How to Write and Manage SOPs

1. How to Write and Manage SOPs By: Farzad Dadgari Soil and Environmental Specialist SWHISA

2. Definition • SOP is a clearly written set of instruction or methods detailing the procedures for carrying out a routine or recurring task or study. • SOPs are used to describe both administrative and technical tasks.

3. Use as a management tool As a management tool SOP: • Provides a foundation for training new employees by establishing operating procedures; • Serves as a continuity tool where regular personnel are absent, enabling others to carry on the function; • Helps maintain QC by providing detailed step-by-step guidance to personnel in carrying out a certain procedure;

4. Use as a management tool (cont.) • Describe study methods that are adequate to ensure the quality and integrity of the data generated in the course of study; and • Provides a documented, historical record of an organization’s operating procedures during specific period of time.

5. Use as an Administration tool As an administration tool it can be used to: • Decide where in an organization a procedure should be carried out; • Decide what material and personnel resources are required; and • Outline the manner in which procedures are to be carried out.

6. Steps for Developing SOPs • Review your procedures & decide what should be explained in SOP. Seek input of personnel who have experience in the procedure; • Collect info on the procedure from references. Contact other organizations performing similar functions and request for their SOPs (if they have one) and modify it to suit your lab’s needs;

7. Steps for Developing SOPs (cont.) • Assemble all blank forms and other documents you will need to reference in the SOP; Assign the SOP a number and title for ID and referencing; • Write a draft of the SOP, following the guidelines provided in this presentation;

8. Steps for Developing SOPs (cont.) • Review the draft SOP for technical adequacy & administrative accuracy. Make sure SOP is written clearly and is easy to follow; • The SOP should answer the question: who, what, when, where, and how:

9. Steps for Developing SOPs (cont.) • Submit the draft SOP for peer review & supervisory approval; • Incorporate proposed changes in final version, sign and date the final version. File a copy.

10. Structure of SOP • Follow the format for administrative and technical SOPs, provided in the handout; • Divisions of SOP (paragraphs, sections, chapters), figures and tables should be numbered for ease of referencing; • If SOP is longer than 10 pages, a table of content should be prepared;

11. Structure of SOP (cont.) Content of SOP should be: • Clear, concise, and thorough, especially when listing step-by-step procedures; • Assume person using the SOP has no previous knowledge of the procedure; • Greatest enemy of a good SOP is vagueness and imprecision. SOP is of no use if no one can understand who should do what;

12. Structure of SOP (cont.) • Include only those steps that needs to be followed within immediate organization; • Be comprehensive, but do not include irrelevant matters; and • Be positive in your presentation.

13. Structure of SOP (cont.) • Only include appendixes (at the end of document) that are necessary to finish additional or supplemental material, say sample contract or list of references; • Provide glossary only if the SOP has more than 15 abbreviations; • Use illustrations only when they are essential and contribute to a cleared understanding of the subject matter and reduces the writing part of the SOP.

14. Filing the SOP • When a number of SOP is prepared, incorporate them into an SOP manual; • Place individual SOPs in a large binder, sorting it into chapters by subject matter; • Arrange chapters in a logical sequence, say administrative in one and laboratory procedures in another; • Develop a ToC in front of the binder;

15. Filing the SOPs (cont.) • Place the SOP manual with other references such as QA/QC manual , analytical and technical guidelines; • Maintain a historical registry for laboratory procedures; • The supervisor must maintain a historical file of obsolete laboratory methodologies and SOPs and revisions for future reference;

16. Filing the SOPs (cont.) • At least one copy of discontinued procedures should be filed in a binder and kept close to SOP manual; • Record the following info and attach to the SOP cover: This SOP/ laboratory methodology was in effect for the period of ….. (original effective date) through (date when SOP was removed from service). This SOP was replace by SOP … (give the SOP number, effective date and title of new SOP).

17. Updating the SOPs • Supervisor should review the SOPs at least once a year to ensure the procedures are up-to-date, reflecting the change in work environment; • If no changes are needed, the reviewing person should sign and date a cover sheet and attach it to the file copy of the SOP;

18. Updating the SOPs (cont.) • If procedures change. Rewrite the section. • Newly added material should be identified by asterisk; • If a paragraph is withdrawn (rescinded), delete the body of the paragraph but keep its original numbering and title in its original place in the text. • Mark the paragraph with an asterisk and write “withdrawn” or “rescinded” in parenthesis after the title;

19. Updating the SOP (cont.) • Prepare a memo to transmit the revised SOP to the users, indicating the number of changes and the number f changed pages;. Attach the memo to the file copy of the SOP. • If changes are extensive, revise the entire SOP and follow steps for preparing a new SOP.

20. Managing the SOPs • One person should be mandated in the laboratory to: • Assign SOP numbers for identification purposes; • Know how many copies of SOPs exist for good control, management, and revision; • Verify that all collected SOPs in the lab: • Are updated and evaluated for being up-to-date, at least annually; • Concise cover sheets to allow the supervisor to review the SOPs.