Difference between revisions of "Template:LIMSpec for Cannabis Testing/Inventory 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;"| | ||
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! 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 | ||
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| style="padding:5px; | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" | | ||
| style="background-color:white;" |'''15.1''' The system should be capable of accurately tracking the specific quantities of received and consumed test samples (as well as related subsamples and aliquots), including the ability to conduct sample weight reconciliation. | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-8-1]<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.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards] | |||
| style="background-color:white; vertical-align: text-top;" |'''15.1''' The system should be capable of accurately tracking the specific quantities of received and consumed test samples (as well as related subsamples and aliquots), including the ability to conduct sample weight reconciliation.<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;" |'''15.2''' The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date. | ▪ [https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (d)]<br /> | ||
▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-8-2]<br /> | |||
▪ [https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.1.2]<br /> | |||
▪ [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards] | |||
| style="background-color:white; vertical-align: text-top;" |'''15.2''' The system should support the recording of inventory items' attributes, including chemical name, internal name, catalog number, reorder level, consumable or reusable status, and expiration date.<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/21/211.84 21 CFR Part 211.84]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/211.101 21 CFR Part 211.101]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/211.101 21 CFR Part 211.101]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (d)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (d)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/226.80 21 CFR Part 226.80]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/226.80 21 CFR Part 226.80]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/606.120 21 CFR Part 606.120 (b)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/606.120 21 CFR Part 606.120 (b)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (g)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (g)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/29/1910.1096 29 CFR Part 1910.1096 (e-6)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/29/1910.1096 29 CFR Part 1910.1096 (e-6)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200 (f-6) and (f-10)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200 (f-6) and (f-10)]<br /> | ||
[https://www.astm.org/ | ▪ [https://www.law.cornell.edu/cfr/text/40/262.206 40 CFR Part 262.206]<br /> | ||
[https://extranet.who.int/ | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-8-3]<br /> | ||
[https://extranet.who.int/ | ▪ [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br /> | ||
| style="background-color:white;" |'''15.3''' The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories. | ▪ [https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1200 OSHA 1910.1200(b)(3) and (f)]<br /> | ||
▪ [https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1450 OSHA 1910.1450(h)]<br /> | |||
▪ [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 14.13, 14.35, and 14.41]<br /> | |||
▪ [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.10–12] | |||
| style="background-color:white; vertical-align: text-top;" |'''15.3''' The system should be capable of designing and printing labels in a variety of sizes, formats, and inventory categories.<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/21/212.40 21 CFR Part 212.40 (c)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/part-117 21 CFR Part 117.420]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/820.50 21 CFR Part 820.50]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/212.40 21 CFR Part 212.40 (c)]<br /> | ||
[https://www.astm.org/ | ▪ [https://www.law.cornell.edu/cfr/text/21/820.50 21 CFR Part 820.50]<br /> | ||
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 7.1]<br /> | ▪ [https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 4.6]<br /> | ||
[https://extranet.who.int/ | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-8-4]<br /> | ||
| style="background-color:white;" |'''15.4''' The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation. | ▪ [https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.5.1.4]<br /> | ||
▪ [https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf Codex Alimentarius CXC 1-1969, Ch.1, 7.2.8]<br /> | |||
▪ [https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2, B1, B2, B3, C0, C1, C2, C3, C4, I, K - FSM 13.2.1]<br /> | |||
▪ [https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, D - FSM 13.2.2]<br /> | |||
▪ [https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, I - FSM 13.2.3]<br /> | |||
▪ [https://mygfsi.com/news-and-resources/?_keyword=GFSI%20Benchmarking%20Requirements&_type=publications GFSI Benchmarking Rqmts., v2020.1, Part 3, A1, A2 - FSM 13.5]<br /> | |||
▪ [https://www.ifs-certification.com/images/standards/ifs_food7/documents/standards/IFS_Food7_en.pdf IFS Food 7, Part 2, 4.4.1]<br /> | |||
▪ [https://www.ifs-certification.com/images/standards/ifs_pacsecure2/documents/standards/IFS_pacsecure2_en.pdf IFS PACsecure 2, Part 2, 4.4.1]<br /> | |||
▪ [https://www.iso.org/standard/44001.html ISO/TS 22002-1:2009, 9.2]<br /> | |||
▪ [https://www.iso.org/standard/60969.html ISO/TS 22002-4:2013, 4.6.2]<br /> | |||
▪ [https://www.iso.org/standard/66126.html ISO/TS 22002-6:2016, 4.6.2]<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, 2.3.4.1]<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, 2.3.4.1]<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, 2.3.4.1]<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 4.6.4)]<br /> | |||
▪ [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 7.1]<br /> | |||
▪ [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #961, Annex 13, 7.1 and 7.3]<br /> | |||
▪ [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 14.8] | |||
| style="background-color:white; vertical-align: text-top;" |'''15.4''' The system should provide a means for ordering inventory through a qualified vendor using a vendor master list containing approval status for order validation.<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/21/211.196 21 CFR Part 211.196]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/211.196 21 CFR Part 211.196]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/212.90 21 CFR Part 212.90]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/212.90 21 CFR Part 212.90]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/225.110 21 CFR Part 225.110]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/225.110 21 CFR Part 225.110]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/606.165 21 CFR Part 606.165]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/606.165 21 CFR Part 606.165]<br /> | ||
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 Appendix A (I)] | ▪ [https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 Appendix A (I)]<br /> | ||
[https://www.astm.org/ | ▪ [https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 4.6]<br /> | ||
| style="background-color:white;" |'''15.5''' The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials. | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-8-5]<br /> | ||
▪ [https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<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 4.6.2)]<br /> | |||
▪ [https://www.ams.usda.gov/sites/default/files/media/TestingGuidelinesforHemp.pdf USDA Hemp Production Program Laboratory Testing Guidelines, Summary of Practice 1.5] | |||
| style="background-color:white; vertical-align: text-top;" |'''15.5''' The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.<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/21/211.82 21 CFR Part 211.82 (b)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/211.82 21 CFR Part 211.82 (b)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84 (a)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84 (a)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/211.89 21 CFR Part 211.89]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/211.89 21 CFR Part 211.89]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/211.110 21 CFR Part 211.110 (d)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/211.110 21 CFR Part 211.110 (d)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/211.142 21 CFR Part 211.142 (a)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/211.142 21 CFR Part 211.142 (a)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/212.40 21 CFR Part 212.40 (c)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/212.40 21 CFR Part 212.40 (c)]<br /> | ||
[https://www.astm.org/ | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-8-6]<br /> | ||
[https:// | ▪ [https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 12.18] | ||
| style="background-color:white;" |'''15.6''' The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of. | | style="background-color:white; vertical-align: text-top;" |'''15.6''' The system should provide a means for quarantining specific material types until they can be validated by a quality control test or disposed of.<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/21/211.89 21 CFR Part 211.89]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/211.89 21 CFR Part 211.89]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/211.110 21 CFR Part 211.110 (d)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/21/211.110 21 CFR Part 211.110 (d)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (d)]<br /> | ▪ [https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (d)]<br /> | ||
[https://www.astm.org/ | ▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-8-7] | ||
| style="background-color:white;" |'''15.7''' The system should allow authorized personnel to retire faulty or poor quality materials from use. | | style="background-color:white; vertical-align: text-top;" |'''15.7''' The system should allow authorized personnel to retire faulty or poor quality materials from use.<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/21/211.89 21 CFR Part 211.89]<br />[https://www.astm.org/ | ▪ [https://www.law.cornell.edu/cfr/text/21/211.89 21 CFR Part 211.89]<br />▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 E-8-8] | ||
| style="background-color:white;" |'''15.8''' The system shall clearly designate a standard or reagent as being disposed or consumed. | | style="background-color:white; vertical-align: text-top;" |'''15.8''' The system shall clearly designate a standard or reagent as being disposed or consumed.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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|} | |} | ||
|} | |} |