Managers on growing teams are often stretched thin, and other staff members may need to adapt to new and changing roles. You can better equip your team members, both new and old, to be efficient in the face of growth by following a standard operating procedure checklist to communicate processes and workflows.
A standard operating procedure (SOP) houses crucial information about your company’s process of record for pretty much any task, telling team members exactly what they need to do to execute the process. When shared proactively with your team, an SOP eliminates communication inefficiencies. Effective SOPs prioritize quality alongside compliance. They’re written to ultimately achieve the best patient outcomes, rather than simply complying with GxP requirements, ISO 9001, and other regulatory standards.
With a quality-informed approach to SOPs, you can develop workflows and procedures that lead to process improvements and efficient teams. Here’s how to create a standard operating procedure checklist for any process.
Identify the Purpose of Your Standard Operating Procedure
The beginning of your SOP document should clearly define its scope and purpose so that you can later write a procedure that’s specific and effective. Identify the processes and scenarios your SOP should and should not apply to. You could say, for example, that the purpose of your SOP is for inputting new patient data only, and team members should follow different steps for updating patient data.
Along with scope, the goal or end result of your SOP should be clear, so you can design a process that achieves it. Qualify your goal to be specifically about efficiency and quality. For instance, instead of defining the goal as “inputting patient data into the system of record,” you might specify “correctly and securely inputting patient data into the system of record.”
You should also talk to relevant stakeholders. They can often provide valuable insight to achieve quality outcomes, not just regulatory compliance. Talking to stakeholders not only improves efficiency between teams and may help break down siloes between departments, which is necessary for getting buy-in from staff members so they’ll actually follow the SOP. Get their input to better understand how their teams operate and what they’ll need from the SOP.
Choose a Logical Structure for Your SOP
Next, write out the process that should be followed from start to finish. The steps should be in a logical order so that team members can follow along easily.
Before you can formally start writing out every step, though, you need to choose one of the following formats for your SOP:
- Checklist: This type of SOP is a procedural checklist. It’s useful for something like a quality assurance check on a medical device or a maintenance check on lab equipment. The person following this SOP just needs to make sure that every requirement is met and each item on the list can be marked confirmed or completed. You may want to provide instructions on how to escalate if a condition isn’t met and an item can’t be checked off.
- Step-by-step: A more expanded version of the procedural checklist, this format is useful when the process at hand is straightforward and has one specific outcome. One example may be drawing blood from a patient in a lab. In that case, the SOP would provide instructions on how to complete that one task.
- Hierarchical: This SOP structure is used to provide additional context for each step. If the final step is to clean a device after use, for instance, a hierarchical SOP would include sub-bullets that might explain what cleaning solution to use and where to retrieve it.
- Flowchart: This type provides a more visual reference for your team members to follow. It’s especially useful when there are multiple outcomes possible for the SOP or if the workflow has different “if/then” scenarios along the way. A flowchart provides an easy-to-follow map of the possible pathways, with instructions on how to handle each one. This COVID-19 triage SOP from the CDC uses flowcharts to explain what to do in different epidemiological scenarios (in this case, whether there is limited transmission or widespread transmission in a community).
Once you’ve decided on a format, it’s time to write out every step from start to finish. Be clear in your direction, and give instructions that prioritize quality for your team. Break the process up into sections when it makes sense so that the information is organized and your staff can quickly find the steps that are relevant to them. Each step should be concise and immediately convey the action to be taken. A good rule of thumb is to begin every step with a verb and emphasize it like Augusta University does in this SOP for handling biological spills.
Draft Your SOP with Context, References, and Tools for Success
In addition to the actual steps of the SOP, include any references that will be helpful. They can go in the appendix or just in a separate section. By offering additional information and data in one central place, you can keep your staff from having to track it down and ensure they have everything they need to do the highest-quality work. Some possible references include:
- A glossary
- A list of equipment or tools
- Diagrams or flowcharts
- Examples of results (such as a completed patient record)
The World Health Organization includes a glossary at the beginning of this SOP for waste management of used vaccine vials. This glossary makes it easy for any reader to understand the acronyms used and also to understand the definition of a “sharp container” in this context; it might be ambiguous otherwise!
The WHO also lists out the equipment and materials needed to complete the SOP. For your own SOP, this could be anything from database software and a tablet to use for patient intake to a pipette used during a chromatography process. Provide a full list so your staff can gather all the needed supplies before they begin and carry out the process more efficiently.
While some of these tools or definitions may seem straightforward to senior staff members, that may not be the case for new employees. When they can find all the info they need in the SOP, they won’t have to waste time looking it up or asking their colleagues.
Test, Re-Test, and Make Changes to Improve the SOP
Your SOPs should be clear and authoritative, but they should also be living documents that are flexible with the needs of your organization. They’re meant to evolve over time, even after implementation. To support that, you need an established process for testing an SOP, providing channels for feedback, and making updates.
Your first task is making sure that the SOP makes sense to the people using it—not just the author. Once a full draft of the SOP is written, have a few colleagues review the entire document to see if it’s clear to them. Adjust as needed and confirm that those changes work with another round of testing before officially going live. Then, once your SOP is implemented, be sure to note future updates to all team members and make clear which is the most recent version.
Share Your SOP Across Your Team for Visibility and Efficiency
The final step is perhaps the most important in order to assure all team members adhere to the SOP—they need to be able to find it! One 2019 report found that 83% of workers say "they’ve had to recreate a document which already existed because they were unable to find it on their corporate network.”
Share your SOP in a place that’s accessible and makes sense based on the procedure. If the SOP applies to operating lab equipment, for example, keep it visible within the physical lab environment for easy reference.
There are manual document control systems available, but they’re not an efficient way to share and update files or carry out key compliance steps, like collecting signatures from your staff on SOPs. For the most part, though, you’ll want to keep everything stored in one central document control system.
According to a report from McKinsey, the average interaction worker spends almost 20% of their time either searching for internal information or the right colleague to answer their questions. On the flip side, a central, searchable system of record can reduce the time employees spend hunting down info by as much as 35%. An automated quality management system is the best solution.
For teams that are growing quickly, SOPs should be stored and shared in a scalable quality management system like ZenQMS. This is just one important step to achieving “intelligent quality”—the approach that goes beyond checking boxes for compliance to creating efficient teams and streamlined workflows.
Learn more about the ZenQMS quality-driven approach to document management and regulatory compliance.