Standard operating procedure: Difference between revisions

Revision as of 10:14, 26 June 2024

Revision as of 05:20, 7 January 2025

Line 10:

In clinical research, the ''[[International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use|International Council for Harmonisation]]'' (ICH) defines SOPs as "detailed, written instructions to achieve uniformity of the performance of a specific function". SOPs usually get applied in pharmaceutical processing and for related clinical studies. There the focus is always set on repeated application of unchanged processes and procedures and its documentation, hence supporting the segregation of origins, causes and effects. Further application is with [[triage]], when limited resources get used according to an assessment on ranking, urgence and staffing possibilities.<ref>{{cite web|url=https://www.nsf.gov/about/contracting/rfqs/support_ant/docs/environ_health_safety/usap_sandh_policy_man/mcmurdostandardmedicalsop-311.pdf |title=McMurdo Station Medical Standard Operating Procedures as of 2006/06 |archive-url=https://web.archive.org/web/20160304225955/https://www.nsf.gov/about/contracting/rfqs/support_ant/docs/environ_health_safety/usap_sandh_policy_man/mcmurdostandardmedicalsop-311.pdf |archive-date=2016-03-04 |url-status=dead}}</ref> Study director is mainly responsible for SOPs. The Quality Assurance Unit are individuals who are responsible for monitoring whether the study report and tests are meeting the SOP.{{citation needed|date=November 2022}}

SOPs can also provide employees with a reference to common business practices, activities, or tasks. New employees use an SOP to answer questions without having to interrupt supervisors to ask how an operation is performed. The international quality standard [[ISO 9001]] essentially requires the determination of processes (documented as standard operating procedures) used in any manufacturing process that could affect the quality of the product.<ref>{{cite web |url=http://www.iso.org/iso/iso_catalogue/management_standards/quality_management/iso_9001_2008/guidance_on_the_documentation_requirements_of_iso_9001_2008.htm |title=Guidance on the Documentation Requirements of ISO 9001:2008 |archiveurl=https://web.archive.org/web/20111015230555/http://www.iso.org/iso/iso_catalogue/management_standards/quality_management/iso_9001_2008/guidance_on_the_documentation_requirements_of_iso_9001_2008.htm |archivedate=2011-10-15 }}</ref>

==Health, safety and environment==

Procedures are extensively employed to assist with working safely. They are sometimes called "safe work methods statements" (SWMS, pronounced as 'swims'). Their development is usually preceded by various methods of analyzing tasks or jobs to be performed in a workplace, including an approach called [[job safety analysis]], in which hazards are identified and their control methods described. Procedures must be suited to the literacy levels of the user, so the readability of procedures is important.<ref>{{cite journal |last=Taylor |first=Geoffrey A. |date=2012 |title=Readability of OHS documents - A comparison of surface characteristics of OHS text between some languages |journal=[[Safety Science]] |volume=50 |number=7 |pages=1627–1635 |doi=10.1016/j.ssci.2012.01.016 |url=https://espace.curtin.edu.au/handle/20.500.11937/4224 }}</ref>