Difference between revisions of "Template:LIMSpec for Cannabis Testing/Results review and verification"
From CannaQAWiki
Jump to navigationJump to searchShawndouglas (talk | contribs) m (Broken urls) |
Shawndouglas (talk | contribs) (Formatting) |
||
| Line 5: | Line 5: | ||
! 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:175px;"| 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/21/211.68 21 CFR Part 211.68 (b)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68 (b)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br /> | ||
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-1]<br /> | ▪ [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-1]<br /> | ||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br /> | ▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br /> | ||
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br /> | ▪ [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br /> | ||
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.5.1.4] | ▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 5.5.1.4] | ||
| style="background-color:white;" |'''4.1''' The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded. | | style="background-color:white; vertical-align: text-top;" |'''4.1''' The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.<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.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-2]<br /> | ▪ [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-2]<br /> | ||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.2]<br /> | ▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.2]<br /> | ||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br /> | ▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br /> | ||
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br /> | ▪ [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br /> | ||
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.2] | ▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.2] | ||
| style="background-color:white;" |'''4.2''' The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests. | | style="background-color:white; vertical-align: text-top;" |'''4.2''' The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.<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/21/211.68 21 CFR Part 211.68]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/211.100 21 CFR Part 211.100]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/211.100 21 CFR Part 211.100]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (a)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (a)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/211.188 21 CFR Part 211.188]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/211.188 21 CFR Part 211.188]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br /> | ||
[https://www.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d)]<br /> | ||
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-3]<br /> | ▪ [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-3]<br /> | ||
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.1.1]<br /> | ▪ [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.1.1]<br /> | ||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7]<br /> | ▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7]<br /> | ||
[https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:262:0022:0026:en:PDF E.U. Commission Directive 2003/94/EC Article 9.2]<br /> | ▪ [https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:262:0022:0026:en:PDF E.U. Commission Directive 2003/94/EC Article 9.2]<br /> | ||
[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9] | ▪ [https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9] | ||
| style="background-color:white;" |'''4.3''' The system shall accurately maintain a full audit trail for modified results. | | style="background-color:white; vertical-align: text-top;" |'''4.3''' The system shall accurately maintain a full audit trail for modified results.<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/21/211.68 21 CFR Part 211.68 (b)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68 (b)]<br /> | ||
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-28–29]<br /> | ▪ [http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-28–29]<br /> | ||
[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 2A.7.7.2 and 7.7.3]<br /> | ▪ [https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 2A.7.7.2 and 7.7.3]<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 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 5.9.4–5]<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 5.9.4–5]<br /> | ||
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-4]<br /> | ▪ [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-4]<br /> | ||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.6]<br /> | ▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.6]<br /> | ||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.2–3 and 4.9.11]<br /> | ▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.2–3 and 4.9.11]<br /> | ||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.4]<br /> | ▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.4]<br /> | ||
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br /> | ▪ [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br /> | ||
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br /> | ▪ [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br /> | ||
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6]<br /> | ▪ [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6]<br /> | ||
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.7.1]<br /> | ▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 5.7.1]<br /> | ||
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.1.1]<br /> | ▪ [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.1.1]<br /> | ||
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 10] | ▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 10] | ||
| style="background-color:white;" |'''4.4''' The system shall provide one or more levels of review, as well as interpretation and documentation of results—whether entered manually or via an automated process—before release. | | style="background-color:white; vertical-align: text-top;" |'''4.4''' The system shall provide one or more levels of review, as well as interpretation and documentation of results—whether entered manually or via an automated process—before release.<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.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-5]<br /> | ▪ [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-5]<br /> | ||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br /> | ▪ [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br /> | ||
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br /> | ▪ [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br /> | ||
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br /> | ▪ [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br /> | ||
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6]<br /> | ▪ [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6]<br /> | ||
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.2] | ▪ [https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.2] | ||
| style="background-color:white;" |'''4.5''' The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results. | | style="background-color:white; vertical-align: text-top;" |'''4.5''' The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.<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.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-6]<br /> | ▪ [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-6]<br /> | ||
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br /> | ▪ [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br /> | ||
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br /> | ▪ [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br /> | ||
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6] | ▪ [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6] | ||
| style="background-color:white;" |'''4.6''' The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits. | | style="background-color:white; vertical-align: text-top;" |'''4.6''' The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
|- | |- | ||
|} | |} | ||
|} | |} | ||
