This articl 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 both performing and 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. Carefully think about how a procedure is performed from the very beginning. Draft the SOP in a flow diagram to help visualize the entire process. Describe specifically what to do, not how to do it. Then state who does each step and where it is recorded to be certain that whoever is performing the procedure can prove that they have done it.
5. Review and Revision State how often the SOP is reviewed, and/or under what circumstances it is to be revised and indicate who is responsible for reviewing the SOP.
6. Contingencies; Corrective Actions State what happens if the SOP cannot be followed and requires contingencies. Identify who needs to be notified of contingencies and what documentation is required. Likewise, state what happens when an SOP is incorrectly followed. Include short term and long-term corrective action measures and how to document the actions.
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 terms 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. Documentation and Attachments List applicable forms that are required to be completed in the SOP. Attach any documents used in support of the SOP, e.g., flowcharts, work instructions, pictures or diagrams, forms and labels.
10. History of Change A separate document should sufficiently detail changes made to an SOP, what parts were affected and when the changes become effective. Follow a uniform format for tracking SOP changes;indicate who made the revision, date of revision and the new version number. Properly archive an outgoing version and – all exisiting copies – to avoid unnecessary confusion.
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.
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 both performing and 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. Carefully think about how a procedure is performed from the very beginning. Draft the SOP in a flow diagram to help visualize the entire process. Describe specifically what to do, not how to do it. Then state who does each step and where it is recorded to be certain that whoever is performing the procedure can prove that they have done it.
5. Review and Revision State how often the SOP is reviewed, and/or under what circumstances it is to be revised and indicate who is responsible for reviewing the SOP.
6. Contingencies; Corrective Actions State what happens if the SOP cannot be followed and requires contingencies. Identify who needs to be notified of contingencies and what documentation is required. Likewise, state what happens when an SOP is incorrectly followed. Include short term and long-term corrective action measures and how to document the actions.
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 terms 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. Documentation and Attachments List applicable forms that are required to be completed in the SOP. Attach any documents used in support of the SOP, e.g., flowcharts, work instructions, pictures or diagrams, forms and labels.
10. History of Change A separate document should sufficiently detail changes made to an SOP, what parts were affected and when the changes become effective. Follow a uniform format for tracking SOP changes;indicate who made the revision, date of revision and the new version number. Properly archive an outgoing version and – all exisiting copies – to avoid unnecessary confusion.
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 name of the Organization, address and if possible the
department or group. The header will then include the SOP number, title, Version number, page
number, and effective date. Often, the author’s name of the SOP is in the header. At the end of the SOP, indicate a section for documenting SOP reviews with space for reviewer’s signature and date signed. If the SOP is to archived or retired, add a line to document this purpose. The page footer should include the complete filename and path.
The page header should include the name of the Organization, address and if possible the
department or group. The header will then include the SOP number, title, Version number, page
number, and effective date. Often, the author’s name of the SOP is in the header. At the end of the SOP, indicate a section for documenting SOP reviews with space for reviewer’s signature and date signed. If the SOP is to archived or retired, add a line to document this purpose. The page footer should include the complete filename and path.
Source: Published on Clinical Research Resource HUB (http://hub.ucsf.edu)
Subscribe to us
100% Free.
close
0 comments:
Post a Comment