Frequent Questions - Standard Operating Procedures (SOPs)
- What is a SOP?
- How should a SOP be organized?
- How much detail needs to be included in a SOP?
- Who should write a SOP?
- What is the benefit of having a SOP?
- I am following a published method. Do I have to
have a SOP?
- Where can I find more information on SOPs?
What is a SOP? A SOP is a set of written instructions that document a routine or repetitive activity. SOPs describe both technical and administrative operational elements of an organization that would be managed under a Quality Assurance Project Plan and under an organization's Quality Management Plan.
How should a SOP be organized? A SOP should be organized to ensure ease and efficiency in use and to be specific to the organization which develops it. There is no one 'correct' format; and internal formatting will vary with each organization and with the type of SOP being written. See Guidance for Preparing Standard Operating Procedures (PDF 58pp, 125K About PDF) for format suggestions and examples of both technical and administrative SOPs.
How much detail needs to be included in a SOP? A SOP should be written with sufficient detail so that someone with a basic understanding of the field, can successfully reproduce the activity or procedure when unsupervised.
Who should write a SOP? SOPs should be written by individuals knowledgeable with the activity and the organization's internal structure. These individuals are essentially subject-matter experts who actually perform the work or use the process. A team approach can also be followed, especially for multi-tasked processes where the experiences of a number of individuals are critical.
What is the benefit of having a SOP? The development and use of SOPs is an integral part of a successful quality system. 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 through consistent implementation of a process or procedure within the organization. SOPs can also be used as a part of a personnel training program, since they should provide detailed work instructions. When historical data are being evaluated for current use, SOPs can be valuable for reconstructing project activities. 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 data comparability, credibility, and legal defensibility.
I am following a published method. Do I have to have a SOP? Yes. SOPs are needed even when published methods are being utilized because cited published methods may not contain pertinent information for conducting the procedure in-house. For example, if the SOP is written for a standard analytical method, the SOP should specify the procedures to be followed in greater detail than appear in the published method, detailing how, if at all, the SOP differs from the standard method and any options, changes or adjustments that the organization follows.
Where can I find more information on SOPs? For more information on SOPs, see Quality Management Tools - Standard Operating Procedures.