QC/QA

Quality Assurance

• Focuses on the processes

• Reduce potential for error

• Educated and trained staff w/ professional develop.

• Validate and std procedures

• Validation

• Equipment: calibration and maintenance logged.

• Proficiency testing

Quality Assurance examples

• Following an SOP (standard operating procedure)

• Performing routine temperature checks on refrigerators and freezers

• Getting pipettes and balances calibrated

Quality Control

• Focus on ensuring quality of product.

• Accountability and preventing repeat errors.

• Measures: reagents, equipment & instruments, documentation.

QC examples

• Reviewing the controls/check for the expected results

• Correcting an error that occurred

• In house reagent prep

• Heat blocks: checked for temp daily and before use

• Sep. pre and post amp areas.

  
  

Validation

• QA

• Robust: Successful high % of time

• Reliable: Accurate results

• Reproducible: Same results each time/

Developmental Valdiation

• Required for forensic DNA

• Testing new kits and sets

• Performed by larger laboratories.

• Ex studies: Case-type, PCR-based, precision.

Internal Validation

• Req. for ALL lab methods.

• Demonstrate reliability of new procedure for specific in lab use.

• Ex studies: known and non-probative, sensitivity.

• Develop SOPs.

Proficiency Testing

• QA

• External evaluation of laboratory’s performance in conducting DNA analysis procedures.

• Prep. by testing co. and treated as evidence.

Accreditation

• By ANAB/ ASCLD lab

• provides audits.

• Process: self eval, application, on site inspection.

Certification

• Inspects qualifications of individuals.

• Not req. (except in Texas).

• From ABC

Negative Controls

• Sample Prep: substrate control

• Req. for DNA extraction and STR amp.

• qPCR: NTC

Positive controls

• Req. through and incl. qPCR. DNA extract has one. not prep.

• qPCR: DNA stds

• CE: ILS and ladder.

Advisory Boards

• 1st: DAB

• ANAB/ ASCLD Lab: enforces the "standards" for a forensic DNA laboratory.

• FBI QA: Establish rules from guidelines.

• SWGDAM and NIST: Make guidelines.