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According to the U.S. Environmental Protection Agency (EPA) document "Guidance for Preparing Standard Operating Procedures (SOPs),""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 of a product or end-result." Thus, the proper preparation of SOPs is key to laying the foundation for achieving consistent processes. By following a few general steps, you can prepare SOPs for use within your organization.
Identify what procedures or processes in your organization require documentation in order to be carried out in a consistent manner and which persons are most qualified to author the associated SOP. A team approach may be used to both identify the need for the SOP and to write the SOP.
Determine a numbering system to ensure adequate document control of your SOPs. The numbering system should be flexible enough to allow for any number of SOPs and any number of revisions for individual SOPs. Have yourself or an assigned document control person maintain the master list so that no duplicate numbers are used.
Develop an SOP template that all organizational SOPs will follow using word processing software. For administrative or programmatic procedures, the template should contain, at a minimum, a title page, procedures (including purpose, scope, summary, definitions, personnel qualifications, the procedure itself, checklists and records management), quality control and references. For technical or laboratory procedures, the template should contain, at a minimum, all of the sections for administrative SOPs listed above in addition to safety information, cautions, interferences, equipment and supplies in the procedures section.
Write a Standard Operating Procedure on how to write Standard Operating Procedures for your organization, quaintly known as the "SOP on SOPs". Use the developed template and set forth your expectations as to how all SOPs should be prepared, for example, who identifies the need, who assigns the number, what format to use and expectations for what should be included in each section.
Prepare the rest of your SOPs based on the method set forth in the SOP on SOPs, making any minor revisions to improve the preparation process in terms of time and quality of the resulting documents.
Look at as many SOP examples as you can prior to preparing yours.
Make sure your SOP template is final before issuing it. Any changes mean you must revise every SOP written using that template.
- Look at as many SOP examples as you can prior to preparing yours.
- Make sure your SOP template is final before issuing it. Any changes mean you must revise every SOP written using that template.
Peter Franczyk has been writing professionally since 2001 and has been published in multiple peer-reviewed biotechnology journals such as "Transfusion." He holds a Bachelor of Science in engineering from a land-grant university and a Master of Science in the life sciences from a leading research university.