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Standard operating procedure

 

Standard operating procedure

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 StandardOperating 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.

Such procedures are a set of step-by-step instructions to achieve a predictable, standardized, desired result often within the context of a longer overall process. For food and drug safety, the related Sanitation Standard Operating Procedures are used.

Contents

  • Clinical research and practice 1
  • Safety and health at work 2
  • See also 3
  • References 4
  • External links 5

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 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.[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. 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.[2]

Safety and health at work

Procedures are extensively employed to assist with working safely. They are sometimes called safe work methods statements (SWMS). They are 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, and as part of this, the readability of procedures is important.[3]

See also


References

  1. ^ "McMurdo Station Medical Standard Operating Procedures as of 2006/06" (PDF). Retrieved 2014-08-02. 
  2. ^ Guidance on the Documentation Requirements of ISO 9001:2008
  3. ^ Taylor, G.A. (2012) Readability of OHS documents - A comparison of surface characteristics of OHS text between some languages, Safety Science, 50(7), 1627-1635.

External links

  • ICH Guidance E6: Good Clinical Practice: Consolidated guideline
  • European Medicines Agency Guideline for Good Clinical Practice
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