NMTM Module 5.pptx

New Member Training Module 5: Introduction to Forensic Quality Assurance The primary purpose of this module is to provide a basic overview of the accreditation process and laboratory quality documents. Accreditatio n Forensic accreditation provides confidence in the testing...

New Member Training Module 5: Introduction to Forensic Quality Assurance The primary purpose of this module is to provide a basic overview of the accreditation process and laboratory quality documents. Accreditatio n Forensic accreditation provides confidence in the testing, inspections, and calibrations conducted by governmental and private agencies for use in criminal and civil proceedings. Accreditation demonstrates that crime laboratories, law enforcement agencies, medical examiners offices and other agencies offering forensic services conduct their activities in conformance with internationally recognized standards. Definition: Accreditation is an assessment of an agency's technical qualifications and competence for conducting specific testing, calibration, and/or inspection activities within the scope of ISO/IEC 17025 or ISO/IEC 17020 and any relevant field-specific standards included in amplification documents Source: Forensic Service Provider – ANAB (ansi.org) History FDLE first received accreditation in 1990 from ASCLD-LAB American Society of Crime Laboratory Directors – Laboratory Accreditation Board Reaccreditation assessments occurred every five years First international accreditation happened during 2010 assessment ASCLD-LAB merged with ANAB in 2016 ANAB – ANSI NAB American National Standards Institute National Accreditation Board Accreditation cycle 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 itself is accredited: Signatory of the International Laboratory Accreditation Cooperation (ILAC) 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 Accreditation Requirements for Forensic Testing and Calibration FDLE Laboratory Standards Forensic Science Quality Manual Laboratory Administrative Procedures Manual Discipline Standards Standard Operating Procedures & Work Instructions Linking ISO 17025 to FDLE ISO 17025 ISO 17025 AR 3125 Just look at all of the Quality Assurance: What is 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: Established laboratory policy & procedure Training, competency and certification program Continuing education Proficiency testing and performance monitoring program Planned annual audits and management review Quarterly evidence and inventory inspections Accreditation and surveillance visits Validation and performance check of laboratory procedures Critical supplies and vendor list Risk and Opportunity Assessments Procedure to handle complaints, deviations and nonconforming work What is Quality Control (QC) Internal activities that are performed to monitor the quality of the data or service being provided when compared to specific criteria Completed during the course of the analysis Examples: Reagent checks Instrument calibrations and controls checks Verifications Trend monitoring Technical and administrative reviews of each casefile Testimony reviews Participation in performance monitoring and proficiency testing Validations All new technical procedures, software and analytical instruments that have never been validated for forensic casework must be evaluated prior to use in casework Process of performing a set of experiments to establish the efficiency and reliability of a technique Precision Limit of Detection / Quantitation Specificity Carryover Stability Reproducibility Determination of Measurement Uncertainty Approved by discipline TLs and AQM; with documentation stored on the Forensics page Performance Checks Modifications to existing procedures, updated versions of software, and updated analytical instrument models are verified and suitable for use in casework Confirming a technique or equipment used for analysis is functioning the way it is intended New instrumentation already in use at the laboratory (similar equipment, not new technology) Moving an existing procedure to a different instrument Updated revision of software or operating system Not to be confused with quality checks When a vendor performs maintenance on an instrument When equipment returns from external service or repair Controlled Documents A controlled document is any document that is 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 An easy way to determine if something is a controlled document is to look at the top and bottom of the documentation Controlled Documents All of these documents are maintained on the FDLE intranet This gives locations for all the disciplines, all publications, safety manuals, and accreditation documentation Below all of these are the Archived controlled documents Controlled Documents When printing or downloading any controlled documents ensure you are using the most recent version of them from the website Controlled documents take effect the day of their implementation Confirm with your supervisor or technical leader for the appropriate action to take when dealing with SOPs and 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. The document is structured to directly correlate to the standards Structural Requirements Resource Requirements Process Requirements Management System Requirement The FSQM is the ‘policy’ to the LAPM ‘procedures’ 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 SOPs containing specific discipline requirements for the analysis, instrumental maintenance, quality control procedures, extraction procedures, abbreviations, chemical reagent preparations and other tasks Work Instructions and Worksheets contain specific instructions to equipment and preparations within the lab system Highly specific with detail and requirements to be followed May pertain to a particular instrument in a region, even if multiple regions have the same instrument Deviations Departing from the established course or accepted standard listed in FSQM, LAPM, or discipline SOP Deviation are requested prior to work being performed on the evidence If the section supervisor agrees to the deviation Request is submitted as a Laboratory Activity Review (LAR) to the COFS and FQM / AQM The request is then forwarded to the Technical Leader; if approved the LAR is added to the casefile Example – a physical barrier was unable to be inserted into a rusted firearm, as required by the LAPM Deviation was approved by AQM, dowel rod was used to show firearm was unloaded, and the LAR was added to the case file 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 prior to submitting a case for review is responsible for their own technical review and verification Any non-conformities found within casework will be handled through quality management Any non-conformities found within an assessment must be fixed prior to receiving reaccreditation 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 Impact to current and previous casework Investigations usually involve the Technical Leader LARs are neither positive or negative, nor mean that something is wrong Quality management tracks the LARs as a part of trend monitoring Quality Assurance Review (QAR) QAR is 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: Could the nonconformance reoccur Doubt of conformity to laboratory operations Acceptability of work by entities outside of the laboratory Corrective Action Request (CAR) CAR is used to document the after action of a quality review Corrective action is specific to each incident and will vary: Additional training or competency testing Additional validations or performance check Recall of casework for additional testing Expected timeframe and follow-up are documented ANAB may need to be notified of results 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. A LAR is used first when a members identifies a risk or opportunity. The ROAR form is used once the suggestion is evaluated by both laboratory and quality management.