Forensic Quality Assurance Module 5

Forensic Accreditation

• Forensic accreditation provides confidence in testing, inspections, and calibrations for use in criminal and civil proceedings
• Accreditation demonstrates that crime laboratories, law enforcement agencies, and medical examiners' offices conduct activities in conformance with internationally recognized standards

Definition of Accreditation

• Accreditation is an assessment of an agency's technical qualifications and competence for conducting specific testing, calibration, and/or inspection activities
• Accreditation is within the scope of ISO/IEC 17025 or ISO/IEC 17020 and any relevant field-specific standards

History of Accreditation

• FDLE first received accreditation in 1990 from ASCLD-LAB
• Reaccreditation assessments occurred every five years, and the first international accreditation happened in 2010
• ASCLD-LAB merged with ANAB in 2016
• Accreditation cycle is now every four years (2019, 2023, 2027)

Accreditation Cycle

• Year 0: Initial accreditation assessment
• Year 1: Offsite quality document review
• Year 2: Surveillance visit for targeted disciplines/quality review
• Year 3: Offsite quality document review
• Year 4: Full reaccreditation assessment

ANAB Accreditation

• ANAB is accredited by the International Laboratory Accreditation Cooperation (ILAC) and has a Mutual Recognition Arrangement (MRA) in both InterAmerican Accreditation Cooperation (IAAC) and Asia-Pacific Accreditation Cooperation (APAC)

Layers of Quality

• International Standards: ISO 17025:2017
• National Forensic Standards: ANAB AR 3125:2023
• FDLE Laboratory Standards: Forensic Science Quality Manual, Laboratory Administrative Procedures Manual
• Discipline Standards: Standard Operating Procedures & Work Instructions

Quality Assurance (QA)

• Planned and systematic actions to provide sufficient confidence that the laboratory's product or service will satisfy the requirements of quality
• Examples: laboratory policy & procedure, training, competency and certification program, continuing education, proficiency testing, and performance monitoring program

Quality Control (QC)

• Internal activities to monitor the quality of data or service being provided compared to specific criteria
• Examples: reagent checks, instrument calibrations and controls checks, verifications, trend monitoring, technical and administrative reviews of each case file

Validations

• Evaluation of new technical procedures, software, and analytical instruments for forensic casework
• Process of performing a set of experiments to establish the efficiency and reliability of a technique
• Examples: precision, limit of detection/quantitation, specificity, carryover, stability, reproducibility, determination of measurement uncertainty

Performance Checks

• Modifications to existing procedures, updated versions of software, and updated analytical instrument models are verified and suitable for use in casework
• Examples: new instrumentation already in use at the laboratory, moving an existing procedure to a different instrument, updated revision of software or operating system

Controlled Documents

• Documents issued and distributed in a trackable manner
• Examples: FSQM, LAPM, discipline SOPs, evidence submission manual, new member training manual, CLA training manual, FT training manual, case worksheets

Forensic Science Quality Manual (FSQM)

• States how the FDLE laboratory system fulfills the accreditation standards detailed in the ISO 17025 standards and AR 3125 accreditation requirements
• Structured to directly correlate to the standards: structural requirements, resource requirements, process requirements, management system requirement

Laboratory Administrative Procedures Manual (LAPM)

• Defines the approved way of performing laboratory tasks with statewide consistency
• Organized in three major categories: casework practices, quality practices, business practices

Standard Operating Procedures (SOPs) and Work Instructions

• Discipline-specific methods and procedures
• Found on the FDLE Forensic Services webpage
• Examples: specific discipline requirements for the analysis, instrumental maintenance, quality control procedures, extraction procedures, abbreviations, chemical reagent preparations, and other tasks

Deviations

• Departing from the established course or accepted standard listed in FSQM, LAPM, or discipline SOP
• Deviation requests are submitted prior to work being performed on the evidence

Nonconforming Work

• Occurs when there is an unexpected discrepancy or departure from the policies or procedure of the management system or to technical operations
• Each analyst is responsible for their own technical review and verification prior to submitting a case for review

Laboratory Activity Review (LAR)

• Used to review deviations or potential nonconforming work
• Completed by CLAS and forwarded to both COFS & AFQM / FQM for review
• Either a correction is granted or further investigation is needed based on significance, risk levels, and impact to current and previous casework

Quality Assurance Review (QAR)

• Used to document the parameters and findings of the investigation
• The results of the investigation are reviewed by the COFS and FQM/AFQM
• Correction action may be needed as determined by quality management based on the investigation

Corrective Action Request (CAR)

• Used to document the after-action of a quality review
• Corrective action is specific to each incident and may vary
• Examples: additional training or competency testing, additional validations or performance check, recall of casework for additional testing

Risk and Opportunity Assessment (ROAR)

• Way to prevent or reduce undesirable events, results, or potential failures while identifying improvements that help the laboratory better achieve its objectives