Template:LIMSpec for Cannabis Testing/Personnel and resource management

Regulation, Specification, or Guidance Requirement ▪ 29 CFR Part 1910.120 ▪ 29 CFR Part 1910.134 (m) ▪ 29 CFR Part 1910.1030 (h-1) ▪ 29 CFR Part 1910.1450 (j) ▪ CJIS Security Policy 5.2.3 ▪ EPA ERLN Laboratory Requirements 4.2.4.1 ▪ EPA QA/G-5 2.1.8 ▪ NIST 800-53, Rev. 4, AT-4 ▪ USDA Administrative Procedures for the PDP 6.1 ▪ USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3 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 ▪ E.U. Commission Directive 2003/94/EC Article 13 ▪ WHO Technical Report Series, #986, Annex 2, 2.1 (j) ▪ 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 211.25 ▪ 29 CFR Part 1910.1450 (f) ▪ 42 CFR Part 73.15 ▪ ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 ▪ ASTM E1578-18 E-1-1 ▪ CJIS Security Policy 5.2.1 ▪ EPA ERLN Laboratory Requirements 4.2.4.1 ▪ FDA Hazard Analysis Critical Control Point Guidelines ▪ NIST 800-53, Rev. 4, AT-2 and AT-3 ▪ NIST 800-53, Rev. 4, CP-3 ▪ NIST 800-53, Rev. 4, IR-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 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 ▪ FDA Hazard Analysis Critical Control Point Guidelines 8.4 The system should provide access to relevant training materials to personnel attending training sessions.     ▪ 5 CFR Part 930.301 ▪ 29 CFR Part 1910.1450 (f) ▪ 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 ▪ 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 ▪ ISO 15189:2012 5.1.9 ▪ NIST 800-53, Rev. 4, AT-2–AT-4 ▪ NIST 800-53, Rev. 4, CP-3 ▪ NIST 800-53, Rev. 4, IR-2 ▪ USDA Administrative Procedures for the PDP 6.1 ▪ USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3 ▪ 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 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 ▪ NIST 800-53, Rev. 4, AT-2 and AT-3 ▪ NIST 800-53, Rev. 4, CP-3 ▪ NIST 800-53, Rev. 4, IR-2 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 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 ▪ 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 2018 (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 ▪ 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.