WRITING EFFECTIVE SOPs

1. WRITING EFFECTIVE SOPs Center Quality Operations Training and Program Development

2. OBJECTIVES • On completing this training you will be able to: • Distinguish between knowledge and procedural type information in an SOP. • Identify information that complies with the 5 C’s (clear, complete, concise, coherent and consistent) Prepared by Victoria Niven – Sept 2008

3. AGENDA • Introduction • Requirements and expectations • Quality system • Contents • Steps in the generation / revision of an effective sop • Conclusion Prepared by Victoria Niven – Sept 2008

4. WHAT ARE SOPs? • SOPs are written procedures that: • Establish how a task is to be performed according to Pfizer’s expectations • Provide a reference to resources that are needed during process execution • SOPs provide: • Process consistency • Training tools for new colleagues Prepared by Victoria Niven – Sept 2008

5. WHY DO WE NEED SOPs? • Regulatory expectation • Auditors will check: • Do we have the required sops to cover our work activities? • Are our SOPs current? • Do we really follow our SOPs? • Can we show/prove we followed our SOPs? • SOPs are a fundamental part of our overall Quality System Prepared by Victoria Niven – Sept 2008

6. SOPs – QUALITY SYSTEM • To ensure compliance for our SOPs, we need to pay attention to: • Accessibility • Format • Content • System of Control • Culture of Compliance Prepared by Victoria Niven – Sept 2008

7. MANTENANCE AND CONTROL SOPs SOPs – QUALITY SYSTEM GENERATION Employee Training & Qualification Sufficiently detailed for consistent performance Revision & Improvement as needed IMPLEMENTATION Employee Training & Qualification Ensure SOPs are Followed Prepared by Victoria Niven – Sept 2008

8. 7 STEPS FOR SOP GENERATION • Identify creator / collaborators • Gather information • Analyze the information • Organize the information • Write the SOP • Review the SOP • Approve the SOP Prepared by Victoria Niven – Sept 2008

9. STEP 1 - CREATOR / COLLABORATORS • Creator / Reviewer – Person Performing task or working with person performing the task • Collaborators - Must have a good grasp of the process, e.g. • The Supervisor • Safety and Environmental Personnel • Process Engineer • Quality Specialist Prepared by Victoria Niven – Sept 2008

10. 7 STEPS FOR SOP GENERATION • Identify creator / collaborators • Gather information • Analyze the information • Organize the information • Write the SOP • Review the SOP • Approve the SOP Prepared by Victoria Niven – Sept 2008

11. STEP 2 - GATHERING DATA • Documentation • Activities Prepared by Victoria Niven – Sept 2008

12. STEP 2 - GATHERING DATA • Documentation • Pfizer Quality Standards (PQS) • Related SOPs • Other documents • Manufacturing record • Packaging record • Analytical methods • Team manual • Validation protocols • Qualification protocols Prepared by Victoria Niven – Sept 2008

13. STEP 2 - GATHERING DATA • Perform activities • Examine the work area • Observe process and task execution • List executed tasks in sequence • Create an operation flow chart • Interview users Prepared by Victoria Niven – Sept 2008

14. STEP 2 - GATHERING DATA INVOLVING AFFECTED PERSONNEL, INCREASESTHE LEVEL OF FULFILLMENT Prepared by Victoria Niven – Sept 2008

15. 7 STEPS FOR SOP GENERATION • Identify creator / collaborators • Gather information • Analyze the information • Organize the information • Write the SOP • Review the SOP • Approve the SOP Prepared by Victoria Niven – Sept 2008

16. STEP 3 - ANALYZING DATA • Decide on the type of information • Knowledge • Description of a process and/or structure • Fact, principle, concept • “What happens” • Procedure • Action, instruction • “How to do it” Prepared by Victoria Niven – Sept 2008

17. 7 STEPS FOR SOP GENERATION • Identify creator / collaborators • Gather information • Analyze the information • Organize the information • Write the SOP • Review the SOP • Approve the SOP Prepared by Victoria Niven – Sept 2008

18. STEP 4 - ORGANIZING DATA • Organize the information according to: • Type of SOP • Administrative • Operational • Type of Information • Knowledge • Procedure Prepared by Victoria Niven – Sept 2008

19. KNOWLEDGE Purpose Scope Responsibilities References Table of Contents Definitions Safety & Environmental General Information Frequency Team Changes Log Annexes PROCEDURE Procedure STEP 4 - ORGANIZING DATA Prepared by Victoria Niven – Sept 2008

20. STEP 4 - ORGANIZING DATA Knowledge • Purpose / aim • Expands on information in the title • Brief statement explaining reason for the procedure • Example • Describe the format to be followed when preparing standard operation procedures (sops). Provide instructions for the creation, control, distribution, and revision of sops. Prepared by Victoria Niven – Sept 2008

21. STEP 4 - ORGANIZING DATA Knowledge • Scope • Describes operations covered by procedure (not the department) • Establishes start and end points • From action to action • From task to task • From stage to stage • From area to area • From location to location Prepared by Victoria Niven – Sept 2008

22. STEP 4 - ORGANIZING DATA Knowledge • Scope – Plan to have short SOPs • 2 to 6 pages • Advantages • Easier to develop & maintain • Less intimidating for the user • Disadvantages • Increased number of SOPs Prepared by Victoria Niven – Sept 2008

23. STEP 4 - ORGANIZING DATA Knowledge • Responsibilities • Primary responsibility • Persons who perform the defined tasks (executors) • Secondary responsibility • Persons responsible for the execution of the task but do not perform the task directly • General audience • Persons that may need to know something about the procedure but do not use it directly       Prepared by Victoria Niven – Sept 2008

24. STEP 4 - ORGANIZING DATA Knowledge • General information • A principle or fact which should be known by an audience in order to execute the procedure • Generally answers the question “why?” • Specific information • A principle or fact applied to specific sections within the procedure   Prepared by Victoria Niven – Sept 2008

25. STEP 4 - ORGANIZING DATA Procedure • PROCEDURE • WHO – Position responsible for performing task/action • WHAT – The Action/Task • WHERE – Location of the Action/Task • WHEN – Hour, Day, Stage, Shift • HOW – Method, Technique, Form • WITH WHAT– Materials, Instruments, Equipment, Resources to Use Prepared by Victoria Niven – Sept 2008

26. Complex Infrequent Highly Critical (Quality, Safety) Many Users Not covered in another SOP Simple Frequent Not very Critical (Quality, Safety) Few users Described in (an)other SOPs STEP 4 - ORGANIZING DATAProcedure • DESCRIPTIVE • DESCRIPTIVE Prepared by Victoria Niven – Sept 2008

27. Examples of Task Instructions • Low Detail: Wash XYZ containers • Medium Detail: Wash XYZ containers in the MDT cabinet washer Use setting #3 • High Detail: Wash XYZ containers • Load XYZ containers into washer trolley with open ends facing down • Place trolley into the MDT cabinet washer • Secure cabinet door • Position cycle dial to setting #3 Prepared by Victoria Niven – Sept 2008

28. Depends Upon SOP Detail STEP 4 - ORGANIZING DATA • Subject Verb Object Conditions WHO WHAT TO WHAT WHERE WHEN HOW WITH WHAT Example Operator to clean the walls and floor at least once a week. Note: English only – different for other languages Prepared by Victoria Niven – Sept 2008

29. 7 STEPS FOR SOP GENERATION • Identify creator / collaborators • Gather information • Analyze the information • Organize the information • Write the SOP • Review the SOP • Approve the SOP Prepared by Victoria Niven – Sept 2008

30. STEP 5 - WRITING THE SOP • Technical vs. Creative writing • Creative – entertains • Technical – transmits information Prepared by Victoria Niven – Sept 2008

31. STEP 5 - WRITING THE SOP • The information should be: • Clear • Concise • Complete • Coherent • Consistent 5C’s Prepared by Victoria Niven – Sept 2008

32. STEP 5 - WRITING THE SOP • Clear • Precise & worded correctly • Familiar language • Allow only one interpretation Prepared by Victoria Niven – Sept 2008

33. STEP 5 - WRITING THE SOP • Clear Statement? • Laboratory Technician must review the data with the QC Manager, sign and release the lot. • Interpretation 1: • Laboratory Technician reviews the data and signs. Then the QC Manager reviews the data and also signs. The QC Manager releases the lot. • Interpretation 2: • After reviewing the data with the QC Manager, the Laboratory Technician signs and releases the lot on their own. Prepared by Victoria Niven – Sept 2008

34. STEP 5 - WRITING THE SOP • Concise • Simple words, with few syllables • Short sentences • Short paragraphs • Avoid redundancy This isnot a literary contest! Prepared by Victoria Niven – Sept 2008

35. STEP 5 - WRITING THE SOP • Complete • Contains all information to obtain desired result • Too descriptive could be too restrictive • Used infrequently  MORE detailed • Used very frequently LESS detailed Prepared by Victoria Niven – Sept 2008

36. STEP 5 - WRITING THE SOP • Coherent • Presents a logical order for the process • Lists steps sequentially • Presents 1 idea/step per sentence Prepared by Victoria Niven – Sept 2008

37. STEP 5 - WRITING THE SOP • Consistent • Use the same terminology within and between SOPs • E.G. Use equipment names or ID numbers • E.G. Use metric measurements • E.G. Use of room names / locations • Use of attachments and appendix • Same place in SOP • Same reference (A, B, or 1. 2) Prepared by Victoria Niven – Sept 2008

38. STEP 5 - WRITING THE SOP • Use graphic material when possible: pictures, drawings, graphics, tables • Reduces number of words • Simplifies complex information • Helps people remember • Clarifies technical language Place graphics next to step & on the same page Prepared by Victoria Niven – Sept 2008

39. STEP 5 - WRITING THE SOP • Example Diagram • Source: The Theory & Practice of Industrial Pharmacy Prepared by Victoria Niven – Sept 2008

40. STEP 5 - WRITING THE SOP • Example - Visual Aid • Source: Ringaskiddy OSP Prepared by Victoria Niven – Sept 2008

41. STEP 5 - WRITING THE SOP • Special information • Notes • Highlight info that clarifies an action or condition. • Helps make decisions or improve task performance • Warning • Alerts to a possible risk for personnel • Caution • Alerts to possible damages to the product or equipment Prepared by Victoria Niven – Sept 2008

42. STEP 5 - WRITING THE SOP • Procedure • Do not write steps that are too simple for the user • Example • Turn on the computer • Press “ENTER” Prepared by Victoria Niven – Sept 2008

43. STEP 5 - WRITING THE SOP • SOP Title • Must be clear and brief • Must be descriptive • State what is done to what • E.G. Operation of the water distiller    Prepared by Victoria Niven – Sept 2008

44. 7 STEPS FOR SOP GENERATION • Identify creator / collaborators • Gather information • Analyze the information • Organize the information • Write the SOP • Review the SOP • Approve the SOP Prepared by Victoria Niven – Sept 2008

45. STEP 6 - REVIEW THE DRAFT • The best person to review the draft is the person most familiar with process • In addition, have someone NOT familiar with process give feedback Prepared by Victoria Niven – Sept 2008

46. STEP 6 – REVIEW THE DRAFT • When reviewing a document, it is effective to read the document twice • 1st time without a pen • Feedback on overall flow and usability • 2nd time with a pen • Specific improvements    Prepared by Victoria Niven – Sept 2008

47. STEP 6 – REVIEW THE DRAFT • Make sure all information is relevant • Necessary • Contributes to the purpose • Relates to the unit/department concerned                  Prepared by Victoria Niven – Sept 2008

48. STEP 6 – REVIEW THE DRAFT • Avoid reader overload • Ensure there is enough ‘white space’. • Verify abbreviations and acronyms • Define new terminology Prepared by Victoria Niven – Sept 2008

49. STEP 6 - REVIEW THE DRAFT • Revise SOP by executing the process in a real work environment (wherever possible) Prepared by Victoria Niven – Sept 2008

50. 7 STEPS FOR SOP GENERATION • Identify creator / collaborators • Gather information • Analyze the information • Organize the information • Write the SOP • Review the SOP • Approve the SOP Prepared by Victoria Niven – Sept 2008