ONE GOOD IDEA
Cut Down on Redundancy
When dealing with too many procedures, reach for a SAW
by Richard F. Pless and Sharon J. Block
Small organizations that provide a variety of services often have difficulty documenting their processes. Standard operating procedures (SOPs) are developed for all activities, but not all activities are required on a project. In fact, SOPs may openly conflict in some cases. Determining which SOPs are appropriate can be confusing for auditors and project teams. The problem is compounded with the addition of project specific procedures (PSPs) required for new and unique activities.
Preparing for recent audits presented a challenge for our organization: Many different SOPs applied in varying degrees to numerous projects. We devised a solution to help staff and auditors better understand which SOPs were applicable and why—a form dubbed the SOP applicability worksheet (SAW).
The SAW is a list of SOPs and their supporting information. The form is very straightforward. The project manager answers questions about the work to be done on the project. These questions serve as a guide to determine whether the SOP applies. If it does, staff can expect to generate the documents listed in the quality records section. The notes section can be used to refer to PSPs that override an SOP or for effective dates if an SOP is not applicable from the outset of a project.
Implementing the form is equally straightforward. At the start of a project, the project manager completes the SAW and consults with project department leads as needed. The SAW is then approved by senior oversight. Completing the SAW during the planning stages of the project accomplishes two goals: It demonstrates a commitment to quality, and it provides easy-to-follow guidelines for the team.
After initial complaints about additional work, we received a lot of positive feedback regarding the SAW. It structured project managers’ thinking about processes and documentation, while also providing a simple checklist to review their projects’ compliance with company procedures.
The SAW also aided internal and external auditors. It became the centerpiece of audit discussions, often becoming the de facto audit agenda. The SAW gave project managers confidence their project processes were adequately documented and that appropriate quality records were generated.
Implementing the SAW across the organization presented unique challenges. Completing the SAW for individual projects took longer than anticipated, something we attributed to increased company focus on quality assurance in general. Another challenging issue was updating the SAW to incorporate new or revised SOPs. In that case, it’s important to weigh the effort required to create an addendum against creating an entirely new SAW.
After numerous audits, the SAW has proven to be an incredibly useful tool for our staff and auditors. The SAW assisted staff members in understanding their work and our procedures. By reviewing the SAW during audits, auditors could understand what to expect from our diverse consulting projects. The SAW aided senior management in identifying gaps that existed in our procedures because many projects had developed similar PSPs.
In the end, this approach greatly simplified quality assurance planning and execution across a diverse array of projects.
Richard F. Pless is the director of data operations for the Lifecycle Sciences Group at ICON Clinical Research in Chicago, where he oversees database and data quality management efforts. A member of ASQ, Pless has a master’s degree in public policy from the University of Chicago.
Sharon J. Block is an associate project manager for the Lifecycle Sciences Group at ICON Clinical Research. She is currently working toward a bachelor’s degree in biology.