Difference between revisions of "Template:LIMSpec for Cannabis Testing/Personnel and resource management"
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! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"| | ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"| | ||
|- | |- | ||
! style="color:brown; background-color:#ffffee; width: | ! style="color:brown; background-color:#ffffee; width:250px;"| Regulation, Specification, or Guidance | ||
! style="color:brown; background-color:#ffffee; width:700px;"| Requirement | ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement | ||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
[https://www.law.cornell.edu/cfr/text/29/1910.120 29 CFR Part 1910.120]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/9/2.32 9 CFR Part 2.32]<br /> | ||
[https://www.law.cornell.edu/cfr/text/29/1910.134 29 CFR Part 1910.134 (m)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/10/20.2103 10 CFR Part 20.2103]<br /> | ||
[https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (h-1)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1150]<br /> | ||
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (j)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1152 (c)]<br /> | ||
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.2.3]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1152 (d)]<br /> | ||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.2.4.1]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/part-110 21 CFR Part 110.10 (c)]<br /> | ||
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.8]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/part-120 21 CFR Part 120.12]<br /> | ||
[https:// | ▪ [https://www.law.cornell.edu/cfr/text/21/part-123 21 CFR Part 123.10]<br /> | ||
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 6.1]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/29/1910.120 29 CFR Part 1910.120]<br /> | ||
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3] | ▪ [https://www.law.cornell.edu/cfr/text/29/1910.134 29 CFR Part 1910.134 (m)]<br /> | ||
| style="background-color:white;" |'''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. | ▪ [https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (h-1)]<br /> | ||
▪ [https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (j)]<br /> | |||
▪ [https://www.law.cornell.edu/cfr/text/40/262.207 40 CFR Part 262.207]<br /> | |||
▪ [https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 4.13.2.3]<br /> | |||
▪ [https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.2]<br /> | |||
▪ [https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.7]<br /> | |||
▪ [https://www.acmg.net/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards.aspx ACMG Technical Standards for Clinical Genetics Laboratories B3–B5]<br /> | |||
▪ [https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br /> | |||
▪ [https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 7.1.x]<br /> | |||
▪ [https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 7.3.1]<br /> | |||
▪ [https://elss.cap.org/elss/ShowProperty?nodePath=/UCMCON/Contribution%20Folders/DctmContent/education/OnlineCourseContent/2017/LAP-TLTM/misc/lam.pdf CAP Laboratory Accreditation Manual]<br /> | |||
▪ [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.2.3]<br /> | |||
▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.2.4.1]<br /> | |||
▪ [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.8]<br /> | |||
▪ [https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1]<br /> | |||
▪ [https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7]<br /> | |||
▪ [https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 3.1]<br /> | |||
▪ [https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 3.3]<br /> | |||
▪ [https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 3.1]<br /> | |||
▪ [https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 3.3]<br /> | |||
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AT-3 and -4]<br /> | |||
▪ [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br /> | |||
▪ [https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1020 OSHA 1910.1020 (throughout)]<br /> | |||
▪ [https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1200 OSHA 1910.1200(b)(3) and (h)]<br /> | |||
▪ [https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1450 OSHA 1910.1450 (throughout)]<br /> | |||
▪ [https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/ PFP Human and Animal Food Testing Laboratories Best Practices Manual]<br /> | |||
▪ [https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf SQF FSC 9, Food Manufacturing, Part B, 2.9]<br /> | |||
▪ [https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_PetFood_v3-2-Final-w-Links.pdf SQF FSC 9, Pet Food Manufacturing, Part B, 2.9]<br /> | |||
▪ [https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9]<br /> | |||
▪ [https://ris.dls.virginia.gov/uploads/1VAC30/dibr/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)]<br /> | |||
▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 6.1]<br /> | |||
▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3]<br /> | |||
▪ [https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.2.2]<br /> | |||
▪ [https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5, 8.1] | |||
| style="background-color:white; vertical-align: text-top;" |'''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.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | |||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
[https://www.law.cornell.edu/cfr/text/21/820.198 21 CFR Part 820.198]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/820.198 21 CFR Part 820.198]<br /> | ||
[https://www.law.cornell.edu/cfr/text/42/493.1233 42 CFR Part 493.1233]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/42/493.1233 42 CFR Part 493.1233]<br /> | ||
[https://eur-lex.europa.eu/ | ▪ [https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.10.1–2]<br /> | ||
[https://www. | ▪ [https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 13]<br /> | ||
[https:// | ▪ [https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, D, I, K - FSM 21]<br /> | ||
| style="background-color:white;" |'''8.2''' The system shall allow authorized personnel to document complaints and problems reported to the laboratory, research facility, or production facility. | ▪ [https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 5.8]<br /> | ||
▪ [https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 5.8]<br /> | |||
▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.9]<br /> | |||
▪ [https://ris.dls.virginia.gov/uploads/1VAC30/dibr/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf TNI EL-V1-2016-Rev.2.1 (V1,M2 4.8)]<br /> | |||
▪ [https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.3.10]<br /> | |||
▪ [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (j)]<br /> | |||
▪ [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 5.0] | |||
| style="background-color:white; vertical-align: text-top;" |'''8.2''' The system shall allow authorized personnel to document complaints and problems reported to the laboratory, research facility, or production facility.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | |||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
[https://www.law.cornell.edu/cfr/text/5/930.301 5 CFR Part 930.301]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/5/930.301 5 CFR Part 930.301]<br /> | ||
[https://www.law.cornell.edu/cfr/text/7/331.15 7 CFR Part 331.15]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/7/331.15 7 CFR Part 331.15]<br /> | ||
[https://www.law.cornell.edu/cfr/text/9/121.15 9 CFR Part 121.15]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/9/121.15 9 CFR Part 121.15]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/211.25 21 CFR Part 211.25]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/part-120 21 CFR Part 120.12]<br /> | ||
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (f)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/part-123 21 CFR Part 123.10]<br /> | ||
[https://www.law.cornell.edu/cfr/text/42/73.15 42 CFR Part 73.15]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/211.25 21 CFR Part 211.25]<br /> | ||
[ | ▪ [https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (f)]<br /> | ||
[https://www.astm.org/ | ▪ [https://www.law.cornell.edu/cfr/text/42/73.15 42 CFR Part 73.15]<br /> | ||
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.2.1]<br /> | ▪ [https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.2]<br /> | ||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.2.4.1]<br /> | ▪ [https://www.aphl.org/aboutAPHL/publications/Documents/GH-2019May-LIS-Guidebook-web.pdf APHL 2019 LIS Project Management Guidebook]<br /> | ||
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Guidelines]<br /> | ▪ [https://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3]<br /> | ||
[https:// | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-1-1]<br /> | ||
[https:// | ▪ [https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 7.1.x]<br /> | ||
[https:// | ▪ [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.2.1]<br /> | ||
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.1.2–3]<br /> | ▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.2.4.1]<br /> | ||
[https:// | ▪ [https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Guidelines]<br /> | ||
| style="background-color:white;" |'''8.3''' The system shall allow training sessions to be scheduled for personnel. | ▪ [https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2 - GAP 7.1]<br /> | ||
▪ [https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, B3, C0, C1, C2, C3, C4, D, I, K - GMP 7]<br /> | |||
▪ [https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 3.3]<br /> | |||
▪ [https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 3.3]<br /> | |||
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AT-2 and AT-3]<br /> | |||
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, CP-3]<br /> | |||
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IR-2]<br /> | |||
▪ [https://www.pfp-ifss.org/ifss-resources/human-and-animal-food-testing-laboratories-best-practices-manual-december-2018/ PFP Human and Animal Food Testing Laboratories Best Practices Manual]<br /> | |||
▪ [https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf SQF FSC 9, Food Manufacturing, Part B, 2.9]<br /> | |||
▪ [https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_PetFood_v3-2-Final-w-Links.pdf SQF FSC 9, Pet Food Manufacturing, Part B, 2.9]<br /> | |||
▪ [https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9]<br /> | |||
▪ [https://ris.dls.virginia.gov/uploads/1VAC30/dibr/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)]<br /> | |||
▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.1.2–3]<br /> | |||
▪ [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 10] | |||
| style="background-color:white; vertical-align: text-top;" |'''8.3''' The system shall allow training sessions and reviews to be scheduled for personnel.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | |||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
[https://www.law.cornell.edu/cfr/text/5/930.301 5 CFR Part 930.301]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/5/930.301 5 CFR Part 930.301]<br /> | ||
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (f)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (f)]<br /> | ||
[ | ▪ [https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. B]<br /> | ||
[ | ▪ [https://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7]<br /> | ||
[https://www.astm.org/ | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-1-2]<br /> | ||
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Guidelines] | ▪ [https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 7.1.x]<br /> | ||
| style="background-color:white;" |'''8.4''' The system should provide access to relevant training materials to personnel attending training sessions. | ▪ [https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Guidelines]<br /> | ||
▪ [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br /> | |||
▪ [https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf SQF FSC 9, Food Manufacturing, Part B, 2.9]<br /> | |||
▪ [https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_PetFood_v3-2-Final-w-Links.pdf SQF FSC 9, Pet Food Manufacturing, Part B, 2.9]<br /> | |||
▪ [https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9] | |||
| style="background-color:white; vertical-align: text-top;" |'''8.4''' The system should provide access to relevant training materials to personnel attending training sessions.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | |||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
[https://www.law.cornell.edu/cfr/text/5/930.301 5 CFR Part 930.301]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/5/930.301 5 CFR Part 930.301]<br /> | ||
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (f)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1152 (d)]<br /> | ||
[ | ▪ [https://www.law.cornell.edu/cfr/text/21/part-110 21 CFR Part 110.10 (c)]<br /> | ||
[ | ▪ [https://www.law.cornell.edu/cfr/text/21/part-120 21 CFR Part 120.12]<br /> | ||
[ | ▪ [https://www.law.cornell.edu/cfr/text/21/part-123 21 CFR Part 123.10]<br /> | ||
[ | ▪ [https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (f)]<br /> | ||
[https://www.astm.org/ | ▪ [https://www.law.cornell.edu/cfr/text/40/262.207 40 CFR Part 262.207]<br /> | ||
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.2.3]<br /> | ▪ [https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.2]<br /> | ||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.2.4.1]<br /> | ▪ [https://www.acmg.net/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards/ACMG/Medical-Genetics-Practice-Resources/Genetics_Lab_Standards.aspx ACMG Technical Standards for Clinical Genetics Laboratories C6.3]<br /> | ||
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.8]<br /> | ▪ [https://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12]<br /> | ||
[https://eur-lex.europa.eu/ | ▪ [https://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1–3]<br /> | ||
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Guidelines]<br /> | ▪ [https://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2]<br /> | ||
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.1.9]<br /> | ▪ [https://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5]<br /> | ||
[https:// | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-1-3]<br /> | ||
[https:// | ▪ [https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 7.1.x]<br /> | ||
[https:// | ▪ [https://www.cdc.gov/labs/BMBL.html CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition]<br /> | ||
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 6.1]<br /> | ▪ [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.2.3]<br /> | ||
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3]<br /> | ▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.2.4.1]<br /> | ||
[https://www. | ▪ [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.8]<br /> | ||
[https:// | ▪ [https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 7.4]<br /> | ||
[https:// | ▪ [https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Guidelines]<br /> | ||
| style="background-color:white;" |'''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. | ▪ [https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 3.3]<br /> | ||
▪ [https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 3.3]<br /> | |||
▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 5.1.9]<br /> | |||
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AT-2–AT-4]<br /> | |||
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, CP-3]<br /> | |||
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IR-2]<br /> | |||
▪ [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br /> | |||
▪ [https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf SQF FSC 9, Food Manufacturing, Part B, 2.9]<br /> | |||
▪ [https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_PetFood_v3-2-Final-w-Links.pdf SQF FSC 9, Pet Food Manufacturing, Part B, 2.9]<br /> | |||
▪ [https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9]<br /> | |||
▪ [https://ris.dls.virginia.gov/uploads/1VAC30/dibr/Microsoft%20Word%20-%20STD-ELV1-2016-Rev2.1_LabReqs_ANSIapp.doc-20210426142653.pdf TNI EL-V1-2016-Rev.2.1 (V1,M2 5.2)]<br /> | |||
▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 6.1]<br /> | |||
▪ [https://www.ams.usda.gov/services/lab-testing/lab-approval USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4e]<br /> | |||
▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3]<br /> | |||
▪ [https://www.wada-ama.org/en/resources/world-anti-doping-program/international-standard-laboratories-isl WADA International Standard for Laboratories (ISL) 5.2.2]<br /> | |||
▪ [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (e)]<br /> | |||
▪ [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 9.4]<br /> | |||
▪ [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 10] | |||
| style="background-color:white; vertical-align: text-top;" |'''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.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | |||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
| style="background-color:white;" |'''8.6''' The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference. | ▪ [https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. B]<br /> | ||
▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-1-4]<br /> | |||
▪ [https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 3.3]<br /> | |||
▪ [https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 3.3] | |||
| style="background-color:white; vertical-align: text-top;" |'''8.6''' The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | |||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
[https:// | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-1-5]<br /> | ||
[https:// | ▪ [https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 7.1.x]<br /> | ||
[https:// | ▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AT-2 and AT-3]<br /> | ||
| style="background-color:white;" |'''8.7''' The system should be able to produce a training matrix of personnel. | ▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, CP-3]<br /> | ||
▪ [https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IR-2]<br /> | |||
▪ [https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodManufacturing_v3-2-FINAL-w-links.pdf SQF FSC 9, Food Manufacturing, Part B, 2.9]<br /> | |||
▪ [https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_PetFood_v3-2-Final-w-Links.pdf SQF FSC 9, Pet Food Manufacturing, Part B, 2.9]<br /> | |||
▪ [https://www.sqfi.com/wp-content/uploads/2020/11/20227FMIN_FoodPackaging_v3-2-Final-w-Links.pdf SQF FSC 9, Manufacture of Food Packaging, Part B, 2.9] | |||
| style="background-color:white; vertical-align: text-top;" |'''8.7''' The system should be able to produce a training matrix of personnel.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | |||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
[https://www.law.cornell.edu/cfr/text/7/331.15 7 CFR Part 331.15]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/7/331.15 7 CFR Part 331.15]<br /> | ||
[https://www.law.cornell.edu/cfr/text/9/121.10 9 CFR Part 121.10 ]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/9/121.10 9 CFR Part 121.10 ]<br /> | ||
[https://www.law.cornell.edu/cfr/text/9/121.15 9 CFR Part 121.15 ]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/9/121.15 9 CFR Part 121.15 ]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (i)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (i)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/58.29 21 CFR Part 58.29]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/58.29 21 CFR Part 58.29]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/ | ▪ [https://www.law.cornell.edu/cfr/text/21/part-1 21 CFR Part 1.1150]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/ | ▪ [https://www.law.cornell.edu/cfr/text/21/211.25 21 CFR Part 211.25]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/ | ▪ [https://www.law.cornell.edu/cfr/text/21/225.10 21 CFR Part 225.10]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/226. | ▪ [https://www.law.cornell.edu/cfr/text/21/226.10 21 CFR Part 226.10]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/ | ▪ [https://www.law.cornell.edu/cfr/text/21/226.40 21 CFR Part 226.40]<br /> | ||
[https://www.law.cornell.edu/cfr/text/ | ▪ [https://www.law.cornell.edu/cfr/text/21/820.25 21 CFR Part 820.25]<br /> | ||
[https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 ( | ▪ [https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (g-2)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/29/1910. | ▪ [https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (h-2)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/29/1910. | ▪ [https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200 (h)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/ | ▪ [https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (e)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/42/73. | ▪ [https://www.law.cornell.edu/cfr/text/42/73.10 42 CFR Part 73.10]<br /> | ||
[https://www.law.cornell.edu/cfr/text/42/ | ▪ [https://www.law.cornell.edu/cfr/text/42/73.15 42 CFR Part 73.15]<br /> | ||
[https://www.law.cornell.edu/cfr/text/42/493. | ▪ [https://www.law.cornell.edu/cfr/text/42/493.43 42 CFR Part 493.43 (c)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/ | ▪ [https://www.law.cornell.edu/cfr/text/42/493.1235 42 CFR Part 493.1235]<br /> | ||
[https://www.law.cornell.edu/cfr/text/45/164. | ▪ [https://www.law.cornell.edu/cfr/text/45/164.308 45 CFR Part 164.308]<br /> | ||
[https://www. | ▪ [https://www.law.cornell.edu/cfr/text/45/164.530 45 CFR Part 164.530]<br /> | ||
[https://www. | ▪ [https://www.govinfo.gov/app/details/FR-1996-07-25/96-17837/summary 61 FR 38806, 9 CFR Part 310.25]<br /> | ||
[https://www. | ▪ [https://www.govinfo.gov/app/details/FR-1996-07-25/96-17837/summary 61 FR 38806, 9 CFR Part 381.94]<br /> | ||
[https:// | ▪ [https://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.359.5506&rep=rep1&type=pdf A2LA C223 5.2]<br /> | ||
▪ [https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6]<br /> | |||
[https://www. | ▪ [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.2]<br /> | ||
[ | ▪ [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.4.2.2]<br /> | ||
[ | ▪ [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Appendix 1]<br /> | ||
[https://www. | ▪ [https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. B]<br /> | ||
[https:// | ▪ [https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2022 (various parts)]<br /> | ||
▪ [https://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12]<br /> | |||
▪ [https://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1–3]<br /> | |||
[https:// | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 C-3-5]<br /> | ||
[https:// | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 D-1-6]<br /> | ||
[https://www. | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-1-6]<br /> | ||
[https://www. | ▪ [https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 5.6.2.3–4]<br /> | ||
[https:// | ▪ [https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 9.3.4]<br /> | ||
[https:// | ▪ [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-2]<br /> | ||
[https:// | ▪ [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. III, Sec. 10 and 17]<br /> | ||
[https:// | ▪ [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 1]<br /> | ||
[https:// | ▪ [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.8]<br /> | ||
[https://www. | ▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 4.1.2.1]<br /> | ||
[ | ▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 5.1.6]<br /> | ||
[https://www. | ▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 5.1.9]<br /> | ||
▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.2]<br /> | |||
▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.3]<br /> | |||
▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.5]<br /> | |||
▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.6]<br /> | |||
▪ [https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 1.1.2]<br /> | |||
▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 6.1] | |||
| style="background-color:white; vertical-align: text-top;" |'''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.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | |||
|- | |- | ||
| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec | ||
| style="background-color:white;" |'''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. | | style="background-color:white; vertical-align: text-top;" |'''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.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
|- | |- | ||
|} | |} | ||
|} | |} |