Standard operating procedure

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For the 2008 documentary film by this name, see Standard Operating Procedure (film).

The term standard operating procedure, or SOP, is used in a variety of different contexts, including healthcare, aviation, engineering, education, industry, and military.

The U.S. military 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. "Standard" could imply that there is one (standard) procedure to be used across all units.

Clinical research and practice

In clinical research, the International Conference on Harmonisation (ICH) defines SOPs as "detailed, written instructions to achieve uniformity of the performance of a specific function". SOPs get usually applied in pharmaceutical processing and for related clinical studies. There the focus is set on always repeated applying of unchanged processes and procedures and its documenting, 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.[1] 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.

SOP's 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.[2] 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.[3]

See also

References

  1. ↑ McMurdo Station Medical Standard Operating Procedures as of 2006/06
  2. ↑ Anderson, Chris. How To Write Standard Operating Procedures, Bizmanualz, June 4, 2012.
  3. ↑ Guidance on the Documentation Requirements of ISO 9001:2008

External links

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