Standard Operating Procedures (SOPs) are written instructions that a worker follows to perform a given task consistently and effectively. These documents communicate who will perform the task, what materials are necessary, where and when when the task must be performed, and how the worker will execute the task. Well-written SOPs are a cornerstone of quality system documentation, and they contribute to the scalability of a company.
For medical device manufacturers, intelligible SOPs serve as a workflow asset. They help companies not only to grow but also to maintain consistent operations and results, which speeds FDA audits. In addition, well-written SOPs simplify employee training by providing all employees with the same information on how to perform the process or task.
Many of the FDA Form 483 observations and Warning Letter citations received by medical devices manufacturers are the result of poorly crafted or incomplete SOPs. Often, these documents have been written by individuals that are unfamiliar with best practices for technical documentation.
It takes skill, training, and practice for individuals to become proficient in technical writing; however, technical documentation managers can add value to the SOP development process by giving Subject Matter Experts (SMEs) the tools to effectively contribute.
By encouraging SMEs to follow these 10 basic technical writing practices when writing procedures, managers can improve the organization’s SOPs and avoid unnecessary corrective action.
10 Basic Technical Writing Best Practices
- Consider the reader as you write. People differ in age, education, knowledge, skills, and experience. Work cultures also differ. Determine the writing style and level of detail that makes the most sense for those performing the process or task. Consider why the reader needs the information and how they will use it. You can even take notes to remember the points you want to cover.
- Focus on the writing process, not the output. Create a first draft with your audience in mind. At this point, don't worry about quantity of your output. You can edit your work later to shorten it.
- Use correct English. Just like engineering, written language has rules that should be followed to remove ambiguity. Familiarize yourself with grammar books and Style Guides as applicable.
- Be concise. Keep your sentences short and to the point. If the SOP is longer than 10 steps, consider breaking it up with visuals.
- Use visuals to support your text. Use flowcharts, tables, and graphics where appropriate and necessary for clarification, and make sure that any text included is large enough to read.
- Be consistent with word choice. Don’t use different words to mean the same thing, especially for technical terms. Add a glossary if needed.
- Keep it singular. Use the singular rather than the plural when describing relationships to minimize confusion.
- Use parallel structure. Order your text so that the reader can easily see how related concepts are different and how they are similar. (See examples here.)
- Review your draft. Edit out any information that your reader does not need to know or that might confuse the reader.
- Don’t be afraid to outsource technical writing. An engineer adds value to a company by conceiving, designing, and producing systems and products for a recognized need. If basic technical writing skills don't come easy or are taking up too much of the engineer's valuable time, use a technical writer that specializes in your industry for some or all of the SOP writing process.
Starting a new SOP? To ensure that all required information is included and that procedures are consistent...
Download this free resource: A Guide to Standard Operating Procedures
For more information on SOPs, read: