ABSTRACT

Active SOP maintenance It seems that as soon as an SOP becomes effective and starts to receive widespread attention and use, possible changes are identified. Most of the early recommendations for changes have to do with clarity of the wording or process and, if implemented, would make the SOP more clear. Sometimes, if some functional groups did not perform as thorough a review of the draft process and associated SOP as perhaps they should have, they may find an issue that they would like to have changed right away. But after that initial period the environment the SOP is released into begins to change and updates to the procedure are needed to reflect process changes, system changes, organizational changes, regulatory changes, changes to other documents, and so forth. This chapter aims to change the view of SOPs as documents that can remain static and untouched for long periods of time, to recognizing that they must be actively maintained. If we promote an active culture of process improvements and updates, while documenting those improvements appropriately as prospective deviations and SOP revisions, we improve both compliance and efficiency.