Method validation

Question 1

Validation for a forensic technique should establish

Answer 1

• Performance characteristics of the technique
• Limitations of the technique
• Identification of factors that may change the performance of the technique
• Extent to which influences change the performance of the technique

Question 2

Validation defined as

Answer 2

a documented program providing a high degree of assurance that a specific technique will consistently produce results within defined specifications and quality parameters

Question 3

Accuracy

Answer 3

how close results are to true value

Question 4

Precision

Answer 4

how close the experimental results to each other – the degree of repeatability of the technique under the same conditions

Question 5

Limit of detection

Answer 5

the smallest amount of a substance that can
be detected, but nor necessarily quantified

Question 6

Limit of quantification / Sensitivity

Answer 6

smallest amount of substance in a sample that can be accurately measured by the
technique

Question 7

Specificity

Answer 7

ability of the technique to measure or detect only what it is intended to measure or detec

Question 8

Range

Answer 8

interval between the lower and upper levels of detection which the technique has been demonstrated to produce accurate and precise results

Question 9

Reproducibility

Answer 9

ability of the technique to produce results that can be replicated by another qualified analyst

Question 10

Robustness

Answer 10

capacity of the technique to remain unaffected by variations in the techniques parameters

Question 11

Ruggedness

Answer 11

ability to use the technique in other laboratories or under different circumstances without unexpected differences in results.