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| ==Sandbox begins below== | | ==Sandbox begins below== |
| | | <div class="nonumtoc">__TOC__</div> |
| ==8. Resource Management==
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| {|
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| | STYLE="vertical-align:top;"|
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| {| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
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| ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
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| ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
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| ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
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| | style="padding:5px; width:500px;" |
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| [https://www.law.cornell.edu/cfr/text/29/1910.120 29 CFR Part 1910.120]<br />
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| [https://www.law.cornell.edu/cfr/text/29/1910.134 29 CFR Part 1910.134 (m)]<br />
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| [https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (h-1)]<br />
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| [https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (j)]<br />
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| [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.2.3]<br />
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| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.2.4.1]<br />
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| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.8]<br />
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| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 6.1]<br />
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| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3]
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| | style="background-color:white;" |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.
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| | style="padding:5px; width:500px;" |
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| [https://www.law.cornell.edu/cfr/text/21/820.198 21 CFR Part 820.198]<br />
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| [https://www.law.cornell.edu/cfr/text/42/493.1233 42 CFR Part 493.1233]<br />
| |
| [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf E.U. Commission Directive 2003/94/EC Article 13]<br />
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| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (j)]<br />
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| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 5.0]
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| | style="background-color:white;" |The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility.
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| | style="padding:5px; width:500px;" |
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| [https://www.law.cornell.edu/cfr/text/7/331.15 7 CFR Part 331.15]<br />
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| [https://www.law.cornell.edu/cfr/text/9/121.15 9 CFR Part 121.15]<br />
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| [https://www.law.cornell.edu/cfr/text/21/211.25 21 CFR Part 211.25]<br />
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| [https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (f)]<br />
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| [https://www.law.cornell.edu/cfr/text/42/73.15 42 CFR Part 73.15]<br />
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| [http://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 />
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| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-1-1]<br />
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| [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.2.1]<br />
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| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.2.4.1]<br />
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| [https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Guidelines]<br />
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| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sampling Procedures for PDP 6.1.2–3]<br />
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| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 10]
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| | style="background-color:white;" |The system shall allow training sessions to be scheduled for personnel.
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| | style="padding:5px; width:500px;" |
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| [https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (f)]<br />
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| [http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. B]<br />
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| [http://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 />
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| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-1-2]<br />
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| [https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Guidelines]
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| | style="background-color:white;" |The system should provide access to relevant training materials to personnel attending training sessions.
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| | style="padding:5px; width:500px;" |
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| [http://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 />
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| [http://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 />
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| [http://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 />
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| [http://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 />
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| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-1-3]<br />
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| [https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (f)]<br />
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| [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.2.3]<br />
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| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.2.4.1]<br />
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| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.8]<br />
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| [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf E.U. Commission Directive 2003/94/EC Article 7.4]<br />
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| [https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Guidelines]<br />
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| [[https://www.iso.org/standard/56115.html ISO 15189:2012 5.1.9]<br />
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| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 6.1]<br />
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| [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 />
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| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (e)]<br />
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| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 9.4]<br />
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| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 10]
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| | style="background-color:white;" |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.
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| | style="padding:5px; width:500px;" |[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. B]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-1-4]
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| | style="background-color:white;" |The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.
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| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-1-5]
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| | style="background-color:white;" |The system should be able to produce a training matrix of personnel.
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| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/7/331.15 7 CFR Part 331.15]<br />
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| [https://www.law.cornell.edu/cfr/text/9/121.10 9 CFR Part 121.10 ]<br />
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| [https://www.law.cornell.edu/cfr/text/9/121.15 9 CFR Part 121.15 ]<br />
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| [https://www.law.cornell.edu/cfr/text/21/11.10 21 CFR Part 11.10 (i)]<br />
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| [https://www.law.cornell.edu/cfr/text/21/58.29 21 CFR Part 58.29]<br />
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| [https://www.law.cornell.edu/cfr/text/21/211.25 21 CFR Part 211.25]<br />
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| [https://www.law.cornell.edu/cfr/text/21/225.10 21 CFR Part 225.10]<br />
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| [https://www.law.cornell.edu/cfr/text/21/226.10 21 CFR Part 226.10]<br />
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| [https://www.law.cornell.edu/cfr/text/21/226.40 21 CFR Part 226.40]<br />
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| [https://www.law.cornell.edu/cfr/text/21/820.25 21 CFR Part 820.25]<br />
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| [https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (g-2)]<br />
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| [https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (h-2)]<br />
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| [https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200 (h)]<br />
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| [https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (e)]<br />
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| [https://www.law.cornell.edu/cfr/text/42/73.10 42 CFR Part 73.10]<br />
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| [https://www.law.cornell.edu/cfr/text/42/73.15 42 CFR Part 73.15]<br />
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| [https://www.law.cornell.edu/cfr/text/42/493.43 42 CFR Part 493.43 (c)]<br />
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| [https://www.law.cornell.edu/cfr/text/42/493.1235 42 CFR Part 493.1235]<br />
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| [https://www.law.cornell.edu/cfr/text/45/164.308 45 CFR Part 164.308]<br />
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| [https://www.law.cornell.edu/cfr/text/45/164.530 45 CFR Part 164.530]<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.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.2]<br />
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| [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.4.2.2]<br />
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| [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Appendix 1]<br />
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| [http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. B]<br />
| |
| [https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 (various parts)]<br />
| |
| [http://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 />
| |
| [http://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.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-5]<br />
| |
| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 D-1-6]<br />
| |
| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-1-6]<br />
| |
| [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-2]<br />
| |
| [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. III, Sec. 10 and 17]<br />
| |
| [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 1]<br />
| |
| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.1.8]<br />
| |
| [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.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 />
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| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.3]<br />
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| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.5]<br />
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| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 6.2.6]<br />
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| [http://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]<br />
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| | style="background-color:white;" |The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.
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| |}
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| |}
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