1. Deborah A Wenger Consultant Training and Regulatory Compliance Downingtown, PA 484-354-5577 dbwengrich@comcast.net

2.  Identify the purpose of an SOP  Identify the basic elements of the Basic SOP Writing Cycle  Examine SOP Drafting Techniques for SOPs  Recognize the ten principle guidelines for writing SOPS  Examine an SOP Format Theseus Professional Services, LLC

5. 1. Develop a plan! 2. Determine title, purpose, and scope 3. Find a sample and template 4. Collect information 5. Draft the SOP 6. Conduct peer review 7. Get management acceptance 8. Validate 9. Submit for approval 10. Provide training 11. Release 12. Check Implementation 13. Revise as necessary

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7.  What information is needed?  Where will it come from?  Data collection methods  Collecting data  Time management Theseus Professional Services, LLC

8. “A picture is worth a thousand words.” “A flowchart is worth a thousand procedures.” So what is a flowchart?  A method of graphically describing an existing process or a proposed process by using simple symbols, lines, or words to display pictorially the activities and sequence in the process. Source: Harrington, H.J., Business Process Improvement, McGraw-Hill, 1991 Theseus Professional Services, LLC

9.  Advantage:  Many decisions and steps  Complex processes  Emergency/critical procedures  Disadvantage:  Minimal detail  Effort to produce and maintain Theseus Professional Services, LLC

11. Mind Map uses words, lines, colors, images, and even sounds to stimulate the brain! Theseus Professional Services, LLC

12.  Characteristics:  Subject represented by a central image  Main themes of the subject radiate from the central image as main branches  Minor themes linked to the main themes  Branches connected forming a nodal structure Theseus Professional Services, LLC

14.  Grammar – Principles 1 to 5  Accuracy/Clarity – Principles 6 to 7  Format – Principles 8 to 10 Sticklers Unite! Theseus Professional Services, LLC

15.  Use Simple Command Statements Action Verb  Object  Supportive Information  Begin with action verb  Omit:  Shall / You / Articles (except for clarity)  Describe object of the verb  Identify it precisely  Complete step with supportive information  Location  Object modifier Theseus Professional Services, LLC

16. Simple Command Statements? Y/N:Load cages on 3-sided rack. Y/N:Put on protective clothing before entering animal holding area. Y/N:Before and after leaving building wash hands. Y/N:The room shall remain locked when the receiving clerk or other authorized personnel are not presented. Theseus Professional Services, LLC

17. Keep Action Steps Simple  Use short, precise sentences  Limit action verbs  Use language that provides direct commands and avoids complex terms (readability factor)  Avoid hidden instructions  Keep steps free of explanatory information  Avoid vague pronouns  Use standard and consistent acronyms, abbreviations, terms, and definitions Theseus Professional Services, LLC

18. Action Steps Simple? Y/N:Remove, shake, and stack clean cages. Y/N:Turn workstation blower on. Gauges should measure flow. Use: Cage Wash versus Cagewash? Use: Disinfectant versus sterilant? Theseus Professional Services, LLC

19. Avoid the Passive Voice  Weak method of expressing action  Comprehension best at beginning of sentence  Passive voice leads to doubt Theseus Professional Services, LLC

20. Passive Voice? Y/N:Soiled disposable garments will be discarded for next entry. Y/N:The HEPA vacuum will not be used on the dirty side of the facility. Theseus Professional Services, LLC

21. Use Parallel Structure  Write headings and words using the same tense, ending, or other value  Quickly helps users read and comprehend  Fit steps to a pattern Examples 1. Remove cage from rack. 2. Place caging in workstation. Trafficking involves reading procedures and the observation of posters. Theseus Professional Services, LLC

22. State Condition First  Use conditional action steps to make a decision  if, then, when, or, and  Write conditional statement first, followed by the action  If pH is below 6 or above 10, then notify a supervisor  Use expected and unexpected conditional steps  Separate multiple conditions from instructions  Emphasize conditional words  Use positive statements  Avoid using and and or in the same statement Theseus Professional Services, LLC

23. Condition Stated First? Y/N:Disposable clothing may be saved at housing area exits if not soiled for next entry. Y/N:When going between animal holding areas and before and after leaving building wash hands. Theseus Professional Services, LLC

24. Identify the Responsible Person  Address procedure to primary user  Identify who is responsible for what  Use job titles consistently  Visually emphasize tasks and responsible performer Theseus Professional Services, LLC

25. Use Quantitative Information  Specify quantitative rather than qualitative  Use standard units of measure  Provide a well defined range of measurement Theseus Professional Services, LLC

26. List Multiple Objects  Single verb followed by several objects Verify the temperature, pressure, and pH level  List in a vertical format (bullets, dashes, asterisks)  Number only to indicate order of performance  List three or more objects of a verb Sample sentinel cage 1, 3, and 5  Use charts and matrixes to present a series of objects Theseus Professional Services, LLC

27. Emphasize Important Information  Information which if overlooked or misinterpreted could result in user error or injury: Warnings alert users to potential hazards to personnel or animals Cautions alert users to potential hazards to products or equipment Alerts advise users of important information when neither danger to individual or equipment is involved Notes call attention to important supplement information Theseus Professional Services, LLC

28.  Use short, concise statements  Do not include action steps  Position before or on same page as step(s) that apply  Remember an SOP is not a training manual Theseus Professional Services, LLC

29. WARNING WEAR RUBBER GLOVES AND FACE SHIELD OR GOGGLES WHEN MIXING CLIDOX CAUTION CHARGE BATTERIES IN A WELL VENTILATED AREA ALERT Do Not Change Switch Unless Power Is Off – Equipment Settings May Be Lost NOTE No smoking allowed within 50 feet of building Theseus Professional Services, LLC

30. APPLICATION:WARNINGCAUTION & NOTES LISTSLOGIC STEPS REFERENCES EMPHASIS TECHNIQUE: Boxed, centered, bold type, all caps Boxed, centered, bold type, initial caps BulletedIndentedInitial caps Theseus Professional Services, LLC

31. Use Referencing and Branching Appropriately  Information already exists or is in another SOP  So what is referencing and branching? Referencing directs users to other steps or sections within the procedure, or to other procedures, and then back to the initial point Branching routes users to other steps or sections within the procedure, or to other procedures, but the user does not return to the initial departure point Theseus Professional Services, LLC

32. Use Referencing and Branching Appropriately User errors  Overlook warnings, cautions, and notes  Lose track of exit and entry points  Get into endless loops  Work becomes hard to track  Rely on memory Theseus Professional Services, LLC

33. Use Referencing and Branching Appropriately Guidelines  For two or three steps, repeat steps  Cite your source  Point user to important information (warnings, cautions, prerequisites, etc.)  Make it clear where the return point is or what steps can be skipped  Avoid unnecessarily going forward or backward Theseus Professional Services, LLC

34. Use Referencing and Branching Appropriately Reference wording  …using SOP 110, Procuring Animals  …in accordance with manufacturer’s instructions  Refer to SOP 160, Cage Wash Operations  Record results on Attachment 1, Census Report Branch verbs  Go to / Proceed to / Return to / Repeat Theseus Professional Services, LLC

35. Grammar 1. Use Simple Command Statements 2. Keep Action Steps Simple 3. Avoid the Passive Voice 4. Use Parallel Structure 5. State the Condition First Accuracy/Clarity 6. Identify the Responsible Person 7. Use Quantitative Information Format 8. List Multiple Objects 9. Emphasize Important Information 10. Use Referencing and Branching Appropriately Theseus Professional Services, LLC

37.  Assures tasks are done properly  Consistent structure for all facility documents  Easy for user to use  Easy to write other SOPs  Easy to review and approve (process followed)  Identifies important information  Provides level of confidence to outside examiners

38. Theseus Professional Services, LLC Header Body Footer After 1 st page? Needed? Watch for white space!

39. Theseus Professional Services, LLC  Animal Care International Special Procedures During Gestation and Weaning of Rodents SOP 24G-104 Rev. 0 (# vs. letter) Approved by:Effective Date: June 8, 2003 Date:Page 1 of 2 Optional Organization Title Footer Reference Only When Printed – Destroy After Use (or) Only Use on Date Printed – Last printed 10/10/2003 8:31 AM Form Number

40. Theseus Professional Services, LLC 1. Purpose 2. Scope 3. Applicability 4. Precautions and Limitations 5. Terms, Definitions, Acronyms, Abbreviations, and References 6. Responsibilities 7. Performance Section 8. Post Performance Activity Test Restoration 9. Results 10. Records 11. Appendixes and Attachments I. Introduction IV. Post-Work III. Work II. Prerequisites V. Results VI. Support

41. Theseus Professional Services, LLC 6.0Quarantine Sanitation 6.1Equipment and Supplies 6.1.1Wipe down all equipment and supplies with a sterilant 6.1.2Do not reuse cleaning equipment (e.g., mop heads, sponges, etc.) after wiped down 6.2Floors and Flat Surfaces 6.2.1Disinfect floors and flat surfaces daily 7.0Exit from Quarantine Area Spacing Style ? ?

42. Theseus Professional Services, LLC Writing SOPs That Work!