Template:LIMSpec for Cannabis Testing/Personnel and resource management

Regulation, Specification, or Guidance Requirement ▪ 9 CFR Part 2.32 ▪ 10 CFR Part 20.2103 ▪ 21 CFR Part 1.1150 ▪ 21 CFR Part 1.1152 (c) ▪ 21 CFR Part 1.1152 (d) ▪ 21 CFR Part 110.10 (c) ▪ 21 CFR Part 120.12 ▪ 21 CFR Part 123.10 ▪ 29 CFR Part 1910.120 ▪ 29 CFR Part 1910.134 (m) ▪ 29 CFR Part 1910.1030 (h-1) ▪ 29 CFR Part 1910.1450 (j) ▪ 40 CFR Part 262.207 ▪ A2LA C211 4.13.2.3 ▪ A2LA C223 5.2 ▪ A2LA C223 5.7 ▪ ACMG Technical Standards for Clinical Genetics Laboratories B3–B5 ▪ APHL 2019 LIS Project Management Guidebook ▪ BRC GSFS, Issue 8, 7.1.x ▪ BRC GSFS, Issue 8, 7.3.1 ▪ CAP Laboratory Accreditation Manual ▪ CJIS Security Policy 5.2.3 ▪ EPA ERLN Laboratory Requirements 4.2.4.1 ▪ EPA QA/G-5 2.1.8 ▪ GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1 ▪ GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7 ▪ IFS Food 7, Part 2, 3.1 ▪ IFS Food 7, Part 2, 3.3 ▪ IFS PACsecure 2, Part 2, 3.1 ▪ IFS PACsecure 2, Part 2, 3.3 ▪ NIST 800-53, Rev. 5, AT-3 and -4 ▪ NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards ▪ OSHA 1910.1020 (throughout) ▪ OSHA 1910.1200(b)(3) and (h) ▪ OSHA 1910.1450 (throughout) ▪ PFP Human and Animal Food Testing Laboratories Best Practices Manual ▪ SQF FSC 9, Food Manufacturing, Part B, 2.9 ▪ SQF FSC 9, Pet Food Manufacturing, Part B, 2.9 ▪ SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9 ▪ TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2) ▪ USDA Administrative Procedures for the PDP 6.1 ▪ USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3 ▪ WADA International Standard for Laboratories (ISL) 5.2.2 ▪ WHO Technical Report Series, #996, Annex 5, 8.1 8.1 The system shall have the ability to create and maintain individual personnel records for tracking such things as demographics, certifications, training, evaluations, medical history, and occupational exposure.     ▪ 21 CFR Part 820.198 ▪ 42 CFR Part 493.1233 ▪ BRC GSFS, Issue 8, 3.10.1–2 ▪ E.U. Commission Directive 2003/94/EC Article 13 ▪ GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21 ▪ IFS Food 7, Part 2, 5.8 ▪ IFS PACsecure 2, Part 2, 5.8 ▪ ISO/IEC 17025:2017 7.9 ▪ TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8) ▪ WADA International Standard for Laboratories (ISL) 5.3.10 ▪ WHO Technical Report Series, #986, Annex 2, 2.1 (j) ▪ WHO Technical Report Series, #986, Annex 2, 5.0 8.2 The system shall allow authorized personnel to document complaints and problems reported to the laboratory, research facility, or production facility.     ▪ 5 CFR Part 930.301 ▪ 7 CFR Part 331.15 ▪ 9 CFR Part 121.15 ▪ 21 CFR Part 120.12 ▪ 21 CFR Part 123.10 ▪ 21 CFR Part 211.25 ▪ 29 CFR Part 1910.1450 (f) ▪ 42 CFR Part 73.15 ▪ A2LA C223 5.2 ▪ APHL 2019 LIS Project Management Guidebook ▪ ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 ▪ ASTM E1578-18 E-1-1 ▪ BRC GSFS, Issue 8, 7.1.x ▪ CJIS Security Policy 5.2.1 ▪ EPA ERLN Laboratory Requirements 4.2.4.1 ▪ FDA Hazard Analysis Critical Control Point Guidelines ▪ GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1 ▪ GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7 ▪ IFS Food 7, Part 2, 3.3 ▪ IFS PACsecure 2, Part 2, 3.3 ▪ NIST 800-53, Rev. 5, AT-2 and AT-3 ▪ NIST 800-53, Rev. 5, CP-3 ▪ NIST 800-53, Rev. 5, IR-2 ▪ PFP Human and Animal Food Testing Laboratories Best Practices Manual ▪ SQF FSC 9, Food Manufacturing, Part B, 2.9 ▪ SQF FSC 9, Pet Food Manufacturing, Part B, 2.9 ▪ SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9 ▪ TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2) ▪ USDA Sampling Procedures for PDP 6.1.2–3 ▪ WHO Technical Report Series, #986, Annex 2, 10 8.3 The system shall allow training sessions and reviews to be scheduled for personnel.     ▪ 5 CFR Part 930.301 ▪ 29 CFR Part 1910.1450 (f) ▪ ABFT Accreditation Manual Sec. B ▪ ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7 ▪ ASTM E1578-18 E-1-2 ▪ BRC GSFS, Issue 8, 7.1.x ▪ FDA Hazard Analysis Critical Control Point Guidelines ▪ NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards ▪ SQF FSC 9, Food Manufacturing, Part B, 2.9 ▪ SQF FSC 9, Pet Food Manufacturing, Part B, 2.9 ▪ SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9 8.4 The system should provide access to relevant training materials to personnel attending training sessions.     ▪ 5 CFR Part 930.301 ▪ 21 CFR Part 1.1152 (d) ▪ 21 CFR Part 110.10 (c) ▪ 21 CFR Part 120.12 ▪ 21 CFR Part 123.10 ▪ 29 CFR Part 1910.1450 (f) ▪ 40 CFR Part 262.207 ▪ A2LA C223 5.2 ▪ ACMG Technical Standards for Clinical Genetics Laboratories C6.3 ▪ ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12 ▪ ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1–3 ▪ ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2 ▪ ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5 ▪ ASTM E1578-18 E-1-3 ▪ BRC GSFS, Issue 8, 7.1.x ▪ CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition ▪ CJIS Security Policy 5.2.3 ▪ EPA ERLN Laboratory Requirements 4.2.4.1 ▪ EPA QA/G-5 2.1.8 ▪ E.U. Commission Directive 2003/94/EC Article 7.4 ▪ FDA Hazard Analysis Critical Control Point Guidelines ▪ IFS Food 7, Part 2, 3.3 ▪ IFS PACsecure 2, Part 2, 3.3 ▪ ISO 15189:2012 5.1.9 ▪ NIST 800-53, Rev. 5, AT-2–AT-4 ▪ NIST 800-53, Rev. 5, CP-3 ▪ NIST 800-53, Rev. 5, IR-2 ▪ NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards ▪ SQF FSC 9, Food Manufacturing, Part B, 2.9 ▪ SQF FSC 9, Pet Food Manufacturing, Part B, 2.9 ▪ SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9 ▪ TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2) ▪ USDA Administrative Procedures for the PDP 6.1 ▪ USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e ▪ USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3 ▪ WADA International Standard for Laboratories (ISL) 5.2.2 ▪ WHO Technical Report Series, #986, Annex 2, 2.1 (e) ▪ WHO Technical Report Series, #986, Annex 2, 9.4 ▪ WHO Technical Report Series, #986, Annex 2, 10 8.5 The system shall be able to record for every trainee their training attendance, progress, assessments, licenses, and certificates of completion for in-house training, continuing education courses, and other required courses of certification.     ▪ ABFT Accreditation Manual Sec. B ▪ ASTM E1578-18 E-1-4 ▪ IFS Food 7, Part 2, 3.3 ▪ IFS PACsecure 2, Part 2, 3.3 8.6 The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.     ▪ ASTM E1578-18 E-1-5 ▪ BRC GSFS, Issue 8, 7.1.x ▪ NIST 800-53, Rev. 5, AT-2 and AT-3 ▪ NIST 800-53, Rev. 5, CP-3 ▪ NIST 800-53, Rev. 5, IR-2 ▪ SQF FSC 9, Food Manufacturing, Part B, 2.9 ▪ SQF FSC 9, Pet Food Manufacturing, Part B, 2.9 ▪ SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9 8.7 The system should be able to produce a training matrix of personnel.     ▪ 7 CFR Part 331.15 ▪ 9 CFR Part 121.10 ▪ 9 CFR Part 121.15 ▪ 21 CFR Part 11.10 (i) ▪ 21 CFR Part 58.29 ▪ 21 CFR Part 1.1150 ▪ 21 CFR Part 211.25 ▪ 21 CFR Part 225.10 ▪ 21 CFR Part 226.10 ▪ 21 CFR Part 226.40 ▪ 21 CFR Part 820.25 ▪ 29 CFR Part 1910.1030 (g-2) ▪ 29 CFR Part 1910.1030 (h-2) ▪ 29 CFR Part 1910.1200 (h) ▪ 29 CFR Part 1910.1450 (e) ▪ 42 CFR Part 73.10 ▪ 42 CFR Part 73.15 ▪ 42 CFR Part 493.43 (c) ▪ 42 CFR Part 493.1235 ▪ 45 CFR Part 164.308 ▪ 45 CFR Part 164.530 ▪ 61 FR 38806, 9 CFR Part 310.25 ▪ 61 FR 38806, 9 CFR Part 381.94 ▪ A2LA C223 5.2 ▪ AAFCO QA/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6 ▪ AAVLD Requirements for an AVMDL Sec. 5.2 ▪ AAVLD Requirements for an AVMDL Sec. 5.4.2.2 ▪ AAVLD Requirements for an AVMDL Appendix 1 ▪ ABFT Accreditation Manual Sec. B ▪ AIHA-LAP Policies 2022 (various parts) ▪ ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12 ▪ ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1–3 ▪ ASTM E1578-18 C-3-5 ▪ ASTM E1578-18 D-1-6 ▪ ASTM E1578-18 E-1-6 ▪ BRC GSFS, Issue 8, 5.6.2.3–4 ▪ BRC GSFS, Issue 8, 9.3.4 ▪ E.U. Annex 11-2 ▪ EPA 815-R-05-004 Chap. III, Sec. 10 and 17 ▪ EPA 815-R-05-004 Chap. IV, Sec. 1 ▪ EPA QA/G-5 2.1.8 ▪ ISO 15189:2012 4.1.2.1 ▪ ISO 15189:2012 5.1.6 ▪ ISO 15189:2012 5.1.9 ▪ ISO/IEC 17025:2017 6.2.2 ▪ ISO/IEC 17025:2017 6.2.3 ▪ ISO/IEC 17025:2017 6.2.5 ▪ ISO/IEC 17025:2017 6.2.6 ▪ OECD GLP Principles 1.1.2 ▪ USDA Administrative Procedures for the PDP 6.1 8.8 The system shall map available system tasks (such as approved test methods) or sample types (such as select agents, toxins, or substrates/matrices) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.     ▪ Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec 8.9 The system should provide accounting and billing functionality, including quoting and invoicing, for not only optimal business operations but also to ensure compliance with any regulations involving monetary transactions for cannabis-related services.