A standard operating procedure (SOP) is a set of step-by-step instructions compiled by an
organization
An organization or organisation (English in the Commonwealth of Nations, Commonwealth English; American and British English spelling differences#-ise, -ize (-isation, -ization), see spelling differences), is an legal entity, entity—such as ...
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
Regulation is the management of complex systems according to a set of rules and trends. In systems theory, these types of rules exist in various fields of biology and society, but the term has slightly different meanings according to context. For ...
s.
Some
military
A military, also known collectively as armed forces, is a heavily armed, highly organized force primarily intended for warfare. It is typically authorized and maintained by a sovereign state, with its members identifiable by their distinct ...
services (e.g., in the
U.S.
The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territori ...
and the
UK) use the term standing (rather than ''standard'') operating procedure, since a military SOP refers to a unit's unique procedures, which are not necessarily standard to another unit. The word "standard" could suggest that only one (standard) procedure is to be used across all units.
The term is sometimes used facetiously to refer to practices that are unconstructive, yet the norm. In the
Philippines
The Philippines (; fil, Pilipinas, links=no), officially the Republic of the Philippines ( fil, Republika ng Pilipinas, links=no),
* bik, Republika kan Filipinas
* ceb, Republika sa Pilipinas
* cbk, República de Filipinas
* hil, Republ ...
, for instance, "SOP" is the term for pervasive corruption within the government and its institutions.
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
In medicine, triage () is a practice invoked when acute care cannot be provided for lack of resources. The process rations care towards those who are most in need of immediate care, and who benefit most from it. More generally it refers to prio ...
, when limited resources get used according to an assessment on ranking, urgence and staffing possibilities. 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
The ISO 9000 family is a set of five quality management systems (QMS) standards that help organizations ensure they meet customer and other stakeholder needs within statutory and regulatory requirements related to a product or service. ISO ...
essentially requires the determination of processes (documented as standard operating procedures) used in any manufacturing process that could affect the quality of the product.
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.
See also
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References
External links
ICH Guidance E6: Good Clinical Practice: Consolidated guidelineEuropean Medicines Agency Guideline for Good Clinical Practice
{{Authority control
Clinical research
Military terminology
Pharmaceutical industry
Operating procedures
Good clinical practice