9. Quality Control Measures
Standards and Calibration
Blanks
Recovery Studies
Precision and Accuracy Studies
Method Detection Limits

10. Standards and Calibration
Prepared vs. Purchased Standard
Calibration Curves
Internal Standards
Performance Testing.

11. The concentration of the analyte
Calibration Curves
Graphical representation of the relationship between:
The concentration of the analyte
and
The analytical signal

12. Internal Standards A compound chemically similar to the analyte
Not expected to be present in the sample
Cannot interfere in the analysis
Added to the calibration standards and to the samples in identical amounts.

13. Internal Standards Refines the calibration process
Analytical signals for calibration standards are compared to those for internal standards
Eliminates differences in random and systematic errors between samples and standards

14. Performance Testing ? ? ? Blind samples submitted to laboratories
Labs must periodically analyze with acceptable results in order to maintain accreditation

15. Blanks, Blanks, Blanks Laboratory Reagent Blanks Instrument Blanks
Field Reagent Blanks
Trip Blanks

16. Laboratory Reagent Blanks
Contains every reagent used in the analysis
Is subjected to all analytical procedures
Must give signal below detection limit
Most methods require one with every batch

17. Instrument Blank
A clean sample (e.g., distilled water) processed through the instrumental steps of the measurement process; used to determine instrument contamination.

18. Field Reagent Blanks Prepared in the lab, taken to the field
Opened at the sampling site, exposed to sampling equipment, returned to the lab.

19. Trip Blanks Prepared in the lab, taken to the field Not opened
Returned to the lab

20. Recovery Studies
Matrix Spikes
Laboratory Control Samples
Surrogates .

21. Matrix Spikes Sample spiked with a known amount of analyte
Subjected to all sample prep and analytical procedures
Determines the effect of the matrix on analyte recovery
Normally one per batch

22. Laboratory Control Sample
Also known as:
Laboratory Fortified Blank (LFB)
Quality Control Sample (QCS)

23. Laboratory Control Sample
Analyte spiked into reagent water
Subjected to all sample prep and
analytical procedures

24. Surrogates Similar to an internal standard
Added to all analytical samples, and to all QC samples to monitor method performance, usually during sample prep
Methods often have specific surrogate recovery criteria
Most common in Organic methods

25. Method Detection Limit
“The minimum concentration of a substance that can be measured and reported with 99% confidence that the analyte concentration is greater than zero”
N.J.A.C 7:

26. Method Detection Limit
MDLs are determined according to 40 CFR, part 136, Appendix B
Seven replicate laboratory control samples, analyzed for precision
Multiply standard deviation by 3.14 (Student’s t- value)

27. Method Detection Limit
Must be performed initially for certification
Must meet criteria specified in method
Must be performed with change in instrumentation or test method
Annually with ELCP