According to the FDA, inadequate standard operating procedures (SOPs) are one of the most frequently cited causes of non-compliance warning letters. And while a poorly written SOP can cause a multitude of additional major compliance problems, a well-crafted SOP offers clear direction specifically designed to avoid deviations—an absolute necessity for maintaining compliance and delivering quality products. In this guide, we’ll walk you through the world of SOPs – what they are, why they’re important, and the best practices for writing them. Read on to learn more.
What Are Standard Operating Procedures (SOPs)?
An SOP is a set of written instructions that describes the step-by-step process that must be taken to perform a routine activity properly. SOPs should be followed the exact same way every time to guarantee that the organization remains consistent and in compliance with industry regulations and business standards.
Often when a company is small, the management team tends to make all the internal decisions. As the company grows, this form of decision-making can limit its capacity to develop further as the management team can’t be involved in every aspect of the business. In this instance, SOPs typically take over and act as your governing word.
Why Are SOPs Important?
SOPs are useful business tools that work to communicate the correct way of carrying out an activity within your organization by providing the proper processes, policies, and standards your team should abide by. At a minimum, these documents give you the following benefits:
- Reduction of errors: With SOPs, the entire organization is following a standardized procedure that produces consistent results and leaves room for little to no error. If employees are performing their responsibilities in different ways deemed best for them, the likelihood of making mistakes, forgetting steps, and reducing the quality of production is higher.
- Meet compliance requirements: In most regulated industries SOPs are required to protect your employees' and customers' safety. So, by having comprehensive ones in place, you can ensure that your company remains in good standing with the organizations who oversee your compliance.
- Increased efficiency: SOPs remove a lot of guesswork and questions that can slow down an organization’s decision-making process. When there’s a defined SOP for the company’s most important tasks, it’s easier for employees to get things done.
- Consistency: With clearly stated standards, the way an individual carries out a particular task or activity increases in consistency. And the more consistent a process is from person to person, the less chance there will be quality problems.
Best Practices for Writing SOPs
We’ve outlined why well-written SOPs are important, but how is your company supposed to make sure yours are up to par? Let’s discuss some best practices for the SOP drafting process.
Write for your audience
Your audience will guide the level of detail in your SOP and the language you use. If you’re addressing a group already experienced in the process you’re writing about, you might opt for more technical wording. If a group doesn’t have as much experience, you might need to add additional context and information to ensure the reader can fully understand the procedure.
The idea here is to be able to create the document that’s useful to those who will implement the process defined within the document. This means remaining focused on the actual duties of the end-user, using the correct language and terminology, explaining certain terminology as needed, and not over-explaining processes and terms that are second nature to the reader.
Make your SOP actionable and measurable
Your audience should know exactly what actions to take to meet the specific task or goal and be able to measure their progress with complying with the SOP. Essentially, when creating your SOPs, be sure to be specific in terms of expectations and leave nothing to interpretation. This will ensure that you can evaluate the effectiveness of each process and adjust as necessary moving forward.
Seek outside input
One of the biggest SOP challenges is the lack of team adoption because these documents can often be perceived as restrictive. To avoid this, it’s important that you involve your team in the creation of the SOP by seeking their input. Talk to your key stakeholders to get their opinions and understand their perspectives. It’s also helpful to share a draft of the SOP with them early on to ensure your team is on the same page with each process document.
Test your SOP
To ensure success, you want to gradually introduce your team to each new SOP. This may involve having your team work through the new SOP in a simulated environment. Here, you might set up different scenarios in which certain team members play different roles, allowing each individual to get a feel for the new processes. Or you can discuss hypothetical situations with your team, allowing them to verbally walk through the processes.
As your team becomes more acclimated to the SOP, you might then begin unrolling it into real-world scenarios. While it’s being introduced, take note of any speedbumps your team comes across. Use these observations to tweak the SOP so it works better for your team’s individual needs.
After the SOP has been drafted and implemented your work isn’t completely done. It’s important to instill a growth mindset in your team; they need to understand that the new processes are not set in stone and will evolve over time as the need arises. As your team continues to adhere to the new SOP, they should regularly take note of any positive or negative experiences they have along the way, noticing areas of improvement, as well as areas in which more improvements need to be made. Your team should also meet regularly to discuss further plans for moving forward. This allows for improvement as your company evolves and grows.
A Few SOP Examples
There are three major types of SOPs: step-by-step, hierarchical, and flowchart. Let’s walk through the differences of each.
A step-by-step SOP is ideal for straightforward processes. This format breaks down a procedure into a numbered list and includes detailed instructions for each.
As an example, a step-by-step SOP for hiring something through HR might look like this:
- Conduct screening of the candidate through his resume and a phone call
- Invite the candidate for an in-person interview
- After the walk-in-interview, conduct a technical and HR evaluation
- Ask the selected candidates for their legal documents and academic certificates
- Send them an offer letter specifying the salary and joining date
A step-by-step SOP should be simple and clear enough for a new employee to follow without hands-on guidance.
If your procedures are more complex and need additional info, you can create hierarchical checklists. A hierarchical SOP uses a top-down approach to break down business processes.
The hierarchical SOP format is ideal for complex processes with many steps involved, such as client onboarding and equipment maintenance.
A flowchart SOP is a diagram that visually maps out a process from start to finish. The boxes show the steps, connected by arrows to indicate their path. Here’s an example of a flowchart for a deviation process:The type of SOP you choose to use will be determined by the complexity of the process and your company’s preferences. For some tasks, you may need the simple format of the step-by-step, but for others you may need a comprehensive flowchart diagram. Be sure to keep in mind that your team should be able to make sense of any given SOP without heavy guidance, don’t over-complicated them.
As you can see, SOPs play an important role in running a smooth business operation. When written well, they can help your company reduce error, meet compliance standards, increase efficiency, and keep a more consistent process. By following the best practices outlined above, you can ensure your SOPs are thorough, helpful, and detailed enough to keep your processes moving smoothly.
Check out some of our other resources with best practices for managing your SOPS and quality documentation:
- How Your Organization Should Manage Documents
- 5 Tips for Improving the FDA Audit Process
- Avoid These 7 Document Management Pitfalls with Document Management Software