It bears repeating: Effective standard operating procedure (SOP) development is the foundation for solid regulatory compliance programs from the efficiency and repeatability perspectives, says Lysa Triantafillou, director of the Quality Management Office at Social & Scientific Systems, Inc.
Early in her career, Triantafillou abandoned the “SOPs by committee” concept. “It was just a miserable failure of a model,” she says. Instead, Triantafillou has found success with a more methodical approach that addresses a significant challenge when developing SOPs: “Most of the people in our industry aren’t writers,” she says. In fact, most are scientists and data specialists who “don’t think in terms of full sentences and paragraph structure and things like that.”
Result: When assigned an SOP writing task, they are overwhelmed. “They think you have to sit down and write it like a novel, and they aren’t capable of doing it—they don’t even know where to start,” Triantafillou explains.
Webinar: Improving Quality and Compliance through Effective SOP Development. Join Triantafillou May 16 to learn a methodical, systematic approach for effectively contributing to or managing an SOP development project. This webinar will focus on the planning, outlining, input, and review of the SOP development cycle. View Program Details
In response to the challenge, Triantafillou has developed a disciplined, clear process that allows scientists and other methodical people to manage SOP-related projects in portions, so that those involved in developing the SOP understand they are responsible for a specific section, and not the entire document. “They don’t have to own the whole thing, which is overwhelming,” she says. “It’ll sit there because people tend to avoid the tough stuff” unless the project can be simplified at the individual level.
The Catch-22 is that the people who are the key subject matter experts tend to be some of your busiest personnel, so anything you can do to help them see it isn’t a gargantuan task inspires greater cooperation. Under Triantafillou’s model, a project manager checks in with each subject matter expert a few days in advance of the SOP development meeting to gently nudge them. “Remind them of their part” and make sure they understand they’re only responsible for a more manageable piece of the machine, she says.
Triantafillou uses a step-by-step planning tool that walks non-writers through the entire process, which includes hard deadlines and accountability. “Most people in our industry like accountability as long as they know clearly what is expected of them,” she notes.
Author: Michael Causey