Two Tricks to Writing an Effective SOP

Standard operating procedures (SOPs) are a stable of corporate life. I have read hundreds of them throughout my career, and they are rarely well written. Often the SOPs are so long and so complicated that once you get to step 15, you forget what step 1 is.

From experience, the most effective SOPs are the simple ones, those that capture the main processes, not the nitty-gritty how-to. The key to writing an effective SOP include the following:

  1. Have a one-page flow diagram

  2. Capture the underlying general procedure

One-Page Flow Diagram

Including a flow diagram in the SOP helps with understanding and training. To ensure that it is easy to understand, my rule of thumb is to keep the flow diagram to just one page. Often, I start with mapping out the flow diagram first. Only when I am satisfied with the end result will I start writing the actual SOP. If you think in terms of the main processes, you should be able to keep it to one page.

When it is a CSOP (Corporate Standard Operating Procedure) that involves multiple departments, I will summarize the process further such that each flow diagram element represents a DOP (Departmental Operating Procedure), with the handoff points and conditions clearly identified. If you find too many crossed lines between different departments, it is time to take a closer look. The handoffs are probably too complicated and it is easy to make mistakes. Try to simplify or improve the process before finalizing your SOP.

Underlying General Procedure

When you start documenting a process, go with the big steps. Remember that a SOP is NOT a training manual nor an instruction menu. Do not include how-to and/or tools used in the actual SOP. Have a separate instruction or reference manual for those kinds of information instead. For example, “log a software bug” is a main step and should be captured in a SOP, but “log a bug using JIRA” is an instruction and should be in the reference manual instead, as well as the details of how to operate JIRA to log that bug.

The tool(s) we use to accomplish a main step can change often, but the underlying general procedures often don’t. When you learn to separate the main steps from the detailed how-to, you will save yourself a lot of time in revising SOPs and then re-training and updating the training records, and you will end up with a more stable process. This is especially important for those procedures that are required for FDA/ISO/GMP/GLP compliance. These SOPs are tightly controlled and required approvals for any change, no matter how small, resulting in a longer turnaround time when instituting a change. Keeping the detailed how-to in an instruction/reference manual will allow your department to react to a changing situation and implement the necessary changes quickly. This reference manual should be kept in a change-control software and any updates should trigger the associated training.

- S. Wallace