Deborah A Wenger Consultant Training and Regulatory Compliance Downingtown, PA 484-354-5577 [email protected].

Deborah A WengerConsultant

Training and Regulatory ComplianceDowningtown, PA

[email protected]

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

Theseus Professional Services, LLC


SOP Change CyclePlanning

Implement

DraftingReview & Release

Check Implementation



1. Develop a plan! 2. Determine title,

purpose, and scope3. Find a sample and

template4. Collect information5. Draft the SOP6. Conduct peer review7. Get management

acceptance

8. Validate9. Submit for approval10. Provide training11. Release 12. Check

Implementation13. Revise as necessary


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


“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


Advantage: Many decisions and steps Complex processes Emergency/critical procedures

Disadvantage: Minimal detail Effort to produce and maintain


Remove animalcarcasses

Place carcasses inplastic bag and

seal.

Place indesignated

refrigerator orfreezer

Submit HealthReport by 10 AM

End removal ofanimal carcasses

See SOP 301Reporting AnimalHealth Problems

Is this BSL2?

Spray beforeexiting room

Yes

No

Double bag


Mind Map uses words, lines, colors, images, and even sounds to stimulate the brain! Theseus Professional Services, LLC

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


CHEMICAL MIXING &

DISPENSING

Safe

ty

1 to 99


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

Sticklers Unite!


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


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.


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


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?


Avoid the Passive Voice

Weak method of expressing action Comprehension best at beginning of

sentence Passive voice leads to doubt


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.


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

Examples1.Remove cage from rack.2.Place caging in workstation.

Trafficking involves reading procedures and the observation of posters.


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


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.


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


Use Quantitative Information

Specify quantitative rather than qualitative

Use standard units of measure Provide a well defined range of

measurement


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


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


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


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


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


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


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



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



Reference wording …using SOP 110, Procuring Animals …in accordance with manufacturer’s instructions Refer to SOP 160, Cage Wash Operations Record results on Attachment 1, Census Report

Branch verbs Go to / Proceed to / Return to / Repeat


Grammar1. Use Simple Command Statements2. Keep Action Steps Simple3. Avoid the Passive Voice4. Use Parallel Structure5. State the Condition First

Accuracy/Clarity6. Identify the Responsible Person7. Use Quantitative Information

Format8. List Multiple Objects9. Emphasize Important Information10. Use Referencing and Branching Appropriately




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


Header

Body

Footer

After 1st page?

Needed?

Watch for white space!


Animal Care International

Special Procedures During Gestation and Weaning of Rodents

SOP 24G-104

Rev. 0(# vs. letter)

Approved by: Effective Date:June 8, 2003

Date: Page 1 of 2

Optional

Organization

Title

FooterReference Only When Printed – Destroy After Use (or)

Only Use on Date Printed – Last printed 10/10/2003 8:31 AM

Form Number


1. Purpose2. Scope3. Applicability

4. Precautions and Limitations5. Terms, Definitions, Acronyms,

Abbreviations, and References6. Responsibilities

7. Performance Section

8. Post Performance ActivityTestRestoration

9. Results10. Records

11. Appendixes and Attachments

I. Introduction

IV. Post-Work

III. Work

II. Prerequisites

V. Results

VI. Support


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

Style

?

?


Writing SOPs That Work!

Deborah A Wenger Consultant Training and Regulatory Compliance Downingtown, PA 484-354-5577 [email protected].

Documents

necessary slide

use conditional action

use quantitative information

supervisor use

action steps simple

use parallel structure

conditional words

fit steps