Standard Operating Procedure Guidelines

This is provides guidance for writing a standard operating procedure (SOP). These guidelines detail the type of information to be included within each particular SOP section, along with writing dos and don’ts.

1. Purpose

• Explain the objective the SOP is intended to achieve.

2. Scope

• State the range of activities the SOP applies to, as well as any limitations or exceptions.

3. Responsibility

• State the personnel, departments, groups, contractors, and/or subcontractors responsible for complying with the SOP.
• State the person or group responsible for assuring the appropriate personnel are trained on the SOP.

4. Procedure

• Explain the procedure in simple steps. Describe what to do, not how to do it.
• State who does each step and how it is recorded to be certain that whoever is performing the procedure can prove that they have done it. Think about what is needed before the procedure is started so that the person performing the function can do it correctly the first time.

5. Review and Revision

• State how often the SOP is reviewed and/or under what circumstances it is to be revised.

6. Contingencies

• State what happens if the SOP cannot be followed. Identify who needs to be notified.

7. References

• List related SOPs, any supporting documentation necessary to understand and correctly follow the procedure, and any applicable regulations and regulatory guidelines.

8. Definitions

• Define words and acronyms that people reading the SOP would not generally know and that would require clarification. If a definition is needed, and one exists in the regulations, use the regulation definition.

9. Attachments

• Attach any documents used in support of the SOP, e.g., flowcharts, work instructions.

10. History of Change

• State in sufficient detail, what changes were made, what parts of the SOP were affected and when the changes become effective.

11. Content

• Check the SOP to make sure it is clear, correct, concise, complete, and comprehensive.
• Use language and detail appropriate to the staff performing the task. Use short sentences to express a single thought wherever possible.
• Use techniques that condense information, e.g., tables, matrices, bulleted lists, checklists, and diagrams.
• Write the text in the third person, present tense, active voice. State in the procedure what is done, not what must, shall, or may be done.
• Avoid references to gender (“they, their” rather than “he, she”).
• Express the main idea early in each sentence.
• Define job titles or unusual terms the first time they appear, followed by the abbreviation in parentheses. The abbreviated form is used in the SOP.
• Avoid the use of “etc.” If the list is limited, write it out in full. If a list is extensive and inappropriate to write out in full, write the term “for example (e.g.)” and give a relevant list.
• Write the numbers 1 through 9 in words within the text. Write the numbers 10 and greater in the numerical form.

12. Style

• The page header should include the SOP number, title, page number, and effective date.
• The page footer should include the complete filename and path.