Template:LIMSpec/Investigation and quality management - Revision history

Shawndouglas: 16.3

2022-12-14T23:44:25Z

16.3

← Older revision		Revision as of 23:44, 14 December 2022
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	[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.2.2.1]<br />		[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.2.2.1]<br />
	[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.10.2]<br />		[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.10.2]<br />
	[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.7.1]<br />		[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.7]<br />
	[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />		[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
	[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 7.3]<br />		[https://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 7.3]<br />

Shawndouglas: Updated for food and bev update

2022-12-01T21:38:43Z

Updated for food and bev update

Shawndouglas: Updated for 2022.

2022-05-05T20:32:50Z

Updated for 2022.

Show changes

Shawndouglas: Fixed broken URLs

2021-01-27T21:23:29Z

Fixed broken URLs

Shawndouglas: Shawndouglas moved page Template:LIMSpec/Investigation management to Template:LIMSpec/Investigation and quality management: Is much more than just clinical investigation

2020-12-30T17:54:29Z

Shawndouglas moved page Template:LIMSpec/Investigation management to Template:LIMSpec/Investigation and quality management: Is much more than just clinical investigation

← Older revision

Revision as of 17:54, 30 December 2020

Shawndouglas: Added ELAP

2020-12-23T21:18:15Z

Added ELAP

← Older revision		Revision as of 21:18, 23 December 2020
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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 13]<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 />
	[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 5]<br />		[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 5]<br />
			[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf New York Department of Health ELAP Microbiology Protocol]<br />
	[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, IR-5]<br />		[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, IR-5]<br />
	[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)]<br />		[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)]<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 13]<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 />
	[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 5]<br />		[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 5]<br />
			[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf New York Department of Health ELAP Microbiology Protocol]<br />
	[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, AU-6(1)]<br />		[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, AU-6(1)]<br />
	[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, IR-4(1) and IR-5]<br />		[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, IR-4(1) and IR-5]<br />

Shawndouglas: Added NIST 800-53 to various items

2019-11-14T15:54:46Z

Added NIST 800-53 to various items

← Older revision		Revision as of 15:54, 14 November 2019
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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 13]<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 />
	[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 5]<br />		[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 5]<br />
			[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, IR-5]<br />
	[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)]<br />		[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)]<br />
	[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 5.0]		[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 5.0]
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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 13]<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 />
	[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 5]<br />		[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 5]<br />
			[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, AU-6(1)]<br />
			[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, IR-4(1) and IR-5]<br />
			[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, SI-2 and SI-4]<br />
	[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)]<br />		[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)]<br />
	[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 5.0]		[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 5.0]

Shawndouglas: Created as needed.

2019-09-19T22:43:58Z

Created as needed.

New page

{|
| STYLE="vertical-align:top;"|
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
|-
! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
|-
| style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/312.62 21 CFR Part 312.62 (b)] [https://www.law.cornell.edu/cfr/text/21/812.140 21 CFR Part 812.140 (a-3)]
| style="background-color:white;" |'''16.1''' The system shall be able to create and accurately maintain complete case histories, allowing them to be electronically signed.
|-
| style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/312.57 21 CFR Part 312.57 (a)] 
[https://www.law.cornell.edu/cfr/text/21/312.62 21 CFR Part 312.62 (a)] 
[https://www.law.cornell.edu/cfr/text/21/606.165 21 CFR Part 606.165] 
[https://www.law.cornell.edu/cfr/text/21/812.140 21 CFR Part 812.140 (a-2) and (b-2)]
| style="background-color:white;" |'''16.2''' The system shall be able to accurately track the reception, use, storage, shipment and disposition of investigational drugs, blood products, and medical devices, including details such as, but not limited to, type, quantity, unique identifiers, dates, names, reasoning for return or disposition, shipping demographics, and signatures.
|-
| style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/58.81 21 CFR Part 58.81 (a)] 
[https://www.law.cornell.edu/cfr/text/21/211.100 21 CFR Part 211.100] 
[https://www.law.cornell.edu/cfr/text/21/211.111 21 CFR Part 211.111] 
[https://www.law.cornell.edu/cfr/text/21/211.192 21 CFR Part 211.192] 
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194] 
[https://www.law.cornell.edu/cfr/text/21/606.171 21 CFR Part 606.171] 
[https://www.law.cornell.edu/cfr/text/42/493.1253 42 CFR Part 493.1253 (b-2)] 
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual C-16] 
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual F-2] 
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual J-3] 
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-9-1] 
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.3] 
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.4] 
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.2.1.7] 
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.2.2.1] 
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.10.2] 
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.7.1] 
[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 7.3] 
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.2.2] 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.3]
| style="background-color:white;" |'''16.3''' The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.
|-
| style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282] [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-9-2]
| style="background-color:white;" |'''16.4''' The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.
|-
| style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/606.100 21 CFR Part 606.100 (c)] 
[https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282] 
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-9-3] 
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10] 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.12]
| style="background-color:white;" |'''16.5''' The system should trigger an alert or notification when an OOS/OOT status is found, prompting a documented investigation to identify the root cause.
|-
| style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/225.58 21 CFR Part 225.58 (d)] 
[https://www.law.cornell.edu/cfr/text/21/225.158 21 CFR Part 225.158] 
[https://www.law.cornell.edu/cfr/text/21/606.100 21 CFR Part 606.100 (c)] 
[https://www.law.cornell.edu/cfr/text/21/820.100 21 CFR Part 820.100] 
[https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282] 
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-9-4] 
[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] 
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 5] 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)] 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 5.0]
| style="background-color:white;" |'''16.6''' The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.
|-
| style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/225.58 21 CFR Part 225.58 (d)] 
[https://www.law.cornell.edu/cfr/text/21/225.158 21 CFR Part 225.158] 
[https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282] 
[https://www.law.cornell.edu/cfr/text/42/493.1289 42 CFR Part 493.1289] 
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-9-5] 
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.3.4] 
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy Appendix G.7] 
[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] 
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 5] 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)] 
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 5.0]
| style="background-color:white;" |'''16.7''' The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.
|-
| style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-9-6]
| style="background-color:white;" |'''16.8''' The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization’s standard operating procedures.
|-
|}
|}

← Older revision		Revision as of 21:38, 1 December 2022
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	\| style="padding:5px; width:500px;" \|		\| style="padding:5px; width:500px;" \|
			[https://www.law.cornell.edu/cfr/text/21/part-117 21 CFR Part 1.1152 (c)]<br />
	[https://www.law.cornell.edu/cfr/text/21/58.81 21 CFR Part 58.81 (a)]<br />		[https://www.law.cornell.edu/cfr/text/21/58.81 21 CFR Part 58.81 (a)]<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 />
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	[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual J-3]<br />		[https://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual J-3]<br />
	[https://www.astm.org/e1578-18.html ASTM E1578-18 E-9-1]<br />		[https://www.astm.org/e1578-18.html ASTM E1578-18 E-9-1]<br />
			[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 5.6.2.3]<br />
			[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 9.3.4]<br />
	[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.2.2]<br />		[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.2.2.2]<br />
	[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.3]<br />		[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.3]<br />
	[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.4]<br />		[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.4]<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, D, I, K - FSM 24.1]<br />
	[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.2.1.7]<br />		[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.2.1.7]<br />
	[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.2.2.1]<br />		[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.2.2.1]<br />
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	\| style="background-color:white;" \|'''16.3''' The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.		\| style="background-color:white;" \|'''16.3''' The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.
	\|-		\|-
	\| style="padding:5px; width:500px;" \|[https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 E-9-2]		\| style="padding:5px; width:500px;" \|[https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282]<br />[https://www.astm.org/e1578-18.html ASTM E1578-18 E-9-2]<br />[https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02005R2073-20200308 E.U. Commission Reg. No. 2073/2005 Article 9]
	\| style="background-color:white;" \|'''16.4''' The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.		\| style="background-color:white;" \|'''16.4''' The system should clearly identify samples and tests that are out-of-specification (OOS) and out-of-trend (OOT) as unique incidents.
	\|-		\|-
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	\| style="padding:5px; width:500px;" \|		\| style="padding:5px; width:500px;" \|
	[https://www.law.cornell.edu/cfr/text/10/30.34 10 CFR Part 30.34 (g)]<br />		[https://www.law.cornell.edu/cfr/text/10/30.34 10 CFR Part 30.34 (g)]<br />
			[https://www.law.cornell.edu/cfr/text/21/part-112 21 CFR Part 112.147]<br />
	[https://www.law.cornell.edu/cfr/text/21/225.58 21 CFR Part 225.58 (d)]<br />		[https://www.law.cornell.edu/cfr/text/21/225.58 21 CFR Part 225.58 (d)]<br />
	[https://www.law.cornell.edu/cfr/text/21/225.158 21 CFR Part 225.158]<br />		[https://www.law.cornell.edu/cfr/text/21/225.158 21 CFR Part 225.158]<br />
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	[https://www.law.cornell.edu/cfr/text/21/820.100 21 CFR Part 820.100]<br />		[https://www.law.cornell.edu/cfr/text/21/820.100 21 CFR Part 820.100]<br />
	[https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282]<br />		[https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282]<br />
			[https://www.govinfo.gov/app/details/FR-1996-07-25/96-17837/summary 61 FR 38806, 9 CFR Part 417.3]<br />
	[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 4.9 and 4.11]<br />		[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 4.9 and 4.11]<br />
	[https://www.astm.org/e1578-18.html ASTM E1578-18 E-9-4]<br />		[https://www.astm.org/e1578-18.html ASTM E1578-18 E-9-4]<br />
			[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.4.3]<br />
			[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 5.6.1.2]<br />
			[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 9.3.5]<br />
	[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.6.4]<br />		[https://clsi.org/standards/products/quality-management-systems/documents/qms22/ CLSI QMS22 2.6.4]<br />
	[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 13]<br />		[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 13]<br />
	[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 5]<br />		[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 5]<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, D, I, K - FSM 25]<br />
	[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />		[https://www.wadsworth.org/regulatory/clep/clinical-labs/laboratory-standards NYSDOH CLEP Clinical Laboratory Standards of Practice, General Systems Standards]<br />
	[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf NYSDOH ELAP Medical Marijuana Microbiology Guidance]<br />		[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf NYSDOH ELAP Medical Marijuana Microbiology Guidance]<br />
	[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IR-5]<br />		[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IR-5]<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.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, 2.5.3]<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, 2.5.3]<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, 2.5.3]<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 (throughout)]<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 (throughout)]<br />
	[https://www.ams.usda.gov/services/lab-testing/lab-approval USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h]<br />		[https://www.ams.usda.gov/services/lab-testing/lab-approval USDA LAS Laboratory Approval Program (LAP) Policies and Procedures 12.4h]<br />
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	[https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282]<br />		[https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282]<br />
	[https://www.law.cornell.edu/cfr/text/42/493.1289 42 CFR Part 493.1289]<br />		[https://www.law.cornell.edu/cfr/text/42/493.1289 42 CFR Part 493.1289]<br />
			[https://www.govinfo.gov/app/details/FR-1996-07-25/96-17837/summary 61 FR 38806, 9 CFR Part 417.3]<br />
	[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 4.8 and 4.11]<br />		[https://www.uslegalforms.com/form-library/256001-c211-specific-checklist-combined-iso-iec-17025-and-veterinary-laboratory-accreditation A2LA C211 4.8 and 4.11]<br />
	[https://www.astm.org/e1578-18.html ASTM E1578-18 E-9-5]<br />		[https://www.astm.org/e1578-18.html ASTM E1578-18 E-9-5]<br />
			[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 3.4.3]<br />
			[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 5.6.1.2]<br />
			[https://cdn.scsglobalservices.com/files/program_documents/brc_food_standard_8_0.pdf BRC GSFS, Issue 8, 9.3.5]<br />
	[https://www.cdc.gov/labs/BMBL.html CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition]<br />		[https://www.cdc.gov/labs/BMBL.html CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition]<br />
	[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.3.4]<br />		[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.3.4]<br />
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	[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 13]<br />		[https://eur-lex.europa.eu/eli/dir/2003/94/oj E.U. Commission Directive 2003/94/EC Article 13]<br />
	[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 5]<br />		[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 5]<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, D, I, K - FSM 22]<br />
	[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf NYSDOH ELAP Medical Marijuana Microbiology Guidance]<br />		[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf NYSDOH ELAP Medical Marijuana Microbiology Guidance]<br />
	[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-6(1)]<br />		[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, AU-6(1)]<br />
	[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IR-4(1) and IR-5]<br />		[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, IR-4(1) and IR-5]<br />
	[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, SI-2 and SI-4]<br />		[https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final NIST 800-53, Rev. 5, SI-2 and SI-4]<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, 2.5.3]<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, 2.5.3]<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, 2.5.3]<br />
	[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)]<br />		[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)]<br />
	[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 5.0]		[https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 5.0]

← Older revision		Revision as of 21:23, 27 January 2021
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	[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 7.3]<br />		[http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 7.3]<br />
	[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.2.2]<br />		[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.2.2]<br />
	[https://~~extranet~~.who.int/~~prequal~~/~~content~~/~~who-technical-report-series~~ WHO Technical Report Series, #986, Annex 2, 16.3]		[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 16.3]
	\| style="background-color:white;" \|'''16.3''' The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.		\| style="background-color:white;" \|'''16.3''' The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.
	\|-		\|-
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	[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-9-3]<br />		[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-9-3]<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://~~extranet~~.who.int/~~prequal~~/~~content~~/~~who-technical-report-series~~ WHO Technical Report Series, #986, Annex 2, 17.12]		[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 17.12]
	\| style="background-color:white;" \|'''16.5''' The system should trigger an alert or notification when an OOS/OOT status is found, prompting a documented investigation to identify the root cause.		\| style="background-color:white;" \|'''16.5''' The system should trigger an alert or notification when an OOS/OOT status is found, prompting a documented investigation to identify the root cause.
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	[https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282]<br />		[https://www.law.cornell.edu/cfr/text/42/493.1282 42 CFR Part 493.1282]<br />
	[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-9-4]<br />		[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-9-4]<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 />		[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 13]<br />
	[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 5]<br />		[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 5]<br />
	[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf New York Department of Health ELAP Microbiology Protocol]<br />		[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf New York Department of Health ELAP Microbiology Protocol]<br />
	[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, IR-5]<br />		[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, IR-5]<br />
	[https://~~extranet~~.who.int/~~prequal~~/~~content~~/~~who-technical-report-series~~ WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)]<br />		[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)]<br />
	[https://~~extranet~~.who.int/~~prequal~~/~~content~~/~~who-technical-report-series~~ WHO Technical Report Series, #986, Annex 2, 5.0]		[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 5.0]
	\| style="background-color:white;" \|'''16.6''' The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.		\| style="background-color:white;" \|'''16.6''' The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.
	\|-		\|-
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	[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.3.4]<br />		[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.3.4]<br />
	[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy Appendix G.7]<br />		[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy Appendix G.7]<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 />		[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 13]<br />
	[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 5]<br />		[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 5]<br />
	[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf New York Department of Health ELAP Microbiology Protocol]<br />		[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf New York Department of Health ELAP Microbiology Protocol]<br />
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	[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, IR-4(1) and IR-5]<br />		[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, IR-4(1) and IR-5]<br />
	[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, SI-2 and SI-4]<br />		[https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf NIST 800-53, Rev. 4, SI-2 and SI-4]<br />
	[https://~~extranet~~.who.int/~~prequal~~/~~content~~/~~who-technical-report-series~~ WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)]<br />		[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 2.1 (f, j)]<br />
	[https://~~extranet~~.who.int/~~prequal~~/~~content~~/~~who-technical-report-series~~ WHO Technical Report Series, #986, Annex 2, 5.0]		[https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 5.0]
	\| style="background-color:white;" \|'''16.7''' The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.		\| style="background-color:white;" \|'''16.7''' The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.
	\|-		\|-