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| | type = notice | | | type = notice |
| | style = width: 960px; | | | style = width: 960px; |
| | text = This is sublevel2 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see [[User_talk:Shawndouglas|my discussion page]] instead.<p></p> | | | text = This is sublevel11 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see [[User_talk:Shawndouglas|my discussion page]] instead.<p></p> |
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| ==Sandbox begins below== | | ==Sandbox begins below== |
| | In their 1974 multi-volume series ''Systematic Materials Analysis'', Richardson and Peterson say the following about the then state of materials testing<ref>{{Cite book |last=Richardson |first=James H. |last2=Peterson |first2=Ronald V. |date= |year=1974 |title=Systematic Materials Analysis, Part 1 |url=https://books.google.com/books?id=BNocpYI8gJkC&printsec=frontcover&dq=Systematic+Materials+analysis&hl=en&newbks=1&newbks_redir=0&sa=X&ved=2ahUKEwjB1OeQx-aAAxWnmmoFHSV2BSsQ6AF6BAgMEAI#v=onepage&q=Systematic%20Materials%20analysis&f=false |chapter=Preface |series=Materials science series |publisher=Academic Press |place=New York |page=xiii |isbn=978-0-12-587801-2 |doi=10.1016/B978-0-12-587801-2.X5001-0}}</ref>: |
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| ==6. Reporting==
| | <blockquote>It is both exciting and dismaying to observe the parade of new and refined instrumental methods available for the analysis of materials—exciting because these instruments provide opportunities for faster and more reliable answers to material analysis problems, dismaying because one is hard pressed to evaluate these various instruments for a given task. Materials analysis often involves the complete characterization of a material, including structural and textural analyses in addition to chemical analysis ... These volumes not only comprise a brief, comprehensive reference for the materials analyst but also provides a source of information for the engineer or researcher who must select the appropriate instrument for his immediate needs.</blockquote> |
| {|
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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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| |-
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| ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
| |
| ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
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| |-
| |
| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-6-1]
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| | style="background-color:white;" |The system shall be able to store files in an electronic format and link them to standards, reagents, and samples tested.
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| |-
| |
| | style="padding:5px; width:500px;" |[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.4]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.1.4]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.12–15]
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| | style="background-color:white;" |The system shall be able to export data in a computer-readable (importable into a relational database) format—such as an unformatted spreadsheet, comma-separated value (CSV) file, or extensible markup language (XML) file—as well as PDF format, for reporting purposes.
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| |-
| |
| | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/42/493.1291 42 CFR Part 493.1291 (g) and (h)]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-6-2]<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 2.4.2]
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| | style="background-color:white;" |The system shall alert users in advance to cases when the sample may be out-of-specification or may not meet expected turnaround time requirements.
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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. G-2]
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| | style="background-color:white;" |The system shall allow an authorized individual to report final results in a semi-quantitative manner (e.g., "less than X mg/L") when doing so would provide relevant information to the report recipient.
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| |-
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| | style="padding:5px; width:500px;" |
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| [https://www.law.cornell.edu/cfr/text/40/141.33 40 CFR Part 141.33]<br />
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| [https://www.law.cornell.edu/cfr/text/42/493.1291 42 CFR Part 493.1291 (c–e)]<br />
| |
| [https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories Sec. 2]<br />
| |
| [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.4.2.1]<br />
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| [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.10.2–5]<br />
| |
| [https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 2A.7.8.1]<br />
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| [http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-12 and -32]<br />
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| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-6-3]<br />
| |
| [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 6.6 and 8]<br />
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| [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. VI, Sec. 8]<br />
| |
| [https://www.iso.org/standard/56115.html ISO 15189:2012 4.5.2]<br />
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| [https://www.iso.org/standard/56115.html ISO 15189:2012 5.8.3]<br />
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| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.5.1]<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 7.8.2.1]<br />
| |
| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.3.1]<br />
| |
| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.43]
| |
| | style="background-color:white;" |The system shall substantiate the status of verified results by using tools like a certificate of analysis, which shall include details like unique identifiers; analysis procedures used; reference intervals; environmental conditions; who provided the results; additional comments, opinions, and interpretations and who provided them; and applicable times and dates.
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| |-
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| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-6-4]
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| | style="background-color:white;" |The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.
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| |-
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| | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-6-5]<br />[https://www.iso.org/standard/56115.html ISO 15189:2012 5.8.1]
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| | style="background-color:white;" |The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.
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| |-
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| | style="padding:5px; width:500px;" |
| |
| [https://www.law.cornell.edu/cfr/text/7/331.5 7 CFR Part 331.5]<br />
| |
| [https://www.law.cornell.edu/cfr/text/9/121.5 9 CFR Part 121.5–6]<br />
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| [https://www.law.cornell.edu/cfr/text/21/58.185 21 CFR Part 58.185]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/312.64 21 CFR Part 312.64]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/812.150 21 CFR Part 812.150]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/812.200 21 CFR Part 812.200]<br />
| |
| [https://www.law.cornell.edu/cfr/text/40/141.31 40 CFR Part 141.31]<br />
| |
| [https://www.law.cornell.edu/cfr/text/40/141.721 40 CFR Part 141.721]<br />
| |
| [https://www.law.cornell.edu/cfr/text/40/part-370/subpart-C 40 CFR Part 370 Subpart C]<br />
| |
| [https://www.law.cornell.edu/cfr/text/40/part-372/subpart-B 40 CFR Part 372 Subpart B]<br />
| |
| [https://www.law.cornell.edu/cfr/text/40/part-704 40 CFR Part 704]<br />
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| [https://www.law.cornell.edu/cfr/text/40/part-717/subpart-A 40 CFR Part 717 Subpart A]<br />
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| [https://www.law.cornell.edu/cfr/text/40/720.40 40 CFR Part 720.40]<br />
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| [https://www.law.cornell.edu/cfr/text/42/73.5 42 CFR Part 73.5–6]<br />
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| [https://www.law.cornell.edu/cfr/text/42/493.43 42 CFR Part 493.43 (d)]<br />
| |
| [http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-7]<br />
| |
| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-6-7]<br />
| |
| [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.3.1]<br />
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| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.12–15]<br />
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| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.3.2]<br />
| |
| [http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 9.1]<br />
| |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP (throughout)]
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| | style="background-color:white;" |The system should, in addition to standard reports, provide the means for custom reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator/sponsor reports.
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| | style="padding:5px; width:500px;" |
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| [https://www.law.cornell.edu/cfr/text/21/58.185 21 CFR Part 58 Sec. 58.185 (c)]<br />
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| [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Sec. 5.10.9–10]<br />
| |
| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.8]<br />
| |
| [http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 9.1]
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| | style="background-color:white;" |The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.
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| |-
| |
| |}
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| |}
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| ==7. Document Management== | | ==References== |
| {| | | {{Reflist|colwidth=30em}} |
| | 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/7/331 7 CFR Part 331 (throughout)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/9/121 9 CFR Part 121 (throughout)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/7 21 CFR Part 7 (throughout)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/58 21 CFR Part 58 (throughout)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/211 21 CFR Part 211 (throughout)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/212 21 CFR Part 212 (throughout)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/225 21 CFR Part 225 (throughout)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/226 21 CFR Part 226 (throughout)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/312 21 CFR Part 312 (throughout)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/606 21 CFR Part 606 (throughout)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/810 21 CFR Part 810 (throughout)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/812 21 CFR Part 812 (throughout)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/21/820 21 CFR Part 820 (throughout)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/29/1910.134 29 CFR Part 1910.134 (throughout)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (throughout)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200 (throughout)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (throughout)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/73 42 CFR Part 73 (throughout)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1200 42 CFR Part 493.1200]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1232 42 CFR Part 493.1232]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1239 42 CFR Part 493.1239]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1251 42 CFR Part 493.1251]<br />
| |
| [https://www.law.cornell.edu/cfr/text/42/493.1291 42 CFR Part 493.1291 (j)]<br />
| |
| [https://www.law.cornell.edu/cfr/text/45/part-164 45 CFR Part 164 (throughout)]<br />
| |
| [https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories (throughout)]<br />
| |
| [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL (throughout)]<br />
| |
| [http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual (throughout)]<br />
| |
| [https://www.astm.org/Standards/E1188.htm ASTM E1188-11 3.5.2]<br />
| |
| [https://www.astm.org/Standards/E1492.htm ASTM E1492-11 4.3.3.3 and 4.4.4]<br />
| |
| [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 D-1-1]<br />
| |
| [https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy (throughout)]<br />
| |
| [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 (throughout)]<br />
| |
| [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements (throughout)]<br />
| |
| [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 (throughout)]<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 (throughout)]<br />
| |
| [https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point (throughout)]<br />
| |
| [https://www.iso.org/standard/56115.html ISO 15189:2012 4.3]<br />
| |
| [https://www.iso.org/standard/56115.html ISO 15189:2012 5.5.3]<br />
| |
| [https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.3]<br />
| |
| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 5.3]<br />
| |
| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 5.5]<br />
| |
| [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.3.2]<br />
| |
| [http://www.oecd.org/chemicalsafety/testing/oecdseriesonprinciplesofgoodlaboratorypracticeglpandcompliancemonitoring.htm OECD GLP Principles 8]<br />
| |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP (throughout)]<br />
| |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP (throughout)]<br />
| |
| [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP (throughout)]<br />
| |
| [https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2 (throughout)]
| |
| | style="background-color:white;" |The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.
| |
| |-
| |
| |}
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| |}
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