WRITING EFFECTIVE SOPs
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Transcript of 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)
Prepared by Victoria Niven – Sept 2008 Slide 3
AGENDA
o Introduction• Requirements and expectations• Quality system
o Contents• Steps in the generation / revision of an
effective sop
o Conclusion
Prepared by Victoria Niven – Sept 2008 Slide 4
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
Prepared by Victoria Niven – Sept 2008 Slide 5
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
Prepared by Victoria Niven – Sept 2008 Slide 6
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
Prepared by Victoria Niven – Sept 2008 Slide 7
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
Prepared by Victoria Niven – Sept 2008 Slide 8
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
Prepared by Victoria Niven – Sept 2008 Slide 9
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
Prepared by Victoria Niven – Sept 2008 Slide 10
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
Prepared by Victoria Niven – Sept 2008 Slide 11
STEP 2 - GATHERING DATA
o Documentationo Activities
Prepared by Victoria Niven – Sept 2008 Slide 12
STEP 2 - GATHERING DATA
o 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 Slide 13
STEP 2 - GATHERING DATA
o 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 Slide 14
STEP 2 - GATHERING DATA
INVOLVING AFFECTED PERSONNEL, INCREASES THE LEVEL OF FULFILLMENT
INVOLVING AFFECTED PERSONNEL, INCREASES THE LEVEL OF FULFILLMENT
Prepared by Victoria Niven – Sept 2008 Slide 15
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
Prepared by Victoria Niven – Sept 2008 Slide 17
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”
Prepared by Victoria Niven – Sept 2008 Slide 18
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
Prepared by Victoria Niven – Sept 2008 Slide 19
STEP 4 - ORGANIZING DATA
o Organize the information according to:– Type of SOP
• Administrative• Operational
– Type of Information• Knowledge• Procedure
Prepared by Victoria Niven – Sept 2008 Slide 20
STEP 4 - ORGANIZING DATA
KNOWLEDGEo Purposeo Scopeo Responsibilitieso Referenceso Table of Contentso Definitionso Safety & Environmentalo General Informationo Frequencyo Teamo Changes Logo Annexes
PROCEDURE
o Procedure
Prepared by Victoria Niven – Sept 2008 Slide 21
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.
Prepared by Victoria Niven – Sept 2008 Slide 22
STEP 4 - ORGANIZING DATA Knowledge
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
Prepared by Victoria Niven – Sept 2008 Slide 23
STEP 4 - ORGANIZING DATA Knowledge
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
Prepared by Victoria Niven – Sept 2008 Slide 24
STEP 4 - ORGANIZING DATA Knowledge
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
Prepared by Victoria Niven – Sept 2008 Slide 25
STEP 4 - ORGANIZING DATA Knowledge
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
Prepared by Victoria Niven – Sept 2008 Slide 26
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
Prepared by Victoria Niven – Sept 2008 Slide 27
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
Prepared by Victoria Niven – Sept 2008 Slide 28
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
Prepared by Victoria Niven – Sept 2008 Slide 29
STEP 4 - ORGANIZING DATA
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
Prepared by Victoria Niven – Sept 2008 Slide 30
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
Prepared by Victoria Niven – Sept 2008 Slide 31
STEP 5 - WRITING THE SOP
o Technical vs. Creative writing– Creative – entertains – Technical – transmits information
Prepared by Victoria Niven – Sept 2008 Slide 32
STEP 5 - WRITING THE SOP
oThe information should be: • Clear• Concise• Complete• Coherent• Consistent
55 C’sC’s55 C’sC’s
Prepared by Victoria Niven – Sept 2008 Slide 33
STEP 5 - WRITING THE SOP
o Clear– Precise & worded
correctly– Familiar language– Allow only one
interpretation
Prepared by Victoria Niven – Sept 2008 Slide 34
STEP 5 - WRITING THE SOP
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.
Prepared by Victoria Niven – Sept 2008 Slide 35
STEP 5 - WRITING THE SOP
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!
Prepared by Victoria Niven – Sept 2008 Slide 36
STEP 5 - WRITING THE SOP
o 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 Slide 37
STEP 5 - WRITING THE SOP
o Coherent– Presents a logical order for the
process– Lists steps sequentially– Presents 1 idea/step per sentence
Prepared by Victoria Niven – Sept 2008 Slide 38
STEP 5 - WRITING THE SOP
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)
Prepared by Victoria Niven – Sept 2008 Slide 39
STEP 5 - WRITING THE SOP
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
Prepared by Victoria Niven – Sept 2008 Slide 40
STEP 5 - WRITING THE SOP
o Example Diagram– Source: The Theory & Practice of Industrial
Pharmacy
Prepared by Victoria Niven – Sept 2008 Slide 41
STEP 5 - WRITING THE SOP
o Example - Visual Aid– Source: Ringaskiddy OSP
Prepared by Victoria Niven – Sept 2008 Slide 42
STEP 5 - WRITING THE SOP
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
Prepared by Victoria Niven – Sept 2008 Slide 43
STEP 5 - WRITING THE SOP
o 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 Slide 44
STEP 5 - WRITING THE SOP
o 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 Slide 45
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
Prepared by Victoria Niven – Sept 2008 Slide 46
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
Prepared by Victoria Niven – Sept 2008 Slide 47
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
Prepared by Victoria Niven – Sept 2008 Slide 48
STEP 6 – REVIEW THE DRAFT
o Make sure all information is relevant– Necessary– Contributes to the purpose– Relates to the unit/department
concerned
Prepared by Victoria Niven – Sept 2008 Slide 49
STEP 6 – REVIEW THE DRAFT
o Avoid reader overload– Ensure there is enough ‘white space’.
o Verify abbreviations and acronymso Define new terminology
Prepared by Victoria Niven – Sept 2008 Slide 50
STEP 6 - REVIEW THE DRAFT
o Revise SOP by executing the process in a real work environment (wherever possible)
Prepared by Victoria Niven – Sept 2008 Slide 51
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
Prepared by Victoria Niven – Sept 2008 Slide 52
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
Prepared by Victoria Niven – Sept 2008 Slide 53
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
Prepared by Victoria Niven – Sept 2008 Slide 54
CONCLUSION
o 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 Slide 55
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.
Prepared by Victoria Niven – Sept 2008 Slide 56
FINALLY
o Thank you
o Questions
o Please:– Sign your training record– Complete the learning assessment