Clear Standard Operating Procedures (SOPs) are essential to the successful quality operations of an organization in order to create consistency in how processes and tasks are performed. An SOP consists of well-documented, step-by-step instructions and checklists that are easy for personnel to follow, and clearly direct team members to perform tasks in a consistent manner. Strong SOPs greatly reduce the chances of mistakes and are particularly important for complex tasks that must conform to regulatory standards.
We know that it is critical to have effective SOPs, but how do we generate them? There are several best practices that we recommend. Start by defining the purpose and scope of your SOP, and then make sure the process you are writing about is well defined and understood. After the procedure is written, reviewed and approved, it can be implemented in order to provide the guidance needed to meet requirements.
Quality Operations: Define the SOP
We need to understand the ‘Who, What, and Why” of the SOP and how to incorporate into the overall quality operations. We need to know why the SOP is needed, what it is going to be used for, and who it applies to. The more we understand its purpose, the better we will be able to gather the information that needs to be included in the SOP.
Be sure you can you answer the following questions within the quality operations:
- Why is this SOP needed?
- Who is the audience for the SOP- how knowledgeable are they about the process?
- What is the applicability of the SOP-when will it be followed?
- What is the scope of the SOP- where does the process start and end? Be careful not to try to cover too much in one SOP.
- What is the focus of the SOP? i.e. safety, compliance, process documentation, etc.
- Will it be used for training or on a day-to-day basis?
Understand the process
In order to write an effective SOP, it is critical to fully understand the process you are writing about. Make sure you have gathered all the information needed to fully describe the process within these quality operations necessary and the desired outcome.
There are many ways to gather the information needed. The best way to start is to observe the process in action. Generate a complete list of the steps required as part of the process, along with the roles and responsibilities of various personnel and departments involved. Determine who is responsible for each of the steps and observe what types of questions or concerns come up while performing the process.
It is also important to interview the Subject Matter Experts who helped develop the process and consult with the people who execute the tasks. Ask them about any current pain points or areas of confusion they face as they perform the tasks. These are areas that should be evaluated, enhanced, and clarified in the SOP.
Look for any documentation about the process that may already be available. There could be formal documentation such as previous SOPs and work instructions, or informal ‘cheat sheets’ used by the operators.
Once you have a good understanding of the process for the SOP within quality operations, create a process map or flow diagram to visually map the process. Confirm your vision with the relevant stakeholders and modify as needed. Be sure to include all the relevant stakeholders in discussions- every department that has responsibility within a procedure should be involved in contributing to the development of the procedure. Once we fully understand the process to be described, the writing can begin.
Write the SOP
It is important to determine the structure of the SOP and identify the sections to be included. Your organization may have standard SOP formats that you use for different purposes and quality operations. It is imperative to clearly state the scope and the purpose of the procedure. Start by creating an outline, to ensure all relevant information will be included.
Be sure to write from the end users’ perspective, so that the SOP will meet the needs of the reader. You will want to focus on what the user needs to know. Think about your target audience- how experienced or educated are they? An SOP should be written with sufficient detail so that someone with a basic understanding, but limited experience with the process, can successfully follow the procedure when unsupervised. Be sure to include all required steps and checkpoints but be careful of setting up future compliance issues: don’t include requirements that are too specific or not mandatory, as they may lead to non-conformances in the future.
Format is important as well. Make sure the text is easy to read and the user can absorb the necessary information. Try to use an outline format to avoid long paragraphs of text. Include diagrams, flowcharts, tables, checklists, pictures and figures as needed to aid in understanding.
Keep the following points in mind as you write:
- Write concisely, clearly, and step by step
- Watch out for ambiguous words- periodically, typically, etc.
- Use active voice and action-oriented verbs
- Avoid jargon or overly technical words
- Articulate and define decision points and options
It is vital to review and test the procedure as you are writing it. Be sure to have the draft reviewed by the involved stakeholders. It may be beneficial to get the stakeholders together to share feedback and discuss any issues.
As part of the review process, have different individuals try using the procedure to perform the task. Test it on both experienced users and new users. See if the SOP can be followed to get appropriate results. Observe where the user may have questions or make errors to determine areas of the SOP that need to be clarified.
After all comments and updates have been incorporated, the procedure can be circulated for final review and approval. It is good practice to assure that all departments that have responsibilities in the SOP are on the review/approval panels. This way, they are signing that they are aware of their responsibilities and agree to follow the procedure as written.
Implement the SOP
After the SOP is approved, it is important to communicate the new requirements to all impacted personnel. Be sure to provide training as needed to ensure that all are personnel are competent to perform any new or updated steps defined by the SOP. Define and implement metrics to provide feedback so you know if the SOP is clear and the process is performing well.
Plan for updates and periodic review to streamline and optimize the process and keep the documentation current. Make sure you have a plan to address document version control.
Developing effective SOPs can be difficult, time-consuming, and labor-intensive. Clarkston Consulting can guide you through this process. Our stewards have the experience and skills to assist you in understanding your current processes and documenting them in clear and effective procedures. Clarkston can also provide training for your personnel regarding best practices in SOP development. With Clarkston, your purpose is our purpose.
Co-Author: Susan Shockey.