STANDARD OPERATING

PROCEDURES

Judith Marshall
Quality Manager
Fera
Slide 1

STANDARD OPERATING
PROCEDURES

Content of SOPs
The aim of this workshop is to enable
you to understand the need for SOPs
and how to write them

Slide 2

STANDARD OPERATING
PROCEDURES
What are SOPs and why do we need them
What to put in an SOP
How to write SOPs

Slide 3

STANDARD OPERATING
PROCEDURES
A standard operating procedure is the how to do
it instruction
May be called an SOP, work instruction, desk
instruction, procedure, protocol
They are for the standard and routine
processes, not expected to cover every
eventuality no matter how unlikely it is to happen

STANDARD OPERATING
PROCEDURES
Purpose

Describe how to perform routine activities

Provide a training aid
Guide & standardise working procedures
Ensure quality & integrity of data
generated/information captured
Reconstruction/repeatability
Provide an auditing tool
Slide 5

STANDARD OPERATING
PROCEDURES
Examples of Categories

Document control
Record control
Technical procedures
Use of equipment
Issuing reports
Archiving processes
Auditing
Slide 6

STANDARD OPERATING
PROCEDURES
Keep language simple
Short steps
Use a direct instruction add solution A to solution
B then replace the stopper and mix
Add tolerances eg 5g 0.5g
Indicate timescales
Refer to other SOPs rather than re-write
instructions
Include flow charts, diagrams and/or photos if
these describe something better than words
Slide 7

STANDARD OPERATING
PROCEDURES
Avoid making it too long (write 2)
Dont need lots of pre-amble
Avoid writing in the third person
Step wise instructions are best
Level of detail is important
Explain acronyms

Slide 8

STANDARD OPERATING
PROCEDURES
Avoid un-necessary specification dont say use
a blue bucket, if the colour doesnt matter
Avoid alternatives unless necessary within the
technical requirements, then explain what
dictates which course of action
Avoid ambiguity can cause extra work if the
reader misunderstands
Slide 9

 Any questions?

STANDARD OPERATING
PROCEDURES
What to include (1)

A title short and to the point

Edition number gives document control
Issue date when did it come into use
Author who to speak to if you have
questions

Slide 11

STANDARD OPERATING
PROCEDURES
What to include (2)
An introduction set the scene
Scope or exclusions
Safety considerations
Materials & Equipment
Slide 12

STANDARD OPERATING
PROCEDURES
What to include (3)
A list of SOPs or other documents referred to
A list other documents referred to
A circulation list

Slide 13

STANDARD OPERATING
PROCEDURES
What to include (4)

The
PROCEDURE
How to do what you are doing
Slide 14

STANDARD OPERATING
PROCEDURES
What to include (5)
Break it into sections
Sections into specific steps
Number the steps or bullet point for clarity

Slide 15

Summary
SOPs are a requirement of all the standards
SOPs needed for the technical procedures
undertaken
SOPs required for the management of the
system eg SOP control, auditing and the
overarching processes eg test item control

Slide 16