How to Write a SOP

Did you know that inadequate standard operating procedures (SOPs) are one of the most frequently cited causes for the Food and Drug Administration (FDA) to file Warning Letters for? For example, in 2022, the FDA issued 42 warning letters, 23 of which addressed documentation and SOPs issues.

While you may not be filing important information for the federal government, the message remains the same: writing effective SOPs can make all the difference. A poorly written SOP can cause a breakdown in communication and potentially grow into a host of other major compliance problems.

What is a SOP?

SOPs are a set of step-by-step instructions designed to help workers carry out routine operations consistently. SOPs act as a guide for specific tasks, ensuring uniformity, reducing errors and maintaining quality across an organization.

SOPs are not exclusive to a specific industry. Because they are used as a template to complete industry-specific tasks, their usage covers multiple industries.

For example, a healthcare worker may utilize a SOP for Patient Admission to guide the staff through registration, collection of medical history and initial assessments. Someone in technology may use a SOP to determine how to back up important data in case of system failure or a critical update. Some other industries you may encounter a SOP could include business, education, banking, manufacturing and nursing.

What makes a good SOP?

While the content of an individual SOP varies, all good SOPs have these basic components:

• They are written concisely and follow a step-by-step format. They don’t use overly technical or jargon-filled terminology, and all steps are chronological.
• They use specific terms. They don’t include words like "periodic," "typical," "general," and "should," which don’t have a concrete meaning. They offer specific tasks, timelines and instructions.
• They define technical terms. If there is a word that can’t be substituted, like epinephrine for the treatment of anaphylaxis, they define what the word is either in the SOP itself or in a word key.
• They make smart use of formatting. They don’t have long, dense paragraphs. They use bullet points, lists and images to convey information. They are attractive documents that don’t feel like a chore to read through.
• They have steps for when things DON’T go to plan. They state what happens if the SOP cannot be followed and identify who needs to be notified of contingencies and what documentation is required. Likewise, they also state what happens when an SOP is incorrectly followed

How to Write a SOP

• 1.  Determine who you are writing for.

Before you sit down to write, think carefully about who the SOP will be used by. A SOP for a peer taking over your position may need less direction than an intern who is just starting in your industry. Additionally, think about how common the task is. Is this something people have a general knowledge about and can research if they run into issues, or is this a highly technical and niche task? Once you figure out who you are writing for, you can start to put together a draft.

• 2. Write while you work

Many find it easier to write an SOP by creating a draft while they do the task. In this way, you can break down the process step-by-step as well as think through your rationale for performing each step. If you find it difficult to write while working, you could ask a coworker to take notes for you or record yourself to watch back later.

• 3. Repeat the process

Writing down the process once doesn’t mean you’re finished. It is best to practice the task by following your own directions. You may realize that you glossed over a step because it is second nature to you. After you have made edits, complete the task a third or fourth time until you feel like you aren’t missing anything.

• 4. Find a reviewer

Congratulations! By reaching this step, you wrote your first SOP. Now it is time to check if the SOP is clear and understandable. Ask a colleague or a friend to read the SOP and, if feasible, execute a test run. Ideally, this person would have the same understanding as your target audience (if the SOP is for an expert, your tester should also be an expert).

As challenging as it may be, don’t interfere with the test so that you can get authentic feedback. Ask the test person to be constructive and critical and wait for his or her feedback or questions. You can work with them after a first or second run through to make edits to the content, formatting or even the process as needed.

• 5. Update as needed

You may think that since you have reviewed your SOP hundreds of times, your reviewer had no issues, and your supervisor considered it flawless, that your SOP is done for good. NOPE!

SOPs are living documents, which means that they reflect current standard operating procedures. If there are any changes to a program, hierarchy structure, technology or data, you may have to go in and make changes to your SOP. There isn’t a specific timeline for if/when your SOP may need to be updated, but you must be at least peripherally aware of these changes and how they could affect your SOP.