Difference between revisions of "User:Shawndouglas/sandbox/sublevel12"

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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]
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Guidelines]
   | style="background-color:white;" |The system should provide access to relevant training materials to personnel attending training sessions.
   | style="background-color:white;" |The system should provide access to relevant training materials to personnel attending training sessions.
|-
  | style="padding:5px; width:500px;" |
[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 />
[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 />
[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 />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-1-3]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (f)]<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://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 />
[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.iso.org/standard/56115.html ISO 15189:2012 5.1.9]<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://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 2.1 (e)]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 9.4]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 10]
  | 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.
|-
  | 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]
  | 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.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-1-5]
  | style="background-color:white;" |The system should be able to produce a training matrix of personnel.
|-
  | style="padding:5px; width:500px;" |
[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/9/121.15 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/21/58.29 21 CFR Part 58.29]<br />
[https://www.law.cornell.edu/cfr/text/21/211.25 21 CFR Part 211.25]<br />
[https://www.law.cornell.edu/cfr/text/21/225.10 21 CFR Part 225.10]<br />
[https://www.law.cornell.edu/cfr/text/21/226.10 21 CFR Part 226.10]<br />
[https://www.law.cornell.edu/cfr/text/21/226.40 21 CFR Part 226.40]<br />
[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 (g-2)]<br />
[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/29/1910.1200 29 CFR Part 1910.1200 (h)]<br />
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (e)]<br />
[https://www.law.cornell.edu/cfr/text/42/73.10 42 CFR Part 73.10]<br />
[https://www.law.cornell.edu/cfr/text/42/73.15 42 CFR Part 73.15]<br />
[https://www.law.cornell.edu/cfr/text/42/493.43 42 CFR Part 493.43 (c)]<br />
[https://www.law.cornell.edu/cfr/text/42/493.1235 42 CFR Part 493.1235]<br />
[https://www.law.cornell.edu/cfr/text/45/164.308 45 CFR Part 164.308]<br />
[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 />
[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 />
[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 />
[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 />
[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 />
  | 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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Revision as of 16:29, 14 September 2019

Sandbox begins below

8. Resource Management

Regulation, Specification, or Guidance Requirement

29 CFR Part 1910.120
29 CFR Part 1910.134 (m)
29 CFR Part 1910.1030 (h-1)
29 CFR Part 1910.1450 (j)
CJIS Security Policy 5.2.3
EPA ERLN Laboratory Requirements 4.2.4.1
EPA QA/G-5 2.1.8
USDA Administrative Procedures for the PDP 6.1
USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3

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.

21 CFR Part 820.198
42 CFR Part 493.1233
E.U. Commission Directive 2003/94/EC Article 13
WHO Technical Report Series, #986, Annex 2, 2.1 (j)
WHO Technical Report Series, #986, Annex 2, 5.0

The system shall allow authorized personnel to document complaints and problems reported to the laboratory or production facility.

7 CFR Part 331.15
9 CFR Part 121.15
21 CFR Part 211.25
29 CFR Part 1910.1450 (f)
42 CFR Part 73.15
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3
ASTM E1578-18 E-1-1
CJIS Security Policy 5.2.1
EPA ERLN Laboratory Requirements 4.2.4.1
FDA Hazard Analysis Critical Control Point Guidelines
USDA Sampling Procedures for PDP 6.1.2–3
WHO Technical Report Series, #986, Annex 2, 10

The system shall allow training sessions to be scheduled for personnel.

29 CFR Part 1910.1450 (f)
ABFT Accreditation Manual Sec. B
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.7
ASTM E1578-18 E-1-2
FDA Hazard Analysis Critical Control Point Guidelines

The system should provide access to relevant training materials to personnel attending training sessions.

ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1–3
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.6.2
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.3.3 and 5.9.3.5
ASTM E1578-18 E-1-3
29 CFR Part 1910.1450 (f)
CJIS Security Policy 5.2.3
EPA ERLN Laboratory Requirements 4.2.4.1
EPA QA/G-5 2.1.8
E.U. Commission Directive 2003/94/EC Article 7.4
FDA Hazard Analysis Critical Control Point Guidelines
[ISO 15189:2012 5.1.9
USDA Administrative Procedures for the PDP 6.1
USDA Sampling Procedures for PDP 6.1.2.8 and 6.1.3
WHO Technical Report Series, #986, Annex 2, 2.1 (e)
WHO Technical Report Series, #986, Annex 2, 9.4
WHO Technical Report Series, #986, Annex 2, 10

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.
ABFT Accreditation Manual Sec. B
ASTM E1578-18 E-1-4
The system should allow the results of tests taken by personnel to be uploaded and made available to authorized individuals for reference.
ASTM E1578-18 E-1-5 The system should be able to produce a training matrix of personnel.

7 CFR Part 331.15
9 CFR Part 121.10
9 CFR Part 121.15
21 CFR Part 11.10 (i)
21 CFR Part 58.29
21 CFR Part 211.25
21 CFR Part 225.10
21 CFR Part 226.10
21 CFR Part 226.40
21 CFR Part 820.25
29 CFR Part 1910.1030 (g-2)
29 CFR Part 1910.1030 (h-2)
29 CFR Part 1910.1200 (h)
29 CFR Part 1910.1450 (e)
42 CFR Part 73.10
42 CFR Part 73.15
42 CFR Part 493.43 (c)
42 CFR Part 493.1235
45 CFR Part 164.308
45 CFR Part 164.530
AAFCO QA/QC Guidelines for Feed Laboratories Sec. 1.4 and 1.6
AAVLD Requirements for an AVMDL Sec. 5.2
AAVLD Requirements for an AVMDL Sec. 5.4.2.2
AAVLD Requirements for an AVMDL Appendix 1
ABFT Accreditation Manual Sec. B
AIHA-LAP Policies 2018 (various parts)
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1–3
ASTM E1578-18 C-3-5
ASTM E1578-18 D-1-6
ASTM E1578-18 E-1-6
E.U. Annex 11-2
EPA 815-R-05-004 Chap. III, Sec. 10 and 17
EPA 815-R-05-004 Chap. IV, Sec. 1
EPA QA/G-5 2.1.8
ISO 15189:2012 4.1.2.1
ISO 15189:2012 5.1.6
ISO 15189:2012 5.1.9
ISO/IEC 17025:2017 6.2.2
ISO/IEC 17025:2017 6.2.3
ISO/IEC 17025:2017 6.2.5
ISO/IEC 17025:2017 6.2.6
OECD GLP Principles 1.1.2
USDA Administrative Procedures for the PDP 6.1

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.