How to Write and Manage SOPs

advertisement
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.
Download