Quality Assurance & Quality Control (QAQC) II PDF

QUALITY ASSURANCE & PART 2 QUALITY CONTROL ANALYTICAL PROCEDURES All labs must have SOPs that are reviewed annually by technical leader in addition to any other laboratory audits All reagents (lot numbers, etc.) must be tracked used only for intended purpose Analytical procedures mus...

QUALITY ASSURANCE & PART 2 QUALITY CONTROL ANALYTICAL PROCEDURES All labs must have SOPs that are reviewed annually by technical leader in addition to any other laboratory audits All reagents (lot numbers, etc.) must be tracked used only for intended purpose Analytical procedures must be monitored through the use of controls Procedures must be checked annually or if substantial changes are made, against appropriate reference material Written guidelines for interpretation of data Verification of all controls Inclusion/exclusion policies Proper statistical interpretation of results Detection and control of contamination STANDARD OPERATION PROCEDURES (SOPs) Specific set of steps to accomplish a task (i.e. recipe) Integral part of a QA/QC system Provide consistency across multiple analysts, laboratories, etc. Exist to govern how any commonly repeated task is done in a lab environment Risk/liability reduction EX. DNA EXTRACTION KEY COMPONENTS OF SOPs Scope and Applicability Describe purpose of process, limits, how its used Include any standards or regulatory requirements, roles/responsibilities different employees Methodology and Procedure All steps in enough detail Include required equipment, decision factors Address any “what ifs” possible interferences and safety considerations KEY COMPONENTS OF SOPs CONTINUED Terminology Define your terms to minimize possible misinterpretations Health and Safety Needs to be listed as a separate section as well as alongside step by step procedures Equipment and Supplies Complete list of what is needed; where to find it; standards required Cautions and Interferences (aka Troubleshooting) What could go wrong, what to look out for REPORTS & REVIEWS Reports Procedures on how to take casework notes and how long all information must be stored Templates and structure of reports Procedures to ensure privacy of all records Reviews Administrative/technical review of all casework to ensure conclusions are reasonable within constraints of scientific knowledge Completion of review must be documented List of specific technical aspects that must be verified Procedures to follow if there is disagreement between analyst and reviewer, for verification of database matches, testimony each analyst PROFICIENCY TESTING On a regular schedule for all analysts Specific records must be kept regarding inclusions/exclusions and how well analyst followed procedures All tests recorded and corrective actions documented where applicable External proficiency tests must be performed by agencies in compliance with ISO standards CORRECTIVE ACTION Corrective action plan to address discrepancies detected in proficiency tests or casework analysis Why level/type discrepancy applicable to corrective action plan and if possible cause(s)/effect(s) of discrepancy and corrective actions or preventative measures taken Document everything AUDITS Laboratory audited annually in accordance with these standards External audit required on a set schedule All audits conducted using quality assurance standards audit documents All audit documentation must be retained for review in subsequent audits OUTSOURCING If work is being performed in a different facility that facility must comply to all the same standards regarding technical expertise, training, etc. HEALTH AND SAFETY All labs must have documented environmental health and safety program Must include blood borne pathogen and chemical hygiene plan Documented training on the above plans Environmental health and safety program must be reviewed annually  BRIEF DETOUR: MENTAL HEALTH POST TRAUMATIC STRESS DISORDER (PTSD) Mental health condition that's triggered by a terrifying event or specific events Either experiencing or witnessing it Symptoms may include flashbacks, nightmares and severe anxiety, as well as uncontrollable thoughts about the event (“vivid recall”) Re-experiencing, avoidance, numbing, hyperarousal continue more than a month after the event It is assumed PTSD in first responders is work related unless otherwise shown – moves the burden of proof to the other side OCCUPATIONAL STRESS INJURY (OSI) Starting to be recognized (RCMP, military) What is traditionally considered “Burn out” High stress environment Accumulation of events, experiences, not one specific event Leads to heightened anxiety, stress, heightened state of alert or numbness Heightened “negative” state Currently lumped in under PTSD for WSIB claims Burden of proof is on claimant, that cumulative effects are all work- related  I ASKED MY FRIEND WHO WAS DISCHARGED FROM THE MILITARY WITH AN OSI … What would you tell your younger self about mental health/job- related stress? You are not your job Everyone struggles in their job Problematic when the struggles are made personal “Something wrong with me” Everyone has a breaking point “Once you’re there, you’re there” No weakness in hitting it Different for everyone Same challenges can affect different people differently Nobody is more worthy of treatment/help than another “A broken femur is a broken femur. Whether you fell off your bike, or fought an elephant, it requires treatment” STANDARDS, CERTIFICATIONS & ACCREDITATION STANDARDS, CERTIFICATIONS & ACCREDITATION Standards Global & National: ISO, SCC Legislation & Local Standards Certifications Field Specific Certifications & Memberships Workplace Certifications Accreditation What, why, how STANDARDS IN THE WORKPLACE “a required or agreed level of quality or attainment” Importance: Fundamental building blocks for consistency or quality History: implementation of standards began during the Industrial Revolution Examples include: Protocols & Guidelines Notes/Instructions Legislations ISO: INTERNATIONAL ORGANIZATION FOR STANDARDS “We develop and publish International Standards” Independent, non-governmental international organization Standards according to ISO “documents that provide requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose.” Membership to date: 164 national standards bodies Full Members Correspondent Members Subscribers Geneva, Switzerland ISO: PRINCIPLES IN STANDARDS DEVELOPMENT To date: 22 572 International Standards have been developed by ISO 1. ISO standards respond to a need in the market 2. ISO standards are based on global expert opinion (incl: technical committees*) 3. ISO standards are developed through a multi-stakeholder process 4. ISO standards are based on a consensus *ISO/TC 272 : Forensic Science Technical Committee (https://www.iso.org/committee/4395817.html) 3 published standards; 4 under development; 24 members; 19 observing members ISO: EXAMPLES ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories ISO 21043-1:2018 Forensic sciences -- Part 1: Terms and definitions ISO 21043-2:2018 Forensic sciences -- Part 2: Recognition, recording, collecting, transport and storage of items ISO 18385:2016 Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes -- Requirements ISO17025 ISO17025: General requirements for the competence of testing and calibration laboratories In most countries, ISO17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent Laboratories use ISO17025 to implement a quality system Improve ability to consistently produce valid results consistently Also the basis for accreditation from an accreditation body  Scope, Normative References, Terms and Definitions, General Requirements, Structural Requirements, Resource Requirements, Process Requirements, and Management System Requirements General Requirements and Structural STRUCTURE Requirements: Organization of the lab OF ISO17025 Issues related to the people, facilities, and other organizations used to produce results Process Requirements Describe activities to ensure that results are based on accepted science and aimed at technical validity SCC: STANDARDS COUNCIL OF CANADA Crown corporation established by Act of Parliament in 1970 to promote voluntary standardization in Canada (operations = independent; financed partially =Parliament) Takes its mandate from the Standards Council of Canada Act: To promote efficient and effective voluntary standardization in Canada, where standardization is not expressly provided for by law Aims to advance national economy, support sustainable development, benefit health, safety and welfare of public, assist and protect consumers and facilitate domestic and international trade Offers discipline specific accreditation to laboratories WHAT IS ACCREDITATION? Procedure where an authoritative body or organization (like SCC) gives formal recognition that a laboratory is competent to carry out specific tests or calibrations IN OTHER WORDS… Doing what you say you are doing and being able to prove it Does the laboratory “say” what they do? Are there written documents (policies, procedures) that meet requirements of ISO 17025? Does the laboratory “do” what they say Are they in compliance with their own quality system, test methods and ISO 17025? Can they “prove” it with their records? Training records, standards preparation instructions, client reports, audit reports, etc. WHY ACCREDITATION? An expensive and time-consuming process… Requirement in Ontario because of the ramifications of bad science getting presented in court FORENSIC LABORATORIES ACT Accreditation mandatory for forensic labs operating in Ontario “Forensic Laboratory Accreditation (1) This section applies to a test in a prescribed category of test that is requested, (a) for the purpose of legal proceedings; (b) for some other legal purpose; or (c) pursuant to an order of a court or other lawful authority Accreditation requirement (2) No person shall, in a laboratory, conduct a test to which this section applies, unless, (a) the laboratory is accredited, by an accrediting body prescribed by the regulations, to a prescribed general standard; and (b) if the test is a prescribed test, the laboratory is accredited, by an accrediting body prescribed by the regulations, to a prescribed standard for that test. (3) A person who operates a laboratory shall ensure that no test is conducted in the laboratory in violation of subsection (2).” FORENSIC LABORATORIES ACT Establish independent advisory committee Build knowledge and leverage the expertise of key forensic science, justice sector, social services and child protection professionals and Indigenous partners Provide ongoing advice on the provincial forensic oversight framework Recommendations related to standards and oversight requirements Research, best practices and education/training in forensics WHY ACCREDITATION? Establish minimum competency standards Identify laboratories specific competencies Document nonconformities Enables continuous improvement Breaks down barriers to international collaboration Forensics – mandated ACCREDITATION Having a Management System and demonstrating competency ISO 17025 written as though all methods in a lab are accredited – this is rarely the case Methods performed infrequently are hard to accredit – difficulty demonstrating track record of performance Methods with little objective content hard to accredit – consistency in application cannot be guaranteed ACCREDITATION IS GRANTED By an identified and qualified accreditation body using prescribed criteria (ISO 17025) For specific test methods After an onsite assessment of the lab’s management and technical expertise Assessment performed by qualified (peer-expert) assessors PROCESS OUTLINE Application On-site assessment Deficiencies Accreditation decisions Annual review Re-assessment/Renewal of accreditation ACCREDITATION IS MAINTAINED Through ongoing surveillance of lab performance Proficiency testing Re-assessment (Audits) at periodic intervals MAINTAINING ACCREDITATION Once accreditation is granted the accreditation cycle will commence Reassessment visits Surveillance visits Witness audits Expansion or reduction of accreditation may require additional visits PROFICIENCY TESTING Laboratories are required to participate in relevant and available PT programs Typical programs include: Proficiency testing activities 2x/year; Cover all sub-disciplines in 4 years Results must be within acceptance criteria Details on specific proficiency testing required for each sub- discipline of forensic science under SCC are outlined in the “Requirements and Guidance for the Accreditation for Forensic Testing Laboratories” document Failure of proficiency testing can result in suspension of analyst and/or loss or suspension of accreditation for a facility FEPAC? Forensic Science Education Programs Accreditation Commission