A standard operating procedure (SOP) is a set of written instructions an organization uses to document how it performs a routine or repetitive activity. SOPs can cover technical work, such as using equipment or collecting samples, and administrative work, such as reviewing data or handling documents. Their purpose is to help people carry out recurring work consistently—not to guarantee good results simply because instructions exist.
What is a standard operating procedure?
The U.S. Environmental Protection Agency (EPA) defines an SOP as “a set of written instructions that document a routine or repetitive activity followed by an organization.” An SOP describes how a particular organization or facility carries out its work; it is not necessarily a universal recipe that can be copied unchanged elsewhere. Organizations may use other names, including protocols, instructions, worksheets, or laboratory operating procedures.
A procedure can explain a technical method or a fundamental programmatic or administrative task. Examples include conducting an analysis, maintaining or calibrating equipment, and following a recurring document-handling process. EPA’s Guidance for Preparing Standard Operating Procedures (SOPs), EPA QA/G-6, published in April 2007, treats SOPs as part of how an organization documents and implements its work.
What are the main types of SOPs?
EPA QA/G-6 describes two useful broad categories: technical and administrative or programmatic SOPs. This is a practical distinction, not a universal or exhaustive taxonomy; industries and organizations may classify their procedures differently.
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| Type | Work described | Typical details to consider |
|---|---|---|
| Technical | A technical method or operational task, such as a laboratory analysis, field test, sample collection, or equipment use. | Relevant materials and conditions, equipment settings, safety cautions, qualifications or training, method steps, quality checks, data handling, and records. The appropriate details depend on the task. |
| Administrative or programmatic | A recurring organizational process or function, such as document handling, data review, approvals, or handoffs. | Responsibilities, sequence, decision points, approvals, and records needed to carry out and track the process. |
Some procedures combine both kinds of work. For instance, a technical method may include administrative steps for approving records or reporting results. The useful question is what a person must do, decide, and document—not which label the organization assigns.
Why do organizations use SOPs?
Written procedures can help an organization make recurring work repeatable, support training and reference, and promote consistency and quality. EPA says SOPs can minimize variation and help maintain consistent implementation even when personnel change. These are intended benefits of useful documentation and its implementation, not quantified guarantees of fewer errors, higher productivity, or compliance.
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An SOP can also support a quality system by documenting how work is expected to be carried out and what records it produces. But the document is only part of the process: EPA cautions that even a well-written SOP has limited value if people do not follow it, and recommends that current copies be readily accessible where the work takes place.
What should an SOP include?
There is no single required layout for every SOP. EPA recommends making a procedure specific to the organization, easy to use, and detailed enough that someone with a basic understanding of the activity can repeat it. The relevant sections depend on the work and any applicable rules; a technical procedure may need different detail from a document-approval process.
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- Purpose and scope: Identify the activity the procedure covers, where it applies, and any important boundaries.
- Roles and prerequisites: Explain who performs, reviews, or approves the work, and state relevant qualifications or training.
- Materials and safety: List equipment, supplies, conditions, and health or safety cautions where they matter.
- Instructions and decisions: Set out the steps in usable order, including decision points, checks, or actions to take when the expected condition is not met.
- Records and data: Specify what to record, how to handle data, and where required records belong.
- Document control: Identify the version in use and provide for review, approval, revision, tracking, and archival as appropriate.
These are content considerations, not a mandatory checklist for every organization. For practical guidance on tailoring format and detail, see EPA’s frequent questions about its Quality Program.
How to write and maintain an SOP
The following sequence is a practical way to apply EPA’s guidance; it is not a workflow that EPA requires every organization to follow.
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- Choose one recurring task. Define what the procedure covers, who performs it, and where the work happens.
- Document the real process. Ask a knowledgeable person who performs or oversees the activity to write the steps, including relevant prerequisites, responsibilities, materials, cautions, decision points, and records.
- Check it with intended users. Have people who will use the SOP review whether the instructions are clear and detailed enough to carry out the task.
- Obtain the required approval. Follow the organization’s approval process before treating the document as the current procedure.
- Control and review the document. Make the current version accessible where the work occurs, and revise it when the process or applicable requirements change. Keep track of revisions and retain older versions as needed.
Is an SOP a regulation or a legal requirement?
No. An SOP is an organization’s documented procedure, not itself a law or a regulation. External regulations or standards may require particular written procedures in a specific sector or situation, and an organization’s SOP may need to address those requirements. The fact that some regulated settings call for written procedures does not establish that every organization must maintain SOPs.
For example, the U.S. Food and Drug Administration’s Facility Operation page compares provisions concerning good laboratory practice (GLP) for covered test facilities, including written-SOP provisions and the treatment of deviations. OSHA’s 1910.119 Appendix C discusses operating procedures in the specific context of process safety management; it is identified as nonmandatory guidance. Neither example should be generalized into a requirement for all businesses. To determine an actual obligation, identify the jurisdiction, industry, activity, and rules that apply.
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