Difference between revisions of "User:Shawndouglas/sandbox/sublevel15"
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[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 16.3] | [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="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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| 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/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. | |||
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| style="padding:5px; width:500px;" | | |||
[https://www.law.cornell.edu/cfr/text/21/606.100 21 CFR Part 606.100 (c)]<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-9-3]<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] | |||
| 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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| style="padding:5px; width:500px;" | | |||
[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/21/606.100 21 CFR Part 606.100 (c)]<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.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://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point Principle 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, 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. | |||
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Revision as of 20:45, 14 September 2019
This is sublevel15 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see my discussion page instead. |
Sandbox begins below
15. Inventory Management
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16. Investigation Management
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