STANDARD

SOP WRITING
4 TH C O F F E E

OPERATI NG
PROCEDURE
finals
 STANDARD OPERATING
PROCEDURE
SOP WRITING
4 TH C O F F E E

“A document consisting of
step-by-step information on
how to execute a task.”
 STANDARD OPERATING PROCEDURE

➢ An existing SOP may need to just be modified

and updated or may in a certain scenario
SOP WRITING

where you have to write one from scratch

4 TH C O F F E E

➢ It is used in a variety of different context,

including healthcare, aviation, engineering,
education, industry and military.

➢ They document the way activities are to be

performed to facilitate consistent
conformance to technical and quality system
requirements and to support data quality.
 …. International Conference on Harmonisation
define SOP as:
SOP WRITING
4 TH C O F F E E

“a detailed, written instruction to

achieve uniformity of a performance of a
specific function”
 A standard operating procedure should never
SOP WRITING
4 TH C O F F E E

be difficult to read or vaguely worded. It

should be brief, easy to understand and
contain action steps that are simple to follow.
 Standard operating procedure help
to maintain safety and efficiency for
department such as
SOP WRITING
4 TH C O F F E E

➢Production or operation
➢Sales and customer services
➢Employee training
➢Legal
➢Financial
 Standard Operating Procedure for pharmacy
SOP WRITING

own interpretation of the way process should

4 TH C O F F E E

be handled in order to:

-comply with law
-protect patients
-protect pharmacy staff
 BENEFITS
SOP WRITING
4 TH C O F F E E

o They save time and money
o They provide consistency
o They improve communication
o They allow you to hold your
employees accountable
o They create a safer work
environment
 Types of Standard
Operating Procedure
SOP WRITING
4 TH C O F F E E

• Fundamental SOP
• Methodic SOP
• Operational SOP
 FUNDAMENTAL SOP:
SOP WRITING

➢These give instruction how to

4 TH C O F F E E

make SOPs of other categories

METHODIC SOP:
➢These describe a complete testing
system or method of investigation
 OPERATIONAL SOP:

➢SOPs for safety precautions

SOP WRITING

➢SOPs for operating instruments, apparatus and

4 TH C O F F E E

other equipment
➢SOPs for analytical method
➢SOPs for the preparation of reagents
➢SOPs for receiving and registration of samples
➢SOPs for Quality Assurance
➢SOPs for archiving and how to deal with
complaints
 STRATEGY IN
SOP WRITING
4 TH C O F F E E

STANDARD
OPERATING
PROCEDURE
 STRATEGY IN STANDARD OPERATING PROCEDURE
1. Develop a list of processes that you believe need SOP
creation
SOP WRITING
4 TH C O F F E E

As you write SOPs, you’ll find you may be able to combine some processes while
others may need to be split up into different SOPs. The main function of this list
is to give you a necessary starting point.

2. Plan the process for developing and managing SOPs

• Choose you format
• Consider your audience
• Consider your knowledge
• Decide between a short or long form SOP
• Keep your SOP purpose in mind
 STRATEGY IN STANDARD OPERATING PROCEDURE
3. Collect information for the content of your SOP
• Identify the subject matter experts you’ll need to get information from
SOP WRITING

• Check for documentation that may already be available

4 TH C O F F E E

• Begin interviewing your subject matter experts

4. Write, review and publish your SOP

5. Maintaining your SOP over time
 STEPS OF
SOP WRITING
4 TH C O F F E E

STANDARD
OPERATING
PROCEDURE
 STEPS OF STANDARD OPERATING PROCEDURE
1. Choose you format
• A simple step format
SOP WRITING
4 TH C O F F E E

A routine procedure that are short. It’s just a bullet list of simple
sentences telling the reader what to do
• A hierarchical steps format
Usually for long procedure. It’s list of main steps all with substeps in
a very particular order
• A hierarchical steps format
usually for a procedure with infinite number of possible outcomes.
It’s good option for procedure when results aren’t always
predictable
 STEPS OF STANDARD OPERATING PROCEDURE
2. Consider your audience
• Your audience’s prior knowledge
SOP WRITING
4 TH C O F F E E

Your language needs to match the knowledge and investment

• Your audience’s language abilities

It is good idea to include lots of annotated pictures and diagrams

• The size of your audience

If multiple people at once are reading your SOP (those in different
role), you should format the document more like conversation in a
play: user 1 completes an action, followed by user 2 and so on.
 STEPS OF STANDARD OPERATING PROCEDURE
3. Consider your knowledge
A poorly-written SOP will not only reduce productivity and lead to
organizational failures, but it can also be unsafe and have adverse
SOP WRITING

impacts on anything from your team to the environment

4 TH C O F F E E

4. Decide between a short or long form SOP

If you’re writing or updating an SOP for a group of individuals that
are familiar with protocol, terminology, etc. and just would benefit
from a short and snappy SOP that’s more like a checklist, you could
just write it in short form.

5. Keep your SOP purpose in mind

Emphasis the main purpose of your SOP
 WRITING YOUR
SOP WRITING
4 TH C O F F E E

STANDARD
OPERATING
PROCEDURE
 WRITING YOUR SOP
1. Cover the necessary material
• Title page
SOP WRITING
4 TH C O F F E E

-title of the procedure, SOP identification number, date of

issue/revision, name of the agency/branch/division the SOP applies
to & signature of those of prepared and approved the SOP
• Table of contents
• Quality Assurance/Quality Control
• References
 WRITING YOUR SOP
2. Procedure
• Scope and applicability
SOP WRITING
4 TH C O F F E E

-purpose of the process, limits and how it’s used. Include standard,
regulatory requirements, roles and responsibilities and inputs/outputs.
• Methodology and procedure
List of all steps, including equipment needed
• Clarification of terminologies.
identify acronyms, abbreviations and all phrases
• Health and safety warnings
• Equipment and supplies
• Caution and interferences
 WRITING YOUR SOP
3. Make your writing concise and easy to read
SOP WRITING
4 TH C O F F E E

Make sure that you clean out all Vacuum all dust from air shaft
of the dust from the air shafts before use.
before you begin using them.

NOTE: don’t use “you”. It should be implied. Speak in the active voice
and start your sentence with command verbs.
 WRITING YOUR SOP
4. If necessary, interview the personnel involve in the process on how
they execute the task
SOP WRITING

This is to ensure accuracy of SOP

4 TH C O F F E E

5. Break up large chunks of text with diagram and flow chart

• To make it easy on your readers to understand the procedure
• Don’t include these just to bulk up your SOP; only do this if
necessary or if trying to bridge a language gap

6. Make sure each page has control document notation

• Each page should have a short title or ID #, a revision number, date
and “page # of #” in the upper right hand corner
 4 TH C O F F E E
SOP WRITING
 4 TH C O F F E E
SOP WRITING
 4 TH C O F F E E
SOP WRITING
 4 TH C O F F E E
SOP WRITING
 4 TH C O F F E E
SOP WRITING
 4 TH C O F F E E
SOP WRITING
 4 TH C O F F E E
SOP WRITING
 4 TH C O F F E E
SOP WRITING
 4 TH C O F F E E
SOP WRITING

THANK YOU