STANDARD OPERATING

PROCEDURES (SOP’s)

and

JOB AIDS

Jan Jacobs

Hilde De Boeck

Philippe Gillet

An Vermaelen

Bjorn Van den Sande

INTRODUCTION

Why having written procedures?

� Reliable and consistent results

� Backbone of the quality system

� Legal requirement (GCLP)

Verbal instructions:

� Forgotten

� Not heard

� Ignored

� Misunderstood

EXCERCISE

Case Study: “Rapid Test for malaria”

Work in groups of four

Study and compare

- Appendix 1: Job Aid “How to use malaria RDT”

- Appendix 2: SOP: “How to perform Paracheck”

• What is the advantage/disadvantage of both formats

• Identify possible problems and make suggestions for improvement

• Verify if all necessary information is present

• Which setting you think they can/will be used.

JOB AIDS

INTRODUCTION

JOB AID = “INSTRUCTIONS”

Describes step by step what you should do to perform

a procedure

� Is used on the job while performing the task at hand

� Tells when to take action

� Gives directions on what actions to take

and how to do each action

WRITING JOB AIDS

How to write a good job aid: general rules

1. Give a Meaningful Title

2. Mention Author, Version number and Date

3. List the Materials

4. Describe the Action Steps

5. Have your job aids Read and Performed by a colleague

DIFFERENT FORMATS

1. “Cookbook format”: describes all alternatives

tells how and when

2. “Decision table”: lists the alternatives

3. “Flowchart”: goes through the alternatives

tells how to think about a task

Example: we will improve the job aids below

Hands are disinfected with either antimicrobial soap or

alcohol. If hands are visibly dirty, they should always

be washed with household soap first. Next, antibacterial

soap should be used in case you have running water; if

not, you should use alcohol.

DIFFERENT FORMATS

→ Describes all alternatives

Example:

1. If your hands are visibly dirty, wash them with Household

Soap.

If your hands are visibly clean, go to step 2.

2. If there is running water, use Antimicrobial Soap.

If there is no running water, use Alcohol.

Format 1: “Cookbook format”:

DIFFERENT FORMATS

Format 2: “Decision Table”:

→ Lists the alternatives

Example:

DIFFERENT FORMATS

If there is no “AND”, use arrow

Format 3: “Decision Table”:

→ Goes through the alternativesExample:

DIFFERENT FORMATS

BENEFITS AND CONSTRAINTS

+ -

Reducing recall training Over simplify

Easier to perform complex tasks Require updating

Reducing errors May not eliminate all training

Motivate less experienced Cannot solve all performance problems

Easier to do tasks that are NOT done often

Slow performance

USE

Use job aids when:

� Performance is infrequent

� Knowledge, education level is limited

� Procedures cover complex decision making

� Training resources are limited

� The consequences of errors are high (ex. job aids for treatment of spills or blood exposure accidents)

Avoid the use of job aids:

� Masterful performance is needed

� Staff fears lack of credibility (towards patients or doctors)

� People don’t how to use them

I. MEANINGFUL TITLE

→ The title must mention the content of the job aid.

Example:

Do NOT give a title like

“Job Aids_ Medical Service_ 015/1”

PREFER Title with meaning

“How to disinfect my hands”

WRITING JOB AIDS

II. MENTION AUTHOR, VERSION NUMBER & DATE

→ Put this information in the “Header” or “Footer” of

your document.

→ In this way, it will be visible on the printed page.

WRITING JOB AIDS

III. LIST THE MATERIALS

→ List what you need

→ Distinguish between

- Materials provided

(for example, in the test kit)

- Materials not provided

Example:

For washing your hands with antimicrobial soap, you need:

• Liquid antimicrobial soap in a dispense

• Running water

• Towels!! Use a Bulleted or Numbered list.

WRITING JOB AIDS

IV. DESCRIBE ACTIONS STEPS

→ Decide on the format:

- Cookbook

- Decision table

- Flowchart

→ Use simple style:

• Number the steps 1,2,3,…

• If more then 10 steps => subdivide

• One step describes 1 action of max 30 sec

WRITING JOB AIDS

2. Use Short and Simple Sentences:

- Not more than 15 words

3. Use Short and Simple Words:

- Avoid use of Acronyms, spell them out the first time you

use them

- Add list of Abbreviations

-Use always same word or termEx: USE always “household soap” and not bar soap

WRITING JOB AIDS

IV. DESCRIBE ACTIONS STEPS

WRITING JOB AIDS

4. Use Active Verb, not passive voice

Use Imperative, not verb or “you”NOT: you have to use household soap

BUT: use household soap

5. Turn any list into a bulleted or numbered list

6. Stress important information:

- use CAPITALS

- use bold or italicized or underlined text

- use Color

IV. DESCRIBE ACTIONS STEPS

WRITING JOB AIDS

7. Put “When’s” or “Ifs” before “What’s”Example :

NOT: Use of towel to cover your hand in case you have to close the tap by hand.

PREFER: If you have to close the tap by hand, use a towel to cover your hand.

8. Put warnings before the steps

IV. DESCRIBE ACTIONS STEPS

WRITING JOB AIDS

9. Use pictures/drawings

- Check if picture fits the text

- Refer to the picture in the text

- Put pictures on the left side of the paper,

text on the right side

- Use colours if needed

IV. DESCRIBE ACTIONS STEPS

WRITING JOB AIDS

1. Ask a Colleague to Read the draft of your job aid and to give comments

2. Ask a Colleague to Perform the job with the draft

- Do NOT help him/her

- Do not give further explanations

- Make notes of what should be added or changed

- Make these notes on your copy of the

job aid

V. LET READ AND PERFORM BY COLLEAGUE

WRITING JOB AIDS

STANDARD OPERATING

PROCEDURES

(SOPs)

SOP definition:

written instructions that document a routine or repetitive

activity

� Part of quality assurance (QA)

� Prevents mistakes (rather then detects)

� Carried out without deviation by every member off staff

� Needs updating

Write down what you do, do what is written down!

INTRODUCTION SOP

Introduction

Benefits:

� Minimize variability (person-to-person, test-to-test)

� Improve and maintain quality

� Consistent and reproducible results

� Training tool

� Continuity (personnel turn-over)

� Procedure review:

� optimalization of techniques

� identification of problems

Constraints for implementation:

� Time-consuming in preparation

� Often not kept up to date

Who writes SOPs?

The staff must not only understand, but also carry out.

� Those who do, should write (prevents unfamiliar SOPs)

� Improves sense of responsibility for using the SOP

Introduction

Steps towards successful integration

1. Get support by all members of staff!!

� Implement appropriate SOP training

� Discuss on current procedures and their steps

� User-Author Principe

2. Ensure Readability

SOPs must be crystal clear on who is to do what

2. Ensure Readability

SOPs must be crystal clear on who is to do what

� Standard lay-out

� Simple words

� Short active sentences: “do this”, “do that”

� Instructions in the right order

� Separate general information

(as a footnote or in different format)

�Diagrams and pictures

Steps towards successful integration

Lay-out

• Different:

No one “correct” format

Lay-out

Lay-out

Lay-out

3. Authorizing of SOPs

Decides on an appropriate method

�Agreement author - supervisor (specialist)

�Way to communicate to all staff

4. Training of SOP

Staff should get familiar with the agreed procedure

(documenting reading and training by staff members can help you in the follow-up)

Steps towards successful integration

5. Regulary Review and Update

�on regular basis by the author

�Communicate changes

6. Organization and archiving

Only current version available in work (bench) area

�Document management

�Change control: withdrawal and archiving

�Maintain list of current SOP’s; including version number

�Archive all versions of SOP’s

Steps towards successful integration

Steps towards successful integration

DOCUMENT LIFE CYCLE

Main reasons for SOP failure

The SOP is

� written in difficult/foreign language

� difficult to follow

� difficult to locate (accessibility)

� Not used

Structure of SOP

Two parts:

1. Info about the SOP

2. Description of the procedure per se

1. Info about SOP:

� Title

� Identification code + version

� Name of author and date of issue

� Name of authorizer

� Page number (with reference to total page number)

PAGE NUMBER

IDENTIFICATION

CODE & VERSION

TITLE

AUTHOR

AUTHORIZER

Structure of SOP

2. Description of procedure:

• Scope

• Responsibilities

• Equipment and reagent/materials

• Sampling

• Test procedure and QC

• Results and reporting

• Sources of error, troubleshooting

• References, legislation, standards

• Maintenance & calibration (equipment)

• If applicable: information on safety

SOPs vs. Job Aids

Which Format to use?

Which format to use?

Depends on various factors:

� Setting

Level: small field vs. reference laboratory

Current status, already written procedures? And Expectations?

� Staff

Education level and experience

Motivation

� Resources

Time and budget

� Type of process or procedure

Frequency, complexity, performance needed

Job Aids

Key features

• Part of SOP

• Version controlled

• Authorized

Summary and conclusion

� Get everyone involved

� Be ambitious but realistic

� Work step- by- step

� Priorities

� Include training

Write down what you do, do what is written down!