WRITING EFFECTIVE SOPs

WRITING EFFECTIVE WRITING EFFECTIVE SOPsSOPs

WRITING EFFECTIVE WRITING EFFECTIVE SOPsSOPs

Center Quality OperationsCenter Quality OperationsTraining and Program Training and Program

DevelopmentDevelopment

Prepared by Victoria Niven – Sept 2008 Slide 2

OBJECTIVES

o 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)


AGENDA

o Introduction• Requirements and expectations• Quality system

o Contents• Steps in the generation / revision of an

effective sop

o Conclusion


WHAT ARE SOPs?

o 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 executiono SOPs provide:

– Process consistency– Training tools for new colleagues


WHY DO WE NEED SOPs?

o 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?

o SOPs are a fundamental part of our overall Quality System


SOPs – QUALITY SYSTEM

o To ensure compliance for our SOPs, we need to pay attention to:– Accessibility– Format– Content– System of Control – Culture of Compliance


SOPs – QUALITY SYSTEM

GENERATIONSOPsSOPs

Revision & Improvement as needed IMPLEMENTATION

MANTENANCE AND CONTROL Employee Training & Qualification

Sufficiently detailed for consistent performance

Ensure SOPs are Followed

Employee Training & Qualification


7 STEPS FOR SOP GENERATION

1. Identify creator / collaborators

2. Gather information3. Analyze the information4. Organize the information5. Write the SOP6. Review the SOP7. Approve the SOP


STEP 1 - CREATOR / COLLABORATORS

o Creator / Reviewer – Person Performing task or working with person performing the task

o Collaborators - Must have a good grasp of the process, e.g.– The Supervisor– Safety and Environmental Personnel– Process Engineer– Quality Specialist






STEP 2 - GATHERING DATA

o Documentationo Activities



o Documentation– Pfizer Quality Standards (PQS)– Related SOPs– Other documents

• Manufacturing record• Packaging record• Analytical methods• Team manual• Validation protocols• Qualification protocols



o Perform activities– Examine the work area – Observe process and task execution – List executed tasks in sequence– Create an operation flow chart– Interview users



INVOLVING AFFECTED PERSONNEL, INCREASES THE LEVEL OF FULFILLMENT

INVOLVING AFFECTED PERSONNEL, INCREASES THE LEVEL OF FULFILLMENT




2. Gather information3. Analyze the

information4. Organize the information5. Write the SOP6. Review the SOP7. Approve the SOP


STEP 3 - ANALYZING DATA

o 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”




2. Gather information3. Analyze the information4. Organize the

information5. Write the SOP6. Review the SOP7. Approve the SOP


STEP 4 - ORGANIZING DATA

o Organize the information according to:– Type of SOP

• Administrative• Operational

– Type of Information• Knowledge• Procedure



KNOWLEDGEo Purposeo Scopeo Responsibilitieso Referenceso Table of Contentso Definitionso Safety & Environmentalo General Informationo Frequencyo Teamo Changes Logo Annexes

PROCEDURE

o Procedure


STEP 4 - ORGANIZING DATA Knowledge

o Purpose / aim– Expands on information in the title– Brief statement explaining reason for the

procedure

o Example– Describe the format to be followed when

preparing standard operation procedures (sops). Provide instructions for the creation, control, distribution, and revision of sops.



o 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



o Scope – Plan to have short SOPs– 2 to 6 pages

o Advantages– Easier to develop & maintain– Less intimidating for the user

o Disadvantages– Increased number of SOPs



o 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



o General information– A principle or fact which should be

known by an audience in order to execute the procedure

– Generally answers the question “why?”

o Specific information– A principle or fact applied to specific

sections within the procedure


STEP 4 - ORGANIZING DATA Procedure

o 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


STEP 4 - ORGANIZING DATAProcedure

o Complexo Infrequento Highly Critical

– (Quality, Safety)

o Many Userso Not covered in

another SOP

o Simpleo Frequento Not very Critical

– (Quality, Safety)

o Few userso Described in

(an)other SOPs

DESCRIPTIVE DESCRIPTIVE


Examples of Task Instructions

o Low Detail:Wash XYZ containers

o Medium Detail:Wash XYZ containers in the MDT cabinet washerUse setting #3

o High Detail:Wash XYZ containers1. Load XYZ containers into washer trolley with

open ends facing down2. Place trolley into the MDT cabinet washer3. Secure cabinet door4. Position cycle dial to setting #3



WHO WHAT WHEREWHEN HOWWITH WHAT

TO WHAT

Subject Verb Object Conditions

Example

Operator to clean the walls and floor at least once a week.

Depends Upon SOP

Detail

Note: English only – different for other languages






STEP 5 - WRITING THE SOP

o Technical vs. Creative writing– Creative – entertains – Technical – transmits information



oThe information should be: • Clear• Concise• Complete• Coherent• Consistent

55 C’sC’s55 C’sC’s



o Clear– Precise & worded

correctly– Familiar language– Allow only one

interpretation



o Clear Statement?– Laboratory Technician must review the data with the

QC Manager, sign and release the lot.

o 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.

o Interpretation 2:– After reviewing the data with the QC Manager, the

Laboratory Technician signs and releases the lot on their own.



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

This isThis is not a literary contest!not a literary contest!This isThis is not a literary contest!not a literary contest!



o Complete – Contains all information to obtain

desired result

– Too descriptive could be too restrictive• Used infrequently MORE detailed• Used very frequently LESS detailed



o Coherent– Presents a logical order for the

process– Lists steps sequentially– Presents 1 idea/step per sentence



o 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)



o 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 pagePlace graphics next to step & on the same page



o Example Diagram– Source: The Theory & Practice of Industrial

Pharmacy



o Example - Visual Aid– Source: Ringaskiddy OSP



o 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



o Procedure– Do not write steps that are too simple

for the user– Example

• Turn on the computer• Press “ENTER”



o SOP Title– Must be clear and brief– Must be descriptive

• State what is done to what

– E.G. Operation of the water distiller






STEP 6 - REVIEW THE DRAFT

o The best person to review the draft is the person most familiar with process

o In addition, have someone NOT familiar with process give feedback


STEP 6 – REVIEW THE DRAFT

o 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



o Make sure all information is relevant– Necessary– Contributes to the purpose– Relates to the unit/department

concerned



o Avoid reader overload– Ensure there is enough ‘white space’.

o Verify abbreviations and acronymso Define new terminology


STEP 6 - REVIEW THE DRAFT

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






STEP 7 - APPROVING THE SOP

o 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






CONCLUSION

o Properly written SOPs: – Establish the basis for training– Information tool for

executors/colleagues– Standardize task performance– Minimize “RFT” variation– Satisfy regulatory requirements


REFERENCES

o Parrilla, Sandra “Writing Effective SOPs” Training Presentation

o Charlton, Erica, Effective Standard Operating Procedures in a Regulatory Environment, Pharmaceutical Engineering, July/August 2003,p. 44-48.

o Vesper, James L, Writing Procedures That Contribute to Performance, BioPharm Magazine, A Learning Plus reprint.

o Gough, Janet, Write It Down: Guidance for Preparing Documentation that Meets Regulatory Requirements, Interpharm Press, Oct 1999.


FINALLY

o Thank you

o Questions

o Please:– Sign your training record– Complete the learning assessment

Documents

WRITING EFFECTIVE SOPs