Writing standard operating procedure
How to write a standard operating procedure specific for an analytical toxicology laboratory?
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As the purpose of a standard operating procedure is to minimise deviations by standardising the process, documenting a process as an SOP starts with knowing the risks and critical steps that should be controlled and carefully communicated. The depth of detail in the SOP will depend on the context of your laboratory, for example, the number of people performing the task and their competency.
Standard operating procedures for any laboratory are typically divided into two categories – Management (nontechnical) and technical. An example of a management procedure would be for handling non-conformances and corrective actions. Technical SOPS could either document, for example, the approach to method validation or document the test methods itself. As the purpose is to minimise deviations by standardising the process, documenting a process as an SOP starts with knowing the risks and critical steps that should be controlled and carefully communicated. The depth of detail in the SOP will depend on the context of your laboratory, for example, the number of people performing the task and their competency. Either way, it is recommended that you have a standard format. For more information, have a look at the Advisera Toolkit https://advisera.com/toolkits/?standard=iso-17025 and a previous question. https://community.advisera.com/topic/document-and-record-control-procedure-means-what-are-the-procedure-will-include/
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Oct 18, 2023