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Wiklund’s Perspective: Applying Human Factors to Standard Operating Procedures (SOPs)

People write SOPs for many important reasons, such as ensuring that company workers manufacture a vaccine properly.

US FDA rolls out notification requirements to protect medical device supply chains

October 18, 2022

Wait a minute…is there a Standard Operating Procedure (SOP) for writing a short piece for TalkingPoints about writing SOPs? If there is, I had better follow it closely.

Then again, closely following SOPs can be difficult, in part because they all look the same, featuring seemingly endless, numbered paragraphs (e.g., paragraph 8.2.11.8) and dense text. They are the conceptual opposite of a magazine article, which is intended to capture your attention with compelling text and carefully curated images, take the reader on an informative journey and perhaps entertain.

Yet SOPs are serious business. People write SOPs for many important reasons, such as ensuring that company workers manufacture a vaccine properly. It is important for SOPs to be complete, accurate and clear. Entertainment is neither an explicit nor implicit a goal. However, making SOPs that grab and hold attention is a reasonable goal.

Anytime you design a user interface, you should start with an understanding of the users, the overall use scenario and what constitutes critical versus non-critical tasks. This is a good starting point for designing the user interfaces to such products as a hemodialysis machine, drug delivery device, diagnostic app running on a smartphone or the instructions for use accompanying a glucose meter, for example. So, does it make sense to apply this approach to designing an SOP? Yes. The approach puts you in a great position to know your readers and set appropriate goals for an SOP, such as the following:

  • Capture and hold the reader’s attention. (UL Solutions estimates that 20% of SOP readers spend less than 30 seconds scanning an SOP before signing-off on it.)
  • Explain things in a clear and concise manner.
  • Write in the active voice (e.g., “Press the start button” versus “The start button should be pressed”).
  • Include meaningful headings and subheadings to aid information navigation while also improving a document’s readability.
  • Include abundant illustrations to replace or complement text.
  • Clearly differentiate procedural steps from supplemental information.

This list could continue, addressing dozens of SOP design characteristics. In fact, any given company could establish a comprehensive set of rules for SOP design, what some people would call a Style Guide. Moreover, a Style Guide could be complemented by exemplars that set the tone for SOP design excellence. (Emergo by UL can assist with the development of such Style Guides and exemplars.)

Developing SOPs that meet these goals is Step 1 of 3.  Step 2 is testing preliminary SOPs to ensure they work as intended.

When you assess an academic achievement test to ensure people are getting answers right or wrong for the right reasons, it is called cognitive laboratory assessment. When you test a hemodialysis machine’s user interface to ensure people can operate the machine safely and effectively, it is called usability testing. When you test whether people understand warnings presented in an insulin pen-injector’s instructions for use, it is called knowledge testing. You could use any of these terms to describe an SOP test. However, I’ll call it a usability test from this point forward.

An SOP usability test should be straightforward and is something a company could do using in-house resources or a third-party resource such as UL Solutions (which incorporates Emergo by UL).

  • You start by assessing the SOP and determining appropriate use scenarios and associated critical tasks. Next, you prepare a usability test protocol with input from many stakeholders.
  • Then, you conduct the usability test, involving perhaps 6-12 representatives of the intended SOP users. You conduct the test either in a conventional office space, usability test laboratory, or actual workspace, depending on the nature of the SOP. For example, if the SOP requires a user to interact with large manufacturing or test equipment, the test might need to take place on a shop floor.
  • Following the test, you can analyze the test results and draw conclusions about the completeness and clarity of the SOP and whether the test participants committed use errors triggered by SOP shortcomings.
  • The logical, final part of this step is to enhance the SOP to resolve usability problems identified through testing.

Step 3 is conducting a final test of the revised SOP. OK, I’ll toss in a fourth step, which is to conduct the equivalent of post-market surveillance. Seek feedback regarding the published SOP and keep watch for any sign that it is either triggering problems or failing to produce good performance.

Ultimately, the people responsible for producing SOPs should see them not only as a necessity  linked to good manufacturing practices, but also as an opportunity to design guidance that will help people in myriad ways, including turning a sometimes tedious task into a genuinely rewarding educational experience.

Michael Wiklund is General Manager and Director, Human Factors Research & Design (HFR&D) at Emergo by UL and Mark Lee is Senior Business Development Manager at UL Solutions ComplianceWire.