Standard Operating Procedures (SOPs) are written instructions that tellan employee how to do a particular job function.
These SOPs get revised often and there is a process (actually a SOP) onhow to change the SOP.
When a person deviates from a SOP - they need to fill out a departure form. There is a process that defines how the departure form gets created, reviewed,signed, and approved.
The current process is manual and requires handwritten signatures.
The process they want to establish will be fully electronic including signatures.
An author creates a draft of a proposed Standard Operating Procedure (SOP).
He sends the same to a Quality Administrator (QA) who assigns a number to the same and sends it to the Quality Manager (QM) for Review.
After review, the QM sends the SOP to various functional heads such as heads of the affected function, Information Services and Training Management.
The QM gets a collated report of their views on the SOP, reviews the same and sends it to the QA.
The QA prepares the SOP for Approval, which is then sent simultaneously to the Author, Reviewer and Approver for their respected confirmation.
These documents are then collated and sent back to the QA who sends it to the distribution department for acknowledgement and implementation.
Departures are identified and documented.
If the same is retrospective in nature, it's impact is evaluated, documented and sent to the Quality Manager for approval.
If not, it is directly sent to the same who then institutes and documents corrective action in order to handle such exceptions in the future.
The information is then archived for further reference.
The established process is fully electronic.
Security issues are addressed.
Historical data is available for future reference.
Centrally maintained work log.
Easy movement of documents.
Integrated module.