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- A Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity followed by an organization. The development and use of SOPs are an integral part of a successful quality system as it provides individuals with the information to perform a job properly, and facilitates consistency in the quality and integrity o a product or end-result. The term SOP may not always be appropriate and terms such as protocols, instructions, worksheets, and laboratory operating procedures may also be used.
- SOPs detail the regularly recurring work processes that are to be conducted or followed within an organization. They document the way activities are to be performed to facilitate consistent conformance to technical and quality system requirements and to support data quality. SOPs are intended to be specific to the organization or facility whose activities are described and assist that organization to maintain their quality control and quality assurance processes and ensure compliance with governmental regulations.
- If not written correctly, SOPs are of limited value. In addition, the best written SOPs will fail if they are not followed. Therefore, the use of SOPs needs to be reviewed and re-enforced by management, preferably the direct supervisor.
- The development and use of SOPs minimizes variation and promotes quality through consistent implementation of a process or procedure within the organization, even if there are temporary or permanent personnel changes. SOPs can indicate compliance with organizational and governmental requirements and can be used as a part of a personnel training program, since they should provide detailed work instructions. It minimizes opportunities for miscommunication and can address safety concerns. When historical data are being evaluated for current use, SOPs can also be valuable for reconstructing project activities when no other references are available. In addition, SOPs are frequently used as checklists by inspectors when auditing procedures. Ultimately, the benefits of a valid SOP are reduced work effort, along with improved comparability, credibility and legal defensibility.
- The operating procedures needed carry out normal work effectively and safely. Usually applied to production facilities and laboratories.
- Management/Operational Integrity