9.4 Standard Operating Procedures (SOPs)

A standard operating procedure (commonly referred to as SOP) consists of instructions for controlled processes. Controlled processes include steps or procedures that must be performed consistently and accurately each time that they are performed due to safety, quality control, or testing considerations. SOPs help organizations maintain consistency in the performance of critical tasks by many employees. The SOP informs the reader about the procedure’s authorization, frequency, purpose, scope, and revision history. It also contains a description of the equipment needed and the steps that must be followed.

Often used in contexts where testing requirements are stringent and where safety is top of mind, these documents help employees maintain quality and safety in their work. Specifically, SOPs are used among the following contexts (de Sain & Sutton, n.d.):

• Manufacturing
• Testing Methods
• Quality Testing Methods
• Maintenance
• Calibration
• Equipment Use

For example, SOPs are required in the pharmaceutical industry to regulate how drugs are manufactured, handled, stored, distributed, sold, transported, labelled, and destroyed. These documents form part of departmental audits by regulators, so they must be frequently and regularly updated.

In addition, SOPs can be used in business, such as in finance, human resources, administration, customer service, and marketing (Brampton Small Business Enterprise Centre, n.d.). In essence, the document guides professionals in performing their responsibilities in a standardized or uniform manner. More importantly, in the sciences, manufacturing, and quality assurance, SOPs enable organizations to comply with the standards established by laws, regulations, and policies.  Review the video below about the importance of having and following an SOP.

(The Importance of a Standard Operating Procedure, 2022)

The SOP Lifecycle

SOPs are created with careful attention to task requirements, compliance exigencies, quality control, and revision protocols. In fact, for critical procedures, SOPs often have their own SOPs that detail methods and frequencies for the documents’ revision. Creating SOPs (including with the assistance of LLMs) can typically include the following steps:

1. Clearly identify and define the need and audience for the SOP.
2. Complete a thorough task analysis so as to create a complete procedure. If you make use of an AI SOP generator, the task analysis can be automated. More on this below.
3. Ask an LLM to review the task analysis for completeness.
4. Submit the task analysis for review by various stakeholders including managers and users.
5. Draft the SOP: You may choose to do this yourself or make use of a dedicated AI SOP generator.
6. Test the document and obtain feedback via survey, interviews, and/or observation.
7. Revise the document and submit it to a quality assurance review.
8. Ensure the document is compliant to laws, regulations, and policies so as to pass audits. Ensure that the related documents are referenced in the SOP.
9. Track revision dates and notifications to employees to ensure they know about the revisions.
10. Control old SOP versions (may involve collecting and destroying outdated SOPs).

AI-Assisted SOP Generation

While it is important to be familiar with all the various standardized components, formatting, and stylistic requirements of SOPs (covered below), AI can now be used to assist in the creation of SOPs. AI SOP generators, like Scribe and Flowster for example, can capture workflows that occur on computer screens. The generators will then create the SOP based on the information gathered from you. The use of AI will reduce the number of hours typically consumed when manually creating SOPs.  Nevertheless, remember that the resulting documents must go through rigorous reviews for completeness and accuracy and be submitted for quality assurance approvals as they are included in industry and certification audits and could be used in legal proceedings.

Choosing an SOP generator for your project will be in part determined by whether the work is being done on a computer screen or in a physical space. SOP generators offer sophisticated capabilities and features described as follows (Botable, n.d,; McFarland, 2024; Richter, 2025):

Use of reference documents: Most SOP generators will allow users to upload reference documents like policies, regulations, best practices, guides and industry standards (Botable, n.d.). The generators will use these to create a knowledge base upon which they will draw information to ensure that the procedures they create align with those guidelines. In addition, some SOP generators will create the documents based on brief prompting, drafts, or outlines.

Workflow capture: Most SOP generators will record or take screenshots of a workflow as it is occurring on the computer. It will then use the information to generate the SOP.  Other generators like Whale will allow users to upload a video, which will be analyzed to capture the procedure. And ClickUp enables the use of voice to text to create the workflow description.

Multimedia formats: Many SOP generators will create multimedia components to support the text-based documentation. To support employees in their workflows, videos, diagrams, photos, flowcharts and the like can become part of the SOP documentation. Notably, voice narrations of processes can be completed in any number of languages as needed.

Dynamic revisions: SOP generators will keep track of revision schedules, send out alerts for required updating, and enable real-time editing and updating of the documentation. In addition, the applications will allow for role-defined collaboration in the process of review, testing, and approval.

Use of templates: Some SOP generators will have a range of industry-specific and purpose-related templates allowing for the more rapid development of SOP content and organization.

Voice-to-text capabilities: For employees working in laboratories or out in the field, some SOP generators will have voice-to-text capabilities so that the procedure can be captured verbally as it is in process. The generator will then take the information shared by voice and convert it to text and video. See ClickUp for an example of such an application.

Customized release: Some organizations especially those in manufacturing; environmental, aeronautics, hydro, and building sciences and technology; research; laboratories; and quality control will require numerous SOPs to help ensure standardized and safe workflows for employees in various departments. SOP generators are able to modify SOPs according to various employee roles and departmental requirements.

Notifications and tracking: Since SOPs are often revised and updated, the generators are enabled with features that will notify the relevant employees about the updated versions. The applications will also keep track of those who have viewed or read the SOPs.

Training modules: SOP generators are capable of using all documentation including the SOP to then create training modules or quizzes for employees to ensure that they are familiar with the procedures.

Whatever method you use to create your SOP, manual or automated, you must first know what SOPs typically contain and how they are formatted. Below, you will find information about SOPs generally.

SOP Format and Components

The format of SOPs is standardized such that within an organization. The title page must contain a standardized header (See Figure 9.4.1). Though there may be some variance across organizations within an industry, the page 1 header usually includes the following elements:

                                        Table 9.4. 1: Components of page 1 of SOPs

You can see by the example in Figure 9.4.1 below how the various components for page 1 of SOPs are typically distributed.

Figure 9.4.1: Sample SOP title page header.

The body of the SOP typically contains these components:

Table 9.4.2: Typical sections of SOP documents

Format Requirements

Though AI applications are now available to help you create an SOP, it’s useful to be familiar with typical formatting requirements so you can choose templates that align with these standards and/or create settings within the generator so the document it creates conforms to the standards. SOPs must be created using formatting consisting of the following:

• Include the SOP title and number, company name, and page number on every page.
• Format the page number as follows: page X of Y; e.g., page 1 of 5.
• Single-space all text, and add a line space between bullet/listed items.
• Number all the parts of the SOP as follows: (e.g., 1, 1.1, 1.1.1, 2, 2.1, 2.1.1. . .) and nest (indent) sub-steps.
• Use bold to highlight headings.

SOP Language and Style

Like any set of instructions, SOPs must be clear and straightforward, so the language must be precise and specific to the particular discipline. To this end, when working with an AI SOP generator, ensure that you choose an application that is either dedicated to the discipline or has functionalities that enable it to use discipline-specific language and terminology. As you edit the text, follow these tips for creating an effective SOP style (see examples in Table 9.4.3):

• Use clear, specific, and concrete language.
• Choose straight-forward, discipline-specific vocabulary.
• Use a concise, active, and direct approach.
• Use the imperative mood by preferring the action word for each step.
  • e.g., “Place the tachometer trigger on one half of the rotor unit.”

Table 9.4.3: Examples of vague and specific wording

To view sample SOPs, click on the following links:

• SOP for the Calibration and Maintenance of Weigh Balances (U.S. Environmental Protection Agency (2017).
• Operational procedure: Fresh fruit or vegetables grade verification – inspection.canada.ca
• Manitoba. (2020, November).  SOP for Protocol Swabbing (Adult and Pediatric). 

Whether you create the SOP from scratch or make use of an AI SOP generator to assist you, remember that you are responsible for ensuring that the contents of the document are accurate and presented in ways that promote ease of use.

For more information about instructions generally, please refer to Chapter 9.3: Instructions.

References

Botable. (n.d.). Botable Blog | AI for Standard Operating Procedures: A Complete Guide

Brampton Small Business Enterprise Centre. (n.d.). What is a standard operating procedure? https://www.brampton.ca/EN/Business/BEC/resources/Documents/What%20is%20a%20Standard%20Operating%20Procedure(SOP).pdf

De Sain, C. & Sutton, C. V. (n.d.).  Standard operating procedures (SOP): Content, format, and management. http://hrvillage.in/docs/584_1.pdf. Document no longer available online.

Inspection Canada. (2025, January 10, modified). Operational procedure: Fresh fruit or vegetables grade verification – inspection.canada.ca

Manitoba. (2020, November 25, rev.).  SOP for Protocol Swabbing (Adult and Pediatric).  SOP # CO-1.  https://sharedhealthmb.ca/files/covid-19-sop-swab.pdf

McFarland, A. (2024, August 7). 5 Best AI SOP (Standard Operating Procedures) Generators in 2025 Unite.ai.

Przekop, V. (2025, April 1). 3 Generative AI Prompts To Strengthen Your SOPs Without Sacrificing Compliance Clinical Leader.

Richter, Z. (2025, April 22). The Smart Future of SOPs: How AI Is Revolutionizing Standard Operating Procedures – Writing Agency, Technical Writers, Ghostwriters  The Writers for Hire.

US Environmental Protection Agency, Office of Pesticide Programs. (2017, March 2, rev.).  Standard operating procedure for calibration and maintenance of weigh balances.

SOP Number: EQ-03-08. Office of Pesticide Programs Microbiology Laboratory Environmental Science Center, Ft. Meade, MD. https://www.epa.gov/sites/production/files/2018-01/documents/eq-03-08.pdf

Whale. (n.d.) Whale | The fastest way to get your team aligned