Writing effective sops
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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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