A standard operating procedure (SOP) is a set of step-by-step instructions created by an organization to ensure efficiency, quality, and uniformity in routine operations while minimizing miscommunication and ensuring compliance with industry regulations. In some military services, like those in the U.S. and the UK, the term "standing operating procedure" is used to describe unit-specific procedures that may differ across units. Occasionally, "SOP" is used humorously or critically to describe common but unproductive practices, such as in the Philippines, where it refers to pervasive government corruption.
Clinical research and practice
In clinical research, the 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.5 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 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.6
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 '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.7
See also
- Best practice – Method or technique that has been generally accepted as superior
- Procedure – Document instructing workers
- Work method statement – document that gives specific instructions on how to safely perform a work related task, or operate a piece of plant or equipmentPages displaying wikidata descriptions as a fallback
- Safe work procedure
- Checklist – Aide-memoire to ensure consistency and completeness in carrying out a task
- Runbook – Record of procedures for IT system staff
- Code of conduct – Set of rules
- GxP – Good practice guidelines and regulations
- Protocol
- Operations research – Discipline concerning the application of advanced analytical methods
- Quality control – Processes that maintain quality at a constant level
- Rules of engagement – Internal limits, authorizations and directives on use of force in combat
- Bureaucracy – Administrative system governing any large institution
External links
- ICH Guidance E6: Good clinical practice: Consolidated guideline
- European Medicines Agency Guideline for Good Clinical Practice
References
“Standard operating procedure.” Merriam-Webster.com Dictionary, Merriam-Webster, https://www.merriam-webster.com/dictionary/standard%20operating%20procedure. Accessed 15 Jun. 2023. https://www.merriam-webster.com/dictionary/standard%20operating%20procedure ↩
Nolen, Jeannette L. "standard operating procedure". Encyclopedia Britannica. Retrieved 15 June 2023. https://www.britannica.com/topic/standard-operating-procedure ↩
In Pursuit of Progress: Narratives of Development on a Philippine Island. University of Hawaii Press. 31 January 2017. ISBN 9780824858902. 9780824858902 ↩
"Anticorruptiondigest.com". anticorruptiondigest.com. https://anticorruptiondigest.com/2016/11/24/philippines-sop-corruption-in-police/ ↩
"McMurdo Station Medical Standard Operating Procedures as of 2006/06" (PDF). Archived from the original (PDF) on 2016-03-04. 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 ↩
"Guidance on the Documentation Requirements of ISO 9001:2008". Archived from the original on 2011-10-15. 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 ↩
Taylor, Geoffrey A. (2012). "Readability of OHS documents - A comparison of surface characteristics of OHS text between some languages". Safety Science. 50 (7): 1627–1635. doi:10.1016/j.ssci.2012.01.016. https://espace.curtin.edu.au/handle/20.500.11937/4224 ↩