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WRITING EFFECTIVE SOPs. Center Quality Operations Training and Program Development. OBJECTIVES. On completing this training you will be able to: Distinguish between knowledge and procedural type information in an SOP.

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writing effective sops

WRITING EFFECTIVE SOPs

Center Quality Operations

Training and Program Development

objectives
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

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

Prepared by Victoria Niven – Sept 2008

what are sops
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

why do we need sops
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

sops quality system
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

sops quality system1
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

7 steps for sop generation
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

step 1 creator collaborators
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

7 steps for sop generation1
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

step 2 gathering data
STEP 2 - GATHERING DATA
  • Documentation
  • Activities

Prepared by Victoria Niven – Sept 2008

step 2 gathering data1
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

step 2 gathering data2
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

step 2 gathering data3
STEP 2 - GATHERING DATA

INVOLVING AFFECTED PERSONNEL, INCREASESTHE LEVEL OF FULFILLMENT

Prepared by Victoria Niven – Sept 2008

7 steps for sop generation2
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

step 3 analyzing data
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

7 steps for sop generation3
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

step 4 organizing data
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

step 4 organizing data1
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

step 4 organizing data knowledge
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

step 4 organizing data knowledge1
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

step 4 organizing data knowledge2
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

step 4 organizing data knowledge3
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

step 4 organizing data knowledge4
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

step 4 organizing data procedure
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

step 4 organizing data procedure1
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

examples of task instructions
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

step 4 organizing data2

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

7 steps for sop generation4
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

step 5 writing the sop
STEP 5 - WRITING THE SOP
  • Technical vs. Creative writing
    • Creative – entertains
    • Technical – transmits information

Prepared by Victoria Niven – Sept 2008

step 5 writing the sop1
STEP 5 - WRITING THE SOP
  • The information should be:
      • Clear
      • Concise
      • Complete
      • Coherent
      • Consistent

5C’s

Prepared by Victoria Niven – Sept 2008

step 5 writing the sop2
STEP 5 - WRITING THE SOP
  • Clear
    • Precise & worded correctly
    • Familiar language
    • Allow only one interpretation

Prepared by Victoria Niven – Sept 2008

step 5 writing the sop3
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

step 5 writing the sop4
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

step 5 writing the sop5
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

step 5 writing the sop6
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

step 5 writing the sop7
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

step 5 writing the sop8
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

step 5 writing the sop9
STEP 5 - WRITING THE SOP
  • Example Diagram
    • Source: The Theory & Practice of Industrial Pharmacy

Prepared by Victoria Niven – Sept 2008

step 5 writing the sop10
STEP 5 - WRITING THE SOP
  • Example - Visual Aid
        • Source: Ringaskiddy OSP

Prepared by Victoria Niven – Sept 2008

step 5 writing the sop11
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

step 5 writing the sop12
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

step 5 writing the sop13
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

7 steps for sop generation5
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

step 6 review the draft
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

step 6 review the draft1
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

step 6 review the draft2
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

step 6 review the draft3
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

step 6 review the draft4
STEP 6 - REVIEW THE DRAFT
  • Revise SOP by executing the process in a real work environment (wherever possible)

Prepared by Victoria Niven – Sept 2008

7 steps for sop generation6
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

step 7 approving the sop
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

Prepared by Victoria Niven – Sept 2008

7 steps for sop generation7
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

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

Prepared by Victoria Niven – Sept 2008

references
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.

Prepared by Victoria Niven – Sept 2008

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

Prepared by Victoria Niven – Sept 2008

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