By using SOP mapping, a manufacturer can define, communicate, and continually improve complex procedures and processes. They can help visualize complex, detailed information in SOPs, serving as a snapshot of how a given process is maintained in a state of control. Process maps can be tools for doing that.
But the FDA wants to see that SOPs are actually being translated into action rather than simply sitting in a filing cabinet or in the cloud. That’s why manufacturing facilities maintain many SOPs.
SOP Process MappingĮnsuring a process is in a state of control begins with defining what that process entails. Process mapping and gap analysis can help manufacturers not only show the FDA that an organization is compliant with regulatory expectations, but also help demonstrate that standard operating procedures (SOPs) are correct and that employees understand them. In the eyes of the FDA, if an activity or event that is not clear and documented, it didn’t happen. But no matter how compliant a quality system is, if the manufacturer cannot sufficiently show and prove it, the agency will not get the message. It may do so by having a quality system in place, understanding FDA expectations, and monitoring these systems. With proper preparation and the right tools, a manufacturing organization can always be ready to pass an FDA inspection relatively stress-free.ĭuring an inspection, a facility must be able to demonstrate that it is in a state of control. Food and Drug Administration (FDA) is to prepare for one, and the best way to prepare for one is to always be ready for one.
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