How to Write and Manage SOPs
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Transcript How to Write and Manage SOPs
By:
Farzad Dadgari
Soil and Environmental Specialist
SWHISA
SOP is a clearly written set of
instruction or methods detailing the
procedures for carrying out a routine
or recurring task or study.
SOPs are used to describe both
administrative and technical tasks.
As a management tool SOP:
Provides a foundation for training new
employees by establishing operating
procedures;
Serves as a continuity tool where regular
personnel are absent, enabling others to
carry on the function;
Helps maintain QC by providing detailed
step-by-step guidance to personnel in
carrying out a certain procedure;
Describe study methods that are
adequate to ensure the quality and
integrity of the data generated in the
course of study; and
Provides a documented, historical
record of an organization’s operating
procedures during specific period of
time.
As an administration tool it can be
used to:
Decide where in an organization a
procedure should be carried out;
Decide what material and personnel
resources are required; and
Outline the manner in which
procedures are to be carried out.
Review your procedures & decide what
should be explained in SOP. Seek input
of personnel who have experience in
the procedure;
Collect info on the procedure from
references. Contact other
organizations performing similar
functions and request for their SOPs (if
they have one) and modify it to suit
your lab’s needs;
Assemble all blank forms and other
documents you will need to
reference in the SOP; Assign the
SOP a number and title for ID and
referencing;
Write a draft of the SOP, following
the guidelines provided in this
presentation;
Review the draft SOP for technical
adequacy & administrative accuracy.
Make sure SOP is written clearly and
is easy to follow;
The SOP should answer the question:
who, what, when, where, and how:
Submit the draft SOP for peer review
& supervisory approval;
Incorporate proposed changes in
final version, sign and date the final
version. File a copy.
Follow the format for administrative
and technical SOPs, provided in the
handout;
Divisions of SOP (paragraphs, sections,
chapters), figures and tables should be
numbered for ease of referencing;
If SOP is longer than 10 pages, a table
of content should be prepared;
Content of SOP should be:
Clear, concise, and thorough,
especially when listing step-by-step
procedures;
Assume person using the SOP has no
previous knowledge of the procedure;
Greatest enemy of a good SOP is
vagueness and imprecision. SOP is of
no use if no one can understand who
should do what;
Include only those steps that needs
to be followed within immediate
organization;
Be comprehensive, but do not
include irrelevant matters; and
Be positive in your presentation.
Only include appendixes (at the end of
document) that are necessary to finish
additional or supplemental material, say
sample contract or list of references;
Provide glossary only if the SOP has
more than 15 abbreviations;
Use illustrations only when they are
essential and contribute to a cleared
understanding of the subject matter and
reduces the writing part of the SOP.
When a number of SOP is prepared,
incorporate them into an SOP manual;
Place individual SOPs in a large
binder, sorting it into chapters by
subject matter;
Arrange chapters in a logical
sequence, say administrative in one
and laboratory procedures in
another;
Develop a ToC in front of the binder;
Place the SOP manual with other
references such as QA/QC manual ,
analytical and technical guidelines;
Maintain a historical registry for
laboratory procedures;
The supervisor must maintain a historical
file of obsolete laboratory methodologies
and SOPs and revisions for future
reference;
At least one copy of discontinued
procedures should be filed in a binder and
kept close to SOP manual;
Record the following info and attach to
the SOP cover:
This SOP/ laboratory methodology was in effect for
the period of ….. (original effective date) through
(date when SOP was removed from service). This
SOP was replace by SOP … (give the SOP number,
effective date and title of new SOP).
Supervisor should review the SOPs at
least once a year to ensure the
procedures are up-to-date, reflecting
the change in work environment;
If no changes are needed, the
reviewing person should sign and date
a cover sheet and attach it to the file
copy of the SOP;
If procedures change. Rewrite the
section.
Newly added material should be
identified by asterisk;
If a paragraph is withdrawn (rescinded),
delete the body of the paragraph but
keep its original numbering and title in
its original place in the text.
Mark the paragraph with an asterisk and
write “withdrawn” or “rescinded” in
parenthesis after the title;
Prepare a memo to transmit the revised
SOP to the users, indicating the number
of changes and the number f changed
pages;. Attach the memo to the file copy
of the SOP.
If changes are extensive, revise the
entire SOP and follow steps for
preparing a new SOP.
One person should be mandated in
the laboratory to:
Assign SOP numbers for identification
purposes;
Know how many copies of SOPs exist for
good control, management, and revision;
Verify that all collected SOPs in the lab:
Are updated and evaluated for being up-
to-date, at least annually;
Concise cover sheets to allow the
supervisor to review the SOPs.