Forensic Quality Assurance Module 5

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Questions and Answers

What is the role of the FSQM in relation to the LAPM?

The FSQM and LAPM are unrelated documents

The FSQM is the policy to the LAPM's procedures (correct)

The FSQM is the procedure to the LAPM's policy

The LAPM is the policy to the FSQM's procedures

What are SOPs and Work Instructions used for?

To explain the structure of the laboratory

To define the LAPM

To provide detailed methods and procedures for specific tasks (correct)

To outline the FSQM

What is a Deviation in the context of the laboratory?

A new policy implemented by the laboratory

A type of quality assurance review

A request to depart from established procedures (correct)

A type of quality control procedure

What happens when a Deviation is approved?

The request is added to the case file as a Laboratory Activity Review (LAR) Signup and view all the answers

What is the purpose of a Laboratory Activity Review (LAR)?

To review deviations or potential nonconforming work Signup and view all the answers

What is Nonconforming Work?

Work that departs from established policies or procedures Signup and view all the answers

What is a Quality Assurance Review (QAR)?

A document of the parameters and findings of an investigation Signup and view all the answers

What is a Corrective Action Request (CAR)?

A document of the after-action of a quality review Signup and view all the answers

What is the purpose of a Risk and Opportunity Assessment (ROAR)?

To prevent or reduce undesirable events Signup and view all the answers

What is organized into three major categories?

Casework Practices, Quality Practices, and Business Practices Signup and view all the answers

What is the primary purpose of forensic accreditation?

To provide confidence in the testing, inspections, and calibrations conducted by governmental and private agencies Signup and view all the answers

What is the frequency of the accreditation cycle?

Every four years Signup and view all the answers

What is the definition of accreditation?

An assessment of an agency's technical qualifications and competence for conducting specific testing, calibration, and/or inspection activities Signup and view all the answers

What is the purpose of Quality Assurance (QA)?

To provide sufficient confidence that the laboratory's product or service will satisfy the requirements of quality Signup and view all the answers

What is the purpose of Quality Control (QC)?

To monitor the quality of data or service being provided during an analysis Signup and view all the answers

What is the purpose of validation?

To establish the efficiency and reliability of a technique Signup and view all the answers

What is the purpose of performance checks?

To verify that a technique or equipment is functioning as intended Signup and view all the answers

What is a controlled document?

Any document that is issued and distributed in a trackable manner Signup and view all the answers

What is the purpose of the Forensic Science Quality Manual (FSQM)?

To states how the FDLE laboratory system fulfills the accreditation standards Signup and view all the answers

What is the organization that ANAB is a signatory of?

International Laboratory Accreditation Cooperation (ILAC) Signup and view all the answers

Study Notes

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

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Description

Learn about the accreditation process and laboratory quality documents in forensic science, including their role in criminal and civil proceedings.