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SOP No: Insert number

SOP Title:

SOP Number Insert Number

SOP Title e.g. Document Control

NAME TITLE SIGNATURE DATE

Author

Reviewer

Authoriser

Effective Date:

READ BY

NAME TITLE SIGNATURE DATE

The first page or cover page of each SOP should contain the following information: a title that
clearly identifies the activity or procedure, an SOP identification (ID) number, date of issue
and/or revision, the name of the applicable agency, division, and/or branch to which this SOP
applies, and the signatures and signature dates of those individuals who prepared and
approved the SOP.
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1. PURPOSE
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A well-written SOP will facilitate training. The purpose of standard operating procedures
(SOP) is to ensure your team carries out its jobs the way you want them done. The objective
of SOP for marketing, for instance, might be to see that all marketing materials get reviewed,
proofread and approved before they reach the public.
Define what the end result or the goal is for the SOP you are writing.

2. INTRODUCTION
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All organizations have processes and procedures that are repeated daily, weekly, and
monthly. As you define your goals, ask whether an SOP document is needed for that
particular goal. Or, see if an SOP has already been created to accomplish the goal and
maybe you just need to review it and look for ways to improve it.
In an SOP, describe what needs to happen for an outcome. In addition, you would include
more detailed steps and information such as who will be benefited from the SOP, when it
needs to be used, and where it is required.

3. SCOPE
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This is a description of the scope and purpose of the SOP, its limits, and how it’s used. You
can include standards, regulatory requirements, roles and responsibilities, and inputs and
outputs.
(Describe the purpose of the process or procedure and any organization or regulatory
requirements, as well as any limits to the use of the procedure)
It’s possible that the SOP you are working on is dependent on other SOPs and teams in
other departments in order to be completed successfully. Determine whether it is sufficient to
reference those other procedures or if you need to add them to the current standard
operating procedure document. Maybe you need a flowchart or a map to clearly define
dependencies and responsible parties.
Also give:
Summary of Method (briefly summarizing the procedure)
Definitions (identifying any acronyms, abbreviations, or specialized terms used)
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4. RESPONSIBILITIES
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SOPs should be written by individuals knowledgeable with the activity and the organization's
internal structure. These individuals are essentially subject-matter experts who actually
perform the work or use the process. A team approach can be followed, especially for multi-
tasked processes where the experiences of a number of individuals are critical.

4.1 CHIEF/PRINCIPAL INVESTIGATOR

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SOPs should be reviewed (that is, validated) by one or more individuals with appropriate
training and experience with the process. It is especially helpful if draft SOPs are actually
tested by individuals other than the original writer before the SOPs are finalized.

5. SPECIFIC PROCEDURE
This is the bulk of the document and includes the specific step-by-step procedures that need
to be followed in order to successfully comply with company standards and safety
regulations.
Denote what sequential procedures should be followed, divided into significant sections; e.g.,
possible interferences, equipment needed; personnel qualifications, and safety
considerations.
While mentioning the step-by-step procedure for a given process, try to give as much detail
as possible.
For example, one may include:
Equipment and Supplies (listing and specifying, where necessary, equipment, materials,
reagents, chemical standards, and biological specimens)
Personnel Qualifications/Responsibilities (denoting the minimal experience the user should
have to complete the task satisfactorily, and citing any applicable requirements, like
certification or “inherently governmental function”)
Health & Safety Warnings (indicating operations that could result in personal injury or loss of
life and explaining what will happen if the procedure is not followed or is followed incorrectly)
Data and Records Management (e.g., identifying any calculations to be performed, forms to
be used, reports to be written, and data and record storage information)

This section may be subdivided into subsections (e.g. for document control):
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5.1 VERSION CONTROL AND NAMING CONVENTION

5.2 OTHER CONSIDERATIONS

5.3 STORAGE AND ARCHIVING

6. FORMS/TEMPLATES TO BE USED
Many activities use checklists to ensure that steps are followed in order. Checklists are also
used to document completed actions. Any checklists or forms included as part of an activity
should be referenced at the points in the procedure where they are to be used and then
attached to the SOP.

7. INTERNAL AND EXTERNAL REFERENCES

Documents or procedures that interface with the SOP should be fully referenced (including
version), such as related SOPs, published literature, or methods manuals.

7.1 INTERNAL REFERENCES

7.2 EXTERNAL REFERENCES

8. CHANGE HISTORY

SOP no. Effective Significant Changes Previous

Date SOP no.

SOPs need to remain current to be useful. Therefore, whenever procedures are changed,
SOPs should be updated and re-approved. SOPs should also be systematically reviewed on
a periodic basis, e.g. every 1-2 years, to ensure that the policies and procedures remain
current and appropriate, or to determine whether the SOPs are even needed. The review
date should be added to each SOP that has been reviewed. If an SOP describes a process
that is no longer followed, it should be withdrawn from the current file and archived.
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