Standard Operating Procedures GENERAL FORMAT ,SOP GENERAL FORMAT
SOPs should be organized to ensure ease and efficiency in use and to be specific to the organization which develops it. There is no one “correct” format; and internal formatting will vary with each organization and with the type of SOP being written. Where possible break the information into a series of logical steps to avoid a long list. The level of detail provided in the SOP may differ based on, e.g., whether the process is critical, the frequency of that procedure being followed, the number of people who will use the SOP, and where training is not routinely available. A generalized format is discussed next.
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 sections; e.g., possible interferences, equipment needed, personnel qualifications, and safety considerations (preferably listed in bold to capture the attention of the user).
Finally, describe next all appropriate QA and quality control (QC) activities for that procedure, and list any cited or significant references.
As noted above, SOPs should be clearly worded so as to be readily understandable by a person knowledgeable with the general concept of the procedure, and the procedures 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 and to briefly summarize a series of steps for the reader.
Attach any appropriate information, e.g., an SOP may reference other SOPs. In such a case, the following should be included:
1. Cite the other SOP and attach a copy, or reference where it may be easily located.
2. If the referenced SOP is not to be followed exactly, the required modification should be specified in the SOP at the section where the other SOP is cited.
SOPs should be organized to ensure ease and efficiency in use and to be specific to the organization which develops it. There is no one “correct” format; and internal formatting will vary with each organization and with the type of SOP being written. Where possible break the information into a series of logical steps to avoid a long list. The level of detail provided in the SOP may differ based on, e.g., whether the process is critical, the frequency of that procedure being followed, the number of people who will use the SOP, and where training is not routinely available. A generalized format is discussed next.
Title Page
The first page or cover page of each SOP should contain the following information: a title that clearly identifies the activity or procedure, an SOP identification (ID) number, date of issue and/or revision, the name of the applicable agency, division, and/or branch to which 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 reference, especially if the SOP is long, for locating information and to denote changes or revisions made only to certain sections of an SOP.Text
Well-written SOPs should first briefly describe the purpose of the work or process, including any regulatory information or standards that are appropriate to the SOP process, 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 sections; e.g., possible interferences, equipment needed, personnel qualifications, and safety considerations (preferably listed in bold to capture the attention of the user).
Finally, describe next all appropriate QA and quality control (QC) activities for that procedure, and list any cited or significant references.
As noted above, SOPs should be clearly worded so as to be readily understandable by a person knowledgeable with the general concept of the procedure, and the procedures 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 and to briefly summarize a series of steps for the reader.
Attach any appropriate information, e.g., an SOP may reference other SOPs. In such a case, the following should be included:
1. Cite the other SOP and attach a copy, or reference where it may be easily located.
2. If the referenced SOP is not to be followed exactly, the required modification should be specified in the SOP at the section where the other SOP is cited.
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