Standard operating procedure: Difference between revisions

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{{short description|Set of detailed instructions to assist in workplace safety}}

{{For|the 2008 documentary film|Standard Operating Procedure (film){{!}}''Standard Operating Procedure'' (film)}}

A '''standard operating procedure''' ('''SOP''') is a set of step-by-step instructions compiled by an [[organization]] to help workers carry out routine operations.<ref>“Standard operating procedure.” Merriam-Webster.com Dictionary, Merriam-Webster, https://www.merriam-webster.com/dictionary/standard%20operating%20procedure. Accessed 15 Jun. 2023.</ref> SOPs aim to achieve efficiency, quality output, and uniformity of performance, while reducing [[miscommunication]] and failure to comply with [[industry regulation]]s.{{citation needed|date=November 2022}}

TheSome [[military]] services (e.g., in the [[United States|U.S.]] and the [[United Kingdom|UK]]) sometimes usesuse the term '''standing operating procedure''',<ref>{{cite (ratherencyclopedia than|last=Nolen ''|first=Jeannette L. |title=standard'') '''operating procedure''' because|encyclopedia=Encyclopedia Britannica |url=https://www.britannica.com/topic/standard-operating-procedure |access-date=15 June 2023 }}</ref> since a military SOP refers to a unit's unique procedures, which are not necessarily standard to another unit. The word "standard" cancould implysuggest that only one (standard) procedure is to be used across all units.{{citation needed|date=November 2022}}

A '''standard operating procedure''' ('''SOP''') is a set of step-by-step instructions compiled by an [[organization]] to help workers carry out routine operations. SOPs aim to achieve efficiency, quality output and uniformity of performance, while reducing [[miscommunication]] and failure to comply with [[industry regulation]]s.

The term can alsois besometimes used facetiously to refer to practices that are unconstructive, yet the norm. In the [[Philippines]], for instance, "SOP" is the term for pervasive corruption within the government and its institutions.<ref>{{Cite book|url=https://wwwbooks.google.com/books/edition/In_Pursuit_of_Progress/wFkEEAAAQBAJ?hlid=en&gbpv=1wFkEEAAAQBAJ&bsqq=sop%20%22operating%20procedure%22|isbn=9780824858902|title=In Pursuit of Progress: Narratives of Development on a Philippine Island|date=31 January 2017|publisher=University of Hawaii Press}}</ref><ref>{{Cite web|url=https://anticorruptiondigest.com/2016/11/24/philippines-sop-corruption-in-police/|title=Anticorruptiondigest.com|website=anticorruptiondigest.com}}</ref>

The [[military]] (e.g. in the U.S. and UK) sometimes uses the term '''standing''' (rather than ''standard'') '''operating procedure''' because a military SOP refers to a unit's unique procedures, which are not necessarily standard to another unit. The word "standard" can imply that only one (standard) procedure is to be used across all units.

==Clinical research and practice==

Standard Operating Procedures are also required by a [[Process Safety Management]] program for operating processes with hazardous conditions. Such SOPs contain the tasks to be performed for startup, full-production, shutdown, and emergency oeprations. SOPs also contain data to be recorded, allowable limits of critical variables, samples to be collected, what to do when an upset condition occurs, what alarms and instruments are pertinent if an upset condition occurs, etc. [[Operating procedure synthesis]] methods can assist the development of SOPs for the startup and shutdown of process plants.

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 |format=PDF |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=March 4, 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 aan 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>[http://www.iso.org/iso/iso_catalogue/management_standards/quality_management/iso_9001_2008/guidance_on_the_documentation_requirements_of_iso_9001_2008.htm{{cite web |title=Guidance on the Documentation Requirements of ISO 9001:2008] {{webarchive |url=https://webwww.archiveiso.org/webfiles/20111015230555live/http:sites/isoorg/www.iso.orgfiles/isoarchive/iso_cataloguepdf/management_standardsen/quality_management/iso_9001_2008/guidance_on_the_documentation_requirements_of_iso_9001_2008documented_information.htmpdf |access-date=October 15,24 2011June 2025}}</ref>

The term can also be used facetiously to refer to practices that are unconstructive, yet the norm. In the Philippines, for instance, "SOP" is the term for pervasive corruption within the government and its institutions.<ref>https://www.google.com/books/edition/In_Pursuit_of_Progress/wFkEEAAAQBAJ?hl=en&gbpv=1&bsq=sop%20%22operating%20procedure%22</ref><ref>https://anticorruptiondigest.com/2016/11/24/philippines-sop-corruption-in-police/</ref>

==Clinical research and practice==

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 |format=PDF |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=March 4, 2016|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.

SOPs can also provide employees with a reference to common business practices, activities, or tasks. New employees use a 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>[http://www.iso.org/iso/iso_catalogue/management_standards/quality_management/iso_9001_2008/guidance_on_the_documentation_requirements_of_iso_9001_2008.htm Guidance on the Documentation Requirements of ISO 9001:2008] {{webarchive |url=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 |date=October 15, 2011 }}</ref>

==Health, safety and environment==

Standard Operating Procedures are extensively employed to assist with working safely. They are sometimes called "safe work methods statements" (SWMS, pronounced as 'Swimsswims'). TheyTheir aredevelopment is usually preceded by various methods of analysinganalyzing 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, and as part of this,so the readability of procedures is important.<ref>{{cite journal |last=Taylor, G.|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), 1627-1635|pages=1627–1635 |doi=10.1016/j.ssci.2012.01.016 |url=https://espace.curtin.edu.au/handle/20.500.11937/4224 |url-access=subscription }}</ref>

==See also==

* {{annotated link|Best practice}}

* {{annotated link|Procedure (business)|Procedure}}

* {{annotated link|Work method statement}}

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==References==

{{reflist|1}}

==External links==

* [http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf ICH Guidance E6]: [[Good Clinicalclinical Practicepractice]]: Consolidated guideline]

* [http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002874.pdf European Medicines Agency Guideline for Good Clinical Practice]