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 Cs
  (clear, complete, concise, coherent and
  consistent)

3
AGENDA

• Introduction
• Requirements and expectations
• Quality system
• Contents
• Steps in the generation / revision of an
  effective sop
• Conclusion

4
WHAT ARE SOPs?

• SOPs are written procedures that
• Establish how a task is to be performed according
  to Pfizers expectations
• Provide a reference to resources that are needed
  during process execution
• SOPs provide
• Process consistency
• Training tools for new colleagues

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

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

7
SOPs QUALITY SYSTEM
GENERATION
Employee Training Qualification
Sufficiently detailed for consistent performance
Revision Improvement as needed
IMPLEMENTATION

• MANTENANCE AND CONTROL

Employee Training Qualification
Ensure SOPs are Followed
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

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

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

11
STEP 2 - GATHERING DATA

• Documentation
• Activities

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

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

14
STEP 2 - GATHERING DATA
INVOLVING AFFECTED PERSONNEL, INCREASES THE LEVEL
OF FULFILLMENT
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

16
STEP 3 - ANALYZING DATA

• Decide on the type of SOP
• Administrative
• Narrative description of a process
• What happens
• Operational
• Tasks require physical activity
• Tasks performed in sequential order
• How to do it

17
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

18
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

19
STEP 4 - ORGANIZING DATA

• Organize the information according to
• Type of SOP
• Administrative
• Operational
• Type of Information
• Knowledge
• Procedure

20
STEP 4 - ORGANIZING DATA

• KNOWLEDGE
• Purpose
• Scope
• Responsibilities
• References
• Table of Contents
• Definitions
• Safety Environmental
• General Information
• Frequency
• Team
• Changes Log
• Annexes

• PROCEDURE
• Procedure

21
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.

22
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

23
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

24
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      

25
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  

26
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

27
STEP 4 - ORGANIZING DATAProcedure

• DESCRIPTIVE

• DESCRIPTIVE

• Simple
• Frequent
• Not very Critical
• (Quality, Safety)
• Few users
• Described in (an)other SOPs

• Complex
• Infrequent
• Highly Critical
• (Quality, Safety)
• Many Users
• Not covered in another SOP

28
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

29
STEP 4 - ORGANIZING DATA
Subject Verb Object Conditions
WHO
WHAT
WHERE WHEN HOW WITH WHAT
TO WHAT
Example Operator to clean the walls and floor at
least once a week.
Note English only different for other languages
30
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

31
STEP 5 - WRITING THE SOP

• Technical vs. Creative writing
• Creative entertains
• Technical transmits information

32
STEP 5 - WRITING THE SOP

• The information should be
• Clear
• Concise
• Complete
• Coherent
• Consistent

5 Cs
33
STEP 5 - WRITING THE SOP

• Clear
• Precise worded correctly
• Familiar language
• Allow only one interpretation

34
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.

35
STEP 5 - WRITING THE SOP

• Concise
• Simple words, with few syllables
• Short sentences
• Short paragraphs
• Avoid redundancy

This is not a literary contest!
36
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

37
STEP 5 - WRITING THE SOP

• Coherent
• Presents a logical order for the process
• Lists steps sequentially
• Presents 1 idea/step per sentence

38
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)

39
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
40
STEP 5 - WRITING THE SOP

• Example Diagram
• Source The Theory Practice of Industrial
  Pharmacy

41
STEP 5 - WRITING THE SOP

• Example - Visual Aid
• Source Ringaskiddy OSP

42
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

43
STEP 5 - WRITING THE SOP

• Procedure
• Do not write steps that are too simple for the
  user
• Example
• Turn on the computer
• Press ENTER

44
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   

45
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

46
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

47
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            

48
STEP 6 REVIEW THE DRAFT

• Make sure all information is relevant
• Necessary
• Contributes to the purpose
• Relates to the unit/department concerned          
         

49
STEP 6 REVIEW THE DRAFT

• Avoid reader overload
• Ensure there is enough white space.
• Verify abbreviations and acronyms
• Define new terminology

50
STEP 6 - REVIEW THE DRAFT

• Revise SOP by executing the process in a real
  work environment (wherever possible)

51
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

52
STEP 7 - APPROVING THE SOP

• Approval process should ensure the SOP
• Is approved by appropriate personnel
• Reflects accepted practices
• Is easy to read follow
• Is technically correct
• Complies with PGM regulatory requirements

53
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

54
CONCLUSION

• Properly written SOPs
• Establish the basis for training
• Information tool for executors/colleagues
• Standardize task performance
• Minimize RFT variation
• Satisfy regulatory requirements

55
REFERENCES

• Parrilla, Sandra Writing Effective SOPs
  Training Presentation
• Charlton, Erica, Effective Standard Operating
  Procedures in a Regulatory Environment,
  Pharmaceutical Engineering, July/August 2003,p.
  44-48.
• Vesper, James L, Writing Procedures That
  Contribute to Performance, BioPharm
  Magazine, A Learning Plus reprint.
• Gough, Janet, Write It Down Guidance for
  Preparing Documentation that Meets Regulatory
  Requirements, Interpharm Press, Oct 1999.

56
FINALLY

• Thank you
• Questions
• Please
• Sign your training record
• Complete the learning assessment