How To Write Standard Operating Procedures

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How To Write Standard Operating Procedures

• Deborah A Wenger
• Consultant
• Training and Regulatory Compliance
• Downingtown, PA
• 484-354-5577
• dbwengrich_at_comcast.net

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Objectives

• Identify the purpose of an SOP
• Identify the basic elements of the Basic SOP
  Writing Cycle
• Examine SOP Drafting Techniques for SOPs
• Recognize the ten principle guidelines for
  writing SOPS
• Examine an SOP Format

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What is the purpose of an SOP?
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SOP Writing Cycle
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Components of the Basic Writing Cycle

1. Validate
2. Submit for approval
3. Provide training
4. Release ?
5. Check Implementation
6. Revise as necessary

1. Develop a plan!
2. Determine title, purpose, and scope
3. Find a sample and template
4. Collect information
5. Draft the SOP
6. Conduct peer review
7. Get management acceptance

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Drafting Techniques for SOPs
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Drafting Techniques for SOPs

• What information is needed?
• Where will it come from?
• Data collection methods
• Collecting data
• Time management

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Drafting SOPs Using Flowcharts

• A picture is worth a thousand words.
• A flowchart is worth a thousand procedures.
• So what is a flowchart?
• A method of graphically describing an existing
  process or a proposed process by using simple
  symbols, lines, or words to display pictorially
  the activities and sequence in the process.
• Source Harrington, H.J., Business Process
  Improvement, McGraw-Hill, 1991

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Drafting SOPs Using Flowcharts

• Advantage
• Many decisions and steps
• Complex processes
• Emergency/critical procedures
• Disadvantage
• Minimal detail
• Effort to produce and maintain

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Flow Charts - Symbols
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Drafting an SOP Using Mind Mapping
Mind Map uses words, lines, colors, images, and
even sounds to stimulate the brain!
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Drafting an SOP Using Mind Mapping

• Characteristics
• Subject represented by a central image
• Main themes of the subject radiate from the
  central image as main branches
• Minor themes linked to the main themes
• Branches connected forming a nodal structure

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Sample Mind Map
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Principle Guidelines for Writing SOPs

• Grammar Principles 1 to 5
• Accuracy/Clarity Principles 6 to 7
• Format Principles 8 to 10

Sticklers Unite!
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Principle 1

• Use Simple Command Statements
• Action Verb ? Object ? Supportive Information
• Begin with action verb
• Omit
• Shall / You / Articles (except for clarity)
• Describe object of the verb
• Identify it precisely
• Complete step with supportive information
• Location
• Object modifier

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Principle 1 - Applied

• Simple Command Statements?
• Y/N Load cages on 3-sided rack.
• Y/N Put on protective clothing before entering
  animal holding area.
• Y/N Before and after leaving building wash
  hands.
• Y/N The room shall remain locked when the
  receiving clerk or other authorized personnel
  are not presented.

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Principle 2

• Keep Action Steps Simple
• Use short, precise sentences
• Limit action verbs
• Use language that provides direct commands and
  avoids complex terms (readability factor)
• Avoid hidden instructions
• Keep steps free of explanatory information
• Avoid vague pronouns
• Use standard and consistent acronyms,
  abbreviations, terms, and definitions

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Principle 2 - Applied

• Action Steps Simple?
• Y/N Remove, shake, and stack clean cages.
• Y/N Turn workstation blower on. Gauges should
  measure flow.
• Use Cage Wash versus Cagewash?
• Use Disinfectant versus sterilant?

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Principle 3

• Avoid the Passive Voice
• Weak method of expressing action
• Comprehension best at beginning of sentence
• Passive voice leads to doubt

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Principle 3 - Applied

• Passive Voice?
• Y/N Soiled disposable garments will be
  discarded for next entry.
• Y/N The HEPA vacuum will not be used on the
  dirty side of the facility.

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Principle 4

• Use Parallel Structure
• Write headings and words using the same tense,
  ending, or other value
• Quickly helps users read and comprehend
• Fit steps to a pattern
• Fit steps to a pattern
• Examples
• Remove cage from rack.
• Place caging in workstation.
• Trafficking involves reading procedures and
  the observation of posters.

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Principle 5

• State Condition First
• Use conditional action steps to make a decision
• if, then, when, or, and
• Write conditional statement first, followed by
  the action
• If pH is below 6 or above 10, then notify a
  supervisor
• Use expected and unexpected conditional steps
• Separate multiple conditions from instructions
• Emphasize conditional words
• Use positive statements
• Avoid using and and or in the same statement

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Principle 5 - Applied

• Condition Stated First?
• Y/N Disposable clothing may be saved at housing
  area exits if not soiled for next entry.
• Y/N When going between animal holding areas and
  before and after leaving building wash hands.

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Principle 6

• Identify the Responsible Person
• Address procedure to primary user
• Identify who is responsible for what
• Use job titles consistently
• Visually emphasize tasks and responsible performer

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Principle 7

• Use Quantitative Information
• Specify quantitative rather than qualitative
• Use standard units of measure
• Provide a well defined range of measurement

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Principle 8

• List Multiple Objects
• Single verb followed by several objects
• Verify the temperature, pressure, and pH level
• List in a vertical format (bullets, dashes,
  asterisks)
• Number only to indicate order of performance
• List three or more objects of a verb
• Sample sentinel cage 1, 3, and 5
• Use charts and matrixes to present a series of
  objects

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Principle 9

• Emphasize Important Information
• Information which if overlooked or misinterpreted
  could result in user error or injury
• Warnings alert users to potential hazards to
  personnel or animals
• Cautions alert users to potential hazards to
  products or equipment
• Alerts advise users of important information when
  neither danger to individual or equipment is
  involved
• Notes call attention to important supplement
  information

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Principle 9 (continued)

• Use short, concise statements
• Do not include action steps
• Position before or on same page as step(s) that
  apply
• Remember an SOP is not a training manual

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Principle 9 (continued)
WARNING WEAR RUBBER GLOVES AND FACE SHIELD OR GOGGLES WHEN MIXING CLIDOX
CAUTION CHARGE BATTERIES IN A WELL VENTILATED AREA
ALERT Do Not Change Switch Unless Power Is Off Equipment Settings May Be Lost
NOTE No smoking allowed within 50 feet of building
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Principle 9 (continued)
APPLICATION WARNING CAUTION NOTES LISTS LOGIC STEPS REFERENCES
EMPHASIS TECHNIQUE Boxed, centered, bold type, all caps Boxed, centered, bold type, initial caps Bulleted Indented Initial caps
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Principle 10

• Use Referencing and Branching Appropriately
• Information already exists or is in another SOP
• So what is referencing and branching?
• Referencing directs users to other steps or
  sections within the procedure, or to other
  procedures, and then back to the initial point
• Branching routes users to other steps or sections
  within the procedure, or to other procedures, but
  the user does not return to the initial departure
  point

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Principle 10 (continued)

• Use Referencing and Branching Appropriately
• User errors
• Overlook warnings, cautions, and notes
• Lose track of exit and entry points
• Get into endless loops
• Work becomes hard to track
• Rely on memory

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Principle 10 (continued)

• Use Referencing and Branching Appropriately
• Guidelines
• For two or three steps, repeat steps
• Cite your source
• Point user to important information (warnings,
  cautions, prerequisites, etc.)
• Make it clear where the return point is or what
  steps can be skipped
• Avoid unnecessarily going forward or backward

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Principle 10 (continued)

• Use Referencing and Branching Appropriately
• Reference wording
• using SOP 110, Procuring Animals
• in accordance with manufacturers instructions
• Refer to SOP 160, Cage Wash Operations
• Record results on Attachment 1, Census Report
• Branch verbs
• Go to / Proceed to / Return to / Repeat

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Summary of Principles

• Grammar
• Use Simple Command Statements
• Keep Action Steps Simple
• Avoid the Passive Voice
• Use Parallel Structure
• State the Condition First
• Accuracy/Clarity
• Identify the Responsible Person
• Use Quantitative Information
• Format
• List Multiple Objects
• Emphasize Important Information
• Use Referencing and Branching Appropriately

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Format Matters
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Why Format Matters

• Assures tasks are done properly
• Consistent structure for all facility documents
• Easy for user to use
• Easy to write other SOPs
• Easy to review and approve (process followed)
• Identifies important information
• Provides level of confidence to outside examiners

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Format
After 1st page?
Watch for white space!
Needed?
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Header
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Body

• Purpose
• Scope
• Applicability
• Precautions and Limitations
• Terms, Definitions, Acronyms, Abbreviations, and
  References
• Responsibilities
• Performance Section
• Post Performance Activity
• Test
• Restoration
• Results
• Records
• Appendixes and Attachments

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Numbering / Lettering
Style
6.0 Quarantine Sanitation 6.1 Equipment and
Supplies 6.1.1 Wipe down all equipment and
supplies with a sterilant 6.1.2 Do not reuse
cleaning equipment (e.g., mop heads, sponges,
etc.) after wiped down 6.2 Floors and Flat
Surfaces 6.2.1 Disinfect floors and flat
surfaces daily 7.0 Exit from Quarantine Area
Spacing
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