Standard Operating Procedure (SOP)

Understanding a Standard Operating Procedure (SOP)

SOP General Format

SOPs should be organized to ensure ease and efficiency and to be specific to the organization which develops them. There is no “correct” format ; and internal formatting will vary in each organization and with the type of an SOP being written. The information of an SOP should be divided into a series of logical stps to avoid a long list. The level of details provided in the SOP may differ based on, e.g., Whether the rocess is critical, the frequency of the procedure being followed, and the number of people who will use the SOP.A generalized format will be discussed next.

Title Page

The first page or cover page of each SOP should contain the following information: a title clearly indentifies the activity of procedure, an SOP indentification (ID) number, date of issue and/ or revision, the name of the applicable agency, division, and/or branch to ehich this SOP applies, and the signatures and signature dates of those individuals who prepared and approved the SOP. Electronic signatures are acceptable for SOPs maintained on a computerized database.

Table of Contents

A table of contents may be needed for quick refrence, especially If the SOP in long, for locating information and for denoting changes or revisions made only to certain sections of an SOP.

Text

Well-written SOPs should first bridfly describe the purpose of the work of process, including any regulatory information or standards that are appropriate to the SOP, and the scope to indicate what is covered. Define any specialized or unusual terms either in a separate definition section or in the appropriate discussion section. Denote what sequential procedures should be followed, divided into significant section. Finally, describe all appropriate quality control (QC) activities for that procedure, and list significant refrences.

          As noted above, SOPs should be clearly worded and the prcedures should be written in a format that clearly describes the steps in order. Use of diagrams and flow charts help to break up long sections of text in any appropriate information e.g., an SOP may refer to other SOPs.