Validation Flashcards
Quality assurance
planned actions to ensure confidence (no contamination)
Quality control
techniques used to fulfill quality assurance requirements
Validation
process of demonstrating reliability, reproducibility, and robustness of a method
Reliability
accurate results
Reproducibility
same results from multiple runs
Robustness
high probability of getting results
Tests to confirm validation
different tissues/fluids, same results reproducible within/between labs population studies mixed samples environmental stress substrates non-human samples DNA quantity precision stutter heterozygote peak balance thermalcycler program
Developmental validation
testing new loci, kits, primers, detection technologies
commercial companies and FBI labs
present results in journals and scientific meetings
Internal validation
testing whether methods previously tested at other labs will work in your lab
smaller local and state labs
test every new method/kit
used to develop SOPs
National Institute of Standards and Technology
periodically coordinate interlay test
develop standard reference materials
Proficiency test
evaluate performance of individual analyst or examiner
usually semi-annual
adherence to SOPs
obtain correct results
Internal proficiency test
administered by member of same lab
External proficiency test
administered by outside organization
Types of blind external proficiency tests
law enforcement
conduit lab
blind analyst
random audit/reanalysis
Lab audit
evaluates entire operation SOPs- chain of custody, evidence handling, specific materials and methods equipment maintenance personnel training results in lab accreditation
