My clients ask me to write SOPs all the time. This is one of their biggest headaches that they would like me to alleviate. It takes skill, time, and effort to write a solid SOP that an organization can use effectively and efficiently.
While Work Instructions provide step-by-step instructions for key tasks (see previous blog post), SOPs provide instructions for how a process or system works. In many cases, SOPs are used by many departments as a process, or a system is interdepartmental. For example, a company’s training SOP will be used by all departments since everyone in the company requires training to perform their job function. One department might own the process, but other departments will participate in that process. In keeping with the same example, the training department would own the training SOP, but the other parts of the company use the SOP to understand their training requirements and how to sign up or attend a training session.
In my many years of writing, reviewing, and using SOPs, I have learned that there are five actions that can help any organization with their SOP headaches. While they may be considered extra steps in an already painstaking process, these actions provide value in the long run.
Five Actions to Write Clear and Effective SOPs
1. Map Out the Process First
Mapping out the process will help you ensure that all steps are captured and are in the correct sequence. From here, the author can write out the steps in the process correctly.
It is important that this exercise be performed as a group with key parties and departments participating. There is no one person that can do this on their own. It is amazing what you will learn from about the process. From experience, I have had managers and directors learn that their team is performing tasks that they did not know about. Another benefit is that the team might discover some inefficiencies in the process that can be easily remediated.
My favorite way to map out a process is very old school. I like getting the team in the room with a whiteboard and sticky note. Each step gets its own sticky note, and they can easily and quickly be rearranged as opposed to someone writing on the white board. In today’s world of remote work and virtual companies, mapping out the process can also happen in a group. Many platforms now have a way of taking notes in real time that can be shared virtually.
2. Create Flowcharts
Once the process has been mapped out, the process can be converted to a flowchart. The flowchart provides the SOP reader with an overall picture of the process in 1 to 2 pages. While many people find flowcharts helpful to use, most do not know or do not like to create them. I typically use Visio which is Microsoft’s software for creating flowcharts. Many organizations do not have Visio but create clear flowcharts using Word or even PowerPoint.
Here is my tip for creating a flowchart. Add the arrows or the connecting lines at the end. I add all the steps for the process to the page first ensuring that they are in the correct sequence. Then I move the steps around to ensure equal spacing between the steps. Once I like the spacing, I then add the arrows and connection lines. Using this method to create flowcharts has saved me time and many, many headaches.
3. Have One Meaning for Each Key Word and Acronym
Pharmaceutical and Medical Device companies love their key words and acronyms. However, each key word or acronym can have a different meaning depending on the organization. I had one client that used the acronym “OOT” to mean “Out of Trend” and “Out of Tolerance”. It was very confusing for the QA group that had to review both types of OOTs.
To combat this, each SOP needs to document each key word and acronym along with its definition. It is also helpful to have a Glossary document for the company that compiles the definitions. In this case, referencing the Glossary document in the SOP will suffice. This will ensure that departments can effectively communicate with each other.
4. Define Roles and Responsibilities Clearly for All
Every department, job title or committee that uses the SOP must be listed in this section with its corresponding responsibilities for the process. This helps individuals understand their function within the process and helps the training department determine who needs to train on the SOP. If there is a committee that performs steps within the process, it is important to document which department or job titles are part of the committee.
I recommend that this section of the SOP be one of the last sections written to ensure that all roles and responsibilities are captured. It happens quite often that someone or some committee is left out and is caught during the review process.
5. Reference Other SOPs
Unless your organization is smaller than the starting lineup for the New York Knicks (in number not in size), you will have at least one SOP per process. Since your processes interact with each other as part of your quality system, it is important to reference the other SOPs than to duplicate the steps. The reason for this is to reduce the number of times that you need to revise the SOPs. For example, if the CAPA steps are listed in two different SOPs (CAPA SOP and the deviation SOP) and the CAPA process changes, you will now need to revise both SOPs instead of one. Having said that, it is important to review linked or referenced SOPs when revising a SOP to ensure there will be no conflicts.
Need Help with Your SOPs?
When used together with a commitment to quality, these actions will reduce the number of revisions needed and potentially reduce the number of deviations.
If you would like to assess your overall Document Management Program, or to get help with writing your SOPs, please contact me at kwallbank@qualitysystemsservices.com I have helped many pharmaceutical and medical device companies assess their processes for gaps and determine solutions.
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