The life cycle of a standard operating procedure consists of six stages as shown in the video above.
These are:
- Initiation, where the need for a new SOP is identified and the necessary approvals are obtained to commence development
- Drafting, where the new SOP is written
- Reviewing, where the draft version of the SOP is reviewed by appropriate members of staff to ensure it covers all required aspects and complies with all regulatory or standard requirements
- Approvals, where the SOP is approved before it is released for use
- Revision, where the SOP is revised to meet changing needs
- Decommissioning, where the SOP is no longer required and is retired from use
We will now look at each of these steps in more detail.
Stage 1: Initiation
There are many events that may call for a new SOP, including:
- Change in Business Conditions
- Input from regulatory activity
- Change in Management Philosophy or Corporate Policies
- Installation of new equipment and instrumentation
- Implementation of new processes of procedures
The person who is initiating the development of a new SOP should fill in the “new SOP form” which should contain fields for:
- The title of the proposed new SOP
- The reason for it
- A description of its purpose
- The SOP’s scope
- The departments affected
- Training requirements
- A list of reviewers
The originator should discuss the proposed SOP with the subject matter expert, who will know if there are other SOPs on the same subject that could be revised to incorporate the new subject matter.
In which case consideration should be given to updating the existing SOP and there would be no need for the new one.
The process for revising SOPs is discussed later in this course.
Stage 2: Drafting the New SOP
The next stage in the SOP life cycle is drafting.
There are many ways to write an SOP, the first consideration is that of format, here are a few formats that can be used:
Simple Steps Format
This format is useful for short, routine procedures, which have few possible outcomes, and are fairly to the point. Apart from the necessary documentation and safety guidelines, it’s really just a bullet list of simple sentences telling the reader what to do.
Hierarchical Steps Format
This format is useful for long procedures with more than ten steps and entails making a few decisions. In addition, they often involve clarification and defining terminology. This format usually consists of a list of main steps all with sub-steps in a very specific order.
Flowchart Format
If the procedure is more like a map with an almost infinite number of possible outcomes, a flowchart may be your best bet. This is the format you should opt for when results aren’t always predictable.