COURSE OUTLINE Course Number: FSCT 8370 Course Title: Quality Assurance for Forensic Science School: Computing and Academic Studies Program: Combined Honours in Biochemistry and Forensic Science Course Credits: 3 Total Hours: 45 Total Weeks: 13 Total Hours/Week: 3.5 Delivery Type (hrs/wk): Lecture: [xxx] Laboratory: [xxx] Field Work: [xxx] Practicum: [xxx] Other [specify]: [xxx] Prerequisites: N/A Prerequisite for: N/A Tutorial: [xxx] Directed Studies: [xxx] Seminar: [xxx] Online: 3.5 Course Description: This course explains the role that quality assurance and quality control play in an accredited forensic science laboratory. The requirements and applications of the standards ISO 17025 (General Requirements for the Competence of Testing and Calibration Laboratories) and SCC Requirements and Guidance for the Accreditation for Forensic Testing Laboratories are covered. The role and duties of a Quality Assurance Manager within a calibration or testing laboratory are covered. Students undergo numerous practical Quality Assurance activities, including conducting corrective action, continual improvement, and controlling documents and records. In addition, students will conduct an internal audit exercise which includes developing an audit plan and program, gathering audit evidence, conducting interviews, writing an audit report, and conducting an audit meeting. Course Learning Outcomes/Competencies: Upon successful completion, the student will be able to: • • • • • • • • • • Describe the role of quality assurance, quality control and the quality manager in a laboratory setting. Identify the components of a laboratory’s Quality Management System. Produce controlled documents and records. Develop strategies for continual improvement of the laboratory. Outline the technical requirements of accredited laboratories including laboratory developed methods, method validation, and maintenance and calibration of laboratory equipment. Describe the guidelines for the levels of security required in forensic laboratories. Differentiate the qualifications of management and analyst positions for the different forensic science areas. Explain the requirements for the reporting of results including test reports, opinions and interpretations. Perform a corrective action for a laboratory issue including the cause analysis, report write-up, and monitoring. Conduct an internal audit including developing an audit plan and program, gathering audit evidence, conducting interviews, writing audit reports and conducting an audit meeting. Evaluation Criteria: Criteria Participation / Assignments Midterm Final Project and Report (Internal Audit) Final Exam TOTAL % 20 Comments The grading system for this course is numeric (percentage) and the passing grade is 60%. 20 20 40 100% Learning Resources: ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories. International Organization of Standardization (ISO). SCC Requirements and Guidance for Accreditation for Forensic Testing Laboratories (2017). Available for free at https://www.scc.ca/en/about-scc/publications/scc-requirements-and-guidance-for-accreditation-for-forensictesting-laboratories The ISO 17025:2017 Laboratory Survival Guide (2018) TEQSUK Course Instructor(s): Henry Wong, BCIT Forensic Science and Technology Department and RCMP Jason Moore, BCIT Forensic Science and Technology Department Information for Students (Information below can be adapted and supplemented as necessary.) The following statements are in accordance with the BCIT Student Regulations Policy 5002. To review the full policy, please refer to: http://www.bcit.ca/~presoff/5002.pdf. Attendance/Illness: In case of illness or other unavoidable cause of absence, the student must communicate as soon as possible with his/her instructor or Program Head or Chief Instructor, indicating the reason for the absence. Prolonged illness of three or more consecutive days must have a BCIT medical certificate sent to the department. Excessive absence may result in failure or immediate withdrawal from the course or program. Academic Misconduct: Violations of academic integrity, including dishonesty in assignments, examinations, or other academic performances are prohibited and will be handled in accordance with the ‘Violations of Standards of Conduct’ section of Policy 5002. Attempts: Students must successfully complete a course within a maximum of three attempts at the course. Students with two attempts in a single course will be allowed to repeat the course only upon special written permission from the Associate Dean. Students who have not successfully completed a course within three attempts will not be eligible to graduate from their respective program. Accommodation: Any student who may require accommodation from BCIT because of a physical or mental disability should refer to BCIT’s Policy on Accommodation for Students with Disabilities (Policy #4501), and contact BCIT’s Disability Resource Centre (SW1-2300, 604-451-6963) at the earliest possible time. Requests for accommodation must be made to the Disability Resource Centre, and should not be made to a course instructor or Program area. Any student who needs special assistance in the event of a medical emergency or building evacuation (either because of a disability or for any other reason) should also promptly inform their course instructor(s) and the Disability Resource Centre of their personal circumstances. Course Schedule: Week of/ Number Material Covered 1. Sept. 9 2021 1. Introduction 2. Quality Control vs. Quality Assurance 3. Accrediting Body 4. Standards 5. PDCA Cycle 6. Impartiality 7. Confidentiality 2. Sept. 16 2021 3. Sept. 23 2021 1. Ethics 2. Cognitive Bias 3. Introduce Internal Audit Exercise (provide each student a BCIT SOP) 1. Ethics (Continued) 2. Structural Requirements (section 5) Reference/ Reading Exercises/ Assignment Learning Outcome Covered 1, 2, 4 Laboratory Survival Guide - Impartiality (4.1) Page 138 - 139 - Confidentiality (4.2) Page 78 – 79 - 1.Laboratory Risks 2.Impartiality 3. Confidentiality ISO – 17025:2017 Section 4 1, 2, 3 - Ethics and Practice of Forensics Science Textbook Chapter 1 Laboratory Survival Guide Structural Requirements of the Standard (5) Page 309 – 312 Feedback (5) Page 104 -108 ISO – 17025:2017 Section 5 1. Ethics News Article Assignment 1, 2, 5 1. Ethical Scenarios 2.. Explain Quality Objectives Assignment 1, 2, 5, 6, 7 4. Sept 30, 2021 1. Quality Objectives Assignment 2. Resource Requirements (section 6) 3. Forensic Standard 4. Measurement Traceability 5. Purchasing Laboratory Survival Guide - Resource Requirement (6.1) Pg. 270 - Personnel (6.2) P 202 – 210 - Accommodation (6.3) Page 17-20 - Equipment (6.4) Page 99 – 101 - Traceability (6.5) Page 328 - 334 - Purchasing (6.6) Page 240- 244 - Sub contracting (6.6) page 313 – 315 ISO 17025:2017 Section 6 1. Qualification requirements 2.. Competency Exercise 3. Precautions, security, contamination prevention 4. Purchasing process 5. Measurement Traceability 2, 3, 4, 5 5. Oct. 7 2021 1. Measurement Traceability Assignment 2. Process Requirements (section 7) 3. Sampling (7.3) 4. Handling of Exhibits 5. Technical Records (7.5) 6. Measurement Uncertainty (7.6) 7. Ensuring Validity of Results (7.7) 8. Court Testimony Monitoring Laboratory Survival Guide -Customer (7.1) Page 81 – 83 -Verified / Validation of Test Methods (7.2) Page 349 – 357 -Sampling (7.3) Page 283 – 289 -Handling Test Samples and Calibration items (7.4) Page 259 – 260 -Uncertainty of Measurement (7.6) Page 335 – 348 -Quality Assurance (7.7) Page 249 251 1.. Method Validation Exercise 2. Handling of Exhibits Exercise 3. Court Testimony Monitoring Exercise 4. Accredited Proficiency Test Providers ISO 17025:2017 Section 7 6. Oct. 14 2021 1. Midterm Exam (20% of final grade; Content weeks 1-5) 2 Accredited Proficiency Test Providers Assignment 3. Reporting of Results (7.8) 4. Complaints (7.9) 5. Non-conforming Work (7.10) 6. Control of Data Information Management (7.11) 7. Management System Documentation (8.2 and 8.3) 8. Control of Records (8.4) 9. Risks and Opportunities (8.5) 10. Improvement (8.6) 7. Oct. 21 2021 1. Risk Analysis Assignment 2. Management System Requirements Overview 3. Internal Audit (8.8) 4. Management Review (8.9) 5. Root Cause Analysis 8. Oct. 28 2021 1. Internal Audit 2. ISO 19011 3. Audit Roles and Responsibilities 4. Types of Audits 5. Principles of Auditing 6. Conducting Interviews 7. Selecting Audit Files 9. Nov 4 2021 1. Managing and Audit Program 2. Conducting Audit Activities 3. Document Review 4. Audit Plan Laboratory Survival Guide -Reporting (7.8) Page 261 – 269 -Complaints (7.9) Page 84 – 90 -Non-conformance Work (7.10) Page 184 – 188 -Root Cause (7.10) Page 278 – 282 -The 5 Whys (7.10) page 358 – 360 -Management Requirements (8.1 – 8.3) Page 165 – 183 -Records (8.4) Page 257 – 258 -Risks and Opportunities (8.5) Page 271-277 -Improvement (8.6) Page 140 - 141 1, 2, 3, 4, 5, 6, 7, 8, 9 1. Report Evaluation Exercise ISO 17025:2017 Section 8 Laboratory Survival Guide Non-Conformances (8.7) Page 184 – 188 (previously assigned) -Auditing (8.8) Page 42 - 49 -Management Review (8.9) Page 166 - 168 None None 1. Root Cause Analysis Exercise 2. Risk Analysis Assignment Homework 1. Characteristics of an Assessor 2. Closed and Open Questions Exercise 3. Audit Questionnaire Exercise 1. Create Audit Checklist Exercise 2. Develop Audit Plan Exercise 2, 4, 9 2, 4, 10 2, 3, 4, 10 10. Nov. 11 2021 1. Internal Audit – Opening Meeting 2. Conducting and On-site Audit None 1. Opening Meeting Exercise 2. Auditing (on-site observing) exercise 1. Writing Audit Findings and Reviewing Responses Exercise 2. Audit Interviews (Lab SOPs) 2, 3, 4, 10 2, 3, 4, 9, 10 11. Nov. 18 2021 1. Internal Audit Process 2. Generating Audit Findings 3. Preparing Audit Report 4. Closing Meeting 12. Nov. 25 2021 1. Opening Meeting 2. Report (Internal Audit) 3. Closing Meeting None 1. Prepare Audit Report 3. Closing Meeting Exercise Final Exam (40% of final grade; Content weeks 1-12) None None 13. Dec 2 2021 None 2, 4, 10 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
