A standard operating procedure , or SOP , is a set of step-by-step instructions set up by the organization to help workers carry out routine complex operations. SOPs aim to achieve efficiency, quality of output and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations.
The military (eg in the US and the UK) sometimes uses the term stand - not standard - operating procedures , because the military SOP refers to a unique procedure unit, which is not necessarily the standard for other units. "Standard" may imply that there is one (standard) procedure to be used in all units.
Video Standard operating procedure
Research and clinical practice
In clinical research, the International Council for Harmonization (ICH) defines SOPs as "detailed written instructions for achieving uniform performance of certain functions". SOPs are usually applied in pharmaceutical processing and for related clinical studies. There the focus is always fixed on the repeated application of unchanged processes and procedures and their documentation, thus supporting the separation of origin, cause and effect. Further applications are with triage, when limited resources are used according to ratings, urgency and staffing possibilities. The study director is primarily responsible for SOP. The Quality Assurance Unit is the individual responsible for monitoring whether research reports and tests meet SOPs. SOPs may also provide employees with references to general business practices, activities, or tasks. New employees use SOPs to answer questions without having to interrupt the supervisor to ask how an operation is performed. ISO 9001 international quality standards basically require the determination of processes (documented as standard operating procedures) used in manufacturing processes that may affect product quality.
Maps Standard operating procedure
Safety and health environment
Procedures are widely used to help work safely. They are sometimes called safe working method statements (SWMS, pronounced as 'Swimming'). They are usually preceded by various methods of analyzing work or tasks to be performed in the workplace, including an approach called work safety analysis, in which hazards are identified and their control methods described. Procedures should be appropriate to the level of user literacy, and as part of this, procedural readability is important.
See also
- Procedure
- Work method statement
- Safe Working Procedures
- Checklist
- Runbook
- Code of Conduct
- GxP
- Protocols
- Operational research
- Quality control
- Engagement rules
- Bureaucracy
References
External links
- ICH E6 Guide: Good Clinical Practice: Consolidation Guidelines
- Guide of the European Drug Agency for Good Clinical Practice
Source of the article : Wikipedia
0 Comments